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TICOVAC (tick-borne encephalitis vaccine,whole virus, inactivated)
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TICOVAC Quick Finder
1 INDICATIONS AND USAGE
TICOVAC™ is indicated for active immunization to prevent tick-borne encephalitis (TBE). TICOVAC is approved for use in individuals 1 year of age and older.
2 DOSAGE AND ADMINISTRATION
For intramuscular use only.
2.1 Dosage and Vaccination Schedule
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- 1 through 15 years of age:...
3 DOSAGE FORMS AND STRENGTHS
TICOVAC is a suspension for injection supplied as a 0.25 mL or 0.5 mL single-dose in pre-filled syringes.
4 CONTRAINDICATIONS
Severe allergic reaction (e.g. anaphylaxis) to any component of TICOVAC [see Description (11)].
5 WARNINGS AND PRECAUTIONS
5.1 Management of Acute Allergic Reactions
Appropriate medical treatment and supervision must be available to manage possible anaphylactic...
6 ADVERSE REACTIONS
In clinical studies, the most common adverse reactions in subjects 1 through 15 years of age who received TICOVAC were local tenderness (18.1%), local pain (11.2%), headache (11.1%), fever (9.6%), and...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
All pregnancies have a...
11 DESCRIPTION
TICOVAC (tick-borne encephalitis vaccine) is a sterile, off-white, homogenous, opalescent suspension for intramuscular injection. TICOVAC is prepared from tick-borne encephalitis (TBE) virus propagated in...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Following administration, TICOVAC induces TBEV-neutralizing antibodies, which are believed to confer protection....
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
TICOVAC has not been evaluated for the potential to cause carcinogenicity,...
14 CLINICAL STUDIES
14.1 Immunogenicity
Primary Immunization Course
The...
15 REFERENCES
- 1.
- Heinz FX, Holzmann H, Essl A, et al. Field effectiveness of vaccination against tick-borne encephalitis. Vaccine 2007;25(43):7559–67.
- 2.
- Heinz FX, Stiasny K, Holzmann H, et al. Vaccination and...
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
TICOVAC is supplied in the following strengths and package configurations:
17 PATIENT COUNSELING INFORMATION
Prior to administration of this vaccine, inform the individual, parent, guardian, or other responsible adult of the following:
- •
- The potential benefits and risks of...
This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
Manufactured...
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