Rocaltrol

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

Calcitriol

Dostupné z:

Roche Products Pty Ltd

Trieda:

Medicine Registered

Príbalový leták

ROCALTROL
®

_contains the active ingredient calcitriol_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ROCALTROL
capsules.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
ROCALTROL capsules against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ROCALTROL IS
USED FOR
ROCALTROL is used to treat people
with osteoporosis and to prevent
osteoporosis in people taking oral
corticosteroids.
ROCALTROL capsules are also
prescribed by doctors for the
treatment of low blood calcium in
patients with osteodystrophy (a form
of bone disease), hypoparathyroidism
(reduced function of the parathyroid
glands) and rickets.
ROCALTROL works by improving
absorption of calcium from the
intestine and by stimulating growth
of healthy bones.
ROCALTROL contains calcitriol
which occurs naturally in humans
and is a biologically active form of
vitamin D.
There are many different types of
medicines used to treat bone
conditions. ROCALTROL belongs to
a group of medicines known as
vitamin D compounds.
Your doctor, may have prescribed
ROCALTROL for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY ROCALTROL HAS
BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
ROCALTROL is not addictive.
BEFORE YOU TAKE
ROCALTROL
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ROCALTROL IF:
1. YOU HAVE HAD AN ALLERGIC
REACTION TO ROCALTROL,
CALCITRIOL, OTHER VITAMIN D
COMPOUNDS, OR ANY INGREDIENTS
LISTED AT THE END OF THIS LEAFLET
2. YOU HAVE HIGH LEVELS OF CALCIUM
IN YOUR BLOOD (CALLED
HYPERCALCAEMIA)
3. YOU HAVE VITAMIN D TOXICITY
4. YOU ARE BREAST-FEEDING OR
INTEND TO BREAST-FEED
 ROCALTROL may pass into
breast milk and have unwanted
e

Súhrn charakteristických

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Rocaltrol
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 PI 111107 

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CDS 3.0

NAME OF THE MEDICINE 

ROCALTROL 
(calcitriol) 

CAS 32222-06-3 

The chemical name
for calcitriol is (5_Z_,7_E_)-9,10-secocholesta-5,7,10(19)-triene-1
α,3β,25-triol

 (calcitriol), the molecular formula is C
27
H
44
O
3
.  Calcitriol has a molecular weight of 416.65. 

DESCRIPTION  

Calcitriol is a white, crystalline compound, which
occurs naturally in humans.  It is soluble in organic 
solvents but practically insoluble in water. 

ROCALTROL is available as soft
gelatin capsules containing 0.25 micrograms of calcitriol.
 Each 
capsule also contains butylated hydroxyanisole, butylated
hydroxytoluene and medium chain 
triglycerides.
 The capsule shell contains gelatin, glycerol, Karion
83, titanium dioxide, iron oxide red and 
iron oxide yellow. 

PHARMACOLOGY 

PHARMACODYNAMICS 

_MECHANISM OF ACTION _

The biological effects of calcitriol are mediated by the
vitamin D receptor, a nuclear hormone receptor 
expressed in most cell types and
functioning as a ligand-activated transcription
factor that binds to 
specific DNA sites to modify the expression of target genes. 
Calcitriol is one of the most important
active metabolites of vitamin D
3
.  It is normally formed in the 
kidney from its precursor 25-hydroxycholecalciferol (25-HCC).
 Physiological daily production is 
normally 0.5 - 1.0
µg and is somewhat higher during periods of increased
bone synthesis (eg growth or 
pregnancy). 

Rocaltrol
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 PI 111107 
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CDS 3.0

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The natural supply of vitamin D in humans depends mainly on
exposure to ultraviolet rays of the sun for 
conversion of 7-dehydrocholesterol in the skin to vitamin D
3 
(cholecalciferol).  Vitamin D
3 
must be 
metabolically activated in the liver and