Menhibrix
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Side Effects & Adverse Reactions
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FDA Labeling Changes
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Uses
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.
History
There is currently no drug history available for this drug.
Other Information
MENHIBRIX (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine), for intramuscular injection, is supplied as a sterile, lyophilized powder which is reconstituted at the time of use with the accompanying saline diluent. MENHIBRIX contains Neisseria meningitidis serogroup C and Y capsular polysaccharide antigens and Haemophilus b capsular polysaccharide (polyribosyl-ribitol-phosphate [PRP]). The Neisseria meningitidis C strain and Y strain are grown in semi-synthetic media and undergo heat inactivation and purification. The PRP is a high molecular weight polymer prepared from the Haemophilus influenzae type b strain 20,752 grown in a synthetic medium that undergoes heat inactivation and purification. The tetanus toxin, prepared from Clostridium tetani grown in a semi-synthetic medium, is detoxified with formaldehyde and purified. Each capsular polysaccharide is individually covalently bound to the inactivated tetanus toxoid. After purification, the conjugate is lyophilized in the presence of sucrose as a stabilizer. The diluent for MENHIBRIX is a sterile saline solution (0.9% sodium chloride) supplied in vials.
When MENHIBRIX is reconstituted with the accompanying vial of saline diluent, each 0.5‑mL dose is formulated to contain 5 mcg of purified Neisseria meningitidis C capsular polysaccharide conjugated to approximately 5 mcg of tetanus toxoid, 5 mcg of purified Neisseria meningitidis Y capsular polysaccharide conjugated to approximately 6.5 mcg of tetanus toxoid, and 2.5 mcg of purified Haemophilus b capsular polysaccharide conjugated to approximately 6.25 mcg of tetanus toxoid. Each dose also contains 96.8 mcg of Tris (trometamol)-HCl, 12.6 mg of sucrose, and ≤0.72 mcg of residual formaldehyde. MENHIBRIX does not contain preservatives. The lyophilized vaccine and saline diluent vial stoppers are not made with natural rubber latex.
Sources
Menhibrix Manufacturers
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Glaxosmithkline Biologicals Sa
![Menhibrix (Meningococcal Groups C And Y And Haemophilus B Tetanus Toxoid Conjugate Vaccine) Injection, Powder, Lyophilized, For Solution [Glaxosmithkline Biologicals Sa]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Menhibrix | Glaxosmithkline Biologicals Sa
2.1 ReconstitutionMENHIBRIX 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.
Figure 2. Transfer saline diluent into the lyophilized vaccine vial.
Figure 3. Shake the vial well.
Figure 4. After reconstitution, withdraw 0.5 mL of reconstituted vaccine and administer intramuscularly.
2.2 AdministrationFor 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.
2.3 Dose and ScheduleA 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.
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