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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Tracleer (bosentan) 62.5mg film-coated tablets (2012)

Εκδότης

Εκδότης Actelion Pharmaceuticals UK Ltd
Διεύθυνση BSI Building 13th Floor, 389 Chiswick High Road, Chiswick, London, W4 4AL
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

Tracleer 62.5 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 62.5 mg bosentan (as monohydrate). For thefull list of excipients, see ...

Pharmaceutical form

Film-coated tablet (tablets): Orange-white, round, biconvex, film-coated tablets, embossed with “62,5” ...

Therapeutic indications

Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients ...

Posology and method of administration

Tablets are to be taken orally morning and evening, with or without food. The film-coated tablets are ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Moderate to ...

Special warnings and precautions for use

The efficacy of Tracleer has not been established in patients with severe pulmonary arterial hypertension. ...

Interaction with other medicinal products and other forms of interaction

Bosentan is an inducer of the cytochrome P450 (CYP) isoenzymes CYP2C9 and CYP3A4. In vitro data also ...

Pregnancy and lactation

Pregnancy Studies in animals have shown reproductive toxicity (teratogenicity, embryotoxicity, see section ...

Effects on ability to drive and use machines

No studies on the effect of Tracleer on the ability to drive and use machines have been performed. Tracleer ...

Undesirable effects

In 20 placebo-controlled studies, conducted in a variety of therapeutic indications, a total of 2,486 ...

Overdose

Bosentan has been administered as a single dose of up to 2400 mg to healthy subjects and up to 2000 mg/day ...

Pharmacodynamic properties

Pharmacotherapeutic group: other antihypertensives ATC code: C02KX01 Mechanism of action Bosentan is ...

Pharmacokinetic properties

The pharmacokinetics of bosentan have mainly been documented in healthy subjects. Limited data in patients ...

Preclinical safety data

A 2-year carcinogenicity study in mice showed an increased combined incidence of hepatocellular adenomas ...

List of excipients

Tablet core: Maize starch Pregelatinised starch Sodium starch glycollate Povidone Glycerol dibehenate ...

Incompatibilities

Not applicable.

Shelf life

4 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets. Cartons contain 14, 56 or 112 film-coated ...

Special precautions for disposal and other handling

No special requirements for disposal.

Marketing authorization holder

Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom ...

Marketing authorization number(s)

EU/1/02/220/001 EU/1/02/220/002 EU/1/02/220/003

Date of first authorization / renewal of the authorization

Date of first authorisation: 15 May 2002 Date of renewal: 15 May 2012

Date of revision of the text

April 2012
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.