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MenHibrix

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MenHibrix

INDICATIONS

MENHIBRIX® is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b. MENHIBRIX is approved for use in children 6 weeks of age through 18 months of age.

DOSAGE AND ADMINISTRATION

Reconstitution

MENHIBRIX is to be reconstituted only with the accompanying saline diluent. The reconstituted vaccine should be a clear and colorless solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

Figure 1: Cleanse both vial stoppers. Withdraw 0.6 mL of saline from diluent vial.

Cleanse both vial stoppers - Illustration

Figure 2: Transfer saline diluent into the lyophilized vaccine vial.

Transfer saline diluent into the lyophilized vaccine vial - Illustration

Figure 3: Shake the vial well.

Shake the vial well - Illustration

Figure 4: After reconstitution, withdraw 0.5 mL of reconstituted vaccine and administer intramuscularly.

Withdraw 0.5 mL of reconstituted vaccine - Illustration

Administration

For intramuscular use only. Do not administer this product intravenously, intradermally, or subcutaneously.

After reconstitution, administer MENHIBRIX immediately.

Use a separate sterile needle and sterile syringe for each individual. The preferred administration site is the anterolateral aspect of the thigh for most infants younger than 1 year of age. In older children, the deltoid muscle is usually large enough for an intramuscular injection.

Dose and Schedule

A 4-dose series, with each 0.5-mL dose given by intramuscular injection at 2, 4, 6, and 12 through 15 months of age. The first dose may be given as early as 6 weeks of age. The fourth dose may be given as late as 18 months of age.

HOW SUPPLIED

Dosage Forms And Strengths

MENHIBRIX is a solution for injection supplied as a single-dose vial of lyophilized vaccine to be reconstituted with the accompanying vial of saline diluent. A single dose after reconstitution is 0.5 mL.

Storage And Handling

MENHIBRIX is available in single-dose vials of lyophilized vaccine, accompanied by vials containing 0.85 mL of saline diluent (packaged without syringes or needles).

Supplied as package of 10 doses (NDC 58160-801-11):

NDC 58160-809-01 Vial of lyophilized vaccine in Package of 10: NDC 58160-809-05

NDC 58160-813-01 Vial of saline diluent in Package of 10: NDC 58160-813-05

Storage Before Reconstitution

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

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

Storage After Reconstitution

After reconstitution, administer MENHIBRIX immediately. Do not freeze. Discard if the vaccine has been frozen.

Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium, US License 1617, and Distributed by : GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: June 2012

Last reviewed on RxList: 7/23/2012
This monograph has been modified to include the generic and brand name in many instances.

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