देश: सिंगापुर
भाषा: अंग्रेज़ी
स्रोत: HSA (Health Sciences Authority)
sucroferric oxyhydroxide 2,500mg eqv iron
FRESENIUS KABI (SINGAPORE) PTE LTD
V03AE05
TABLET, CHEWABLE
sucroferric oxyhydroxide 2,500mg eqv iron 500 mg
ORAL
Prescription Only
Catalent Germany Schorndorf GmbH
ACTIVE
2015-01-29
VELPHORO ® 1. NAME OF THE MEDICINAL PRODUCT Velphoro ® (sucroferric oxyhydroxide) chewable tablet 500 mg iron. 2. QUALITATIVE AND QUANTI TATIVE COMPOSITION Each tablet of Velphoro contains sucroferric oxyhydroxide corresponding to 500 mg iron. The sucroferric oxyhydroxide contained in one tablet is comprised of polynuclear iron (III)-oxyhy - droxide (containing 500 mg iron),750 mg sucrose and 700 mg starches (potato starch and prege- latinised maize starch). For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Chewable tablet. Red-brown, round, flat-faced tablets embossed with PA500 on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Velphoro is indicated for the control of serum phosphorus levels in adult patients with end- stage renal disease (ESRD) on haemodialysis or peritoneal dialysis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Velphoro is for oral administration only. POSOLOGY STARTING DOSE The recommended starting dose of Velphoro is 1,500 mg iron (3 tablets) per day administered as 1 tablet (500 mg iron) 3 times daily with meals. TITRATION AND MAINTENANCE Serum phosphorus levels must be monitored and the dose of Velphoro up or down titrated in incre- ments of 500 mg iron (1 tablet) per day as needed every 1–2 weeks until an acceptable serum phos- phorus level is reached, with regular monitoring afterwards. In clinical practice, treatment will be based on the need to control serum phosphorus levels. In case of hypophosphatemia occurring during the titra - tion and maintenance phase, Velphoro should be down titrated to achieve appropriate serum phos - phorus levels. Based on clinical studies, on average patients required 1,500 mg iron to 2,000 mg iron (3 to 4 tab- lets) a day to control serum phosphorus level. If one or more doses are missed, the normal dose of the medicinal product should be resumed with the next meal. MAXIMUM TOLERATED DAILY DOSE The maximum recommended dose is 3,000 mg iron (6 tablets). SPECIAL POPULATIONS PAEDIATRIC POPULATION The safety and effica पूरा दस्तावेज़ पढ़ें