Drug Information Sheet ("Kusuri-no-Shiori") For Injectables Revised : 6/2005 Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries other than Japan. Brand Name:Liple Injection 10μg Nonproprietary DESCRIPTION (Generic) Name:Alprostadil THIS INJECTION WORKS FOR Classification:Chronic arterial occlusion, progressive systemic sclerosis, systemic lupus erythematosus, diabetes mellitus, vibration disease Liple dilates peripheral blood vessels and increases blood flow, and thereby improves ulcers of limbs and pains. Liple improves skin ulcers in diabetes mellitus. ・Tell your Health Care Provider: - If you ever had any unusual or allergic reaction to any medicines. - Patients with heart/kidney disease, black stools or cough up blood, glaucoma, high eye pressure, gastric ulcer or history of such disease, interstitial pneumonia, bleeding tendency. BEFORE RECEIVING INJECTION ・Dosage Schedule: Your doctor decides the duration of treatment depending upon the severity. ・Administration: Usually, Liple is once a day given, either without mixing or dilution, or as an admixture with an infusion solution, by intravenous injection or intravenous drip infusion. ・Others: If you are already pregnant, may possibly be pregnant, or are breast-feeding, tell your doctor before taking Liple. SIDE EFFECT(S) ・An injection may cause some unwanted effects. ◎Check with your doctor immediately if any of the following side effects occur: <Shock, anaphylactoid reaction> Chills, nausea, abdominal pain, pale face, cold sweat, dizziness, palpitation, rash, itching, urticaria, choking feeling in the chest, respiratory distress. <Loss of consciousness> <Heart failure> Shortness of breath, fatigability, swelling of limbs, breathing difficulty in lie-down position, coughing at night, choking feeling in the chest. <Pulmonary oedema> Respiratory distress, easy breathing in upright position, chest pain, cough. <Interstitial pneumonia> Fever, cough, respiratory distress, chest pain, dullness. <Myocardial infarction> Choking feeling in the chest, chest pain, cold sweat. <Cerebral hemorrhage> Headache, nausea, vomiting, absent-mindedness, paralysis of the limbs on either or both sides. <Hemorrhage of digestive tract> Stomachache, nausea, blood vomitting, black stools. Continued on next page Liple Injection 10μg (Chronic arterial occlusion, progressive systemic sclerosis, systemic lupus erythematosus, diabetes mellitus, vibration disease) <Agranulocytosis, leucopenia> Sore throat, fever, stomatitis, dullness. <Thrombocytopenia> Red spot or bruise appearing on limbs, bleeding tendency from the gums or nose. <Hepatic function disorder, jaundice> Loss of appetite, nausea, yellowing of the skin on the whites of the eyes, dullness. <Strangled feeling of chest, chest pain> Choking feeling in the chest, chest pain, choking feeling in the throat. <Dropped blood pressure> Dizziness on standing up, dizzness, weakness. <Increased blood pressure> Headache, dull headache, stiff shoulder, palpitation. <Asthma> Wheezing, respiratory distress. <Exacerbation of renal failure> Swelling, dullness, urine volume decreased. <Ocular fundus bleeding> Vision disorder, mosquito flying-like vision. <Subcutaneous haemorrhage> Bruise, bluish-purpling of the skin due to subcutaneous bleeding. <Haematuria> Blood in the urine. <Epistaxis> Bleeding from the nose. ◆Check with your doctor early if any of the following side effects occur: ◇Other side effects not listed above: <Diarrhea> <Abdomen enlarged feeling, abdominal discomfort> Bloated feeling of the stomach, abdominal discomfort. <Constipation> <Oral cavity swelling feeling> Swelling in the mouth. <Facial hot flushes> Feeling hot. <Redness> Red skin. <Tremor> Tremor of limbs. <Convulsions> <Feeling of warmth> Feeling hot or feverish. <Pain in extremities> Pain in limbs. <Feeling bad> Feeling unwell. <Alopecia> Depilation. <Cerebral infarction> Numbness of the limbs, unable to articulate property. ・If you