BIOKTA [Normal human immunoglobulin] 2.5 g Solution for intravenous administration

instructions for the medical use of the medicinal product

BIOKTA

Tradename:

Biokta, Биокта

International non-proprietary name or generic name: Normal human immunoglobulin, Иммуноглобулин человека нормальный

Dosage form: solution for intravenous administration.

Composition

Each vial contains:

active substance: immunoglobulin 2.5 g;

excipients: maltose, water for injection.

Pharmacotherapeutic group: Immunoglobulin.

Code АТХ: J06BA02

Pharmacological properties

Pharmacodynamics

This drug contains broad-spectrum immunoglobulin G antibodies resistant to viruses, bacteria, and other infectious agents. Furthermore, idiotypic immunoglobulin G antibodies and idiotypic antibodies are capable of forming a complex immune network, providing a dual therapeutic effect: immune replacement and immune regulation. After intravenous administration, the drug can rapidly increase the recipient's blood immunoglobulin G levels and enhance the body's anti-infective properties and immunoregulatory functions.

Pharmacokinetics

After intravenous administration, the drug immediately enters the systemic circulation and is relatively quickly redistributed between the plasma and extravascular compartments. Steady-state is reached within 3-5 days. The half-life is approximately 24-36 days; half-life may vary among patients, particularly those with primary immunodeficiency. Immunoglobulin G and immune complexes containing immunoglobulin G are destroyed by cells of the reticuloendothelial system.

Indications for use

• severe forms of bacterial and viral infections;

• postoperative complications associated with bacteremia and septicopyemic conditions;

• primary antibody deficiency syndrome: agamma- or hypogammaglobulinemia (congenital form, period of physiological deficiency in newborns);

• secondary antibody deficiency syndrome;

• blood disorders, consequences of immunosuppressive therapy, acquired immunodeficiency, especially in children infected with the human immunodeficiency virus.

Contraindications

• Hypersensitivity to any component of the drug;

• Hypersensitivity to human immunoglobulins, especially in patients with antibodies to immunoglobulin A.

Use with caution during pregnancy and lactation, in patients with diabetes mellitus, renal failure, overweight, elderly patients, patients with hypovolemia, and those receiving treatment with nephrotoxic drugs.

Method of administration and dosage

Administer intravenously by drip, only in a hospital setting.

Before administration, the vials must be kept at a temperature of (20 ± 2) °C for at least 2 hours.

Immediately before administration, the drug is diluted with 0.9% sodium chloride solution or 5% glucose solution at a ratio of 1 part drug to 4 parts diluent. The diluted immunoglobulin is administered intravenously by drip at a rate of 8-10 drops per minute.

Immunoglobulin (without additional dilution) is administered intravenously by drip at a rate of 30-40 drops per minute.

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

For children, a single dose is 3-4 ml per 1 kg of body weight, but not more than 25 ml. The infusion rate and duration of therapy are determined individually by the physician.

For adults, a single dose is 25-50 ml. The infusion rate and duration of therapy are determined individually by the physician.

Side effect

Flu-like syndrome: chills, headache, hyperthermia, weakness, body aches.

Gastrointestinal: nausea, vomiting, abdominal pain, diarrhea.

Cardiovascular: decreased blood pressure; rarely, collapse; with cerebral or cardiac ischemia, in elderly patients, with obesity, severe hypovolemia, increased plasma viscosity (e.g., hypergammaglobulinemia, hyperfibrinogenemia, sickle cell anemia), and occlusive vascular diseases—transient ischemic attacks and/or thromboembolic complications.

Urinary: hypercreatininemia, acute renal failure (especially with a history of renal failure, diabetes mellitus, hypovolemia, obesity, concomitant therapy with nephrotoxic drugs, in patients over 65 years of age).

Hematopoietic system disorders: transient hemolytic anemia, hemolysis.

Allergic reactions: skin rash, itching; rarely, anaphylactic shock.

Other: infusion site reactions, arthralgia, back pain, and lumbar pain.

If any of the side effects listed in the instructions worsen, or you notice any other side effects not listed in the instructions, notify your doctor.

Special instructions and precautions

Consult a physician before using this medication.

This medication is for intravenous use only.

This medication should be used for injection once the package has been opened. Do not reuse or administer to another person.

Do not use if the liquid is cloudy, contains sediment or foreign matter, if the glass vial is cracked, if the vial cap is not tightly closed, or if the medication is past its expiration date or unsuitable for use.

If necessary, dilute the medication with 5% glucose solution for injection. However, diabetics should use this medication with caution.

Caution should be exercised in patients with severe acid-base imbalance.

In patients with acute renal failure, renal function should be monitored, including blood urea nitrogen, serum creatinine, and urine output. In patients with renal impairment or renal failure, the infusion rate should be minimal. In susceptible patients, renal impairment may occur with this medication.

Thrombotic complications may develop. Patients with known risk factors for thrombotic complications should be monitored. In patients with a high risk of hyperviscosity, baseline blood viscosity assessment should be performed. Patients at risk for thrombosis require a slow infusion at the minimum dose.

9. Aseptic meningitis syndrome may develop, especially with high doses or rapid transfusion.

Hemolytic anemia may develop. Clinical signs and symptoms should be monitored in patients with hemolytic anemia.

Treatment with immunoglobulin preparations reduces the effectiveness of vaccinations, so vaccinations should not be administered earlier than 2-3 months after immunoglobulin administration.

Individuals with allergic diseases (asthma, atopic dermatitis, recurrent urticaria) or those prone to allergic reactions are recommended to take antihistamines on the day of immunoglobulin administration and for the following 8 days. During periods of exacerbation of the allergic reaction, the drug should be administered according to the opinion of an allergist. For individuals with autoimmune diseases (blood diseases, connective tissue diseases, nephritis), the drug should be administered in conjunction with appropriate therapy. Immunoglobulin is excreted in breast milk and may facilitate the transfer of protective antibodies to the newborn.

After administration, the patient's condition should be monitored for at least 30 minutes. Anti-shock therapy equipment should be available in the room where the drug is administered. If anaphylactoid reactions develop, antihistamines, glucocorticosteroids, and adrenergic agonists should be used.

A temporary increase in antibody levels in the patient's blood after immunoglobulin administration may cause false-positive serological test results.

Do not exceed the intravenous infusion rate due to the risk of collapsing reactions.

Interaction with other medicinal products

This drug should be administered separately, not mixed with other medications.

Administration of this drug may reduce the effectiveness of live attenuated viral vaccines (measles, smallpox, rubella, mumps, and chickenpox) for a period of 6 weeks to 3 months. At least 3 months should elapse after administration of this drug before administering live attenuated vaccines. For measles vaccines, this effect may persist for up to 1 year. Therefore, measles antibody titers should be tested before administering the measles vaccine.

Overdose

Overdose may result in fluid overload and increased blood viscosity, especially in at-risk patients, including the elderly or those with impaired cardiac or renal function.

Release form

In glass vials with halogenated butyl rubber stoppers for single use. One vial, along with instructions for use, is packaged in a cardboard box.

Storage conditions

Store in a dark place at a temperature of 2 to 8°C. Do not freeze.

Keep out of reach of children.

Shelf life

3 years. Do not use after the expiration date printed on the package.

Vacation conditions

By prescription.