Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
risedronate sodium hemipentahydrate, Quantity: 34.43 mg (Equivalent: risedronate sodium, Qty 30 mg)
Arrotex Pharmaceuticals Pty Ltd
Risedronate sodium hemipentahydrate
Tablet, film coated
Excipient Ingredients: lactose monohydrate; hyprolose; crospovidone; microcrystalline cellulose; magnesium stearate; hypromellose; macrogol 400; titanium dioxide
Oral
28, 14
(S4) Prescription Only Medicine
Treatment of Paget?s disease of bone
Visual Identification: White to off-white coloured, circular shaped film coated biconvex tablets debossed with 'L' on one side and '30' on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2012-10-03
AURO-RISEDRONATE CONSUMER MEDICINE INFORMATION Ver 1.1 Page 1 of 4 AURO-RISEDRONATE 5, 30 & 35 Risedronate Sodium (as hemipentahydrate) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about AURO- RISEDRONATE. 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 AURO-RISEDRONATE 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 AURO-RISEDRONATE IS USED FOR AURO-RISEDRONATE is used to treat bone disease and belongs to a group of medicines called bisphosphonates. AURO-RISEDRONATE works directly on your bones to make them stronger and therefore less likely to break or fracture. AURO-RISEDRONATE 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 AURO-RISEDRONATE 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 Lees het volledige document
Product Information: AURO-RISEDRONATE (Risedronate Sodium Tablets 5 mg, 30 mg & 35 mg) Ver 1.1 Page 1 of 22 PRODUCT INFORMATION AURO-RISEDRONATE 5 (5 MG RISEDRONATE SODIUM TABLETS) AURO-RISEDRONATE 30 (30 MG RISEDRONATE SODIUM TABLETS) AURO-RISEDRONATE 35 (35 MG RISEDRONATE SODIUM TABLETS) 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. AURO-RISEDRONATE 5, 30 & 35 is available as tablets containing 5 mg, 30 mg & 35 mg risedronate sosium as hemipentahydrate. AURO-RISEDRONATE tablets contain following inactive ingredients: Lactose, microcrystalline cellulose (PH 101 & PH 102), hydroxypropylcellulose, crospovidone, magnesium stearate. Each AURO-RISEDRONATE 5 tablet also contains Opadry Yellow 20C82695 (PI ARTG- 106484). Each AURO-RISEDRONATE 30 tablet also contains hypromellose, macrogol 400 & titanium dioxide. Each AURO-RISEDRONATE 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 Product Information: AURO-RISEDRONATE (Risedronate Sodium Tablets 5 mg, 30 mg & 35 mg) Ver 1.1 Page 2 of 22 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 Lees het volledige document