Fosrenol 500 mg Tuggtablett

Država: Švedska

Jezik: švedščina

Source: Läkemedelsverket (Medical Products Agency)

Aktivna sestavina:

lantan(III)karbonattetrahydrat

Dostopno od:

Paranova Läkemedel AB

Koda artikla:

V03AE03

INN (mednarodno ime):

lanthanum(III)karbonattetrahydrat

Odmerek:

500 mg

Farmacevtska oblika:

Tuggtablett

Sestava:

dextrat, hydratiserat Hjälpämne; lantan(III)karbonattetrahydrat 954 mg Aktiv substans

Razred:

Apotek

Tip zastaranja:

Receptbelagt

Terapevtsko območje:

Lantankarbonat

Status dovoljenje:

Avregistrerad

Datum dovoljenje:

2013-06-27

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1.
N
AME OF THE
M
EDICINAL
P
RODUCT
Fosrenol 500 mg chewable tablets.
2.
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each chewable tablet contains lanthanum carbonate hydrate
corresponding to 500 mg lanthanum.
Excipient(s) with known effect
Chewable tablets also contain on average 1066 mg of dextrates,
containing glucose.
For the full list of excipients, see section 6.1.
3.
P
HARMACEUTICAL
F
ORM
Chewable tablet.
White, round, 18-mm, bevelled-edge flat tablets debossed with
‘S405/500’ on one side.
4.
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fosrenol is indicated in adult patients as a phosphate binding agent
for use in the control of
hyperphosphataemia in chronic renal failure patients on haemodialysis
or continuous ambulatory
peritoneal dialysis (CAPD). Fosrenol is also indicated in adult
patients with chronic kidney disease not
on dialysis with serum phosphate levels

1.78 mmol/L in whom a low phosphate diet alone is
insufficient to control serum phosphate levels.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Fosrenol is for oral administration.
The tablets must be chewed completely and not swallowed whole. To aid
with chewing the tablets
may be crushed. Where Fosrenol oral powder is available, it can
replace chewable tablets in patients
who have difficulty chewing the tablets (see section 4.4).
_Adults, including elderly (>65 years)_
Fosrenol should be taken with or immediately after food, with the
daily dose divided between meals.
Patients should adhere to recommended diets in order to control
phosphate and fluid intake. Fosrenol
is presented as a chewable tablet therefore avoiding the need to take
additional fluid. Serum phosphate
levels should be monitored and the dose of Fosrenol titrated every 2
to 3 weeks until an acceptable
serum phosphate levels is reached, with regular monitoring thereafter.
Control of serum phosphate level has been demonstrated at doses
starting from 750 mg per day. The
maximum dose studied in clinical trials, in a limited number of
pati