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S2 FLUARIX Tetra Quadrivalent influenza vaccine (split virion, inactivated) Suspension for injection (53/30.2/0641). Each 0,5 ml vaccine dose contains: A/
Victoria/2570/2019 (H1N1) pdm09 – like strain (A/Victoria/2570/2019, IVR-215) 15 μg HA*, A/Hong Kong/2671/2019 (H3N2) – like strain (A/Hong Kong/2671/2019,
NIB-121) 15 μg HA*, B/Washington/02/2019 – like strain (B/Washington/02/2019, wild type) 15 μg HA*, B/Phuket/3073/2013 – like strain (B/Phuket/3073/2013, wild
type) 15 μg HA*. *HA = haemagglutinin. FLUARIX Tetra complies with the WHO recommendation (southern hemisphere) for the 2021 season. INDICATIONS: FLUARIX
Tetra is a quadrivalent vaccine indicated for active immunisation of adults and children from 6 months of age for the prevention of influenza disease caused by
influenza virus types A and B contained in the vaccine. CONTRA-INDICATIONS: FLUARIX Tetra should not be administered to subjects with known hypersensitivity
after previous administration of FLUARIX Tetra or influenza vaccines or to any component of the vaccine. WARNINGS AND SPECIAL PRECAUTIONS: It is good clinical
practice to precede vaccination by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and
a clinical examination. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic
event following the administration of the vaccine. As with other vaccines, vaccination with FLUARIX Tetra should be postponed in subjects suffering from an acute
severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination. It may be expected that in patients receiving
immunosuppressive treatment or patients with immunodeficiency, an adequate immune response may not be elicited. FLUARIX Tetra is not effective against all
possible strains of influenza virus. FLUARIX Tetra is intended to provide protection against those strains of virus from which the vaccine is prepared and to closely
related strains. As with any vaccine, a protective immune response may not be elicited in all vaccinees. FLUARIX Tetra SHOULD UNDER NO CIRCUMSTANCES
BE ADMINISTERED INTRAVASCULARLY. As with other vaccines administered intramuscularly, FLUARIX Tetra should be given with caution to individuals with
thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects. Syncope (fainting) can occur
following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.
Effects on ability to drive and use machines: FLUARIX Tetra is unlikely to produce an effect on the ability to drive and use machines. INTERACTIONS: FLUARIX Tetra can
be concomitantly administered with pneumococcal vaccines (see Pharmacodyamic properties). If FLUARIX Tetra is to be given at the same time as another injectable
vaccine, the vaccines should always be administered at different injection sites. False positive ELISA serologic tests for HIV-1, Hepatitis C, and especially HTLV-1
may occur following influenza vaccination. These transient false-positive results may be due to cross-reactive IgM elicited by the vaccine. For this reason, a definitive
diagnosis of HIV-1, Hepatitis C, or HTLV-1 infection requires a positive result from a virus-specific confirmatory test (e.g. Western Blot or immunoblot). HUMAN
REPRODUCTION: Pregnancy – The safety of FLUARIX Tetra when administered to pregnant women has not been evaluated. Animal studies with FLUARIX Tetra do not
indicate direct or indirect harmful effects with respect to reproductive and developmental toxicity. FLUARIX Tetra should be used during pregnancy as recommended
in National Immunization guidelines for influenza (www.nicd.ac.za). Lactation – The safety of FLUARIX Tetra when administered to breastfeeding women has not been
evaluated. It is unknown whether FLUARIX Tetra is excreted in human breast milk. FLUARIX Tetra should be used during breast feeding as recommended in National
Immunization guidelines for influenza (www.nicd.ac.za). DOSAGE AND DIRECTIONS FOR USE: FLUARIX Tetra should be administered as a single 0,5 ml injection.
Children 6 months to less than 9 years of age who have not previously been vaccinated against influenza should receive a second dose of 0,5 ml after an interval
of at least 4 weeks. Children aged < 6 months – The safety and efficacy of FLUARIX Tetra in children aged less than 6 months have not been established. Method
of Administration – Vaccination should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle
mass). Incompatibilities – In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Use and Handling – The
vaccine presents as a colourless to slightly opalescent suspension. The syringe should be shaken and inspected visually for any foreign particulate matter and/or
variation of physical aspect prior to administration. In the event of either being observed, discard the vaccine. Refer to the package insert for full dosing guideline. SIDE
EFFECTS: Clinical trial data – Very common: Injection site pain, fatigue, myalgia, loss of appetite, irritability and fussiness, drowsiness, redness, swelling. Common:
Gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain), loss of appetite, headache, sweating, arthralgia, injection site redness,
injection site swelling, shivering, fever, injection site induration, drowsiness, Fever (≥ 38,0 °C). Uncommon: dizziness, injection site hematoma, injection site pruritus,
rash. Rare: Transient lymphadenopathy, allergic reactions (including anaphylactic reactions), neuritis, acute disseminated encephalomyelitis, Guillain-Barré syndrome,
urticaria, pruritus, erythema, angioedema, influenza-like illness, malaise. KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Insufficient
data are available.
All adverse events should be reported by calling the Ethicare Medical Careline number 0800 227 302 or
directly to GlaxoSmithKline on +27 11 745 6000. Please refer to the professional information for
comprehensive safety and efficacy information.
S4 SYNFLORIX. VARILRIX (Reg. No. 32/30.1/0468). Lyophilised virus vaccine. Powder for solution and injection. Each 0,5 ml of the reconstituted vaccine contains not less than 2 000 plaque forming units (PFU) of the live attenuated varicella-zoster (OKa strain) virus. INDICATIONS: Active immunisation against varicella of healthy infants (from the age of 9 months), children and adolescents. Active immunisation against varicella of susceptible high-risk patients and their susceptible healthy close
contacts. In seronegative patients suffering from leukaemia but maintenance chemotherapy should be withheld one week before and one week after immunisation. Patients under immunosuppressive treatment (including corticosteriod therapy) for malignant solid tumours or for serious chronic diseases are immunised when they are in complete haematological remission from the disease. If organ transplantation (e.g. kidney transplant) is being considered, immunisation should be carried
out a few weeks before the administration of the immunosuppressive treatment. Susceptible healthy close contacts should be immunised in order to reduce the risk of transmission of the virus to high-risk patients. CONTRA-INDICATIONS: In subjects with severe humoral or cellular immunodeficiency (e.g. in subjects with primary or acquired immunodeficiency states, with a total lymphocyte count < 1 200/mm3 or presenting other evidence of lack of cellular immune competence, or
patients receiving immunosuppressive therapy (including high dose corticosteroids). In subjects with known hypersensitivity to neomycin, or to any component of the vaccine. Pregnant women. Avoid pregnancy one month after immunisation. In high-risk patients, do not administer at the same time as other live attenuated vaccines. WARNINGS AND SPECIAL PRECAUTIONS: Administration should be postponed in patients suffering from acute severe febrile illness, presence of minor
infection, is not a contra-indication for immunisation. Syncope (fainting) can occur and procedures should be in place to avoid injury from faints. Alcohol and other disinfecting agents must be allowed to evaporate from the skin before injection. Limited protection against varicella may be obtained by vaccination up to 72 hours after exposure to natural disease. A protective immune response may not be elicited in all vaccinees. Cases of varicella disease have been shown to occur
in persons who have previously received VARILRIX. Transmission of the Oka vaccine virus has been shown to occur at a very low rate in seronegative contacts of vaccinees with rash. Transmission of the Oka vaccine from a vaccinee who does not develop a rash to seronegative contacts cannot be excluded. Contact of vaccinees with persons who may be immunocompromised due to HIV infection or other immunodeficiency should be avoided for at least 14 days post immunisation.
