מדינה: מלטה
שפה: אנגלית
מקור: Medicines Authority
IMMUNOGLOBULIN G, HUMAN
Octapharma (IP) Limited
J06BA02
IMMUNOGLOBULIN G, HUMAN
SOLUTION FOR INFUSION
IMMUNOGLOBULIN G, HUMAN 100 mg I/ml
POM
IMMUNE SERA AND IMMUNOGLOBULINS
Authorised
2009-08-25
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER OCTAGAM 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 pharmacist. This medicine has been prescribed for you. 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 of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Octagam 10% is and what it is used for 2. What you need to know before you use Octagam 10% 3. How to use Octagam 10% 4. Possible side effects 5. How to store Octagam 10% 6. Contents of the pack and other information 1 WHAT OCTAGAM 10% IS AND WHAT IT IS USED FOR WHAT OCTAGAM 10% IS Octagam 10% is a human normal immunoglobulin (IgG) solution (i.e. solution of human antibodies) for intravenous administration (i.e. infusion into a vein). Immunoglobulins are normal constituents of the human body and support the immune defence of your body. Octagam 10% contains all IgG activities which are present in the normal population. Adequate doses of this medicinal product may restore abnormally low IgG levels to the normal range. Octagam 10% has a broad spectrum of antibodies against various infectious agents. WHAT OCTAGAM 10% IS USED FOR Octagam 10% is used * as replacement therapy in patients who do not have sufficient amounts of own antibodies. * in certain inflammatory diseases * to prevent or treat infections after a bone marrow transplantation Octagam 10% is used as replacement therapy. There are 3 groups of replacement therapy: - Patients with inborn deficiency of antibodies (primary immunodeficiency syndromes: congenital agammaglobulinaemia and hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunod קרא את המסמך השלם
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT OCTAGAM 10%,solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human normal immunoglobulin (IVIg)* 100mg/ml * corresponding to the total protein content of which at least 95% is human Immunoglobulin G Distribution of IgG subclasses: IgG 1 ca. 60% IgG 2 ca. 32% IgG 3 ca. 7% IgG 4 ca. 1% Maximum IgA content: 400 micrograms/ml Each vial of 20 ml contains 2g of human normal immunoglobulin. Each bottle of 50 ml contains 5g of human normal immunoglobulin. Each bottle of 60 ml contains 6g of human normal immunoglobulin. Each bottle of 100 ml contains 10g of human normal immunoglobulin. Each bottle of 200 ml contains 20g of human normal immunoglobulin. Produced from plasma of human donors. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion The liquid preparation is clear to slightly opalescent and colourless to slightly yellow. The pH of the liquid preparation is 4.5 – 5.0, the osmolality is ≥ 240 mosmol/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _REPLACEMENT THERAPY IN ADULTS, AND CHILDREN AND ADOLESCENTS (0-18 YEARS) IN: _ Primary immunodeficiency syndromes with impaired antibody production (see Section 4.4). 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. Page 2 of 15 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 inflammat קרא את המסמך השלם