Gabreglobine^® (Solution, Lyophilisate) Instructions for Use

ATC Code

J06BA02 (Normal human immunoglobulin for intravenous administration)

Active Substance

Human normal immunoglobulin (Ph.Eur.)

Clinical-Pharmacological Group

Immunological preparation. Immunoglobulin

Pharmacotherapeutic Group

Immunoglobulin

Pharmacological Action

Gabreglobine is an immunologically active protein fraction containing a wide spectrum of antibodies, isolated from human plasma or serum of donors tested for the absence of antibodies to the human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus and hepatitis B surface antigen. The active component of the drug is immunoglobulin G, which possesses antibody activity of various specificities.

Pharmacokinetics

The drug is not subjected to chemical or enzymatic processing, does not contain preservatives or antibiotics. The stabilizer is maltose.

With intravenous infusion, bioavailability is 100%. Immunoglobulin G crosses the placenta and passes into breast milk. The maximum concentration of antibodies in the blood persists for 21 days. In patients with primary hypo- or agammaglobulinemia, the half-life is more than 32 days.

Indications

• Severe forms of bacterial and viral infections;
• Postoperative complications accompanied by bacteremia and septicopyemic conditions;
• Primary antibody deficiency syndrome: agamma- or hypogammaglobulinemia (congenital form, period of physiological deficiency in newborns);
• Secondary antibody deficiency syndrome;
• Blood diseases, consequences of immunosuppressive therapy, acquired immunodeficiency (AIDS), especially when children are infected with the human immunodeficiency virus.

ICD codes

Dosage Regimen

Lyophilisate

Immunoglobulin for intravenous administration is used only in a hospital setting. Before administration, the vials are kept at a temperature of (20+2)°C for at least 2 hours. Immediately before administration, the immunoglobulin is dissolved in water for injections in the volume indicated on the label. The drug containing impurities is not suitable for use.

The dose and frequency of administration of the drug depend on the indications for use. A single dose is 0.05-0.2 g/kg of body weight. The diluted immunoglobulin is administered intravenously by drip in the first 10-15 minutes at a rate of 15-20 drops per minute, then at a rate of 30-40 drops per minute. Faster administration may cause the development of a collaptoid reaction. The course of treatment consists of 3-10 transfusions performed every 24 – 72 hours (depending on the severity of the disease).

Solution

Immunoglobulin for intravenous administration is used only in a hospital setting via an infusion system. Before administration, the vials are kept at a temperature of (20+2)°C for at least 2 hours. Cloudy solutions and solutions containing sediment are not suitable for use.

The dose and frequency of administration of the drug depend on the indications for use.

For children, a single dose is 3 -4 ml per 1 kg of body weight. Immunoglobulin is administered intravenously by drip at a rate of 8-10 drops per minute.

Infusions are performed daily for 3-5 days.

For adults, a single dose of the drug is 25-50 ml. Immunoglobulin is administered intravenously by drip in the first 10-15 minutes at a rate of 15-20 drops per minute, then at a rate of 30-40 drops per minute. Faster administration may cause the development of a collaptoid reaction. The course of treatment consists of 3-10 transfusions performed every 24 – 72 hours (depending on the severity of the disease).

Adverse Reactions

Within the first 24 hours after administration of the drug, a slight increase in body temperature and allergic reactions are possible.

Sometimes headache, dizziness, dyspeptic phenomena, arterial hypo- or hypertension, tachycardia, and shortness of breath occur.

In extremely rare cases, with individual intolerance, the development of anaphylactic reactions is possible.

Contraindications

• Allergic reactions or severe systemic reactions to human blood products in the anamnesis;
• Anaphylactic shock to human blood products in the anamnesis in cases of severe sepsis;
• Hypersensitivity (including to maltose), IgA immunodeficiency.

With caution severe heart failure, diabetes mellitus, renal failure.

Use in Pregnancy and Lactation

During pregnancy and lactation, it is administered only for strict indications, when the intended benefit to the mother outweighs the potential risk to the child.

Use in Renal Impairment

Use with caution in renal failure.

Pediatric Use

Can be used in children according to indications.

Special Precautions

In persons suffering from autoimmune diseases (blood diseases, connective tissue diseases, nephritis), the drug should be administered against the background of appropriate therapy. Immunoglobulin passes into breast milk and may contribute to the transmission of protective antibodies to the newborn.

After administration of the drug, the patient’s condition should be monitored for at least 30 minutes. The room where the drug is administered must have anti-shock therapy means. In case of development of anaphylactoid reactions, antihistamines, glucocorticosteroids and adrenomimetics are used.

A temporary increase in the content of antibodies in the patient’s blood after the administration of immunoglobulin may cause false-positive results of serological tests.

The rate of intravenous administration should not be exceeded due to the possibility of developing collaptoid reactions.

Drug Interactions

Transfusion therapy with intravenous immunoglobulin can be combined with other drugs, in particular, antibiotics. The administration of immunoglobulins may weaken (for 1.5-3 months) the effect of live vaccines against such viral diseases as measles, rubella, mumps and chickenpox (vaccinations with these vaccines should be carried out no earlier than after 3 months). After the administration of large doses of immunoglobulin, its effect may last in some cases up to one year.

Do not use simultaneously with calcium gluconate in infants.

Storage Conditions

The drug should be stored in a dry, light-protected place at a temperature of 2 to 10°C (50°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

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.