RENVELA 2.4 G POWDER

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

SEVELAMER CARBONATE ANHYDROUS

متاح من:

SANOFI ISRAEL LTD

ATC رمز:

V03AE02

الشكل الصيدلاني:

POWDER FOR SUSPENSION

تركيب:

SEVELAMER CARBONATE ANHYDROUS 2.4 G/SACHET

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

GENZYME EUROPE B.V., THE NETHERLANDS

المجموعة العلاجية:

SEVELAMER

المجال العلاجي:

SEVELAMER

الخصائص العلاجية:

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.

تاريخ الترخيص:

2016-03-31

نشرة المعلومات

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�

خصائص المنتج

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,