Universal reference book for medicines
Name of the drug: FSME-IMMUN (FSME-IMMUN)

Active substance: tick-borne encephalitis vaccine (inactivated)

Type: Vaccine for the prevention of tick-borne encephalitis

Manufacturer: BAXTER (Austria)
Composition, form of production and packaging
Suspension for the / m introduction is
whitish, opaque, without foreign inclusions.

1 dose (0.5 ml)

antigen of tick-borne encephalitis virus 2.38 μg

Auxiliary substances: aluminum hydroxide gel (adjuvant) - 1 mg (0.28 mg to 0.41 mg in terms of aluminum), human blood album (stabilizer) - 0.5 mg, formaldehyde (inactivator) - not more than 0.005 mg, sucrose - no more than 20 mg mg, protamine sulfate - not more than 0.005 mg, neomycin (traces), gentamicin (traces), sodium chloride - 3.45 mg, sodium hydrogen phosphate dihydrate - 0.22 mg, potassium dihydrogen phosphate - 0.045 mg, water up to 0.5 ml.

Preservatives do not contain.

0.5 ml - disposable syringes of transparent glass with a needle (1) - blisters (1) - packs of cardboard.

0.5 ml - disposable syringes of transparent glass with a needle (1) - blisters (10) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Inactivated vaccine against tick-borne encephalitis.
The level of seroconversion and protection is achieved in 97-100% of vaccinated people after a triple vaccination and persists for 3 years or more.
INDICATIONS

Prevention of tick-borne encephalitis in adults and adolescents from the age of 16, permanently residing on endemic encephalitis encephalitis territories, as well as those arriving on these territories who perform the following works:

- agricultural, irrigation and drainage, construction, excavation and transfer of soil, harvesting, fishing, geological, survey, expedition, deratization and disinsection;

- logging, clearing and improvement of the forest, recreation and recreation areas;

- working with live cultures of the causative agent of tick-borne encephalitis.

DOSING MODE

The vaccine is given in / m in the deltoid muscle.
Before use, shake the syringe thoroughly to completely mix the suspension. The vaccine should not be administered IV.
Incorrect intravenous administration can cause reactions, up to a shock.
In such cases it is necessary to immediately carry out anti-shock therapy. The room where the vaccine is administered should be provided with anti-shock therapy.
The vaccine should be used immediately after removing the protective cover from the needle.
The vaccination procedure should be carried out with strict adherence to aseptic and antiseptic rules.
On the day of vaccination, a doctor (or paramedic) conducts a survey and examines the vaccine with mandatory thermometry.
The doctor is responsible for the correct administration of the vaccine.
The vaccination is recorded in the prescribed registration forms with the date of vaccination, dose, name of vaccine, manufacturer, serial number, expiry date.

1. The primary course of vaccination

Vaccination is carried out three times in one of two schemes.

Vaccination Dose Scheme A Routine vaccination Scheme B Emergency vaccination

The first inoculation is 0.5 ml 0 day 0 day

Second Inoculation 0.5 ml After 1-3 months After 14 days

Third vaccine 0.5 ml After 5-12 months after the second vaccination After 5-12 months after the second vaccination

Planned vaccination is recommended before the beginning of the season of ticks.
The first and second inoculations are preferably administered in the winter or spring months (Scheme A - routine vaccination). Vaccination is allowed in summer (especially for urban residents) according to scheme B - emergency vaccination. In this case, the second vaccination is carried out at an interval of 2 weeks after the first vaccination.
The third vaccination is carried out before the start of the epidemic season and completes the full course of primary vaccination (scheduled or emergency) in accordance with the chosen scheme.

Visiting the natural focus of tick-borne encephalitis is recommended not earlier than 2 weeks after the second inoculation.

2. Revaccination

After a course of primary vaccination, carried out according to one of the two schemes, one 0.5 ml injection of the FSME-Immun vaccine is given every 3 years as a single injection.
It is recommended to conduct before the season of activity of ticks.
SIDE EFFECT

Local reactions: short-term redness, swelling and tenderness at the injection site;
very rarely - a slight increase in regional lymph nodes.
General reactions: allergic reactions are possible (generalized rash, mucosal edema, laryngeal edema, dyspnoea, bronchospasm or hypotension);
in some cases - neuritis of varying severity.
Although according to modern scientific knowledge, vaccination is not a source of autoimmune diseases and there is no indication of an increase in the frequency of autoimmune diseases after vaccination (eg, multiple sclerosis, iridocyclitis), in the case of a known or suspected autoimmune disease, it is necessary to assess the risk of possible infection with tick-borne encephalitis virus in comparison with possible adverse effects of vaccination on autoimmune disease.

CONTRAINDICATIONS

- acute feverish conditions of any etiology or exacerbation of chronic infectious diseases (vaccination is carried out not earlier than 2 weeks after recovery);

- history of allergy to vaccine components;

- Anaphylactic reaction to egg and chicken protein in the anamnesis.

PREGNANCY AND LACTATION

Reliably significant data on the effect of the drug on the course of pregnancy and fetal development there.
It is known that the drug is excreted in breast milk. In this regard, the vaccine can be prescribed to pregnant and lactating women only for emergency indications after a thorough assessment of the possible risks and benefits.
APPLICATION FOR CHILDREN

It is used in adults and adolescents with 16 years .

SPECIAL INSTRUCTIONS

In the event that the tick bite occurred before the first vaccination or during the period until the second vaccination (schemes A and B), a single vaccination can not prevent the possible development of tick-borne encephalitis.

If emergency protection is required for persons who received only one vaccination or who are not vaccinated, passive immunization with a specific immunoglobulin against tick-borne encephalitis should be prescribed in accordance with the instruction for use on this drug.
4 weeks after the introduction of a specific immunoglobulin, the vaccination course should be restarted.
Increased sensitivity to the protein of a hen's egg in an anamnesis is not an absolute contraindication.
However, such vaccinated should be vaccinated with caution under close supervision.
The vaccine is used with caution in individuals with cerebral disorders in history.

DRUG INTERACTION

Simultaneous immunization with FSME-Immun and the introduction of other inactivated or live vaccines (except rabies and BCG) by individual syringes in different parts of the body is allowed in accordance with the vaccination calendar.

After the introduction of immunoglobulin against tick-borne encephalitis, the PCME-Immun vaccine can be administered no earlier than 4 weeks, otherwise the level of specific antibodies can be reduced.

TERMS OF RELEASE FROM PHARMACY

The vaccine is dispensed by prescription.

For sanitary and preventive and treatment-and-prophylactic establishments.

TERMS AND CONDITIONS OF STORAGE

The vaccine should be stored out of the reach of children at a temperature of 2 ° to 8 ° C.
Do not freeze. Shelf life - 30 months.
Transport conditions: at a temperature of 2 ° to 8 ° C.
Do not freeze.
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