Riik: Malta
keel: inglise
Allikas: Medicines Authority
CLODRONATE DISODIUM
Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom
M05BA02
CLODRONATE DISODIUM 400 mg
HARD CAPSULE
CLODRONATE DISODIUM 400 mg
POM
DRUGS FOR TREATMENT OF BONE DISEASES
Withdrawn
2005-05-30
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Page 1 of 11 v021_0 1.3.1 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF MEDICINAL PRODUCT Bonefos 400 mg capsules. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 500 mg sodium clodronate tetrahydrate, equivalent to 400 mg anhydrous sodium clodronate. Excipients with known effect Each capsule contains 41.5mg lactose (as monohydrate) , see section 4.4. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Pale yellow, hard gelatin capsules printed 'BONEFOS' in black for oral use. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bonefos capsules are indicated for the management of osteolytic lesions, hypercalcaemia and bone pain associated with skeletal metastases in patients with carcinoma of the breast or multiple myeloma. Bonefos capsules are also indicated for the maintenance of clinically acceptable serum calcium levels in patients with hypercalcaemia of malignancy initially treated with an intravenous bisphosphonate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ A daily dose of 1600 mg should be taken as a single dose. When higher daily doses are used, the part of the dose exceeding 1600 mg should be taken separately (as a second dose) as recommended below. _Paediatric population_ Bonefos has not been evaluated in children. _Elderly_ There are no special dosage recommendations in the elderly. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported. Page 2 of 11 v021_0 1.3.1 2 _Renal impairment_ Clodronate is eliminated mainly via the kidneys. Therefore, it should be used with caution in patients with renal failure; daily doses exceeding 1600mg should not be used continuously. It is recommended that the clodronate dosage be reduced as follows: DEGREE OF RENAL FAILURE CREATININE CLEARANCE, ML/MIN DOSE Mild 50-80 ml/min 1600 mg daily (no dose reduction recommended) Moderate 30- <50 ml/min 1200 mg/daily Severe 10 - ˂30 ml/min 800 mg/daily Method of administration Adequate fluid intake should Lugege kogu dokumenti