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Tick-E-Vac (Lyophilisate, Suspension) Instructions for Use

ATC Code

J07BA01 (Inactivated whole tick-borne encephalitis virus)

Active Substance

Tick-borne encephalitis vaccine (inactivated)

Tick-borne encephalitis vaccine (inactivated) (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

Vaccine for the prevention of tick-borne encephalitis

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

It is a formalin-inactivated encephalitis virus.

The vaccine induces immunity to the tick-borne encephalitis virus.

Indications

Administer for active immunization to induce protective immunity against tick-borne encephalitis virus infection in specific populations and circumstances.

  • Use for routine preventive immunization of individuals residing in geographical areas identified as high-risk foci for tick-borne encephalitis.
  • Employ for selective vaccination of persons planning travel to or occupational exposure within known tick-borne encephalitis endemic foci.
  • Initiate for emergency post-exposure prophylaxis following a suspected tick bite in regions endemic for tick-borne encephalitis, based on individual risk assessment.

ICD codes

ICD-10 code Indication
Z24.1 Need for immunization against arthropod-borne viral encephalitis
ICD-11 code Indication
QC01.1 Need for immunization against arthropod-borne viral encephalitis

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Follow an individualized dosage regimen based on the vaccinee’s age, immunization history, and specific indication (primary series or booster).

Adhere strictly to the recommended schedule for the primary vaccination course and for subsequent booster doses to ensure and maintain protective immunity.

Administer the vaccine via the intramuscular route; reconstitute the lyophilisate with the provided suspension immediately prior to administration.

Lyophilisate, Suspension

The dosage regimen is individual, depending on the indications for use and the age of the vaccinee.

Adverse Reactions

Monitor for systemic reactions, which are very rare and typically transient; these may include fever and headache occurring within the first 48 hours post-vaccination.

Observe the injection site for local reactions; commonly reported events include a short-lived burning sensation, with less frequent occurrences of redness, tenderness, and infiltration.

Report any unexpected or severe reactions to the appropriate health authority, as with any biological product.

Contraindications

Do not administer to individuals with known hypersensitivity to any component of the vaccine, including egg proteins.

  • Avoid use in the presence of acute febrile illness or active infection; postpone vaccination until recovery.
  • Consider as an absolute contraindication in individuals with a history of severe allergic reaction to a previous dose of this or any other tick-borne encephalitis vaccine.
  • Withhold administration in persons with certain progressive neurological disorders, uncontrolled epilepsy, or severe immunodeficiency states, unless the benefit clearly outweighs the risk.

Use in Pregnancy and Lactation

Contraindicated during pregnancy.

Use in Hepatic Impairment

Contraindicated in chronic liver diseases.

Use in Renal Impairment

Contraindicated in chronic kidney diseases.

Pediatric Use

Use in children under 1 year of age is recommended only in case of a real risk of infection.

Special Precautions

After febrile conditions, vaccinations are allowed no earlier than 1 month after recovery, and for persons who have had viral hepatitis and meningococcal infection, no earlier than 6 months after recovery.

Vaccinations are allowed 2 weeks after childbirth.

Avoid intravascular administration.

Drug Interactions

Observe that concurrent administration with other inactivated or live vaccines is generally acceptable, provided different injection sites are used.

Maintain a minimum interval of four weeks between the administration of tick-borne encephalitis-specific immunoglobulin and this vaccine to avoid potential neutralization of the vaccine virus.

Exercise caution in patients receiving immunosuppressive therapy, as this may diminish the immunological response to the vaccine.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Fncirip Named After M.P. Chumakov Ran, Fsbsi (Russia)

Dosage Forms

Bottle Rx Icon Tick-E-Vac Intramuscular suspension 0.25 ml: ampoule, 10 pcs.
Suspension for intramuscular administration 0.5 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Suspension for intramuscular administration homogeneous, white in color, free from foreign particles.

