VAQTA PAEDIATRIC Suspension for injection Ref.[50245] Active ingredients: Hepatitis A, inactivated vaccine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, UK

Product name and form

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.

Qualitative and quantitative composition

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
Sodium chloride
Water for injections

For adjuvant and for information regarding residual components in trace quantities, see sections 2, 4.3 and 4.

Pack sizes and marketing

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.

Marketing authorization holder

Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, UK

Marketing authorization dates and numbers

PL 53095/0008

Date of first authorisation: 15 August 1996
Date of latest renewal: 16 October 2006

Drugs

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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