Flebogamma® 5% DIF / Flebogamma® DIF 50 mg/ml
Highly purified, human immunoglobulin 5% solution ready for intravenous use
For ease of ordering please use the codes below:
| Product | License | GUK Product Code |
|---|---|---|
| Flebogamma DIF 50mg/ml 5g | EU/1/07/404/003 | 726524 |
| Flebogamma DIF 50mg/ml 10g | EU/1/07/404/004 | 726525 |
| Flebogamma DIF 50mg/ml 20g | EU/1/07/404/005 | 726526 |
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: 99.58 ± 0.14%)*.
- Only trace amounts of IgA (< 0.0031 mg/ml)*.
- Wide spectrum of antibodies.
- The product formulation does not contain preservatives.
- Stabilised with sorbitol; sucrose and maltose free.
- Storage conditions: storable at room temperature (≤ 30 ºC) for the entire 2 year shelf life.
* Data obtained from 158 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).
Grifols monitors the entire plasma derivatives production process from start to finish. All Grifols products are subjected to rigorous donor screening, testing and viral elimination (inactivation and removal) processes to enhance their quality and safety.
Grifols has been awarded the Quality Standards of Excellence Assurance and Leadership (QSEAL) by the Plasma Protein Therapeutics Association (PPTA).
This is only basic information. Please see Prescribing Information to learn more about this product.
Further information
Please Download our Brochure for more information (PDF).
Prescribing Information
24 May 2016
About Grifols
Grifols plasma-derived products are the result of a rigorous methodology, the latest technology and a highly qualified team of professionals.