Infanrix-IPV+Hib

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Diphtheria toxoid, adsorbed 30 [iU] (Not less than); Pertactin 8ug; Pertussis filamentous haemagglutinin 25ug; Pertussis toxoid, adsorbed 25ug; Polio virus type 1 40 DAgU (Inactivated); Polio virus type 2 8 DAgU (Inactivated); Polio virus type 3 32 DAgU (Inactivated); Tetanus toxoid, adsorbed 40 [iU] (Not less than); Haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (20 - 40 mcg of tetanus toxoid per dose)

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Detoxified pertussis toxin 25 µg

Dosage:

0.5 mL

Pharmaceutical form:

Suspension for injection

Composition:

Active: Diphtheria toxoid, adsorbed 30 [iU] (Not less than) Pertactin 8ug Pertussis filamentous haemagglutinin 25ug Pertussis toxoid, adsorbed 25ug Polio virus type 1 40 DAgU (Inactivated) Polio virus type 2 8 DAgU (Inactivated) Polio virus type 3 32 DAgU (Inactivated) Tetanus toxoid, adsorbed 40 [iU] (Not less than) Excipient: Aluminium Lactose Medium 199 Sodium chloride Water for injection Active: Haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (20 - 40 mcg of tetanus toxoid per dose)

Units in package:

Syringe, glass, single dose, 0.5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

GlaxoSmithKline Biologicals SA

Therapeutic indications:

INFANRIX??-IPV+Hib is indicated as a booster dose for children aged 15 months and older who have previously been immunised with DTP, polio and Hib antigens. The Hib component of the vaccine does not protect against diseases due to other serotypes of Haemophilus influenzae nor against meningitis caused by other organisms.

Product summary:

Package - Contents - Shelf Life: Combination pack, 1 x vial + 1 x syringe - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, glass, single dose, 0.5 mL - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, single dose - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

1998-07-22

Summary of Product characteristics

NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
INFANRIX-IPV+Hib Combined diphtheria-tetanus-acellular pertussis
(DTPa) enhanced inactivated
polio and _Haemophilus influenzae_ type b suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
INFANRIX-IPV+Hib contains diphtheria toxoid, tetanus toxoid, three
purified pertussis antigens (PT,
FHA and pertactin) adsorbed on aluminium salts. It contains three
types of inactivated polio viruses
(type 1: Mahoney strain; type 2: MEF-1 strain; type 3: Saukett strain)
and contains purified
polyribosyl-ribitol-phosphate capsular polysaccharide (PRP) of
_Haemophilus influenzae _type b (Hib),
covalently bound to tetanus toxoid.
The diphtheria and tetanus toxoids obtained from cultures of _
Corynebacterium diphtheriae_ and_ _
_Clostridium tetani_ are inactivated 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 and purified. FHA and pertactin are
treated with formaldehyde, PT is
treated with glutaraldehyde and formaldehyde, and irreversibly
inactivated.
The three polioviruses are cultivated on a continuous VERO cell line,
purified and inactivated with
formaldehyde.
The Hib polysaccharide is prepared from _ Haemophilus influenzae _
type b, strain 20,752 and is
coupled to tetanus toxoid. After purification the conjugate is
lyophilised in the presence of lactose
as stabiliser.
INFANRIX-IPV+Hib meets the World Health Organisation requirements for
the manufacture of
biological substances, of diphtheria, tetanus, pertussis and combined
vaccines, of inactivated
poliomyelitis vaccines and Hib conjugate vaccines.
After reconstitution, 1 dose (0.5 mL) of the vaccine contains:
Diphtheria toxoid
1
not less than 30 International Units (IU) (25 Lf)
Tetanus toxoid
1
not less than 40 International Units (IU) (10 Lf)
_Bordetella pertussis_ antigens
Pertussis toxoid
1
(PT)
25 micrograms
Filamentous haemagglutinin
1
(FHA)
25 micrograms
Pertactin
1
(PRN/69 kilo