Ig Vena 50g/l 100ml
IG VENA is a solution for infusion containing Human normal immunoglobulin (IVIg). It is a human plasma derived product for intravenous administration.
IG VENA is used for:Replacement therapy in adults, and children and adolescents (0-18 years) in:• Primary immunodeficiency syndromes with impaired antibody production;• Hypogammaglobulinaemia and recurrent bacterial infections in patients withchronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed;• Hypogammaglobulinaemia and recurrent bacterial infections in plateau phasemultiple myeloma patients who have failed to respond to pneumococcal immunisation;• Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem celltransplantation (HSCT);• Congenital AIDS with recurrent bacterial infections.
Immunomodulation in adults, and children and adolescents (0-18 years) in:• Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding orprior to surgery to correct the platelet count;• Guillain Barré syndrome;• Chronic Inflammatory Demyelinating Poliradiculoneuropathy (CIDP);• Kawasaki disease.
IG VENA 50 g/l Solution for infusion, included in this EPD, is provided in Vial of 100 ml contains: 5 g of human normal immunoglobulin;
A single dose kit includes: 100ml vial containing 50g/L IG VENA; stopper; blister; pipe; needle; leaflet; cardboard box
| Registration number | EPD-IES-0001596:002 (S-P-01596) |
|---|---|
| PCR | 2016:07 Blood and blood derived products for therapeutic or prophylactic uses 2.0 |
| Status | Valid |
| Initial version date | 2019-06-05 |
| Validity date | 2028-07-18 |
| EN 15804 compliant | No |
| Geographical scope | Global |
| LCA Practitioner | elena.neri@indaco2.it |