Prograf
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
24-09-2013
Summary of Product characteristics
(SPC)
24-09-2013
Active ingredient:
Tacrolimus 1mg
Available from:
Research Associates Ltd
INN (International Name):
Tacrolimus 1 mg
Dosage:
1 mg
Pharmaceutical form:
Capsule
Composition:
Active: Tacrolimus 1mg Excipient: Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate
Units in package:
Blister pack, 100 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, - 100 capsules - 36 months from date of manufacture stored at or below 30°C 12 months opened stored at or below 30°C
Authorization date:
1996-02-09
Patient Information leaflet
PROGRAF
®
1
PROGRAF
®
_CAPSULES, CONCENTRATED INJECTION _
_Tacrolimus _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PROGRAF 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
against the benefits this medicine is
expected to have for you.
If you have any concerns about using
PROGRAF ask your doctor or
pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT PROGRAF 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 stops this attack; it is
very important to take PROGRAF
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.
PROGRAF contains the active
ingredient tacrolimus, which is an
immunosuppressive agent.
Your doctor may have prescribed
PROGRAF for another reason. Ask
your doctor if you have any questions
about why this medicine has been
prescribed for you.
BEFORE YOU USE
PROGRAF
_WHEN YOU MUST NOT USE IT _
Do not use PROGRAF if
• you have an allergy to tacrolimus,
other macrolides (these are
antibiotics of the erythromycin
Read the complete document
Summary of Product characteristics
1
PROGRAF(130927)DDS
DATA SHEET
NAME OF MEDICINE
PROGRAF
®
Tacrolimus
PROGRAF 0.5mg 1 mg, 5 mg Capsules
PROGRAF 5mg/mL Concentrated Injection
Molecular Formula: C
44
H
69
NO
12
.H
2
0
Molecular Weight: 822.05
PRESENTATION
CAPSULES
PROGRAF capsules 0.5mg: light yellow, hard
gelatine capsules with ‘0.5mg’ and ‘[f]607
printed in red. Each capsule contains 0.5 mg tacrolimus.
PROGRAF capsules 1mg: white, hard gelatin capsules with
'1 mg' and '[f]617' printed in
red. Each capsule contains 1 mg tacrolimus.
PROGRAF capsules 5 mg: greyish-red, hard gelatine capsules with
'5 mg' and '[f]657'
printed in white. Each capsule contains 5 mg tacrolimus.
PROGRAF capsules are supplied as blister strips each
containing 10 capsules packed
within a protective aluminium wrapper. The 1 mg and 5
mg capsules should be stored
below 30°C and the 0.5 mg capsules below 25°C.
After opening the aluminium wrapper,
Prograf 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.
CONCENTRATED INJECTION
PROGRAF concentrate for infusion
5 mg/mL: colourless, clear, sterile liquid in transparent
glass ampoules. Each mL of concentrate for infusion contains 5
mg tacrolimus together
with PEG-60 hydrogenated castor oil and ethanol.
2
PROGRAF(130927)DDS
PROGRAF concentrate for infusion should be
protected from light and stored below 25°C.
Once an ampoule is opened, the contents should be used
immediately. Following
reconstitution in either 5% w/v glucose solution in polyethylene
or glass containers or in
0.9% Sodium Chloride Injection in polyethylene
containers, the resulting infusion mixture is
stable for 24 hours.
USES
ACTIONS
Tacrolimus is an immunosuppressan
Read the complete document
