Țară: Uniunea Europeană
Limbă: engleză
Sursă: EMA (European Medicines Agency)
azacitidine
Celgene Europe BV
L01BC07
azacitidine
Antineoplastic agents
Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Azacitidine Celgene is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:intermediate 2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),chronic myelomonocytic leukaemia (CMML) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (AML) with 20 30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification,AML with >30% marrow blasts according to the WHO classification.
Revision: 2
Withdrawn
2019-08-02
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Azacitidine Celgene 25 mg/mL powder for suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 100 mg azacitidine. After reconstitution, each mL of suspension contains 25 mg azacitidine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for suspension for injection. White lyophilised powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Azacitidine Celgene is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: • intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), • chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder, • acute myeloid leukaemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification, • AML with > 30% marrow blasts according to the WHO classification. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Azacitidine Celgene treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic agents. Patients should be premedicated with anti-emetics for nausea and vomiting. Posology The recommended starting dose for the first treatment cycle, for all patients regardless of baseline haematology laboratory values, is 75 mg/m 2 of body surface area, injected subcutaneously, daily for 7 days, followed by a rest period of 21 days (28-day treatment cycle). It is recommended that patients be treated for a minimum of 6 cycles. Treatment should be continued as long as the patient continues to benefit or until disease progression. _ _ Patients should be monitored for haematologic response/toxicity and renal toxicities (see section 4.4); a delay in starting the next cycle or a dose reduction as described below may be necessary Citiți documentul complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Azacitidine Celgene 25 mg/mL powder for suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 100 mg azacitidine. After reconstitution, each mL of suspension contains 25 mg azacitidine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for suspension for injection. White lyophilised powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Azacitidine Celgene is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: • intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), • chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder, • acute myeloid leukaemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification, • AML with > 30% marrow blasts according to the WHO classification. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Azacitidine Celgene treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic agents. Patients should be premedicated with anti-emetics for nausea and vomiting. Posology The recommended starting dose for the first treatment cycle, for all patients regardless of baseline haematology laboratory values, is 75 mg/m 2 of body surface area, injected subcutaneously, daily for 7 days, followed by a rest period of 21 days (28-day treatment cycle). It is recommended that patients be treated for a minimum of 6 cycles. Treatment should be continued as long as the patient continues to benefit or until disease progression. _ _ Patients should be monitored for haematologic response/toxicity and renal toxicities (see section 4.4); a delay in starting the next cycle or a dose reduction as described below may be necessary Citiți documentul complet