Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
risedronate sodium hemipentahydrate, Quantity: 5.74 mg (Equivalent: risedronate sodium, Qty 5 mg)
Amneal Pharma Australia Pty Ltd
Risedronate sodium hemipentahydrate
Tablet, film coated
Excipient Ingredients: magnesium stearate; lactose monohydrate; microcrystalline cellulose; crospovidone; hyprolose; titanium dioxide; hypromellose; macrogol 8000; colloidal anhydrous silica; iron oxide yellow; macrogol 400
Oral
14, 28
(S4) Prescription Only Medicine
? Treatment of osteoporosis,? Treatment of glucocorticoid-induced osteoporosis,? Preservation of bone mineral density in patients on long term corticosteroid therapy
Visual Identification: Yellow coloured, circular shaped, beveled edge, film-coated biconvex tablets debossed with 'X' on one side and '61' on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2012-10-03
Risedronate AN CMI v 2.0 Page 1 of 4 RISEDRONATE AN Risedronate Sodium (as hemipentahydrate) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about RISEDRONATE AN. 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 RISEDRONATE AN against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT RISEDRONATE AN IS USED FOR RISEDRONATE AN is used to treat bone disease and belongs to a group of medicines called bisphosphonates. RISEDRONATE AN works directly on your bones to make them stronger and therefore less likely to break or fracture. RISEDRONATE AN 5mg daily & 35mg Once-a- Week tablets are used to treat: osteoporosis (brittle or fragile bones that may fracture easily) osteoporosis caused by taking steroids RISEDRONATE AN 30mg tablets are used to treat: Paget's disease of the bone. These conditions are caused by changes in the way bone is normally maintained. _ _ _UNDERSTANDING BONE_ Bone is a living tissue consisting of calcium and other minerals. Throughout life, old bone is constantly broken down and replaced with new bone. After the age of 35, bone loss may occur faster than your body can replace it. If you lose too much bone then they become weaker and are more likely to break. _OSTEOPOROSIS _ Osteoporosis (brittle bone disease) is a disease that causes bones to become weaker. Weak bones break (fracture) easily. Many patients with osteoporosis have no symptoms and may not even know that they have osteoporosis. However osteoporosis makes you more likely to break bones when you have a fall or bump. The spine, hip and wrist are the most likely bones to break, although this can happen to any bone in your body. Osteoporosis can also cause back pain, Przeczytaj cały dokument
_Risedronate AN tablets Product Information _ _ _ _ _ _ Amneal Pharma Australia Pty Ltd _ Risedronate AN PI v 2.0 Page 1 RISEDRONATE AN _ _ _(RISEDRONATE SODIUM TABLETS) _ _ _ PRODUCT INFORMATION _ _ NAME OF THE MEDICINE Risedronate Sodium Hemipentahydrate CHEMICAL NAME: [1-hydroxy-2-(3-pyridinyl)-ethylidene]Bisphosphonic acid monosodium salt, hemipentahydrate MOLECULAR FORMULA: C 7 H 10 NO 7 P 2 Na.2.5 H 2 O MOLECULAR WEIGHT: 350.13 CAS REGISTRY NUMBER: _[329003-65-8]_ DESCRIPTION Risedronate sodium hemipentahydrate is a white to off-white powder. It is soluble in water and insoluble in common organic solvents. RISEDRONATE AN is available as tablets containing 5 mg, 30 mg & 35 mg risedronate sodium as hemipentahydrate. RISEDRONATE AN tablets contain following inactive ingredients: Lactose, microcrystalline cellulose (PH 101 & PH 102), hydroxypropylcellulose, crospovidone, magnesium stearate. Each RISEDRONATE AN 5 tablet also contains Opadry Yellow 20C82695 (PI ARTG-106484). Each RISEDRONATE AN 30 tablet also contains hypromellose, macrogol 400 & titanium dioxide. Each RISEDRONATE AN 35 tablet also contains Opadry Brown 20C86893 (PI ARTG-106485). PHARMACOLOGY Risedronate is a potent pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast-mediated bone resorption. Risedronate is a third generation bisphosphonate. In preclinical studies risedronate demonstrated potent anti-osteoclast and anti-resorptive activity, increasing bone mass and biomechanical strength dose-dependently. The activity of risedronate was confirmed by bone marker measurements during pharmacodynamic and clinical studies. With risedronate 5 mg daily, decreases in biochemical markers of bone turnover were observed within 1 month of treatment and reached a maximum decrease in 3-6 months, remaining stable during the _Risedronate AN tablets Product Information _ _ _ _ _ _ Amneal Pharma Australia Pty Ltd _ Risedronate AN PI v 2.0 Page 2 course of therapy. This data demonstrates that risedronate causes a moderate reduction in Przeczytaj cały dokument