EnceVir - instructions for use, dose, side effects, contraindications

Excipients: aluminum hydroxide (adjuvant) 0.30-0.50 mg; sucrose (stabilizer) 20-30 mg; human albumin (stabilizer) * 0.20-0.25 mg; salts of the buffer system **: sodium chloride 3.94 mg, sodium hydrogen phosphate dodecahydrate 7.13 mg, sodium dihydrogen phosphate dihydrate 0.42 mg.

The vaccine does not contain antibiotics and preservatives.

Notes.

* Antibodies to HIV-1, HIV-2, to the hepatitis C virus and the surface antigen of the hepatitis B virus are absent. The manufacturer guarantees a viral security. The content of albumin in the finished product is not determined.

** Salts of the buffer system in the finished product are not determined.

Description:

Homogenous suspension of white color without foreign inclusions.

Pharmacotherapeutic group:MIBP vaccine

ATX: & nbsp

J.07.B.A Vaccine for the prevention of encephalitis

J.07.B.A.01 Tick-borne encephalitis virus - inactivated whole

Pharmacodynamics:

The EnceVir® vaccine is a sterile purified concentrated suspension of formalin-inactivated virus tick-borne encephalitis (strain "205") obtained by reproducing it in suspended kulьa round of cells of chicken embryos sorbed on aluminum hydroxide.

The introduction of the vaccine stimulates the production of specialistand antibodies to the tick-borne encephalitis virus (TBE). Provides protection from strains of the European and Far Eastern genotypes of the CE virus.

Indications:

Specific prophylaxis of tick-borne encephalitis in persons from 18 years of age.

Preventive vaccination is subject to:

- Persons living in endemic areas of tick-borne encephalitis;

- persons attending endemic for tick-borne encephalitis territory for the purpose of recreation, tourism, work in the country and garden areas;

- Medical staff working with live cultures of tick-borne encephalitis virus.

Vaccination of donors for the purpose of obtaining a specific immunoglobulin.

Contraindications:

1. Complications or a strong reaction to the previous dose of the vaccine - an increase in temperature above 40 ° C, swelling, hyperemia more than 8 cm in diameter at the site of administration.

2. Acute diseases and exacerbation of chronic diseases. Vaccination is performed not earlier than 1 month after recovery (remission).

3. Severe allergic reactions in the anamnesis for food and medicinal substances.

4. Allergic reactions to vaccine components.

5. Bronchial asthma.

6. Systemic diseases of connective tissue.

7. Somatic diseases in the stage of sub- and decompensation.

8. Epilepsy with frequent seizures.

9. Diabetes, thyrotoxicosis and other diseases of the endocrine system.

10. Malignant neoplasms, blood diseases.

11. Pregnancy.

12. Children under 18 years.

The possibility of vaccination of persons suffering from diseases not listed in the list of contraindications is determined by the attending physician, based on the state of health of the vaccinated person and the risk of infection with tick-borne encephalitis.

Carefully:

Hypersensitivity to a chicken embryo protein in an anamnesis is not an absolute contraindication, excluding anaphylaxis. However, such individuals should be vaccinated with caution.

The vaccine is used with caution in individuals with cerebral disorders in history.

Pregnancy and lactation:

The use of the vaccine in pregnancy is contraindicated, it is permissible to carry out the vaccination two weeks after the birth.

Vaccination of women during breastfeeding is carried out by the doctor's decision taking into account the possible risk of infection with TBE.

Dosing and Administration:

The vaccine is injected into the deltoid muscle of the arm (preferably the left one) at a dose of 0.5 ml.

Before opening the ampoule, it is necessary to make a visual inspection. Immediately prior to injection, the vaccine in the ampoule is warmed to room temperature and shaken until a homogeneous suspension is obtained. The neck of the ampoule is treated with alcohol. For each vaccine, a separate disposable syringe should be used. The drug is administered immediately after opening the ampoule.

The vaccination procedure should be carried out with strict adherence to aseptic and antiseptic rules.

The vaccination is recorded in the prescribed registration forms with the name of the drug, the date of vaccination, the dose, the number of the series, the expiration date, the vaccine manufacturing company, the vaccine response.

Vaccination schedules:

1. Prophylactic vaccination:

PlanNew vaccination

The vaccination course consists of two injections of 1 dose (0.5 ml) at intervals of 1-7 months (preferably 2 months).

The first and second injection is preferably carried out from autumn to spring. If necessary, vaccination can be carried out at any time of the year, including in the summer (epidemic season). Visiting the natural focus of CE is allowed no earlier than 2 weeks after the second vaccination.

Emergency vaccination

If emergency prevention is necessary (first of all, if vaccination is necessary in summer), the interval between the first and second vaccinations can be reduced to 2 weeks. Visiting the natural focus of CE is recommended not earlier than 2 weeks after the second vaccination.

Revaccination

The first revaccination in both regimens is carried out once every 12 months after completion of the course of primary vaccination, subsequent remote revaccinations are performed once every 3 years.

