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.
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Brand name :
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Levofolinate for Injection 25mg "NP"
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Effects of this medicine
This medicine is used concomitantly with Fluorouracil (antitumor medicine) to enhance the growth-inhibitory effect against cancer cells.
It is usually used to enhance the effect of Fluorouracil for the gastric cancer (inoperable/recurrent), colorectal cancer and pancreatic cancer difficult to be removed by surgery.
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Before using this medicine, be sure to tell your doctor and pharmacist
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If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have myelosuppression, diarrhea, complication of infection, ascites, pleural effusion, heart disease or a history of it, poor general condition.
If you are receiving the combination preparation of Tegafur, Gimeracil and Oteracil Potassium or had discontinued receiving it within 7 days.
If you have hepatic disorder, renal disorder, hepatic metastasis.
If you have gastrointestinal ulcer or haemorrhage.
If you are receiving radiotherapy.
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If you are pregnant or breastfeeding.
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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.)
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Dosing schedule (How to take this medicine)
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Your dosing schedule prescribed by your doctor is << to be written by a healthcare professional>>
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In general, this medicine is administered by intravenous drip infusion at one time over the period of 2 hours.
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Duration of administration may vary by other concomitant drug and your condition. Ask your doctor about your dosing schedule.
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Precautions while taking this medicine
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Treatment with this medicine may cause decreased bone-marrow function. If you have decreased bone-marrow function, infection or bleeding may tend to occur. However, it is difficult to find out these symptoms so that you should receive clinical examination (blood test, liver/renal function test, etc) regularly (frequently during early treatment period, in particular) to find any symptoms early.
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Possible adverse reactions to this medicine
The most commonly reported adverse reactions include loss of appetite, nausea, vomiting, taste abnormality, abdominal pain, epigastric pain, dry mouth, constipation, gum inflammation, cheilitis, melena, angular cheilitis, glossitis, heart burn, abdominal bloating or rash. 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.
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intense abdominal pain, diarrhea, hematochezia [serious enterocolitis]
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general malaise, bruise, dizziness [myelosuppression]
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rash, breathing difficulty, decreased blood pressure [shock, anaphylaxis]
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unsteady gait, numbness of terminal portion of extremities, impaired tongue movement [leukoencephalopathy, mental/nerve disorder]
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chest pain, cold sweat, feeling of strong pressure in chest [congestive heart failure, myocardial infraction, angina at rest]
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general swelling, fatigability, difficulty in urination [acute renal failure]
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fever, dry cough, difficult to breathe [interstitial pneumonia]
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general malaise, loss of appetite, yellowing in skin and white of eyes [hepatic function disorder, jaundice]
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nausea, vomiting, gastric pain, oral erosion and pain [gastrointestinal ulcer, serious stomatitis]
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sudden intense pain in low back and back , fever, nausea, vomiting [acute pancreatitis]
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impaired consciousness, flapping tremor in hands, tremor in limbs [hyperammonemia]
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hypesthesia and supersensitivity, pain, skin exfoliation in volar [hand-foot syndrome]
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difficult to smell, feel no smell [anosmia]
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sweating, intense abdominal pain, watery stool [severe diarrhea]
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nasal bleeding, palpitation, shortness of breath, bruise, yellow urine [disseminated intravascular coagulation]
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.
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