EnceVir^® (Suspension) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

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)

Dosage Form

EnceVir®

Suspension for intramuscular administration 0.5 ml/1 dose: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Suspension for intramuscular administration is white in color, homogeneous, and free from foreign impurities.

Excipients: aluminum hydroxide (adjuvant) – 0.3-0.5 mg, sucrose (stabilizer) – 20-30 mg, human albumin (stabilizer) – 0.2-0.25 mg; buffer system salts: sodium chloride – 3.94 mg, disodium hydrogen phosphate dodecahydrate – 7.13 mg, sodium dihydrogen phosphate dihydrate – 0.42 mg.

Does not contain antibiotics or preservatives.

0.5 ml (1 dose) – ampoules with a capacity of 1 ml (5) – contour cell packaging (2) – cardboard packs.
0.5 ml (1 dose) – ampoules with a capacity of 1 ml (10) – cardboard packs.

Clinical-Pharmacological Group

Vaccine for the prevention of tick-borne encephalitis

Pharmacotherapeutic Group

Vaccines; viral vaccines; vaccines against viral encephalitides

Pharmacological Action

The vaccine for the prevention of tick-borne encephalitis is produced by reproducing the tick-borne encephalitis virus in a suspended primary culture of chicken embryo cells, followed by purification, inactivation with formalin, and adsorption onto aluminum hydroxide.

It stimulates the production of cellular and humoral immunity to the tick-borne encephalitis virus. Provides protection against strains circulating in both Asia and Europe.

Indications

• Active prevention of tick-borne encephalitis in the following groups of individuals over 3 years of age: the population residing in territories endemic for tick-borne encephalitis, and individuals arriving in these territories who are engaged in agricultural, land reclamation, construction, procurement, commercial, geological work, work involving excavation and movement of soil, survey, expedition, deratization, and disinfection activities; persons employed in logging, forest clearing and improvement, and in areas of recreation and health improvement for the population;
• Active prevention of tick-borne encephalitis in individuals working with live cultures of the tick-borne encephalitis pathogen;
• Immunization of donors for the purpose of obtaining specific immunoglobulin.

ICD codes

Dosage Regimen

The primary vaccination course is carried out according to the following schemes.

Scheme 1

1st vaccination – 0.5 ml on the selected day.

2nd vaccination – 0.5 ml after 1-2 months.

3rd vaccination – 0.5 ml after 12 months.

Scheme 2

1st vaccination – 0.5 ml on the selected day.

2nd vaccination – 0.5 ml after 5-7 months.

3rd vaccination – 0.5 ml after 12 months.

Subsequent remote revaccinations are carried out every 3 years as a single dose.

When vaccinations are carried out during the period of tick activity (in the spring and summer months), contact of the vaccinated person with the source of infection should be avoided throughout the entire vaccination period and for 2 weeks after it.

Vaccine Administration Rules

The vaccine is administered intramuscularly into the deltoid muscle of the shoulder. Intravascular administration of the drug must be avoided. In case of erroneous intravascular administration, reactions up to shock may develop. In such cases, anti-shock therapy should be initiated immediately.

Immediately before injection, the vaccine in the ampoule is mixed by shaking until a homogeneous suspension is obtained. A separate syringe must be used for each vaccinated person.

The vaccine should appear as a homogeneous, opaque, white suspension without flakes or foreign inclusions. The drug in ampoules with damaged integrity, labeling, changed color, presence of non-dispersible flakes, expired shelf life, or improper storage is not suitable for use.

Vaccination is carried out in vaccination or procedure rooms under the jurisdiction of medical institutions. The average medical staff must have permission to work in the procedure room and to perform vaccinations, working under the supervision of a physician. The room where vaccination is carried out must be equipped with means for anti-shock therapy.

The performed vaccination is registered in the established accounting forms, indicating the date of its administration, dose, vaccine manufacturer, batch number, and reaction to the vaccination.

Adverse Reactions

Local reactions hyperemia, swelling, pain at the injection site, a slight enlargement of regional lymph nodes is possible. The duration of reactions does not exceed 3-5 days.

General reactions may develop within the first 2 days and include an increase in body temperature from 37.1°C (98.8°F) to 38°C (100.4°F) (9-10%), headache, malaise, muscle and joint pain. The duration of reactions does not exceed 3 days.

Other rarely – allergic reactions (medical monitoring of the condition is necessary for 30 minutes after vaccination).

Contraindications

• Acute diseases and exacerbation of chronic diseases;
• History of severe allergic reactions to food (especially chicken protein), medicinal substances;
• Bronchial asthma;
• Systemic connective tissue diseases;
• Severe (increase in body temperature above 40°C (104°F)) and local (swelling, hyperemia more than 8 cm in diameter) reaction or complication to the previous vaccine administration;
• Somatic diseases in the stage of sub- and decompensation;
• Epilepsy with frequent seizures;
• Diabetes mellitus;
• Thyrotoxicosis and other severe diseases of the endocrine system;
• Malignant neoplasms;
• Blood diseases;
• Pregnancy.

Use in Pregnancy and Lactation

Vaccination is contraindicated during pregnancy. Vaccination can be carried out no earlier than 2 weeks after childbirth.

Special Precautions

The vaccine does not contain antibiotics, formaldehyde, or preservatives.

The possibility of vaccinating individuals with various diseases not listed in the contraindications is determined individually, based on the health status of the vaccinated person and the risk of tick-borne encephalitis infection. To identify contraindications, a medical examination and interview of the vaccinated person with mandatory thermometry are carried out on the day of vaccination.

All cases of unusual reactions after vaccination must be reported to the local health department, the L.A. Tarasevich State Research Institute for Standardization and Control of Medical Biological Preparations of the Ministry of Health of Russia (121002, Moscow, Sivtsev Vrazhek, 41) with subsequent submission of medical documentation to the L.A. Tarasevich Institute. Complaints regarding non-compliance of the drug with the specified requirements for physical properties, packaging, and packaging should also be sent to the L.A. Tarasevich Institute.

Overdose

Currently, no cases of EnceVir^® vaccine overdose have been reported.

Drug Interactions

Vaccination against tick-borne encephalitis can be carried out simultaneously with other inactivated vaccines of the National Calendar of Preventive Vaccinations and the Calendar of Vaccinations for Epidemic Indications, or with an interval of 1 month.

Storage Conditions

The vaccine should be stored at a temperature from 2°C (35.6°F) to 8°C (46.4°F); do not freeze.

Shelf Life

Shelf life – 2 years.

The vaccine should be transported at a temperature from 2°C (35.6°F) to 8°C (46.4°F). Short-term (no more than 24 hours) transportation at a temperature not exceeding 20°C (68°F) is allowed.

Pharmacy dispensing terms

The vaccine is dispensed by prescription.

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.