TACROLIMUS APOTEX tacrolimus 0.5 mg capsule blister pack

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

tacrolimus monohydrate, Quantity: 0.51 mg (Equivalent: tacrolimus, Qty 0.5 mg)

Доступно од:

Pharmacor Pty Ltd

INN (Међународно име):

tacrolimus monohydrate

Фармацеутски облик:

Capsule

Састав:

Excipient Ingredients: dichloromethane; lactose; ethanol absolute; magnesium stearate; croscarmellose sodium; hypromellose; titanium dioxide; purified water; iron oxide yellow; Gelatin; sodium lauryl sulfate

Пут администрације:

Oral

Јединице у пакету:

100's [10x(1x10's)], 100's [2x(5x10's)]

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

Tacrolimus is indicated for use as an adjunct to liver, kidney, lung or heart allograft transplantation in adults and children.

Резиме производа:

Visual Identification: White to off white powder filled in size '5' yellow cap/body HGC printed with '0.5mg' on cap and 'Tacro' on body with red ink; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Статус ауторизације:

Licence status A

Датум одобрења:

2014-04-29

Информативни летак

Tacrolimus APOTEX Capsules - v02-0517
1
TACROLIMUS APOTEX
_CONTAINS _
_THE _
_ACTIVE _
_INGREDIENT _
_TACROLIMUS_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 _
_195 055_
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Tacrolimus
APOTEX
Capsules. It does not contain all the
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 Tacrolimus APOTEX
.
Tacrolimus
APOTEX
contains
the
active
ingredient
tacrolimus,
which
is
an
immunosuppressive agent.
Your
doctor
may
have
prescribed
Tacrolimus
APOTEX
for
another
reason.
Ask your doctor if you have any questions
about why this medicine has been prescribed
for you.
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
Tacrolimus APOTEX against
the benefits
this medicine is expected to have for you.
If
you
have
any
concerns
about
using
Tacrolimus
APOTEX
ask
your
doctor
or
pharmacist.
Keep this leaflet with your medicine. You
may need to read it again.
WHAT THIS MEDICINE 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.
Tacrolimus
APOTEX
stops
this
attack;
it
is
very
important
to
take
Tacrolimus APOTEX given to you by your BEFORE YOU TAKE THIS MEDICINE
WHEN YOU MUST NOT USE IT
Do not use Tacrolimus APOTEX if

you have an allergy
to tacrolimus,
other
macrolides
(these
are
antibiotics
of
the
erythromycin
family – trade names are Eryc, EES,
Klacid,
Zithromax,
Rulide
and
Biaxsig) or
any of
the
ingredients
con

Карактеристике производа

___________________________________________________________________________________
TACROLIMUS APOTEX PI
Version 05
Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION
TACROLIMUS APOTEX (TACROLIMUS MONOHYDRATE)
CAPSULES
1
NAME OF THE MEDICINE
Tacrolimus (as monohydrate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.5 mg, 1 mg or 5 mg tacrolimus.
EXCIPIENTS WITH KNOWN EFFECT
Lactose, gelatin (contains sulfites).
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
TACROLIMUS APOTEX CAPSULES 0.5 MG: White to off white powder filled in
size ‘5’ yellow
cap/yellow coloured body HGC printed with “0.5 mg” on cap and
“Tacro” on body with red ink.
TACROLIMUS APOTEX CAPSULES 1 MG: White to off white powder filled in
size ‘5’ white cap/white
coloured body HGC printed with “1 mg” on cap and “Tacro” on
body with red ink.
TACROLIMUS APOTEX CAPSULES 5 MG: White to off white powder filled in
size ‘4’ greyish red cap/
greyish red coloured body HGC printed with “5 mg” on cap and
“Tacro” on body with white ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indicated for use as an adjunct to liver, kidney, lung or heart
allograft transplantation in adults and
children.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The dosage recommendations given below for oral and intravenous
administration (intravenous
dosage form can be available from other brand/s) should act as a
guideline. Tacrolimus doses should
be adjusted according to individual patient requirements.
If allograft rejection or adverse events occur, alteration in the
immunosuppressive regimen should be
considered.
METHOD OF ADMINISTRATION
It is recommended that the oral daily dose of Tacrolimus APOTEX be
administered as two divided
doses, in the morning and in the evening.
Tacrolimus APOTEX capsules should generally be administered on an
empty stomach or at least 1
hour before or 2 to 3 hours after a meal, to achieve maximum
absorption (Refer to section 5.2
PHARMACOKINETIC PROPERTIES -