Replacement therapy in adults and children in cases of primary immunodeficiency syndromes such as congenital agammaglobulinemia and hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiency, IgG subclasses deficiency with recurrent infections. Replacement therapy in multiple myeloma or chronic lymphocytic leukemia with severe secondary hypogammaglobulinemia and recurrent infections.
Composition:
1 vial (5 ml or 10 ml) contains 800 mg or 1600 mg of human protein (including at least 95% of immunoglobulin), respectively.
Action:
Normal human immunoglobulin contains mainly immunoglobulin G with a broad spectrum of antibodies against infectious agents. It contains IgG antibodies present in the normal population. The distribution of IgG subclasses is strictly proportional to that found in natural human plasma. By administering sufficiently high doses of the preparation, a reduced concentration of IgG can be normalized. After subcutaneous administration of a human immunoglobulin, the maximum circulating concentration is reached after a delay of about 4 days. Using a dose of 1.25 ml (0.2 g) / kg every 2 weeks an IgG concentration of at least 7.24-7.86 g / L can be maintained. After intramuscular administration, human immunoglobulin is biologically available in the recipient's circulation with a delay of 2-3 days. Immunoglobulin G and its complexes are degraded in the reticuloendothelial system.
Contraindications:
Hypersensitivity to any of the ingredients. The preparation must not be administered intravascularly. The preparation must not be administered intramuscularly in case of severe thrombocytopenia and other hemostatic disorders.
Precautions:
The instructions on how to administer must be strictly adhered to. The injection rate should be strictly recommended. In the event of accidental administration of the preparation into a blood vessel, shock may occur, so it is important to check that the preparation is not administered to the container. Patients should be carefully monitored during administration. Patients who take their medicine at home or their caregivers must be trained to recognize the early symptoms of pressure reduction. If an allergic or anaphylactic reaction is suspected, treatment should be stopped immediately. Actual hypersensitivity reactions are rare. You can ensure that the patient is not hypersensitive to the preparation by slowly injecting it at the first dose. Some side effects may occur more frequently in patients who receive normal human immunoglobulin for the first time, or in rare cases after switching to another human natural immunoglobulin product, or after a treatment break lasting longer than 8 weeks. Patients who are affected by the above situations, they should be monitored during the first injection and the first hour after the injection. All other patients should be observed at least 20 minutes after administration of the drug, and if an allergic or anaphylactic reaction occurs - immediately discontinue the preparation. The preparation is made from human plasma; despite the use of methods of inactivation of infectious agents, the transfer of known and unknown pathogens, especially of non-enveloped viruses, can not be completely ruled out. The drug contains 1.2 mg sodium in 1 ml solution.
Pregnancy and lactation:
The safety of the preparation during pregnancy has not been established - caution should be exercised when used during pregnancy and breast-feeding.
Side effects:
Rarely, a sudden drop in blood pressure may occur, in individual cases, anaphylactic shock, even without previously detected hypersensitivity. Occasionally you may experience chills, headache, vomiting, fever, allergic reactions, nausea, dizziness, excessive sweating, pallor, paresthesia, tachycardia, arthralgia, hypotonia, moderate back pain. Local reactions at the injection site: swelling, pain, redness, induration, local warming, local pain, pruritus, bruising and rash.Very rarely, anaphylactic or anaphylactoid reactions may occur: dyspnea, tightness in the chest, redness of the face and skin, feeling hot, urticaria. In addition, fatigue, malaise, tremor, nausea, and moderate back pain have been reported after the medicine has been marketed.
Dosage:
Treatment should be started and monitored under the supervision of a doctor who has experience in the treatment of immunodeficiency. Individual dose adjustments may be required for each patient depending on the pharmacokinetic and clinical response. The dose should be adjusted to achieve IgG concentration of at least 4-6 g / l /. The dosing regimen of the subcutaneously administered drug should allow reaching a constant level of IgG (measured before the Next infusion). The patient may require a loading dose of at least 0.2-0.5 g / kg. during the week (0.1-0.15 g / kg in one day). After constant IgG levels are reached, maintenance doses are given at regular intervals up to a cumulative monthly dose of 0.4-0.8 g / kg. The minimum concentration should be determined to adjust the doses and the interval between doses. The drug is administered subcutaneously (the route of administration of choice) or intramuscularly (exceptionally, when subcutaneous administration is impossible). When administered intramuscularly, the cumulative monthly dose should be divided into doses administered once every 1 week or once every 2 weeks, in order to maintain a small volume of injection, changing the injection site. Subcutaneous administration is carried out using an infusion pump. The initial rate of administration is 10 ml / hr / pump, which can be increased by 1 ml / hr / hr for each subsequent injection until the recommended maximum speed of 20 ml / hr / pump is reached. At the same time, you can use more than one pump. The injection site should be changed each time after administration of 5-15 ml of solution.
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