Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, UK
VAQTA Adult, suspension for injection.
Hepatitis A vaccine, inactivated, adsorbed.
For adults.
| Pharmaceutical Form |
|---|
|
Suspension for injection in a prefilled syringe or vial. |
One dose (1mL) contains:
Hepatitis A virus (strain CR 326F) (inactivated)1,2: 50 U3.
1 Produced on human diploid (MRC–5) fibroblast cells.
2 Adsorbed on amorphous aluminium hydroxyphosphate sulphate (0.45 mg Al3+).
3 Units measured according to the in-house method of the manufacturer-Merck Sharp & Dohme Corp.
This vaccine may contain traces of neomycin and formaldehyde, which are used during the manufacturing process. See sections 4.3 and 4.4.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Hepatitis A, inactivated vaccine |
Inactivated virus of a strain which was originally derived by further serial passage of a proven attenuated strain. The virus is grown, harvested, highly purified, formalin inactivated, and then adsorbed onto amorphous aluminum hydroxyphosphate sulphate. |
| List of Excipients |
|---|
|
Sodium borate For adjuvant and for information regarding residual components in trace quantities, see sections 2, 4.3 and 4.4. |
1 mL suspension in a pre-filled syringe (type I glass) with plunger-stopper (chlorobutyl isoprene blend).
1 mL suspension in a pre-filled syringe (type I glass) with plunger-stopper (chlorobutyl isoprene blend), without needle, with a tip-cap (chlorobutyl isoprene blend), with 0, 1 or 2 separate needles.
1 mL suspension in a vial (type I glass), grey rubber stopper (chlorobutyl isoprene blend).
Pack sizes: Pack of 1 syringe or 1 vial.
Not all pack sizes or presentations may be marketed.
Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, UK
PL 53095/0007
Date of first authorisation: 15 August 1996
Date of latest renewal: 16 October 2006
| Drug | Countries | |
|---|---|---|
| VAQTA | Austria, Brazil, Canada, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Malta, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom, United States |
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