TACROLIMUS ACTAVIS tacrolimus 0.5 mg capsules blister pack

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

tacrolimus, Quantity: 0.5 mg

Sẵn có từ:

Accord Healthcare Pty Ltd

INN (Tên quốc tế):

Tacrolimus

Dạng dược phẩm:

Capsule, hard

Thành phần:

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

Tuyến hành chính:

Oral

Các đơn vị trong gói:

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

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

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

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

Licence status A

Ngày ủy quyền:

2015-05-27

Tờ rơi thông tin

TACROLIMUS ACTAVIS
CONSUMER MEDICINE INFORMATION
Version: 1.0
-2015- Page: 1 of 4
TACROLIMUS ACTAVIS
(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
Tacrolimus Actavis. 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
Tacrolimus Actavis against the
benefits this medicine is expected
to have for you.
If you have any concerns about
using Tacrolimus Actavis ask
your doctor or pharmacist.
Keep this leaflet with your
medicine. You may need to read
it again.
WHAT TACROLIMUS
ACTAVIS 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 Actavis stops this
attack; it is very important to take
Tacrolimus Actavis 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
Tacrolimus Actavis.
Tacrolimus Actavis contains the
active ingredient tacrolimus,
which is an immunosuppressive
agent.
Your doctor may have prescribed
Tacrolimus Actavis for another
reason. Ask your doctor if you
have any questions about why
this medicine has been
prescribed for you.
BEFORE YOU TAKE
TACROLIMUS ACTAVIS
_WHEN YOU MUST NOT USE IT _
Do not use Tacrolimus Actavis
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 in

Đặc tính sản phẩm

Tacrolimus Actavis (Tacrolimus Capsules 0.5 mg, 1 mg and 5 mg) Version
1.0
-2015- Page 1 of 21
PRODUCT INFORMATION
TACROLIMUS ACTAVIS
(TACROLIMUS CAPSULES 0.5 MG, 1 MG AND 5 MG)
NAME OF THE MEDICINE
Tacrolimus (as monohydrate)
_[3S-_
_[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-_
_5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a_
-hexadecahydro-5,19-dihydroxy-3-[2-
(4-hydroxy-
3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-
tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido [2,1-c]
[1,4]oxaazacyclotricosine-
1,7,20,21(4H,23H)-tetrone, monohydrate.
Molecular Formula: C
44
H
69
NO
12
.H
2
O
Molecular Weight: 822.03. CAS 109581-93-3
DESCRIPTION
Tacrolimus
appears
as
white
crystals
or
a
crystalline
powder,
very
soluble
in
methanol, and chloroform, freely soluble in acetone and ethanol and
practically
insoluble in hexane and water. Tacrolimus is obtained by fermentation
as a single
enantiomer but exists in tautomeric equilibration in aqueous solution.
Tacrolimus
Actavis
capsules
also
contain
hypromellose,
croscarmellose
sodium,
lactose anhydrous and magnesium stearate. The capsule shell contains
gelatin, water-
purified and titanium dioxide and a dye (iron oxide yellow (E172) for
0.5 mg capsules
and iron oxide red (E172) for 5 mg capsules). The capsules also have a
trace of
TekPrint SW-9008 black ink (ARPING Number: 2328), which contains
shellac,
propylene glycol, ammonia, iron oxide black and potassium hydroxide.
PHARMACOLOGY
Tacrolimus Actavis (Tacrolimus Capsules 0.5 mg, 1 mg and 5 mg) Version
1.0
-2015- Page 2 of 21
Tacrolimus is a macrolide lactone with potent
_in vitro _
and
_in vivo _
immunosuppressive
activity.
Studies
suggest
that
tacrolimus
inhibits
the
formation
of
cytotoxic
lymphocytes which are regarded as being primarily 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 and -3
and
gamma-interferon
and
the
expression
of
the
inter