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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Clomethiazole 192 mg Capsules (2011)

Εκδότης

Εκδότης Intrapharm Laboratories Ltd
Διεύθυνση The Granary, The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berkshire, SL6 6PT
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Περιεχόμενα

Name of the medicinal product

Heminevrin 192 mg Capsules. Clomethiazole 192 mg Capsules.

Qualitative and quantitative composition

Clomethiazole 192 mg (base) per capsule. 10 mg Sorbitol (E420) per capsule. For a full list of excipients, ...

Pharmaceutical form

Soft Capsules. Greyish-brown, soft gelatin capsules.

Therapeutic indications

Clomethiazole is a short acting hypnotic and sedative with anticonvulsant effect. It is used for the: ...

Posology and method of administration

For oral use. The capsules should be swallowed whole. Management of restlessness and agitation in the ...

Contraindications

Known sensitivity to clomethiazole. Acute pulmonary insufficiency.

Special warnings and precautions for use

Clomethiazole should be used cautiously in patients with sleep apnoea syndrome and chronic pulmonary ...

Interaction with other medicinal products and other forms of interaction

A combination of clomethiazole and diazoxide should be avoided as an adverse neonatal reaction suspected ...

Pregnancy and lactation

Do not use in pregnancy especially during the first and last trimesters, unless there are compelling ...

Effects on ability to drive and use machines

As with all centrally acting depressant drugs, the driving of vehicles and the operating of machinery ...

Undesirable effects

The most common side-effect is nasal congestion and irritation, which may occur 15 to 20 minutes after ...

Overdose

The main effects to be expected with overdose of clomethiazole are: coma, respiratory depression, hypotension ...

Pharmacodynamic properties

Clomethiazole is pharmacologically distinct from both the benzodiazepines and the barbiturates. Clomethiazole ...

Pharmacokinetic properties

Clomethiazole has a short half-life, low oral bioavailability, high plasma clearance and shows no evidence ...

Preclinical safety data

Extensive clinical use and experience with clomethiazole has provided a well established safety profile ...

List of excipients

Medium-chain triglycerides Gelatin Glycerol (85%) Sorbitol (E420) Mannitol Oligosaccharides Titanium ...

Incompatibilities

Not applicable.

Shelf life

Amber glass bottles: 24 months. Aluminium foil blister packs: 24 months.

Special precautions for storage

Do not store above 25°C. Store in the original container.

Nature and contents of container

Amber glass bottle with either a screw cap or clic-loc cap containing 60 or 100 capsules. Transparent ...

Special precautions for disposal and other handling

The capsules should remain in the container in which they are supplied. The capsules should be swallowed ...

Marketing authorization holder

CHEPLAPHARM Arzneimettel GmbH Bahnhofstrasse 1A D-17498 Mesekenhagen Germany

Marketing authorization number(s)

PL 27041/0001

Date of first authorization / renewal of the authorization

18th March 2002 / 7th March 2003

Date of revision of the text

28 March 2011
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.