Immunocompromised subjects who have no contra-indication for this vaccination may not respond as well as immunocompetent subjects, and some may acquire varicella despite appropriate vaccine administration. Immunocompromised subjects should be monitored carefully for signs of varicella. Must not be administered intravascularly or intradermally. Appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following administration of
the vaccine. It must be expected that the reactogenicity following co-administration of VARILRIX and more reactogenic vaccines will be determined by the reactions of the latter. Excipient Warnings: Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not be given VARILRIX. Also contains traces of neomycin and should not be used in patients with a known hypersensitivity to this antibiotic. INTERACTIONS: Tuberculin testing should not be performed within 6 weeks after vaccination to avoid false negative results. In subjects who have received immune globulin or a blood transfusion, immunisation should be delayed for at least three months. Salicylates should be avoided for 6 weeks after varicella vaccination, as Reye’s syndrome has been reported. Healthy subjects: can be administered at the same time as any other vaccines. Different injectable vaccines should be administered at different injection sites. High-risk patients: Do not administer at the same time as other live attenuated vaccines. Inactivated vaccines may be administered if no specific interaction has been given. Different injectable vaccines should always be administered at different injection sites. PREGNANCY AND LACTATION: Contra-indicated. Pregnant women must not be vaccinated. Pregnancy should be avoided for one month after immunisation. Women who intend to become pregnant should be advised to delay pregnancy. Administration is not advised during breastfeeding. DOSAGE AND DIRECTIONS FOR USE: By SC injection in the deltoid region or in the anterolateral area of the thigh. Children from the age of 9 months up to and including 12 years of age should receive 2 doses. Administer the second dose at least 6 weeks after the first dose but in no circumstances less than 4 weeks. From 13 years of age and above: 2 doses. Administer the second dose at least 6 weeks after the first dose. In high risk patients additional doses of vaccine might be required. SIDE EFFECTS: Very Common: pain, redness. Common: rash, swelling at the injection site, fever (oral/axillary temperature ≥ 37,5 °C or rectal temperature ≥38,0 °C). Uncommon: upper respiratory tract infection, pharyngitis; lymphadenopathy; irritability; headache, somnolence; cough, rhinitis; nausea, vomiting; varicella-like rash, pruritus; arthralgia, myalgia; fever (oral/axillary temperature > 39,0 °C or rectal temperature > 39,5 °C), fatigue, malaise. Rare: conjunctivitis; abdominal pain, diarrhoea; urticarial. Post-marketing data: Refer to package insert. MANAGEMENT OF OVERDOSAGE: Lethargy and convulsions have been reported. Treatment is symptomatic and supportive.
All adverse events should be reported by calling the Ethicare Medical Careline number 0800 227 302 or
directly to GlaxoSmithKline on +27 11 745 6000. Please refer to the professional information for
comprehensive safety and efficacy information.
S4 TWINRIX (Reg. No. 32/30.1/0244). Inactivated hepatitis A virus (HAV) and recombinant-DNA hepatitis B virus (HBV) surface antigen vaccine. Suspension for
injection. Each 1,0 ml contains Hepatitis A virus antigen 720 ELISA units, r-DNA Hepatitis B virus surface antigen 20 μg. INDICATIONS: Active immunisation against
hepatitis A and hepatitis B virus infection in adults and children aged from 1 year upwards. CONTRA-INDICATIONS: Should be postponed in subjects suffering
from acute, severe febrile illness. The presence of a minor infection, is not a contra-indication for vaccination. Should not be administered to subjects with known
hypersensitivity to any constituent of the vaccine, or to subjects having shown signs of hypersensitivity after previous administration of TWINRIX or the monovalent
hepatitis A or hepatitis B vaccine. WARNINGS & SPECIAL PRECAUTIONS: Syncope (fainting) can occur and procedures should be in place to avoid injury from
faints. If administered during the incubation period of a hep A or hep B infection, it is unknown if TWINRIX will prevent hep A and hep B. Will not prevent infection
caused by other agents e.g. hep C, hep E and other pathogens known to infect the liver. In haemodialysis patients and persons with an impaired immune system,
adequate anti-HAV and anti-HBs antibody titres may not be obtained after the primary immunisation course and such patients may therefore require administration
of additional doses of vaccine. Do not administer intravenously. Should not be mixed with other vaccines in the same syringe. Not recommended for post-exposure
prophylaxis (e.g. needle stick injury). Appropriate medical treatment should always be readily available in cases of a rare anaphylactic event following administration.
INTERACTIONS: If different syringes and other injection sites are used, no interaction will be observed. In patients receiving immunosuppressive treatment or patients
with immunodeficiency, an adequate immunologic response may not be achieved. PREGNANCY AND LACTATION: Safety not established. DOSAGE AND DIRECTIONS
FOR USE: By IM injection, but SC to subjects with thrombocytopenia or bleeding disorders. The recommended dose for adults and children aged from 1 year upwards
is 1,0 ml. Primary vaccination schedule: Adults and adolescents of 16 years of age and above: Three doses, the first administered at the elected date, the second one
month later and the third six months after the first dose. When urgent travel is anticipated, a schedule of three IM injections given at 0, 7 and 21 days may be used, but
a 4th dose is recommended 12 months after the first dose. Children of 1 to 15 years of age: Two doses, the first is administered at the elected date and the second
between six and twelve months after the first dose. It is important that the second dose be administered to assure protection against hepatitis B infection. Booster
dose: Long-term antibody persistence data are available for up to 60 months after vaccination. General guidelines for booster vaccination can therefore be drawn from
experience with the monovalent vaccines. Hepatitis B: The need for a booster dose of hepatitis B vaccine in healthy individuals has not been established; however
some official vaccination programmes currently include a recommendation for a booster dose of hepatitis B vaccine. For some categories of subjects or patients
exposed to HBV (e.g. haemodialysis or immunocompromised patients) a precautionary attitude should be considered to ensure a protective antibody level ≥10 IU/L.
Hepatitis A: Anti-HAV antibodies have been predicted to persist for at least 10 years. In situations where a booster dose of both hepatitis A and hepatitis B are desired,
TWINRIX can be given. Alternatively, subjects primed with TWINRIX may be administered a booster dose of either of the monovalent vaccines. Use and Handling:
Refer to package insert. SIDE EFFECTS: Very common: drowsiness, headache, pain and redness at the injection site, fatigue. Common: irritability, gastrointestinal
symptoms (such as diarrhoea, nausea, vomiting), swelling at the injection site, injection site reaction, malaise. Uncommon: upper respiratory tract infection, dizziness,
myalgia, fever (≥ 37,5 °C). Rare: lymphadenopathy, decreased appetite, hypoaesthesia, paraesthesia, hypotension, rash, pruritus, arthralgia, influenza like illness, chills.
Very rare: urticaria. Post-marketing: refer to package insert. MANAGEMENT OF OVERDOSAGE: Cases of overdose have been reported.
