Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
cytarabine, Quantity: 40 mg
Accord Healthcare Pty Ltd
Injection, solution
Excipient Ingredients: sodium hydroxide; hydrochloric acid; water for injections; sodium chloride
Intravenous, Subcutaneous, Intrathecal
1
(S4) Prescription Only Medicine
Cytarabine is indicated primarily for:,? Induction and maintenance of remission in acute myelocytic leukaemia of both adults and children.,It has also been found to be useful in the treatment of other leukaemias such as:,? Acute lymphocytic leukaemia,? Chronic myelocytic leukaemia (blast phase).,Cytarabine may be used alone or in combination with other antineoplastic agents, the best results are often obtained with combination therapy.,Children with non-Hodgkin?s lymphoma have benefited from a combination drug program (LSA2L2) that includes cytarabine.,Remissions induced by cytarabine not followed by maintenance treatment have been brief. Maintenance therapy has extended these and provided useful and comfortable remissions with relatively little toxicity.,Cytarabine has been used intrathecally in meningeal leukaemia. Focal leukaemic involvement of the central nervous system may not respond to intrathecal cytarabine and may better be treated with radiotherapy.
Visual Identification: A clear, colourless solution in a glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2019-04-16
Version 1.0 Page 1 of 4 CYTARABINE ACC AND CYTARABINE ACCORD _Cytarabine Injection 20 mg/mL and 100 mg/mL _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cytarabine Accord/Cytarabine ACC. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Cytarabine Accord/Cytarabine ACC against the benefits this medicine is expected to have for you. This medicine will be used while you are at the clinic or in hospital. If possible, please read this leaflet carefully before this medicine is given to you. In some cases this leaflet may be given to you after the medicine has been used. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT CYTARABINE IS USED FOR Cytarabine belongs to a group of medicines known as antineoplastics. It is used to treat cancer. _HOW CYTARABINE _ _ACCORD/CYTARABINE ACC _ _WORKS _ Cytarabine works by preventing the growth of cancer cells and eventually destroying them. It is used alone or in combination with other medicines to treat some cancers, particularly cancers of the blood (especially leukaemia). Cytarabine Accord/Cytarabine ACC may be used to treat other conditions that are not mentioned above. Your doctor will be able to tell you about the specific condition for which you have been prescribed Cytarabine Accord/Cytarabine ACC. This medicine is available only with a doctor's prescription. _USE IN CHILDREN _ Cytarabine Accord/Cytarabine ACC is also used in children to treat blood cancers such as leukaemia. It is also sometimes used in combination with other medicines to treat Non-Hodgkins Lymphoma. BEFORE YOU ARE GIVEN CYTARABINE _WHEN YOU MUST NOT BE _ _GIVEN IT _ DO NOT HAVE CYTARABINE ACCORD/CYTARABINE ACC IF YOU HAVE AN ALLERGY TO: • any medicine containing cytarabine • any of the ingredients listed Soma hati kamili
Page 1 of 13 AUSTRALIAN PRODUCT INFORMATION CYTARABINE ACC (20 MG/ML) AND CYTARABINE ACCORD (100 MG/ML) (CYTARABINE) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Cytarabine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CYTARABINE ACC, 1 ML CONTAINS 20 MG CYTARABINE 1 vial of 2 mL solution for injection contains 40 mg cytarabine. 1 vial of 5 mL solution for injection contains 100 mg cytarabine. CYTARABINE ACCORD, 1 ML CONTAINS 100 MG CYTARABINE 1 vial of 1 mL solution for injection contains 100 mg cytarabine. 1 vial of 5 mL solution for injection contains 500 mg cytarabine. 1 vial of 10 mL solution for injection contains 1000 mg cytarabine. 1 vial of 20 mL solution for injection contains 2000 mg cytarabine. 1 vial of 40 mL solution for injection contains 4000 mg cytarabine. 1 vial of 50 mL solution for injection contains 5000 mg cytarabine. Cytarabine is a synthetic nucleoside which differs from the normal nucleosides cytidine and deoxycytidine in that the sugar moiety is arabinose rather than ribose or deoxyribose. It is a white or almost white, crystalline powder, freely soluble in water, very slightly soluble in alcohol and in methylene chloride. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM Cytarabine Accord and Cytarabine ACC are clear, colourless solutions for injection. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Cytarabine is indicated primarily for: • Induction and maintenance of remission in acute myelocytic leukaemia of both adults and children. It has also been found to be useful in the treatment of other leukaemias such as: • Acute lymphocytic leukaemia • Chronic myelocytic leukaemia (blast phase). Cytarabine may be used alone or in combination with other antineoplastic agents, the best results are often obtained with combination therapy. Children with non-Hodgkin’s lymphoma have benefited from a combination drug program (LSA2L2) that includes cytarabine. Remissions induced by cytarabine not followed by maintenance treatment have been brief. Soma hati kamili