INFORMATION FOR HEALTH PROFESSIONALS
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INFANRIX-HepB contains diphtheria toxoid, tetanus toxoid, three purified pertussis antigens: [pertussis toxoid, (PT), filamentous haemagglutinin, (FHA), and pertactin, (69 kiloDalton outer membrane protein)] and the purified major surface antigen of the hepatitis B virus, (HBV), adsorbed on aluminium salts.
The diphtheria and tetanus toxins obtained from cultures of Corynebacterium diphtheriae and Clostridium tetani are detoxified and purified. The acellular pertussis vaccine components, (PT, FHA and pertactin), are prepared by growing phase I Bordetella pertussis from which the PT, FHA and pertactin are extracted, purified and treated with formaldehyde; PT is irreversibly detoxified.
The surface antigen of the HBV, (HBsAg), is produced by culture of genetically-engineered yeast cells, (Saccharomyces cerevisiae), which carry the gene coding for the major surface antigen of HBV. This HBsAg expressed in yeast cells is purified by several physico-chemical steps. The HBsAg assembles spontaneously, in the absence of chemical treatment, into sperical particles of 20nm in average diameter containing non-glycosylated HBsAg polypeptides and a lipid matrix consisting mainly of phospholipids. Extensive tests have demonstrated that these particles display the characteristic properties of natural HBsAg.
A 0.5mL dose of vaccine contains not less than 30 International Units, (IU), of diphtheria toxoid, not less than 40 IU of tetanus toxoid, 25µg of PT, 25µg of FHA, 8µg of pertactin and 10µg of recombinant HBsAg protein.
Suspension for injection.
INFANRIX-HepB is indicated for active primary immunisation against diphtheria, tetanus, pertussis, (DTP), and hepatitis B (HepB) infection.
A fourth, booster dose of INFANRIX-HepB is recommended for children from 15-24 months of age who have previously been immunised with three doses of this vaccine.
The recommended dose is 0.5mL.
The primary vaccination course consists of three doses. INFANRIX-HepB can be recommended for administration from the age of 2 months in which case subsequent doses should be given with an interval of 2 months, (2, 4, and 6 months). When INFANRIX-HepB is administered from the age of 3 months an interval of a least 1 month between doses should be respected, (schedules such as 3, 4, and 5 months, 3, 5, and 7 months, or 3, 5 and 11 or 12 months).
At this point in time, insufficient data are available to support the recommendation of a booster dose of the combined vaccine. The administration of a booster dose with the GlaxoSmithKline Biologicals combined diphtheria, tetanus, acellular pertussis vaccine is recommended before the end of the second year of life, (applies to children receiving three doses within the first seven months. For long-term protection, a booster dose of hepatitis B vaccine could also be administered after the first year of life.
INFANRIX-HepB vaccine must be administered by deep intramuscular injection. It is recommended that subsequent INFANRIX-HepB vaccine doses be administered at alternated injection sites.
INFANRIX-HepB SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED INTRAVENOUSLY
INFANRIX-HepB should not be administered to subjects with known hypersensitivity to any component of the vaccine, or to subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis or hepatitis B vaccines.
INFANRIX-HepB is contraindicated if the child has experienced an encephalopathy of unknown aetiology, occurring within seven days following previous vaccination with pertussis containing vaccine. In these circumstances the vaccination course should be continued with diphtheria, tetanus vaccine and hepatitis B vaccine.
Vaccinations should be preceded 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 other vaccinations, the administration of INFANRIX-HepB should be postponed in subjects suffering from acute febrile illness with temperature >38ºC. The presence of a minor infection is not a contraindication.
If any of the following events occur in temporal relation to receipt of INFANRIX-HepB, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered.
There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.
As with all injectable vaccines appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
INFANRIX-Hep B should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C, hepatitis E and other pathogens known to infect the liver.
A history of febrile convulsions, a family history of convulsions, a family history of sudden Infant Death syndrome, (SIDS), and a family history of an adverse event following INFANRIX-HepB vaccination do not constitute contraindications.
Human immunodeficiency virus, (HIV), infection is not considered as a contra-indication for diphtheria, tetanus, pertussis and hepatitis B vaccination. The expected immunological response may not be obtained after vaccination of immunosuppressed patients, e.g. patients on immonosuppressive therapy.
INFANRIX-Hep B does not contain thiomersal as a preservative, however, trace amounts of thiomersal residue resulting from the manufacturing process are present in the vaccine.
