Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
fulvestrant
AstraZeneca UK Ltd.
L02BA03
fulvestrant
50mg/ml, (2) pre-filled syringes, (2) needles
solution for injection
50mg/ml, (2) pre-filled syringes, (2) needles
Prescription
Registered
2020-06-08
2 1. NAME OF THE MEDICINAL PRODUCT Faslodex 250 mg solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution. Excipients with known effect (per 5 ml) Ethanol (96%, 500 mg) Benzyl alcohol (500 mg) Benzyl benzoate (750 mg) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless to yellow, viscous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Faslodex is indicated: as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: - not previously treated with endocrine therapy, or - with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy (see section 5.1). In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adult females (including Elderly) _ The recommended dose is 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose. When Faslodex is used in combination with palbociclib, please also refer to the Summary of Product Characteristics of palbociclib. Prior to the start of treatment with the combination of Faslodex plus palbociclib, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice. 3 Special populations _Renal impairment _ No dose adjustments are recommended for patients with mild to moderate renal impairment (creatinine clearance 30 ml/min). Safety and efficacy have not been evaluated in patients with severe renal impairm Прочитать полный документ