Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
human normal immunoglobulin (IVIg)
CSL Behring GmbH
J06BA02
human normal immunoglobulin (IVIg)
Immune sera and immunoglobulins,
Purpura, Thrombocytopenic, Idiopathic; Bone Marrow Transplantation; Immunologic Deficiency Syndromes; Guillain-Barre Syndrome; Mucocutaneous Lymph Node Syndrome
Replacement therapy in adults, and children and adolescents (0-18 years) in:primary immunodeficiency (PID) 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;Kawasaki disease;chronic inflammatory demyelinating polyneuropathy (CIDP). Only limited experience is available of use of intravenous immunoglobulins in children with CIDP.
Revision: 31
Authorised
2008-04-24
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE USER PRIVIGEN 100 MG/ML (10%) 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 or healthcare professional. - If you get any side effects, talk to your doctor or healthcare professional. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Privigen is and what it is used for 2. What you need to know before you are given Privigen 3. How to use Privigen 4. Possible side effects 5. How to store Privigen 6. Contents of the pack and other information 1. WHAT PRIVIGEN IS AND WHAT IT IS USED FOR WHAT PRIVIGEN IS Privigen belongs to the class of medicines called human normal immunoglobulins. Immunoglobulins are also known as antibodies and are blood proteins that help your body to fight infections. HOW PRIVIGEN WORKS Privigen contains immunoglobulins that have been prepared from the blood of healthy people. The medicine works in exactly the same way as the immunoglobulins naturally present in human blood of healthy people. WHAT PRIVIGEN IS USED FOR Privigen is used for the treatment of adults and children (0-18 years) in the following situations: A) To increase abnormally low immunoglobulin levels in your blood to normal levels (replacement therapy): 1. Patients who are born with a reduced ability or inability to produce immunoglobulins (primary immunodeficiencies (PID)). 2. Patients with an acquired immunodeficiency (SID) who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure or serum IgG level of <4 g/l. B) To treat certain inflammatory disorders (immunomodulation). There are 5 groups: 1. Patients who do not have enough blood platelets (primary immune thrombocytopenia (ITP) and who are at high risk of bleedin Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Privigen 100 mg/ml solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human normal immunoglobulin (IVIg)* One ml contains: Human normal immunoglobulin 100 mg (purity of at least 98% IgG) Each vial of 25 ml solution contains: 2.5 g human normal immunoglobulin Each vial of 50 ml solution contains: 5 g human normal immunoglobulin Each vial of 100 ml solution contains: 10 g human normal immunoglobulin Each vial of 200 ml solution contains: 20 g human normal immunoglobulin Each vial of 400 ml solution contains: 40 g human normal immunoglobulin Distribution of the IgG subclasses (approx. values): IgG 1 .......................69 % IgG 2 .......................26 % IgG 3 ........................ 3 % IgG 4 ........................ 2 % The maximum IgA content is 25 micrograms/ml. *Produced from the plasma of human donors. Excipients with known effects: Privigen contains approximately 250 mmol/L (range: 210 to 290) of L-proline. 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 to pale yellow. Privigen is isotonic, with an approximate osmolality of 320 mOsmol/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Replacement therapy in adults, and children and adolescents (0-18 years) in: – Primary immunodeficiency syndromes (PID) with impaired antibody production (see section 4.4). – 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. * PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines. 3 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 platele Przeczytaj cały dokument