Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
sucroferric oxyhydroxide, Quantity: 2500 mg
Seqirus Pty Ltd
sucroferric oxyhydroxide
Tablet, chewable
Excipient Ingredients: colloidal anhydrous silica; neohesperidin-dihydrochalcone; magnesium stearate; Flavour
Oral
30 (as both sale and starter packs), 90
(S4) Prescription Only Medicine
Velphoro is indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease (CKD) on dialysis.
Visual Identification: VELPHORO chewable tablets are brown, round, flat faced tablets embossed with PA500 on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2014-11-27
Vifor Pharma Pty Ltd Version 09 1 VELPHORO ® 500 MG CHEWABLE TABLETS_ _ _EACH CHEWABLE TABLET CONTAINS 500 MG IRON (EQUIVALENT TO 2500 MG _ _SUCROFERRIC OXYHYDROXIDE) _ CONSUMER MEDICINE INFORMATION _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about VELPHORO. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT VELPHORO IS USED FOR VELPHORO is used to control the phosphorus levels in the blood of patients with chronic kidney disease (CKD) on dialysis. It contains 2.5 g of the active substance sucroferric oxyhydroxide which corresponds to 500 mg iron. This medicine belongs to a group of drugs used when the levels of phosphorus in blood are too high (a condition called hyperphosphataemia). The active ingredient works by binding phosphate from food in the digestive tract. This reduces how much is absorbed and the levels of phosphorus in the blood. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU TAKE VELPHORO _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • the active substance sucroferric oxyhydroxide, or to any of the other ingredient(s) listed at the end of this leaflet • any other similar medicines Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin DO NOT TAKE THIS MEDICINE IF YOU HAVE TOO MUCH IRON IN YOUR BODY (HAEMOCHROMATOSIS) OR ANY OTHER PROBLEMS WITH THE IRON LEVELS IN YOUR BODY. DO NOT TAKE THIS MEDICINE A Lestu allt skjalið
_Velphoro _ _®_ _ _ _ _ _ _ _Page 1/13 _ AUSTRALIAN PRODUCT INFORMATION - VELPHORO ® (SUCROFERRIC OXYHYDROXIDE) CHEWABLE TABLETS 1. NAME OF THE MEDICINE Sucroferric oxyhydroxide 2. QUALITATIVE AND QUANTITIATIVE COMPOSITION Each Velphoro chewable tablet contains 500 mg iron, equivalent to 2500 mg sucroferric oxyhydroxide. The active ingredient sucroferric oxyhydroxide contains 750 mg sucrose and 700 mg starches. For the full list of excipients see SECTION 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Velphoro chewable tablets are brown, round, flat-faced, chewable 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 chronic kidney disease (CKD) on dialysis. 4.2. DOSE AND METHOD OF ADMINISTRATION Tablets must be taken with meals, chewed and not swallowed whole. The tablets may be crushed as an aid to chewing. Patients receiving Velphoro should adhere to their prescribed diets. STARTING DOSE The recommended starting dose of Velphoro is 1,500 mg iron per day (3 tablets). Velphoro is for oral administration only and must be taken with meals. 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. _Velphoro _ _®_ _ _ _ _ _ _ _Page 2/13 _ 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 to 2,000 mg iron per day (3 to 4 tablets). If one or more doses are missed, the normal dose of the medication should be resumed with the next meal. MAXIMUM TOLERATED DAILY DOSE The maximum recommended dose is 3,000 mg iron (6 tablets) per day. PAEDIATRIC POPULATION The safety and efficacy of Velphoro in children below the age of 18 years has n Lestu allt skjalið