Immunoglobulin of the person antiallergic

General characteristics. Structure:

Active ingredient: not less than 97% of immunoglobulin of the person of G, having antiallergic activity, from protein lump.

Excipients: glycine.

Pharmacological properties:

Pharmacodynamics. Drug represents strong solution of the cleared fraction of immunoglobulins allocated with a fractionation method alcohol from a blood plasma of healthy donors. The fraction of immunoglobulins makes not less than 97% of crude protein.

Drug does not contain a surface antigen of a virus of hepatitis In (HBsAg) and antibodies to a virus of hepatitis C and a human immunodeficiency virus (VICh-1 and VICh-2), and also VICh-1 antigen r24. Drug does not contain preservatives and antibiotics.

Effective agent of drug is the immunoglobulin G having the expressed antiallergic effect at allergic diseases of immediate (atopic) type.

Indications to use:

— complex treatment of allergic diseases (pollinoses, atopic dermatitis, atopic bronchial asthma, a dermorespiratorny syndrome) at adults and children.

Route of administration and doses:

To children 5 years are more senior and appoint drug the adult at pollinoses with various clinical manifestations, atopic bronchial asthma, recurrent forms of a small tortoiseshell and a Quincke's edema, allergodermatoza. The drug is administered on 2 ml (2 doses) intramusculary in an outside upper quadrant of a gluteus or to the anteroexternal area of a hip. The course of treatment consists of five injections with an interval of 4 days.

To the children from 1 year to 5 years suffering from easy forms of atipichesky dermatitis, a dermo-respiratory syndrome at prescription of a disease no more than 1 year, the drug is administered on 1 ml (1 dose) intramusculary to the anteroexternal area of a hip, by 5 times with an interval of 4 days. At atopic bronchial asthma, pollinoses, atopic dermatitis and a moderately severe dermorespiratorny syndrome and at prescription of a disease more than 1 year the drug is administered on 2 ml (2 doses) according to the same scheme.

The repeated course of treatment is carried out in 4-5 months. At pollinoses treatment is carried out once a year, in 1-2 months prior to a seasonal aggravation.

Before an injection the ampoule with drug is maintained 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. Considering the increased viscosity of drug, in order to avoid foaming immunoglobulin 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 disturbance of temperature condition of storage.

Features of use:

Use at pregnancy and feeding by a breast. Safety of use of this medical supply at pregnancy and during breastfeeding in the course of controlled clinical tests was not investigated.

Use for children. Contraindicated to children till 1 year. Perhaps use for children is more senior than 1 year according to indications.

Special instructions. Precautionary measures at use.

Considering possibility of anaphylactic reactions at especially sensitive persons, it is necessary to provide after administration of drug medical observation of patients during 1 h. At emergence of symptoms of allergic reaction the corresponding therapy is immediately carried out.

Administration of immunoglobulin is registered in the established registration forms with the indication of the name of drug, number of a series, period of validity, the manufacturing enterprise, Date of Introduction, a dose and the nature of reaction to introduction.

Data on possible influence of medicine on ability to manage vehicles, mechanisms. Drug does not exert impact on ability to manage vehicles, mechanisms, and also the activity requiring the increased concentration attention and speed of psychomotor reactions.

Side effects:

In the course of treatment at some patients there can come the insignificant and short-term aggravation of a basic disease, in rare instances within the first days after introduction local reactions in the form of a hyperemia, and also temperature increase to 37 °C can develop that is not the basis for the termination of administration of drug.

At emergence of the expressed general reactions (lowering of arterial pressure, weakness, nausea, dizziness), and also the expressed aggravation of a basic disease, treatment by drug is stopped. Treatment is cancelled by immunoglobulin at development of intercurrent diseases (flu, acute respiratory diseases).

The patient has to be warned about need of informing the attending physician on all cases of the adverse reactions which developed during a course of treatment drug.

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.

Administration of drug can reduce efficiency of live virus vaccines (against measles, epidemic parotitis and a rubella) in this connection vaccination by live virus vaccines is carried out not earlier than in 3 months on the termination of a course of treatment.

Contraindications:

— allergic reactions (in the anamnesis) on maintaining immunoglobulin or other drugs from blood of the person;

— flu, acute respiratory diseases;

— children's age till 1 year.

With care: at administration of drug by the patient with a polyvalent sensitization.

Overdose:

Cases of overdose are not described.

Storage conditions:

To transport according to the joint venture 3.3.2.1248-03 at a temperature from 2 to 8 °C. Freezing is not allowed. To store according to the joint venture 3.3.2.1248-03 at a temperature from 2 to 8 °C in the place, unavailable to children. Freezing is not allowed. A period of validity - 2 years. Not to use after a period of validity.

Issue conditions:

According to the recipe

Packaging:

1 ml (1 dose) - ampoules (10) - packs cardboard.
2 ml (2 doses) - ampoules (10) - packs cardboard.