Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
romiplostim
Amgen Europe B.V.
B02BX04
romiplostim
Antihemorrhagics
Purpura, Thrombocytopenic, Idiopathic
Adults:Nplate is indicated for the treatment of primary immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).Paediatrics:Nplate is indicated for the treatment of chronic primary immune thrombocytopenia (ITP) in paediatric patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).
Revision: 26
Authorised
2009-02-04
77 B. PACKAGE LEAFLET 78 PACKAGE LEAFLET: INFORMATION FOR THE USER NPLATE 125 MICROGRAMS POWDER FOR SOLUTION FOR INJECTION NPLATE 250 MICROGRAMS POWDER FOR SOLUTION FOR INJECTION NPLATE 500 MICROGRAMS POWDER FOR SOLUTION FOR INJECTION Romiplostim 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 Nplate is and what it is used for 2. What you need to know before you use Nplate 3. How to use Nplate 4. Possible side effects 5. How to store Nplate 6. Contents of the pack and other information 1. WHAT NPLATE IS AND WHAT IT IS USED FOR Nplate’s active ingredient is romiplostim, which is a protein used to treat low platelet counts in patients with immune primary thrombocytopenia (called ITP). ITP is a disease in which your body’s immune system destroys its own platelets. Platelets are the cells in your blood that help seal cuts and form blood clots. Very low platelet counts can cause bruising and serious bleeding. Nplate is used to treat adult patients with ITP who may or may not have had their spleen removed and who have been previously treated with corticosteroids or immunoglobulins, where these treatments don’t work. Nplate is also used to treat children aged 1 year and over with chronic ITP who may or may not have had their spleen removed and who have been previously treated with corticosteroids or immunoglobulins, where these treatments don’t work. Nplate works by stimulating the bone marrow (part of the bone which makes blood cells) to produce more platelets. This should help to Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Nplate 125 micrograms powder for solution for injection Nplate 250 micrograms powder for solution for injection Nplate 500 micrograms powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Nplate 125 micrograms powder for solution for injection Each vial contains 125 mcg of romiplostim. After reconstitution, a deliverable volume of 0.25 mL solution contains 125 mcg of romiplostim (500 mcg/mL). An additional overfill is included in each vial to ensure that 125 mcg of romiplostim can be delivered. Nplate 250 micrograms powder for solution for injection Each vial contains 250 mcg of romiplostim. After reconstitution, a deliverable volume of 0.5 mL solution contains 250 mcg of romiplostim (500 mcg/mL). An additional overfill is included in each vial to ensure that 250 mcg of romiplostim can be delivered. Nplate 500 micrograms powder for solution for injection Each vial contains 500 mcg of romiplostim. After reconstitution, a deliverable volume of 1 mL solution contains 500 mcg of romiplostim (500 mcg/mL). An additional overfill is included in each vial to ensure that 500 mcg of romiplostim can be delivered. Romiplostim is produced by recombinant DNA technology in _Escherichia coli_ (_E. coli_). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection (powder for injection). The powder is white. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults: Nplate is indicated for the treatment of primary immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1). Paediatrics: Nplate is indicated for the treatment of chronic primary immune thrombocytopenia (ITP) in paediatric patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should rema Przeczytaj cały dokument