2 DOSAGE AND ADMINISTRATION
For intramuscular use only.
2.1 Dosage and Vaccination Schedule
- 1 through 15 years of age: each dose 0.25 mL
- 16 years of age and older: each dose 0.5 mL
Primary Vaccination: Three doses
|1 through 15 years of age||16 years of age and older|
|First dose||Day 0||Day 0|
|Second dose||1 to 3 months after the first vaccination||14 days to 3 months after the first vaccination|
|Third dose||5 to 12 months after the second vaccination||5 to 12 months after the second vaccination|
Complete the primary immunization series at least 1 week prior to potential exposure to TBEV (tick-borne encephalitis virus) [see Clinical Studies (14.1)].
A booster dose (fourth dose) may be given at least 3 years after completion of the primary immunization series if ongoing exposure or re-exposure to TBEV is expected.
Bring the vaccine to room temperature before administration. Shake well prior to administration to thoroughly mix the vaccine suspension. After shaking, the vaccine should be a homogenous off-white, opalescent suspension. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer if particulate matter or discoloration remains after shaking. Administer vaccine by intramuscular injection.