Kleshch-E-Vak Vaccine tick-borne encephalitis cultural purified concentrated inactivated adsorbed (Suspension) Instructions for Use

ATC Code

J07BA01 (Inactivated whole tick-borne encephalitis virus)

Dosage Forms

	Kleshch-E-Vak (Vaccine tick-borne encephalitis cultural purified concentrated inactivated adsorbed)	Suspension for intramuscular administration 0.5 ml/dose
		Suspension for intramuscular administration 0.25 ml/dose

Dosage Form, Packaging, and Composition

Suspension for intramuscular administration

0.5 ml – ampoules (10 pcs.) – cardboard packs – for treatment-and-prophylaxis institutions

Suspension for intramuscular administration

0.25 ml – ampoules (10 pcs.) – cardboard packs – for treatment-and-prophylaxis institutions

Pharmacotherapeutic Group

Vaccines; viral vaccines; vaccines against viral encephalitides

Indications

• For the active immunization of individuals from 3 years of age and older for the prevention of tick-borne encephalitis (TBE).
• The vaccine is indicated for persons residing in or visiting TBE-endemic areas, particularly those with occupational or recreational exposure to tick habitats, such as forestry workers, farmers, military personnel, tourists, and hikers.
• Immunization is a critical public health measure in regions where the TBE virus is known to be circulating.

Contraindications

• Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including formaldehyde, protamine sulfate, or gentamicin, following a prior dose.
• Acute febrile illness or acute infectious disease; vaccination should be postponed until recovery. A minor illness, such as a mild upper respiratory infection without fever, is not generally a contraindication.
• Known severe allergic reaction to eggs or chicken proteins, as the virus is propagated in chicken embryo cells.
• Individuals with a history of severe neurological disorders, such as Guillain-Barré syndrome, temporally related to a previous vaccination should be evaluated with extreme caution.
• Progressive neurological diseases, including uncontrolled epilepsy and progressive encephalopathy, are contraindications for vaccination.

Dosage Regimen

The primary vaccination course consists of two intramuscular injections administered at an interval of 1 to 7 months. The preferred interval is 5 to 7 months, which can include the seasonal period of low tick activity (autumn-winter).

A first booster dose is administered once, 12 months after the completion of the primary course. Subsequent booster doses are given every 3 years thereafter to maintain protective immunity.

The dosage volume is age-dependent: individuals aged 3 to 15 years receive a 0.25 ml dose per injection, while individuals aged 16 years and older receive a 0.5 ml dose per injection. The vaccine must be administered by a healthcare professional via the intramuscular route, preferably into the deltoid muscle.

Before administration, the ampoule should be inspected visually for any particulate matter or discoloration; the suspension should be a homogeneous white, opalescent liquid. Shake the ampoule well immediately before use. Do not administer the vaccine intravenously, subcutaneously, or intradermally.

Adverse Reactions

Adverse reactions are generally mild to moderate in intensity and transient, resolving within 1-3 days. Very common (≥1/10) reactions include pain, redness, and swelling at the injection site, as well as systemic reactions such as fever, malaise, headache, and myalgia.

Common (≥1/100 to <1/10) adverse reactions may include enlargement of regional lymph nodes, induration at the injection site, and transient increases in body temperature. Uncommon (≥1/1,000 to <1/100) reactions can include generalized skin reactions like rash or urticaria.

Rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000) adverse events have been reported and may include neurological disorders such as neuritis, paresthesia, and, in extremely rare instances, encephalitis or meningitis-like symptoms. Immediate allergic reactions, including anaphylaxis, can occur and require immediate medical attention. Healthcare providers should be prepared to manage such events.

Drug Interactions

The Kleshch-E-Vak vaccine may be administered concurrently with other inactivated vaccines using separate syringes and at different injection sites. The immune response to either vaccine may be attenuated if administered simultaneously; however, clinical data for co-administration with specific vaccines should be consulted.

Concomitant administration with live viral vaccines is generally not recommended unless given on the same day. If not administered on the same day, an interval of at least 4 weeks should be observed between vaccinations to minimize potential interference with the immune response.

Immunosuppressive therapies, including corticosteroids (at supraphysiological doses), chemotherapy, and radiation therapy, may reduce the efficacy of the vaccine. Vaccination should be deferred until after such therapy, or administered at least two weeks before its initiation, whenever possible. The immune response in individuals with innate or acquired immunodeficiency may be suboptimal.

There are no known interactions with food or beverages. The effect of antiviral medications on the vaccine’s efficacy has not been specifically studied.

Overdose

There is a very low risk of overdose due to the single-dose packaging of the vaccine in ampoules. Administration of a dose larger than recommended is unlikely to lead to serious consequences, as the vaccine contains inactivated virus particles.

However, in the event of an inadvertent overdose, symptomatic and supportive treatment is recommended. Monitor the patient for signs of intensified local reactions (e.g., extensive swelling, pain, redness) or systemic reactions (e.g., high fever, severe headache, pronounced malaise).

There is no specific antidote. Management should focus on alleviating symptoms, such as administering antipyretics for fever or analgesics for pain. As with any vaccine administration, healthcare providers should be prepared to manage rare but potential immediate hypersensitivity reactions.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.