Prograf-XL
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
24-09-2013
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Active ingredient:
Tacrolimus 0.5mg
Available from:
Research Associates Ltd
INN (International Name):
Tacrolimus 0.5 mg
Dosage:
0.5 mg
Pharmaceutical form:
Modified release capsule
Composition:
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
Units in package:
Blister pack, PVC/PVDC/Alu, 30 capsules, 30 capsules
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Astellas Pharma Tech Co Limited
Therapeutic indications:
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.
Product summary:
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
Authorization date:
2009-01-08
Summary of Product characteristics
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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.
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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
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