Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Nimodipine
Bayer Limited
C08CA; C08CA06
Nimodipine
0.02 percent weight/volume
Concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Dihydropyridine derivatives; nimodipine
Marketed
1994-02-15
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 functi Прочетете целия документ
Health Products Regulatory Authority 21 November 2022 CRN00D8K3 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. After the end of the Прочетете целия документ