Trivax Hib

Adsorbed Diphtheria, Tetanus and Pertussis Vaccine BP, DTPer/Vac/Ads (Trivax-AD®) and Haemophilus type b conjugate Vaccine

Presentation

Combination pack containing a glass vial of Hib vaccine for reconstitution with Trivax-AD supplied in a glass prefilled syringe. When mixed a 0.5 ml dose contains > 30 IU of diphtheria toxoid, > 60 IU of tetanus toxoid and < 2 x 10 10 Bordetella pertussis organisms with a potency of > 4 IU, adsorbed on to aluminium hydroxide and 10 mcg of purified capsular polysaccharide of Hib covalently bound to approx. 30 mcg of tetanus toxoid. £14.50 per pack. PL 10592/0083.

Uses

Active immunisation against diphtheria, tetanus, pertussis and Haemophihis influenzae type B in infants and children under 10 years of age.

Posology and method of administration

The primary course should start at 2 months of age, and consists of three doses with an interval of at least one month between each dose. Each dose consists of 0.5 ml of the vaccine by intramuscular injection.

Contra-indications

Hypersensitivity to any component of the vaccine or previous diphtheria, tetanus, pertussis or Hib vaccines. Acute severe febrile illness. Progressive degenerative neurological disorder. Hypotonic hvporesponsiveness. Severe local or general reaction to a previous dose of the vaccine. Children with a personal or family history of idiopathic epilepsy or other diseases of the central nervous system. Children with a history of seizures, convulsions, and other neurological disorders. Children aged 10 years and over, adults and the elderly.

Special warnings and precautions for use

Adrenaline 1:1000 solution should be available in case of anaphylaxis. Take antipyretic measures for febrile convulsions. Severe hypersensitivity reactions may occur in subjects aged 10 years and over. Administer with caution in subjects with bleeding disorders. Do not administer intravenously or intradermally. Do not use during pregnancy or lactation.

Undesirable effects

Local reactions e.g. erythema, pain and swelling at site of injection. Transient raised temperature, restlessness, irritability, crying, loss of appetite, vomiting or diarrhoea. Headache, malaise, somnolence and rarely allergic reactions have been reported. Neurological events, including febrile convulsions, infantile spasms. persistent screaming and severe encephalopathy have occasionally been observed.

Legal category POM

1.11.96

SmithKIine Beecham Pharmaceuticals, Mundells, Welwyn Garden City, Hertfordshire AL7 IEY

Trivax-AD and ‘Trivax-Hib’ are trade marks of Evans Medical; Combi-Pack’ and the SB logo are trade marks of SmithKline Beecham Pharmaceuticals

1096TR:MF/6/001

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