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Drug Information Sheet("Kusuri-no-Shiori") Injection Published: 02/2014 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. Brand name:IFOMIDE for Injection 1g Active ingredient:Ifosfamide Dosage form:injection Print on wrapping: Effects of this medicine This medicine shows antitumor effects by suppressing tumor cell growth due to DNA synthesis inhibition. It is usually used for the treatment of small cell lung cancer, prostate cancer, uterine cervix cancer, osteosarcoma, relapsed or refractory germ cell tumor (testicular tumor, ovarian tumor, extragonadal tumor) and malignant lymphoma, and for the combination therapy with other anti-malignant tumor drugs against malignant tumor of bone and soft tissue, childhood malignant solid tumor (Ewing's sarcoma family tumor, rhabdomyosarcoma, neuroblastoma, retinoblastoma, hepatoblastoma, nephroblastoma, etc.). Before using this medicine, be sure to tell your doctor and pharmacist ・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you have disorders in kidney and/or bladder. ・If you are pregnant or breastfeeding. ・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) ・Your dosing schedule prescribed by your doctor is<< to be written by a healthcare professional>> ・Small cell lung cancer, prostate cancer, uterine cervix cancer, osteosarcoma: In general, for adults, this medicine is administered for 3 to 5 consecutive days, by intravenous drip infusion or by intravenous injection. This dosing schedule as 1 course is repeated every 3 or 4 weeks. Relapsed or refractory germ cell tumor (testicular tumor, ovarian tumor, extragonadal tumor): This medicine is used for the combination therapy with other anti-malignant tumor drugs. In general, for adults, this medicine is administered for 5 consecutive days, by intravenous drip infusion. This dosing schedule as 1 course is repeated every 3 or 4 weeks. Malignant lymphoma: This medicine is used for the combination therapy with other anti-malignant tumor drugs. In general, this medicine is administered for 3 to 5 consecutive days, by intravenous drip infusion. This dosing schedule as 1 course is repeated every 3 or 4 weeks. Malignant tumor of bone and soft tissue: For the combination therapy with other anti-malignant tumor drugs, in general, for adults, this medicine is administered for 3 to 5 consecutive days, by intravenous drip infusion or by intravenous injection. This dosing schedule as 1 course is repeated every 3 or 4 weeks. For the single use, for adults, this medicine is administered by intravenous drip infusion or by intravenous injection. This dosing schedule is repeated. Childhood malignant solid tumor (Ewing's sarcoma family tumor, rhabdomyosarcoma, neuroblastoma, retinoblastoma, hepatoblastoma, nephroblastoma, etc.): This medicine is used for the combination therapy with other anti-malignant tumor drugs. In general, this medicine is administered for 3 to 5 consecutive days, by intravenous drip infusion. This dosing schedule as 1 course is repeated every 3 or 4 weeks. ・To protect the urinary organs, you are instructed to take a lot of water, or a transfusion is administered by intravenous drip infusion, before and after using this medicine. ・Consult with your doctor about your concrete schedule for use. Precautions while taking this medicine ・If you are breastfeeding, discontinue breastfeeding while using this medicine. Possible adverse reactions to this medicine The most commonly reported adverse reactions include loss of appetite, nausea, vomiting, hair loss and malaise. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated 1/2 in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. ・fever, symptoms of anemia, bleeding tendency [myelosuppression] ・pain during urination, increased urinary frequency, blood in the urine [hemorrhagic cystitis, dysuria] ・hand tremor, swelling, loss of appetite [Fanconi syndrome, acute renal failure] ・disturbance of consciousness, disturbance of memory, disturbance of language [encephalopathy] ・fever, dry cough, breathlessness [interstitial pneumonia, pulmonary edema] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions and other information For healthcare professional use only / / For further information, talk to your doctor or pharmacist. 2/2