notice any other unusual symptoms, check with your doctor. PRECAUTIONS AFTER INJECTION OTHERS INFORMATION GIVEN DATE INFORMATION PROVIDED BY For more detailed information about this injection, ask your health care provider. Drug Information Sheet ("Kusuri-no-Shiori") For Injectables Revised : 6/2005 Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries other than Japan. Brand Name:Liple Injection 10μg DESCRIPTION Nonproprietary (Generic) Name:Alprostadil THIS INJECTION WORKS FOR BEFORE RECEIVING INJECTION SIDE EFFECT(S) Classification:Ductus arteriosus dependent congenital heart disease Liple dilates ductus arteriosus in congenital heart disease of newborns caused by ductus arteriosus constriction. ・Tell your Health Care Provider: - If you ever had any unusual or allergic reaction to any medicines. - Patients with heart/kidney/disease, black stools or cough up blood, interstitial pneumonia, bleeding tendency. ・Dosage Schedule: Your doctor decides the duration of treatment depending upon the severity. ・Administration: Usually, Liple is given by continuous intravenous drip infusion as an admixture with an infusion solution. ・Others: ・An injection may cause some unwanted effects. ◎Check with your doctor immediately if any of the following side effects occur: <Apnoeic seizures>Absence of breathing. <Shock, anaphylactoid reaction> Chills, nausea, abdominal pain, pale face, cold sweat, dizziness, palpitation, rash, itching, urticaria, choking feeling in the chest, respiratory distress. <Loss of consciousness> <Heart failure> Shortness of breath, fatigability, swelling of limbs, breathing difficulty in lie-down position, coughing at night, choking feeling in the chest. <Pulmonary oedema> Respiratory distress, easy breathing in upright position, chest pain, cough. <Interstitial pneumonia> Fever, cough, respiratory distress, chest pain, dullness. <Myocardial infarction> Choking feeling in the chest, chest pain, cold sweat. <Cerebral hemorrhage> Headache, nausea, vomiting, absent-mindedness, paralysis of the limbs on either or both sides. <Hemorrhage of digestive tract> Stomachache, nausea, blood vomitting, black stools. <Agranulocytosis, leucopenia> Sore throat, fever, stomatitis, dullness. Continued on next page Liple Injection 10μg (Ductus arteriosus dependent congenital heart disease) <Thrombocytopenia> Red spot or bruise appearing on limbs, bleeding tendency from the gums or nose. <Hepatic function disorder, jaundice> Loss of appetite, nausea, yellowing of the skin on the whites of the eyes, dullness. <Strangled feeling of chest, chest pain> Choking feeling in the chest, chest pain, choking feeling in the throat. <Dropped blood pressure> Dizziness on standing up, dizzness, weakness. <Increased blood pressure> Headache, dull headache, stiff shoulder, palpitation. <Asthma> Wheezing, respiratory distress. <Exacerbation of renal failure> Swelling, dullness, urine volume decreased. <Ocular fundus bleeding> Vision disorder, mosquito flying-like vision. <Subcutaneous haemorrhage> Bruise, bluish-purpling of the skin due to subcutaneous bleeding. <Haematuria> Blood in the urine. <Epistaxis> Bleeding from the nose. ◆Check with your doctor early if any of the following side effects occur: ◇Other side effects not listed above: <Diarrhea> <Abdomen enlarged feeling, abdominal discomfort> Bloated feeling of the stomach, abdominal discomfort. <Constipation> <Oral cavity swelling feeling> Swelling in the mouth. <Facial hot flushes> Feeling hot. <Redness> Red skin. <Tremor> Tremor of limbs. <Convulsions> <Feeling of warmth> Feeling hot or feverish. <Pain in extremities> Pain in limbs. <Feeling bad> Feeling unwell. <Alopecia> Depilation. <Cerebral infarction> Numbness of the limbs, unable to articulate property. ・If you notice any other unusual symptoms, check with your doctor. PRECAUTIONS AFTER INJECTION OTHERS INFORMATION GIVEN DATE INFORMATION PROVIDED BY For more detailed information about this