Immunization standards

Meningococcal ACYW-135 Polysaccharide (10 dose vial)

Vaccine Trade Name: Menomune

Vaccine Type: Meningococcal ACYW-135 Polysaccharide vaccine

Manufacturer: Sanofi Pasteur

Country of Manufacture: USA

Date of prequalification: 22 May 2013

NRA of Record: US FDA (CBER)

Product Description

Pharmaceutical form: lyophilised (active) + liquid (diluent)

Presentation: 10 dose vial (active) + diluent vial

Route of administration: subcutaneous

Vaccine Vial Monitor: Type 30 (Vaccine with VVM will be available from Q4 2013)

Shelf life: 24 months at 2 - 8 °C

Secondary Packaging: Carton containing one vial of active and one vial of diluent [58.67 x 30.48 x 62.23 mm ]

Cold Chain volume per dose (cm3): 11.13

Tertiary Packaging: Carton containing 100 secondary cartons 298.45 x 307.975 x 133.35 mm . Several different sized insulated shipping containers are available

Preservative: Thiomersal (100μg/mL) in the Water for Injection diluent

Handling of opened multi-dose vials: WHO recommends that opened vials of the vaccine may be kept for use in subsequent immunisation sessions (up to a maximum of 28 days) provided the conditions outlined in the WHO Policy Statement:The use of opened multi-dose vials of vaccine in subsequent immunization sessions are met

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Last update:

25 July 2013 10:31 CEST