HCR: GlaxoSmithKline South Africa (Pty) Ltd (Co. reg. no. 1948/030135/07), 39 Hawkins Avenue, Epping Industria 1, 7460
S2 SYNFLORIX. Reg. No.: 43/30.2/0401. Pneumococcal polysaccharide and Non-Typeable Haemophilus influenzae (NTHi) protein D conjugate vaccine, adsorbed. Suspension for injection. COMPOSITION: One dose (0,5 ml) contains 1 μg of polysaccharide for serotypes 11,2, 51,2, 6B1,2, 7F1,2, 9V1,2, 141,2 and 23F1,2, and 3 μg of serotypes 41,2, 18C1,3 and 19F1,4. (1 adsorbed on aluminium phosphate: 0,5 mg Al3+;2 conjugated to protein D (derived from Non-Typeable Haemophilus influenzae) carrier protein: 13 micrograms; 3conjugated to tetanus toxoid carrier protein: 8 micrograms; 4conjugated to diphtheria toxoid carrier protein: 5 micrograms). INDICATIONS: Active immunisation of infants and children from 6 weeks up to 5 years of age against disease caused by Streptococcus pneumoniae vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F and cross-reactive serotype 19A (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) and against acute otitis media caused by Non-Typeable Haemophilus influenzae. CONTRA-INDICATIONS: Should not be administered to subjects with known hypersensitivity to any component of the vaccine. WARNINGS AND SPECIAL PRECAUTIONS: Precede vaccination by review of medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and clinical examination. Appropriate medical treatment and supervision should be readily available in case of rare anaphylactic event. Postpone in subjects suffering from acute severe febrile illness – minor infection, such as a cold, should not result in the deferral of vaccination. Do not administer intravascularly or intradermally. No data are available on subcutaneous administration. Syncope (fainting) can occur. Give with caution to individuals with thrombocytopenia or any coagulation disorder. Safety and immunogenicity data in children with increased risk for pneumococcal infections are not available. Children with impaired immune responsiveness may have reduced antibody response to active immunisation. For children at high-risk for pneumococcal disease: the appropriate-for-age SYNFLORIX vaccination series should be given below 2 years of age and a 23-valent pneumococcal polysaccharide vaccine should be given ≥ 2 years of age. Potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering primary immunization series to very premature infants (born ≤ 28 weeks of gestation) and for those with a previous history of respiratory immaturity. Vaccination should not be withheld or delayed in this group. SYNFLORIX will not protect against pneumococcal serogroups other than those included in the vaccine. SYNFLORIX does not substitute routine immunization with diphtheria, tetanus or Haemophilus influenzae type b vaccines. A protective immune response may not be elicited in all vaccinees. Prophylactic administration of antipyretics before or immediately after vaccines administration can reduce the incidence and intensity of post-vaccination febrile reactions. Use of prophylactic paracetamol might reduce the immune response to pneumococcal vaccines. INTERACTIONS: Can be given concomitantly with any of the following monovalent or combination vaccines [including DTPa-HBV-IPV/Hib and DTPw-HBV/Hib]: diphtheria-tetanus-acellular pertussis vaccine (DTPa), hepatitis B vaccine (HBV), inactivated polio vaccine (IPV), Haemophilus influenzae type b vaccine (Hib), diphtheria-tetanus-whole cell pertussis vaccine (DTPw), measlesmumps-rubella vaccine (MMR), varicella vaccine, meningococcal serogroup C conjugate vaccine (CRM197 and TT conjugates), meningococcal serogroups A, C, W-135 and Y conjugate vaccine (TT conjugate), oral polio vaccine (OPV) and rotavirus vaccine. Different injectable vaccines should always be given at different injections sites. Immune responses and safety profiles of the co-administered vaccines were unaffected, with the exception of the inactivated poliovirus type 2 response, for which inconsistent results were observed across studies. When the meningococcal serogroups A, C, W-135 and Y vaccine (TT conjugate) was co-administered with a booster dose of SYNFLORIX during the 2nd year of life in children primed with 3 doses of SYNFLORIX, lower antibody GMC and OPA GMT were observed for one pneumococcal serotype (18C). There was no impact of co-administration on the other nine pneumococcal serotypes. Enhancement of antibody response to Hib-TT conjugate diphtheria and tetanus antigens was observed. In patients receiving immunosuppressive treatment an adequate response may not be elicited. Incompatibilities: Must not be mixed with other medicinal products. PREGNANCY AND LACTATION: Data not available. DOSAGE AND DIRECTIONS FOR USE: Infants from 6 weeks to 6 months of age: Three-dose primary series: The recommended immunisation series to ensure optimal protection consists of four doses, each of 0,5 ml. The primary infant series consists of three doses with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. The first dose may be given as early as six weeks of age. A booster dose is recommended at least 6 months after the last primary dose. Two-dose primary series: Alternatively, when SYNFLORIX is given as part of a routine infant immunisation programme, a series consisting of three doses, each of 0,5 ml may be given. The first dose may be administered from the age of 2 months, with a second dose 2 months later. A booster dose is recommended at least 6 months after the last primary dose. Preterm infants born after at least 27 weeks of gestational age: The recommended immunisation series consists of four doses, each of 0,5 ml. The primary infant series consists of three doses with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. A booster dose is recommended at least 6 months after the last primary dose. Previously unvaccinated older infants and children: infants aged 7-11 months: The vaccination schedule consists of two doses of 0,5 ml with an interval of at least 1 month between doses. A third dose is recommended in the second year of life with an interval of at least 2 months. children aged 12 months to 5 years: The vaccination schedule consists of two doses of 0,5 ml with an interval of at least 2 months between doses. Official recommendations should be taken into account when immunising with SYNFLORIX. It is recommended that subjects who receive a first dose of SYNFLORIX complete the full vaccination course with SYNFLORIX. Method of administration: Intramuscular injection. The preferred sites are anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in children. Use and Handling: Refer to package insert. SIDE EFFECTS: allergic reactions (such as allergic dermatitis, atopic dermatitis, eczema); angioedema; appetite lost; irritability; crying abnormal; drowsiness; convulsions (including febrile convulsions); Kawasaki disease; apnoea; diarrhoea, vomiting; rash; urticaria; pain, redness, swelling at the injection site, fever ≥ 38 °C rectally (age < 2 years); injection site reactions like injection site induration, fever > 39 °C rectally (age < 2 years); injection site reactions like injection site haematoma, haemorrhage and nodule. The following adverse reactions have additionally been reported after booster vaccination of primary series and/or catch-up vaccination: headache (age 2 to 5 years); nausea (age 2 to 5 years); fever ≥ 38 °C rectally (age 2 to 5 years); injection site reactions like pruritus, fever > 40 °C rectally (age < 2 years), fever > 39 °C rectally (age 2 to 5 years), diffuse swelling of the injected limb, sometimes involving the adjacent joint. Post-marketing Data: anaphylaxis; hypotonic-hyporesponsive episode. OVERDOSAGE: Insufficient data are available.
All adverse events should be reported by calling the Ethicare Medical Careline number 0800 227 302 or
directly to GlaxoSmithKline on +27 11 745 6000. Please refer to the professional information for
comprehensive safety and efficacy information.
All adverse events should be reported by calling the Ethicare Medical Careline number 0800 227 302 or
directly to GlaxoSmithKline on +27 11 745 6000. Please refer to the professional information for
comprehensive safety and efficacy information.
All adverse events should be reported by calling the Ethicare Medical Careline number 0800 227 302 or
directly to GlaxoSmithKline on +27 11 745 6000. Please refer to the professional information for
comprehensive safety and efficacy information.
All adverse events should be reported by calling the Ethicare Medical Careline number 0800 227 302 or
directly to GlaxoSmithKline on +27 11 745 6000. Please refer to the professional information for
comprehensive safety and efficacy information.
S4 HAVRIX JUNIOR Suspension for injection (Reg. No. 31/30.1/0294). One dose (0,5 ml) contains Hepatitis A virus (inactivated) 720 ELISA Units, produced on human diploid (MRC-5) cells, adsorbed on aluminium hydroxide, hydrated 0,25 mg Al3+. INDICATIONS: Active immunisation against hepatitis A virus (HAV) infection in subjects at risk of exposure to HAV. Will not prevent hepatitis infection caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus or other pathogens known to infect the liver. CONTRA-INDICATIONS: Known hypersensitivity to any components of the vaccine, or to subjects having shown signs of hypersensitivity after previous Hep A vaccination. WARNINGS & SPECIAL PRECAUTIONS: Do not freeze; discard if vaccine has been frozen. Postpone admin in subjects suffering from acute severe febrile illness. Presence of a minor infection is not a contra-indication. Not known if vaccination will prevent hepatitis A when given to subjects during the incubation period. In subjects with an impaired immune system adequate anti-HAV antibody titres may not be obtained after the primary immunisation course and may therefore require administration of additional doses of vaccine and it is advised that antibody titres be done in these cases to monitor the effectiveness. Syncope (fainting) can occur as a psychogenic response to the needle injection and procedures should be in place to avoid injury from faints. Can be given to HIV- infected persons. Seropositivity against Hepatitis A is not a contra-indication. Appropriate medication (e.g. adrenaline) should be readily available for immediate use in case of anaphylaxis or anaphylactoid reactions following the administration of the vaccine. Vaccinee should remain under medical supervision for 30 minutes after immunisation. Use with caution in subjects with thrombocytopenia or a bleeding disorder. Firm pressure should be applied to the injection site (without rubbing) for at least 2 minutes. INTERACTIONS: Concomitant administration of immunoglobulins, typhoid, yellow fever, cholera (injectable) or tetanus or with monovalent and combination vaccines comprised of measles, mumps, rubella and varicella, does not interfere with the immune response. Concomitant administration of other vaccines or of immunoglobulins must be given with different syringes and at different injection sites. PREGNANCY & LACTATION: Not recommended – only use when clearly needed. DOSAGE & DIRECTIONS FOR USE: IM injection. Children & adolescents from 1 year up to and including 15 years of age: A single dose (0,5 ml suspension) of HAVRIX JUNIOR is used for primary immunisation. Booster vaccination: A booster dose is recommended at any time between 6 and 12 months after the primary dose. The vaccine should never be administered intravenously. SIDE EFFECTS: Very Common: irritability; headache; pain and redness at the injection site, fatigue. Common: appetite lost; drowsiness; dizziness; gastrointestinal symptoms (such as diarrhoea, nausea, vomiting); swelling, malaise, fever (≥37,5 °C), injection site reaction (such as induration). Uncommon: upper respiratory tract infection, rhinitis; rash; myalgia, musculoskeletal stiffness; influenza like illness. Other: hypoaesthesia, paraesthesia; pruritus; anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness; convulsions; vasculitis; angioneurotic oedema, urticaria, erythema multiforme; arthralgia. MANAGEMENT OF OVERDOSAGE: AEs reported following overdosage were similar to those reported with normal vaccine administration. HCR: GlaxoSmithKline South Africa (Pty) Ltd., (Co. reg. no. 1948/030135/07), 39 Hawkins Ave, Epping Industria 1, 7460.
