Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
TicoVac 0.5 ml Suspension for injection in a pre-filled syringe.
Tick-Borne Encephalitis Vaccine (whole Virus, inactivated).
| Pharmaceutical Form |
|---|
|
Suspension for injection in a pre-filled syringe. After shaking the vaccine is an off-white, opalescent suspension. |
One dose (0.5 ml) contains:
Tick-Borne Encephalitis Virus1,2 (strain Neudörfl) 2.4 micrograms
1 adsorbed on aluminium hydroxide, hydrated (0.35 milligrams Al3+)
2 produced in chick embryo fibroblast cells (CEF cells)
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Encephalitis, tick borne |
Encephalitis, tick borne suspension for injection is indicated for the active (prophylactic) immunization of persons of 16 years of age and older against tick-borne encephalitis (TBE). Its pharmacodynamic effect consists of the induction of a sufficiently high concentration of anti-TBE antibody to provide protection against the TBE virus. |
| List of Excipients |
|---|
|
Human albumin |
0.5 ml of suspension for injection in pre-filled syringe (type I glass) with a plunger stopper (halogenobutyl rubber). Pack sizes of 1 and 10 are available. The pack may include no needles or 1 separate needle per syringe. Needles are sterile and for single use only. Not all pack sizes may be marketed.
Each pre-filled syringe is packed in a blister. The opening in the blister seal is intended and allows for the equilibration of moisture during the recommended warm-up prior to the administration of the vaccine. Open the blister by removing the lid to take out the syringe. Do not press the syringe through the blister.
For subcutaneous administration, see section 6.6.
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
PL 00057/1518
Date of first authorisation: 30 June 2004
Date of last renewal: 18 January 2007
| Drug | Countries | |
|---|---|---|
| TICOVAC | Estonia, Finland, France, Ireland, Israel, Lithuania, Malta, United Kingdom |
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