BindRen
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
01-04-2015
Vara einkenni
(SPC)
01-04-2015
Opinber matsskýrsla
(PAR)
01-04-2015
Virkt innihaldsefni:
colestilan
Fáanlegur frá:
Mitsubishi Pharma Europe Ltd
ATC númer:
V03AE
INN (Alþjóðlegt nafn):
colestilan
Meðferðarhópur:
Drugs for treatment of hyperkalaemia and hyperphosphataemia
Lækningarsvæði:
Hyperphosphatemia
Ábendingar:
Treatment of hyperphosphataemia in adult patients with chronic kidney disease stage 5 receiving haemodialysis or peritoneal dialysis.
Vörulýsing:
Revision: 2
Leyfisstaða:
Withdrawn
Leyfisdagur:
2013-01-21
Upplýsingar fylgiseðill
43
B. PACKAGE LEAFLET
Medicinal product no longer authorised
44
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BINDREN 1 G FILM-COATED TABLETS
colestilan
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What BindRen is and what it is used for
2.
What you need to know before you take BindRen
3.
How to take BindRen
4.
Possible side effects
5.
How to store BindRen
6.
Contents of the pack and other information
1.
WHAT BINDREN IS AND WHAT IT IS USED FOR
BindRen contains the active substance colestilan. It is used to lower
high blood phosphorus levels in adult
patients undergoing dialysis due to poor kidney function.
About high blood phosphorus levels (hyperphosphataemia)
If your kidneys no longer function properly you may undergo dialysis,
which replaces many of the functions
of your kidneys. You have also been advised to follow a special diet
to reduce the amount of phosphorus that
your body takes from food. Sometimes, the dialysis and diet are not
enough to stop the phosphorus in your
blood rising to high levels, a condition referred to by your doctor as
hyperphosphataemia. Keeping the
phosphorus level in your blood low is important to maintain healthy
bones and blood vessels and to prevent
itchy skin, red eyes, bone pain or bone fractures.
How BindRen works
Colestil
Lestu allt skjalið
Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of new
safety information. Healthcare professionals are asked to report any
suspected adverse reactions. See section
4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
BindRen 1 g film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 g colestilan.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, oval shaped, film-coated tablet approximately 20.2 mm in length
and 10.7 mm wide printed with
“BINDREN” (in blue ink) on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BindRen is indicated for the treatment of hyperphosphataemia in adult
patients with Chronic Kidney Disease
(CKD) Stage 5 receiving haemodialysis or peritoneal dialysis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended starting dose is 6-9 g per day (2-3 g three times
daily).
Patients previously on other phosphate binders who are switched to
BindRen should start taking 6-9 g per
day (2-3 g three times daily).
_Dose titration _
Serum phosphorus concentrations should be monitored. If an acceptable
serum phosphorus concentration is
not achieved, the dose may be increased by 3 g per day (1 g three
times daily) in 2-3 weekly intervals. The
maximum daily dose of BindRen tested in clinical trials was 15 g per
day (5 g three times daily).
_Special populations _
_Elderly population _
Experience from clinical studies in patients above the age of 75 years
is very limited.
_ _
_Renal impairment _
BindRen is indicated for use in patients with Chronic Kidney Disease
(CKD) Stage 5 receiving
haemodialysis or peritoneal dialysis. No data on the use of BindRen in
pre-dialysis patients are available.
_Severe hepatic impairment _
Patients with severe hepatic impairment were excluded from clinical
studies. Therefore, the use of BindRen
is not rec
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