Tasermity
Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Uputa o lijeku
(PIL)
27-03-2018
Svojstava lijeka
(SPC)
27-03-2018
Izvješće o ocjeni javnog
(PAR)
27-03-2018
Aktivni sastojci:
sevelamer hydrochloride
Dostupno od:
Genzyme Europe BV
ATC koda:
V03AE02
INN (International ime):
sevelamer hydrochloride
Terapijska grupa:
All other therapeutic products
Područje terapije:
Hyperphosphatemia; Renal Dialysis
Terapijske indikacije:
Tasermity is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer hydrochloride 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.,
Proizvod sažetak:
Revision: 4
Status autorizacije:
Withdrawn
Datum autorizacije:
2015-02-25
Uputa o lijeku
16
B.
PACKAGE LEAFLET
Medicinal product no longer authorised
17
PACKAGE LEAFLET: INFORMATION FOR THE USER
TASERMITY 800 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 Tasermity is and what it is used for
2. What you need to know before you take Tasermity
3. How to take Tasermity
4. Possible side effects
5. How to store Tasermity
6. Contents of the pack and other information
1.
WHAT TASERMITY IS AND WHAT IT IS USED FOR
Tasermity contains sevelamer as the active ingredient. It binds
phosphate from food in the digestive
tract and so reduces serum phosphate levels in the blood.
Tasermity 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.
Tasermity 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 TASERMITY
DO NOT
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Svojstava lijeka
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Tasermity 800 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 800 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 “SH800” on one
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tasermity
is
indicated
for
the
control
of
hyperphosphataemia
in
adult
patients
receiving
haemodialysis or peritoneal dialysis. Sevelamer hydrochloride 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 or
4.8 g per day based on clinical
needs and serum phosphorus level. Sevelamer hydrochloride must be
taken three times per day with
meals.
Serum phosphate level in patients not on
phosphate binders
Starting dose of Sevelamer
hydrochloride 800 mg tablets
1.76 – 2.42 mmol/L (5.5-7.5 mg/dl)
1 tablet, 3 times per day
> 2.42 mmol/L (>7.5 mg/dl)
2 tablets, 3 times per day
For patients previously on phosphate binders, Sevelamer hydrochloride
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 0.8 g three times per day (2.4 g/day) increments with the goal of
lowering serum phosphate to 1.76
mmol/L (5.5 mg/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 5 tablets of 800 mg per meal.
The average actual daily dose
used in the chronic
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