Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sucroferric oxyhydroxide
Vifor Fresenius Medical Care Renal Pharma UK Ltd
V03AE05
Sucroferric oxyhydroxide
500mg
Chewable tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 7640114723773
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VELPHORO 500 MG CHEWABLE TABLETS Iron as sucroferric oxyhydroxide This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Velphoro is and what it is used for 2. What you need to know before you take Velphoro 3. How to take Velphoro 4. Possible side effects 5. How to store Velphoro 6. Contents of the pack and other information 1. WHAT VELPHORO IS AND WHAT IT IS USED FOR Velphoro is a medicine that contains the active substance sucroferric oxyhydroxide, which is made up from iron, sugar (sucrose) and starches. One tablet of Velphoro corresponds to 500 mg iron. Each tablet also contains 750 mg sucrose and 700 mg 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). 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. V Preberite celoten dokument
OBJECT 1 VELPHORO 500 MG CHEWABLE TABLETS Summary of Product Characteristics Updated 11-Apr-2018 | Vifor Fresenius Medical Care Renal Pharma UK Ltd This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. Name of the medicinal product Velphoro 500 mg chewable tablets 2. Qualitative and quantitative composition Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide also known as a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches. The active ingredient sucroferric oxyhydroxide contains 750 mg sucrose and 700 mg starches. For the full list of excipients, see section 6.1. 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 wil Preberite celoten dokument