국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
cytarabine, Quantity: 1 g
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: sodium hydroxide; hydrochloric acid; water for injections
Intravenous, Subcutaneous
10mL x 1
(S4) Prescription Only Medicine
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 (blastphase) and erythroleukaemia. May be used alone or in combination with other antineoplastic agents, the best results often being obtained with combination therapy. Children with non-Hodgkin's lymphoma have benefited from a combination drug program (LSA 2L2) that includes cytarabine. INDICATIONS AS AT 24 OCTOBER 2001: 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 combined therapy. Children with
Visual Identification: Clear, colourless to almost pale-yellow aqueous solution, free from visible particles.; Container Type: Vial; Container Material: PP; Container Life Time: 18 Months; Container Temperature: Store between 15-25 degrees Celsius
Registered
1991-08-13
CYTARABINE INJECTION _Cytarabine_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cytarabine Injection. 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 Cytarabine Injection against the benefits they expect it will 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 BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CYTARABINE INJECTION IS USED FOR Cytarabine belongs to a group of medicines known as antineoplastics. It is used to treat cancer. _HOW CYTARABINE INJECTION_ _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 Injection 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 Injection. This medicine is available only with a doctor's prescription. _USE IN CHILDREN_ Cytarabine Injection 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 INJECTION _WHEN YOU MUST NOT BE GIVEN_ _IT_ DO NOT HAVE CYTARABINE INJECTION IF YOU HAVE AN ALLERGY TO: • any medicine containing cytarabine • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or diffic 전체 문서 읽기
Version: pfpcytai10320 Supersedes: pfpcytai11117 Page 1 of 16 AUSTRALIAN PRODUCT INFORMATION – CYTARABINE (CYTARABINE 20 MG/ML, 100 MG/ML) SOLUTION FOR INJECTION 1. NAME OF THE MEDICINE Cytarabine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cytarabine Injection is a sterile, isotonic, preservative-free solution containing either Cytarabine BP 20mg/mL with Sodium Chloride BP 6.8mg/mL in Water for Injections BP or Cytarabine BP 100mg/mL in Water for Injections BP. 3. PHARMACEUTICAL FORM Cytarabine Injection is a clear, colourless solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC 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. 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. Version: pfpcytai10320 Supersedes: pfpcytai11117 Page 2 of 16 4.2 DOSE AND METHOD OF ADMINISTRATION Cytarabine may be administered by intravenous injection or infusion, or subcutaneously. It has been administered intrathecally as a special application. Thrombophlebitis has occurred at the site of drug injection or infusion in some patients, and rarely patients have noted pain and inflammation at subcutaneous injection sites. In most instances, howeve 전체 문서 읽기