Fsme-Immun Junior (Suspension) Instructions for Use

Marketing Authorization Holder

Pfizer, Inc. (USA)

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

Fsme-Immun Junior

Suspension for intramuscular administration 0.25 ml/1 dose: syringes 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Suspension for intramuscular administration whitish in color, opaque, free from foreign particles.

Excipients: aluminum hydroxide gel (adjuvant) – 0.5 mg (from 0.14 mg to 0.21 mg in terms of aluminum), human albumin (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, disodium hydrogen phosphate dihydrate – 0.11 mg, potassium dihydrogen phosphate – 0.0225 mg, water for injections – up to 0.25 ml.

Does not contain preservatives.

0.25 ml – disposable syringes made of clear glass with a needle (1) – blisters (1) – cardboard boxes.
0.25 ml – disposable syringes made of clear glass with a needle (1) – blisters (10) – cardboard boxes.

Clinical-Pharmacological Group

Vaccine for the prevention of tick-borne encephalitis

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

The FSME-IMMUN Junior vaccine is a purified, concentrated, sterile suspension of the tick-borne encephalitis virus (strain “Neudörfl”), obtained by its reproduction in a culture of chicken embryo “SPF” cells, inactivated with formaldehyde, and adsorbed on aluminum hydroxide gel.

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

Indications

• Prevention of tick-borne encephalitis (TBE) in children and adolescents aged from 1 year to 16 years, permanently residing in territories endemic for tick-borne encephalitis, as well as persons arriving in these territories.

ICD codes

Dosage Regimen

The vaccine is administered intramuscularly into the deltoid muscle.

For children under 18 months of age (or depending on the child’s weight and development), the vaccine should be administered into the anterolateral aspect of the thigh. Care should be taken to prevent accidental intravascular administration of the vaccine.

Shake the syringe thoroughly before use for complete mixing of the suspension!

The vaccine must not be administered intravenously!

Erroneous intravenous administration may cause reactions, up to shock. In such cases, anti-shock therapy must be carried out immediately. The room where vaccination is carried out must be equipped with means for anti-shock therapy.

The vaccine should be used immediately after removing the protective cap from the needle. The vaccination procedure must be carried out in strict compliance with the rules of asepsis and antisepsis.

On the day of vaccination, the doctor (or paramedic) conducts a survey and examination of the vaccinee with mandatory thermometry. The doctor (paramedic) is responsible for the correct prescription of the vaccination.

The performed vaccination is registered in the established accounting forms indicating the date of vaccination, dose, name of the vaccine, manufacturer, batch number, and expiration date.

1. Primary vaccination course

Vaccination is carried out three times according to one of two schemes.

Routine vaccination is recommended to be carried out before the start of the tick activity season. The first and second vaccinations are preferably carried out in the winter or spring months (Scheme A – routine vaccination). Vaccination in the summer (especially for urban residents) according to Scheme B – emergency vaccination is allowed. 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 (routine or emergency) in accordance with the chosen scheme.

Visiting a natural focus of tick-borne encephalitis is recommended no earlier than two weeks after the second vaccination.

2. Revaccination

After the course of primary vaccination, carried out according to one of the two schemes, revaccination in the form of a single injection of 0.25 ml of FSME-IMMUN Junior vaccine is carried out every 3 years before the start of the tick activity season.

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

Adverse Reactions

After administration of the vaccine, local and systemic reactions may develop in some cases.

Local reactions

Manifest as short-term redness, swelling, and pain at the injection site, in very rare cases, slight enlargement of regional lymph nodes.

Systemic reactions

Some first-time vaccinees experience an increase in body temperature, which usually decreases within 24 hours.

In children from 1 year to 2 years: low-grade fever (38-39°C (100.4-102.2°F))* in 27.9% of vaccinees, febrile temperature (39.1-40°C (102.4-104°F))* in 3.4% of vaccinees.

In children from 3 to 15 years: low-grade fever (38-39°C (100.4-102.2°F))* in 6.8% of vaccinees, febrile temperature (39.1-40°C (102.4-104°F))* in 0.6% of vaccinees.

With repeated vaccination, the described reaction, as a rule, occurs less frequently, and the temperature increase is less pronounced: in children from 1 year to 2 years in 15.6% of vaccinees, in children from 3 to 15 years: in 1.9% of vaccinees.

If necessary, an antipyretic agent can be used.

Allergic reactions (generalized rash, mucosal edema, laryngeal edema, dyspnea, bronchospasm, or hypotension), as well as neuritis of varying severity, are observed in extremely rare cases.

Although, according to current scientific knowledge, vaccination is not a source of autoimmune diseases and there are no indications of an increase in the frequency of autoimmune diseases (e.g., multiple sclerosis, iridocyclitis) after vaccination, in the case of a known or suspected autoimmune disease, it is necessary to assess the degree of risk of possible infection with the tick-borne encephalitis virus in comparison with the possible adverse effect of vaccination on the autoimmune disease.

* In children from 1 year to 3 years of age, temperature was measured rectally, in children over 3 years of age orally.

Contraindications

• Acute febrile conditions of any etiology or exacerbation of chronic infectious diseases. Vaccination is carried out no earlier than 2 weeks after recovery (remission);
• History of allergy to vaccine components;
• History of anaphylactic reaction to egg white.

Use in Pregnancy and Lactation

There are no reliably significant data on the effect of the drug on the course of pregnancy and fetal development, as well as on penetration into 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 risk and benefit.

Pediatric Use

Used in children and adolescents aged from 1 year to 16 years

Special Precautions

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

If emergency protection of persons who have received only one vaccination or are unvaccinated is necessary, passive immunization with specific immunoglobulin against tick-borne encephalitis should be prescribed in accordance with the Instructions for Use for that drug. Four weeks after the administration of specific immunoglobulin, the vaccination course should be started anew.

A history of hypersensitivity to chicken egg protein is not an absolute contraindication, excluding anaphylaxis. However, such persons should be vaccinated with caution.

The vaccine is used with caution in persons with a history of cerebral disorders.

Drug Interactions

Simultaneous administration of FSME-IMMUN Junior vaccination and other inactivated vaccines of the national vaccination calendar and the vaccination calendar for epidemic indications (except for anti-rabies) with separate syringes in different parts of the body is allowed.

After the administration of immunoglobulin against tick-borne encephalitis, the FSME-IMMUN Junior vaccine can be administered no earlier than 4 weeks later, otherwise the level of specific antibodies may be reduced.

Storage Conditions

Store and transport the drug at a temperature from 2°C (35.6°F) to 8°C (46.4°F). Do not freeze. Keep out of reach of children.

Shelf Life

Shelf life – 30 months. The drug with an expired shelf life must not be used.

Dispensing Status

The drug is dispensed by prescription.

For use in therapeutic-prophylactic and sanitary-prophylactic institutions.

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.