AROMASIN Coated tablets (2018)
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Περιεχόμενα
Name of the medicinal product
Aromasin 25 mg coated tablets.
Qualitative and quantitative composition
Active substance: exemestane. Each coated tablet contains 25 mg exemestane. Excipients with known effect: Each tablet contains 30.2 mg of sucrose and 0.003 mg of methyl parahydroxybenzoate (E218). For ...
Pharmaceutical form
Coated tablet. Round, biconvex, off-white coated tablet marked 7663 on one side.
Therapeutic indications
Aromasin is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer (EBC), following 2–3 years of initial adjuvant tamoxifen therapy. ...
Posology and method of administration
Posology Adult and elderly patients The recommended dose of Aromasin is one 25 mg tablet to be taken once daily, preferably after a meal. In patients with early breast cancer, treatment with Aromasin should ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. In pre-menopausal women and in pregnant or lactating women.
Special warnings and precautions for use
Aromasin should not be administered to women with pre-menopausal endocrine status. Therefore, whenever clinically appropriate, the post-menopausal status should be ascertained by assessment of LH, FSH ...
Interaction with other medicinal products and other forms of interaction
In vitro evidence showed that the drug is metabolised through cytochrome P450 CYP3A4 and aldoketoreductases (see section 5.2) and does not inhibit any of the major CYP isoenzymes. In a clinical pharmacokinetic ...
Fertility, pregnancy and lactation
Pregnancy No clinical data on exposed pregnancies are available with Aromasin. Studies on animals have shown reproductive toxicity (see section 5.3). Aromasin is therefore contraindicated in pregnant women. ...
Effects on ability to drive and use machines
Exemestane has moderate influence on the ability to drive and use machines. Drowsiness, somnolence, asthenia and dizziness have been reported with the use of exemestane. Patients should be advised that, ...
Undesirable effects
Aromasin was generally well tolerated across all clinical studies conducted with Aromasin at a standard dose of 25 mg/day, and undesirable effects were usually mild to moderate. The withdrawal rate due ...
Overdose
Clinical trials have been conducted with Aromasin given up to 800 mg in a single dose to healthy female volunteers and up to 600 mg daily to postmenopausal women with advanced breast cancer; these dosages ...
Pharmacodynamic properties
Pharmacotherapeutic group: steroidal aromatase inhibitor; anti-neoplastic agent ATC: L02BG06 Mechanism of action Exemestane is an irreversible, steroidal aromatase inhibitor, structurally related to the ...
Pharmacokinetic properties
Absorption After oral administration of Aromasin tablets, exemestane is absorbed rapidly. The fraction of the dose absorbed from the gastrointestinal tract is high. The absolute bioavailability in humans ...
Preclinical safety data
Toxicological studies Findings in the repeat dose toxicology studies in rat and dog were generally attributable to the pharmacological activity of exemestane, such as effects on reproductive and accessory ...
List of excipients
Tablet core: Silica colloidal hydrated Crospovidone Hypromellose Magnesium stearate Mannitol Microcrystalline cellulose Sodium starch glycolate (Type A) Polysorbate Sugar-coating: Hypromellose Polyvinylalcohol ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
15, 20, 30, 90, 100 and 120 tablets in blister packs (Aluminium-PVDC/PVC-PVDC) Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, CT13 9NJ, UK
Marketing authorization number(s)
PL 00057/0930
Date of first authorization / renewal of the authorization
16<sup>th</sup> December 1998 / 8<sup>th</sup> August 2008
Date of revision of the text
11/2018
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