Kraj: Singapur
Język: angielski
Źródło: HSA (Health Sciences Authority)
DISODIUM CLODRONATE
BAYER (SOUTH EAST ASIA) PTE LTD
M05BA02
400 mg
CAPSULE
ORAL
Prescription Only
BAYER OY
1990-10-09
Bonefos Cap & Tab_SG PI_CCDS 9_21 Dec 2012 1 1. NAME OF THE MEDICINAL PRODUCT Bonefos 400mg Capsule Bonefos 800mg Tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ One capsule contains 400 mg disodium clodronate One tablet contains 800 mg disodium clodronate 3. PHARMACEUTICAL FORM 400mg Caps ule: Pale yellow hard gelatin capsule, marked “Bonefos”. 800mg Tablet: White, oval, scored, film-coated tablets, marked L134 on one side. Size of tablet 9mm x 20 mm 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hypercalcemia due to malignancy. Treatment of osteolysis due to malignancy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Bonefos capsules should be swallowed whole. Bonefos Tablets are recommended to be swallowed whole. A Bonefos 800mg tablet may be divided into two to ease swallowing, but the halves have to be taken at the same time of administration. Bonefos tablets should not be crushed or dissolved before intake. When Bonefos is taken as a single daily dose, it should preferably be taken in the morning on an empty stomach together with a glass of water. If it is not possible to take the dose in the morning, Bonefos should be taken more than two hours after eating and drinking (with the exception of plain water). Thereafter, the patient should then refrain from eating and drinking (other than plain water), and taking any other oral drugs for one hour. If the daily dose of Bonefos is taken as divided doses, the first dose sho Przeczytaj cały dokument