All adverse events should be reported by calling the Ethicare Medical Careline number 0800 227 302 or
directly to GlaxoSmithKline on +27 11 745 6000. Please refer to the professional information for
comprehensive safety and efficacy information.
All adverse events should be reported by calling the Ethicare Medical Careline number 0800 227 302 or directly to GlaxoSmithKline on +27 11 745 6000. Please refer to the professional information for comprehensive safety and efficacy information.
S2 ENGERIX-B (Reg. No. U/30.1/186). Each 1 ml dose contains 20 μg of antigen protein adsorbed on 0,5 mg Al3+ as aluminium hydroxide. S2ENGERIX-B PAEDIATRIC (Reg. No. W/30.1/35). Each 0,5 ml dose contains 0,5 ml and consists of 10 μg of antigen protein adsorbed on 0,25 mg Al3+ as aluminium hydroxide. Recombinant DNA hepatitis B vaccine. Suspension for injection. INDICATIONS: Active immunisation against hepatitis B virus infection. In areas of low prevalence of hepatitis B, vaccination is specially recommended in subjects who are at increased risk of infection e.g HCPs, persons at increased risk due to their sexual practices, illicit users of addictive injectable drugs, travellers to high endemicity areas and their close contacts, infants born to mothers who are carriers, subjects with chronic liver disease (CLD) or at risk of developing CLD. CONTRA-INDICATIONS: Hypersensitivity to any component or previous ENGERIX-B administration. Should be postponed in subjects suffering from acute severe febrile infections; but presence of a minor infection does not contra-indicate vaccination. HIV infection is not contra-indicated. WARNINGS AND SPECIAL PRECAUTIONS: Syncope can occur as a psychogenic response to the needle injection. Procedures should be in place to avoid injuries from faints. It is possible for unrecognised infection to be present at the time of vaccination and the vaccine may not prevent hepatitis B in such cases. ENGERIX-B should under no circumstances be administered intravascularly. In patients with renal insufficiency including patients undergoing haemodialysis, HIV infected patients and persons with an impaired immune system, adequate HBs antibody titres may not be obtained after the usual primary vaccination course and such patients may therefore require administration of additional doses of the vaccine. Will not prevent infection caused by other pathogens known to infect the liver such as hepatitis A, hepatitis C and hepatitis E virus. The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. Adrenalin should be immediately available in case of anaphylactic shock. INTERACTIONS: Should not be mixed with other vaccines. Can be given concomitantly with BCG, DTP, DT, polio, measles-mumps-rubella, haemophilus b, HPV and hepatitis A vaccine, but at different injection sites. Can be interchanged either with plasma-derived or with other genetically engineered hepatitis B vaccines. PREGNANCY AND LACTATION: Safety not established. Vaccination of a pregnant woman may be considered in order to prevent hepatitis B in high-risk situations. DOSAGE AND DIRECTIONS FOR USE: IM injection. May be administered subcutaneously in patients with thrombocytopenia or bleeding disorders. Do not administer intravascularly. Adults and children over 16 years of age: A 1 ml dose of 20 μg. Neonates, infants and children 15 years and younger: Three 0,5 ml doses of 10 μg at 6, 10 and 14 weeks of age. Primary Immunisation schedule: All subjects: 0, 1 and 6 months. An accelerated schedule, at 0, 1 and 2 months, will confer protection more quickly but a booster should be administered at 12 months. Subjects from 11 years up to and including 15 years of age: 20 μg vaccine according to a 0, 6 months schedule, but protection against hepatitis B infections may not be obtained until after the 2nd dose. This schedule should only be used when there is a low risk of hepatitis B infection during the vaccination course and when completion of the two-dose vaccination course can be assured. If both conditions cannot be assured (e.g patients undergoing haemodialysis, travellers to endemic regions and close contacts of infected subjects), the three-dose or the accelerated schedule of the 10 μg vaccine should be used. Subjects 18 years of age and above: When a more rapid induction of protection is required, a schedule of three injections given at 0, 7 and 21 days may be used one month before departure. A booster dose is recommended 12 months after the first dose. Booster dose: Recommended for haemodialysis and other immunocompromised patients only. Special dosage recommendations: Neonates born of mothers who are HBV carriers; Dosage recommendation for known or presumed exposure to HBV; Patients with renal insufficiency including patients undergoing haemodialysis 16 years of age and above; Patients with renal insufficiency including patients undergoing haemodialysis up to and including 15 years of age, including neonates; See package insert. Use and Handling: See package insert. SIDE EFFECTS: Irritability; appetite lost; headache, drowsiness; gastrointestinal symptoms (such as nausea, vomiting, diarrhoea, abdominal pain); pain and redness at injection site, fatigue; swelling at injection site, malaise, injection site reaction (such as induration), fever (≥ 37,5 °C); dizziness; myalgia; influenza-like illness; lymphadenopathy; paresthesia; rash, pruritus, urticaria; arthralgia. Other: meningitis, thrombocytopenia, anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness, paralysis, convulsions, hypoaesthesia, encephalitis, encephalopathy, neuropathy, neuritis, hypotension, vasculitis, angioneurotic oedema, lichen planus, erythema multiforme, arthritis, muscular weakness. MANAGEMENT OF OVERDOSAGE: AEs reported following overdosage were similar to those reported with normal vaccine administration. HCR: GlaxoSmithKline South Africa (Pty) Ltd (Co. reg. no. 1948/030135/07), 39 Hawkins Avenue, Epping Industria 1, 7460
S2 BOOSTRIX Suspension for Injection (Reg. No. 49/30.2/1042). 1 dose (0,5 ml) contains: Diphtheria toxoid1 ≤ 2 IU (2,5 Lf), Tetanus toxoid1 ≤ 20 IU (5 Lf), Bordetella
pertussis antigens Pertussis toxoid1 8 μg; Filamentous Haemagglutinin1 8 μg; Pertactin1 2,5 μg. (1 adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 0,3 mg Al3+
and aluminium phosphate (AlPO4) 0,2 mg Al3+.) INDICATIONS: Booster vaccination against diphtheria, tetanus and pertussis of individuals from the age of four years
onwards. CONTRAINDICATIONS: Known hypersensitivity to any component of the vaccine, or hypersensitivity after previous administration of diphtheria, tetanus or
pertussis vaccines. If the subject has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis
containing vaccine – pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria and tetanus vaccines. Should not
be administered to subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria
and/or tetanus (for convulsions or hypotonic-hyporesponsive episodes). WARNINGS AND SPECIAL PRECAUTIONS: Administration should be postponed in subjects
suffering from acute severe febrile illness. Should under no circumstances be administered intravenously. Vaccination should be preceded by a review of the medical
history and a clinical examination. If any of the following events are known to have occurred in temporal relation to receipt of pertussis-containing vaccine, the decision
to give doses of pertussis-containing vaccines should be carefully considered: temperature of ≥ 40,0 °C within 48 hours of vaccination, not due to another identifiable
cause; collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination; persistent, inconsolable crying lasting ≥ 3 hours,
occurring within 48 hours of vaccination; convulsions with or without fever, occurring within 3 days of vaccination. Defer pertussis (Pa or Pw) immunisation until the
condition is corrected or stable in children with progressive neurological disorders, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy.
Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following administration. Administer with
caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. Human
Immunodeficiency Virus (HIV) infection is not considered a contra-indication for diphtheria, tetanus and pertussis vaccination. The expected immunological response
may not be obtained after vaccination of immunosuppressed patients. Extremely rare cases of collapse or shock-like state (hypotonichyporesponsiveness episode)
and convulsions within 2 to 3 days of vaccination have been reported in DTPa and DTPa combination vaccines. Syncope (fainting) can occur following, or even
before, any vaccination as a psychogenic response to the needle injection. A protective immune response may not be elicited in all vaccinees. Effects on ability to
drive and use machines: Unlikely to produce an effect on the ability to drive and use machines. INTERACTIONS: Can be administered simultaneously with other
vaccines or immunoglobulins. If given at the same time as another injectable vaccine or immunoglobulin, the products should always be administered at different
sites. Patients receiving immunosuppressive therapy or patients with immunodeficiency may not achieve an adequate response. In these patients, when tetanus
vaccine is needed for tetanus prone wound, plain tetanus vaccine will be used. PREGNANCY AND LACTATION: May be considered during the third trimester of
pregnancy. Use during the first and second trimester of pregnancy not available. Should only be used during breastfeeding when the possible advantages outweigh
the potential risks. DOSAGE AND DIRECTIONS FOR USE: A single 0,5 ml dose. May be administered to adolescents and adults with unknown vaccination status or
incomplete vaccination against diphtheria, tetanus and pertussis as part of an immunisation series against diphtheria, tetanus and pertussis (see Pharmacodynamic
properties). Based on data in adults, two additional doses of a diphtheria and tetanus containing vaccine are recommended one and six months after the first dose
to maximize the vaccine response against diphtheria and tetanus. Repeat vaccination against diphtheria, tetanus and pertussis should be performed at intervals
as per official recommendations (generally 10 years). Method of administration: Deep IM injection, preferably in the deltoid region. Use and Handling: Refer to
package insert. Incompatibilities: Do not mix with other vaccines in the same syringe. SIDE EFFECTS: Children from 4 to 9 years of age: Very common: irritability,
somnolence, injection site reactions (including pain, redness and swelling), fatigue. Common: anorexia, headache, diarrhoea, vomiting, gastrointestinal disorders, fever
≥ 37,5 °C (including fever > 39 °C). Uncommon: upper respiratory tract infection, disturbances in attention, conjunctivitis, rash, other injection site reactions (such as
induration), pain. Adults, adolescents and children from the age of 10 years onwards: Very common: headache, injection site reactions (including pain, redness and
swelling), fatigue, malaise. Common: dizziness, nausea, gastrointestinal disorders, fever ≥ 37,5 °C, injection site reactions (such as injection site mass and injection
site abscess sterile). Uncommon: upper respiratory tract infection, pharyngitis, lymphadenopathy, syncope, cough, diarrhoea, vomiting, hyperhidrosis, pruritus, rash,
arthralgia, myalgia, joint stiffness, musculoskeletal stiffness, fever > 39 °C, influenza like illness, pain. MANAGEMENT OF OVERDOSAGE: Adverse events following
overdosage, when reported, were similar to those reported with normal administration. HCR: GlaxoSmithKline South Africa (Pty) Ltd. (Co. reg. no. 1948/030135/07),
39 Hawkins Ave, Epping Industria 1, 7460.
For full prescribing information, refer to the professional information approved by the medicines regulatory authority (BOOSTRIX Suspension for Injection May 2020).
All adverse events should be reported by calling the Ethicare Medical Careline number or directly to GlaxoSmithKline on +27 11 745 6000. Trade marks are owned
by or licensed to the GSK Group of companies. © 2021 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare
Limited. Healthcare Park, Woodlands Drive, Woodmead, 2191. ZAR-VAP-07-21-00003 09/2021.
DO NOT INJECT. FOR ORAL USE ONLY.
S2 ROTARIX Liquid Oral Vaccine. Reg. No.: 43/30.2/0290. Rotavirus vaccine. Oral suspension. PHARMACOLOGICAL CLASSIFICATION: A 30.2 Antigens. INDICATIONS: Prevention of gastro-enteritis caused by rotavirus in infants in the first six months of life. Should not be administered to children older than 24 weeks of age. CONTRAINDICATIONS: Known hypersensitivity after previous administration of ROTARIX or to any component of the vaccine. In infants who have known or suspected immunodeficiency. However, caution advised when administered to asymptomatic HIV infected subjects. Subjects with history of intussusceptions. Uncorrected congenital malformation (such as Meckel’s diverticulum) of the gastrointestinal tract that would predispose for intussusception. Severe Combined Immunodeficiency (SCID) disorder. WARNINGS AND SPECIAL PRECAUTIONS: UNDER NO CIRCUMSTANCES TO BE INJECTED. Should not be administered to children older than 24 weeks of age, particularly in relation to risk of intussusception. Administration should be postponed in subjects suffering from acute severe febrile illness. Presence of a minor infection, should not result in the deferral of vaccination. Administration should be postponed in subjects suffering from diarrhoea or vomiting. No data available on use in infants with gastrointestinal illnesses. Vaccinate with caution when, in the opinion of the physician, withholding the vaccine entails greater risk. HCPs should follow-up on any symptoms indicative of intussusception (severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating and/or high fever). Parents/guardians should be advised to promptly report such symptoms. Contra-indicated in subjects with a predisposition for intussusception. Contra-indicated in infants who have known or suspected immunodeficiency. Can be given to asymptomatic human immunodeficiency virus (HIV) infected subjects. Administration in immunosuppressed infants, including infants on immunosuppressive therapy, should be based on careful consideration of potential benefits and risks. Do not use interchangeably with any other rotavirus vaccine. Vaccination should be preceded by a review of the medical history and a clinical examination. Excretion of the vaccine virus in the stools is known to occur after vaccination. Should be administered with caution to individuals with immunodeficient close contacts, such as individuals with malignancies, or who are otherwise immunocompromised or receiving immunosuppressive therapy. Contacts of recent vaccinees should be advised to observe careful hygiene (including washing their hands after changing child’s nappies). A protective immune response may not be elicited in all vaccinees. The extent of protection against rotavirus strains that have not been circulating in clinical trials is currently unknown. Does not protect against gastroenteritis due to other pathogens than rotavirus. ROTARIX SHOULD NEVER BE INJECTED. INTERACTIONS: Can be given with DTPa-HBV-IPV/Hib, DTPw, DTPa, Hib, IPV, hepatitis B vaccine (HBV), pneumococcal vaccine and meningococcal serogroup C vaccine. Oral polio vaccine (OPV) does not affect the immune response to the polio antigens. The immune response to ROTARIX is unaffected when OPV is administered two weeks apart from ROTARIX. PREGNANCY AND LACTATION: Not intended for use in adults. DOSAGE AND DIRECTIONS FOR USE: The vaccination course consists of two doses. The first dose may be administered from the age of 6 weeks. There should be an interval of at least 4 weeks between doses. The vaccination course should be completed by the age of 24 weeks. May be given to preterm infants with the same posology. In the unlikely event that an infant spits out or regurgitates most of the dose, a single replacement dose may be given at the same vaccination visit. It is strongly recommended that infants who receive a first dose of ROTARIX complete the 2-dose regimen with ROTARIX. Method of administration: For oral use only. SHOULD UNDER NO CIRCUMSTANCES BE INJECTED. There are no restrictions on the infant’s consumption of food or liquid, including breast milk, either before or after vaccination. Breastfeeding may be continued during the vaccination schedule. Incompatibilities: Must not be mixed with other medicinal products. Instructions for use and handling: No reconstitution or dilution is required. Administer orally without mixing with any other vaccines or solutions. The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. If not, discard the vaccine. Any unused vaccine or waste material should be disposed of in accordance with local requirements. Instructions for administration of the vaccine in oral applicator: See package insert. SIDE EFFECTS: Common: diarrhoea, irritability. Uncommon: flatulence, abdominal pain and dermatitis. Safety in preterm infants: The first dose was administered from 6 weeks after birth. SAEs were observed in 5,1 % of ROTARIX recipients compared to 6,8 % of placebo recipients. Similar rates of solicited and unsolicited symptoms were observed in ROTARIX and placebo recipients. No cases of intussusception were reported. Post-Marketing Data: intussusception, haematochezia, gastroenteritis with vaccine viral shedding in infants with SCID disorder. MANAGEMENT OF OVERDOSAGE: The adverse events reported in overdosage were similar to those observed after administration of the recommended dose.
