Prograf-XL

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Tacrolimus 0.5mg

Fáanlegur frá:

Research Associates Ltd

INN (Alþjóðlegt nafn):

Tacrolimus 0.5 mg

Skammtar:

0.5 mg

Lyfjaform:

Modified release capsule

Samsetning:

Active: Tacrolimus 0.5mg Excipient: Ethanol Ethylcellulose Gelatin Hypromellose Iron oxide red Iron oxide yellow Lactose monohydrate Magnesium stearate Opacode red S-1-15083 Sodium laurilsulfate Titanium dioxide

Einingar í pakka:

Blister pack, PVC/PVDC/Alu, 30 capsules, 30 capsules

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Astellas Pharma Tech Co Limited

Ábendingar:

Primary immunosuppression in liver, kidney, pancreas, kidney-pancreas, lung or heart allograft recipients and rescue use in liver, kidney or other solid organ (heart, lung, pancreas or kidney-pancreas) transplantation, that has either failed conventional immunosuppressive agents, or where such agents are producing intolerable side effects.

Vörulýsing:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Alu, 30 capsules - 30 capsules - 36 months from date of manufacture stored at or below 25°C

Leyfisdagur:

2009-01-08

Vara einkenni

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1 

PROGRAF XL(130927)DDS 

DATA SHEET 
NAME OF MEDICINE 
PROGRAF-XL


Tacrolimus 
PROGRAF-XL 0.5 mg, 1 mg, 5 mg Prolonged-release Capsules 

Molecular Formula: C
44 
H
69
NO
12
.H
 2
0 
Molecular Weight: 822.05 
PRESENTATION 
PROGRAF-XL 0.5
mg prolonged-release capsules: oblong capsules with a
light yellow cap 
imprinted with “0.5 mg” and an orange body imprinted with
“
647”.  
PROGRAF-XL 1
mg prolonged-release  capsules: oblong capsules with a white
cap 
imprinted with “1 mg” and an orange body imprinted with “
677”.  
PROGRAF-XL 5 mg prolonged-release capsules: oblong capsules with
a greyish red cap 
imprinted with “5 mg” and an orange body imprinted with “
687”.  
PROGRAF-XL prolonged-release
capsules contain hypromellose, ethylcellulose, lactose 
and magnesium stearate.  The capsule shells contain
gelatin, titanium dioxide, iron oxide 
yellow CI77492, iron oxide red CI77491
and sodium lauryl sulfate.  The capsules also have 
a trace of printing ink, Opacode S-1-15083 red, which
contains shellac, soya lecithin, 
simethicone and iron oxide red CI77491. 

PROGRAF-XL  prolonged-release  capsules are supplied
as blister strips each containing 
10 capsules packed within a protective aluminium wrapper.  The
capsules should be 
stored below 25°C.  After opening the
aluminium wrapper, PROGRAF-XL  capsules are 
stable for 12 months when
stored at room temperature.  The blister strips should be
kept in 
a dry place
and the capsules should be left in the blister until required for use. 

_ _

2 

PROGRAF XL(130927)DDS 

USES 
ACTIONS 
Tacrolimus is an immunosuppressant.  It 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