Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
cytarabine, Quantity: 500 mg
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: sodium hydroxide; hydrochloric acid; water for injections; sodium chloride
Intravenous, Subcutaneous
25mL x 1
(S4) Prescription Only Medicine
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 non-Hodgkin's lymphoma have benefited from a combination drug program (LSA212) 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: 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
1994-12-20
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 Citiți documentul complet