Rocaltrol

Страна: Армения

Език: английски

Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активна съставка:

calcitriol

Предлага се от:

Hoffmann-La Roche Ltd.

INN (Международно Name):

calcitriol

дозиране:

0,25mcg

Лекарствена форма:

capsules

Вид предписание :

Prescription

Листовка

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

Данни за продукта

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