Treatment of severe bacterial infections with the simultaneous use of antibiotics. Replacement therapy in patients with weakened immune system.
Composition:
1 ml of solution contains 50 mg of human plasma protein, including ≥ 95% of immunoglobulin: 38 mg of IgG (including approximately 63% of IgG)1, about 26% IgG2, about 4% IgG3, about 7% IgG4), 6 mg IgM and 6 mg IgA.
Action:
The preparation is a highly purified concentrate of modified monomeric, human immunoglobulin G (IgG), enriched with the addition of IgM and IgA. High, in comparison to other intravenous preparations, the content of IgM in concentrate results in increased efficacy of the product in the control of bacterial sepsis. The IgM class contains the majority of neutralizing antibodies of Gram-negative bacterial endotoxins, responsible inter alia for inducing shock symptoms (eg high TNF stimulation). The content of opsonins and agglutinins against Gram-positive bacteria is also increased in this class. As a result, the preparation contains an 7S immunoglobulin concentrate with a typical distribution of specific antibodies of the three basic classes of immunoglobulins. Currently used methods of IvIg production inactivate HBV, HCV and HIV 1 and 2 viruses, HTLV I and II and others.
Contraindications:
Hypersensitivity to the components of the preparation. Hypersensitivity to homologous immunoglobulins, especially in IgA deficient patients in whom anti-IgA antibodies are present.
Precautions:
Particularly cautiously use in patients to whom human immunoglobulin is administered for the first time, which has been changed immunoglobulin preparation and in patients who are given an immunoglobulin after a long break (patients should be observed during the whole procedure and for the first hour after infusion) and in obese patients. Use with caution in patients with a history of renal failure, diabetes mellitus, hypovolemia, patients over 65 years, or receiving nephrotoxic drugs. The patient should be properly hydrated before starting the infusion.
Pregnancy and lactation:
Use with caution during pregnancy and breast-feeding. Immunoglobulins are excreted into breast milk, which may cause an increase in antibody titers in the newborn.
Side effects:
The following may occur: chills, headache, fever, vomiting, hypersensitivity reactions, nausea, arthralgia, hypotension, back pain, increased creatinine, acute renal failure. Rare: sudden decrease in blood pressure and anaphylactic shock. In individual cases: sterile meningitis, transient haemolytic anemia or haemolysis. Preparing to undergo thrombotic events in patients with symptoms of cerebral ischemia or heart disease, overweight, severe hypovolaemia and in elderly patients.
Dosage:
Intravenously. Individually. Adults and children: severe bacterial infections - initially 5 ml / kg / day for 3 days, if necessary, continue with the same dose; immunoglobulin substitution in immunosuppressed patients and in severely acquired immunodeficiency disorders - 3-5 ml / kg, and if necessary, administer subsequent doses at one week intervals. Administer at a rate of 0.4 ml / kg / h or the first 100 ml at a rate of 0.4 ml / kg / h, then continuously 0.2 ml / kg / h to reach 15 ml / kg. / 72 h. Newborns and infants: initially 5 ml / kg / day for 3 days, if necessary, the treatment should be continued with the same dose. Serve at a rate of 1.7 ml / kg / h using an infusion pump.
(C)
