ROCALTROL CAPSULE 0.25 mcg

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

CALCITRIOL

Διαθέσιμο από:

DKSH SINGAPORE PTE. LTD.

Φαρμακολογική κατηγορία (ATC):

A11CC04

Δοσολογία:

0.25 mcg

Φαρμακοτεχνική μορφή:

CAPSULE, LIQUID FILLED

Σύνθεση:

CALCITRIOL 0.25 mcg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

Catalent Germany Eberbach GmbH

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

1990-02-10

Φύλλο οδηγιών χρήσης

Jun 2013 

1 
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 
Orally. 
1.4 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
_Active ingredient:_ synthetic calcitriol (biologically active form
of vitamin D
3
). 
_Chemical names:  _1

, 25 - dihydroxycholecalciferol; 

(5Z-/E)- 9, 10-secocholesta - 5, 7, 10 (19) - triene - 1

, 3

, 25 - triol._ _
Capsules 0.25 µg and 0.5 µg. 
_Excipients:_ 
Capsules:  Butylhydroxyanisol,  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 Patient monitoring)._ 
Jun 2013 

2 
A prerequisite for optimal efficacy of Rocaltrol is adequate but not excessive calcium intake at the 
beginning  of  therapy.  C

Αρχείο Π.Χ.Π.

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
Orally.
1.4
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient:_
synthetic calcitriol (biologically active form of vitamin D
3
).
_Chemical names: _
1
α
, 25 - dihydroxycholecalciferol;
(5Z-/E)- 9, 10-secocholesta - 5, 7, 10 (19) - triene - 1
α
, 3
β
, 25 - triol.
Capsules 0.25 µg and 0.5 µg.
_Excipients:_
Capsules: Butylhydroxyanisol, butylhydroxytoluene, medium-chain
triglycerides, gelatin, glycerol
85%, hydrogenated products of partial
ly 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 Patient monitoring)._
A prerequisite for optimal efficacy 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 hypercalcaemia may
require only low doses of calcium or no supplementation at all.
_Patient monitoring _
During the stabilization phase of
treatment with Rocaltrol, serum calcium