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 is indicated for the active (prophylactic) immunization of persons of 16 years of age and older against tick-borne encephalitis (TBE).
TicoVac 0.5 ml is to be given on the basis of official recommendations regarding the need for, and timing of, vaccination against TBE.
The primary vaccination schedule is the same for all persons from the age of 16 onwards and consists of three doses of TicoVac 0.5 ml.
The first and second dose should be given at a 1 to 3 month interval.
If there is a need to achieve an immune response rapidly, the second dose may be given two weeks after the first dose.
After the first two doses sufficient protection for the ongoing tick season is to be expected (see section 5.1).
The third dose should be given 5 to 12 months after the second vaccination. After the third dose protection is expected to last for at least 3 years.
To achieve immunity before the beginning of the seasonal tick activity, which is in spring, the first and second doses should preferably be given in the winter months. The vaccination schedule should ideally be completed with the third vaccination within the same tick season or at the least before the start of the following tick season.
| Basic Immunization | Dose | Conventional Schedule | Rapid Immunization Schedule |
|---|---|---|---|
| 1st dose | 0.5 ml | Elected date | Elected date |
| 2nd dose | 0.5 ml | 1 to 3 months after the 1st vaccination | 14 days after the 1st vaccination |
| 3rd dose | 0.5 ml | 5 to 12 months after the 2nd vaccination | 5 to 12 months after the 2nd vaccination |
The first booster dose should be given 3 years after the third dose (see section 5.1).
Sequential booster doses should be given every 5 years after the last booster dose.
In general, in individuals over 60 years of age the booster intervals should not exceed three years.
| Booster dose ≥16 to <60 years | Dose | Timing |
|---|---|---|
| 1st booster | 0.5 ml | 3 years after the 3rd vaccination |
| Sequential booster doses | 0.5 ml | every 5 years |
| Booster dose ≥60 years | Dose | Timing |
| All booster doses | 0.5 ml | every 3 years |
Extending the interval between any of the doses (primary vaccination schedule and booster doses) may leave subjects with inadequate protection against infection (see section 5.1).
However, in the case of an interrupted vaccination schedule of at least two previous vaccinations, a single catch-up dose is sufficient to continue the vaccination schedule (see section 5.1).
There are no specific clinical data on which to base dose recommendations. However, consideration may be given to determining the antibody concentration at four weeks after the second dose and administering an additional dose if there is no evidence of seroconversion at this time. The same applies to any of the following doses.
The vaccine should be given by intramuscular injection into the upper arm (deltoid muscle).
In exceptional cases only (in subjects with a bleeding disorder or in subjects receiving prophylactic anticoagulation), the vaccine may be administered subcutaneously (see sections 4.4 and 4.8).
Care must be taken to avoid accidental intravascular administration (see section 4.4).
No case of overdose has been reported. However, due to the presentation of the vaccine, accidental overdose in terms of volume is unlikely.
30 months.
Store in a refrigerator (2°C-8°C). Keep the syringe in the outer carton in order to protect from light.
Do not freeze.
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.
The vaccine should reach room temperature before administration. Shake well prior to administration to thoroughly mix the vaccine suspension. After shaking, TicoVac 0.5 ml is an off-white, opalescent homogenous suspension. The vaccine should be inspected visually for any foreign particulate matter and/or variation in physical appearance prior to administration. In the event of either being observed, discard the vaccine.
After removing the syringe cap, attach the needle immediately and remove the needle shield prior to administration. Once the needle is attached, the vaccine must be administered immediately. In the exceptional cases of subcutaneous administration, an appropriate needle should be used.
Any unused product or waste material should be disposed of in accordance with local requirements.
The administration of the vaccine should be documented by the physician, and the lot number recorded. A detachable documentation label is attached to each preloaded syringe.
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