البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
ALPELISIB
NOVARTIS ISRAEL LTD
L01XX65
FILM COATED TABLETS
ALPELISIB 150 MG
PER OS
Required
NOVARTIS PHARMA STEIN AG, SWITZERLAND
ALPELISIB
PIQRAY is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CAmutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen
2020-12-06
Artwork Order No.: Artwork Order description: AW identifier No. New: Proof No.: Dimension: Tech. Drawing No.: Live text: Condensed font: Font type: Creation date: Artwork creator: Braille: Printing colours: Technical colours: Print enhancements: AW identifier No. Old: Packaging site: Minimum font size body text: Variable data prefixes font size: ! P L E A S E T U R N O V E R P R I N T I N G O N ! 730 X 289 MM Yes No Both Artwork Service Provider Black Yes No Arial 8 pt Nurit Assayag 31/07/22 Leaflet-Piqray 1 X DOR 730x289 (60x110) - PIQRAYBYL719. pdf :ة ّ يفاضإ ةيبناج ضارعأ :)نيلمعتسم 10 نيب نم دحاو لمعتسم نم رثكأ يف رثؤت دق( ( VERY COMMON ( ادج ةعئاش ةيبناج ضارعأ - حفط - نايثغ - فعضو بعت - ة ّ يهشلا ضافخنا - ؤيقت - نزولا ضافخنا - رعشلا طقاست - )ةيومف حورقو )aphtha( علاق ،ةيومف حورج كلذ يف امب ،مفلا يف ةيطاخملا ةيشغلأا باهتلا( مفلا باهتلا - مضهلا رسع - ةيطاخملا ةيشغلأا باهتلا - ةيطيحم ةمذو - ةعفترم ةرارح - )جرفلاو لبهملا فافج ،مفلا فافج ىلع لمتشي( ةيطاخملا ةيشغلأا فافج - )ةمعطلأا هاجت ةيساسحلا ضافخناو ق ُّ وذتلا ةساح نادقف كلذ يف امب( ق ّ وذتلا ةساح يف تابارطضا - عادص - ةكح - فاج دلج - نطبلا يف م َ لأ - :مدلا تاصوحف ضعب يف تارييغت • زابيل ،نينلالأا نيمأ ةلقان ،ليماتولچ اماچ ديتببلا ةلقان :مدلا يف ةيلاتلا تاميزنلإا نم ةعفترم تايوتسم • مدلا يف عفترم نينيتايرك ىوتسم • مدلا يف نيموبللأا وأ/و نيبولچوميهلا ،زوكولﭽلا ،ةيومدلا حئافصلا ،تايوافمللا نم مدلا يف ضفخنم ىوتسم • )مدلا رثخت ءادلأ رشؤم - ac اقرأ الوثيقة كاملة
PIQ API JAN23 V5 USPI NOV2022 FULL PRESCRIBING INFORMATION 1 NAME OF THE MEDICINAL PRODUCT PIQRAY 50 MG PIQRAY 150 MG PIQRAY 200 MG 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EACH FILM-COATED TABLET CONTAINS: Piqray 50 mg: alpelisib 50 mg Piqray 150 mg: alpelisib 150 mg Piqray 200 mg: alpelisib 200 mg For the full list of excipients, see section 12. 3 PHARMACEUTICAL FORM Film-Coated Tablets 50 mg: light pink, unscored, round, curved film-coated tablet with beveled edges, imprinted with “L7” on one side and “NVR” on the other side. 150 mg: pale red, unscored, ovaloid, curved film-coated tablet with beveled edges, imprinted with “UL7” on one side and “NVR” on the other side. Piqray 200 mg: light red, unscored , ovaloid, curved film-coated tablet with beveled edges, imprinted with “YL7” on one side and “NVR” on the other side. 4 THERAPEUTIC INDICATIONS PIQRAY is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA- mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. 5 DOSAGE AND ADMINISTRATION 5.1 PATIENT SELECTION Select patients for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer with PIQRAY, based on the presence of one or more PIK3CA mutations in tumor tissue or plasma specimens _[see Clinical Studies (15)]_ . If no mutation is detected in a plasma specimen, test tumor tissue. PIQ API JAN23 V5 USPI NOV2022 5.2 DOSAGE AND ADMINISTRATION The recommended dose of PIQRAY is 300 mg (two 150 mg film-coated tablets) taken orally, once daily, with food _[see Clinical Pharmacology (13.3)]_ . Continue treatment until disease progression or unacceptable toxicity occurs _[see _ _Dosage and Administration (5.3)]_ . Patients should take their dose of PIQRAY at approximately the same time each day. Swallow PIQRAY tablets whole (tablets should not be chewed, crushed or split pr اقرأ الوثيقة كاملة