Country: Israel
Language: English
Source: Ministry of Health
LANTHANUM AS CARBONATE HYDRATE
TAKEDA ISRAEL LTD
V03AE03
POWDER
LANTHANUM AS CARBONATE HYDRATE 750 MG
PER OS
Required
SHIRE PHARMACEUTICALS IRELAND LIMITED , IRELAND
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 ≥ 1.78 mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels.
2019-12-31
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 Read the complete document
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 Read the complete document