HIBERIX VACCINE 10 mcg0.5 ml

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

PURIFIED CAPSULAR POLYSACCHARIDE OF HIB

Disponível em:

GLAXOSMITHKLINE PTE LTD

Código ATC:

J07AG01

Dosagem:

10mcg/0.5ml

Forma farmacêutica:

INJECTION, POWDER, FOR SOLUTION

Composição:

PURIFIED CAPSULAR POLYSACCHARIDE OF HIB 10mcg/0.5ml

Via de administração:

INTRAMUSCULAR

Tipo de prescrição:

Prescription Only

Fabricado por:

GlaxoSmithKline Biologicals

Status de autorização:

ACTIVE

Data de autorização:

1998-07-02

Folheto informativo - Bula

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

Características técnicas

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