NIMOTOP Film-coated tablet (2017)
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Περιεχόμενα
Name of the medicinal product
Nimotop 30mg Tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 30 mg nimodipine. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. Yellow, round biconvex tablets with SK marked on one side and the Bayer cross marked on the other side.
Therapeutic indications
Nimodipine is indicated for the prevention of ischaemic neurological deficits following aneurysmal subarachnoid haemorrhage.
Posology and method of administration
Posology Aneurysmal subarachnoid haemorrhage Prophylactic administration Adults The recommended dose is two tablets at 4-hourly intervals (total daily dose 360 mg) to be taken with water. Prophylactic ...
Contraindications
Nimodipine must not be administered in case of hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Nimodipine should not be administered to patients during or within ...
Special warnings and precautions for use
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 ...
Interaction with other medicinal products and other forms of interaction
Nimotop tablets should not be administered concomitantly with Nimotop solution. Drugs that affect nimodipine Nimodipine is metabolised via the cytochrome P450 3A4 system, located both in the intestinal ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate and well controlled studies in pregnant women. Reproductive toxicology studies in animals using oral administration showed no teratogenic effect, although studies in animals ...
Effects on ability to drive and use machines
In theory, the possibility of the occurrence of the side-effect dizziness may impair the patients ability to drive or operate machinery.
Undesirable effects
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 ...
Overdose
Symptoms of intoxication Symptoms of acute overdosage to be anticipated are marked lowering of the blood pressure, tachycardia, bradycardia and (after oral administration) gastro-intestinal complaints ...
Pharmacodynamic properties
Pharmacotherapeutic group: selective calcium channel blockers with mainly vascular effect, dihydropyridine derivatives ATC Code: C08CA06 Nimodipine is a dihydropyridine calcium channel blocker with particular ...
Pharmacokinetic properties
The intravenous Nimotop solution is 100 % available to the tissues as the peripheral venous blood takes the drug to the lungs and heart and from there to all organs. Absorption After oral ingestion, absorption ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction. ...
List of excipients
Microcrystalline cellulose Maize starch Povidone Crospovidone Magnesium stearate Hypromellose Macrogol 4000 Titanium dioxide E171 Iron oxide yellow E172
Incompatibilities
None known.
Shelf life
5 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
PP/aluminium blister packs contained in cardboard outer, containing 100 30mg tablets.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Marketing authorization number(s)
PL 00010/0137
Date of first authorization / renewal of the authorization
23 February 1989/23 November 2003
Date of revision of the text
31 August 2017
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