Index of drugs

Substitution therapy for primary immunodeficiencies in adults and children, such as congenital agammaglobulinemia and hypogammaglobulinaemia, common variable immunodeficiency (CVID), severe composite immunodeficiency, shortage of IgG subclasses with recurrent infections. Replacement therapy in multiple myeloma or chronic lymphatic leukemia with severe secondary hypogammaglobulinaemia and recurrent infections.

1 ml of solution contains 165 mg of human plasma protein (purity: at least 95% IgG). Distribution of IgG subclasses: IgG1 - 59%, IgG2 - 36%, IgG3 - 4.9%, IgG4 - 0.5%. The maximum IgA content is 0.082 mg / ml. The product contains 4.35 millimoles (or 100 mg) of sodium per dose (40 ml).

Normal human immunoglobulin containing mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. Normal human immunoglobulin contains IgG antibodies present in the normal population. It is usually prepared from a pool of plasma from at least 1000 donors. Its distribution of subclasses of immunoglobulin G is similar to that found in the plasma of a healthy human. Appropriate doses of the preparation may restore the abnormal concentration of immunoglobulin G to normal values. The level of immunoglobulins after application can be maintained at a dose of 100 mg / kg / week. After subcutaneous administration, peak plasma concentrations were achieved after approximately 4 - 6 days, after intramuscular administration after 2-3 days. IgG and IgG-complexes are degraded in cells of the reticuloendothelial system.

Hypersensitivity to the active substances or to any of the excipients. Do not administer intravenously. Do not administer intramuscularly in cases of deep thrombocytopenia and other hemostasis disorders.

It is essential to follow the instructions for the method of administration and strictly maintain the recommended infusion rate. Some side effects may be more common in patients who are taking human normal immunoglobulin for the first time, or in rare occasions when this preparation is switched to another or the treatment has been discontinued for longer than 8 weeks. Allergic reactions may occur especially in patients with IgA deficiency and the presence of anti-IgA antibodies that should be treated with extreme caution. In rare cases, normal human immunoglobulin may cause a fall in blood pressure combined with anaphylactic reaction, even in patients who have previously tolerated normal treatment with human immunoglobulin. Potential complications can often be avoided by making sure that patients: do not show hypersensitivity to normal human immunoglobulin by first injecting the formulation at low speed; they are carefully monitored to detect any symptoms during the entire infusion period. In particular, during administration of the first infusion and the first hour after its completion, patients not previously treated with normal human immunoglobulin should be monitored, patients receiving an alternative alternative product, or a longer interval from the previous infusion. All other patients should be monitored for at least 20 minutes after administration. Suspected allergic or anaphylactic reactions require immediate interruption of the injection. In the event of a shock, standard treatment should be used. Despite the use of standard measures to prevent infections resulting from the use of a medicinal product prepared from human blood or plasma, when administering such preparations, the possibility of transferring infectious agents can not be completely ruled out. This also applies to unknown or newly discovered viruses and other pathogens. The measures taken are considered effective against enveloped viruses such as HIV, HBV and HCV; have limited efficacy against HAV and parvovirus B19. Clinical experience confirms the absence of the transmission of hepatitis A virus or parvovirus B19 mediated by immunoglobulins.In addition, it is assumed that the content of antibodies contributes significantly to providing protection against these viruses. The drug does not prevent hepatitis A. The product contains 4.35 millimoles (or 100 mg) of sodium per dose (40 ml), this should be taken into consideration in patients with reduced renal function and in patients who are controlling sodium in the diet.

The safety of the preparation in pregnant women has not been established in controlled clinical trials. The drug should be administered to pregnant women and during lactation with extreme caution. Clinical experience with the use of immunoglobulins indicates that they do not have a detrimental effect on pregnancy, fetal and neonatal development.

Common: reactions at the site of administration. Rare: hypersensitivity, pressure drop. Very rare: anaphylactic shock, headache and dizziness, nausea, vomiting, back pain, arthralgia, fever, chills, fatigue.

Treatment should be started and monitored initially under the supervision of a specialist doctor experienced in the treatment of immunodeficiency. The dose may need to be individually determined for each patient depending on the pharmacokinetic and clinical response and the minimum serum IgG concentrations. Immunoglobulins should be tested to determine the dose and frequency of administration. The subcutaneous dosing regimen should lead to a stable IgG level. The initial dose may be at least 0.2 - 0.5 g / kg. After reaching a constant level of IgG, maintenance doses are given at intervals such that the monthly total dose is 0.4-0.8 g / kg. In exceptional cases, when subcutaneous administration can not be used, small doses of the preparation may be administered intramuscularly. The drug can also be used in subcutaneous infusion with the use of popmage. The basic dose of the preparation is 0.6 ml (100mg) / kg. administered once a week to various places. The initial infusion rate is 10 ml / h. The infusion rate can be increased by 1 ml / h every three to four weeks. The maximum dose administered was 40 ml / h using two pumps at the same time. When high doses are administered, it is recommended to administer them in divided doses to various sites. In children after reaching a constant level of IgG, maintenance doses in the size of approx. 80-100 mg / kg / week. is given to achieve a total monthly dose of 0.4-0.8 g / kg.
Injecting the drug by a patient or caregiver in a home treatment environment requires training by a physician, and providing the patient with instructions on injecting techniques, keeping a treatment log, and actions to be taken if severe side effects occur.