Universal reference book for medicines
Product name: FSME-IMMUN JUNIOR (FSME-IMMUN JUNIOR)

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 (0.25 ml)

antigen of tick-borne encephalitis virus 1.19 μg

Auxiliary substances: aluminum hydroxide gel (adjuvant) - 0.5 mg (0.14 mg to 0.21 mg in terms of aluminum), human blood album (stabilizer) 0.25 mg, formaldehyde (inactivator) - not more than 0.0025 mg, sucrose - not more than 7.5 mg, protamine sulfate - not more than 0.0025 mg, neomycin (traces), gentamicin (traces), sodium chloride - 1.725 mg, sodium hydrogen phosphate dihydrate - 0.11 mg, potassium dihydrogen phosphate - 0.0225 mg, water d / and - up to 0.25 ml.

Preservatives do not contain.

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

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

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

The FSME-IMMUN Junior vaccine is a purified, concentrated, sterile suspension of tick-borne encephalitis virus (Neidorf strain) obtained by reproducing it in a "SPF" chicken embryo cell culture inactivated with formaldehyde sorbed on an aluminum hydroxide gel.

The level of seroconversion and protection is achieved in 97-100% of vaccinated children and adolescents aged 1 year and up to 16 years after the triple vaccination and lasts for three years or more.

INDICATIONS

- prevention of tick-borne encephalitis (TBE) in children and adolescents aged 1 to 16 years, permanently residing on endemic encephalitis encephalitis territories, as well as those arriving in these territories.

DOSING MODE

The vaccine is given in / m in the deltoid muscle.

Children under the age of 18 months (or depending on the weight and development of the child) should be vaccinated in the outer surface of the wide thigh muscle.Care should be taken to prevent accidental intravascular administration of the vaccine.

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 (paramedic) is responsible for the correct appointment 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 vaccine 0.25 ml 0 day 0 day

The second inoculation 0.25 ml After 1-3 months After 14 days

Third vaccine 0.25 ml 5-12 months after the second vaccination 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 two 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 two weeks after the second vaccination.

2. Revaccination

After a course of primary vaccination, performed according to one of the two schemes, a single injection of 0.25 ml of the FSME-IMMUN Junior vaccine is given every 3 years prior to the beginning of the tick activity season.

Revaccination after reaching the age of 16 years is carried out with the vaccine FSME-IMMUN (for adults and adolescents with 16 years) at a dose of 0.5 ml.

SIDE EFFECT

After the introduction of the vaccine in some cases, local and general reactions may develop.

Local reactions:

They manifest short-term redness, swelling and tenderness at the site of administration of the vaccine, in very rare cases, a slight increase in regional lymph nodes.

Common reactions:

Some people who are newly vaccinated are noted to have a rise in body temperature, which usually decreases within 24 hours.

In children from 1 year to 2 years: subfebrile temperature (38-39 ° C) * in 27.9% of the grafted, febrile temperature (39.1-40 ° C) * in 3.4% of the grafted.

In children from 3 to 15 years: subfebrile temperature (38-39 ° C) * in 6.8% of the grafted, febrile temperature (39.1-40 ° C) * in 0.6% of the grafted.

During re-inoculation, the described reaction is usually less frequent, and the temperature increase is less pronounced: in children from 1 year to 2 years of age 15.6% of the vaccinated, in children from 3 to 15 years: 1.9% of those vaccinated.

If necessary, you can apply antipyretic.

Allergic reactions (generalized rash, swelling of the mucous membranes, laryngeal edema, dyspnoea, bronchospasm or hypotension), as well as neuritis of varying severity are observed in extremely rare cases.

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 the effect of vaccination on autoimmune disease.

* In children from 1 year to 3 years of age, the temperature was measured rectally, in children older than 3 years, oral.

CONTRAINDICATIONS

- acute feverish conditions of any etiology or exacerbation of chronic infectious diseases.
Vaccination is performed no earlier than 2 weeks after recovery (remission);
- history of allergy to vaccine components;

anaphylactic reaction to egg white in history.

PREGNANCY AND LACTATION

Reliably significant data on the effect of the drug on the course of pregnancy and development of the fetus, as well as on the penetration of breast milk are absent.

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 children and adolescents aged 1 to 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, excluding anaphylaxis.
However, such individuals should be vaccinated with caution.
The vaccine is used with caution in individuals with cerebral disorders in history.

DRUG INTERACTION

Simultaneous vaccination of FSEM-IMMUN Junior and the introduction of other inactivated vaccines of the national calendar of vaccinations and vaccination schedules for epidemiological indications (other than anti-rabies) by individual syringes in different parts of the body are allowed.

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

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

For use in medical and preventive and sanitary facilities.

TERMS AND CONDITIONS OF STORAGE

The preparation should be stored and transported at a temperature of 2 ° C to 8 ° C.
Do not freeze. Keep out of the reach of children.
Shelf life - 30 months.
The drug with expired shelf life is not subject to application.
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