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 with
chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed;
• Hypogammaglobulinaemia and recurrent bacterial infections in plateau phase
multiple myeloma patients who have failed to respond to pneumococcal immunisation;
• Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell
transplantation (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 or
prior 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)
StatusValid
Version date2023-06-22
Validity date2028-07-18
PCR2016:07 Blood and blood derived products for therapeutic or prophylactic uses
Standards conformance
Geographical scopeGlobal