EnceVir - Instructions For Using The Vaccine, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

EnceVir

EnceVir: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. Drug interactions
12. 12. Analogs
13. 13. Terms and conditions of storage
14. 14. Terms of dispensing from pharmacies
15. 15. Reviews
16. 16. Price in pharmacies

Latin name: EnceVir

ATX code: J07BA01

Active ingredient: inactivated antigen de tick-genuisset encephalitis virus

Producer: FSUE NPO Microgen (Russia)

Description and photo update: 2018-04-07

Prices in pharmacies: from 4434 rubles.

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EnceVir is a drug intended for vaccination for the specific prevention of tick-borne encephalitis (TBE).

Release form and composition

EnceVira dosage form - suspension for intramuscular administration: a homogeneous white suspension without foreign inclusions (in an ampoule of 0.5 ml, in a contour cassette package made of cardboard 5 ampoules, in a cardboard box 2 packages; in an ampoule of 0.5 ml, in a cardboard box 10 ampoules).

Composition of 1 dose (0.5 ml) of EnceVira:

• active substance: inactivated tick-borne encephalitis virus antigen with a titer in an enzyme immunoassay of at least 1: 128 - from 0.6 to 3 μg;
• auxiliary components: adjuvant (aluminum hydroxide), sucrose (stabilizer), human albumin (stabilizer), salts of the buffer system (sodium chloride, 12-water disubstituted sodium phosphate, 2-water monosodium phosphate), water for injection.

The suspension does not include preservatives, formalin and antibiotics.

Pharmacological properties

Pharmacodynamics

EnceVir vaccine is a concentrated sterile purified suspension of the TBE virus strain 205, obtained by its reproduction in a primary weighed culture of chicken embryo cells and sorbed on aluminum hydroxide. The virus is inactivated with formalin.

When the vaccine is administered in the body, the production of specific antibodies to the TBE virus is stimulated. EnceVir protects against strains of the Far Eastern and European genotypes of this virus.

Indications for use

• specific prevention of TBE in persons over 18 years of age. Persons living in TBE endemic territories, arriving in these territories, as well as medical workers working with live cultures of the TBE virus are subject to vaccination;
• vaccination of donors in order to obtain a specific immunoglobulin.

Contraindications

• acute diseases and exacerbations of chronic diseases. Vaccination is carried out no earlier than four weeks after recovery (remission);
• a history of severe allergic reactions to foods (especially chicken protein) and drugs;
• bronchial asthma;
• systemic connective tissue diseases;
• a strong reaction or complications to the previous vaccination: an increase in body temperature above 40 ° C, hyperemia at the injection site with a diameter of more than 8 cm, edema;
• epileptic diseases with frequent seizures;
• somatic diseases in the stage of subcompensation and decompensation;
• endocrine system diseases, including diabetes, thyrotoxicosis;
• blood diseases;
• malignant neoplasms;
• pregnancy;
• age up to 18 years.

Care should be taken to vaccinate persons with a history of hypersensitivity to the chicken embryo protein, as well as with a history of cerebral disorders.

If the patient has diseases that are not listed in the list of contraindications, the attending physician determines the possibility of using EnceVir, depending on the risk of infection with TBE and the patient's condition.

Instructions for use of EnceVir: method and dosage

The EnceVir vaccine is injected into the deltoid muscle of the shoulder (preferably the left one) in 1 dose (0.5 ml).

Before opening the ampoule, it should be visually inspected. Immediately before inoculation, the ampoule is warmed to room temperature, stirred by shaking to a homogeneous suspension, the neck of the ampoule is treated with alcohol. The vaccine is administered immediately after opening the ampoule. It is necessary to use an individual disposable syringe for each patient. During vaccination, the rules of asepsis and antiseptics should be strictly observed.

Preventive vaccination

• routine vaccination: the course includes two injections of 1 dose (0.5 ml) of EnceVir with an interval of 1–7 months between them (preferably 2 months). It is advisable to carry out both injections during the period from autumn to spring. But if necessary, vaccination can be carried out at any time of the year, including the epidemic season (summer period). A visit to the territory of the natural focus of TBE is possible not earlier than two weeks after the second vaccination;
• emergency vaccination: two injections of 1 dose (0.5 ml) of EnceVir. If urgent vaccination is required (especially in the summer), the interval between the first and second vaccinations can be reduced to 2 weeks. It is recommended to visit the territory of the natural focus of TBE not earlier than two weeks after the second vaccination;
• revaccination: with both schemes, the first revaccination is carried out once in 1 dose (0.5 ml) of EnceVir 1 year after the course of primary vaccination, all subsequent revaccinations are performed once, 1 dose (0.5 ml) every 3 years.

Donor vaccination

The donor vaccination course consists of three injections: the first - 1 dose (0.5 ml) of the drug, the second - 2 doses (1 ml) 3-5 weeks (preferably 2 months) after the first, the third - 2 doses (1 ml) 3–5 weeks after the second vaccination.

