INFANRIX ®

Available from October 2004, for pre-school use in children aged 4-5 years.

Abbreviated vaccine composition: DTaP/IPV (high-dose Diphtheria, Tetanus and Pertussin; inactivated Polio).

Contains:

• Purified Diphtheria toxoid (30 I.U.)

• Purified Tetanus toxoid (40 I.U.)

• Purified Pertussis toxoid (PT)

• Inactivated Polio virus, types 1/2/3 (40, 8 and 32 Dantigen units respectively); cultured on Vero(African green monkey kidney) cells

• Aluminium hydroxide

• Formaldehyde

• Neomycin, streptomycin and polymyxin B - antibiotics

• 2-phenoxyethanol (phenol) - a preservative

• Polysorbate 80 - an emulsifier

• Polyribosylribitol - an artificial sweetener

Undesirable effects (as reported by Dept of Health and Aventis Pasteur ® ):

• Injection site pain; redness; swelling

• Headache; fever

• Rigors; febrile convulsions and pain

• Myalgia; arthralgia; joint swelling

• Diarrhoea & vomiting

• Lymph node swelling

• Allergic/anaphylactic reactions

• Rash, urticaria

• Pruritis; earache; pharyngitis; eye pain; insomnia; rhinitis; coughing; urinary incontinence; abdominal pain; back pain

• Guillain-Barré syndrome has been reported after vaccination containing tetanus toxoid

• As observed with other vaccines containing DTaP, cases of extensive swelling of the affected limb - sometimes involving the entire limb

Side effects of the vaccine include adverse reactions to all components