Immunoglobulin human antiallergenic (Solution) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J06BB (Specific immunoglobulins)

Dosage Form

Immunoglobulin human antiallergenic

Solution for intramuscular injection 1 ml/dose: 1 ml or 2 ml amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection transparent or slightly opalescent, colorless or with a faint yellow tint; during storage, the appearance of a slight sediment is allowed, which disappears upon gentle shaking.

Excipients: glycine (stabilizer) 22.5±7.5 mg.

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

Clinical-Pharmacological Group

Immunological preparation. Immunoglobulin

Pharmacotherapeutic Group

MIBP-globulin

Pharmacological Action

The drug is a concentrated solution of a purified immunoglobulin fraction isolated by ethanol fractionation from the plasma of healthy donors. The immunoglobulin fraction constitutes not less than 97% of the total protein.

The drug does not contain the 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 p24 antigen. The drug does not contain preservatives or antibiotics.

The active substance of the drug is immunoglobulin G, which has a pronounced antiallergic effect in immediate (atopic) type allergic diseases.

Indications

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

ICD codes

Dosage Regimen

Children over 5 years of age and adults are prescribed the drug for pollinosis with various clinical manifestations, atopic bronchial asthma, recurrent forms of urticaria and angioedema, and allergodermatoses. The drug is administered at a dose of 2 ml (2 doses) intramuscularly into the upper outer quadrant of the gluteal muscle or the anterolateral thigh. The treatment course consists of five injections at 4-day intervals.

Children from 1 to 5 years of age suffering from mild forms of atopic dermatitis, dermorespiratory syndrome with a disease duration of no more than 1 year, are administered the drug at a dose of 1 ml (1 dose) intramuscularly into the anterolateral thigh, 5 times with a 4-day interval. For atopic bronchial asthma, pollinosis, atopic dermatitis and dermorespiratory syndrome of moderate severity and with a disease duration of more than 1 year, the drug is administered at a dose of 2 ml (2 doses) according to the same scheme.

A repeated course of treatment is carried out after 4-5 months. For 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 (71.6°F). Opening of ampoules and the injection procedure are carried out in strict compliance with the rules of asepsis and antisepsis. Considering the increased viscosity of the drug, to avoid foam formation, the immunoglobulin is drawn into the syringe with a needle with a wide lumen; a different needle is used for the injection. The drug in an opened ampoule must not be stored. The drug is unsuitable for use in ampoules with damaged integrity or labeling, if physical properties have changed (color change, solution turbidity, presence of non-dispersible flakes), or if the storage temperature regime has been violated.

Adverse Reactions

During treatment, some patients may experience a slight and short-term exacerbation of the underlying disease; in rare cases, during the first 24 hours after administration, local reactions may develop in the form of hyperemia, as well as an increase in temperature to 37°C (98.6°F), which is not a reason to discontinue the drug.

If pronounced general reactions (decreased blood pressure, weakness, nausea, dizziness), as well as a pronounced exacerbation of the underlying disease occur, treatment with the drug is discontinued. Treatment with immunoglobulin is canceled if intercurrent diseases (influenza, acute respiratory diseases) develop.

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.

Contraindications

• Allergic reactions (in history) to the administration of immunoglobulin or other drugs made from human blood;
• Influenza, acute respiratory diseases;
• Children under 1 year of age.

With caution: when administering the drug to patients with polyvalent sensitization.

Use in Pregnancy and Lactation

The safety of using this medical drug during pregnancy and breastfeeding has not been studied in controlled clinical trials.

Pediatric Use

Contraindicated in children under 1 year of age. Can be used in children over 1 year of age according to indications.

Special Precautions

Precautionary measures for use.

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

The administration of immunoglobulin is recorded in the established accounting forms indicating the name of the drug, batch number, expiration date, manufacturer, date of administration, dose, and nature of the reaction to administration.

Information on the possible effect of the medicinal product on the ability to drive vehicles, mechanisms.

The drug does not affect the ability to drive vehicles, mechanisms, or engage in activities requiring increased concentration and speed of psychomotor reactions.

Overdose

Cases of overdose have not been described.

Drug Interactions

The drug can be used in combination with other medicinal products provided it is administered as a separate injection, not mixed with other drugs.

The administration of the drug may reduce the effectiveness of live virus vaccines (against measles, mumps, and rubella), therefore vaccination with live virus vaccines is carried out no earlier than 3 months after the end of the treatment course.

Storage Conditions

Transport in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8°C (46.4°F). Freezing is not allowed.

Store in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8°C (46.4°F) in a place inaccessible to children. Freezing is not allowed.

Shelf Life

Shelf life – 2 years. Do not use after the expiration date.

Dispensing Status

Dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.