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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Rivotril 0.5 mg and 2 mgTablets (2011)

Εκδότης

Εκδότης Roche Products Limited
Διεύθυνση Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

Rivotril 0.5mg Tablets. Rivotril 2mg Tablets.

Qualitative and quantitative composition

Rivotril 0.5mg Tablets: Each tablet contains 0.5mg clonazepam. Excipients: Also contains 40mg lactose ...

Pharmaceutical form

Tablets. Rivotril 0.5mg Tablets: Round, dull pinkish-buff tablets with ROCHE 0,5 imprinted on one face ...

Therapeutic indications

Tablets: All clinical forms of epileptic disease and seizures in infants, children and adults, especially ...

Posology and method of administration

The scored 0.5mg tablets facilitate the administration of lower daily doses in the initial stages of ...

Contraindications

Patients with known sensitivity to benzodiazepines; or any of the drugs excipients; acute pulmonary insufficiency; ...

Special warnings and precautions for use

Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in ...

Interaction with other medicinal products and other forms of interaction

Not recommended In combination with Rivotril, alcohol may modify the effects of the drug, compromise ...

Fertility, pregnancy and lactation

Preclinical studies in animals have shown reproductive toxicity (see section 5.3 Preclinical safety data). ...

Effects on ability to drive and use machines

As a general rule, epileptic patients are not allowed to drive. Even when adequately controlled on Rivotril, ...

Undesirable effects

The following have been observed: Immune System Disorders Allergic reactions and very few cases of anaphylaxis ...

Overdose

As with other benzodiazepine drugs, overdosage should not present undue problems of management or threat ...

Pharmacodynamic properties

Pharmacotherapeutic group: Benzodiazepine derivatives ATC code: N03AE01 Clonazepam exhibits pharmacological ...

Pharmacokinetic properties

Absorption Clonazepam is quickly and completely absorbed after oral administration of Rivotril. Peak ...

Preclinical safety data

Carcinogenicity Conventional studies of carcinogenic potential have not been conducted with clonazepam. ...

List of excipients

Rivotril 0.5mg tablets: Lactose (monohydrate) Maize starch Pregelatinised potato starch Talc Magnesium ...

Incompatibilities

Not applicable.

Shelf life

5 years.

Special precautions for storage

Store in the original container and in the outer carton, in order to protect from light.

Nature and contents of container

Rivotril 0.5mg Tablets: Amber glass bottles with polyethylene screw closures, containing 50, 100 or 150 ...

Special precautions for disposal and other handling

There are no special instructions. Any unused product or waste material should be disposed of in accordance ...

Marketing authorization holder

Roche Products Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom

Marketing authorization number(s)

Rivotril 0.5mg Tablets: PL 00031/0076R Rivotril 2mg Tablets: PL 00031/0077R

Date of first authorization / renewal of the authorization

26 July 1983 / 27 May 2005

Date of revision of the text

11 October 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.