Fsme-Immun (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

Suspension for intramuscular administration 0.5 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) – 1 mg (from 0.28 mg to 0.41 mg in terms of aluminum), human albumin (stabilizer) – 0.5 mg, formaldehyde (inactivator) – not more than 0.005 mg, sucrose – not more than 20 mg, protamine sulfate – not more than 0.005 mg, neomycin (traces), gentamicin (traces), sodium chloride – 3.45 mg, disodium hydrogen phosphate dihydrate – 0.22 mg, potassium dihydrogen phosphate – 0.045 mg, water for injections – up to 0.5 ml.

Does not contain preservatives.

0.5 ml – single-use syringes made of transparent glass with a needle (1) – blisters (1) – cardboard boxes.
0.5 ml – single-use syringes made of transparent 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

Inactivated vaccine against tick-borne encephalitis. Seroconversion and protection levels are achieved in 97-100% of vaccinated individuals after three-time vaccination and persist for 3 years or more.

Indications

Prevention of tick-borne encephalitis in adults and adolescents from 16 years of age, permanently residing in territories endemic for tick-borne encephalitis, as well as persons arriving in these territories who perform the following work

• Agricultural, land reclamation, construction, excavation and movement of soil, procurement, commercial, geological, survey, expedition, deratization and disinfection;
• Logging, forest clearing and improvement, areas for public health improvement and recreation;
• Working with live cultures of the tick-borne encephalitis pathogen.

ICD codes

Dosage Regimen

The vaccine is administered intramuscularly into the deltoid muscle. Before use, shake the syringe thoroughly to completely mix 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 performed 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 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 with 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 (routine or emergency) in accordance with the chosen scheme.

Visiting a natural focus of tick-borne encephalitis is recommended no earlier than 2 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 0.5 ml of FSME-Immun vaccine is carried out every 3 years. It is recommended to carry out before the start of the tick activity season.

Adverse Reactions

Local reactions possible short-term redness, swelling, and pain at the injection site; very rarely – slight enlargement of regional lymph nodes.

General reactions possible allergic reactions (generalized rash, mucosal edema, laryngeal edema, dyspnea, bronchospasm, or hypotension); in some cases – neuritis of varying severity.

Although, according to current scientific knowledge, vaccination is not a source of autoimmune diseases and there are no indications of an increased 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 compared to the possible adverse effect of vaccination on the autoimmune disease.

Contraindications

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

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. 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 risk and benefit.

Pediatric Use

Used in adults and adolescents from 16 years of age.

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 is necessary for persons who have received only one vaccination or are unvaccinated, passive immunization with specific immunoglobulin against tick-borne encephalitis should be prescribed in accordance with the instructions for use of 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. However, such vaccinees should be vaccinated with caution under careful supervision.

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

Drug Interactions

Simultaneous administration of FSME-Immun vaccination and other inactivated or live vaccines (except for rabies and BCG) with separate syringes into different parts of the body is allowed in accordance with the vaccination calendar.

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

Storage Conditions

The vaccine should be stored out of the reach of children at a temperature from 2°C (35.6°F) to 8°C (46.4°F). Do not freeze.

Shelf Life

Shelf life – 30 months.

Transportation conditions: at a temperature from 2°C (35.6°F) to 8°C (46.4°F). Do not freeze.

Dispensing Status

The vaccine is dispensed by prescription.

For sanitary-preventive and treatment-and-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.