Initial U.S. Approval: 1997
INFANRIX is a vaccine indicated for active immunization against diphtheria, tetanus, and pertussis…
Postmarketing Experience
– Bronchitis, cellulitis, respiratory tract infection.
– Lymphadenopathy, thrombocytopenia.
– Anaphylactic reaction, hypersensitivity.
– Encephalopathy, headache, hypotonia, syncope.
– Ear pain.
– Cyanosis.
– Apnea, cough.
– Angioedema, erythema, pruritus, rash, urticaria.
– Fatigue, injection site induration, injection site reaction, Sudden Infant Death Syndrome.
Each 0.5-mL dose contains aluminum hydroxide as adjuvant (not more than 0.625 mg aluminum by assay) and 4.5 mg of sodium chloride. Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80).
INFANRIX has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility.