البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Sevelamer carbonate
Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.
Sevelamer carbonate
270 Tablets; 30 Tablets
DR. REDDY'S LABORATORIES LIMITED
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ CAVSAMIR Sevelamer carbonate Tablets 800 mg 1 WHAT IS IN THIS LEAFLET 1. What Cavsamir is used for 2. How Cavsamir works 3. Before you use Cavsamir 4. How to use Cavsamir 5. While you are using it 6. Side effects 7. Storage and Disposal of Cavsamir 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT CAVSAMIR IS USED FOR Cavsamir is used for patients who have kidneys that do not work properly are not able to control the level of serum phosphorus in their blood. The amount of phosphate then rises (your doctor will call this hyperphosphataemia). Increased levels of serum phosphorus can lead to hard deposits in your body called calcification. These deposits is can stiffen your blood vessels and make it harder for blood to be pumped around the body. Increased serum phosphorus can also lead to itchy skin, red eyes, bone pain and fractures. HOW CAVSAMIR WORKS Cavsamir contains sevelamer carbonate as the active ingredient. It binds phosphate from food in the digestive tract and so reduces serum phosphorus levels in the blood. BEFORE YOU USE CAVSAMIR _-When you must not use it _ Do not take Cavsamir if: • You are allergic (hypersensitive) to sevelamer carbonate or to any of the other ingredients of this medicine (listed in Section 8 below). -Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue • You have low levels of phosphate in your blood (your doctor will check this for you) • You have bowel obstruction. _-Before you start to use it_ Check with your doctor before taking Cavsamir if: • You have swallowing problems • You have problems related with motility (movement) in your stomach and bowel • You are being sick frequently • You have active inflammation of the bowel • You have undergone major surgery on your stomach or bowel • You have severe constipation. _Additional treatments: _ Due to either your kidney condition اقرأ الوثيقة كاملة
ARTWORK APPROVAL FORM UNIT: FTO-HO DEPARTMENT: Packaging Development PAGE: 1 of 2 Component: Leaflet Product Name: CAVSAMIR Strength: 800 mg Counts: NA Market / Customer: Malaysia Material Code: 150086414 Supersedes:150086020 REFERENCE SOP NO. SOP-GLOB-PG-0002 LEGACY DOCUMENT NO. FTCPD033/A02 Any Comments: Approval from CMS / Marketing / Country Manager / Country Regulatory / Customer enclosed (tick as applicable) Dimensions: (WxH) 170 x 380 mm PANTONE CODES Version No: 00 WI-GLOB-PG-0002-2.0 BLACK C (W) 170 mm Dimensions: (WxH) 170 x 380 mm Folding: 30 x 30 mm 30 mm 30 mm 30 mm CAVSAMIR 150086414 CAVSAMIR 150086414 62 mm For paediatric patients the oral suspension should be administered, as tablet formulations are not appropriate for this population. F) ROUTE OF ADMINISTRATION For oral use. Tablets should be swallowed intact and should not be crushed, chewed, or broken into pieces prior to administration. G) CONTRAINDICATIONS • Hypersensitivity to the active substance or to any of the excipients • Hypophosphataemia • Bowel obstruction. H) SPECIAL WARNINGS AND PRECAUTIONS FOR USE Sevelamer is currently not recommended for use in adult patients with chronic kidney disease not on dialysis with serum phosphorus < 1.78 mmol/l. Caution should be exercised when Sevelamer is used in patients with the following disorders: • Dysphagia • swallowing disorders • Severe gastrointestinal motility disorders including untreated or severe constipation or major gastrointestinal tract surgery. Use with caution in patients with these gastrointestinal disorders. Monitor serum chemistries: Bicarbonate and chloride levels should be monitored. Reductions in Vitamins A, D, E, K (clotting factors) and Folic Acid Levels: Patients with CKD may develop low levels of fat-soluble vitamins A, D, E and K, depending on dietary intake and the severity of their disease. It cannot be excluded that Sevelamer can bind fat-soluble vitamins contained in ingested food. In patients not taking supplemental vitamins but on sevelamer, serum vitam اقرأ الوثيقة كاملة