Country: Armenía
Tungumál: enska
Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
calcitriol
Hoffmann-La Roche Ltd.
calcitriol
0,25mcg
capsules
Prescription
ROCALTROL ® Calcitriol 1. DESCRIPTION 1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG Biologically active form of vitamin D 3 . ATC code: A11CC04. 1.2 TYPE OF DOSAGE FORM Capsules containing 0.25 μg and 0.5 μg calcitriol. 1.3 ROUTE OF ADMINISTRATION Oral. 1.4 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient:_ synthetic calcitriol (biologically active form of vitamin D 3 ). _Chemical names: _ 1α, 25 - dihydroxycholecalciferol; (5Z-/E)- 9, 10-secocholesta - 5, 7, 10 (19) - triene - 1α, 3β, 25 - triol. _Excipients:_ Butylhydroxyanisole, butylhydroxytoluene, medium-chain triglycerides, gelatin, glycerol 85%, hydrogenated products of partially hydrolyzed starch, titanium dioxide (E 171), red and yellow iron oxide (E 172). 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) Established postmenopausal osteoporosis. Renal osteodystrophy in patients with chronic renal failure, particularly those undergoing hemodialysis. Postsurgical hypoparathyroidism. Idiopathic hypoparathyroidism. Pseudohypoparathyroidism. Vitamin D-dependent rickets. Hypophosphatemic vitamin D-resistant rickets. 2.2 DOSAGE AND ADMINISTRATION The optimal daily dose of Rocaltrol must be carefully determined for each patient on the basis of the serum calcium level. Rocaltrol therapy should always be started at the lowest possible dose and should not be increased without careful monitoring of serum calcium _(see below, Patient monitoring)._ A prerequisite for optimal effi cacy of Rocaltrol is adequate but not excessive calcium intake at the beginning of therapy. Calcium supplements may be necessary and should be administered according to local guidelines. Because of improved calcium absorption from the gastrointestinal tract, some patients on Rocaltrol may be maintained on a lower calcium intake. Patients who tend to develop hypercalcemia may require only low doses of calcium or no supplementation at all. _Patient monitoring_ During the stabilization phase of treatment with Rocaltrol, serum calcium levels should be checked at least twice w Lestu allt skjalið
1 Rocaltrol-UK-spc-1.0-0.25_0.5mcg-caps 11 tidied up erratic font ONLY - No other changes. SUMMARY OF PRODUCT CHARACTERISTICS ROCALTROL ® 1. NAME OF THE MEDICINAL PRODUCT Rocaltrol 0.25 microgram Capsules. Rocaltrol 0.5 microgram Capsules. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains either 0.25 or 0.5 microgram of calcitriol. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Soft capsules. 0.25 microgram: One length brown-orange to red-orange opaque and the other white to grey- yellow or grey-orange opaque. 0.5 microgram: Both lengths brown-orange to red-orange opaque. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Established postmenopausal osteoporosis. Renal osteodystrophy in patients with chronic renal failure, particularly those undergoing hemodialysis. Postsurgical hypoparathyroidism. Idiopathic hypoparathyroidism. Pseudohypoparathyroidism. Vitamin D-dependent rickets. Hypophosphatemic vitamin D-resistant rickets. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dose of Rocaltrol should be carefully adjusted for each patient according to the biological response so as to avoid hypercalcaemia. The effectiveness of treatment depends in part on an adequate daily intake of calcium, which should be augmented by dietary changes or supplements if necessary. The capsules should be swallowed with a little water. Adults Renal Osteodystrophy 2 Rocaltrol-UK-spc-1.0-0.25_0.5mcg-caps 11 tidied up erratic font ONLY - No other changes. The initial daily dose is 0.25 μg. In patients with normal or only slightly reduced serum calcium levels, doses of 0.25 μg every other day are suffi cient. If no satisfactory response in the biochemical parameters and clinical manifestations of the disease is observed within 2-4 weeks, the daily dosage may be increased by 0.25 μg at two to four-week intervals. During this period, serum calcium levels should be determined at least twice weekly. Most patients respond to dosages between 0.5 μg and 1.0 μg daily. An oral Rocaltrol pulse therapy with an initial dosage of Lestu allt skjalið