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SANDIMMUN
®
_cyclosporin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sandimmun.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Sandimmun
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 SANDIMMUN IS
USED FOR
Sandimmun 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.
Sandimmun 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)
Sandimmun 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 rea
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제품 특성 요약
1
SANDIMMUN
®
(CYCLOSPORIN)
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.
EXCIPIENTS
Sandimmun capsules and oral solution contain maize oil,
ethanol (see PRECAUTIONS), and
inter-esterified maize oil.
Sandimmun soft gelatin capsule shells contain gelatin, glycerol,
titanium dioxide, iron oxide
red CI77491 (25 and 100 mg capsules only), iron
oxide yellow CI 77492 (50 mg capsules),
and Anidrisorb 85/70 (sorbitol syrup).
Sandimmun concentrate for intravenous infusion
contains castor oil – polyoxyethylated,
macrogolglycerol ricinoleate (Cremophor
®
EL) 65 %, and ethanol 26 % w/v (see
PRECAUTIONS).
2
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: immunosuppressive agents, calcineurin
inhibitors
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