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Side Effects & Adverse Reactions
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Uses
MENVEO is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. MENVEO is approved for use in persons 2 months through 55 years of age.
MENVEO does not prevent N. meningitidis serogroup B infections.
History
There is currently no drug history available for this drug.
Other Information
MENVEO [Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine] is a sterile liquid vaccine administered by intramuscular injection that contains N. meningitidis serogroup A, C, Y and W-135 oligosaccharides conjugated individually to Corynebacterium diphtheriae CRM197 protein. The polysaccharides are produced by bacterial fermentation of N. meningitidis (serogroups A, C, Y or W-135). N. meningitidis strains A, C, Y and W-135 are each cultured and grown on Franz Complete medium and treated with formaldehyde. MenA, MenW-135 and MenY polysaccharides are purified by several extraction and precipitation steps. MenC polysaccharide is purified by a combination of chromatography and precipitation steps.
The protein carrier (CRM197) is produced by bacterial fermentation and is purified by a series of chromatography and ultrafiltration steps. C. diphtheriae is cultured and grown on CY medium containing yeast extracts and amino acids.
The oligosaccharides are prepared for conjugation from purified polysaccharides by hydrolysis, sizing, and reductive amination. After activation, each oligosaccharide is covalently linked to the CRM197 protein. The resulting glycoconjugates are purified to yield the four drug substances, which compose the final vaccine. The vaccine contains no preservative or adjuvant. Each dose of vaccine contains 10 μg MenA oligosaccharide, 5 μg of each of MenC, MenY and MenW-135 oligosaccharides and 32.7 to 64.1 μg CRM197 protein. Residual formaldehyde per dose is estimated to be not more than 0.30 μg.
The vials in which the vaccine components are contained are composed of Type I glass, USP. The container closures (synthetic rubber stoppers) do not contain latex.
Sources
Menveo Manufacturers
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Novartis Vaccines And Diagnostics S.r.l.
![Menveo (Meningococcal (Groups A, C, Y And W-135) Oligosaccharide Diphtheria Crm197 Conjugate Vaccine) Kit [Novartis Vaccines And Diagnostics S.r.l.
]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Menveo |
For intramuscular injection only.
2.1 Reconstitution InstructionsMENVEO is supplied in two vials that must be combined prior to administration. MENVEO must be prepared for administration by reconstituting the MenA lyophilized conjugate vaccine component with the MenCYW-135 liquid conjugate vaccine component. Using a graduated syringe, withdraw the entire contents of the vial of MenCYW-135 liquid conjugate component and inject into the MenA lyophilized conjugate component vial. Invert the vial and shake well until the vaccine is dissolved and then withdraw 0.5mL of reconstituted product.
Please note that it is normal for a small amount of liquid to remain in the vial following withdrawal of the dose.
Following reconstitution, the vaccine is a clear, colorless solution, free from visible foreign particles. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If any of these conditions exist, MENVEO should not be administered.
The reconstituted vaccine should be used immediately, but may be held at or below 77°F (25°C) for up to 8 hours.
2.2 AdministrationEach MENVEO dose should be administered as a single 0.5 mL intramuscular injection, preferably into the anterolateral aspect of the thigh in infants or into the deltoid muscle (upper arm) in toddlers, adolescents and adults. Do not administer MENVEO intravenously, subcutaneously or intradermally.
2.3 Dosing ScheduleThe dosing schedule for individuals initiating vaccination is as follows:
Infants 2 Months of Age
MENVEO is to be administered as a four-dose series at 2, 4, 6, and 12 months of age.
Children 7 Months through 23 Months of Age
MENVEO is to be administered as a two-dose series with the second dose administered in the second year of life and at least three months after the first dose.
Children 2 Years through 10 Years of Age
MENVEO is to be administered as a single dose. For children 2 years through 5 years of age at continued high risk of meningococcal disease, a second dose may be administered 2 months after the first dose.
Adolescents and Adults 11 Years through 55 Years of Age
MENVEO is to be administered as a single dose.
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