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TICOVAC (tick-borne encephalitis vaccine,whole virus, inactivated)

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TICOVAC Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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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.

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2 DOSAGE AND ADMINISTRATION

For intramuscular use only.

2.1 Dosage and Vaccination Schedule

•
1 through 15 years of age:...
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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.

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4 CONTRAINDICATIONS

Severe allergic reaction (e.g. anaphylaxis) to any component of TICOVAC [see Description (11)].

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5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic...

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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...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

All pregnancies have a...

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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...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Following administration, TICOVAC induces TBEV-neutralizing antibodies, which are believed to confer protection....

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

TICOVAC has not been evaluated for the potential to cause carcinogenicity,...

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14 CLINICAL STUDIES

14.1 Immunogenicity

Primary Immunization Course

The...

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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...
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16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

TICOVAC is supplied in the following strengths and package configurations:

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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...
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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

Manufactured...

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Report Adverse Event
Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.