NIMOTOP

e. 5 ml Nimotop solution, (about 15 μg/kg bw/h), should be infused each hour via a central catheter. e. 10 ml Nimotop solution per hour (about 30 μg/kg bw/h), providing no severe decrease in blood pressure is observed. 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 not be used concomitantly. 4). Paediatric Population The safety and efficacy of Nimotop in patients under 18 years of age have not been established.

V. infusion via a central catheter using an infusion pump. It should be connected to a three-way stopcock using the infusion line provided. The three-way stopcock should be used to connect the Nimotop polyethylene tube with the co-infusion line and the central catheter.

9%, glucose 5%, Ringer’s lactate solution, lactated Ringer’s solution with magnesium, dextran 40, HAES® (poly[O-2- hydroxyethyl]) starch 6%, human albumin 5%, blood or mannitol 10% in a ratio of about 1:4 (Nimotop:co-infusion), which is connected to the second port of the three- way stopcock prior to its connection with the central line catheter.

Nimotop solution must not be added to an infusion bag or bottle and must not be mixed with other drugs. Nimotop solution may be used during anaesthesia, angiography or surgical procedures.

The frequencies of ADRs reported with nimodipine summarized in the tables below are based on clinical trials with nimodipine in the indication aSAH 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).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Frequencies are defined as:

Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to ≤ 1/100), Rare (≥ 1/10,000 to ≤ 1/1,000), Very rare (≤ 1/10,000) Not known (cannot be estimated from the available data). System Organ Class (MedDRA) Uncommon Rare Not known Blood and the lymphatic system disorders Thrombocytopenia Immune system disorders Allergic reaction Rash Nervous system disorders Headache Cardiac disorders Tachycardia Bradycardia Vascular disorders Hypotension Vasodilatation Gastrointestinal disorders Nausea Ileus Hepato-biliary disorders Transient increase in liver enzymes General disorders and administration site conditions Respiratory, thoracic and mediastinal disorders Injection and infusion site reactions Infusion site (thrombo-) phlebitis Hypoxia 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.

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

Nimotop solution should be used with care when cerebral oedema or severely raised intracranial pressure are present. Although treatment with Nimotop has not been shown to be associated with increases in intracranial pressure, close monitoring is recommended in these cases or when the water content of the brain tissue is elevated (generalised cerebral oedema).

Nimotop solution must be used with caution in hypotensive patients (systolic blood pressure lower than 100 mm Hg). Decreased drug clearance may occur in cirrhotic patients receiving Nimotop and, therefore, close monitoring of blood pressure is recommended in these patients.

75 %, respectively, of the WHO recommended maximum daily intake of 2 g sodium for an adult. To be taken into consideration by patients on a controlled sodium diet. 5). Nimodipine is metabolised via the cytochrome P450 3A4 system. g. g. g.

5). Upon co-administration with these drugs, the blood pressure should be monitored and, if necessary, a reduction in the nimodipine dose should be considered. e. up to 50 g per daily dose (250 ml). This may be harmful for those suffering from alcoholism or impaired alcohol metabolism and 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). A dose of 10 ml of this medicine administered per hour to an adult weighing 70 kg would result in exposure to 28 mg/kg/h of ethanol which may cause a rise in blood alcohol concentration (BAC) of about 4 mg/100 ml. For comparison, for an adult drinking a glass of wine or 500 ml of beer, the BAC is likely to be about 50 mg/100 ml.

1. Nimodipine should not be administered to patients during or within one month of a myocardial infarction or an episode of unstable angina.