Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
AZACITIDINE
BRISTOL, MYERS SQUIBB (ISRAEL) LIMITED, ISRAEL
L01BC07
FILM COATED TABLETS
AZACITIDINE 300 MG
PER OS
Required
CELGENE CORPORATION, USA
AZACITIDINE
ONUREG is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy
2022-06-27
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 THIS MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY ONUREG 200 MG ONUREG 300 MG FILM-COATED TABLETS Active ingredient and its quantity: Onureg 200 mg: Each film-coated tablet contains 200 mg azacitidine Onureg 300 mg: Each film-coated tablet contains 300 mg azacitidine Inactive ingredients – See section 6 “Additional information” and section 2 under “Important information about some of this medicine’s ingredients”. 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, consult 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. 1. WHAT IS THIS MEDICINE INTENDED FOR? Onureg is indicated for continued treatment of adult patients with acute myeloid leukaemia )AML( who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy. THERAPEUTIC GROUP: Antineoplastic agent, antimetabolite, pyrimidine analogue HOW ONUREG WORKS AML is a type of cancer which affects the bone marrow and can cause problems in producing normal blood cells. Onureg prevents cancer cells from growing. Azacitidine, the active substance in Onureg, alters the way by which the cell turns genes on and off. It also reduces the production of new genetic material (DNA or RNA). These effects are thought to block the growth of cancer cells in leukaemia. Talk to your doctor or nurse if you have any further questions about how Onureg works or why this medicine has been prescribed for you. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: You are sensitive (allergic) to azacitidine or to any of the other ingredients of this medicine (listed in section 6) Yo Baca dokumen lengkapnya
1 Onureg_API_June2022_clean 1. NAME OF THE MEDICINAL PRODUCT Onureg 200 mg Onureg 300 mg Film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Onureg 200 mg film-coated tablets Each film-coated tablet contains 200 mg azacitidine. _Excipient with known effect _ Each film-coated tablet contains 3.61 mg of lactose (as lactose monohydrate). Onureg 300 mg film-coated tablets Each film-coated tablet contains 300 mg azacitidine. _Excipient with known effect _ Each film-coated tablet contains 5.42 mg of lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Onureg 200 mg film-coated tablets Pink, oval, film-coated tablet, debossed with “200” on one side and “ONU” on the other side. Onureg 300 mg film-coated tablets Brown, oval, film-coated tablet, debossed with “300” on one side and “ONU” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Onureg is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Onureg treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic medicinal products. Patients are to be treated with an anti-emetic 30 minutes prior to each dose of Onureg for the first 2 treatment cycles. Anti-emetic prophylaxis may be omitted after 2 cycles, if there has been no nausea and vomiting (see section 4.4). 2 Onureg_API_June2022_clean Posology The recommended dose is 300 mg azacitidine orally once daily. Each repeated cycle consists of a treatment period of 14 days followed by a treatment free period of 14 days (28-day treatment cycle). Onureg treatment should be continued until no more than 15% blasts are observed in peripheral blood or bone marrow or until un Baca dokumen lengkapnya