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Prevenar 13 Multidose Vial

Product overview

Vaccine type
Pneumococcal (conjugate)
Commercial Name
Prevenar 13 Multidose Vial
Manofacturer
Pfizer Europe MA EEIG
Responsible NRA
European Medicines Agency
Country
Netherlands

Prequalification

Prequalification Status
Current
Effective Date

Product description

Pharmaceutical Form
Liquid: ready to use
Presentation
Vial
Number of Doses
4
Diluent
Not Applicable
Route of Administration
Intramuscular
Shelf Life
36 months
Storage Temperature
2-8°C
Vaccine Vial Monitor
Type 30
Secondary Packaging
50 vial carton (200 doses) [dimensions: 17.9 x 9.2 x 4.3 cm]; 25 vial carton (100 doses) [dimensions: 9.1 x 9.2 x 4.3 cm]
Tertiary Packaging
box of 36 x 50-vial cartons or 72 x 25-vial cartons; box placed in isocontainer and exterior carton [dimensions 70.2 x 70.2 x 53 cm] OR single pallet shipper used with 30 tertiary boxes
Multidose Vial Policy
WHO recommends that opened vials of this vaccine may be kept for use in subsequent immunization 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.
Vaccine Preservative
2-phenoxyethanol
Vaccine Preservative Concentration
4mg/dose
Cold Chain Volume
3.5 [50 vial carton]; 3.6 [25 vial carton] cm3/dose (in secondary packaging)

Attachments

VPSAR (Vaccine Public Summary Assessment Report)
Container Photo
Package Insert