S2 PRIORIX (Reg No 33/30.1/0346). Lyophilised live attenuated vaccine against measles, mumps and rubella with sterile diluent. Powder and diluent for solution for Injection. After reconstitution, 1 dose (0,5 ml) contains: Live attenuated measles virus (Schwarz strain): ≤ 103,0 CCID50, Live attenuated mumps virus (RIT4385 strain, derived from Jeryl Lynn strain): ≤ 103,7 CCID50, Live attenuated rubella virusb (Wistar RA 27/3 strain): not less than 103,0 CCID50. INDICATIONS: Active immunisation against measles, mumps and rubella in the second year of life and booster at the age of 4-6 years. CONTRA-INDICATIONS: In patients with active untreated tuberculosis; blood dyscrasias, leukaemias, lymphomas of any type or malignant neoplasms affecting bone marrow or lymphatic system; known systemic hypersensitivity to neomycin or any other component; hypersensitivity after previous administration of measles, mumps and/or rubella vaccines; humoral or cellular (primary or acquired) immunodeficiency; in pregnancy. Vaccination should be deferred for at least 3 months following plasma or blood transfusions, or administration of human immune serum globulin. WARNINGS AND SPECIAL PRECAUTIONS: Do not administer intravascularly. Postpone in subjects suffering from acute severe febrile illness. Syncope (fainting) can occur and procedures should be in place to avoid injury from faints. Use with caution in patients who have experienced anaphylaxis after egg ingestion, with adequate treatment for anaphylaxis on hand should such a reaction occur. Use with caution in patients with a history or family history of allergic diseases or those with a history or family history of convulsions. A protective immune response may not be elicited in all vaccinees. Cases of worsening of thrombocytopenia and recurrence of thrombocytopenia. Immunocompromised subjects may not respond as well as immunocompetent subjects, and may acquire measles, mumps or rubella despite appropriate vaccine administration. Immunocompromised subjects should be monitored carefully for signs of measles, mumps and rubella. Alcohol and other disinfecting agents must be allowed to evaporate from the skin before injection of the vaccine. Limited protection against measles may be obtained by vaccination up to 72 hours after exposure to natural measles. Infants below 12 months of age may not respond sufficiently to the measles component of the vaccine and revaccination at or after 12 months of age should be considered. Appropriate medical treatment including adrenalin and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. Transmission of measles and mumps virus from vaccinees to susceptible contacts has never been documented. Pharyngeal excretion of the rubella virus is known to occur about 7 to 28 days after vaccination, however there is no evidence of transmission of this excreted vaccine virus to susceptible contacts. Contains lactose – should not be given to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Contains traces of neomycin – should not be used in patients with a known hypersensitivity to this antibiotic. INTERACTIONS: Tuberculin testing should be carried out before or simultaneously with vaccination or for 4-6 weeks post-vaccination. Can be administered at the same time as another injectable vaccine if separate injection sites are used. May be given at the same time as the OPV, IPV, DTPw, Hib, DTPa-HBV-IPV/Hib, DTPa, dTpa, HBV, HAV, MenB,MenC, MenACWY, PCV, if separate injection sites are used. If cannot be given at the same time as other live attenuated vaccines, an interval of at least one month should be left between both vaccinations. In subjects who have received human gammaglobulins or a blood transfusion, vaccination should be delayed for at least three months. May be given as a booster dose in subjects who have previously been vaccinated with other MMR combined vaccine. PREGNANCY AND LACTATION: Contra-indicated. Pregnancy should be avoided for one month after vaccination. Women who intend to become pregnant should be advised to delay pregnancy. DOSAGE AND DIRECTIONS FOR USE: A single 0,5 ml dose SC. PRIORIX is for subcutaneous injection, although it can also be given by intramuscular injection, in the deltoid region or in the anterolateral area of the thigh. The vaccine should be administered subcutaneously in subjects with bleeding disorders (e.g. thrombocytopenia or any coagulation disorder). Use and Handling: Refer to package insert. SIDE EFFECTS AND SPECIAL PRECAUTIONS: Very common: redness at the injection site, fever  38 °C. Common: upper respiratory tract infection, rash, pain and swelling at the injection site, fever > 39,5 °C. Uncommon: otitis media, lymphadenopathy, anorexia, nervousness, abnormal crying, insomnia, conjunctivitis, bronchitis, cough, parotid gland enlargement, diarrhoea, vo
S2 INFANRIX HEXA Powder and suspension for injection (Reg. No. 36/30.1/0347). DTPa-HepB-IPV + Hib. Each 0,5 ml dose of the vaccine contains ≤ 30 IU of adsorbed diphtheria toxoid, ≤ 40 IU of adsorbed tetanus toxoid, 25 μg of adsorbed PT, 25 μg of adsorbed FHA, 8 μg of adsorbed pertactin, 10 μg of adsorbed recombinant HBsAg protein, 40 D-antigen units of type 1 (Mahoney), 8 D-antigen units of type 2 (MEF-1) and 32 D-antigen units of type 3 (Saukett) of the polio virus. It also contains 10 μg of adsorbed purified capsular polysaccharide of Hib (PRP) covalently bound to 20-40 μg tetanus toxoid (T). INDICATIONS: For primary and booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b in infants from the age of 6 weeks and may be given to infants who received a first dose of hepatitis B vaccine at birth. CONTRAINDICATIONS: Hypersensitivity to the active substances or to any of the excipients or residues and after after previous administration of diphtheria, tetanus, pertussis, hepatitis B, polio or Hib vaccines. If child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine -pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria-tetanus, hepatitis B, inactivated polio and Hib vaccines. WARNINGS & SPECIAL PRECAUTIONS: Should not be used according to the EPI (SA) schedule of 6, 10 and 14 weeks, unless a priming dose of a registered hepatitis B vaccine has been administered at birth. Administration should be postponed in subjects suffering from acute severe febrile illness. Presence of a minor infection is not a contra-indication. Vaccination should be preceded by a review of the medical history and a clinical examination. If any of the following events are known to have occurred in temporal relation to receipt of pertussiscontaining vaccine. Decision to give further doses of should be carefully considered if any of the following events have occurred following pertussis-containing vaccines: temperature of ≥40,0 °C within 48 hours, not due to another identifiable cause; collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination; persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours of vaccination; convulsions with or without fever, occurring within 3 days of vaccination. In children with progressive neurological disorders, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy, it is better to defer pertussis immunisation until the condition is corrected or stable. Administer with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following IM administration to these subjects. Should not be administered intravascularly or intradermally. Contains traces of neomycin and polymyxin and should be used with caution in patients with known hypersensitivity to these antibiotics. A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute contra-indications but vaccinees with a history of febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days post vaccination. Syncope (fainting) can occur as a psychogenic response to the needle injection and procedures should be in place to avoid injury from faints. Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following administration. Will not prevent disease caused by other pathogens except hepatitis D, as hepatitis D does not occur in the absence of hepatitis B infection. A protective immune response may not be elicited in all vaccinees. HIV infection is not a contra-indication. The expected immunological response may not be obtained after vaccination of immunosuppressed patients. A positive urine test for HIB infection can be observed within 1 to 2 weeks following vaccination and other tests should be performed during this period. Can be given to premature children, but a lower immune response may be observed and the level of clinical protection remains unknown. The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed. INTERACTIONS: In patients receiving immunosuppressive therapy or patients with immunodeficiency, an adequate response may not be achieved. Simultaneous administration with MMR vaccine not recommended. A higher incidence of fever (> 39,5 °C) was reported with concomitant vaccination with pneumococcal saccharide conjugated vaccine. Antipyretic treatment should be initiated. Should not be mixed with other vaccines in the same syringe. PREGNANCY AND LACTATION: Safety not establishd. DOSAGE AND DIRECTIONS FOR USE: Primary vaccination: Three doses of 0,5 ml administered at intervals of at least 1 month starting between 2 and 3 months of age. If intended to administer according to the EPI schedule (6, 10, 14 weeks of age), then the vaccine must receive a dose of hepatitis B vaccine at birth. Booster vaccination: After primary vaccination, a booster dose may be given at least 6 GDS-10 Abbreviated pi months after the last priming dose and preferably before 18 months of age. Method of administration: IM injection. Instructions for use and handling: Refer to package insert. SIDE EFFECTS: Very common: appetite loss; irritability, crying abnormal, restlessness; pain, redness, local swelling at the injection site (≤50 mm), fever ≥38 °C, fatigue. Common: nervousness; vomiting, diarrhea; pruritus; local swelling at the injection site (> 50 mm), fever > 39,5 °C, injection site reactions, including induration. Uncommon: upper respiratory tract infection; somnolence; cough; diffuse swelling of the injected limb, sometimes involving the adjacent joint. Other: convulsions (with or without fever); bronchitis; rash, dermatitis, urticaria. Post-Marketing Data: Lymphadenopathy, thrombocytopenia; allergic reactions (including anaphylactic and anaphylactoid reactions); collapse or shock-like state (hypotonic-hyporesponsiveness episode); apnoea; angioneurotic oedema; extensive swelling reactions, swelling of the entire injected limb, vesicles at the injection site. Experience with hepatitis B vaccine: Meningitis, mimicking serum sickness, paralysis, encephalitis, encephalopathy neuropathy, neuritis, hypotension, vasculitis, lichen planus, erythema multiforme, arthritis and muscular weakness. MANAGEMENT OF OVERDOSAGE: Insufficient data are available.
