Renvela ® Tablet 800mg

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

有效成分:

Anhydrous Sevelamer Carbonate

可用日期:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC代码:

V03AE02

剂量:

800 mg

药物剂型:

TABLET, FILM COATED

组成:

Anhydrous Sevelamer Carbonate 800 mg

给药途径:

ORAL

处方类型:

Prescription Only

厂商:

Sanofi Winthrop Industrie

授权状态:

ACTIVE

授权日期:

2009-11-06

资料单张

TEXT AND GRAPHICS TO
APPEAR WITHIN THE
BLUE BORDERS ONLY
EXCEPT WHERE THEY
HAVE TO BLEED OFF
Inside Front Cover - Page 2
Page 3
Page 4
Page 5
Page 6
Page 7
Page 8
Page 9
Page 10
Front Page - Page 1
Page 11
Page 12
Page 13
Page 14
Page 15
Page 16
Lo
t:
M
fg
:
Ex
p:
a, b = number of primary amine groups
a + b = 9
c = number of crosslinking groups
c = 1
m = large number to indicate extended polymer network
PHOSPHORUS CHANGE FROM BASELINE (MG/DL)
Improvement
Active Control
Sevelamer Hydrochloride
No Improvement
CU
M
UL
AT
IV
E
PE
RC
EN
T
100
90
80
70
60
50
40
30
20
10
0
-8
-6
-4
-2
0
+2
+4
STUDY WEEK
PH
OS
PH
OR
US
CH
AN
GE
FRO
M
BA
SE
LIN
E
TRT:
SEVELAMERHYDROCHLORIDE
ACTIVE CONTROL
0
2
1
0
-1
-2
-3
-4
-5
2
6
10
14
18
22
26
30
34
38
42
46
52
USUAL DOSAGE:
SEE PACKAGE INSERT
FOR DOSAGE INFORMATION.
SIN13725P
4FA0064
USUAL DOSAGE:
SEE PACKAGE INSERT
FOR DOSAGE INFORMATION.
SIN13725P
4FA0064
EACH TABLET CONTAINS:
Active Ingredient: Sevelamer
carbonate................ 800 mg.
Inactive Ingredients:
Hypromellose,
diacetylated monoglycerides,
microcrystalline cellulose,
sodium chloride, and zinc stearate.
For Oral Use
Dispense in a tight container.
Protect from moisture.
Store at 25°C (77°F).
Manufactured by:
Genzyme Ireland Ltd.
IDA Industrial Park
Old Kilmeaden Road
Waterford, Ireland
Manufactured for:
Genzyme Corporation
500 Kendall Street
Cambridge, MA 02142 USA
180 FILM-COATED TABLETS
RX ONLY
SEVELAMER
ACTIVE-
HYDROCHLORIDE
CONTROL
(N=81)
(N=83)
Baseline at End of Washout
8.4
8.0
Change from Baseline at Endpoint
-2.0*
-2.1*
(95% Confidence Interval)
(-2.5, -1.5)
(-2.6, -1.7)
SEVELAMER
ACTIVE-
HCL
CONTROL
(N=94)
(N=99)
Phosphorus
Baseline
7.5
7.3
Change from Baseline at Endpoint
-2.1
-1.8
Ca x Phosphorus Ion Product
Baseline
70.5
68.4
Change from Baseline at Endpoint
-19.4
-14.2
SERUM PHOSPHORUS
RENVELA
®
800 MG
> 5.5 and < 7.5 mg/dL
1 tablet three times daily with�

产品特点

SG/REN/1022/CCDSv8
Renvela
Sevelamer carbonate
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Renvela safely and effectively.
See full prescribing information for Renvela.
Renvela (sevelamer carbonate), tablets, for Oral use
INDICATIONS AND USAGE

Renvela is indicated for the control of hyperphosphataemia in adult
patients receiving hemodialysis
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 D3 or one of its analogues
to control the development
of renal bone disease.
DOSAGE AND ADMINISTRATION

Starting dose is one or two 800 mg tablets three times per day with
meals. (2)

Adjust by one tablet per meal in two week intervals as needed to
obtain serum phosphorus target
(3.5 to 5.5 mg/dL). (2)
DOSAGE FORMS AND STRENGTHS

Tablets: 800 mg (3)
CONTRAINDICATIONS

In patients with hypophosphatemia or bowel obstruction. (4)

Known hypersensitivity to sevelamer carbonate, sevelamer
hydrochloride, or to any of the
excipients. (4)
WARNINGS AND PRECAUTIONS

Serious cases of dysphagia, bowel obstruction, bleeding
gastrointestinal ulcers, colitis, ulceration,
necrosis, and perforation have been associated with sevelamer use,
some requiring hospitalization
and surgery. (5.1)
ADVERSE REACTIONS

Most of the safety experience is with sevelamer carbonate tablets and
sevelamer hydrochloride. In
long-term studies with sevelamer hydrochloride, which contains the
same active moiety as
sevelamer carbonate, the most common adverse events included: vomiting
(22%), nausea (20%),
diarrhea (19%), dyspepsia (16%), abdominal pain (9%), flatulence (8%)
and constipation (8%).
(6.1)
DRUG INTERACTIONS

For oral medication where a reduction in the bioavailability of that
medication would ha