Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
patiromer sorbitex calcium, Quantity: 50.4 g (Equivalent: patiromer, Qty 25.2 g)
Seqirus Pty Ltd
Powder, oral
Excipient Ingredients: xanthan gum
Oral
30 sachets
(S4) Prescription Only Medicine
Veltassa is indicated for the treatment of hyperkalaemia in adults.
Visual Identification: Off-white to light-brown powder; occasional white particles may be present; Container Type: Sachet; Container Material: Al laminated with PE/paper; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2017-12-12
VELTASSA Page 1 of 3 VELTASSA ® 8.4 G, 16.8 G AND 25.2 G POWDER FOR ORAL SUSPENSION PATIROMER (AS SORBITEX CALCIUM) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET _ _ This leaflet answers some common questions about VELTASSA. 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 being given VELTASSA against the expected benefits it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT VELTASSA IS USED FOR VELTASSA contains the active ingredient patiromer (as sorbitex calcium). VELTASSA is used to help remove excessive amounts of potassium from the blood (hyperkalaemia). It works by binding extra potassium in your digestive tract. This increases the amount of potassium excreted and thus lowers potassium levels in your 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 VELTASSA _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE VELTASSA IF YOU HAVE AN ALLERGY TO PATIROMER SORBITEX CALCIUM OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some symptoms of an allergic reaction include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips or tongue or other parts of the body • rash, itching, or hives on the skin DO NOT TAKE IT AFTER THE EXPIRY DATE (EXP) PRINTED ON THE PACK. If you take it after the expiry date has passed, it may not work as well. DO NOT TAKE IT IF THE PACKAGING IS DAMAGED OR SHOWS SIGNS OF TAMPERING. IF YOU ARE NOT SURE WHETHER YOU SHOULD TAKE VELTASSA, TALK TO YOUR DOCTOR OR PHARMACIST. _ _ _BEFORE YOU START TO TAKE _ _VELTASSA _ TELL YOUR DOCTOR OR PHARMACIST IF YOU HAVE ALLERGIES TO ANY OTHER MEDICINES, FOODS, PRESERVATIVES OR DYES. TELL YOUR DOCTOR IF YOU HAVE Прочитајте комплетан документ
____________________________________________________________________________________________________ Page 1 of 13 AUSTRALIAN PRODUCT INFORMATION – VELTASSA ® (PATIROMER SORBITEX CALCIUM) 1 NAME OF THE MEDICINE Patiromer sorbitex calcium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of Veltassa powder for oral suspension contains 8.4 g, 16.8 g or 25.2 g of patiromer (as sorbitex calcium). For the full list of excipients, see Section 6.1 List of excipients 3 PHARMACEUTICAL FORM Veltassa powder for oral suspension is an off-white to light-brown powder, with occasional white particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Veltassa is indicated for the treatment of hyperkalaemia in adults. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE The recommended starting dose of Veltassa is 8.4 g patiromer (as sorbitex calcium) once daily. Take the prepared Veltassa suspension with or without food and preferably at the same time each day. Adjust the daily dose of Veltassa based on the serum potassium level and the desired target range. The daily dose may be increased at 1-week or longer intervals by increments of 8.4 g, or decreased by 8.4 g, as necessary to reach the desired target range, up to a maximum dose of 25.2 g daily. If serum potassium falls below the desired range, the dose should be reduced or discontinued. If a Veltassa dose is missed, the missed dose should be taken as soon as possible on the same day. The missed dose should not be taken with the next dose. Upon discontinuation of Veltassa, serum potassium levels may rise, especially if renin angiotensin aldosterone system (RAAS) inhibitor treatment is continued (see 4.4 Special warnings and precautions for use). Therefore, patients should consult their doctor before discontinuing this medication. ____________________________________________________________________________________________________ Page 2 of 13 Veltassa should be taken at least 3 hours before or after other oral medications (see 4.5 Interactions with other medicines and other fo Прочитајте комплетан документ