Cyclosporin Sandoz

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Cyclosporin

Available from:

Sandoz Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

CYCLOSPORIN SANDOZ
®

1 
CYCLOSPORIN SANDOZ
®

_cyclosporin _
CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 
This leaflet answers some common 
questions about Cyclosporin 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 Cyclosporin 
Sandoz 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 CYCLOSPORIN 
SANDOZ IS USED FOR 
Cyclosporin Sandoz is used for 
people who have had a kidney, heart 
or liver transplant, to prevent the 
body from rejecting the new organ. It 
does this by blocking the 
development of special cells which 
would normally attack the 
transplanted tissue. 
Cyclosporin Sandoz is also used to 
treat several other conditions which 
are thought to be caused by a 
problem with the immune system: 
•  a kidney disease called nephrotic 
syndrome 
•  severe cases of rheumatoid 
arthritis (a disease, affecting the 
joints with pain and swelling) 
•  severe cases of: 
−  psoriasis (a skin disease with 
thickened patches of red skin, 
often with silvery scales) 
−  atopic dermatitis (skin allergies). 
Cyclosporin Sandoz contains the 
active ingredient, cyclosporin. It 
belongs to a group of medicines 
called immuno-suppressive agents. 
These medicines help to control your 
body's immune system. 
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. 
Cyclosporin Sandoz is only available 
with a doctor's prescription. It is not 
addictive. 
BEFORE YOU TAKE 
CYCLOSPORIN SANDO

Summary of Product characteristics

_Product Information _
_ _
_Cyclosproin Sandoz 25mg, 50mg and 100mg Capsules _
_08/2012_ 

_Page 1 of 25_ 

_Sandoz Pty Ltd _
_ _
_Version 02   _

PRODUCT INFORMATION 
CYCLOSPORIN SANDOZ

 25MG, 50MG, 100MG CAPSULES 
Immunosuppressive agent 
DESCRIPTION 
Cyclosporin (BAN, AAN), ciclosporin (prop. INN), cyclosporine (USAN),
also known as 
Cyclosporin A.  A cyclic polypeptide consisting of 11 amino acids.
 It is produced as a 
metabolite by the fungus species _Beauveria
nivea_ (formerly _Tolypocladium inflatum Gams_). 
Chemical Name: 
Cyclo[[(2_S_,3_R_,4_R_,6_E_)-3-hydroxy-4-methyl-2-(methylamino)oct-6- 

 enoyl]-_L_-2-aminobutanoyl-_N_-methylglycyl-_N_-methyl-_L_-leucyl-_L_-valyl- 

_N_-methyl-l-leucyl-_L_-alanyl-_D_-alanyl-_N_-methyl-_L_-leucyl-_N_-methyl-_L_- 
   leucyl-_N_-methyl-_L_-valyl] 
Chemical formula:        C
62
H
111
N
11
O
12

Chemical structure: 
N CH
CO N
CH
C
N
CH
CO
N
CH
C
N
CH
2
CH
CH
N
CO
CH
OC
N
CO
CO
CH
N
O
H
N
C
CH
N
O
H
O
H
CO
CH
CO
N
CH
2
CH
CH
3
CH
3
CH
3
CH
CH
3
CH
3
CH
3
CH
CH
CH
3
HO
CH
2
C
H
C
H
CH
3
CH
2
CH
3
CH
3
CH
2
CH
CH
3
CH
3
CH
CH
3
CH
3
CH
3
CH
2
CH
CH
3
CH
3
CH
3
H
CH
3
CH
2
CH
CH
3
CH
3
CH
3
CH
3
CH
3
L
L
L
L
L
L
L
L
L
D
(R)
(R)

Molecular Weight:      1202.635 
CAS Number:  
59865-13-3 
Cyclosporin is poorly soluble in water (0.004% w/w) and n-hexane, but
is very soluble in 
other organic solvents and in lipids. 
Cyclosporin Sandoz is a microemulsion pre-concentrate formulation of
cyclosporin. When 
mixed with water (either in the form of gastric fluid or a beverage),
Cyclosporin Sandoz 
immediately forms a microemulsion which facilitates the
gastrointestinal absorption of 
cyclosporin.  Pharmacokinetic studies have demonstrated that
Cyclosporin Sandoz provides 
more consistent cyclosporin absorption than the conventional oral
forms of Sandimmun
®
 (see 
PHARMACOLOGY - Pharmacokinetics).  Also, in a small number of
patients, conversion 
_Product Information _
_