Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Μητρότητα και φάρμακα Ενημερωθείτε για την ασφάλεια χορήγησης ενός φαρμάκου κατά τη διάρκεια της εγκυμοσύνης ή του θηλασμού
Συνδρομές Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του Galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του Galinos.gr από το 2011 μέχρι σήμερα

FARESTON Tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Περιεχόμενα

Name of the medicinal product

Fareston 60 mg tablets.

Qualitative and quantitative composition

Each tablet contains 60 mg toremifene (as citrate). Excipient with known effect: One tablet contains 28.5 mg of lactose. For the full list of excipients, see section 6.1.

Pharmaceutical form

Tablet. White, round, flat, bevelled edge tablet with TO 60 on one side.

Therapeutic indications

First line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients. Fareston is not recommended for patients with estrogen receptor negative tumours.

Posology and method of administration

Posology The recommended dose is 60 mg daily. Renal impairment No dose adjustment is needed in patients with renal insufficiency. Hepatic impairment Toremifene should be used cautiously in patients with ...

Contraindications

Pre-existing endometrial hyperplasia and severe hepatic failure are contra-indications in longterm use of toremifene. Hypersensitivity to the active substance or to any of the excipients listed in section ...

Special warnings and precautions for use

Gynaecological examination should be performed before treatment administration, closely looking at pre-existing endometrial abnormality. Afterwards gynaecological examination should be repeated at least ...

Interaction with other medicinal products and other forms of interaction

An additive effect on QT interval prolongation between Fareston and the following drugs and other medicinal products that may prolong the QTc interval cannot be excluded. This might lead to an increased ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of Fareston in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Fareston ...

Effects on ability to drive and use machines

Toremifene has no influence on the ability to drive and use machines.

Undesirable effects

The most frequent adverse reactions are hot flushes, sweating, uterine bleeding, leukorrhea, fatigue, nausea, rash, itching, dizziness and depression. The reactions are usually mild and mostly due to the ...

Overdose

Vertigo, headache and dizziness were observed in healthy volunteer studies at daily dose of 680 mg. The dose-related QTc interval prolongation potential of Fareston should also be taken into account in ...

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-estrogens ATC code: L02BA02 Toremifene is a nonsteroidal triphenylethylene derivative. As other members of this class, e.g. tamoxifen and clomifene, toremifene binds to ...

Pharmacokinetic properties

Absorption Toremifene is readily absorbed after oral administration. Peak concentrations in serum are obtained within 3 (range 2-5) hours. Food intake has no effect on the extent of absorption but may ...

Preclinical safety data

The acute toxicity of toremifene is low with LD-50 in rats and mice of more than 2000 mg/kg. In repeated toxicity studies the cause of death in rats is gastric dilatation. In the acute and chronic toxicity ...

List of excipients

Maize starch Lactose monohydrate Povidone Sodium starch glycolate Magnesium stearate Cellulose, microcrystalline Silica, colloidal anhydrous

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Green PVC foil and aluminium foil blister in a cardboard box. Package sizes: 30 and 100 tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Orion Corporation, Orionintie 1, FI-02200, Espoo, Finland

Marketing authorization number(s)

EU/1/96/004/001 EU/1/96/004/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 14 February 1996 Date of latest renewal: 2 February 2006

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

Μπορείτε να υποστηρίξετε τον Γαληνό στην αποστολή του να παρέχει δωρεάν έγκυρη πληροφόρηση για κάθε φάρμακο απενεργοποιώντας το Ad Blocker για αυτόν τον ιστότοπο.