国家: 以色列
语言: 英文
来源: Ministry of Health
ARSENIC TRIOXIDE
MEDISON PHARMA LTD
L01XX27
SOLUTION FOR INJECTION
ARSENIC TRIOXIDE 1 MG/ML
I.V
Not required
CP PHARMACEUTICALS LTD, U.K.
ARSENIC TRIOXIDE
ARSENIC TRIOXIDE
TRISENOX is indicated for induction of remission, and consolidation in adult patients with:• Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 1000/μl) in combination with all-trans-retinoic acid (ATRA)• Relapsed/refractory acute promyelocytic leukaemia (APL)(Previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene.The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.
2014-02-28
)תוחיטב עדימ ( הרמחה לע העדוה :ךיראת 13.12.12 :תילגנאב רישכת םש TRISENOX 1 MG/ML :םושיר רפסמ 140-10-31787-00 מ"עב המראפ ןוסידמ :םושירה לעב םש ןולעב םייונישה בוהצ עקר לע םינמוסמ אפורל ןולעב םי/שקובמה םי/יונישה לע םיטרפ ןולעב קרפ יחכונ טסקט שדח טסקט 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The same dose is recommended for children, adults, and elderly. Consolidation schedule: Consolidation treatment must begin 3 to 4 weeks after completion of induction therapy. TRISENOX is to be administered intravenously at a dose of 0.15 mg/kg/day for 25 doses given 5 days per week, followed by 2 days interruption, repeated for 5 weeks. Paediatric use: The experience in children is limited. Of 7 patients under 18 years of age (range 5 to 16 years) treated with TRISENOX at the recommended dose of 0.15 mg/kg/day, 5 patients achieved a complete response. Safety and effectiveness in paediatric patients under 5 years of age have not been studied. The same dose is recommended for children, adults, and elderly. Consolidation schedule: Consolidation treatment must begin 3 to 4 weeks after completion of induction therapy. TRISENOX is to be administered intravenously at a dose of 0.15 mg/kg/day for 25 doses given 5 days per week, followed by 2 days interruption, repeated for 5 weeks. Paediatric use: The experience in children is limited. Of 7 patients under 18 years of age (range 5 to 16 years) treated with TRISENOX at the recommended dose of 0.15 mg/kg/day, 5 patients achieved a complete response. Safety and effectiveness in paediatric patients under 5 years of age have not been studied. .םייק אל .הז םוקימב םייק אל .הז םוקימב םייק אל Dose delay, modification and reinitiation Treatment with TRISENOX must be interrupted, adjusted, or discontinued before the scheduled end of therapy at any time that a toxicity grade 3 or greater on the National Canc 阅读完整的文件
Physician's Prescribing Information 1 This leaflet format has been determined by the Ministry of Health and the content thereof has been checked and approved in February 2018 1. NAME OF THE MEDICINAL PRODUCT TRISENOX 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of TRISENOX contains 1 mg of arsenic trioxide For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection Sterile, clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TRISENOX is indicated for induction of remission, and consolidation in adult patients with: Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 10 3 /µl) in combination with all- _trans_ -retinoic acid (ATRA) Relapsed/refractory acute promyelocytic leukaemia (APL)(Previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptor- alpha (PML/RAR-alpha) gene. The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION TRISENOX must be administered under the supervision of a physician who is experienced in the management of acute leukaemias, and the special monitoring procedures described in section 4.4 must be followed. _ _ Posology The same dose is recommended for adults and elderly _. _ _Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) _ _Induction treatment schedule _ TRISENOX must be administered intravenously at a dose of 0.15 mg/kg/day, given daily until complete remission is achieved. If complete remission has not occurred by day 60, dosing must be discontinued. Physician's Prescribing Information 2 _Consolidation schedule _ TRISENOX must be administered intravenously at a dose of 0.15 mg/kg/day, 5 days per week. Treatment should be continued for 4 weeks on and 4 weeks off, for a total of 4 cyc 阅读完整的文件