Product overview
Type
Varicella
Commercial Name
Varivax
Manufacturer
Merck Sharp & Dohme LLC
Responsible NRA
CBER/FDA
Country
United States of America
Prequalification
Prequalification Status
Current
Product description
Pharmaceutical Form
Lyophilised active component to be reconstituted with excipient diluent before use
Presentation
Two vial set (active + excipient)
Number of Doses
1
Diluent
Water for Injection
Route of Administration
Subcutaneous
Shelf Life
24 months
Storage Temperature
2-8°C
Vaccine Vial Monitor
Type 7
Secondary Packaging
Carton of 10 single dose vaccine vials (10 doses)[Dimensions: 3.95 x 8.6 x 4.45 cm] and Carton of 10 single dose vial of diluent (10 doses)[Dimensions: 3.95 x 8.6 x 4.45 cm]
Tertiary Packaging
Shipping configuration for vaccine and diluent shipped in separate cases: a) Box [Dimensions: 74 x 66 x 61 cm] containing 2 cases of 48 cartons holding 10 single dose vials (960 doses); b) Box [Dimentions: 120 x 100 x 160 cm] containing 30 cases of 48 cartons holding 10 single dose vials (14 400 doses); c) Box [Dimensions: 120 x 100 x 160 cm] containing 64 cases of 48 cartons holding 10 single dose vials (30 720 doses)
Multidose Vial Policy
Not Applicable.
Vaccine Preservative
none
Cold Chain Volume
Vaccine: 15.11 Diluent: 15.11 cm3/dose (in secondary packaging)
Attachments