Renagel

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

sevelamer

Saatavilla:

Sanofi B.V.

ATC-koodi:

V03AE02

INN (Kansainvälinen yleisnimi):

sevelamer

Terapeuttinen ryhmä:

All other therapeutic products

Terapeuttinen alue:

Renal Dialysis; Hyperphosphatemia

Käyttöaiheet:

Renagel is indicated for the control of hyperphosphataemia in adult patients receiving  haemodialysis or peritoneal dialysis.Renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 - dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.

Tuoteyhteenveto:

Revision: 36

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2000-01-28

Pakkausseloste

42
B. PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE USER
RENAGEL 400 MG FILM-COATED TABLETS
sevelamer hydrochloride
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Renagel is and what it is used for
2. What you need to know before you take Renagel
3. How to take Renagel
4. Possible side effects
5. How to store Renagel
6. Contents of the pack and other information
1.
WHAT RENAGEL IS AND WHAT IT IS USED FOR
Renagel contains sevelamer as the active ingredient. It binds
phosphate from food in the digestive tract
and so reduces serum phosphate levels in the blood.
Renagel is used to control the levels of phosphate in the blood of
adult kidney failure patients on
haemodialysis or peritoneal dialysis treatment.
Adult patients whose kidneys have failed and who are undergoing
haemodialysis or peritoneal dialysis
are not able to control the level of serum phosphate 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 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.
Renagel may be used with other medicines which include calcium or
vitamin D supplements to control
the development of renal bone disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RENAGEL
DO NOT TAKE RENAGEL:
•
if you have low levels of phosphate in yo

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Renagel 400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg sevelamer hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
The off-white, oval tablets are imprinted with “Renagel 400” on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Renagel is indicated for the control of hyperphosphataemia in adult
patients receiving haemodialysis
or peritoneal dialysis. Renagel should be used within the context of a
multiple therapeutic approach,
which could include calcium supplements, 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 hydrochloride is 2.4 g, 3.6
g or 4.8 g per day based on
clinical needs and serum phosphorus level. Renagel must be taken three
times per day with meals.
Serum phosphate level in patients not on
phosphate binders
Starting dose of Renagel 400 mg
tablets
1.76 – 2.42 mmol/L (5.5-7.5 mg/dl)
2 tablets, 3 times per day
2.42- 2.91 mmol/L (7.5-9 mg/dl)
3 tablets, 3 times per day
> 2.91 mmol/L
4 tablets, 3 times per day
For patients previously on phosphate binders, Renagel should be given
on a gram for gram basis with
monitoring of serum phosphorus levels to ensure optimal daily doses.
_Titration and maintenance _
Serum phosphate levels should be closely monitored and the dose of
sevelamer hydrochloride titrated
by 0.4 g or 0.8 g three times per day (1.2 g/day or 2.4 g/day)
increments with the goal of lowering
serum phosphate to 1.76 mmol/L (5.5mg/dl)
or less. Serum phosphate should be tested every two to
three weeks until a stable serum phosphate level is reached and on a
regular basis thereafter.
_ _
The dose range may vary between 1 and 10 tablets per meal. The average
actual daily dose used in the
chronic phase of a one year clinical st