Country: Նոր Զելանդիա
language: անգլերեն
source: Medsafe (Medicines Safety Authority)
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)
GlaxoSmithKline NZ Limited
Detoxified pertussis toxin 25 µg
0.5 mL
Suspension for injection
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)
Syringe, glass, single dose, 0.5 mL
Prescription
Prescription
GlaxoSmithKline Biologicals SA
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.
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)
1998-07-22
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 read_full_document