Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, UK
VAQTA Paediatric, suspension for injection.
Hepatitis A Vaccine, inactivated, adsorbed.
For children and adolescents.
| Pharmaceutical Form |
|---|
|
Suspension for injection in a prefilled syringe or vial. |
One dose (0.5 mL) contains:
Hepatitis A virus (strain CR 326F) (inactivated)1,2 25 U3.
1 Produced on human diploid (MRC–5) fibroblast cells.
2 Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.225 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. |
0.5 mL suspension in a pre-filled syringe (type I glass) with plunger-stopper (chlorobutyl isoprene blend or bromobutyl).
0.5 mL suspension in a pre-filled syringe (type I glass) with plunger-stopper (chlorobutyl isoprene blend or bromobutyl), without needle, with a tip-cap (chlorobutyl isoprene blend or bromobutyl isoprene blend), with 0, 1 or 2 separate needles.
0.5 mL suspension in a vial (glass), grey rubber stopper (chlorobutyl isoprene blend).
Pack sizes: Pack of 1 syringe or 1 vial.
Not all pack sizes and presentations may be marketed.
Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, UK
PL 53095/0008
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 |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
