FOSRENOL 750 MG ORAL POWDER

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

LANTHANUM AS CARBONATE HYDRATE

متاح من:

TAKEDA ISRAEL LTD

ATC رمز:

V03AE03

الشكل الصيدلاني:

POWDER

تركيب:

LANTHANUM AS CARBONATE HYDRATE 750 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

SHIRE PHARMACEUTICALS IRELAND LIMITED , IRELAND

المجال العلاجي:

LANTHANUM CARBONATE

الخصائص العلاجية:

Fosrenol is indicated as a phosphate binding agent for use in the control of hyperphosphatemia in CRF patients on haemodyalisis 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.

تاريخ الترخيص:

2019-12-31

نشرة المعلومات

Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) -
1986
This medicine is dispensed with physician’s prescription only
Fosrenol 750 mg
oral powder
Fosrenol 1000 mg
oral powder
Each sachet contains 750 mg
Each sachet contains 1000 mg
of the active ingredient lanthanum (as carbonate hydrate)
Inactive ingredients and allergens: See section 2 "Important
information about some
of this medicine’s ingredients" and section 6 ("Additional
information") in this leaflet.
Read the entire leaflet carefully before you start using this
medicine. This leaflet
contains concise information about this medicine. If you have any
further questions,
consult your physician or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It
may harm them, even if it seems to you that their illness is similar
to yours.
This medicine is not intended for users under the age of 18. The
safety and efficacy of
Fosrenol in children below the age of 18 years has not been examined.
It is important to take the medicine with or immediately after food.
Inform your physician if you need to undergo X-ray imaging, as use of
Fosrenol may
affect the results.
1. What is this medicine intended for?
The
medicine
is
indicated
for
reduction
of
high
blood
phosphate
levels
(hyperphosphataemia) in chronic renal failure patients on
haemodialysis or ambulatory
peritoneal dialysis. The medicine is also indicated for patients with
chronic kidney
disease not on dialysis with high serum phosphate levels (greater than
1.78 mmol/L),
which are not controlled by low phosphate diet alone.
Therapeutic activity: Fosrenol binds phosphate originating from food
in the intestine.
Phosphate bound in such manner cannot be absorbed in the body; thus,
Fosrenol
assists in reduction of blood phosphate level.
Therapeutic group: medicines for treatment of hyperkalaemia and
hyperphosphatemia.
2. Before using this medicine
Do not use this medicine if:
- You are sensitive (allergic) to the active ingredient lanthanum
carb

خصائص المنتج

SUMMARY
OF
PRODUCT
CHARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Fosrenol 750 mg oral powder
Fosrenol 1000 mg oral powder
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each sachet contains 750 mg lanthanum (as lanthanum carbonate
hydrate).
Each sachet contains 1000 mg lanthanum (as lanthanum carbonate
hydrate).
_Excipient(s) with known effect:_
Each sachet of 750 mg also contains 641.7 mg dextrates, containing
glucose.
Each sachet of 1000 mg also contains 855.6 mg dextrates, containing
glucose.
For the full list of excipients, see section 6.1.
3
P
HARMACEUTICAL
F
ORM
Oral Powder.
White to off-white powder.
4
C
LINICAL
P
ARTICULARS
4.1
Therapeutic indications
Fosrenol is indicated as a phosphate binding agent for use in the
control of hyperphosphataemia
in chronic renal failure (CRF) 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.
Fosrenol oral powder is intended to be mixed with a small quantity of
soft food (e.g. applesauce
or other similar food product) and consumed immediately (within 15
minutes). The sachet must
not be opened until ready to use. Once mixed with food, Fosrenol oral
powder must not be stored
for future use. Fosrenol oral powder is insoluble and must not be
dissolved in liquid for
administration.
_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 an oral powder intended to be mixed
with soft food, 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