0.25 ml (1 dose)
Antigen of inactivated tick-borne encephalitis virus Titer not less than 1:128

Excipients : human albumin (infusion solution* 10% or 20%) 0.125 mg, sucrose 15 mg, aluminum hydroxide 0.2 mg; buffer system salts: sodium chloride 1.9 mg, trometamol 0.03 mg.

*Albumin infusion solutions contain (in addition to albumin) sodium caprylate and sodium chloride.

0.25 ml (1 dose for children from 1 year to 16 years) – ampoules (10) – cardboard packs.

Suspension for intramuscular administration homogeneous, white in color, free from foreign particles.

0.5 ml (1 dose)
Antigen of inactivated tick-borne encephalitis virus Titer not less than 1:128

Excipients : human albumin (infusion solution* 10% or 20%) 0.25 mg, sucrose 30 mg, aluminum hydroxide 0.4 mg; buffer system salts: sodium chloride 3.8 mg, trometamol 0.06 mg.

*Albumin infusion solutions contain (in addition to albumin) sodium caprylate and sodium chloride.

0.5 ml (1 dose for persons 16 years and older) – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Fncirip Named After M.P. Chumakov Ran, Fsbsi (Russia)

Dosage Forms

Bottle Rx Icon Tick-E-Vac Intramuscular suspension 0.25 ml: ampoule, 10 pcs.
Suspension for intramuscular administration 0.5 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Suspension for intramuscular administration homogeneous, white in color, free from foreign particles.

0.25 ml (1 dose)
Antigen of inactivated tick-borne encephalitis virus Titer not less than 1:128

Excipients : human albumin (infusion solution* 10% or 20%) 0.125 mg, sucrose 15 mg, aluminum hydroxide 0.2 mg; buffer system salts: sodium chloride 1.9 mg, trometamol 0.03 mg.

*Albumin infusion solutions contain (in addition to albumin) sodium caprylate and sodium chloride.

0.25 ml (1 dose for children from 1 year to 16 years) – ampoules (10) – cardboard packs.

Suspension for intramuscular administration homogeneous, white in color, free from foreign particles.

0.5 ml (1 dose)
Antigen of inactivated tick-borne encephalitis virus Titer not less than 1:128

Excipients : human albumin (infusion solution* 10% or 20%) 0.25 mg, sucrose 30 mg, aluminum hydroxide 0.4 mg; buffer system salts: sodium chloride 3.8 mg, trometamol 0.06 mg.

*Albumin infusion solutions contain (in addition to albumin) sodium caprylate and sodium chloride.

0.5 ml (1 dose for persons 16 years and older) – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Fncirip Named After M.P. Chumakov Ran, Fsbsi (Russia)

Dosage Form

Bottle Rx Icon Tick-borne encephalitis vaccine cultural purified concentrated inactivated dry Lyophilisate for the preparation of suspension for intramuscular administration 0.5 ml/1 dose: amp. 0.5 ml or 1 ml or vial 50 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for the preparation of suspension for intramuscular administration is a porous white mass, hygroscopic; the supplied solvent is a homogeneous opaque white suspension, which separates upon standing into a colorless transparent liquid and a loose white sediment; upon shaking, flakes, conglomerates and foreign particles should be absent.

1 dose (0.5 ml)
Inactivated antigen of tick-borne encephalitis virus 1:128

Excipients : albumin – 250 µg (stabilizer), sucrose – 37.5 mg (stabilizer), gelatin – 5 mg (forming agent), sodium chloride – 3.8 mg (buffer system salts), trometamol – 0.06 mg.

Solvent aluminum hydroxide gel.
The preparation does not contain formaldehyde, antibiotics, or preservatives.

0.5 ml (1 dose) – ampoules (1) in a kit with solvent (amp. 0.65 ml 1 pc.) – cardboard packs (5 kits).
1 ml (2 doses) – ampoules (1) in a kit with solvent (amp. 1.2 ml 1 pc.) – cardboard packs (5 kits).

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