Human normal immunoglobuline intravenous – [25 ml vial]

Description

Human Immunoglobulin Normal Pharmacodynamics
Characteristics of the drug. Human immunoglobulin normal is a highly purified preparation of immunoglobulin G, isolated from the blood plasma of healthy donors. Each series of immunoglobulin is made from a mixture of the plasma of at least 1000 donors individually tested for the absence of hepatitis B virus surface antigen (HBsAg) and antibodies to hepatitis C virus and human immunodeficiency virus HIV-1 and HIV-2. The drug has low anticomplement activity.
Immunobiological properties. The drug contains a wide range of specific antibodies against infectious agents capable of opsonization and neutralization of microbes and toxins. Injection of the drug replenishes the level of antibodies in the recipient’s blood. The drug also has a nonspecific activity, which manifests itself in increasing the body’s resistance. Administration of the drug restores low levels of immunoglobulin G to normal values.

Indications
The drug is used without age restrictions.
As part of the complex therapy:
– For the treatment of severe toxic forms of bacterial and viral infections;
– For the treatment of postoperative complications accompanied by septicemia.
As substitution therapy:
– In primary immunodeficiency (congenital agammaglobulinemia and hypogammaglobulinemia);
– In multiple myeloma with a severe form of secondary hypogammaglobulinemia and recurrent bacterial infections;
– chronic lymphocytic leukemia with severe secondary hypogammaglobulinemia and recurrent bacterial infections when prophylactic antibiotic therapy is ineffective;
– In congenital HIV infection with recurrent infections in children.

Contraindications
– Hypersensitivity to human immunoglobulin, especially in rare cases of blood deficiency of immunoglobulin class A (IgA) and presence of antibodies against IgA;
– hypersensitivity to the components of the drug;
– history of allergic reactions to blood products. In cases of severe sepsis the only contraindication for administration is anaphylactic shock to blood products in the history.

Dosage and administration method

• The drug is administered intravenously by drop infusion.
• A single dose of the drug in children is 3-4 ml/kg of body weight, but not more than 25 ml. Just before injection the drug is diluted with 0.9% sodium chloride solution or 5% glucose solution at the ratio of 1 part of the drug and 4 parts of the diluting solution.
• Diluted drug shall not be stored. Diluted immunoglobulin is administered by IV dropwise at a rate of 8-10 drops per minute (faster administration may cause collaptoid reaction). Infusions are given daily for 3-5 days.
• For adults, a single dose of the drug is 25-50 ml. Immunoglobulin (without additional dilution) is administered by IV drops at a rate of 30-40 drops per minute (faster administration may cause a collaptoid reaction). The course of treatment consists of 3-10 transfusions every 24-72 hours (depending on the severity of the disease).
• Replacement therapy in primary immunodeficiency: a single dose is 8-16 ml/kg of body weight once. The administration is repeated every 2-4 weeks in dose 4-16 ml/kg of body weight for maintenance of IgG titer in plasma at the level of 4-6 g/l. Plasma IgG levels should be monitored to determine the optimal dose and interval between injections.
• Replacement therapy in multiple myeloma with severe secondary hypogammaglobulinemia and recurrent bacterial infections: in chronic lymphocytic leukemia with severe secondary hypogammaglobulinemia and recurrent bacterial infections when prophylactic antibacterial therapy is not effective; in congenital HIV infection with recurrent infections in children: the dose is 4-8 ml/kg body weight.
• Administration is repeated after 3-4 weeks to maintain plasma IgG concentration at 4-6 g/l. To determine the optimal dose and interval between injections, monitor plasma IgG levels.
• The drug is used only under hospital conditions in compliance with all rules of asepsis.
• The drug is not suitable for use in bottles (vials) with compromised integrity, labeling, as well as with changes in color, transparency, with expired shelf life, improperly stored.
• Before administration bottles (vials) should be kept at (20±2) ° C for at least 2 hours.