Brand name: Ig Vena
Active ingredient (generic name): Human Immunoglobulin
Manufacturer: Kedrion
Importer: Behestan Darou
Pharmacotherapeutic group:
Pharmaceutical form: 5% vial (100ml)
Pharmacodynamic:
Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents.
It has a distribution of immunoglobulin G-subclasses closely proportional to that in native human plasma. Adequate doses of this medicinal product may restore abnormally low immunoglobulin G level to the normal range.
Pharmacokinetic:
Human normal immunoglobulin is immediately and completely bioavailable in the recipient's circulation after intravenous administration. It is distributed relatively rapidly between plasma and extravascular fluid, after approximately 3-5 days equilibrium is reached between the intra- and extravascular compartments. Human normal immunoglobulin has a half-life of 18 to 32 days.
Therapeutic indication:
Replacement therapy in:
• Primary immunodeficiency syndromes such as:
- Congenital agammaglobulinaemia and hypogammaglobulinaemia
• Myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.
Immunomodulation
• Idiopathic thrombocytopenic purpura (ITP) in children or adults at high risk of bleeding or prior to surgery to correct the platelet count.
• Kawasaki disease
Allogeneic bone marrow transplantation
Dosage and administration:
In treatment of infections and prophylaxis of graft versus host disease 0.5 g/kg every week from day -7 up to 3 months after transplantation.
In Kawasaki syndrome 1.6 – 2.0 g/kg in several doses should be administered for 2 - 5 days or 2.0 g/kg in one dose.
Adverse reaction:
The undesirable effects are: hypersensitivity, leucopenia and acute renal failure.
Contraindication:
It is prohibited in case of hypersensitivity to homologous Ig.
Pharmacokinetic interactions:
Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines.
Special warnings:
Do not shake Ig Vena vials before administration.
Pregnancy and lactation:
Pregnancy category is C. There is no evidence on harmful effects of Ig Vena on the course of pregnancy.
Storage temperature:
Room temperature (15-25 C)
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