Haemophilus b conjugate vaccine how supplied

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Haemophilus b conjugate vaccine
HIBERIX® FDA Package Insert
Description
Clinical Pharmacology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

How Supplied/Storage And Handling

HIBERIX is available in single-dose vials (contains no latex)of lyophilized vaccine, accompanied by disposable prefilled TIP-LOK syringes (may contain latex) (packaged without needles) containing 0.7 mL of saline diluent. The tip caps of the needleless prefilled syringes may contain natural rubber latex.

Supplied as

NDC 58160-806-01 Vial of lyophilized vaccine in Package of 10: NDC 58160-806-05

NDC 58160-951-02 Syringe containing diluent in Package of 10: NDC 58160-951-11

Storage Before Reconstitution

Lyophilized vaccine vials: Store refrigerated between 2° and 8°C (36° and 46°F). Protect vials from light.

Diluent: Store refrigerated between 2° and 8°C (36° and 46°F) or at a controlled room temperature between 20° and 25°C (68° and 77°F). Do not freeze. Discard if the diluent has been frozen.

Storage After Reconstitution

HIBERIX should be administered within 24 hours of reconstitution. After reconstitution, store refrigerated between 2° and 8°C (36° and 46°F). Discard the reconstituted vaccine if not used within 24 hours. Do not freeze. Discard if the vaccine has been frozen.[1]


References

  1. "HIBERIX (HAEMOPHILUS B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA]".

Adapted from the FDA Package Insert.