Sanofi Pasteur #49281-0511-05 Pentacel® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Suspension for Intramuscular Injection INDICATIONS AND USAGE ——————————— Á Pentacel is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b. Pentacel is approved for use as a four dose series in children 6 weeks through 4 years of age (prior to 5th birthday). (1) —————————— DOSAGE AND ADMINISTRATION —————————— Á The four dose immunization series consists of a 0.5 mL intramuscular injection, after reconstitution, administered at 2, 4, 6 and 15-18 months of age. (2.1) Á Pentacel consists of a liquid vaccine component (DTaP-IPV component) and a lyophilized vaccine component (ActHIB vaccine). Reconstitute the ActHIB vaccine component with the DTaP-IPV component immediately before administration. (2.2) ————————— DOSAGE FORMS AND STRENGTHS ————————— Á Suspension for injection (0.5 mL dose) supplied as a liquid vaccine component that is combined through reconstitution with a lyophilized vaccine component, both in single-dose vials. (3) 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied The vial stoppers for the DTaP-IPV and ActHIB vaccine components of Pentacel are not made with natural rubber latex. 5 Dose Package (NDC No. 49281-511-05) containing 5 vials of DTaP-IPV component (NDC No. 49281-561-01) to be used to reconstitute 5 single-dose vials of lyophilized ActHIB vaccine component (NDC No. 49281-544-58). 16.2 Storage and Handling Pentacel should be stored at 2° to 8°C (35° to 46°F). Do not freeze. Product which has been exposed to freezing should not be used. Do not use after expiration date shown on the label.`
Size: .5ML
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