Drug Information Sheet("Kusuri-no-Shiori") Injection Published: 06/2015 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:Radicut Bag for I.V. Infusion 30mg Active ingredient:Edaravone Dosage form:Injection Print on wrapping: Effects of this medicine This medicine scavenges harmful free radicals that increase in cerebral region with constricted blood flow and protects the brain. It protects motor nerves by reducing the production of free radicals. It is usually used to improve neurological symptoms, disorder of activities of daily living, and functional disorder associated with acute ischemic stroke. It is also used to inhibit progression of functional disorder in patients with amyotrophic lateral sclerosis (ALS). 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 renal dysfunction, infection, hepatic dysfunction, heart disease, or conscious disorder. ・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>> ・For acute ischemic stroke: In general, for adults, this medicine is given by intravenous drip infusion over 30 minutes twice a day. The treatment span is within 14 days. For amyotrophic lateral sclerosis (ALS): In general, for adults, it is given by intravenous drip infusion over 60 minutes once a day. Usually, the duration of injection and no injection of this medicine are combined in one cycle of treatment for 28 days and the cycle should be repeated. This medicine is consecutively infused for 14 days in the duration of injection followed by no injection for 14 days in the 1st cycle, and from the 2nd cycle, this medicine is infused for 10 of 14 days in the duration of injection followed by no injection for 14 days. Depending on your symptoms, this medicine may be administered over a long period of time. Precautions while taking this medicine ・When this medicine is used, examination of kidney and liver function as well as blood tests should be frequently conducted with your collected blood sample. (Frequency of these tests varies according to your symptoms.) Possible adverse reactions to this medicine The most commonly reported adverse reactions include liver disorder (general malaise, loss of appetite, yellow discoloration in the skin or white of the eyes), renal dysfunction (urine volume decreased, edema), insomnia, fever, rash, redness, swelling, wheal, itch and erythema. 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. ・urine volume decreased, edema, malaise [acute renal failure, nephrotic syndrome] ・general malaise, loss of appetite, yellow discoloration in the skin or white of the eyes [fulminant hepatitis, hepatic dysfunction, jaundice] ・nose/gum bleeding, fever, sore throat [decreased platelets, decreased granulocytes] ・bruise, nose/gum bleeding, palpitation or shortness of breath [disseminated intravascular coagulation syndrome] ・fever, cough, respiratory distress [acute pulmonary disorder] 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