Land: Europeiska unionen
Språk: engelska
Källa: EMA (European Medicines Agency)
Sucroferric oxyhydroxide
Vifor Fresenius Medical Care Renal Pharma France
V03AE05
sucroferric oxyhydroxide
Drugs for treatment of hyperkalemia and hyperphosphatemia
Hyperphosphatemia; Renal Dialysis
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 is indicated for the control of serum phosphorus levels in paediatric patients 2 years of age and older with CKD stages 4-5 (defined by a glomerular filtration rate
Revision: 9
Authorised
2014-08-26
41 B. PACKAGE LEAFLET 42 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VELPHORO 500 MG CHEWABLE TABLETS iron as sucroferric oxyhydroxide 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. This medicine is used to control high blood phosphate levels (hyperphosphataemia) in: • adult patients who undergo haemodialysis or peritoneal dialysis (procedures to eliminate toxic substances from the blood) because of chronic kidney disease; • children from 2 years of age and adolescents with chronic kidney disease stages 4 and 5 (severe decrease in the ability of the kidneys to work properly) or on dialysis. 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. This medicine 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 Läs hela dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Velphoro 500 mg chewable tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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. 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 is indicated for the control of serum phosphorus levels in paediatric patients 2 years of age and older with CKD stages 4-5 (defined by a glomerular filtration rate <30 mL/min/1.73 m²) or with CKD on dialysis. Velphoro should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D 3 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 for adults and adolescents (_ ≥ _12 years of age) _ The recommended starting dose is 1,500 mg iron (3 tablets) per day, divided across the meals of the day. _Titration and maintenance for adults and adolescents (_ ≥ _12 years of age) _ Serum phosphorus levels must be monitored and the dose of sucroferric oxyhydroxide 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 usu Läs hela dokumentet