DAIVOBET 50/500 gel

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

Betamethasone dipropionate; Calcipotriol

Dostupné s:

LEO Pharma Pty Ltd

Třída:

Medicine Registered

Informace pro uživatele

PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START YOUR
TREATMENT.
Daivobet
®
50/500 gel is the brand name. Daivobet
®
gel is a
combination product. The generic names of the two active
ingredients are calcipotriol and betamethasone
KEEP THIS LEAFLET. You may want to read it again.
WHAT IS IN THIS LEAFLET?
This leaflet answers some common questions about using the
medicine Daivobet
®
gel. 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 using Daivobet
®
gel against the
benefits it is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING DAIVOBET
®
GEL, TALK TO
YOUR DOCTOR OR PHARMACIST.
WHAT DAIVOBET
®
GEL IS USED FOR
Daivobet
®
gel is used as topical treatment of body and scalp
psoriasis. Psoriasis is a skin disorder in which skin cells are
overactive. This causes redness, scaling and thickness of
your skin. 
Daivobet
®
gel contains two active ingredients:
• calcipotriol (related to Vitamin D);
• betamethasone dipropionate (a corticosteroid).
The calcipotriol in Daivobet
®
gel treats the overactive skin
cells. The betamethasone dipropionate relieves redness,
swelling, itching and irritation of the skin.
Daivobet
®
gel is available only with a doctor’s prescription.
This medicine is not expected to affect your ability to drive a
car or operate machinery.
This medicine is not addictive.
BEFORE YOU USE DAIVOBET
®
GEL
WHEN YOU MUST NOT USE DAIVOBET
®
GEL
DO NOT USE DAIVOBET
®
GEL IF YOU:
• are allergic to calcipotriol, betamethasone dipropionate or
any of the other ingredients listed at the end of this leaflet
(see PRODUCT DESCRIPTION) or any other similar medicine,
such as topical corticosteroids
• have high blood calcium levels (ask your doctor)
• have other types of psoriasis known as generalised pustular
or erythrodermic exfoliative psoriasis (your doctor will
identify these conditions for you)
• have serious liver or ki

Charakteristika produktu

 
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PRODUCT INFORMATION 

DAIVOBET
®
 50/500 GEL  

_Calcipotriol 50 microgram/g  _
_Betamethasone 500 microgram/g present as dipropionate      _
AUST R 161936 

NAME OF THE MEDICINE:  

Daivobet
® 
50/500 gel 

OH
OH
O
H
H
H
H
2
O

Calcipotriol  

   Betamethasone dipropionate 

Calcipotriol is (1S, 3R, 5Z, 7E, 22E, 24S) -24-Cyclopropyl-9, 10-secochola-5,7,10(19), 22-
tetraene-1,3,24-triol (CAS no.: 112828-00-9). The molecular weight of calcipotriol hydrate is 
430.6. 

Betamethasone dipropionate is 9-fluoro-11

, 17, 21-trihydroxy-16

-methylpregna-1,4-diene-
3,20-dione 17,21-dipropionate (CAS no.: 5593-20-4). The empirical formula is C
28
H
37
FO
7
.  
The molecular weight of betamethasone dipropionate is 504.6.  

DESCRIPTION 

Daivobet
®
  gel  is  an  almost  clear,  colourless  to  slightly  off-white  gel  and  contains  50 
microgram/g calcipotriol and 500 microgram/g betamethasone (as dipropionate).   

Calcipotriol is a white or almost white crystalline substance.  It is freely soluble in ethanol, 
soluble in chloroform and propylene glycol, particularly insoluble in liquid paraffin.  Solubility in 
water is 0.6 

g/mL and the melting point is 166 to 168ºC.  Calcipotriol is a vitamin D derivative 
and behaves in a similar manner to vitamin D, forming a reversible temperature-dependent 
equilibrium between calcipotriol and pre-calcipotriol.   

Betamethasone  dipropionate  is  a  white  or  almost  white,  crystalline  powder,  practically 
insoluble in water, freely soluble in acetone and in methylene chloride, sparingly soluble in 
alcohol. 

Daivobet
®
 gel also contains paraffin-liquid, PPG-15 stearyl ether, hydrogenated castor oil, 
butylated hydroxyl toluene (E321) an