PEDIACEL ® - The 5:1 Vaccine

Available from October 2004, for use in babies aged 2/3/4 months.

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

Contains:

• Purified Diphtheria toxoid (30 I.U.)

• Purified Tetanus toxoid (40 I.U.)

• Purified Pertussis toxoid (PT)

• Inactivated Polio virus

• Haemophylus influenza type B

• Polyribosylribitol phosphate - an artificial sweetener

• Formaldehyde or gluteraldehyde

• Polio virus produced on Vero cells (African green monkey kidney cells)

• Neomycin, streptomycin and polymyxin B - antibiotics

• 2-phenoxyethanol (phenol) - a preservative

• Polysorbate 80 - an emulsifier

• Aluminium phosphate or aluminium hydroxide

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

• HHE (hypotonic hyporesponsive episode)

• Loss of consciousness; pallor; no muscle tone (floppy)

• Persistent inconsolable crying or high-pitched screaming for 3 hours or more

• Convulsions, with or without fever

• Anorexia; diarrhoea & vomiting

• Pain, swelling and redness at the injection site

• Arthralgia (joint pain); myalgia

• Lymphadenopathy (swelling of lymph nodes)

• Acute allergic reactions; dyspnoea; cyanosis; urticaria

• Angioneurotic oedema; hypotension; and rarely, anaphylaxis

Side effects of the vaccine include adverse reactions to all of the components.