BioGam human normal immunoglobulin chromatographically purified (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

BioGam Human normal immunoglobulin chromatographically purified

Solution for infusion 100 mg/ml: 20, 50, or 100 ml

Dosage Form, Packaging, and Composition

Solution for infusion transparent or slightly opalescent, colorless or light yellow.

Excipients: glycine (aminoacetic acid) – 25 mg, water for injections – up to 1 ml.

20 ml – bottles (1) – cardboard boxes.
50 ml – bottles (1) – cardboard boxes.
100 ml – bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

Immunological preparation. Immunoglobulin

Pharmacotherapeutic Group

Immune sera and immunoglobulins; immunoglobulins; normal human immunoglobulins

Pharmacological Action

Human Ig, by replenishing the deficiency of antibodies, reduces the risk of developing infections in patients with primary and secondary immunodeficiency.

Indications

Congenital immunodeficiency states (congenital complete or partial immunodeficiency, variable immunodeficiency, severe combined immunodeficiencies, Wiskott-Aldrich syndrome); idiopathic thrombocytopenic purpura (especially acute forms in children).

Acquired immunodeficiency (chronic lymphocytic leukemia, AIDS in children, bone marrow transplantation and other types of transplantation); Kawasaki syndrome (as an adjunct to acetylsalicylic acid therapy); prevention and therapy of infectious diseases.

ICD codes

Dosage Regimen

Administer by intravenous infusion only. Do not administer as a bolus injection.

Determine the dose and frequency based on the specific indication, the patient’s clinical response, and individual tolerance.

For primary immunodeficiencies, administer a dose of 0.2-0.4 g/kg body weight every 3-4 weeks. Titrate the dose to achieve a trough IgG level of at least 5-6 g/L.

For idiopathic thrombocytopenic purpura (ITP), administer a dose of 0.8-1.0 g/kg body weight as a single day infusion. A second dose of 0.8-1.0 g/kg may be administered if required.

For Kawasaki disease, administer a single dose of 2.0 g/kg body weight as an infusion, concomitantly with acetylsalicylic acid therapy.

For secondary immunodeficiencies, administer a dose of 0.2-0.4 g/kg body weight every 3-4 weeks.

Initiate the infusion at a rate of 0.5-1.0 ml/kg/hour for the first 30 minutes. If well tolerated, gradually increase the rate to a maximum of 3.0-4.0 ml/kg/hour.

Do not exceed the recommended infusion rate. Continuously monitor the patient’s vital signs throughout the infusion and for at least 20 minutes after its completion.

For pediatric patients, calculate the dose based on body weight. Adhere to the same infusion rate guidelines as for adults, adjusting for patient size and tolerance.

Adverse Reactions

Headache, chills, increased body temperature, nausea, vomiting, joint aches, back pain, allergic reactions.

Rarely – decreased blood pressure, in isolated cases – anaphylactic shock, symptoms of aseptic meningitis (severe headache, nausea, vomiting, increased body temperature, neck stiffness, photophobia, impaired consciousness), worsening of renal failure in patients with impaired renal function.

Contraindications

Hypersensitivity, IgA deficiency in the presence of antibodies against IgA in the patient.

With caution pregnancy, lactation period.

Use in Pregnancy and Lactation

Use with caution during pregnancy and during the lactation (breastfeeding) period.

Pediatric Use

Use is possible according to indications and in accordance with the dosage regimen.

Special Precautions

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

The recommended infusion rate of the drug should not be exceeded (severe adverse events may develop). The patient should be under medical supervision throughout the entire infusion period and for 20 minutes after it.

Drug Interactions

Reduces the activity of attenuated live vaccines against measles, rubella, mumps, chickenpox (if administered within the first 2 weeks after vaccination against measles, mumps, and rubella, vaccinations with the specified vaccines should be repeated no earlier than after 3 months).

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.