Immunoglobulin of the person antitetanic

General characteristics. Structure:

Active ingredients: not less than 50 ME of antibodies to a tetanin in 1 ml of solution and not less than 250 ME in 1 ampoule.

Excipients: glycine (the aminoacetic acid) in concentration (2,25±0,75) %. Drug does not contain preservatives and antibiotics.

Immunoglobulin of the person antitetanic, solution for intramuscular introduction represents strong solution of the cleared fraction of the immunoglobulins, allocated by a fractionation method alcohol from a blood plasma of donors, immunizirovanny tetanic anatoxin and checked individually for lack of a surface antigen of a virus of hepatitis In (HBsAg) and antibodies to a virus of hepatitis C and the human immunodeficiency viruses VICh-1 and VICh-2.

Pharmacological properties:

Pharmacodynamics. An effective agent of drug are the class G immunoglobulins having activity of the antibodies neutralizing a tetanin.

Pharmacokinetics. The maximum concentration of antibodies in blood is reached in 24-48 hours after introduction; the elimination half-life of antibodies makes 3-4 weeks of an organism.

Indications to use:

The emergency prevention of tetanus at the adults and children who did not receive a full course of immunization by tetanic anatoxin or with the unknown inoculative anamnesis.

Route of administration and doses:

The drug is administered intramusculary once in an upper outside quadrant of a gluteus or in the outside surface of a hip in a dose by not less than 250 ME irrespective of age. It is FORBIDDEN to ADMINISTER the DRUG INTRAVENOUSLY. Before an injection the ampoule with drug is maintained by 2 hours at a temperature from 18 to 22 °C.

Opening of ampoules and the procedure of introduction are carried out at strict observance of rules of an asepsis and antiseptics. In order to avoid foaming drug is gathered in the syringe a needle with a wide gleam, for an injection use other needle.

Drug in the opened ampoule is not subject to storage. Drug in ampoules with the broken integrity or marking is not suitable for use, at change of physical properties (discoloration, solution opacification, existence of not breaking flakes), at the expired period of validity, at the wrong storage.

Side effects:

Reactions to administration of immunoglobulin, as a rule, are absent. In rare instances local reactions in the form of a small hyperemia and pain in the field of an injection can develop. Temperature increase to 37,5 °C within the first days after administration of drug is possible.

At individuals with the changed reactivity allergic reactions, and in exclusively exceptional cases – an acute anaphylaxis can develop. In this regard the persons who received drug have to be under medical observation not less than 30 minutes.

Rooms for medical procedures where administration of immunoglobulin is carried out, have to be provided with means of antishock therapy.

Interaction with other medicines:

Drug can be used in a complex with other medicines on condition of introduction it in the form of a separate injection, without mixing with other drugs.

After administration of immunoglobulin active immunization against measles of epidemic parotitis, a rubella and tetanus is carried out not earlier than in 3 months.

Contraindications:

Administration of immunoglobulin is contraindicated to the persons which had heavy allergic reactions to introduction of blood preparations of the person in the anamnesis.

And during the next 3 days, purpose of antihistaminic drugs is recommended to the persons having allergic diseases or having clinically expressed allergic reactions in the anamnesis in day of administration of immunoglobulin.

To the persons suffering from system immune diseases (a disease of blood, connecting fabric, etc.), it is necessary to enter immunoglobulin against the background of the corresponding therapy.

Data on administration of immunoglobulin register in the corresponding registration forms with the indication of number of a series, date of issue, a period of validity, manufacturer, the nature of reaction to introduction.

Storage conditions:

In the dry, protected from light place, at a temperature of 2-8 °C. Freezing is not allowed. To store in the place, unavailable to children. A period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

On 1 dose (not less than 250 ME) of no more than 5 ml (depending on specific activity) in an ampoule. On 10 ampoules with the application instruction and the scarificator ampoule in a pack from a cardboard. When packaging the ampoules having a ring of a break or a point for opening the scarificator ampoule is not put.