Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

sevelamer carbonate

Διαθέσιμο από:

Sanofi B.V.

Φαρμακολογική κατηγορία (ATC):

V03AE02

INN (Διεθνής Όνομα):

sevelamer carbonate

Θεραπευτική ομάδα:

All other therapeutic products

Θεραπευτική περιοχή:

Hyperphosphatemia; Renal Dialysis

Θεραπευτικές ενδείξεις:

Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.Sevelamer carbonate Winthrop 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.Sevelamer carbonate Winthrop 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.

Περίληψη προϊόντος:

Revision: 21

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2015-01-15

Φύλλο οδηγιών χρήσης

52
B. PACKAGE LEAFLET
53
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEVELAMER CARBONATE WINTHROP 800 MG FILM-COATED TABLETS
sevelamer carbonate
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 further questions, ask your doctor or pharmacist.
-
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. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Sevelamer carbonate Winthrop is and what it is used for
2. What you need to know before you take Sevelamer carbonate Winthrop
3. How to take Sevelamer carbonate Winthrop
4. Possible side effects
5. How to store Sevelamer carbonate Winthrop
6. Contents of the pack and other information
1.
WHAT SEVELAMER CARBONATE WINTHROP IS AND WHAT IT IS USED FOR
Sevelamer carbonate Winthrop contains the active substance sevelamer
carbonate. It binds phosphate from
food in the digestive tract and so reduces serum phosphorus levels in
the blood.
This medicine is used to control hyperphosphataemia (high blood
phosphate levels) in:
•
adult patients on dialysis (a blood clearance technique). It can be
used in patients undergoing
haemodialysis (using a blood filtration machine) or peritoneal
dialysis (where fluid is pumped into the
abdomen and an internal body membrane filters the blood);
•
patients with chronic (long-term) kidney disease who are not on
dialysis and have a serum (blood)
phosphorus level equal to or above 1.78 mmol/L.
This medicine should be used with other treatments such as calcium
supplements and vitamin D to prevent
the development of bone disease.
Increased levels of serum phosphorus can lead to hard deposits in your
body called calcification. These
deposits can stiffen your blood vessels and make it harder for blood
to b

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Sevelamer carbonate Winthrop 800 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 800 mg sevelamer carbonate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
White to off-white oval tablet, engraved with “RV800” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sevelamer carbonate Winthrop is indicated for the control of
hyperphosphataemia in adult patients receiving
haemodialysis or peritoneal dialysis.
Sevelamer carbonate Winthrop is also indicated for the control of
hyperphosphataemia in adult patients with
chronic kidney disease (CKD) not on dialysis with serum phosphorus ≥
1.78 mmol/L.
Sevelamer carbonate Winthrop 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. Sevelamer carbonate Winthrop 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, see section “Titration and
maintenance”
For patients previously on phosphate binders (sevelamer hydrochloride
or calcium based), Sevelamer
carbonate Winthrop should be given on a gram for gram basis with
monitoring of serum phosphorus levels to
ensure optimal daily doses.
_Titration and maintenance _
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 re