Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: SmithKline Beecham Ltd, 980, Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom Trading as: GlaxoSmithKline UK
Varilrix powder and solvent for solution for injection in pre-filled syringe.
Varicella vaccine (live).
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection in pre-filled syringe. Before reconstitution, the powder is slightly cream to yellowish or pinkish coloured cake and the solvent is a clear colourless liquid. |
After reconstitution, one dose (0.5 mL) contains:
Varicella virus1 Oka strain (live, attenuated) not less than 103.3 PFU2.
1 produced in human diploid cells (MRC-5)
2 plaque forming units
This vaccine contains a trace amount of neomycin (see section 4.3).
Excipients with known effect:
The vaccine contains 6 mg of sorbitol per dose.
The vaccine contains 331 micrograms of phenylalanine per dose (see section 4.4).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Varicella, live attenuated |
Natural infection induces a cellular and humoral immune response to the varicella-zoster virus, which can be rapidly detected following infection. IgG, IgM and IgA directed against viral proteins usually appear at the same time that a cellular immune response can be demonstrated, making the relative contribution of humoral and cellular immunity to disease progression difficult to ascertain. Vaccination has been shown to induce both humoral and cell-mediated types of immunity. |
| List of Excipients |
|---|
|
Powder: Amino acids (containing phenylalanine) Solvent: Water for injections |
Powder in a single-dose glass vial (type I glass) with a stopper (bromobutyl rubber).
0.5 ml of solvent in a pre-filled syringe (type I glass) with plunger stopper (bromobutyl rubber), with or without separate needles in the following pack sizes:
0.5 ml of solvent in an ampoule (type I glass).
Pack size of 10.
Not all pack sizes may be marketed.
SmithKline Beecham Ltd, 980, Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom
Trading as: GlaxoSmithKline UK
Vaccine: PL 10592/0121
Diluent: PL 10592/0021
Date of first authorisation: 25 June 2002
Date of last renewal: 12 March 2009
| Drug | Countries | |
|---|---|---|
| VARILRIX | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong, Israel, Lithuania, Malta, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa |
© 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.
