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NIMOTOP 0.02% Solution for infusion (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Nimotop 0.02% Solution for Infusion.

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 ...

Pharmaceutical form

Clear yellow sterile solution for intravenous use.

Therapeutic indications

Nimodipine is indicated for the treatment of ischaemic neurological deficits following aneurysmal subarachnoid haemorrhage.

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 μg/kg bw/h), should be infused each hour via ...

Contraindications

Nimodipine solution for infusion must not be used in cases of hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Nimodipine should not be administered to patients ...

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 Concurrent twice daily administration of 30mg nimodipine and daily administration of 20mg of ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate and well controlled studies in pregnant women. No reproductive toxicology studies following parenteral administration are available. Reproductive toxicology 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. However, this is unlikely to be of clinical relevance in patients ...

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

Nimodipine 0.02% solution contains the following excipients: Ethanol 96% Macrogol 400 Sodium citrate Citric acid Water for Injections Ph. Eur.

Incompatibilities

Nimotop solution reacts with polyvinylchloride (PVC) and should not be allowed to come in contact with PVC. Nimotop solution must not be added to an infusion bag or bottle and must not be mixed with other ...

Shelf life

Shelf life of the product as packaged for sale:   Shelf life Pack size Primary packaging material A B (ml) Brown glass type II infusion vials 4 years N/A 50 A = Unopened B = After reconstitution ...

Special precautions for storage

Nimotop solution is light sensitive and therefore should be stored in the manufacturers light-protective container within the cardboard carton at a temperature not above 25°C.

Nature and contents of container

Brown glass type II infusion vials containing 50 ml of solution; with grey chlorobutyl stopper laminated with fluoropolymer. 150 cm of colorless transparent polyethylene tubing with conus connector for ...

Special precautions for disposal and other handling

The only plastic materials suitable for use are polyethylene or polypropylene. Nimotop solution is compatible with glass infusion bottles and infusion packs made of polyethylene (e.g. Polyfusor, Boots). ...

Marketing authorization holder

Bayer plc, 400 South Oak Way, Reading, RG2 6AD

Marketing authorization number(s)

PL 00010/0138

Date of first authorization / renewal of the authorization

21 January 1988/23 November 2003

Date of revision of the text

31 August 2017

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