"The U.S. Food and Drug Administration today approved Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
Bexsero is the second vaccine approved"...
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
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 diluents vial.
Figure 2: Transfer saline diluent into the lyophilized
Figure 3: Shake the vial well.
Figure 4: After reconstitution, withdraw 0.5 mL of
reconstituted vaccine and administer intramuscularly.
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.
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, and Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: Nov 2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/22/2015
Additional MenHibrix Information
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