Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
LANTHANUM AS CARBONATE HYDRATE
TAKEDA ISRAEL LTD
V03AE03
CHEWABLE TABLETS
LANTHANUM AS CARBONATE HYDRATE 500 MG
PER OS
Required
SHIRE PHARMACEUTICAL CONTRACTS LTD, UK
LANTHANUM CARBONATE
LANTHANUM CARBONATE
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 > or = 1.78 mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels.
2014-04-30
- Regulations (Preparations) Patient leaflet in accordance with the Pharmacists' 1986 This medicine is dispensed with physician’s prescription only Fosrenol ® 500 mg chewable tablets Fosrenol ® 750 mg chewable tablets Fosrenol ® 1000 mg chewable tablets Each chewable tablet contains 500 mg; 750 mg; 1000 mg of the active ingredient lanthanum (as carbonate hydrate), respectively. 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. Attention: Do not swallow! You must chew the tablet completely. It is important to take the medicine with or immediately after a meal. 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. Đọc toàn bộ tài liệu
SUMMARY OF THE PRODUCT CHARACTERISTICS 1 N AME OF THE M EDICINAL P RODUCT Fosrenol 500 mg chewable tablets Fosrenol 750 mg chewable tablets Fosrenol 1000 mg chewable tablets 2 Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Fosrenol 500 mg chewable tablets: Each chewable tablet contains lanthanum carbonate hydrate corresponding to 500 mg lanthanum. Fosrenol 750 mg chewable tablets: Each chewable tablet contains lanthanum carbonate hydrate corresponding to 750 mg lanthanum Fosrenol 1000 mg chewable tablets: Each chewable tablet contains lanthanum carbonate hydrate corresponding to 1000 mg lanthanum. Excipient(s) with known effect Fosrenol 500 mg chewable tablets: Chewable tablets also contain on average 1066 mg of dextrates, containing glucose. Fosrenol 750 mg chewable tablets: Chewable tablets also contain on average 1599 mg of dextrates, containing glucose. Fosrenol 1000 mg chewable tablets: Chewable tablets also contain on average 2132 mg of dextrates, containing glucose. For the full list of excipients, see section 6.1. 3 P HARMACEUTICAL F ORM Chewable tablet. Fosrenol 500 mg chewable tablets: White, round, 18mm, bevelled-edge flat tablets debossed with ‘S405/500’ on one side. Fosrenol 750 mg chewable tablets: White, round, 20mm, bevelled-edge flat tablets debossed with ‘S405/750’ on one side. Fosrenol 1000 mg chewable tablets: White, round, 22mm, bevelled-edge flat tablets debossed with ‘S405/1000’ on one side. 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. The tablets must be chewed completely and no Đọc toàn bộ tài liệu