Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
NIMODIPINE
Bayer PLC
C08CA06
NIMODIPINE
SOLUTION FOR INFUSION OR INJECTION
NIMODIPINE 0.02 % (W/V)
POM
CALCIUM CHANNEL BLOCKERS
Authorised
2006-12-21
PMR 85991671 (AB/01-C/MU-201710621) Pantone: Black, 021 85991671 PACKAGE LEAFLET: INFORMATION FOR THE USER 0 NIMOTOP ® 0.02% 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 or pharmacist. This medicine has been prescribed for you only. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1 WHAT NIMOTOP SOLUTION IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NIMOTOP SOLUTION 3 HOW YOU ARE GIVEN NIMOTOP SOLUTION 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE NIMOTOP SOLUTION 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT NIMOTOP SOLUTION IS AND WHAT IT IS USED FOR Nimotop solution contains nimodipine, which belongs to a group of medicines called_ calcium antagonists_. NIMOTOP SOLUTION 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 SOLUTION DO NOT TAKE NIMOTOP SOLUTION YOU SHOULD NOT BE GIVEN NIMOTOP SOLUTION: • 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 ARE ALLERGIC TO NIMODIPINE or any of the ingredients of this medicine (listed in section 6). TELL YOUR DOCTOR AND DO NOT TAKE NIMOTOP SOLUTION if any of these apply to you. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before receiving Nimotop solution • IF YOU HAD A HEAD INJURY which caused bleeding around the brain_ (traumatic subarachnoid haemorrhage)_. • 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 Διαβάστε το πλήρες έγγραφο
1.3.1 1 016_0 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Nimotop 0.02% Solution for Infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION A sterile solution containing 10 mg nimodipine in 50 ml vials of aqueous alcoholic solvent (0.02%). Excipients with known effect Ethanol and sodium citrate For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Clear yellow sterile solution for intravenous use. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nimodipine 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 g/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 g/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. Duration of treatment _Aneurysmal subarachnoid haemorrhage_ _ _ Intravenous treatment should begin as early as possible after neurological deficit occurs due to arterial spasm, post subarachnoid haemorrhage. This should continue for at least five days up to a maximum of 14 days. In the event of surgical intervention during treatment, administration of nimodipine should be continued (dose as above) for at least five days. Nimotop solution may be used with or without pre-treatment with Nimotop tablets. In the event of Nimotop tablets and Nimotop solution being administered sequentially the total duration of treatment should not exceed 21 days. Nimotop solution should not be administered for longer than 14 days. Nimotop solution and tablets should Διαβάστε το πλήρες έγγραφο