S2 CERVARIX. Reg. No. 41/30.1/0366. Human Papillomavirus vaccine Types 16 and 18 (Recombinant AS04 adjuvanted). Suspension for injection. COMPOSITION:
1 dose (0,5 ml) contains: Human Papillomavirus type 16 L1 protein 20 μg, Human Papillomavirus type 18 L1 protein 20 μg, 3-O-desacyl-4’-monophosphoryl lipid A
(MPL) 50 μg, aluminium hydroxide, hydrated 0,5 mg Al3+. INDICATIONS: CERVARIX is indicated from the age of 9 years for the prevention of persistent infection,
premalignant ano-genital lesions (cervical, vulvar, vaginal and anal) and cervical, vulvar, vaginal and anal cancers (squamous-cell carcinoma and adenocarcinoma)
caused by oncogenic Human Papillomaviruses (HPV). CONTRA-INDICATIONS: Known hypersensitivity to any component of the vaccine. WARNINGS AND SPECIAL
PRECAUTIONS: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that
procedures are in place to avoid injury from faints. Vaccination should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor
infection should not result in the deferral of vaccination. Should not be administered intravascularly or intradermally. Should be given with caution to individuals with
thrombocytopenia or any coagulation disorder since bleeding may occur following an IM administration. A protective immune responses may not be elicited in all
vaccinees. Vaccination is for primary prevention and not a substitute for regular cervical screening (secondary prevention) or for precautions against exposure to
HPV and sexually transmitted diseases. Duration of protection observed for up to 9,4 years after the first dose. Not intended to prevent progression of HPV-related
lesions present at the time of vaccination. Except for asymptomatic HIV infected subjects, there is data in subjects with impaired immune responsiveness and an
adequate immune response may not be elicited in these patients. Precede vaccination by a review of the medical history and a clinical examination. Appropriate
medical treatment and supervision should always be readily available in case of a rare anaphylactic event following administration. Does not provide protection
against all oncogenic HPV types. Effect on ability to drive and use machines: No studies. INTERACTIONS: Can be given concomitantly with dTpa, IPV and the
combined dTpa-IPV vaccine; HepA, HepB and the combined HepA-HepB vaccine. If to be given at the same time as another injectable vaccine, the vaccines should
always be administered at different injection sites. There is no evidence that the use of hormonal contraceptives has an impact on the efficacy. In patients receiving
immunosuppressive treatment, an adequate response may not be elicited. Should not be mixed with other medicinal products. PREGNANCY AND LACTATION:
Postpone vaccination until completion of pregnancy. Should only be used during breastfeeding when the possible advantages outweigh the possible risks. DOSAGE
AND DIRECTIONS FOR USE: By IM injection. From age 9 to and including 14 years of age at the time of the first injection –2 doses. Second dose between 5 and
13 months after the first dose. If 2nd dose given before 5 months, then 3rd dose must be given. From 15 years and above – 3-dose schedule at 0, 1, 6 months. For
flexibility in this vaccination schedule, see package insert. Necessity for a booster dose has not been established. Use and Handling: See package insert. SIDE
EFFECTS: Very common: headache, myalgia, injection site reactions including pain, redness, swelling, fatigue. Common: gastrointestinal including nausea, vomiting,
diarrhoea and abdominal pain, itching/pruritus, rash, urticaria, arthralgia, fever (≥38 °C). Uncommon: upper respiratory tract infection, lymphadenopathy, dizziness,
other injection site reactions such as induration, local paraesthesia. Other: allergic reactions (including anaphylactic and anaphylactoid reactions), angioedema,
syncope or vasovagal responses to injection, sometimes accompanied by tonic-clonic movements. Precede vaccination by a review of the medical history and a
clinical examination. Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following administration.
Does not provide protection against all oncogenic HPV types. MANAGEMENT OF OVERDOSAGE: None known.
All adverse events should be reported by calling the Ethicare Medical Careline number 0800 227 302 or directly to GlaxoSmithKline on +27 11 745 6000. Please refer to the professional information for comprehensive safety and efficacy information.
All adverse events should be reported by calling the Ethicare Medical Careline number 0800 227 302 or directly to GlaxoSmithKline on +27 11 745 6000. Please refer to the professional information for comprehensive safety and efficacy information.
S1CANALBA Cream. Reg. No.: 29/20.2.2/0129. Each 1 g of cream contains 10,0 mg clotrimazole. For full prescribing information refer to the professional information approved by the medicines regulatory authority (09/1997). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
DRICLOR Solution. Contains Alcohol, Aluminium chloride, Aqua. For full prescribing information refer to the professional information approved by the medicines regulatory authority (2015). DRICLOR is a registered trade mark of Stiefel Laboratories, Inc. Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. GlaxoSmithKline South Africa,39 Hawkins Avenue, Epping, 7460. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S0DUOFILM LIQUID. Reg. No.: S/13.8/82. Contains per 100 g: 16,7 g Salicylic Acid BP and 15,03 g Lactic Acid Anhydrous in Flexible Collodion BP. For full prescribing information refer to the professional information approved by the medicines regulatory authority (08/1994). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. All rights reserved. GlaxoSmithKline South Africa,39 Hawkins Avenue, Epping, 7460. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
MODUCARE (Capsules). Each capsule contains ß-Sitosterol 20,0 mg and ß-Sitosterol- ß-D-Glucoside 0,2 mg. Complementary medicine: Health supplement. Complementary Medicine: Nutritional Supplement. This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use. Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.:1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead 2191.
MODUCARE PLUS + (Capsules). Each capsule contains Grape Seed 70,00 mg, Sterols/Sterolins 20,20 mg, Beta-Carotene 2,00 mg, Vitamin A 250 RE/ 832.5 I.U., Vitamin E 2,5 TE/3.725 I.U., Vitamin C 30,0 mg, Vitamin B1 0,70 mg, Vitamin B2 0,80 mg, Vitamin B6 1,00 mg, Folic acid 100,0 mcg, Vitamin B12 0,50 mcg, Biotin 50,00 mcg, Calcium 30,00 mg, Iron 3,75 mg, Magnesium 15,00 mg, Selenium 0,05 mg and Zinc 3,75 mg. Complementary Medicine: Nutritional Supplement. This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use. Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.:1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead 2191.
S0NORMACOL PLUS (granules). Reg. No.: E1483 (Act 101/1965). Each 10 g of NORMACOL PLUS contains 6,2 g of sterculia and 0,8 g of frangula. For full prescribing information refer to the professional information approved by the medicines regulatory authority (02/1991). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Norgine (Pty) Ltd., First Floor 108 Elizabeth Avenue, Cnr 11th St and Elizabeth Avenue, Parkmore. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S0NORMACOL (granules). Ref. No.: E1974 (Act 101/1965). Each 10 g contains: Sterculia 6,2 g. Contains sugar. For full prescribing information refer to the professional information approved by the medicines regulatory authority (03/2013). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Norgine (Pty) Ltd., First Floor 108 Elizabeth Avenue, Cnr 11th St and Elizabeth Avenue, Parkmore. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S1MUCAINE SUSPENSION. Reg. No.: E/11.4.3/1223. Each 5 ml contains 10 mg of oxethazaine, 291 mg of aluminium hydroxide, Magnesium Hydroxide 98 mg. For full prescribing information refer to the professional information approved by the medicines regulatory authority (02/1994). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S1SOLMUCOL 200 (granules). Reg. Nr.: 28/10.2.2/0128. Each sachet contains 200 mg N-acetylcysteine.
