Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex TW8 9GS Trading as: GlaxoSmithKline UK
Boostrix-IPV suspension for injection in pre-filled syringe.
Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content).
| Pharmaceutical Form |
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Suspension for injection in pre-filled syringe. Boostrix-IPV is a turbid white suspension. |
1 dose (0.5 ml) contains:
Diphtheria toxoid1: not less than 2 International Units (IU) (2.5 Lf)
Tetanus toxoid1: not less than 20 International Units (IU) (5 Lf)
Bordetella pertussis antigens:
Pertussis toxoid1: 8 micrograms
Filamentous Haemagglutinin1: 8 micrograms
Pertactin1: 2.5 micrograms
Inactivated poliovirus:
type 1 (Mahoney strain)2: 40 D-antigen unit
type 2 (MEF-1 strain)2: 8 D-antigen unit
type 3 (Saukett strain)2: 32 D-antigen unit
1 adsorbed on aluminium hydroxide, hydrated (Al(OH)3) and aluminium phosphate (AlPO4): 0.3 milligrams Al3+
2 propagated in VERO cells: 0.2 milligrams Al3+
The vaccine may contain traces of formaldehyde, neomycin and polymyxin which are used during the manufacturing process (see section 4.3).
Excipients with known effect: The vaccine contains para-aminobenzoic acid <0.07 nanograms per dose and phenylalanine 0.0298 micrograms per dose (see section 4.4).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Diphtheria toxoid |
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| Pertactin |
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| Pertussis filamentous hemagglutinin |
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| Pertussis toxoid |
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| Tetanus toxoid |
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| List of Excipients |
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Medium 199 (as stabilizer containing amino acids (including phenylalanine), mineral salts (including sodium and potassium), vitamins (including para-aminobenzoic acid) and other substances) For adjuvants, see section 2. |
0.5 ml of suspension in a pre-filled syringe (Type I glass) with a stopper (butyl rubber) with or without needles in pack sizes of 1 or 10.
Not all pack sizes may be marketed.
SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex TW8 9GS
Trading as: GlaxoSmithKline UK
PL 10592/0214
Date of first authorisation: 6 July 2005
Date of last renewal: 16 December 2008
| Drug | Countries | |
|---|---|---|
| BOOSTRIX | Austria, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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