National manufacturer of
immunobiological products in Russia
En
National manufacturer of
immunobiological products in Russia

Human tetanus immunoglobulin

Trade name

Human tetanus immunoglobulin

Dosage form

Solution for intramuscular injection 250 IU

Shelf life

2 years

Manufacturer

NPO Microgen, 177, Bratskaya str., Perm, Perm Territory, 614089 Russia

Presentation

One dose (at least 250 IU) in the volume of not more than 5 ml (depending on the specific activity) in each ampoule. 10 ampoules in each cardboard package with a package insert and an ampoule cutter. If the ampoule has a score line, a ring or a dot, an ampoule cutter is not inserted.

Ingredients

The human tetanus immunoglobulin, a solution for intramuscular administration, is a concentrated solution of purified immunoglobulin fraction isolated by fractionation with ethanol from the blood plasma of donors immunized with tetanus toxoid and checked individually for the absence of surface antigen of hepatitis B virus (HBsAg) and antibodies to hepatitis C virus and human immunodeficiency viruses HIV-1 and HIV-2.

Protein concentration in the preparation is 10 to 16%. Content of antibodies to the tetanus toxin – at least 50 international units (IU) per ml or at least 250 IU per ampoule (dose) of the preparation. The product does not contain preservatives and antibiotics. Stabilizer - glycine in concentration (2.25 ± 0.75)%.

Clear or slightly opalescent liquid, colorless or yellowish. During storage, a slight sediment may appear, provided that it disappears after gentle agitation at a temperature of 18 to 220С.

Indications

Emergency prevention of tetanus in children and adults who have not received the full course of immunization with a tetanus toxoid or having unknown vaccination history.