RENVELA 800 MG TABLETS

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

SEVELAMER CARBONATE ANHYDROUS

Tilgængelig fra:

SANOFI ISRAEL LTD

ATC-kode:

V03AE02

Lægemiddelform:

FILM COATED TABLETS

Sammensætning:

SEVELAMER CARBONATE ANHYDROUS 800 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

GENZYME EUROPE B.V., THE NETHERLANDS

Terapeutisk gruppe:

SEVELAMER

Terapeutisk område:

SEVELAMER

Terapeutiske indikationer:

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 disease not 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.

Autorisation dato:

2016-03-31

Indlægsseddel

PLANT PM CODE:
782589
OLD PM CODE:
749757
DESCRIPTION:
LABEL/INSERT RENV 800MG BT180 IL
VISTA FOLDER #:
4115192
REVISION:
1
MARKET:
Israel
LANGUAGE(S):
ENGLISH/HEBREW/ARABIC
DATE:
TBC
OPERATOR:
Israel Artwork Studio
MIN POINT SIZE:
8.5PT
LOT/BATCH:
TBC
EXPIRY:
TBC
DOM/ID:
TBC
SERIAL NUMBER (S/N):
TBC
PRINTING COLS:
TBC
NON-PRINTING COLS:
TBC,
PRODUCT BARCODE:
TBC,
PLANT BARCODE:
782589
SPEC:
WAT_SPEC-000250
TEMPLATE REF.:
IE01 PK 4002 (Rev 4)
DIMENSIONS:
58mm x 185mm
IDA INDUSTRIAL PARK,
OLD KILMEADEN ROAD,
WATERFORD, IRELAND.
782589
782589 םיחקורה תונקת יפל ןכרצל ןולע
1986 - ו״משתה )םירישכת(
דבלב אפור םשרמ יפ לע תקוושמ הפורתה
ג״מ 800 תוילבט הלוונר
:הליכמ הפוצמ היילבט לכ :ליעפ רמוח
ג״מ 800 סורדיהנא טנוברק רמאלבס
Sevelamer carbonate anhydrous 800 mg
.6 ףיעס האר :םיליעפ יתלב םירמוח
.הפורתב שמתשת םרטב ופוס דע ןולעה תא
ןויעב ארק
,ןולעה לע רומש .הפורתה לע יתיצמת עדימ
ליכמ הז ןולע
.ךשמהב ול קקדזתו ןכתיי
.חקורה לא וא אפורה לא הנפ ,תופסונ תולאש
ךל שי םא
.םירחאל התוא ריבעת לא .ךתלחמב לופיטל
המשרנ וז הפורת
.המוד םתלחמ יכ ךל הארנ םא וליפא םהל
קיזהל הלולע איה
.18 ליגל תחתמ םירגבתמו םידליל תדעוימ
הניא וז הפורת
?הפורתה תדעוימ המל
.1
:ל תדעוימ הפורתה
יא םע םירגובמ םילוחב םדב תוהובג ןחרז
תומר ןוזיא ∙
וא הזילאידומה( הזילאידב םילפוטמה
,תיתיילכ הקיפס
.)]תילאינוטירפ[ תיקפצ הזילאיד
תלחמ םע םירגובמ םילוחב םדב תוהובג ןחרז
תומר ןוזיא ∙
תומר םע ,הזילאידב םילפוטמ םניא רשא
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Produktets egenskaber

1
1.
NAME OF THE MEDICINAL PRODUCT
Renvela 800 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 800 mg sevelamer carbonate anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
The white to off-white tablets are imprinted with “RENVELA 800” on
one side.
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 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 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.
_ _
Titration and Maintenance
2
Serum phosphorus levels must be monitored and the dose of sevelamer
carbonate titrated by 0.8 g
three times per day (2.4 g/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, treatment will be continuous based on the need
to control serum p