Included in the formulation
Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):ONLS
VED
АТХ:J.06.B.A.02 Immunoglobulin normal human for intravenous administration
Pharmacodynamics:Contains about 90% monomeric IgG and a small fraction of degradation products, polymeric and dimeric IgA and IgG, IgM in trace concentrations. Subclasses of IgG are fractionally distributed similarly to human serum.
Has a wide spectrum of opsonizing and neutralizing antibodies against bacteria, viruses and other pathogens. In patients with secondary or primary immunodeficiency, the deficiency of the class IgG, decreasing the risk of infection.
Pharmacokinetics:After intravenous infusion, it is redistributed between blood plasma and extravascular space, reaching equilibrium after 7 days.
Penetrates through the blood-brain and placental barriers, enters the breast milk.
The half-life period is 21 days; in patients with primary hypogammaglobulinemia (agammaglobulinemia), the half-life period is 32 days.
Indications:It is used to treat severe toxic forms of bacterial and viral infections, postoperative complications, accompanied by septicemia in children and adults. Used in the postoperative period for complications accompanied by bacteremia. As a substitution therapy is used in the primary and secondary state of immunodeficiency.
I.A30-A49.A41.9 Septicemia, unspecified
I.B00-B09.B09 Viral infection characterized by skin and mucous membrane damage, unspecified
I.B99 Other infectious diseases
III.D80-D89.D84.9 Immunodeficiency, unspecified
XXI.Z20-Z29.Z29.1 Prophylactic immunotherapy
Contraindications:Individual intolerance.
Carefully:Renal failure, heart failure, diabetes mellitus.
Pregnancy and lactation:Recommendations for FDA - Category C. It is used in pregnancy and lactation only for life indications.
Dosing and Administration:Use in children
In order to prevent infection in preterm infants with low birth weight, 0.5-1 g / kg is injected at an interval of 1-2 weeks.
Adults
Intravenously drip with an initial speed of 15-20 drops per minute, after 15-20 minutes the rate increases to 30-40 drops per minute. The course of treatment is from 3 to 10 infusions with an interval of 24 to 72 hours.
The highest daily dose: 0.2 g / kg.
The highest single dose: 0.2 g / kg.
Side effects:Central and peripheral nervous system: headache, dizziness, rarely - hallucinations.
The cardiovascular system: tachycardia, arterial hypotension, cyanosis, dyspnea, chest pain, tides, chills.
Digestive system: abdominal pain, diarrhea.
Musculoskeletal system: myalgia.
Dermatological reactions: Hyperhidrosis.
Allergic reactions.
Overdose:Cases of overdose are not described.
Treatment is symptomatic.
Interaction:Immunoglobulin should not be mixed in the same volume with any other medicines.
Reduces the effectiveness of active immunization against rubella, chicken pox, measles, mumps. It is recommended to use antiviral vaccines 3 months after the application of immunoglobulin [IgG + IgA + IgM].
Special instructions:After the introduction of immunoglobulin, a passive increase in the antibody content in the patient's blood is noted, which can lead to erroneous false positive interpretation of the results of serological testing.