Instruction for use: FSME-Bulin

Dosage form: Suspensium for intramuscular injection

Active substance: Immunoglobulinum antiencephaliticum

ATX

J06BB12 Human immunoglobulin against tick-borne encephalitis

Pharmacological groups:

Immunoglobulins

The nosological classification (ICD-10)

A84 Tick-borne viral encephalitis: Tick-borne encephalitis; Tick-borne encephalitis

Composition and release form

1 vial contains 1, 2, 5 or 10 ml of a concentrated solution of the purified human immunoglobulin fraction against tick-borne encephalitis virus with a minimum antibody titer of 1: 640. The plasma used to produce the drug undergoes mandatory testing for ALT, as well as the absence of HBsAg, anti-HCV, HIV-1 and HIV-2 antibodies. Contains 100-170 mg / ml protein (not less than 90% gamma globulin), 22.5 mg / ml glycine, 3 mg / ml sodium chloride, does not contain preservatives.

Pharmachologic effect

Mode of action - immunostimulating.

Contains antibodies against tick-borne encephalitis virus and protects against infection.

Indication of the FSME-Bulin

Prevention of tick-borne encephalitis before visiting the natural foci of infection or for 96 hours after a tick bite (in the absence of vaccination, as well as in case of ineffective vaccination).

Contraindications

Hypersensitivity.

Application in pregnancy and breastfeeding

It is permissible.

Side effects

Allergic reactions.

Interaction

Incompatible with live vaccines (they should not be used for 3 months).

Dosing and Administration

IM deeply, slowly (warmed to body temperature). Introduction before the bite of the tick - 0.05 ml / kg (the protective effect manifests itself in 24 hours and lasts about 4 weeks), then again - after 4 weeks; Introduction after a tick bite - 0.2 ml / kg.

If by the time of tick bite the patient had to reintroduce the vaccine against tick-borne encephalitis FSOME-IMMUN Inject (ie, 2-4 weeks after 1 dose), and after the bite was no more than 48 hours, the vaccine was administered.

Storage conditions of the drug FSME-Bulin

At a temperature of 2-8 ° C.

Keep out of the reach of children.

Shelf life of the drug FSME-Bulin

3 years.

Do not use after the expiry date printed on the package.