Land: Armenia
Språk: engelsk
Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ribociclib(ribociclib succinate)
Novartis Pharma Produktions GmbH
L01XE42
ribociclib(ribociclib succinate)
200mg
tablets film-coated
(21/1x21/) in blister, (63/3x21/) in blister
Prescription
Registered
2019-05-17
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT KISQALI COMPOSITION: _ACTIVE SUBSTANCE_: ribociclib. Each film-coated tablet contains ribociclib succinate, equivalent to 200 mg ribociclib. _EXCIPIENTS_: _ _ _core: _ microcrystalline cellulose, crospovidone type A, low-substituted hydroxypropylcellulose, magnesium stearate, colloidal anhydrous silica. _composition of coating: _ iron oxide black (E172), iron oxide red (E172), soya lecithin (E322), polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide (E171), xanthan gum. PHARMACEUTICAL FORM: film-coated tablet. PHARMACOTHERAPEUTIC GROUP. Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors. ATC code: L01XE42 CLINICAL PARTICULARS._ _ _INDICATIONS. _ Kisqali is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, _ _ the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. CONTRAINDICATIONS. Hypersensitivity to the active substance or to peanut, soya or any of the excipients. POSOLOGY AND METHOD OF ADMINISTRATION. Treatment with Kisqali should be initiated by a physician experienced in the use of anticancer therapies. Posology The recommended dose is 600 mg (three 200 mg film-coated tablets) of ribociclib once daily for 21 consecutive days followed by 7 days off treatment, resulting in a complete cycle of 28 days. The treatment should be continued as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs. Kisqali should be used together with 2 read_full_document
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Kisqali 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains ribociclib succinate, equivalent to 200 mg ribociclib. Excipients with known effect Each film-coated tablet contains 0.344 mg soya lecithin. 3. PHARMACEUTICAL FORMS Film-coated tablet. Light greyish violet, unscored, round, curved with bevelled edges (approximate diameter: 11.1 mm), debossed with “RIC” on one side and “NVR” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kisqali is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, _ _ the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Kisqali should be initiated by a physician experienced in the use of anticancer therapies. Posology The recommended dose is 600 mg (three 200 mg film-coated tablets) of ribociclib once daily for 21 consecutive days followed by 7 days off treatment, resulting in a complete cycle of 28 days. The treatment should be continued as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs. Kisqali should be used together with 2.5 mg letrozole or another aromatase inhibitor or with 500 mg fulvestrant. When Kisqali is used in combination with an aromatase inhibitor, the aromatase inhibitor should be taken orally once daily continuously throughout the 28-day cycle. When Kisqali is read_full_document