Ig Vena 50g/l 100ml

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;
• 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

Detailed information

Registration number:
S-P-01596
Status:
Valid
PCR:
2016:07
En15804 Compliant:
No
Registration date:
June 5, 2019
Version date:
June 22, 2023
Valid until:
July 18, 2028
Geographical scopes:
Global
LCA practitioner:
elena.neri@indaco2.it

Company information

Logotype
Company Name:
Kedrion SpA
Country:
Italy
Contact:
Website:

Other documents

Included products in this EPD

  • Ig Vena 50g/l 100ml
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