Nchi: Malta
Lugha: Kiingereza
Chanzo: Medicines Authority
NIMODIPINE
Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland
C08CA06
NIMODIPINE 0.2 mg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION
NIMODIPINE 0.2 mg/ml
POM
CALCIUM CHANNEL BLOCKERS
Withdrawn
2006-12-21
BP22036_REC30610 1 Package leaflet: Information for the user Nimotop 0.02% w/v Concentrate for Solution for Infusion nimodipine Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. -If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Nimotop is and what it is used for 2. What you need to know before you are given Nimotop 3. How you are given Nimotop 4. Possible side effects 5. How to store Nimotop 6. Contents of the pack and other information 1. What Nimotop is and what it is used for Nimotop contains nimodipine, which belongs to a group of medicines called calcium antagonists . Nimotop is used to prevent changes in brain function after bleeding around the brain ( subarachnoid haemorrhage). 2. What you need to know before you are given Nimotop Do not take Nimotop You will not be given Nimotop: If you are allergic to nimodipine or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Nimotop Your doctor will take special care: While you are having a heart attack. If you have had a heart attack within the last month. If you suffer from angina and notice an increase in the frequency and severity of attacks. If you have fluid in the brain or severely raised pressure in your skull. Your doctor will be able to advise you about this. If you have low blood pressure. If you have liver disease. You will probably need to have your blood pressure measured regularly. If you have kidney problems and/or you have been given drugs which may alter kidney function (e.g. aminoglycosides, cephalosporins, furosemide). Your doctor may need to monitor your kidney function during treatme Soma hati kamili
BP22036_REC30610 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Nimotop 0.02% w/v Concentrate for Solution for Infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 50 ml vial contains 10 mg of nimodipine (0.2 mg/ml). Excipients with known effect: Each 50 ml vial also contains 10 g of ethanol (0.2 g/ml) and 23 mg of sodium (as sodium citrate dihydrate). Please see section 4.4 for further information. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). A clear, yellow solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Nimotop solution is indicated for the treatment of ischaemic neurological deficits following aneurysmal subarachnoid haemorrhage. 4.2 Posology and method of administration Posology Recommended dose - aneurysmal subarachnoid haemorrhage: For the first two hours of treatment, 1 mg of nimodipine, i.e. 5 ml Nimotop solution (about 15 micrograms/kg bw/h), should be infused each hour via a central catheter. If it is well tolerated, the dose should be increased after two hours to 2 mg nimodipine, i.e. 10 ml Nimotop solution per hour (about 30 micrograms/kg bw/h), providing no severe decrease in blood pressure is observed. Patients of body weight less than 70 kg or with unstable blood pressure should be started on a dose of 0.5 mg nimodipine per hour (2.5 ml of Nimotop solution, or less if necessary). Aneurysmal subarachnoid haemorrhage PROPHYLACTIC USE Intravenous therapy should be started no later than 4 days after the haemorrhage, and be continued during the period of maximum risk of vasospasm, i.e. up to 10-14 days after the haemorrhage. This should continue for at least five days up to a maximum of 10-14 days. If during prophylactic administration of Nimotop, the source of the haemorrhage is treated surgically, intravenous treatment with Nimotop should be continued post-operatively for at least 5 days. BP22036_REC30610 Page 2 of 8 After the end of the infusion therapy, it is Soma hati kamili