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: .5MLMore Information
