Highly purified, human immunoglobulin 10% solution ready for intravenous use.

Flebogamma® 10% DIF
Flebogamma® DIF 100 mg/ml

Grifols plasma-derived products result from a rigorous methodology, the latest technology and a highly qualified team of professionals.

Indications

• Replacement therapy in adults, children and adolescents (2-18 years) in:

• Primary immunodeficiency syndromes with impaired antibody production.

• Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed.

• Hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who failed to respond to pneumococcal immunisation.

• Hypogammaglobulinaemia in patients after allogenic haematopoietic stem cell transplantation (HSCT).

• Congenital AIDS with recurrent bacterial infections.

• Immunomodulation in adults, children and adolescents (2-18 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.

  • Kawasaki disease.

• Production process with 7 validated pathogen elimination steps including nanofiltration (20 nm), pasteurisation and solvent/detergent.

• Highly purified (Ig content: 99.40 ± 0.1%)*.

• Only trace amounts of IgA (< 0.006 mg/ml)*.

• Wide spectrum of antibodies.

• The product formulation does not contain preservatives.

• Stabilized with sorbitol; sucrose and maltose free.

• Storage conditions: storable at room temperature (≤ 30 ºC) for the entire 2 year shelf life.

* Data obtained from 3 consecutive lots.

PediGri®: a commitment to providing healthcare professionals with transparent information. A unique service which offers all the information on the origin and quality of Grifols plasma derivatives (www.pedigri.grifols.com).

You can also visit the EMA website for further details.

For more information, please contact us