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Βιβλιογραφική αναφορά

Προτάσεις

SPC, Ireland: Lexotan Tablets (2014)

Εκδότης

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

Lexotan 1.5 mg Tablets. Lexotan 3 mg Tablets.

Qualitative and quantitative composition

Lexotan 1.5 mg Tablets: Each tablet contains 1.5 mg bromazepam. Excipients: Also contains 96.1 mg lactose ...

Pharmaceutical form

Lexotan 1.5 mg Tablets: Tablet: Off-white to slightly yellow, cylindrical, biplane tablets scored on ...

Therapeutic indications

Anxiety. Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the ...

Posology and method of administration

Anxiety Treatment should be as short as possible. The overall duration of treatment generally should ...

Contraindications

Bromazepam must not be administered to patients with known hypersensitivity to the active substance or ...

Special warnings and precautions for use

Amnesia Benzodiazepines may induce anterograde amnesia. The condition occurs most often several hours ...

Interaction with other medicinal products and other forms of interaction

Pharmacodynamic Interaction Benzodiazepines produce an additive effect when co-administered with alcohol ...

Fertility, pregnancy and lactation

Pregnancy Although no specific clinical data are available for bromazepam, a large amount of data based ...

Effects on ability to drive and use machines

Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the ability ...

Undesirable effects

Lexotan is well tolerated in therapeutic doses. : The following undesirable effects have been reported ...

Overdose

Symptoms Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of bromazepam ...

Pharmacodynamic properties

Pharmacotheapeutic group: Anxiolytic ATC code: N05BA08 Bromazepam is a pyridylbenzodiazepine compound ...

Pharmacokinetic properties

Absorption Lexotan is rapidly absorbed from the gastro-intestinal tract. Peak plasma concentrations are ...

Preclinical safety data

Carcinogenicity Carcinogenicity studies conducted in rats did not reveal any evidence of a carcinogenic ...

List of excipients

Lexotan 1.5 mg Tablets: Microcrystalline cellulose Lactose monohydrate Magnesium stearate Talc Lexotan ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: PVDC blister packs: 5 year shelf life. HDPE bottles: 5 year shelf life. PVC blister packs: ...

Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from light and moisture. ...

Nature and contents of container

PVDC blister packs of 4, 10, 20, 60 or 100 tablets. HDPE bottles of 100 tablets. PVC blister packs of ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

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

Marketing authorization number(s)

Lexotan 1.5 mg Tablets: PA 50/49/1 Lexotan 3 mg Tablets: PA 50/49/2

Date of first authorization / renewal of the authorization

Date of first authorisation: 31 October 1980 Date of last renewal: 31 October 2010

Date of revision of the text

22 July 2014
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.