Clinical studies have demonstrated that INFANRIX-Hep B can be administered simultaneously with Haemophilus influenzae type b vaccine, inactivated polio vaccine or oral polio vaccine. In these clinical studies, the injectable vaccines were given at different injection sites.
The impact of mixing other injectable vaccines with INFANRIX-Hep B has not been established. INFANRIX-Hep B should not be mixed in the same syringe with any other vaccine.
As with other vaccines it may be expected that in patients receiving immunosuppressive therapy or patients with immunodeficiency, an adequate response may not be achieved.
Adequate human data on use during pregnancy or lactation and adequate animal reproduction studies are not available.
Not applicable.
In controlled clinical studies, signs and symptoms were actively monitored in all subjects for four days following the administration of the vaccine. A checklist was used for this purpose. The most commonly reported local reactions were redness, swelling and pain at the injection site.
General symptoms which were solicited and reported in temporal association with vaccination included fever, unusual crying, vomiting, diarrhoea, loss of appetite and restlessness. All symptoms resolved without sequelae.
The following symptoms have been very rarely reported : fatigue, malaise, headache, arthralgia, myalgia, drowsiness, sleeping less than usual, urticaria, anaphylaxis, allergic reactions, including anaphylactoid reactions and serum sickness like disease.
Extremely rare cases of collapse or shock-like state, (hypotonic-hyporesponsiveness episode), and convulsions within two to three days of vaccination have been reported. All the subjects recovered totally and spontaneously without sequelae.
Thrombocytopenia has been reported very rarely with hepatitis B containing vaccines.
Not applicable.
Pharmaco-therapeutic group : Bacterial and viral vaccines combined, ATC code JO7CA.
In a comparative study it has been shown that INFANRIX-HepB after primary vaccination induces an immune response to all vaccine components at least equivalent to that achieved following separate injection of the GlaxoSmithKline Biologicals combined diphtheria, tetanus, acellular pertussis vaccine and Engerix-B. The immune response elicited has been confirmed in five non-comparative trials using historical controls.
One month after a primary vaccination course, all infants vaccinated with INFANRIX-HepB had antibody titers higher than 0.1 IU/mL to both diphtheria and tetanus.
As the immune response to pertussis antigens following INFANRIX-HepB administration is equivalent to that of the GlaxoSmithKline Biologicals combined diphtheria, tetanus, acellular pertussis vaccine, it can be assumed that the protective efficacy of the two vaccines will also be equivalent.
The protective efficacy of the GlaxoSmithKline Bilogicals combined diphtheria, tetanus, acellular pertussis vaccine, against WHO-defined typical pertussis, (≥ 21 days of paroxysmal cough with laboratory confirmation), was demonstrated in :
After the primary vaccination course with INFANRIX-HepB, > 96% of infants developed antibody titers of ≥ 10 mIU/mL.
Evaluation of pharmacokinetic properties is not required for vaccines.
Not applicable.
Aluminium hydroxide, aluminium phosphate, formaldehyde, 2-phenoxyethanol, polysorbate 20 and 80, sodium chloride, water for injections.
INFANRIX-HepB should not be mixed with other vaccines in the same syringe.
The expiry date is indicated on the label and packaging. The shelf life is 36 months.
INFANRIX-HepB should be stored at +2ºC to + 8ºC and be protected from light.
Do not freeze. Discard if the vaccine has been frozen.
During transport, recommended conditions of storage must be respected.
The vaccine should be administered immediately after opening of the vial (not later than 8 hours after opening).
INFANRIX-HepB is presented as a suspension in a single dose glass vial or prefilled syringe. Upon storage, a white deposit and clear supernatant can be observed.
The vials and prefilled syringes are made of neutral glass type I, which conforms to European Pharmacopoeia Requirements.
The vaccine should be shaken in order to obtain a homogenous turbid white suspension, and visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either being observed, discard the vaccine.
Prescription Medicine
INFANRIX-HepB glass vials and prefilled syringes - available in packs of 1, 10s and 25s.
| Manufacturer : | GlaxoSmithKline Biologicals sa, rue de l'Institut 89, 1330 Rixensart, Belgium |
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Distributed in New Zealand By :
GlaxoSmithKline NZ Ltd
Quay Tower
Cnr Albert & Customs Street
Private Bag 106600
Downtown
Auckland
NEW ZEALAND
ph (09) 367 2900
fax (09) 367 2506
2 June 2003
Ref: MDS Version 004