RENVELA (SEVELAMER CARBONATE) TABLET 800MG

国: マレーシア

言語: 英語

ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有効成分:

SEVELAMER CARBONATE

から入手可能:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN（国際名）:

SEVELAMER CARBONATE

パッケージ内のユニット:

180Tablet Tablets; 30Tablet Tablets; 270Tablet Tablets; 30Tablet Tablets; 180Tablet Tablets; 270Tablet Tablets

製:

Genzyme Ireland Limited

情報リーフレット

Consumer Medication Information Leaflet (RiMUP)
1
RENVELA
®
FILM-COATED TABLETS
Sevelamer Carbonate 800mg
What is in this leaflet
1.
What Renvela is used for
2.
How Renvela works
3.
Before you use Renvela
4.
How to use Renvela
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Renvela
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
What Renvela is used for
Renvela is used for patients who have
kidneys that do not work properly are
not able to control the level of serum
phosphorus in their blood. The amount
of phosphate then rises (your doctor
will call this hyperphosphataemia).
Increased levels of serum phosphorus
can lead to hard deposits in your body
called calcification. These deposits is
can stiffen your blood vessels and make
it harder for blood to be pumped
around the body. Increased serum
phosphorus can also lead to itchy skin,
red eyes, bone pain and fractures.
How Renvela works
Renvela contains sevelamer carbonate
as the active ingredient. It binds
phosphate from food in the digestive
tract and so reduces serum phosphorus
levels in the blood.
Before you use Renvela
When you must not use it
Do not take Renvela if:
•
You are allergic (hypersensitive) to
sevelamer carbonate, sevelamer
hydrochloride, or to any of the other
ingredients of this medicine (listed
in Section 8 below).
-Signs of an allergic reaction include: a
rash, swallowing or breathing
problems, swelling of your lips, face,
throat or tongue
•
You have bowel obstruction.
Before you start to use it
Check with your doctor before taking
Renvela if:
•
You have swallowing problems
•
You have problems related with
motility (movement) in your stomach
and bowel
•
You are being sick frequently
•
You have active inflammation of the
bowel
•
You have undergone major surgery on
your stomach or bowel
•
You have severe constipation.
Additional
treatments:
Due to either your kidney condition or
your dialysis treatment you may:
-
develop low or high levels of calciu

製品の特徴

MY/REN/0422/CCDSv8
Renvela
Sevelamer carbonate Tablets
800mg
Revision date:
Apr 2022
(CCDS V8 based on US PI Apr 2020)
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 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 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
(1.13 to 1.78 mmol/L). (2)
DOSAGE FORMS AND STRENGTHS

Tablets: 800 mg (3)
CONTRAINDICATIONS

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)
MY/REN/0422/CCDSv8
DRUG INTERACTIONS

For oral medication where a reduct