PROGRAF and PROGRAF XL

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

Tacrolimus

Dostupné s:

Janssen-Cilag Pty Ltd

Třída:

Medicine Registered

Informace pro uživatele

PROGRAF

®
 CAPSULES,  
PROGRAF

®
 XL PROLONGED-RELEASE 
CAPSULES, 
PROGRAF

®
CONCENTRATED INJECTION

_TACROLIMUS _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET 
This leaflet answers some common questions about 
PROGRAF Capsules or PROGRAF-XL Prolonged-
Release Capsules and PROGRAF Concentrated 
Injection.  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 PROGRAF or 
PROGRAF-XL against the benefits this medicine is 
expected to have for you. 
If you have any concerns about using PROGRAF or 
PROGRAF-XL ask your doctor or pharmacist.  
Keep this leaflet with your medicine.  You may need 
to read it again. 
WHAT PROGRAF / PROGRAF-XL IS 
USED FOR 
You have been given a new transplanted liver or 
kidney, lung or heart from another person because 
your own was no longer healthy.  Your body 
recognises that this new organ is different from your 
organs and will try to reject it by attacking it in the 
same way that it would attack germs that enter your 
body.  This could make you become ill again.  
PROGRAF or PROGRAF-XL stops this attack; it is 
very important to take PROGRAF or PROGRAF-XL 
given to you by your doctor regularly so that your new 
liver, kidney, lung or heart will not be attacked or 
rejected. 
If you have been taking other medicines for this 
purpose, but are still feeling unwell, your doctor may 
change your treatment and begin giving you 
PROGRAF or PROGRAF-XL. 
PROGRAF or PROGRAF-XL contains the active 
ingredient tacrolimus, which is an immunosuppressive 
agent. 
Your doctor may have prescribed PROGRAF or 
PROGRAF-XL for another reason.  Ask your doctor if 
you have any questions about why this medicine has 
been prescribed for you. 
BEFORE YOU USE PROGRAF OR 
PRO

Charakteristika produktu

CCSI111216 
1 
jcpprogr10812.doc 
PROGRAF


0.5 MG, 1 MG, 5 MG CAPSULES & 
5 MG/ML CONCENTRATED INJECTION 
PROGRAF

 XL 
0.5 MG, 1 MG, 5 MG PROLONGED-RELEASE CAPSULES 

PRODUCT INFORMATION

NAME OF THE DRUG  
Tacrolimus 

[_3S-_[_3R*_[_E(1S*,3S*,4S*)_]_,4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*_]]_-_
_5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a_-hexadecahydro-5,19-dihydroxy-3-
[2-(4-
hydroxy- 
3-methoxycyclohexyl)-1-methylethenyl
]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-
(2-propenyl)-15,19-epoxy-3H-pyrido 
[2,1-c] [1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)- 
tetrone, monohydrate.

Molecular Formula: C
44 
H
69
NO
12
.H
 2
0 
Molecular Weight: 822.03. CAS 104987-11-3

DESCRIPTION

Tacrolimus appears as white crystals or a crystalline powder, very soluble in methanol, and 
chloroform, freely soluble in acetone and
ethanol and practically insoluble in hexane and 
water.  Tacrolimus is obtained by fermentation as a single enantiomer but exists in tautomeric 
equilibration in aqueous solution. 

CCSI111216 
2 
jcpprogr10812.doc 
PHARMACOLOGY

Tacrolimus is a macrolide lactone with
potent_ in vitro_ and_ in vivo_ immunosuppressive activity. 
Studies suggest that tacrolimus inhibits the formation
of cytotoxic lymphocytes which are 
regarded as being primarily responsible for graft rejection. 
Tacrolimus suppresses T-cell 
activation and
T-helper-cell-dependent B-cell proliferation, as well as the
formation of 
lymphokines such as interleukins-2 and -3 and gamma-interferon and
the expression of the 
interleukin-2 receptor.  At the
molecular level, the effects of tacrolimus appear to be
mediated 
by binding to a cytosolic protein (FKBP), which is responsible
for the intracellular accumulation 
of the
compound. A complex of tacrolimus-FKBP-12,  calcium, calmodulin
and calcineurin is 
formed and the phosphat