CALCITRIOL SANDOZ

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

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Hent Indlægsseddel (PIL)
31-05-2024
Hent Produktets egenskaber (SPC)
31-05-2024

Aktiv bestanddel:

Calcitriol

Tilgængelig fra:

Sandoz Pty Ltd

Klasse:

Medicine Registered

Indlægsseddel

                                Calcitriol Sandoz
®
 
 
 
 
1 
 
CALCITRIOL SANDOZ
®
_ _
 
CALCITRIOL_ _CAPSULES_ _
_ _
 
CONSUMER MEDICINE INFORMATION 
WHAT IS IN THIS LEAFLET 
This leaflet answers some common questions about Calcitriol Sandoz.
 
 
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 this medicine 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 CALCITRIOL SANDOZ IS USED FOR 
This medicine is used to treat: 
•  patients with osteoporosis (where the bones of the body
weaken) and to prevent osteoporosis in patients 
taking oral corticosteroids  
•  low blood calcium levels due to osteodystrophy (a type of bone
disease) 
•  hypoparathyroidism (a condition where the parathyroid
glands have decreased function) 
•  rickets.  
 
It contains the active ingredient calcitriol, one of the naturally
occurring and biologically active forms of 
vitamin D. Calcitriol belongs to a group of medicines known as
vitamin D compounds. It works by 
increasing calcium absorption in the intestine and stimulating
healthy bone growth, by acting in a similar 
manner to vitamin D in the body.  
 
There are many different types of medicines used to treat bone
conditions.  
 
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.  
Your doctor may have prescribed it for another reason.  
 
This medicine is available only with a doctor's prescription.  
 
This medicine is not addictive.  
BEFORE YOU TAKE CALCITRIOL SANDOZ 
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU HAVE HAD AN ALLERGY TO:  
•  calcitriol, the active ingredient, or to any of the other
ingredients listed at the end o
                                
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Produktets egenskaber

                                _Product Information  _
_                                          
                   _
_ Page                                                                                               _
Calcitriol Sandoz 0.25microgram capsules
 
_09/2011 _
 
_Sandoz Pty Ltd _
_ _
_Version 05  _
 
_1 _
 
PRODUCT INFORMATION 
CALCITRIOL SANDOZ
®
 0.25 MICROGRAM CAPSULES 
 
 
NAME OF THE MEDICINE 
_ _
Generic name: Calcitriol 
 
Chemical name:
(5_Z_,7_E_)-9,10-secocholesta-5,7,10(19)-triene-1α,3β,25-triol 
 
 
 
CAS: 32222-06-3 
 
Empirical formula: C
27
H
44
O
3
   
MW: 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.  
 
Calcitriol Sandoz is available as soft gelatin capsules containing 0.25 micrograms of 
calcitriol.  Each  capsule  also  contains  butylated  hydroxyanisole,  butylated 
hydroxytoluene,  fractionated  coconut  oil,  gelatin,  glycerol,  sorbitol  solution  (70%) 
(non-crystallising), iron oxide red and iron oxide yellow.  
_ _
_ _
PHARMACOLOGY 
 
Pharmacodynamics 
Calcitriol is the most important active metabolite 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  microgram  and  is  somewhat  higher  during 
periods of increased bone synthesis (e.g. growth or pregnancy).  
 
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). 
                                
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