Imbioglobulin (Solution) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J06BA02 (Normal human immunoglobulin for intravenous administration)

Active Substance

Human normal immunoglobulin (Ph.Eur. European Pharmacopoeia)

Dosage Form

Imbioglobulin

Solution for infusion 50 mg/1 ml: 20 ml, 50 ml, 100 ml, or 200 ml vial or bottle 1 pc.

Dosage Form, Packaging, and Composition

Solution for infusion transparent or slightly opalescent, colorless.

Excipients: maltose monohydrate – 90 mg, water for injections – up to 1 ml.

The preparation does not contain preservatives or antibiotics.

20 ml – glass vials (1) – cardboard packs.
50 ml – glass vials (1) – cardboard packs.
100 ml – glass vials (1) – cardboard packs.
200 ml – glass vials (1) – cardboard packs.
20 ml – glass bottles (1) – cardboard packs.
50 ml – glass bottles (1) – cardboard packs.
100 ml – glass bottles (1) – cardboard packs.
200 ml – glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Immunological preparation. Immunoglobulin

Pharmacotherapeutic Group

Immune sera and immunoglobulins; immunoglobulins; normal human immunoglobulins

Pharmacological Action

A highly purified IgG preparation isolated from human plasma of healthy donors, individually tested for the absence of hepatitis B virus surface antigen (HBsAg) and antibodies to hepatitis C virus and human immunodeficiency viruses HIV-1 and HIV-2. It has low anticomplementary activity as a result of additional purification of Ig from aggregated proteins and impurities. It does not contain preservatives or antibiotics.

It increases the content of antibodies in the body. It contains a wide spectrum of opsonizing and neutralizing antibodies against bacteria, viruses, and other pathogens. In patients suffering from primary or secondary immunodeficiency syndromes, it provides replacement of missing IgG class antibodies, which reduces the risk of infection.

It possesses activity of antibodies of various specificities, as well as nonspecific activity, manifested in increasing the body’s resistance.

Pharmacokinetics

Bioavailability after IV infusion is 100%. Redistribution of the preparation between plasma and extravascular space occurs, with equilibrium reached in approximately 7 days. In individuals with normal serum IgG levels, the biological half-life averages 21 days, while in patients with primary hypo- or agammaglobulinemia it is 32 days.

Indications

• Replacement therapy for the purpose of infection prevention in primary immunodeficiency syndromes: agammaglobulinemia, common variable immunodeficiencies associated with a- or hypogammaglobulinemia; IgG subclass deficiency;
• Replacement therapy for the purpose of infection prevention in secondary immunodeficiency syndrome caused by chronic lymphocytic leukemia, AIDS in children, or bone marrow transplantation,
• Idiopathic thrombocytopenic purpura;
• Kawasaki syndrome (in addition to treatment with acetylsalicylic acid preparations);
• Severe bacterial infections, including sepsis (in combination with antibiotics), viral infections, infection prevention in premature infants with low birth weight (less than 1500 g);
• Guillain-Barré syndrome and chronic inflammatory demyelinating polyneuropathy;
• Autoimmune neutropenia, partial red cell aplasia of hematopoiesis;
• Immune-mediated thrombocytopenia, including post-transfusion purpura, isoimmune neonatal thrombocytopenia, hemophilia caused by antibody formation to coagulation factors;
• Myasthenia gravis;
• Prevention and treatment of infections during therapy with cytostatics and immunosuppressants;
• Prevention of habitual miscarriage.

ICD codes

Dosage Regimen

IV drip. The infusion rate for children is 0.08-0.5 ml/min depending on body weight, for adults it is 1-1.5 ml/min. A faster rate of administration may cause collapse.

In the treatment of bacterial and viral infections, a single dose for children is 4 ml (200 mg) per 1 kg of body weight, administered 1-2 times, for adults it is 2 ml (100 mg) per 1 kg of body weight over 4 days.

For primary immunodeficiency in patients with congenital agammaglobulinemia and hypogammaglobulinemia – 4-6 ml (200-300 mg) per 1 kg of body weight. The repeat course is after 3-4 weeks.

For secondary immunodeficiency in patients with chronic lymphocytic leukemia – 4-10 ml (from 200 to 500 mg) per 1 kg of body weight. The repeat course is after 3-4 weeks.

Adverse Reactions

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

Headache, nausea, dizziness, vomiting, abdominal pain, diarrhea, dyspeptic phenomena, arterial hypo- or hypertension, tachycardia, cyanosis, shortness of breath, feeling of pressure or pain in the chest sometimes occur; rarely – severe hypotension, collapse, loss of consciousness, hyperthermia, chills, increased sweating, feeling of fatigue, malaise, back pain, myalgia, numbness, hot flashes or feeling of cold. In exceptionally rare cases, with individual intolerance, anaphylactic reactions may develop.

Contraindications

• Hypersensitivity to human immunoglobulins, especially in patients with IgA deficiency due to antibody formation against it.

Use in Pregnancy and Lactation

Immunoglobulin passes into breast milk and may contribute to the transfer of protective antibodies to the newborn.

Special Precautions

Imbioglobulin is used only in a hospital setting while observing aseptic rules.

Due to the possibility of developing allergic reactions, persons who have received the preparation should be under medical supervision. The room where the preparation is administered must have anti-shock therapy means.

For persons with allergic diseases (bronchial asthma, atopic dermatitis, recurrent urticaria) or prone to allergic reactions, the preparation is administered against the background of antihistamines. It is recommended to continue their administration for 8 days after the end of the treatment course.

For persons with diseases in the pathogenesis of which immunopathological mechanisms are leading (collagenosis, immune blood diseases, nephritis), the preparation is prescribed after consultation with the appropriate specialist.

During an exacerbation of the allergic process, the preparation is administered based on the conclusion of an allergist for vital indications.

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

The intravenous infusion rate must not be exceeded due to the possibility of developing collapse-like reactions.

Before administration, the vials are kept at a temperature of 20±2°C (68±3.6°F) for at least 2 hours. A cloudy preparation or one containing sediment is not suitable for use.

The administration of Imbioglobulin is recorded in the established accounting forms indicating the batch number, manufacturing date, expiration date, manufacturer, dose, and the nature of the reaction to the administration of the preparation.

Cases of increased reactogenicity should be reported by telephone (fax) or telegraph to the L.A. Tarasevich State Research Institute for Standardization and Control of Medical Biological Preparations (L.A. Tarasevich GISC) with subsequent submission of medical documentation.

Drug Interactions

Transfusion therapy with intravenous immunoglobulin can be combined with other medications, 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 the specified vaccines should be carried out no earlier than 3 months later).

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

Store in a dry place, protected from light, at a temperature not exceeding 2-8°C (35.6-46.4°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The preparation is 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.