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Rotateq

Product overview

Type
Rotavirus
Commercial Name
Rotateq
Manufacturer
Merck Sharp & Dohme LLC
Responsible NRA
CBER/FDA
Country
United States of America

Prequalification

Prequalification Status
Current
Effective Date

Product description

Pharmaceutical Form
Liquid: ready to use
Presentation
Plastic Tube
Number of Doses
1
Diluent
Not Applicable
Route of Administration
Oral
Shelf Life
24 months
Storage Temperature
2-8°C
Vaccine Vial Monitor
none
Secondary Packaging
a) Carton of 10 monodose tubes [Dimensions: 13.9 x 9.5 x 5.7 cm]; b) Carton of 25 monodose tubes [Dimensions: 12.9 x 8.3 x 10.8 cm]
Tertiary Packaging
a) Box containing 20 cartons of 10 monodose tubes (200 tubes) [Dimensions: 39.7 x 30.5 x 14.8 cm]; b) Box containing 18 cartons of 25 monotubes (450 tubes) [Dimensions: 39.2x33.2x17.1 cm]
Multidose Vial Policy
Not Applicable.
Vaccine Preservative
none
Cold Chain Volume
a) 75.26; b) 46.25 cm3/dose (in secondary packaging)

Attachments

Container Photo
Package Insert