Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Human normal immunoglobulin
Instituto Grifols S.A.
J06BA02
human normal immunoglobulin
Immune sera and immunoglobulins,
Mucocutaneous Lymph Node Syndrome; Guillain-Barre Syndrome; Bone Marrow Transplantation; Purpura, Thrombocytopenic, Idiopathic; Immunologic Deficiency Syndromes
Replacement therapy in adults, children and adolescents (0-18 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 (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;, Kawasaki disease.
Revision: 19
Authorised
2007-07-23
- 49 - B. PACKAGE LEAFLET - 50 - PACKAGE LEAFLET: INFORMATION FOR THE USER FLEBOGAMMA DIF 50 MG/ML SOLUTION FOR INFUSION Human normal immunoglobulin (IVIg) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Flebogamma DIF is and what it is used for 2. What you need to know before you use Flebogamma DIF 3. How to use Flebogamma DIF 4. Possible side effects 5. How to store Flebogamma DIF 6. Contents of the pack and other information 1. WHAT FLEBOGAMMA DIF IS AND WHAT IT IS USED FOR WHAT FLEBOGAMMA DIF IS Flebogamma DIF contains human normal immunoglobulin, highly purified protein extracted from human plasma (part of the blood of donors). This medicine belongs to the group of medicines called intravenous immunoglobulins. These are used to treat conditions where the body’s defence system against disease is not working properly. WHAT FLEBOGAMMA DIF IS USED FOR Treatment of adults, children and adolescents (2 - 18 years) who do not have sufficient antibodies (Flebogamma DIF is used as replacement therapy). There are two groups: • Patients with Primary Immunodeficiency Syndromes (PID), an inborn lack of antibodies (group 1) • Patients with Secondary Immunodeficiency Syndromes (SID) with severe or recurrent infections, ineffective antimicrobial treatment and either PROVEN SPECIFIC ANTIBODY FAILURE (PSAF)* or serum IgG level of <4 g/l (group 2) *PSAF= failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines. Treatment o Pročitajte cijeli dokument
- 1 - ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS - 2 - 1. NAME OF THE MEDICINAL PRODUCT Flebogamma DIF 50 mg/ml solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human normal immunoglobulin (IVIg) One ml contains: Human normal immunoglobulin ……….. 50 mg (purity of at least 97% of IgG) Each vial of 10 ml contains: 0.5 g of human normal immunoglobulin Each vial of 50 ml contains: 2.5 g of human normal immunoglobulin Each vial of 100 ml contains: 5 g of human normal immunoglobulin Each vial of 200 ml contains: 10 g of human normal immunoglobulin Each vial of 400 ml contains: 20 g of human normal immunoglobulin Distribution of the IgG subclasses (approx. values): IgG 1 66.6% IgG 2 28.5% IgG 3 2.7% IgG 4 2.2% Minimum level anti-measles IgG is 4.5 IU/ml. The maximum IgA content is 50 micrograms/ml. Produced from the plasma of human donors. Excipient with known effect: One ml contains 50 mg of D-sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. The solution is clear or slightly opalescent and colourless or pale yellow. Flebogamma DIF is isotonic, with an osmolality from 240 to 370 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Replacement therapy in adults, children and adolescents (2 - 18 years) in: - Primary immunodeficiency syndromes (PID) with impaired antibody production - Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either PROVEN SPECIFIC ANTIBODY FAILURE (PSAF)* or serum IgG level of <4 g/l - 3 - *PSAF= failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines Measles pre-/post exposure prophylaxis for susceptible adults, children and adolescents (2 - 18 years) in whom active immunisation is contraindicated or not advised. Consideration should also be given to official recommendations on intravenous human immunoglobulin use in measles pre-/post exposure prophylaxis an Pročitajte cijeli dokument