Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Sucroferric Oxyhydroxide
FRESENIUS KABI MALAYSIA SDN. BHD
Sucroferric Oxyhydroxide
90 Tablets; 30 Tablets; 90 Tablets; 30 Tablets; 90 Tablets; 30 Tablets; 90 Tablets; 30 Tablets
Vifor SA
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ CHEWABLE TABLET 500MG VELPHORO Iron (as sucroferric oxyhydroxide) 500mg WHAT IS IN THIS LEAFLET 1.What Velphoro is used for 2.How Velphoro works 3.Before you use Velphoro 4.How to use Velphoro 5.While you are using it 6.Side effects 7. Storage and Disposal of Velphoro 8. Product Description 9.Manufacturer and Product Registration Holder 10.Date of Revision 11. Serial number 1. WHAT VELPHORO IS USED FOR Velphoro is a medicine that contains the active substance sucroferric oxyhydroxide, which is made up from iron, sugar (sucrose) and starches. Velphoro is for use by adult patients who undergo haemodialysis or peritoneal dialysis (procedures to eliminate toxic substances from the blood) because of chronic kidney disease; it is used in order to help control the phosphorus level in their blood when it is too high (hyperphosphataemia). 2. HOW VELPHORO WORKS Too much phosphorus in the blood can lead to calcium being deposited in tissues (calcification). This can result in stiffening of the blood vessels, making it harder for the blood to be pumped around the body. It may also lead to calcium deposits in soft tissues and bone causing effects such as red eyes, itchy skin and bone pain. Velphoro works by binding phosphorus from food in your digestive tract (stomach and intestines). This reduces the amount of phosphorus that can be absorbed into the bloodstream and thus lowers phosphorus levels in your blood. 3. BEFORE YOU USE VELPHORO WHEN YOU MUST NOT USE IT: - if you are allergic to sucroferric oxyhydroxide or any of the other ingredients of this medicine (listed in section 8) - if you have a history of abnormal iron build-up in your organs (haemochromatosis) - if you have any other disorder associated with too much iron. If you are not sure, talk to your doctor before taking this medicine. BEFORE YOU START TO USE IT Talk to your doctor or pharmacist before taking Velphoro: - if you have had peritonitis, an inflammation of the peritoneum (the thin tissue that lines the in Läs hela dokumentet
Velphoro PI Malaysia V3 – 03 Feb 2023 Page 1 / 9 . NAME OF THE MEDICINAL PRODUCT Velphoro 500 mg chewable tablets 2. PRODUCT DESCRIPTION Each chewable tablet contains sucroferric oxyhydroxide corresponding to 500 mg iron. The sucroferric oxyhydroxide contained in one tablet is comprised of polynuclear iron(III)- oxyhydroxide (containing 500 mg iron), 750 mg sucrose and 700 mg starches (potato starch and pregelatinised maize starch). For the full list of excipients, see section 6.1. Velphoro is provided in HDPE bottles containing 30 or 90 tablets, packed in a single carton with a package insert (see section 6.5). 3. PHARMACEUTICAL FORM Chewable tablet. Brown, circular tablets embossed with PA500 on one side. Tablets have a 20 mm diameter and a thickness of 6.5 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Velphoro is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD). Velphoro should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues, or calcimimetics to control the development of renal bone disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Starting dose _ The recommended starting dose of Velphoro is 1,500 mg iron (3 tablets) per day, divided across the meals of the day. Velphoro is for oral administration only and must be taken with meals. Patients receiving Velphoro should adhere to their prescribed diets. _Titration and maintenance _ Serum phosphorus levels must be monitored and the dose of Velphoro up or down titrated in increments of 500 mg iron (1 tablet) per day every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring afterwards. In clinical practice, treatment will be based on the need to control serum phosphorus levels, though patients who respond to Velphoro therapy usually achieve optimal serum phosphorus levels at doses of 1,500 -2,000 mg iron p Läs hela dokumentet