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Drug Information Sheet("Kusuri-no-Shiori") Injection Revised: 04/2015 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:FLUMARIN Kit for Intravenous Injection 1g Active ingredient:Flomoxef sodium Dosage form:injection Print on wrapping: Effects of this medicine This medicine is an oxacephem antibiotic and has an antibacterial effect by inhibiting bacterial cell wall synthesis. It is usually used for the treatment of a wide range of bacterial infections including surgical infections, respiratory infections, urinary tract infections, intra-abdominal infections, biliary tract infections, obstetric and gynecologic infections, otorhinolaryngologic infections, 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 a history of shock. ・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>> ・In general, for adults, the medicine is administered by intravenous drip infusion daily in 2 divided doses. For children, it is administered by intravenous drip infusion daily in 3 or 4 divided doses. For premature infants and neonates within 3 days after birth, it is administered by intravenous drip infusion daily in 2 or 3 divided doses. For premature infants and neonates on the 4th day or later after birth, it is administered by intravenous drip infusion daily in 3 or 4 divided doses. In case of intractable and/or severe infections, for adults, the medicine is administered by intravenous drip infusion daily in 2 to 4 divided doses, and for premature infants, neonates and children, the medicine is administered by intravenous drip infusion daily in 3 or 4 divided doses. ・Duration of use is determined according to your symptoms. ・From the strart to the end of drip infusion, you should keep quiet. Precautions while taking this medicine ・This medicine may have an influence on tests for glucose in urine etc. Possible adverse reactions to this medicine The most commonly reported adverse reactions include rash, hives, itch, redness, fever, facial hot flush, skin paraesthesia, anemia and oliguria. 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, see your doctor immediately. ・breathlessness, dizziness, wheezing, swelling around eyes and/or mouth (lips) [shock, anaphylaxis] ・swelling, decreased urine output or anuria, loss of appetite [acute renal failure] ・palpitation and shortness of breath, fever, sore throat, gum bleeding [pancytopenia, agranulocytosis, thrombocytopenia, hemolytic anemia] ・diarrhea (mucous stool), pain in abdomen, nausea [pseudomembranous colitis] ・high fever, fluid-filled blister, inflammation in mucous membrane of eyes, mouth, etc., general redness [toxic epidermal necrolysis, mucocutaneous ocular 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. Storage conditions and other information For healthcare professional use only / / For further information, talk to your doctor or pharmacist. 1/1