Fosrenol

देश: न्यूज़ीलैंड

भाषा: अंग्रेज़ी

स्रोत: Medsafe (Medicines Safety Authority)

सक्रिय संघटक:

Lanthanum carbonate hydrate 1431mg equivalent to elemental lanthanum 750mg

थमां उपलब्ध:

Takeda New Zealand Limited

डोज़:

750 mg

फार्मास्यूटिकल फॉर्म:

Powder for oral solution

रचना:

Active: Lanthanum carbonate hydrate 1431mg equivalent to elemental lanthanum 750mg 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: Sachet, laminate, PET/aluminium/PE foil (9x10 sachets) - 90 dose units - 36 months from date of manufacture stored at or below 25°C

प्राधिकरण की तारीख:

2018-07-11

उत्पाद विशेषताएं

FOSRENOL POWDER V3.0 (CCDS V13.0)
1
NEW ZEALAND DATA SHEET
1
FOSRENOL
®
750 MG AND 1000 MG ORAL POWDER
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FOSRENOL oral powder is presented in sachets. Each sachet contains
lanthanum carbonate
hydrate corresponding to 750 mg or 1000 mg lanthanum.
Excipient(s) with known effect:
Each 750mg sachet contains 641.7 mg and 1000mg sachet contains 855.6
mg of dextrates,
containing glucose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL
FORM
Oral powder.
APPEARANCE
White to off-white powder.
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
Patients should adhere to recommended diets in order to control
phosphate and fluid intake.
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 l