PACROLIM tacrolimus 0.5 mg capsules blister pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

tacrolimus, Quantity: 0.5 mg

可用日期:

Accord Healthcare Pty Ltd

INN（国际名称）:

Tacrolimus

药物剂型:

Capsule, hard

组成:

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

给药途径:

Oral

每包单位数:

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

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

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

產品總結:

Visual Identification: 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; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

授权状态:

Licence status A

授权日期:

2015-05-27

资料单张

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

产品特点

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