দেশ: মাল্যাশিয়া
ভাষা: ইংরেজি
সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NIMODIPINE
BAYER CO. (MALAYSIA) SDN. BHD.
NIMODIPINE
50ml mL
BAYER AG
Reference: Nimotop / solution for infusion / CCDS / Version 05 / Rebranding and Rena ming Nimotop® (aSAH) 1. NAME OF THE MEDICINAL PRODUCT Nimotop solution for infusion 10 mg (50 mL) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 bottle of Nimotop solution for infusion 10 mg (50 mL) contains 10 mg nimodipine in 50 mL alcoholic solvent. 3. PHARMACEUTICAL FORM Clear slightly yellowish solution 4. CLINICAL PARTICULARS 4.1 Indication(s) Prophylaxis and treatment of ischemic neurological deficits caused by cerebral vasospasms following subarachnoid hemorrhage of aneurysmal origin. 4.2 Dosa ge and m ethod of administration 4.2.1 Method of administration Nimotop solution for infusion is administered as a continuous i.v. infusion via a central catheter using an infusion pump. It should be given via a three -way stopcock together with either gluco se 5%, sodium chloride 0.9%, lactated Ringer's solution, lactated Ringer's solution with magnesium, dextran 40 solution or HAES® (poly(O -2- hydroxyethyl) starch 6% in a ratio of about 1:4 (nimodipine: co -infusion). Also ma nnitol, human albumin or blood are suitable for co -infusion. The three -way stopcock should be used to connect the nimodipine polyethylene tube with the co infusion line and the central catheter. Nimotop solution for infusion must not be added to an infusion bag or bottle and must not be m ixed with other drugs. Administration of Nimotop solution for infusion should be continued during anesthesia, surgery and angiography. 4.2.2 Dosage regimen Intravenous infusion: At the beginning of treatment 1 mg/h nimodipine (= 5 mL Nimotop solution for infusion /h) for 2 h (about 15 µg/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 h to 2 mg/h nimodipine (= 10 mL Nimotop solution for infusion /h) (about 30 µg/kg body weight/h). সম্পূর্ণ নথি পড়ুন