FARESTON Tablet (2019)
Βιβλιογραφική αναφορά
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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
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