Country: Singapura
Bahasa: Inggeris
Sumber: HSA (Health Sciences Authority)
ALFACALCIDOL
LEO PHARMA ASIA PTE LTD
A11CC03
2 mcg/ml
SOLUTION
ALFACALCIDOL 2 mcg/ml
ORAL
Prescription Only
LEO Pharma A/S
ACTIVE
1991-05-14
ONE‐ALPHA ® 1. NAME OF MEDICINAL PRODUCT One‐Alpha ® Alfacalcidol Carefully read this insert before administering this product. It contains information about your treatment. If you have any doubt or you are not sure about something, please ask your physician or Pharmacist chemist. Keep this insert as you might need to read it again. Verify this product fully corresponds to the one prescribed by your physician. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CAPSULES Alfacalcidol 0.25 microgram, 0.5 microgram and 1 microgram Pack sizes: 10, 30, 50 and 100 capsules Excipients the clinician should be aware of: Sesame oil DROPS Alfacalcidol 2 micrograms/ml (one drop provides 0.1 microgram) Excipients the clinician should be aware of: Ethanol, sorbitol, methyl parahydroxybenzoate, macrogolglycerol hydroxystearate Pack sizes: 10 ml and 20 ml SOLUTION FOR INJECTION Alfacalcidol 2 micrograms/ml (for i.v. use) Pack sizes: 0.5 ml x 10 ampules and 1 ml x 10 ampules List of excipients, see section 6.1 Not all pack sizes, strengths and formulations may be marketed 3. PHARMACEUTICAL FORM CAPSULES Soft capsules; cream‐coloured (0.25 microgram), pink (0.5 microgram), or brownish (1 microgram) DROPS Oral drops; slightly cloudy to clear, colourless SOLUTION FOR INJECTION Solution for injection (for i.v. use); clear and colourless 4. CLINICAL P A RTICULARS 4.1 THERAPEUTIC INDICATIONS Diseases caused by disturbances in the calcium metabolism in consequence of reduced endogenous production of 1.25‐dihydroxyvitamin D 3 . Renal osteodystrophy, postoperative or idiopathic hypo‐parathyroidism, pseudohypoparathyroidism, as an adjunct to the management of tertiary hyperparathyroidism, vitamin D‐resistant rickets or osteomalacia, vitamin D‐dependent rickets, neonatal hypocalcaemia or rickets, malabsorption of calcium, osteoporosis, malabsorptive and nutritional rickets, and osteomalacia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Individual dosage under thorough control of serum calcium. Adults and children over 20 kg: Initially Baca dokumen lengkap
ONE-ALPHA ® 1. NAME OF MEDICINAL PRODUCT One-Alpha ® Alfacalcidol Carefully read this insert before administering this product. It contains information about your treatment. If you have any doubt or you are not sure about something, please ask your physician or Pharmacist chemist. Keep this insert as you might need to read it again. Verify this product fully corresponds to the one prescribed by your physician. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CAPSULES Alfacalcidol 0.25 microgram, 0.5 microgram and 1 microgram Pack sizes: 10, 30, 50 and 100 capsules Excipients the clinician should be aware of: Sesame oil DROPS Alfacalcidol 2 micrograms/ml (one drop provides 0.1 microgram) Excipients the clinician should be aware of: Ethanol, sorbitol, methyl parahydroxybenzoate, macrogolglycerol hydroxystearate Pack sizes: 10 ml and 20 ml SOLUTION FOR INJECTION Alfacalcidol 2 micrograms/ml (for i.v. use) Pack sizes: 0.5 ml x 10 ampules and 1 ml x 10 ampules List of excipients, see section 6.1 Not all pack sizes, strengths and formulations may be marketed. 3. PHARMACEUTICAL FORM CAPSULES Soft capsules; cream-coloured (0.25 microgram), pink (0.5 microgram), or brownish (1 microgram) DROPS Oral drops; slightly cloudy to clear, colourless SOLUTION FOR INJECTION Solution for injection (for i.v. use); clear and colourless 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diseases caused by disturbances in the calcium metabolism in consequence of reduced endogenous production of 1.25- dihydroxyvitamin D 3 . Renal osteodystrophy, postoperative or idiopathic hypo-parathyroidism, pseudohypoparathyroidism, as an adjunct to the management of tertiary hyperparathyroidism, vitamin D-resistant rickets or osteomalacia, vitamin D-dependent rickets, neonatal hypocalcaemia or rickets, malabsorption of calcium, osteoporosis, malabsorptive and nutritional rickets, and osteomalacia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Individual dosage under thorough control of serum calcium. Adults and children over 20 kg: Initially 1 microgram da Baca dokumen lengkap