NIMODIPINE

Posology Intravenous infusion. Treatment begins with a continuous intravenous infusion of 1 mg/h of nimodipine (5 ml of Nimodipine/hour) during 2 hours (approximately 15 micrograms/kg body weight/h). If it is well tolerated and no severe decrease in blood pressure is observed, the dose should be increased after two hours to 2 mg/h of nimodipine (10 ml of Nimodipine/hour) (approximately 30 micrograms/kg body weight/h.

5 ml of Nimodipine/hour), or less if necessary. 4). 4). 4). Paediatric population The safety and efficacy of nimodipine in patients under 18 years have not been established. Method of administration This medicinal product is administered as a continuous intravenous infusion via a central catheter connected to an infusion pump using a three-way stopcock.

9%, Ringer’s lactate solution, lactated Ringer’s solution with magnesium or dextran 40, HAES® poly(O-2-hydroxyethyl) starch 6% in a ratio of about 1:4 (nimodipine: co-infusion). Also, mannitol or albumin or human blood are suitable for the simultaneous infusion.

2). The solution must be removed from the vial using a syringe. Then, place the needleless syringe in a syringe infusion pump and connect it with a three-way stop cock using a polyethylene tube. 2). Connect the three-way stopcock, the co-infusion tube and the central catheter.

Nimodipine may be used during anesthesia, surgical procedures and brain angiography. In patients in whom the administration of an additional volume of fluid is not recommended or may be contraindicated, the solution for infusion can be administered through a central catheter, without a co-infusion.

e. for 5-14 days after the subarachnoid hemorrhage. v. treatment with nimodipine will be continued in the postoperative period for at least 5 days. After finishing the infusion, it is recommended to continue with the oral administration of nimodipine, tablets 60 mg every 4 hours (6 x 60 mg of nimodipine daily) for approximately 7 days.

The adverse reactions based in clinical trials with nimodipine in the indication of subarachnoid hemorrhage of aneurysmal origin and sorted by CIOMS III categories of frequency (placebo-controlled studies: nimodipine N = 703; placebo N = 692; uncontrolled studies: nimodipine N = 2496; status: 31 Aug 2005) are listed below: System Organ Class (MedDRA) Uncommon (> 1/1,000 to <1/100) Rare (> 1/10,000 to <1/1,000) Not Known (cannot be estimated from available data) Blood and lymphatic system disorders Thrombocytopenia Immune system disorders Allergic reaction Rash Nervous system disorders Headache Cardiac disorders Tachycardia Bradycardia Respiratory, thoracic and mediastinal disorders Hypoxia Vascular disorders Hypotension Vasodilatation Gastrointestinal disorders Nausea Ileus Hepatobiliary disorders Transient increase in liver enzymes General disorders and administration site conditions Injection and infusion site reactions Infusion site (thrombo-) phlebitis Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Caution is required in patients with hypotension (systolic blood pressure lower than 100 mm Hg). Although treatment with nimodipine has not been shown to be associated with increases in intracranial pressure, it should be used with caution in cases of water content of brain tissue (generalised cerebral edema) or if severely raised intracranial pressure are present.

Nimodipine should not be used in patients with traumatic subarachnoid hemorrhage as a positive benefit to risk ratio has not been established and the specific patient groups that might benefit with the use of nimodipine cannot be identified for this indication.

Altered liver function may increase the bioavailability of nimodipine due to reduced metabolic clearance. g. lowering of blood pressure) may be more pronounced. 2). g. aminoglycosides, cephalosporins, furosemide), as well as in patients who already have impaired renal function.

5). 2). g. g. improvement of brain perfusion). Clinical and electrocardiographic monitoring should be performed if the product is prescribed for patients with advanced heart failure or intracardiac conduction problems. Excipients with known effect This medicine contains 24% v/v of ethanol (alcohol), which corresponds to an amount of 200 mg per ml.

5). Because this medication is given slowly through a continuous infusion, the effects of alcohol may be reduced. This medicinal product may be harmful for those suffering from alcoholism or impaired alcohol metabolism. The alcohol content should be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

5). The amount of alcohol in this medicinal product may alter the effects on the ability to drive and use machinery This medicinal product contains less than 23 mg (1 mmol) of sodium per dose; that is to say essentially ‘sodium-free.

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