LEGALS
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.