Fosrenol

देश: न्यूज़ीलैंड

भाषा: अंग्रेज़ी

स्रोत: Medsafe (Medicines Safety Authority)

सक्रिय संघटक:

Lanthanum carbonate hydrate 954mg equivalent to elemental lanthanum 500mg

थमां उपलब्ध:

Takeda New Zealand Limited

डोज़:

500 mg

फार्मास्यूटिकल फॉर्म:

Chewable tablet

रचना:

Active: Lanthanum carbonate hydrate 954mg equivalent to elemental lanthanum 500mg Excipient: Colloidal silicon dioxide Dextrates Magnesium stearate

प्रिस्क्रिप्शन प्रकार:

Prescription

चिकित्सीय संकेत:

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 above or equal to 1.78 mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels.

उत्पाद समीक्षा:

Package - Contents - Shelf Life: Bottle, plastic, white opaque HDPE with PP tamper-evident CR screw cap (2x45 tablets) - 90 tablets - 36 months from date of manufacture stored at or below 25°C

प्राधिकरण की तारीख:

2018-07-11

उत्पाद विशेषताएं

FOSRENOL Tablets V3.0 (CCDS V13.0)
1
NEW ZEALAND DATA SHEET
1
FOSRENOL
®
500 MG, 750 MG, AND 1000 MG CHEWABLE TABLETS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FOSRENOL tablet contains lanthanum carbonate hydrate corresponding to
500 mg, 750 mg,
or 1000 mg lanthanum.
EXCIPIENT(S) WITH KNOWN EFFECT:
Each chewable tablet contains dextrates, containing glucose; the
dextrate quantity is as below:
500 mg tablet – 1066.4mg
750 mg tablet – 1599.6 mg
1000 mg tablet – 2132.8 mg
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL
FORM
Tablet, chewable
For details on appearance, please refer to section
6.5
NATURE
AND
CONTENTS
OF
CONTAINER.
4
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FOSRENOL is indicated in adult patients as a phosphate binding agent
for use in the control
of hyperphosphataemia in adults with chronic renal failure 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
DOSE 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. FOSRENOL oral powder can be used 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 2-3 weeks until an acceptable serum phosphate
level is reached,
with regular monitoring thereafter.
FOSRENOL Tablets V3.0 (CCDS V13.0)
2
Control of serum phosphate level has been