Nazione: Israele
Lingua: inglese
Fonte: Ministry of Health
SEVELAMER CARBONATE ANHYDROUS
SANOFI ISRAEL LTD
V03AE02
POWDER FOR SUSPENSION
SEVELAMER CARBONATE ANHYDROUS 2.4 G/SACHET
PER OS
Required
GENZYME EUROPE B.V., THE NETHERLANDS
SEVELAMER
SEVELAMER
For the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.Also indicated for the control of hyperphosphataemia in adult patients with chronic kidney diseasenot on dialysis with serum phosphorus ≥ 1.78 mmol/l.Should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
2016-03-31
PLANT PM CODE: 782591 OLD PM CODE: 749812 DESCRIPTION: LEAFLET RENV 2.4G SC60 IL VISTA FOLDER #: 4115191 REVISION: 1 MARKET: Israel LANGUAGE(S): ENGLISH/HEBREW/ARABIC DATE: 19 Nov 2020 OPERATOR: Israel Artwork Studio MIN POINT SIZE: 8.5PT LOT/BATCH: N/A EXPIRY: N/A DOM/ID: N/A SERIAL NUMBER (S/N): N/A PRINTING COLS: PMS 2995 PROCESS BLACK PMS 367 PMS130 NON-PRINTING COLS: DIELINE, PRODUCT BARCODE: N/A PLANT BARCODE: 782591 SPEC: WAT_SPEC-000167 TEMPLATE REF.: IE01 PK 4012 (REV 2) DIMENSIONS: CARD (140mm x 2mm x 60mm ) LEAFLET (405mm x 324mm) IDA INDUSTRIAL PARK, OLD KILMEADEN ROAD, WATERFORD, IRELAND. 1986 - )تارضحتسم( ةلديصلا ةمظنأ بجومب كلهتسملل ةرشن طقف بيبط ةفصو بجومب ءاودلا ق ّ وسي قوحسم مارغ 2.4 لايڤنير :ىلع قوحسملا نم سيك لك يوتحي - ةلاعفلا ةداملا مارغ 2.4 يئام لا تانوبراك ريملايڤيس .6 ةرقفلا رظنأ :ةلاعفلا ريغ داوملا .ءاودلا نع ةزجوم تامولعم ىلع ةرشنلا هذه يوتحت .ءاودلل كلامعتسإ لبق اهتياهن ىتح نعمتب ةرشنلا أرقإ . ً اقحلا اهجاتحت نأ زئاجلا نم .ةرشنلا ظفحإ .يلديصلا وأ بيبطلا عجار ،ةيفاضإ ةلئسأ كيدل ترفوت اذإ .كضرمل هباشم مهضرم نأ كل ادب ولو ىتح مهرضي دق وهف .نيرخلآل هيطعت لا .كضرم جلاعل ءاودلا اذه فصو .ةنس 18 رمع نود نيقهارملاو لافطلأل صصخم ريغ ءاودلا اذه ؟ءاودلا صصخم ضرغ يلأ )1 :ـل صصخم ءاودلا ةيقافص ةزليد وأ ةيومد ةزليد( ةزليدلاب نيجلاعملا ،يولك روصق نم نوناعي نيذلا رابكلا ىضرملا ىدل مدلا يف ةعفترملا روفسوفلا بسن ةنزاوم ∙ .)]peritoneal[ بسن مهيدل ،ةزليدلاب نيجلاعملا ريغو ،نمزم يولك ضرم نم نون Leggi il documento completo
1 1. NAME OF THE MEDICINAL PRODUCT Renvela 2.4 g powder 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 2.4 g sevelamer carbonate anhydrous. Excipient with known effect This medicine contains 25.27 mg propylene glycol alginate (E405) in each 2.4 g sachet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral suspension. Pale yellow powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Renvela is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease patients not on dialysis with serum phosphorus > 1.78 mmol/l. Renvela should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy Vitamin D 3 or one of its analogues to control the development of renal bone disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: _Starting dose _ The recommended starting dose of sevelamer carbonate is 2.4 g or 4.8 g per day based on clinical needs and serum phosphorus level. Renvela powder for oral suspension must be taken three times per day with meals. Serum phosphorus level in patients Total daily dose of sevelamer carbonate to be taken over 3 meals per day 1.78 – 2.42 mmol/l (5.5 – 7.5 mg/dl) 2.4 g* > 2.42 mmol/l (> 7.5 mg/dl) 4.8 g* *Plus subsequent titrating as per instructions For patients previously on phosphate binders (sevelamer hydrochloride or calcium based), Renvela should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses. 2 _Titration and Maintenance _ Serum phosphorus must be monitored and the dose of sevelamer carbonate titrated by 0.8 g three times per day (2.4g/day) increments every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter. Patients taking Renvela should adhere to their prescribed diets. In clinical practice, Leggi il documento completo