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Bivalent Oral Poliomyelitis Vaccine Type 1&3 (bOPV 1&3)

Product overview

Type
Polio Vaccine - Oral (OPV) Bivalent Types 1 and 3
Commercial Name
Bivalent Oral Poliomyelitis Vaccine Type 1&3 (bOPV 1&3)
Manufacturer
PT Bio Farma (Persero)
Responsible NRA
National Agency of Drug and Food Control Indonesia
Country
Indonesia

Prequalification

Prequalification Status
Current
Effective Date

Product description

Pharmaceutical Form
Liquid: ready to use
Presentation
Vial
Number of Doses
20
Diluent
Not Applicable
Route of Administration
Oral
Shelf Life
24 months
Storage Temperature
-20°C
Vaccine Vial Monitor
Type 2
Secondary Packaging
Carton fo 50 vials (1000 doses) [Dimensions: 17.0 x 8.5 x 3.8 cm]
Tertiary Packaging
a) Box of 48 cartons of 50 vials (2400 vials/48000 doses)[Dimensions: 6.5 x 5.1 x 6.0 cm]; b) Box of 30 cartons of 50 vials (1500 vials/ 30000 doses)[Dimensions: 52 x 52 x 53 cm]; Box of 6 cartons of 50 vials (300 vials/6000 doses) [Dimensions: 52 x 49 x 46 cm]
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
none
Cold Chain Volume
0.55 cm3/dose (in secondary packaging)

Attachments

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