ARIMIDEX Film-coated tablets (2017)
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Περιεχόμενα
Name of the medicinal product
Arimidex 1 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 1 mg anastrozole. Excipients with known effect: Each film-coated tablet contains 93 mg of lactose monohydrate (see section 4.4). For the full list of excipients, see section ...
Pharmaceutical form
Film-coated tablet. White, round, biconvex film-coated tablets of about 6.1 mm marked with A on one side and Adx1 on the other side.
Therapeutic indications
Arimidex is indicated for the: Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women. Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal ...
Posology and method of administration
Posology The recommended dose of Arimidex for adults including the elderly is one 1 mg tablet once a day. For postmenopausal women with hormone receptor-positive early invasive breast cancer, the recommended ...
Contraindications
Arimidex is contraindicated in: Pregnant or breastfeeding women. Patients with known hypersensitivity to anastrozole or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
General Arimidex should not be used in premenopausal women. The menopause should be defined biochemically (luteinizing-hormone [LH], follicle stimulating hormone [FSH], and/or estradiol levels) in any ...
Interaction with other medicinal products and other forms of interaction
Anastrozole inhibits CYPs 1A2, 2C8/9 and 3A4 in vitro. Clinical studies with antipyrine and warfarin showed that anastrozole at a 1 mg dose did not significantly inhibit the metabolism of antipyrine and ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of Arimidex in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Arimidex is contraindicated during pregnancy (see section ...
Effects on ability to drive and use machines
Arimidex has no or negligible influence on the ability to drive and use machines. However, asthenia and somnolence have been reported with the use of Arimidex and caution should be observed when driving ...
Undesirable effects
The following table presents adverse reactions from clinical trials, post-marketing studies or spontaneous reports. Unless specified, the frequency categories were calculated from the number of adverse ...
Overdose
There is limited clinical experience of accidental overdose. In animal studies, anastrozole demonstrated low acute toxicity. Clinical trials have been conducted with various dosages of Arimidex, up to ...
Pharmacodynamic properties
Pharmacotherapeutic group: Enzyme inhibitors ATC code: L02BG03 Mechanism of action and pharmacodynamic effects Arimidex is a potent and highly selective non-steroidal aromatase inhibitor. In postmenopausal ...
Pharmacokinetic properties
Absorption Absorption of anastrozole is rapid and maximum plasma concentrations typically occur within two hours of dosing (under fasted conditions). Food slightly decreases the rate but not the extent ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction for the ...
List of excipients
Lactose monohydrate Povidone Sodium starch glycollate Magnesium stearate Hypromellose Macrogol 300 Titanium dioxide
Incompatibilities
Not applicable.
Shelf life
Shelf life: 5 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
PVC blister/aluminium foil packs of 20, 28, 30, 84, 98, 100 and 300 tablets contained in a carton. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK
Marketing authorization number(s)
PL 17901/0002
Date of first authorization / renewal of the authorization
Date of first authorisation: 18 June 2000 Date of latest renewal: 14 December 2013
Date of revision of the text
22<sup>nd</sup> December 2017
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