PACROLIM tacrolimus 5 mg capsules blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

tacrolimus, Quantity: 5 mg

Disponível em:

Accord Healthcare Pty Ltd

DCI (Denominação Comum Internacional):

Tacrolimus

Forma farmacêutica:

Capsule, hard

Composição:

Excipient Ingredients: croscarmellose sodium; magnesium stearate; ethanol absolute; Gelatin; hypromellose; lactose; purified water; titanium dioxide; methyl chloride; iron oxide red; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Via de administração:

Oral

Unidades em pacote:

10 capsules in blister pack, 100 capsules in blister pack, 50 capsules in blister pack

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Indicated for use as an adjunct to liver, kidney, lung or heart allograft transplantation in adults and children

Resumo do produto:

Visual Identification: Pink / Pink hard gelatin capsules, size "4" imprinted with "TCR" on cap & "ABZ 5" on body containing white to off white granular powder.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status de autorização:

Licence status A

Data de autorização:

2015-05-27

Folheto informativo - Bula

PACROLIM
CONSUMER MEDICINE INFORMATION
Version: 2.0
-2015-
Page: 1 of 4
PACROLIM
(TACROLIMUS CAPSULES 0.5 MG, 1 MG AND 5 MG)
_Tacrolimus (as monohydrate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Pacrolim. 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
Pacrolim against the benefits this
medicine is expected to have for
you.
If you have any concerns about
using Pacrolim ask your doctor
or pharmacist.
Keep this leaflet with your
medicine. You may need to read
it again.
WHAT PACROLIM 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.
Pacrolim stops this attack; it is
very important to take Pacrolim
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
Pacrolim.
Pacrolim contains the active
ingredient tacrolimus, which is
an immunosuppressive agent.
Your doctor may have prescribed
Pacrolim for another reason. Ask
your doctor if you have any
questions about why this
medicine has been prescribed for
you.
BEFORE YOU TAKE
PACROLIM
_WHEN YOU MUST NOT USE IT_
Do not use Pacrolim 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
contained in the capsules. See
‘
Product Description
’
at the end
of this leaflet for a list of
ingredients.
Do not us

Características técnicas

1
AUSTRALIAN PRODUCT INFORMATION – PACROLIM (TACROLIMUS)
CAPSULES
1
NAME OF THE MEDICINE
Tacrolimus monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each PACROLIM 0.5 mg capsule contains 0.5 mg Tacrolimus (as
monohydrate)
Each PACROLIM 1 mg capsule contains 1 mg Tacrolimus (as monohydrate)
Each PACROLIM 5 mg capsule contains 5 mg Tacrolimus (as monohydrate)
Contains: lactose
The capsules also have a trace of TekPrint SW-9008 black ink
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
PACROLIM capsules 0.5 mg (AUST R No. 224283): Light yellow/light
yellow hard gelatin capsules, size
“4” imprinted with “TCR” on cap & “ABZ 0.5” on body
containing white to off white granular powder.
PACROLIM
capsules
1
mg
(AUST
R
No.
224268):
White/white
hard
gelatin
capsules,
size
“4”
imprinted with “TCR” on cap & “ABZ 1” on body containing white
to off white granular powder.
PACROLIM capsules 5 mg (AUST R No. 224271): Pink/pink hard gelatin
capsules, size “4” imprinted
with “TCR” on cap & “ABZ 5” on body containing white to off
white granular powder.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Indicated for use as an adjunct to liver, kidney, lung or heart
allograft transplantation in adults and
children
4.2
D
OSE AND METHOD OF ADMINISTRATION
The dosage recommendations given below for oral should act as a
guideline. PACROLIM
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 _
2
It is recommended that the oral daily dose of PACROLIM be administered
as two divided doses, in
the morning and in the evening.
PACROLIM 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 (see
Section 5.2 Pharmacokinetic
Properties – Absorption).
PACROLIM capsules should be taken immediately following removal fr