البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
alendronate sodium, Quantity: 91.37 mg (Equivalent: alendronic acid, Qty 70 mg); colecalciferol, Quantity: 0.0693 mg
ORGANON PHARMA PTY LTD
alendronate sodium
Tablet, uncoated
Excipient Ingredients: croscarmellose sodium; colloidal anhydrous silica; lactose; microcrystalline cellulose; magnesium stearate; purified water; Gelatin; aluminium starch octenylsuccinate; aluminium sodium silicate; sucrose; medium chain triglycerides
Oral
4 Tablets, 1 Tablet
Medicine Registered
(S4) Prescription Only Medicine
The treatment of osteoporosis in select patients where vitamin D supplementation is recommended.
Visual Identification: White to off-white, modified capsule-shaped tablets with code 710 on one side and an outline of a bone image on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2006-03-08
FOSAMAX PLUS™ ONCE WEEKLY _Alendronate sodium/colecalciferol_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about FOSAMAX PLUS. It is particularly important that you read the sections "When to take it" and "How to take it" before you take this medicine. This leaflet 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 FOSAMAX PLUS 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 WITH THE MEDICINE. You may need to read it again. WHAT FOSAMAX PLUS IS USED FOR FOSAMAX PLUS is used to treat osteoporosis and to provide additional vitamin D. Osteoporosis is caused by changes in the way bone is normally maintained. Vitamin D is an essential nutrient required for calcium absorption and healthy bones. _UNDERSTANDING BONE_ Bone is a living, growing tissue. Throughout life, our bodies are breaking down old bone and rebuilding new bone in a continuous cycle. Until our late 20s, while bones are still developing, we gain bone by building more than we lose. From then until about age 35 the process is usually in balance, so that the amount of bone lost is about equal to the amount that is replaced. This balanced process keeps your skeleton healthy and strong. After about age 35 this balance is disturbed, with bone loss occurring at a slightly faster rate than it can be replaced. In women, after menopause, hormonal changes cause bone loss at an even faster rate. When bone loss is excessive, bones can become thinner and weaker, and therefore are more likely to break. _OSTEOPOROSIS_ "Osteo" means bone, and "porosis" means something that has holes in it, like a sponge. Therefore, osteoporosis is a disease which causes bones to become more porous, gradually making them weaker, more brittle and likely to break. Osteoporosis is co اقرأ الوثيقة كاملة
FOSAMAX PLUS PI Page 1 of 27 S-WPC-MK0217-MF-052015, S-WPC-MK0217A-T-052015 [Organon] Proprietary AUSTRALIAN PRODUCT INFORMATION- FOSAMAX PLUS ™ (ALENDRONATE SODIUM/COLECALCIFEROL) 1 NAME OF THE MEDICINE FOSAMAX PLUS tablets contain alendronate sodium and colecalciferol (vitamin D 3 ). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Alendronate is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Colecalciferol is a white, crystalline, odourless powder. Colecalciferol is practically insoluble in water, freely soluble in usual organic solvents, and slightly soluble in vegetable oils. Each tablet of FOSAMAX PLUS 70 mg/70 μg contains 91.4 mg of alendronate sodium, which is the molar equivalent to 70 mg of alendronic acid, and 70 μg of colecalciferol equivalent to 2800 IU vitamin D. Each tablet of FOSAMAX PLUS 70 mg/140 μg contains 91.4 mg of alendronate sodium, which is the molar equivalent to 70 mg of alendronic acid, and 140 μg of colecalciferol equivalent to 5600 IU vitamin D. List of excipients with known effect: lactose, sucrose For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM FOSAMAX PLUS (alendronate sodium/colecalciferol) 70 mg/ 70 µg Once Weekly Tablet, providing 2800 IU vitamin D 3 . White to off-white, modified capsule-shaped tablet with the outline of a bone image on one side and 710 on the other._ _ FOSAMAX PLUS (alendronate sodium/colecalciferol) 70 mg/ 140 µg, once weekly tablet, providing 5600 IU vitamin D 3 . White to off-white, modified rectangle-shaped tablet with "270" on one side and a bone image on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FOSAMAX PLUS Once Weekly tablet and FOSAMAX PLUS 70 mg/140_ _µg are indicated for the treatment of: • Osteoporosis* in select patients where vitamin D supplementation is recommended * Prior to treatment, osteoporosis must be confirmed by: • the finding of low bone mass of at least 2 standard deviat اقرأ الوثيقة كاملة