Immunoglobulin human antiallergic - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspsolution for intramuscular injection

Composition:

1 ml of the drug contains active ingredient - immunoglobulin G, Has anti-allergic activity (protein concentration from 9.5 to 10.5%);

auxiliary substance: stabilizer - glycine (aminoacetic acid) - (22.5 ± 7.5) mg.

Description:

Transparent or slightly opalescent liquid, colorless or slightly yellow in color.

In the course of storage, a slight deposit may appear, disappearing with slight shaking.

Pharmacotherapeutic group:MIBP globulin

ATX: & nbsp

Other immunoglobulins

Pharmacodynamics:

The preparation is a concentrated solution of the purified immunoglobulin fraction, isolated by the method of fractionation with ethyl alcohol from blood plasma of healthy donors. Fraction of immunoglobulins is not less than 97% of the total protein.

The preparation does not contain a surface antigen of the hepatitis B virus (HBsAg) and antibodies to the hepatitis C virus and human immunodeficiency virus (HIV-1 and HIV-2), as well as the HIV-1 antigen p24. The drug does not contain preservatives and antibiotics.

Immunobiological properties

The active principle of the preparation is immunoglobulin G, It has a pronounced antiallergic effect for allergic diseases of immediate (atopic) type.

Indications:Complex treatment of allergic diseases (pollinosis, atopic dermatitis, atopic bronchial asthma, dermorespiratory syndrome) in adults and children.

Contraindications:

- Allergic reactions (in anamnesis) for the management of immunoglobulin or other drugs from human blood;

- influenza, acute respiratory infections;

- children under 1 year.

Carefully:When the drug is administered to patients with polyvalent sensitization.

Pregnancy and lactation:

The safety of the use of this medication during pregnancy and during breastfeeding during controlled clinical trials has not been investigated.

Dosing and Administration:

Children over 5 years and adults the drug is prescribed for pollinosis with various clinical manifestations, atopic bronchial asthma, recurrent forms of urticaria and Quincke edema, allergic dermatoses. The drug is injected 2 ml (2 doses) intramuscularly into the outer upper quadrant of the gluteus muscle or into the antero-anterior region of the thigh. The course of treatment consists of five injections with an interval of 4 days.

Children from 1 to 5 years, suffering from mild forms of atopic dermatitis,dermorespiratory syndrome with a prescription period of not more than 1 year, the drug is administered 1 ml (1 dose) intramuscularly into the anterior thoracic region of the thigh, 5 times with an interval of 4 days. Atopic bronchial asthma, pollinosis, atopic dermatitis and dermorespiratory syndrome of moderate severity and with a prescription period of more than 1 year, the drug is administered 2 ml (2 doses) according to the same scheme.

Repeated treatment is carried out after 4-5 months. With pollinosis treatment is carried out once a year, 1-2 months before the seasonal exacerbation.

Before injection, the ampoule with the drug is kept at a temperature of 18 to 22 ° C. Opening of ampoules and the procedure of administration are carried out with strict adherence to aseptic and antiseptic rules. Given the increased viscosity of the drug, in order to avoid the formation of foam immunoglobulin is injected into the syringe with a needle with a wide lumen, another needle is used for injection. The drug in the opened ampoule is not subject to storage. The preparation is not suitable for use in ampoules with broken integrity or marking, with a change in physical properties (color change, cloudiness of solution, the presence of unbreakable flakes), in the event of a violation of the temperature storage regime.

Side effects:

In the course of treatment, some patients may experience a slight and short-term exacerbation of the underlying disease, in rare cases within the first day after administration local reactions in the form of hyperemia may develop, as well as an increase in temperature to 37 ° C, which is not a reason for stopping the drug administration.

When there are pronounced general reactions (lowering blood pressure, weakness, nausea, dizziness), as well as severe exacerbation of the underlying disease, drug treatment is discontinued.

The treatment with immunoglobulin in the development of intercurrent diseases (influenza, acute respiratory diseases) is canceled.

The patient should be warned about the need to inform the attending physician of all cases of adverse reactions that developed during the course of treatment with the drug.

Overdose:

Cases of overdose are not described.

Interaction:

The drug can be used in conjunction with other drugs, provided it is administered as a separate injection, without mixing with other drugs.

Administration of the drug may reduce the effectiveness of live viral vaccines (against measles, mumps and rubella),in connection with which vaccination with live viral vaccines is carried out not earlier than 3 months after the end of the course of treatment.

Special instructions:

Given the possible occurrence of anaphylactic reactions in particularly sensitive individuals, it is necessary to provide medical supervision of patients for 1 hour after the administration of the drug. If symptoms of an allergic reaction appear, appropriate therapy is immediately performed.

The introduction of immunoglobulin is recorded in the prescribed registration forms with the name of the drug, the serial number, the expiration date, the manufacturer, the date of administration, the dose and the nature of the reaction to the administration.

Effect on the ability to drive transp. cf. and fur:

The drug has no effect on the ability to drive vehicles, mechanisms, as well as activities that require a high concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Solution for intramuscular injection.

Packaging:

1 ml (1 dose) or 2 ml (2 doses) into glass ampoules.

For 10 ampoules in a pack (box) of cardboard with instructions for use, an ampoule or ampoule knife with a knife.

When packing ampoules having a notch, a ring or break point, the ampoule knife or ampoule scaper is not put.

Storage conditions:

To transport in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Freezing is not allowed.

Keep in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C, out of reach of children. Freezing is not allowed.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LS-001280

Date of registration:27.09.2011 / 02.12.2013

Expiration Date:Unlimited

The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia

Manufacturer: & nbsp

MICROGEN FGUP NGO Russia

Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia

Information update date: & nbsp24.10.2017

Illustrated instructions

Instructions

Immunoglobulin human antiallergic (Immunoglobulinum humanum antiallergicum)