Drug Information Sheet ("Kusuri-no-Shiori") For Injectables Newly-created : 01/2011 Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries other than Japan. Brand Name:Pazucross Injection 500mg DESCRIPTION Nonproprietary (Generic) Name:Pazufloxacin mesilate THIS INJECTION WORKS FOR Classification: Pazucross is for the treatment of bacterial infections. The pazufloxacin mesilate contained in Pazucross is one of a group of antibacterial agents called new quinolones which work by killing bacteria that cause infections. ・Tell your Health Care Provider: - If you ever had any unusual or allergic reaction to any medicines. - If you are or your parents or siblings are liable to have allergic reactions, such as asthma, rash, urticaria. - Patients with kidney/heart disease, myasthenia gravis. BEFORE RECEIVING INJECTION - If you have previously had fits or suffer from epilepsy. ・Dosage Schedule: Your doctor decides the duration of treatment depending upon the severity. It is within 14days in principle. ・Administration: Usually, Pazucross is given by intravenous drip infusion over a period of 30‐60 minutes twice a day. ・Others: If you are already pregnant, may possibly be pregnant, or are breast-feeding, tell your doctor before taking Pazucross. SIDE EFFECT(S) ・An injection may cause some unwanted effects. ◎Check with your doctor immediately if any of the following side effects occur: <Acute renal failure > Urine volume decreased, swelling, headache, loss of appetite, thirst. <Hepatic function disorder, jaundice> Loss of appetite, nausea, yellowing of the skin on the whites of the eyes, dullness. <Pseudomembranous colitis > Watery diarrhoea, frequent diarrhoea containing blood and mucus, fever, abdominal pain, nausea, vomiting, loss of appetite. <Agranulocytosis, decreased platelet count> Sore throat, fever, stomatitis, blue spots indelible even at a push on the skin, red spots or bruises on limbs, bleeding tendency from the gums or nose. <Rhabdomyolysis> Numbness of the limbs, weakness, sore muscles, stiffness, dullness, urine like red wine. Continued on next page Pazucross Injection 500mg <Psychological symptoms such as confusion and hallucination> Disturbed/confused, disoriented, to see or hear something that is not really there. <Convulsions> <Shock, anaphylactoid reaction (dyspnoea, oedema, redness, etc.)> Chills, nausea, abdominal pain, pale face, cold sweat, dizziness, palpitation, rash, itching, urticaria, choking feeling in the chest, respiratory distress, swelling, redness. <Toxic epidermal necrolysis, oculomucocutaneous syndrome> Fever, red skin, rash, blisters, soreness in mucous membrane of mouth, nose, conjunctiva, blisters are easily broken, severe skin reactions such as burn, blurred vision. <Interstitial pneumonia> Fever, cough, respiratory distress, chest pain, dullness. <Hypoglycaemia> Sweating, trembling, dizziness, chills, palpitation, craving for food, weakness. <Tendon disorders such as achilless tendonitis and tendon rupture> Pain or swelling seen in the Achilles tendon area, difficulty of going up and down the strains, rupture of Achilles tendon. <Injection site reactions> Pain, rash, swelling, induration of injection site. ◆Check with your doctor early if any of the following side effects occur: ◇Other side effects not listed above: <Anaemia> Fatigability, whiting of the back of your eyelids or your face. <Diarrhoea> <Abdominal distension> <Hypoaesthesia> Derangement of sensory. <Abnormal feeling> Feeling ill, strange feeling, floating feeling. <Dry mouth> <Glossitis> Rough tongue, tongue stinging. ・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.