Nazione: Singapore
Lingua: inglese
Fonte: HSA (Health Sciences Authority)
PURIFIED CAPSULAR POLYSACCHARIDE OF HIB
GLAXOSMITHKLINE PTE LTD
J07AG01
10mcg/0.5ml
INJECTION, POWDER, FOR SOLUTION
PURIFIED CAPSULAR POLYSACCHARIDE OF HIB 10mcg/0.5ml
INTRAMUSCULAR
Prescription Only
GlaxoSmithKline Biologicals
ACTIVE
1998-07-02
1 HIBERIX™ _HAEMOPHILUS INFLUENZAE_ TYPE B (HIB) VACCINE QUALITATIVE AND QUANTITATIVE COMPOSITION Each single dose of vaccine is formulated to contain 10 μg of purified capsular polysaccharide covalently bound to approximately 30 μg tetanus toxoid. _HIBERIX_™ is a lyophilised vaccine of purified polyribosyl-ribitol-phosphate capsular polysaccharide (PRP) of Hib, covalently bound to tetanus toxoid. The Hib polysaccharide is prepared from Hib, strain 20,752 and after activation with cyanogen bromide and derivatisation with an adipic hydrazide spacer is coupled to tetanus toxoid via carbodiimide condensation. After purification the conjugate is lyophilised in the presence of lactose as stabiliser. _HIBERIX_™ meets the WHO requirements for the manufacture of biological substances and of Hib conjugated vaccines. PHARMACEUTICAL FORM Powder and diluent for solution for injection. CLINICAL PARTICULARS INDICATIONS _HIBERIX_™ is indicated for active immunisation of all infants from the age of 6 weeks against disease caused by Hib _._ _HIBERIX_™ does not protect against disease due to other types of _H. influenzae_ nor against meningitis caused by other organisms. DOSAGE AND ADMINISTRATION POSOLOGY The primary vaccination schedule consists of three doses in the first 6 months of life and can start from the age of 6 weeks. To ensure a long term protection, a booster dose is recommended in the second year of life. Infants between the ages of 6 and 12 months previously unvaccinated should receive 2 injections, given with an interval of one month, followed by a booster in the second year of life. Previously unvaccinated children aged 1-5 years should be given one dose of vaccine. As vaccination schemes vary from country to country, the schedule for each country may be used in accordance with the different national recommendations. 2 METHOD OF ADMINISTRATION The reconstituted vaccine is for INTRAMUSCULAR inje Leggi il documento completo
1 HIBERIX _HAEMOPHILUS INFLUENZAE_ TYPE B (HIB) VACCINE POWDER AND SOLVENT FOR SOLUTION FOR INJECTION QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 ml) contains: _Haemophilus influenzae_ type b polysaccharide 10 micrograms conjugated to tetanus toxoid as carrier protein approximately 25 micrograms _HIBERIX_ is a white powder. The solvent is a clear and colourless liquid. CLINICAL INFORMATION INDICATIONS _HIBERIX_ is indicated for active immunisation of all infants from the age of 6 weeks against disease caused by Hib _._ _HIBERIX_ does not protect against disease due to other types of _H. influenzae_ nor against meningitis caused by other organisms. DOSAGE AND ADMINISTRATION POSOLOGY The primary vaccination schedule consists of three doses in the first 6 months of life and can start from the age of 6 weeks. To ensure a long term protection, a booster dose is recommended in the second year of life. Infants between the ages of 6 and 12 months previously unvaccinated should receive 2 injections, given with an interval of one month, followed by a booster in the second year of life. Previously unvaccinated children aged 1-5 years should be given one dose of vaccine. As vaccination schemes vary from country to country, the schedule for each country may be used in accordance with the different national recommendations. METHOD OF ADMINISTRATION The reconstituted vaccine is for INTRAMUSCULAR injection. However, it is good clinical practice that in patients with thrombocytopenia or bleeding disorders the vaccine should be administered subcutaneously. 2 CONTRAINDICATIONS _HIBERIX_ 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 Hib vaccines. WARNINGS AND PRECAUTIONS As with other vaccines, the administration of _HIBERIX_ should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contraindi Leggi il documento completo