देश: न्यूज़ीलैंड
भाषा: अंग्रेज़ी
स्रोत: Medsafe (Medicines Safety Authority)
Nimodipine 0.2 mg/mL
Bayer New Zealand Limited
Nimodipine 0.2 mg/mL
0.2 mg/mL
Solution for infusion
Active: Nimodipine 0.2 mg/mL Excipient: Citric acid Ethanol Macrogol 400 Sodium citrate dihydrate Water for injection
Vial, glass, 50 mL
Prescription
Prescription
Bayer AG
Prophylaxis and treatment of ischaemic neurological deficits caused by cerebral vasospasm following subarachnoid haemorrhage of aneurysmal origin. Patients should be in good neurological condition post-ictus.
Package - Contents - Shelf Life: Vial, glass, with a polyethylene infusion line (perfusion tube) - 50 mL - 36 months from date of manufacture stored at or below 25°C
1991-09-30
NIMOTOP® 1 NIMOTOP ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING NIMOTOP? NIMOTOP contains the active ingredient nimodipine. NIMOTOP is used to prevent or to treat a lack of blood supply in the brain caused by narrowing of the blood vessels after a haemorrhage (burst blood vessel in the brain). For more information, see Section 1. Why am I using NIMOTOP? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE NIMOTOP? Do not use if you have ever had an allergic reaction to nimodipine or any of the ingredients listed at the end of the CMI. NIMOTOP infusion solution contains alcohol. Tell your doctor if you suffer from alcoholism or impaired alcohol metabolism. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use NIMOTOP? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with NIMOTOP and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE NIMOTOP? • Your doctor will decide the appropriate dose for you. Follow all instructions given to you by your doctor and pharmacist. • A doctor or nurse will prepare and administer the infusion. More instructions can be found in Section 4. How do I use NIMOTOP? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING NIMOTOP? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using NIMOTOP. • Keep all of your doctor’s appointments so that your progress can be checked. • Tell your doctor straightaway if you become pregnant while taking this medicine. THINGS YOU SHOULD NOT DO • Do not stop taking your medicine or lower the dosage without checking with your doctor. DRIVING OR USING MACHINES • NIMOTOP may cause diz पूरा दस्तावेज़ पढ़ें
NIMOTOP DS XV3.2; CCDS 5 1 DATA SHEET 1. NIMOTOP ® Nimotop 10 mg/ 50 mL concentrated intravenous infusion solution Nimotop 30 mg tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION NIMOTOP CONCENTRATED INTRAVENOUS INFUSION SOLUTION Each bottle of 50 mL Nimotop concentrated intravenous infusion solution contains 10mg nimodipine in 50 mL alcoholic solvent. NIMOTOP TABLETS Each Nimotop tablet contains 30mg nimodipine. For a full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM NIMOTOP CONCENTRATED INTRAVENOUS INFUSION SOLUTION Clear intravenous solution for infusion. NIMOTOP TABLETS Round, convex, yellow film coated tablets marked with “SK” on top and the Bayer cross on the bottom. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NIMOTOP CONCENTRATED INTRAVENOUS INFUSION SOLUTION Prophylaxis and treatment of ischaemic neurological deficits caused by cerebral vasospasm following subarachnoid haemorrhage of aneurysmal origin. Patients should be in good neurological condition post-ictus. NIMOTOP TABLETS After a preceding infusion of Nimotop concentrated intravenous infusion solution, for:- Prophylaxis and treatment of ischaemic neurological deficits caused by cerebral vasospasm following subarachnoid haemorrhage of aneurysmal origin. Patients should be in good neurological condition post-ictus. NIMOTOP DS XV3.2; CCDS 5 2 4.2 DOSE AND METHOD OF ADMINISTRATION Dose Unless otherwise prescribed, the following dose is recommended: NIMOTOP CONCENTRATED INTRAVENOUS INFUSION SOLUTION _ _ _Intravenous infusion _ At the beginning of treatment 1mg/hr nimodipine (= 5 mL Nimotop concentrated intravenous infusion solution/h) for 2 hours (about 15µg/kg body weight/h). If this is well tolerated, and particularly if there is no marked reduction in blood pressure, the dose is increased after 2 hours to 2mg/hr nimodipine (= 10 mL Nimotop concentrated intravenous infusion solution/h) (about 30µg/kg body weight/h). Patients whose body weight is appreciably below 70kg or who have labile blood pressure should be started w पूरा दस्तावेज़ पढ़ें