Tacrocord 5 Capsules 5 mg

Land: Maleisië

Taal: Engels

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

Werkstoffen:

TACROLIMUS MONOHYDRATE

Beschikbaar vanaf:

HOVID BERHAD

INN (Algemene Internationale Benaming):

TACROLIMUS MONOHYDRATE

Eenheden in pakket:

60 Capsules

Geproduceerd door:

CONCORD BIOTECH LIMITED

Bijsluiter

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
TACROCORD CAPSULES
_ _
Tacrolimus (0.5mg, 1mg, 5mg)
Page no.1
WHAT IS IN THIS LEAFLET
1.
What Tacrocord is used for
2.
How Tacrocord works
3.
Before you use Tacrocord
4.
How to use Tacrocord
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Tacrocord
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT TACROCORD IS USED FOR
Following
your
organ
transplant
(e.g.
liver, kidney, heart), your body’s immune
system will try to reject the new organ.
Tacrocord is used to control your body’s
immune response enabling your body to
accept the transplanted organ.
Tacrocord is often used in combination
with other medicines that also suppress
the immune system.
You may also be given Tacrocord for an
ongoing
rejection
of
your
transplanted
liver
and
kidney
or
if
any
previous
treatment you were taking was unable to
control this immune response after your
transplantation.
Only for Tacrolimus Capsules 0.5mg and
1mg
Tacrocord is also used for lupus nephritis
(a
disease
whereby
body own
immune
system
targets
the
kidneys
and
causes
damage to the kidneys) when effect of
steroids is not adequate or administration
of steroids is difficult because of their
side effects.
HOW TACROCORD WORKS
Tacrocord
consists
of
active
ingredient
tacrolimus.
It
belongs
to
a
group
of
medicines called immunosuppressants. It
is used to control your body’s immune
response
by
preventing
your
body
to
reject the transplanted organ.
BEFORE YOU USE TACROCORD
_When you must not use it _
-
If you are allergic (hypersensitive) to
tacrolimus
or
any
of
the
other
ingredients of Tacrocord.
-
If you are allergic (hypersensitive) to
macrolide
antibiotics
such
as
erythromycin,
clarithromycin
and
josamycin.
-
If you are pregnant or think you may be
pregnant or are planning to have a baby
-
If you are breastfeeding as Tacrocord is
excreted in the breast milk.
-
If you have intolerance to some sugars
as Tacrocord contains lactose.
_Before _
_y

Productkenmerken

DESCRIPTION
TACROCORD 0.5 CAPSULES 0.5 MG:
Opaque light yellow color, size “4” hard gelatin capsules
imprinted with “C5” “0.5mg” on cap with
black ink, containing white to off white granular powder.
TACROCORD 1 CAPSULES 1 MG:
Opaque white color, size "4" hard gelatin capsules imprinted with "C6"
"1mg" on cap with black ink,
containing white to off white granular powder.
TACROCORD 5 CAPSULES 5 MG:
Opaque grayish red color, size “4” hard gelatin capsules imprinted
with “C7” “5mg” on cap with
black ink, containing white to off white granular powder.
COMPOSITION
TACROCORD 0.5 CAPSULES 0.5 MG:
Each hard gelatin capsule contains: Tacrolimus 0.5mg
TACROCORD 1 CAPSULES 1 MG:
Each hard gelatin capsule contains: Tacrolimus 1mg
TACROCORD 5 CAPSULES 5 MG:
Each hard gelatin capsule contains: Tacrolimus 5mg
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 immunosuppressive agent and has proven activity
in both in vivo and in vitro
experiments.
In
particular,
tacrolimus
inhibits
the
formation
of
cytotoxic
lymphocytes,
which
are
mainly
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, 3 and γ
-interferon) and the expression of the interleukin-2 receptor.
PHARMACOKINETICS
ABSORPTION
Tacrolimus has been shown to be able to be absorbed throughout the
gastrointestinal tract.
Following oral administration of tacrolimus capsules, peak
conc