Revaccination consists in the introduction of a single dose of 2 doses (1 ml) of EnceVir 1 year after the initial course of vaccination.

Side effects

In some cases, after the introduction of EnceVir, local and general reactions may develop, which disappear on their own within a period of several hours to three days. Local reactions are manifested in soreness, swelling, redness at the injection site, a slight increase in the lymph nodes of the regional group. General reactions can occur during the first two days after vaccination, they are expressed in malaise, headache, fever up to 38.0 ° C, nausea, dizziness, pain in joints and muscles, weakness, fatigue, drowsiness.

The permissible frequency of development of general reactions with a body temperature of 37.5 ° C and above is no more than 7%.

Allergic reactions of an immediate type are possible in rare cases.

As a result of clinical studies, the following frequency of possible adverse reactions was established:

• very often (more than 10%) - soreness at the injection site;
• often (more than 1%, but less than 10%) - swelling, hyperemia at the injection site, headache, malaise, weakness, drowsiness, fatigue, an increase in body temperature up to 38.0 ° C;
• infrequently (more than 0.1%, but less than 1%) - dizziness, nausea, pain in muscles and joints;
• rarely (more than 0.01%, but less than 0.1%) - delayed and immediate allergic reactions;
• very rarely (less than 0.01%) - severe neurological symptoms.

Overdose

To date, no cases of EnceVir overdose have been reported.

special instructions

Vaccination is carried out in treatment or vaccination rooms at medical institutions. In the office, there must be a means of emergency and anti-shock therapy. Nursing staff must have permission to vaccinate. The vaccination procedure must be carried out under the supervision of a physician.

EnceVir is not suitable for use in case of violation of the ampoule's integrity, incomplete labeling, change in the color of the suspension, the presence of unbreakable flakes, as well as in case of expiration of the drug's shelf life and violation of the storage and / or transportation temperature regime.

According to the instructions, EnceVir cannot be used for intravenous administration.

To identify contraindications, on the day of vaccination, a specialist examines the patient's medical record, examines and interviews the vaccinated person with the mandatory measurement of body temperature, which should not exceed 36.9 ° C. The doctor is responsible for ensuring that vaccinations are prescribed correctly.

It is important to avoid intravascular vaccine administration. If accidentally introduced into a vessel, serious reactions may develop, including shock. In such cases, immediate anti-shock therapy is required.

Since in rare cases allergic reactions may develop, patients after the administration of EnceVir should be under the supervision of a medical professional for 30 minutes.

Vaccination data (name of the drug, date of vaccination, dose, batch number, shelf life, name of the vaccine manufacturer, description of the patient's response to vaccination) must be entered in the established registration forms.

To reduce the risk of post-vaccination reactions after an injection, the following protective measures should be observed for three days: do not overheat (it is not recommended to visit steam rooms, saunas, taking general hot baths, prolonged exposure to the sun), not to overcool, to limit physical activity (hard physical labor, sports), exclude the use of alcoholic beverages, do not contact with infectious patients.

Influence on the ability to drive vehicles and complex mechanisms

Due to the likely development of pronounced general reactions to the introduction of EnceVir (headache, significant fever, drowsiness, fatigue), it is not recommended to drive vehicles and perform actions associated with an increased risk of accidents.

Application during pregnancy and lactation

Vaccination with EnceVir during pregnancy is contraindicated. Vaccinations are allowed two weeks after delivery.

Vaccination of women during breastfeeding should be carried out at the discretion of a specialist, taking into account the likely risk of contracting TBE.

Pediatric use

It is prohibited to use EnceVir in children and adolescents under 18 years of age.

Drug interactions

Vaccination against TBE is permissible simultaneously with the introduction of other inactivated vaccines of the national vaccination calendar and the calendar of preventive vaccinations for epidemic indications (except for immunization against rabies). In this case, vaccines should be injected into different parts of the body with different syringes.

In other cases, the interval between vaccinations should be at least 4 weeks.

Analogs

EnceVir analogs are: Cultural purified concentrated inactivated dry tick-borne encephalitis vaccine, Tick-E-Vac, FSME-Immun, EnceVir Neo for children, Encepur for adults, Encepur for children.

Terms and conditions of storage

Store at 2 to 8 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

For hospitals.

Reviews about EnceVir

From the reviews about EnceVir, it follows that the administration of the vaccine can cause all sorts of individual reactions, from slight redness at the injection site to serious complications, such as provoked polymyalgia.

Price for EnceVir in pharmacies

The average price for EnceVir is 5000 rubles for a pack of 10 ampoules.

EnceVir: prices in online pharmacies

Drug name Price Pharmacy

EnceVir Tick-borne encephalitis vaccine cultural purified concentrated inactivated sorbed 0.5 ml / dose suspension for intramuscular administration 0.5 ml 10 pcs 4434 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!