Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
alendronate sodium, Quantity: 91.37 mg (Equivalent: alendronic acid, Qty 70 mg); colecalciferol, Quantity: 0.07 mg
Dr Reddys Laboratories Australia Pty Ltd
alendronate sodium,colecalciferol
Tablet, uncoated
Excipient Ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; povidone; magnesium stearate; butylated hydroxytoluene; Gelatin; medium chain triglycerides; sucrose
Oral
1 Tablet, 4 Tablets
(S4) Prescription Only Medicine
TRADENAMES 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 deviations below the gender specific mean for young adults or by - the presence of osteoporotic fracture
Visual Identification: White to off-white, modified capsule-shaped uncoated tablet, debossed with ADC on one side and 28 on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2013-12-16
AUSTRALIAN PRODUCT INFORMATION FONATPLUS 70 MG/70 ΜG (ALENDRONATE SODIUM AND COLECALCIFEROL) FONATPLUS 70 MG/140 ΜG (ALENDRONATE SODIUM AND COLECALCIFEROL) 1 NAME OF THE MEDICINE Alendronate sodium and colecalciferol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of FonatPlus 70 mg/70 µg contains 91.37 mg of alendronate sodium, which is the molar equivalent to 70 mg of alendronic acid, and 70 mcg of colecalciferol equivalent to 2800 IU vitamin D. Each tablet of FonatPlus 70 mg/140 µg contains 91.37 mg of alendronate sodium, which is the molar equivalent to 70 mg of alendronic acid, and 140 mcg of colecalciferol equivalent to 5600 IU vitamin D. EXCIPIENTS WITH KNOWN EFFECT Sucrose For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM FonatPlus 70 mg/ 70 µg once weekly tablet is a white to off-white, modified capsule- shaped uncoated tablet, debossed with 'ADC' on one side and '28' on the other side. FonatPlus 70 mg/ 140 µg once weekly tablet is a white to off-white, modified capsule- shaped uncoated tablet, debossed with 'ADC' on one side and '56' on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FonatPlus 70 mg/70 µg and FonatPlus 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 deviations below the gender specific mean for young adults or by • the presence of osteoporotic fracture 4.2 DOSE AND METHOD OF ADMINISTRATION FonatPlus (70 mg/70 µg or 70 mg/140 µg) Treatment of osteoporosis in patients where vitamin D 3 supplementation is recommended 1 The recommended dose is one tablet of Alendronate Plus D3 (70 mg/70 µg or 70 mg/140 µg) once weekly. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. (see 5.1 PHARMACODYNAMIC PROPERTIES Aqra d-dokument sħiħ