The general scheme of vaccination is presented in the table:

View vaccination	Primary vaccination		Revaccination	Remote revaccination
	The first	The second
Scheduled	0 day of vaccination	1-7 months after the first vaccination (preferably 2 months)	12 months after completion of course vaccination	every 3 years
Emergency		2 weeks after the first vaccination
Dose	0.5 ml	0.5 ml	0.5 ml	0.5 ml

2. Vaccination of donors:

The donors are vaccinated in the following way:

Vaccination			Revaccination
First Inoculation	Second Inoculation	Third Inoculation	Revaccination
0 day of vaccination	3-5 weeks after the first vaccination (preferably 2 months)	3-5 weeks after the second vaccination	after 12 months
0.5 ml	1.0 ml	1.0 ml	1.0 ml

Side effects:

After the introduction of the vaccine in some cases, local and general reactions can develop which pass independently for a period of several hours to 3 days.

Local Reactions expressed in redness, swelling, tenderness at the injection site, perhaps a slight increase in regional lymph nodes.

General reactions can develop in the first two days and be expressed in an increase in body temperature to 38.0 FROM, headache, malaise, pain in muscles and joints, nausea, dizziness, weakness, fatigue, drowsiness.

The permissible frequency for general reactions with a temperature of 37.5 ° C and above is not more than 7%.

In rare cases, the development of allergic reactions of immediate type is possible.

If the patient is not well tolerated, symptomatic therapy is performed.

Based on the data obtained from the clinical study of the vaccine and its practical application, the following information was obtained on the incidence of adverse reactions:

Very often (≥1 / 10) - soreness in the injection site.

Often (1/10 - 1/100) - Hyperemia at the injection site, swelling at the injection site, temperature rise to 38.0 ° C, passing for 1-3 days, headache, weakness, malaise, fatigue, drowsiness.

Sometimes (1/100 - 1/1000) - nausea, dizziness, pain in the muscles and joints.

Rarely (1/1000 -1/10000) - allergic reactions of immediate and delayed types.

Very rarely (<1 / 10,000) marked neurological symptoms.

Overdose:

The dose is strictly regulated.

Interaction:

1. After the introduction of immunoglobulin against tick-borne encephalitis, immunization should be carried out no earlier than 4 weeks later.

2. Simultaneous administration of inactivated or recombinant vaccines of the National calendar of preventive vaccinations and vaccination schedules for epidemiological indications (except rabies vaccine and BCG) is allowed, provided vaccines are administered with different syringes to different parts of the body.

In the case of live virus vaccines, the interval between vaccinations should be at least 1 month.

Special instructions:

1. The preparation with the broken integrity of the ampoule, incomplete marking, in the presence of non-breaking flakes, with expired shelf life, in case of violation of the temperature regime of storage or transportation is not suitable for use.

2. In order to identify contraindications, the doctor on the day of vaccination conducts a survey and examination of the vaccine with obligatory thermometry (the body temperature at the time of vaccination should not exceed 36.9 ° C), examines the medical certificate of the vaccinated person.The doctor is responsible for the correctness of the vaccination appointment.

3. Given that in rare cases, the risk of developing allergic reactions is possible, vaccines should be under medical supervision within 30 minutes after vaccination; It is absolutely necessary to have emergency and anti-shock therapy in places of immunization.

4. In order to reduce the risk of postvaccinal reactions within 3 days after the injection, it is necessary to observe the protective regime:

- Do not overheat (steam room, sauna, common hot tubs, long stay in the sun is not recommended);

- do not overcool;

- to exclude the use of alcohol;

- limit physical activity (sports, hard physical work);

- avoid contact with infectious patients.

5. The vaccine can not be administered intravenously!

Effect on the ability to drive transp. cf. and fur:

The expressed general reactions to the introduction of the vaccine (significant temperature increase, headache, fatigue, drowsiness) are a contraindication for the management of vehicles and mechanisms.

Form release / dosage:

A suspension for intramuscular administration, 0.5 ml / dose.

Packaging:

For 0.5 ml (1 dose) in the ampoule.

For 10 ampoules in a pack of cardboard along with instructions for use and a scarifier ampoule. When packaging ampoules that have a break ring or a point for dissection, the ampoule scapegrator is not inserted.

For 5 ampoules in a cassette outline package made of cardboard. 2 cassette contour packs in a pack of cardboard along with instructions for use.

Storage conditions:

In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C in a place inaccessible to children. Freezing is not allowed.

Transportation conditions

AT According to SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. A single short-term (not more than 24 hours) transportation at a temperature of 9 to 20 ° C is allowed. Freezing is not allowed.

Shelf life:

2 years.

The drug with expired shelf life is not subject to application.

Terms of leave from pharmacies:For hospitals

Registration number:P N000763 / 01

Date of registration:26.11.2007

The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia

Manufacturer: & nbsp

MICROGEN FGUP NGO Russia

Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia

Information update date: & nbsp14.12.2015

Illustrated instructions

Instructions

EnceVir® (EnceVir®)