Octagam solution for infusions 10% 1 mg/20 ml. vial №1

Description

Octagam composition
Available in the form of a solution (10%) for infusion.
1 ml of solution contains: class G immunoglobulin (at least 95%, which is equivalent to the total human blood protein content – 100 mg).

Release form
Solution for injections, in a bottle of 20 ml.

Pharmacological properties
Octagam is a solution of immunoglobulin G with a wide range of antibodies to various pathogens. Has an immunomodulatory effect. This drug is made from the pooled plasma obtained from donors, contains antibodies present in healthy people. The distribution of immunoglobulin subclasses is close to that in natural human plasma.

Indications
Octagam is prescribed for replacement therapy:

• with syndromes of primary immunodeficiency: hypogammaglobulinemia, congenital agammaglobulinemia, unclassified variable immunodeficiency, congenital HIV infection in children, Wiskott-Aldrich syndrome, severe combined immunodeficiency, multiple myeloma or chronic lymphocytic leukemia;
• for immunomodulatory treatment: idiopathic thrombocytopenic purpura in adults or children with a high risk of bleeding; before surgery, with Kawasaki disease, Guillain-Barré syndrome;
• with allogeneic (from a donor) bone marrow transplantation.

Contraindications:

• with allergies to components;
• with intolerance to homologous immunoglobulins (for example, with a deficiency of immunoglobulin A).

Use with caution:

• with obesity;
• in old age;
• with arterial hypertension;
• with diabetes mellitus;
• with diseases of the vascular system;
• with a tendency to develop thrombosis;
• with prolonged motionless position;
• with severe dehydration;
• with increased blood viscosity;
• with renal failure, therapy with nephrotoxic drugs.

Application during pregnancy and lactation
With care.

Method of administration and dosage
Octagam solution is administered intravenously. Before introduction, the temperature of the solution must be brought to room temperature. The solution should be slightly opalescent or clear. Do not use cloudy, sediment-containing solutions.
The initial injection rate is 0.01–0.02 ml / kg per minute for 30 minutes. With good tolerance, the speed can be gradually increased to a maximum dose of 0.12 ml / kg per minute.

• For replacement therapy for primary immunodeficiency: the initial dose is 0.4–0.8 g / kg, followed by the introduction of 0.2 g / kg every 3 weeks. The interval between injections is 2–4 weeks.
• For replacement therapy for multiple myeloma, chronic lymphocytic leukemia, in children with congenital HIV infection: 0.2–0.4 g / kg g every 3-4 weeks.
• In idiopathic thrombocytopenic purpura: 0.8–1.0 g / kg on the first day with the introduction again (if necessary) on the third day or 0.4 g / kg per day, the course is 2–5 days.
• With Kawasaki disease: 1.6–2.0 g / kg for 2–5 days or once – 2.0 g / kg.
• With Guillain-Barré syndrome: 0.4 g / kg per day for 3-7 days.
• For bone marrow transplantation: the initial dose is 0.5 g / kg per week, starting 7 days before the transplant. The therapy is continued for three months after the transplant. In the case of permanent deficiency of immunoglobulins – 0.5 g / kg monthly until their level returns to normal.

Overdose
Overdose symptoms: increased blood viscosity, edema.

Side effects
Possible leukopenia, hemolysis, hemolytic anemia, allergic reactions, headache, agitation, cerebrovascular accidents, aseptic meningitis, paresthesia, migraine, dizziness, myocardial infarction, cyanosis, tachycardia, heartbeat, blood circulation, hypotension / hypertension , pulmonary edema, respiratory failure, shortness of breath, pulmonary embolism, cough, bronchospasm, nausea, diarrhea, abdominal pain, eczema, dermatitis, alopecia, back pain and joint pain, myalgia, renal failure, increased liver function tests, fever, fatigue , chills, chest pain, hyperhidrosis, hyperthermia, malaise.

Storage conditions and periods
At 2-8 ° C. Cannot be frozen. The shelf life of the solution is 2 years.