LETROLE Film-coated tablet (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Letrole, 2.5 mg, film coated tablet.
2. Qualitative and quantitative composition
Each film coated tablet contains 2.5 mg of letrozole. <u>Excipient with known effect:</u> Lactose. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Dark yellow, capsule shape, film-coated, slightly biconvex tablet, debossed with LZ 2.5 on one side and G on the other.
4.1. Therapeutic indications
Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. Extended adjuvant treatment of early breast cancer in post-menopausal women who have received ≥4.5 and ≤6.0 ...
4.2. Posology and method of administration
The recommended dose of Letrole is 2.5 mg once daily. In the adjuvant and extended adjuvant setting, treatment with Letrole should continue for 5 years or until tumour relapse occurs, whichever comes first. ...
4.3. Contraindications
Known hypersensitivity to the active substance letrozole or to any of the excipients listed in section 6.1. Premenopausal endocrine status. Pregnancy (see sections 4.6 and 5.3). Breast-feeding (see sections ...
4.4. Special warnings and precautions for use
Menopausal status In patients whose menopausal status is unclear, luteinising hormone (LH), follicle-stimulating hormone (FSH) and/or oestradiol levels should be measured before initiating treatment with ...
4.5. Interaction with other medicinal products and other forms of interaction
Metabolism of letrozole is partly mediated via CYP2A6 and CYP3A4. Cimetidine, a weak, unspecific inhibitor of CYP450 enzymes, did not affect the plasma concentrations of letrozole. The effect of potent ...
4.6. Fertility, pregnancy and lactation
Women of perimenopausal status or child-bearing potential Letrozole should only be used in women with a clearly established postmenopausal status (see section 4.4). As there are reports of women regaining ...
4.7. Effects on ability to drive and use machines
Letrole has minor influence on the ability to drive and use machines. Since fatigue and dizziness have been observed with the use of letrozole and somnolence has been reported uncommonly, caution is advised ...
4.8. Undesirable effects
Summary of safety profile The frequencies of adverse reactions for letrozole are mainly based on data collected from clinical trials. Up to approximately one third of the patients treated with letrozole ...
4.9. Overdose
Isolated cases of overdose with letrozole have been reported. No specific treatment for overdose is known. Treatment should be symptomatic and supportive. For further advice on management of overdose please ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Endocrine therapy. Hormone antagonist and related agents: aromatase inhibitor <b>ATC code:</b> L02BG04 Pharmacodynamic effects The elimination of oestrogen-mediated growth ...
5.2. Pharmacokinetic properties
Absorption Letrozole is rapidly and completely absorbed from the gastrointestinal tract (mean absolute bioavailability: 99.9%). Food slightly decreases the rate of absorption (median t<sub>max</sub> 1 ...
5.3. Preclinical safety data
In a variety of preclinical safety studies conducted in standard animal species, there was no evidence of systemic or target organ toxicity. Letrozole showed a low degree of acute toxicity in rodents exposed ...
6.1. List of excipients
<u>Letrole 2.5mg tablet core contains:</u> Lactose monohydrate Microcrystalline cellulose Maize starch Sodium starch glycollate Magnesium stearate Colloidal silicon dioxide <u>Letrole 2.5mg tablet film ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store at or below 25°C.
6.5. Nature and contents of container
PVC/PVdC/Aluminium blister. Pack size of 30 film-coated tablets.
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
Viatris Ltd, PO Box 11-183, Ellerslie, AUCKLAND www.viatris.co.nz Telephone 0800 168 169
9. Date of first authorization / renewal of the authorization
Date of first approval: 1 April 2010
10. Date of revision of the text
04 August 2022
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