Composition, form of production and packaging
The solution for intravenous administration is clear or slightly opalescent.
human immunoglobulin normal 50 mg
Excipients: maltose, water d / and.
20 ml - bottles (1) - packs of cardboard.
50 ml - vials (1) complete with a dropper for intravenous infusions - packs cardboard.
100 ml - bottles (1) complete with a dropper for intravenous infusions - packs cardboard.
200 ml - vials (1) complete with a dropper for intravenous infusions - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
The drug has the activity of immunoglobulin G (IgG), present in the plasma of a healthy person.
Introduction of IG VIENNA NIIV restores low levels of immunoglobulin G in human plasma to normal. The mechanism of action in idiopathic thrombocytopenic purpura has not been fully studied.
Preparation IG VIENNA NIIV contains mainly immunoglobulin G, which has a wide range of antibodies against various infectious agents. The composition of subclasses of immunoglobulin G in the preparation corresponds to their composition in normal human plasma.
The preparation is prepared from a pool of plasma of not less than 1000 donors. Production includes inactivation / removal of viruses and subsequent monitoring of the confirming absence of the surface antigen of hepatitis B, hepatitis C virus, HIV-1 and HIV-2.
Preparation IG VIENNA NIIV is a means of substitution therapy for primary and secondary antibody deficiency and is indicated for the prevention and treatment of infectious diseases associated with immunodeficiency.
Suction and distribution
With iv administration of the drug, its bioavailability is complete.
Rapidly distributed between plasma and extravascular fluid, the balance between intra- and extravascular volumes is reached, approximately, in 3-5 days.
T 1/2 from human normal immunoglobulin plasma for iv administration is 3 weeks, it has individual variations, especially in patients with primary immunodeficiency.Immunoglobulin G and its complexes are destroyed in the cells of the reticuloendothelial system.
Syndrome of primary immunodeficiency:
- congenital agammaglobulinemia and hypogammaglobulinemia;
- usual variable immunodeficiency;
- severe combined immunodeficiencies;
- Wiskott-Aldrich syndrome.
Idiopathic thrombocytopenic purpura (ITP), incl. acute forms in children.
- chronic lymphocytic leukemia;
- AIDS in children;
- bone marrow transplantation.
Doses and dosing regimen depend on the diagnosis and age of the patient, the choice of the method of treatment (prevention or substitution therapy).
When carrying out substitution treatment for primary and secondary immunodeficiencies, the drug is prescribed in a dose of 100-400 mg (2-8 ml) / kg of body weight at intervals of 1 month to restore the IgG level to normal. If the required level of IgG in the blood is not attained, it is possible to increase the dose to 800 mg (16 ml) / kg of body weight or frequency of administration.
In transplantation, immunosuppressive patients are used iv injection of IgG before and after surgery. Doses are selected individually; usually the initial dose is 500 mg (10 ml) / kg / week, maintaining a dose of 500 mg / kg / month. To prevent hospital infection of cytomegalovirus or hepatitis B virus, antibody titers are determined to justify the dosing regimen.
With idiopathic thrombocytopenic purpura (ITP), the drug is prescribed at a dose of 400 mg (8 ml) / kg of body weight every day or 1000 mg (20 ml) / kg of body weight every other day for 5 days. Supportive doses are administered at a clinically established increase in the number of platelets.
Before use, the preparation is warmed to room temperature or to body temperature. The drug is injected / in the drip with an initial rate of 10-20 cap / min for 20-30 minutes. With good tolerability, the rate of administration can be gradually increased to 40 cap / min until the end of the injection.
Allergic and anaphylactic reactions: possible - chills, headache, fever, allergic reactions, arthralgia, back pain; rarely - a sharp decrease in blood pressure, anaphylactic shock (even if the patient was not sensitive in previous injections).
On the part of the digestive system: vomiting, nausea.
- intolerance of the donor immunoglobulin, especially in very rare cases of IgA deficiency, when the patient has antibodies to IgA.
PREGNANCY AND LACTATION
In controlled clinical trials, the safety of the use of IgG in pregnant women has not been established, therefore caution is required when prescribing the drug during this period.
The long clinical practice of using immunoglobulins has not revealed a negative effect on the course of pregnancy, on the fetus and the newborn.
The drug is excreted with the mother's milk, which can lead to the transport of protective antibodies to the newborn's body.
In / in the introduction of immunoglobulin leads to a transient increase in antibodies, which can give a false-positive result in serological studies.
To avoid severe allergic reactions, the recommended dosage regimen should be strictly adhered to. When developing an allergic reaction, you should reduce the rate of administration or cancel the drug. With the development of an anaphylactic reaction or shock, anti-shock therapy should be given. At the beginning of the drug, the patient should be monitored for at least 20 minutes.
Before use, check the transparency and color of the solution. Do not use turbid solutions or sediment. Unused solution must be disposed of.
Cases of overdose of human immunoglobulin preparations are not described.
Simultaneous use of immunoglobulin can reduce the effectiveness of live vaccines (including vaccines against measles, rubella, mumps, chicken pox) for a period of 6 weeks. up to 3 months.
Preparation IG VIENNA NIIV Do not mix in the same syringe with other drugs.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dark place at a temperature of 2 В° to 8 В° C; Do not freeze. Shelf life - 2 years.