Land: Israel
Språk: engelska
Källa: Ministry of Health
LUSPATERCEPT
BRISTOL, MYERS SQUIBB (ISRAEL) LIMITED, ISRAEL
B03XA06
POWDER FOR SOLUTION FOR INJECTION
LUSPATERCEPT 25 MG
S.C
Required
CELGENE CORPORATION, USA
LUSPATERCEPT
Reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non-transfusion-dependent beta-thalassaemia
2022-01-30
Patient leaflet in accordance with the Pharmacists’ Regulations (Preparations) - 1986 This medicine is dispensed with a doctor’s prescription only Reblozyl ® 25 mg Reblozyl ® 75 mg Powder for solution for injection Active ingredient and its quantity: Reblozyl ® 25 mg: Each vial contains 25 mg luspatercept Reblozyl ® 75 mg: Each vial contains 75 mg luspatercept After reconstitution, each mL of solution contains 50 mg luspatercept Inactive ingredients - see section 6 under ‘Additional information’ and the section ‘Important information about some of this medicine’s ingredients’ in section 2. Read the entire leaflet carefully before you start using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. In addition to the leaflet, Reblozyl has a Patient Card (for women of childbearing potential). This card contains important safety information that you should know before starting and during the treatment with Reblozyl and which you should follow. Carefully read the Patient Card (for women of childbearing potential) and patient leaflet before starting treatment with this medicine. Keep the card for further reference if needed. 1. What is this medicine intended for? - Reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy. - Reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia associated with beta-thalassaemia. Therapeutic group: anti-anaemic medicines Myelodysplastic syndromes (MDS) Myelodysplastic syndromes (MDS) are a collection of many different blood and bone marrow disorders. Red b Läs hela dokumentet
1 Reblozyl_NPI_July2023 1. NAME OF THE MEDICINAL PRODUCT Reblozyl 25 mg Reblozyl 75 mg Powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Reblozyl 25 mg powder for solution for injection Each vial contains 25 mg of luspatercept. After reconstitution, each mL of solution contains 50 mg luspatercept. Reblozyl 75 mg powder for solution for injection Each vial contains 75 mg of luspatercept. After reconstitution, each mL of solution contains 50 mg luspatercept. Luspatercept is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection. White to off-white lyophilised powder. 4. CLINICAL PARTICULARS Patient Safety Information Card The marketing of Reblozyl is subject to risk management plan (RMP) including a ‘Patient Card (for Women of Childbearing Potenial)’, emphasizes important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review the card before starting treatment. Prescriber’s Checklist This product is marketed with a prescriber’s checklist providing important safety information. Please ensure you are familiar with this material as it contains important safety information. 4.1 Therapeutic indications Reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (see section 5.1). Reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia associated with beta-thalassaemia (see section 5.1). 2 Reblozyl_NPI_July2023 4.2 Posology and method of administration Reblozyl treatment should be initiated by a physician experienced in treatment of haematological diseases. Posology Prior to each Reblozyl administration, the haemoglobin (Hb) leve Läs hela dokumentet