EPD-IES-0001596:002 (S-P-01596)

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 numberEPD-IES-0001596:002 (S-P-01596)
PCR2016:07 Blood and blood derived products for therapeutic or prophylactic uses 2.0
StatusValid
Publication date2019-06-05
Valid until2028-07-18
EN 15804 compliantNo
Geographical scopeGlobal
LCA Practitionerelena.neri@indaco2.it