Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
azacitidine
Celgene Pty Ltd
Azacitidine
Registered
CELAZADINE _POWDER FOR INJECTION_ _azacitidine 100 mg_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Celazadine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Celazadine against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS CELAZADINE USED FOR Celazadine is an anti-cancer agent. This product contains a medicine called azacitidine which prevents the growth of cancer cells. Celazadine has been prescribed by your doctor for the treatment of myelodysplastic syndrome (MDS). Myelodysplastic syndrome is a blood disorder in which the bone marrow is not working normally and does not produce enough mature blood cells. This causes a lack of healthy blood cells that can function properly in the body. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT HOW THIS MEDICINE WORKS, OR WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. Celazadine will only be prescribed to you by a doctor who has experience in medicines to treat cancers of the blood. BEFORE YOU ARE GIVEN CELAZADINE _WHEN YOU MUST NOT BE GIVEN_ _CELAZADINE_ TELL YOUR DOCTOR: • IF YOU ARE ALLERGIC TO AZACITIDINE OR ANY OF THE OTHER INGREDIENTS OF THE PRODUCT LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. • IF YOU HAVE ADVANCED LIVER CANCER. • IF YOU ARE PREGNANT. • IF YOU HAVE SEVERE PROBLEMS WITH YOUR KIDNEY FUNCTION. _BEFORE YOU ARE GIVEN_ _CELAZADINE_ 1. USE BY WOMEN AVOID BECOMING PREGNANT WHILE RECEIVING THIS MEDICINE B Prečítajte si celý dokument
Celazadine® (azacitidine) 100 mg Powder for Injection – AU PI Celgene V2.7 – 24 July 2020 (CCDS V12) 1 AUSTRALIAN PI – CELAZADINE ® (AZACITIDINE 100 MG) POWDER FOR INJECTION 1 NAME OF THE MEDICINE Australian approved name: azacitidine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 100 mg azacitidine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Vials of Celazadine contain 100 mg of azacitidine and 100 mg mannitol as a white to off-white, sterile lyophilised powder. Azacitidine is a white to off-white solid. It is insoluble in acetone, ethanol, and methyl ethyl ketone. Azacitidine is slightly soluble in ethanol/water (50/50) and propylene glycol; it is sparingly soluble in water (13.8 mg/mL), 5% glucose in water and in normal saline. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Celazadine is indicated for the treatment of patients with: • Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS) according to the International Prognostic Scoring System (IPSS), • Chronic Myelomonocytic Leukemia [CMMoL (10%-29% marrow blasts without Myeloproliferative Disorder)], • Acute Myeloid Leukemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to World Health Organisation Classification (WHO), in whom allogenic stem cell transplantation is not indicated. 4.2 D OSE AND METHOD OF ADMINISTRATION Azacitidine treatment should only be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Patients should be premedicated for nausea and vomiting. DOSE First Treatment Cycle 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 given subcutaneously or by intravenous infusion, daily for seven days, follow Prečítajte si celý dokument