国: ニュージーランド
言語: 英語
ソース: Medsafe (Medicines Safety Authority)
Sevelamer carbonate 2400mg
sanofi-aventis new zealand limited
Sevelamer carbonate 2400 mg
2.4 g
Powder for oral suspension
Active: Sevelamer carbonate 2400mg Excipient: 'Natural and Artificial Citrus Cream' proprietary flavouring Iron oxide yellow Propylene glycol alginate Sodium chloride Sucralose
Prescription
Genzyme Ltd
Renvela is indicated for the management of hyperphosphataemia in adult patients with stage 4 and 5 chronic kidney disease.
Package - Contents - Shelf Life: Sachet, Opaque, foil lined heat sealed - 15 dose units - 36 months from date of manufacture stored at or below 25°C protect from moisture. Do not refrigerate. - Sachet, Opaque, foil lined heat sealed - 60 dose units - 36 months from date of manufacture stored at or below 25°C protect from moisture. Do not refrigerate. - Sachet, Opaque, foil lined heat sealed - 90 dose units - 36 months from date of manufacture stored at or below 25°C protect from moisture. Do not refrigerate.
2014-06-05
RENVELA ® 1 RENVELA ® _Sevelamer carbonate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Renvela. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Renvela against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET . You may need to read it again. WHAT RENVELA IS USED FOR Renvela contains the active substance sevelamer carbonate and is used to treat hyperphosphatemia, a condition caused by too much dietary phosphorus being retained in your body due to a diseased kidney. Increased levels of serum phosphorus can lead to hard deposits in your body called calcification. These deposits can stiffen your blood vessels and make it harder for blood to be pumped around the body. Renvela helps to remove excess phosphorus that has built up in your body by binding the phosphorus that is in the food that you eat. Your doctor, however, may have prescribed Renvela for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU . This medicine is only available with a doctor's prescription. BEFORE YOU TAKE RENVELA _WHEN YOU MUST NOT TAKE _ _RENVELA _ DO NOT TAKE RENVELA IF YOU HAVE AN ALLERGY TO: • any medicine containing sevelamer carbonate (the active ingredient) • any of the ingredients listed at the end of this leaflet • any other similar medicine, such as sevelamer hydrochloride. Symptoms that may indicate an allergic reaction include • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. Tell your doctor if you are experiencing these symptoms. DO NOT TAKE RENVELA IF YOU HAVE: • hypophosphatemia, a condition where you do not have enough phosphorus in 完全なドキュメントを読む
renvela-ccdsv8-dsv4-09apr20 Page 1 NEW ZEALAND DATA SHEET 1 PRODUCT NAME Renvela 800mg film coated tablet Renvela 1.6g powder for oral suspension Renvela 2.4g powder for oral suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Renvela film-coated tablet contains 800 mg of sevelamer carbonate on an anhydrous basis. Each Renvela sachet contains 1.6 g or 2.4 g of sevelamer carbonate for oral suspension on an anhydrous basis. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Renvela film-coated tablets: white oval film-coated tablets imprinted with “RENVELA 800” on one side and are blank on the other side. Renvela powder for oral suspension: pale yellow powder free from foreign particles in a sachet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Renvela is indicated for the management of hyperphosphataemia in adult patients with stage 4 and 5 chronic kidney disease. 4.2 DOSE AND METHOD OF ADMINISTRATION Renvela is available as tablets or powder for oral suspension. renvela-ccdsv8-dsv4-09apr20 Page 2 Renvela should be taken in conjunction with a prescribed diet for the management of hyperphosphatemia. Renvela 800 mg tablets must be taken three times per day with meals at a dosage based on individual patient requirements to control phosphate levels. Tablets should be swallowed intact and should not be crushed, chewed, or broken into pieces prior to administration. Patients should swallow the tablets whole with water. Renvela 1.6 or 2.4 g powder sachet must be taken three times per day with meals individually or in combination at a dosage based on individual patient requirements to control phosphate levels. The powder should be dispersed in water (40 ml for 1.6 g powder sachet and 60 ml for 2.4 g powder sachet) prior to administration. Multiple sachets may be mixed together, as long as the appropriate amount of water is used. Patients should drink the preparation within 30 minutes. STARTING DOSE The recommended starting dose of Renvela is 2.4 to 4.8 g per day base 完全なドキュメントを読む