injection, ask your health care provider. Drug Information Sheet ("Kusuri-no-Shiori") For Injectables Revised : 6/2005 Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries other than Japan. Brand Name:Liple Injection 10μg DESCRIPTION Nonproprietary (Generic) Name:Alprostadil THIS Classification:Improvement of contrast in superior mesenteric arterial portography Liple improves contrast in portography. INJECTION WORKS FOR BEFORE RECEIVING INJECTION ・Tell your Health Care Provider: - If you ever had any unusual or allergic reaction to any medicines. - Patients with heart/kidney/liver disease, black stools or cough up blood, glaucoma, high eye pressure, gastric ulcer or history of such disease, interstitial pneumonia, bleeding tendency. ・Dosage Schedule: Your doctor decides the duration of treatment depending upon the severity. ・Administration: Usually, Liple is injected into the superior mesenteric artery as an admixture with physiological saline before injection of a contrast medium. ・Others: If you are already pregnant, may possibly be pregnant, or are breast-feeding, tell your doctor before taking Liple. SIDE EFFECT(S) ・An injection may cause some unwanted effects. ◎Check with your doctor immediately if any of the following side effects occur: <Shock, anaphylactoid reaction> Chills, nausea, abdominal pain, pale face, cold sweat, dizziness, palpitation, rash, itching, urticaria, choking feeling in the chest, respiratory distress. <Loss of consciousness> <Heart failure> Shortness of breath, fatigability, swelling of limbs, breathing difficulty in lie-down position, coughing at night, choking feeling in the chest. <Pulmonary oedema> Respiratory distress, easy breathing in upright position, chest pain, cough. <Interstitial pneumonia> Fever, cough, respiratory distress, chest pain, dullness. <Myocardial infarction> Choking feeling in the chest, chest pain, cold sweat. <Cerebral hemorrhage> Headache, nausea, vomiting, absent-mindedness, paralysis of the limbs on either or both sides. <Hemorrhage of digestive tract> Stomachache, nausea, blood vomitting, black stools. <Agranulocytosis, leucopenia> Sore throat, fever, stomatitis, dullness. Continued on next page Liple Injection 10μg (Improvement of contrast in superior mesenteric arterial portography) <Thrombocytopenia> Red spot or bruise appearing on limbs, bleeding tendency from the gums or nose. <Hepatic function disorder, jaundice> Loss of appetite, nausea, yellowing of the skin on the whites of the eyes, dullness. <Strangled feeling of chest, chest pain> Choking feeling in the chest, chest pain, choking feeling in the throat. <Dropped blood pressure> Dizziness on standing up, dizzness, weakness. <Increased blood pressure> Headache, dull headache, stiff shoulder, palpitation. <Asthma> Wheezing, respiratory distress. <Exacerbation of renal failure> Swelling, dullness, urine volume decreased. <Ocular fundus bleeding> Vision disorder, mosquito flying-like vision. <Subcutaneous haemorrhage> Bruise, bluish-purpling of the skin due to subcutaneous bleeding. <Haematuria> Blood in the urine. <Epistaxis> Bleeding from the nose. ◆Check with your doctor early if any of the following side effects occur: ◇Other side effects not listed above: <Diarrhea> <Abdomen enlarged feeling, abdominal discomfort> Bloated feeling of the stomach, abdominal discomfort. <Constipation> <Oral cavity swelling feeling> Swelling in the mouth. <Facial hot flushes> Feeling hot. <Redness> Red skin. <Tremor> Tremor of limbs. <Convulsions> <Feeling of warmth> Feeling hot or feverish. <Pain in extremities> Pain in limbs. <Feeling bad> Feeling unwell. <Alopecia> Depilation. <Cerebral infarction> Numbness of the limbs, unable to articulate property. ・If you notice any other unusual symptoms, check with your doctor. PRECAUTIONS AFTER INJECTION OTHERS INFORMATION GIVEN DATE INFORMATION PROVIDED BY For more detailed information about this injection, ask your health care provider.