S1SOLMUCOL (lozenges). Reg. Nr.: 28/10.2.2/0451. Each lozenge contains 100 mg N-acetylcysteine.
For full prescribing information refer to the professional information approved by the medicines regulatory authority (SOLMUCOL 200 (granules) 10/2014. SOLMUCOL (lozenges) 10/2014). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies
or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.:1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S1MERTHIOLATE (tincture). G1352 (Act 101/1965). Each 100 ml MERTHIOLATE tincture contains 100 mg thimerosal. For full prescribing information refer to the professional information approved by the medicines regulatory authority (09/1974). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191
S1CLARINESE 10 mg TABLETS. Reg. No.: 35/5.7.1/0288. Each tablet contains Loratadine 10 mg. CONTAINS LACTOSE MONOHYDRATE. For full prescribing information refer to the professional information approved by the medicines regulatory authority (11/2002). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S1CLARINESE SYRUP. Reg. No.: 38/5.7.1/0087 Each 5 ml of CLARINESE SYRUP contains: 5 mg Loratidine, 0,1 % m/v Sodium Benzoate. For full prescribing information refer to the professional information approved by the medicines regulatory authority (09/2005). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
KELO-COTE GEL 15 ml. Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
SINUCLEAR HYPERTONIC SEA WATER SOLUTION FOR ADULTS (nasal spray). Each 125 ml contains: Sea water 87,5 ml, Purified water to 125 ml (Equivalent to approximately 2.3 % Sodium Chloride). For full prescribing information refer to the professional information approved by the medicines regulatory authority (10/2009). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
SINUCLEAR HYPERTONIC SEA WATER SOLUTION FOR CHILDREN (nasal spray). Each 100 ml contains: Sea water 70 ml, Purified water to 100 ml (Equivalent to approximately 2.3 % Sodium Chloride).For full prescribing information refer to the professional information approved by the medicines regulatory authority (10/2009). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S1AP-LORATADINE 10 mg TABLET. Reg. No.: 35/5.7.1/0084. Each tablet of AP-LORATADINE 10 mg TABLET contains 10 mg of loratadine. For full prescribing information refer to the professional information approved by the medicines regulatory authority (05/2002). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S1AP- LORATADINE SYRUP. Reg. No.: 38/5.7.1/0083. Each 5 ml of AP LORATADINE SYRUP contains 5 mg of loratadine. For full prescribing information refer to the professional information approved by the medicines regulatory authority (07/2005). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S0CRUCIALE (capsules) Ref. No.: D: 34.12. Each capsule contains: Phosphatidyl choline 175 mg, Vitamin E 3,3 mg, Vitamin C 65 mg, Vitamin B1 3 mg, Vitamin B2 3 mg, Nicotinamide 8 mg, Vitamin B6 3 mg, Vitamin B12 3 ug, Calcium hydrogen Phosphate 5,244 mg, Contains sugar: Glycerol 47,025 mg. For full prescribing information refer to the professional information approved by the medicines regulatory authority (12/2017). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S1AUTRIN CAPSULES (capsules). Ref. No.: H689 (Act 101/1965). Each AUTRIN haematinic capsule contains: Vitamin B12 (15 ug) with Intrinsic Factor Concentrate 1 1/2 N.F. Units (Oral), Ferrous fumarate 350 mg (Elemental iron 115mg), Ascorbic acid (Vitamin C) 150 mg, Folic Acid 2 mg. For full prescribing information refer to the professional information approved by the medicines regulatory authority (07/1992). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S1A-POR Vaginal (cream). Reg. No.: Z/20.2.2/376. Each 1 g of cream contains 10,0 mg of clotrimazole. For full prescribing information refer to the professional information approved by the medicines regulatory authority (07/1992). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S1CANDIZOLE V (cream). Reg. No.: 27/20.2.2/0150. Each 5 g vaginal cream contains 50 mg clotrimazole. For full prescribing information refer to the professional information approved by the medicines regulatory authority (10/1992). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S1CANALBA Vaginal (cream). Reg. No.: 29/20.2.2/0130. Each 1 g of cream contains 10,0 mg of clotrimazole. For full prescribing information refer to the professional information approved by the medicines regulatory authority (09/1997). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S1DEQUADIN MOUTH PAINT (solution). Reg. No.: C/16.4/217. Each 100 ml of DEQUADIN MOUTH PAINT contains Dequalinium chloride 0,4 g, Lignocaine base 1,75 g. For full prescribing information refer to the professional information approved by the medicines regulatory authority (11/1996). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S1OROCHLOR Spray Solution. Reg. No.: 28/16.3/0057. Each 100 ml contains 266,625 mg benzocaine, 1,071425 ml chlorhexidine gluconate solution 20 %. For full prescribing information refer to the professional information approved by the medicines regulatory authority (10/1997). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S0KAOSTATEX (suspension). Reg. No.: F/11.9.2/181. Each 30 ml KAOSTATEX suspension contains: Light kaolin 6,0 g, Pectin 0,12 g, Sodium lactate 0,0864 g, Potassium chloride 0,0414 g, Sodium chloride 0,0789 g. For full prescribing information refer to the professional information approved by the medicines regulatory authority (06/1976). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S0AMPHOJEL (suspension). Reg. No.: E/11.4.1/1229. Each 5 ml of AMPHOJEL suspension contains 300 mg of aluminium hydroxide. For full prescribing information refer to the professional information approved by the medicines regulatory authority (07/1993). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S1PODINE (ointment). Reg. No.: L/14.1/80. Each 25 g of PODINE contains 2,5 g povidine-iodine which is equivalent to 1 % of available iodine. For full prescribing information refer to the professional information approved by the medicines regulatory authority (05/1981). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S1XYLOCAINE 10 mg/0,1 ml PUMP SPRAY (liquid). Reg. No.: G 2826 (Act 101/1965). Each metered dose (0,1 ml) of XYLOCAINE 10 mg/0,1 ml PUMP SPRAY contains 10 mg of lidocaine. For full prescribing information refer to the professional information approved by the medicines regulatory authority (08/2009). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S1A-POR Cream. Reg. No.: Z/20.2.2/375. Each 1 g of cream contains 10 mg of clotrimazole. For full prescribing information refer to the professional information approved by the medicines regulatory authority (08/1992). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S1CANSTAT TOPICAL (cream). Reg. No.: F/13.9.2/158. Each 1 g cream of CANSTAT TOPICAL contains 100 000 units of nystatin. For full prescribing information refer to the professional information approved by the medicines regulatory authority (07/1973). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S1CANDIZOLE TOPICAL CREAM. Reg. No.: P/20.2.2/164. Each 20 g of CANDIZOLE TOPICAL CREAM contains 200 mg of clotrimazole. For full prescribing information refer to the professional information approved by the medicines regulatory authority (09/1983). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S1TERBICIL 1 % Cream. Reg. No.: 38/20.2.2/0148. Each 1 gram of cream contains 10 mg of terbinafine hydrochloride. For full prescribing information refer to the professional information approved by the medicines regulatory authority (04/2006). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S1KETAZOL Cream. Reg. No.: 33/20.2.2/0503. Each gram of cream contains 20 mg ketoconazole. For full prescribing information refer to the professional information approved by the medicines regulatory authority (10/1999). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
S1FUREX Ointment. Reg. No.: 27/14.1/0494. Each 25 g contains 50 mg nitrofurazone in a water miscible base. For full prescribing information refer to the professional information approved by the medicines regulatory authority (07/1993). Trademarks are owned by or licensed to the Aspen Group of companies. © 2020 Aspen Group of companies or its licensor. All rights reserved. Marketed by Ethicare, a division of Pharmacare Limited. Co. Reg. No.: 1898/000252/06. Healthcare Park, Woodlands Drive, Woodmead, 2191.
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