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Ig Vena 50g/l 100ml, 50ml and 200ml

  • S-P-01596 Image 1.jpg

Product information

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 (see
section 4.4);
• 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, are provided in 3 different
sizes:
• Vial of 50 ml contains: 2.5 g of human normal immunoglobulin;
• Vial of 100 ml contains: 5 g of human normal immunoglobulin;
• Vial of 200 ml contains:10 g of human normal immunoglobulin.

A single dose kit includes: 100ml, 50ml or 200ml vial containing 50g/L IG VENA; stopper; blister; pipe; needle; leaflet; cardboard box

Detailed information

Registration number: S-P-01596
Publication/issue date: 2019-06-05
Valid until: 2024-03-10
Verified by: SGS Italia S.p.A.
Reference PCR(s): Blood and blood derived products for therapeutic or prophylactic uses
Geographical scope: Global

Company information

Kedrion SpA
Company name: Kedrion SpA
Country: Italy
Contact: Marta Bonaldi
Website: www.kedrion.com
Management systems: ISO 9001, ISO 14001, OHSAS 18001

More EPD from Kedrion SpA

Included products in this epd

    • Ig Vena 50g/l 100ml
    • Ig Vena 50g/l 50ml 
    • Ig Vena 50g/l 200ml