TRANSGRAF CAPSULE 5.0 MG

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Δραστική ουσία:

TACROLIMUS

Διαθέσιμο από:

Ascend Laboratories Sdn Bhd

INN (Διεθνής Όνομα):

TACROLIMUS

Μονάδες σε πακέτο:

50 Capsules; 100 Capsules

Κατασκευάζεται από:

Alkem Laboratories Limited

Φύλλο οδηγιών χρήσης

_CONSUMER MEDICINE INFORMATION LEAFLET (RIMUP) _
TRANSGRAF
_Tacrolimus Capsule _
(0.5 mg, 1 mg, 5 mg)
1
WHAT IS IN THIS LEAFLET
1.
What
_Transgraf _
is used for
2.
How
_Transgraf _
works
_3._
_ _
Before you use
_Transgraf _
_4._
_ _
How to use
_Transgraf _
_5._
_ _
While you are using
_Transgraf _
6.
Side effects
_7._
_ _
Storage and disposal of
_Transgraf _
8.
Product description
9.
Manufacturer and Product registration
holder
10.
Date of revision
WHAT _TRANSGRAF _IS USED FOR
_Transgraf _
is used to control your body’s
immune response enabling your body to
accept the transplanted liver or kidney.
_Transgraf _
is often used in combination
with other medicines that also suppress
the immune system.
You may also be given
_Transgraf _
for an
ongoing
rejection
of
your
transplanted
liver
or
kidney,
or
if
any
previous
treatment you were taking was unable to
control this immune response after your
transplantation.
or pharmacist for advice before taking any
medicine.
-
_Transgraf _
contains lactose. If you have
been old by your doctor that you have an
intolerance to some sugars, contact your
doctor
before
taking
this
medicinal
product.
_-Before you start to use it _
-
You will need to take
_Transgraf _
every
day
as
long
as
you
need
immunosuppression to prevent rejection
of your transplanted organ. You should
keep in regular contact with your doctor.
-
Whilst you are taking
_Transgraf _
your
doctor may want to carry out a number of
tests
(including
blood,
urine,
heart
function,
visual
and
neurological
tests)
from time to time. This is quite normal
and will help your doctor to decide on the
most appropriate dose of
_Transgraf _
for
you.
-
Please avoid taking any herbal remedies,
e.g.
St.
John’s
wort
(Hypericum
perforatum) or any other herbal products
_Transgraf _
blood levels can be affected by
other medicines you take, and blood levels
of
other
medicines
can
be
affected
by
taking
_Transgraf _
which may require an
increase or decrease in
_Transgraf _
dose. In
particular, you should tell your doctor if
you
are
taking
or

Αρχείο Π.Χ.Π.

TRANSGRAF CAPSULE
( 0.5/1/5 MG)
TACROLIMUS CAPSULES USP
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Tacrolimus Monohydrate
COMPOSITION:
1.
TRANSGRAF CAPSULE 0.5 MG
Each Hard gelatin capsule contains :
Tacrolimus USP (as Monohydrate) equivalent to Tacrolimus .....0.5mg
Colour : Titanium Dioxide and Yellow Iron Oxide
2.
TRANSGRAF CAPSULE 1 MG
Each hard gelatin capsule contains :
Tacrolius USP (as Monohydrate) equivalent to Tacrolimus ...........1mg
Colour : Titanium Dioxide
3.
TRANSGRAF CAPSULES 5 MG
Each hard gelatin capsule contains :
Tacrolimus USP (as Monohydrate) equivalent to Tacrolimus ........5mg
Colour : Titanium Dioxide, Red iron oxide
PRODUCT DESCRIPTION
TRANSGRAF CAPSULE 0.5 MG
White to off white powder filled in size "5" yellow coloured
cap/yellow coloured body hard gelatin capsules printed with "0.5 mg"
on cap and
"Tacro" on body with red ink.
TRANSGRAF CAPSULE 1 MG
White to off white powder filled in size "5" white coloured cap/white
coloured body hard gelatin capsules printed with "1 mg" on cap and
"Tacro" on body with red ink.
TRANSGRAF CAPSULES 5 MG
White to off white powder filled in size "4" greyish red coloured
cap/greyish red coloured body hard gelatin capsules printed with "5
mg" on
cap and "Tacro" on body with white ink.
PHARMACODYNAMICS
Pharmacotherapeutic group: Calcineurin inhibitors, ATC code: L04AD02
Mechanism of action and pharmacodynamic effects
At the molecular level, the effects of tacrolimus appear to be
mediated by binding to a cytosolic protein (FKBP12) which is
responsible for
the intracellular accumulation of the compound. The FKBP12-tacrolimus
complex specifically and competitively binds to and inhibits
calcineurin, leading to a calcium-dependent inhibition of T-cell
signal transduction pathways, thereby preventing transcription of a
discrete
set of lymphokine genes.
Tacrolimus is a highly potent immunosuppressive agent and has proven
activity in both in vitro and in vivo experiments.
In particular, tacrolimus inhibits the formation of cytotoxic
lymphocytes, which are mainly respons