TAXOL INJECTION（Paclitaxel）TAXOL INJECTION 30mg（タキソール注射液30mg）Brand name : TAXOL INJECTION 30mg Active ingredient: Paclitaxel Dosage form: injection Print on wrapping:Effects of this medicineThis medicine enters the cells and suppresses growth of malignant cells to destroy them.It is usually used to treat ovarian cancer, non-small cell lung cancer, breast cancer, gastric cancer, uterine corpus cancer, recurrent/distant metastatic head and neck cancer, recurrent/distant metastatic esophageal cancer, angiosarcoma, progressive/recurrent uterine cervical cancer and recurrent/refractory germ cell tumor (testicular/ovarian/extragonadal tumor).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 bone-marrow suppression, infections or alcohol hypersensitivity.•If you are pregnant, possibly 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>>•For non-small cell lung cancer and uterine corpus cancer: In general, repeat the cycle of administering intravenous infusion for 3 hours once a day with a drug cessation period of at least 3 weeks.For breast cancer: In general, repeat the cycle of administering intravenous infusion for 3 hours once a day with a drug cessation period of at least 3 weeks, or administer for 1 hour once a week for 6 weeks in a row as 1 course with a drug cessation period of at least 2 weeks and repeat the course.For ovarian cancer: In general, repeat the cycle of administering intravenous infusion for 3 hours once a day with a drug cessation period of at least 3 weeks, or administer for 1 hour once a week for 3 weeks in a row as 1 course and repeat the course.For gastric cancer: In general, repeat the cycle of administering intravenous infusion for 3 hours once a day with a drug cessation period of at least 3 weeks, or administer for 1 hour once a week for 3 weeks in a row as 1 course with a drug cessation period of at least 2 weeks and repeat the course.For recurrent/refractory germ cell tumor: In general, repeat the cycle of administering intravenous infusion for 3 hour once a day with a drug cessation period of at least 3 weeks.For recurrent/distant metastatic head and neck cancer recurrent/distant metastatic esophageal cancer and angiosarcoma: In general, administer for 1 hour by intravenous infusion once a week for 6 weeks in a row as 1 course with a drug cessation period of at least 2 weeks and repeat the course.For progressive/recurrent uterine cervical cancer: In general, repeat the cycle of administering intravenous infusion for 24 hours once a day with a drug cessation period of at least 3 weeks.•It may be administered over a long period according to your response to the treatment.•Dexamethasone, Ranitidine or Famotidine, and Diphenhydramine will be used before treatment with this medicine in order to prevent hypersensitivity reaction.Precautions while taking this medicine•This medicine contains alcohol which may cause drowsiness or dizziness. Avoid driving a car or operating dangerous machinery after administering this medicine.Possible adverse reactions to this medicineThe most commonly reported adverse reactions include peripheral neuropathy, joint pain, muscle pain, nausea/vomiting, loss of hair, fever, rash, nail disorder, taste disorder, dizziness, fatigue, edema, diarrhea, constipation, loss of appetite, stomatitis, nasopharyngitis, weight loss, weight gain, hypertension and interstitial pneumonia. 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 in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.•sudden respiratory distress, chest pain, reduction in blood pressure, fast/slow pulse, hot flush in face, edema, sweating [shock, anaphylactoid symptoms]•fever, chill, sore throat, cough, pain during urination, bleeding tendency, continuous bleeding, anemia [myelosuppression such as leukopenia]•paralysis of limbs, difficulty in buttoning up clothes or manual dexterity task [peripheral neuropathy, paralysis]•persistent cough, breathing difficulty, fever [interstitial pulmonary disease, fibrosis of the lung]•sudden respiratory distress [acute respiratory distress syndrome]•palpitation, shortness of breath, chest pain, breathing difficulty [myocardial infarction, congestive heart failure, cardiac conduction disorder, pulmonary embolism, thrombophlebitis, stroke, pulmonary edema]•hearing loss, ear ringing [hearing impairment, ear ringing]•severe stomachache, hematoma [gastrointestinal necrosis, gastrointestinal perforation, gastrointestinal bleeding, gastrointestinal ulceration]•severe stomachache, diarrhea [serious bowel inflammation]•loss of appetite, nausea/vomiting, severe constipation, stomachache, abdominal distention [intestinal tract obstruction, paralysis of intestine]•jaundice [hepatic function disorder, jaundice]•severe upper abdominal pain [pancreatitis]•inability to pass urine, urine with blood [acute renal failure]•ring-shaped erythema in limbs, fever, diarrhea, burn-like symptoms [oculomucocutaneous syndrome, toxic epidermal necrolysis]•bleeding tendency, continuous bleeding [disseminated intravascular coagulation]•loss of urine volume [tumor lysis syndrome]•unstableness while walking, speech disorder, memory loss, slow movement [leukoencephalopathy (includes reversible posterior leukoencephalopathy syndrome)]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.Bristol-Myers SquibbInjectionRevised: 9/2015The 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.