Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
lanthanum carbonate hydrate, Quantity: 1908 mg
Takeda Pharmaceuticals Australia Pty Ltd
Lanthanum carbonate hydrate
Tablet, chewable
Excipient Ingredients: dextrates; magnesium stearate; silicon dioxide
Oral
15 tablets
(S4) Prescription Only Medicine
Treatment of hyperphosphataemia in adults with chronic renal failure on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Visual Identification: White to off white round, flat, bevel-edged tablet debossed on one side with S405 above 1000. 22 mm diameter.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2005-11-08
FOSRENOL ® _500 MG, 750 MG, 1000 MG CHEWABLE TABLETS_ _Lanthanum carbonate hydrate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET PLEASE READ THIS LEAFLET BEFORE YOU START TAKING FOSRENOL. This leaflet answers some common questions about FOSRENOL chewable tablets. It does not contain all of the available information. This information is not intended to replace the advice of your health care professional. All medicines have risks and benefits. Your doctor has weighed the risks of you taking FOSRENOL against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING FOSRENOL, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT FOSRENOL IS USED FOR Phosphorus is found in your body as "Phosphate" and is needed for building strong teeth and bones as well as keeping other parts of your body healthy. When your kidneys fail to work properly, phosphate can build up in the blood. This build up of excess phosphate is called hyperphosphataemia. FOSRENOL is a phosphate binder and is used to lower the amount of phosphate in your body. It prevents the body from absorbing the phosphate from the food you eat. The phosphate in the food binds to FOSRENOL and is carried through the digestive tract to be eliminated in your stool. FOSRENOL tablets are not addictive. FOSRENOL tablets are only available on a doctor's prescription. BEFORE YOU TAKE FOSRENOL FOSRENOL chewable tablets are not suitable for everyone. _WHEN YOU MUST NOT TAKE_ _FOSRENOL_ DO NOT TAKE FOSRENOL IF: • you are hypersensitive (allergic) to lanthanum carbonate hydrate or any of the other ingredients of FOSRENOL listed at the end of this leaflet • you have too little phosphate in your blood (hypophosphataemia). _BEFORE YOU START TO TAKE_ _FOSRENOL_ YOU MUST TELL YOUR DOCTOR IF: • you have reduced liver function. It is possible that your liver will not be able to "clean" FOSRENOL from your body adequately • you have a disease involving the gastrointestinal tract • you have C Olvassa el a teljes dokumentumot
FOSRENOL Tablets V2 CCDS V12.1 1 AUSTRALIAN PRODUCT INFORMATION FOSRENOL ® (LANTHANUM CARBONATE HYDRATE) – CHEWABLE TABLETS 1 NAME OF THE MEDICINE Lanthanum carbonate hydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION FOSRENOL is presented as chewable tablets. Each tablet contains lanthanum carbonate hydrate corresponding to 500 mg, 750 mg or 1000 mg lanthanum. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Tablet, chewable • FOSRENOL 500 mg: White, round, bevel-edged flat tablets debossed with ‘S405/500’ on one side. • FOSRENOL 750 mg: White to off-white round, flat bevel-edged tablets debossed on one side with ‘S405’ above ‘750’. • FOSRENOL 1000 mg: White to off-white round, flat bevel-edged tablets debossed on one side with ‘S405’ above ‘1000’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hyperphosphataemia in adults with chronic renal failure on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD) 4.2 DOSE AND METHOD OF ADMINISTRATION Patients should adhere to recommended diets in order to control phosphate and fluid intake. FOSRENOL tablets must be chewed completely before swallowing. The tablets may be crushed as an aid to chewing. Intact tablets must not be swallowed whole. ADULTS, INCLUDING ELDERLY (>65 YEARS) For patients taking FOSRENOL for the first time, the starting dose may be determined individually based on serum phosphate concentration as indicated in the following table (Table 1): TABLE 1 PRE-TREATMENT SERUM PHOSPHATE LEVEL RECOMMENDED INITIAL DAILY DOSE OF FOSRENOL >1.8 and ≤2.4 mmol/L 750 mg >2.4 and ≤2.9 mmol/L 1500 mg >2.9 mmol/L 2250 mg FOSRENOL Tablets V2 CCDS V12.1 2 FOSRENOL should be taken with or immediately after food, with the daily dose divided between meals, i.e. three times daily. 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. Control of s Olvassa el a teljes dokumentumot