IG. VIENNA N.I.V.

Active material: Human normal immunoglobulin
When ATH: J06BA02
CCF: Preparation, affecting the immune system. Immunoglobulin
ICD-10 codes (testimony): B24, Q91.1, D69.3, D80, D81, D82.0, D83, M30.3, Z94
When CSF: 14.05
Manufacturer: KEDRION S.p.A. (Italy)

Pharmaceutical form, composition and packaging

The solution for the on / in the clear or slightly opalescent.

Excipients: maltose, water d / and.

20 ml – bottles (1) – packs cardboard.
50 ml – bottles (1) complete with a dropper to a / infusion – packs cardboard.
100 ml – bottles (1) complete with a dropper to a / infusion – packs cardboard.
200 ml – bottles (1) complete with a dropper to a / infusion – packs cardboard.

Pharmacological action

Preparation, affecting the immune system. It has active immunoglobulin G (IgG), present in the plasma of a healthy person.

The introduction of the drug IG. VIENNA N.I.V. restores low levels of immunoglobulin G in human plasma to normal. The mechanism of action in idiopathic thrombocytopenic purpura is not fully understood.

The drug IG. VIENNA N.I.V. It contains, primarily, immunoglobulin G , which has a broad spectrum of antibodies against different infectious agents. The composition of immunoglobulin G subclasses in the preparation of their matches in the composition of normal human plasma.

The drug is prepared from pooled plasma of at least, than 1000 Donor. The production includes the inactivation / removal of viruses and confirms the lack of follow-hepatitis B surface antigen, HCV, HIV-1 and HIV-2, and measuring the levels of ALT.

The drug IG. VIENNA N.I.V. a means of substitution therapy for the primary and secondary antibody deficiency and is indicated for the prevention and treatment of infectious diseases, associated with immunodeficiency.

Pharmacokinetics

Absorption and distribution

The on / in the introduction of the drug bioavailability complete.

Rapidly distributed between plasma and extravascular fluid, balance between the inside – and extravascular volumes achieved, about, through 3-5 days.

Deduction

T_1/2 from the plasma of human normal immunoglobulin for the on / in the equals 3 Weekly, it has individual variations, especially in patients with primary immunodeficiency. Immunoglobulin G and its complex is decomposed into cells of the reticuloendothelial system.

Testimony

Primary immunodeficiency syndrome:

- Congenital agammaglobulinemia and hypogammaglobulinemia;

- Common variable immunodeficiency;

- Severe combined immunodeficiency;

- Wiskott-Aldrich syndrome.

Idiopaticheskaya trombotsitopenicheskaya purpura (ITP), incl. acute form in children.

Secondary immunodeficiency:

- Chronic lymphocytic leukemia;

- AIDS in children;

- Bone marrow transplantation.

Dosage regimen

Doses and dosing regimen depend upon the diagnosis and the patient's age, choice of treatment (prophylaxis or therapy zamestitelynaya).

During the replacement therapy in primary and secondary immunodeficiencies the drug is prescribed in a dose 100-400 mg (2-8 ml)/kg body weight at an interval of 1 Months, to restore IgG levels to normal. If the desired level of IgG in blood is not reached, may increase the dose to 800 mg (16 ml)/kg body weight or frequency of administration.

At transplantation immunocompromised patients used / introduction IgG before and after surgery. Doses are selected individually; usual starting dose is 500 mg (10 ml)/kg / week, maintenance dose – 500 mg / kg / month. To prevent hospital infection cytomegalovirus or hepatitis B virus titers are determined to justify the dosing regimen.

At idiopathic thrombocytopenic purpura (ITP) the drug is prescribed in a dose 400 mg (8 ml)/kg of body weight every day or 1000 mg (20 ml)/kg body weight every other day for 5 days. Maintenance doses administered at clinically established increase in the number of platelets.

Before use, the drug is heated to room temperature or body temperature. The drug is introduced into / in the drip an initial rate 10-20 cap. / min for 20-30 m. With good endurance speed can be gradually increased to 40 cap. / min until the end of the introduction.

Side effect

Allergic and anaphylactic reactions: possible – chills, headache, fever, allergic reactions, arthralgia, backache; rarely – a sharp decrease in blood pressure, anaphylactic shock (even if the patient did not show sensitivity in previous administrations).

From the digestive system: vomiting, nausea.

Contraindications

- Intolerance of the donor immunoglobulin, especially in the very rare cases of IgA deficiency, when the patient has an antibody to IgA.

Pregnancy and lactation

In controlled clinical trials has not been established safety of IgG in pregnant women, therefore caution is required when administering the drug during this period.

Long-term clinical practice of immunoglobulins did not reveal the negative impact on pregnancy, on the fetus and newborn.

The drug is excreted in mother's milk, which can lead to transport of protective antibodies in the body of the newborn.

Cautions

In / in the introduction of immunoglobulin resulting in a transient increase in antibody, that can give a false positive result in serological tests.

To prevent severe allergic reactions should strictly adhere to the recommended dosing regimen. With the development of an allergic reaction should slow down or stop the drug administration. With the development of anaphylactic reactions or shock therapy should be undertaken protivoshokovym. At the start of drug administration should monitor the condition of the patient for at least 20 m.

Prior to use, to check the transparency and color of the solution. Do not use the cloudy solution or precipitate. Unused solution should be discarded.

Overdose

Cases of overdose IG. VIENNA N.I.V. not disclosed.

Drug Interactions

The simultaneous use of immunoglobulin may reduce the effectiveness of live vaccines (incl. measles vaccine, Rubella, mumps, varicella) a period of 6 Sun. to 3 Months.

The drug IG. VIENNA N.I.V. should not be mixed in the same syringe with other drugs.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored in a dark place at a temperature of 2 ° to 8 ° C. Do not freeze. Shelf life – 2 year.