IRINOTECAN ACT irinotecan hydrochloride trihydrate 500mg/25mL concentrated injection vial

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

irinotecan hydrochloride trihydrate

Sẵn có từ:

Medis Pharma Pty Ltd

INN (Tên quốc tế):

irinotecan hydrochloride trihydrate

Tình trạng ủy quyền:

Registered

Tờ rơi thông tin

_Irinotecan ACT – Consumer Medicine Information _
_ _
_Irinotecan ACT CMI v1.0_
1
Irinotecan ACT Injections
_contains the active ingredient irinotecan hydrochloride trihydrate _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about Irinotecan ACT.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Irinotecan ACT
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING TREATED WITH THIS MEDICINE,
TALK TO YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
What Irinotecan ACT is
used for
Irinotecan ACT is used to treat
bowel cancer which has spread to
other parts of the body. Cancer
which has spread cannot be
treated by surgery alone and one
of the options in this situation is
treatment with an anticancer
medicine, known as chemotherapy.
Irinotecan ACT may be used once
spread of cancer beyond the bowel
is first diagnosed. At this time
Irinotecan ACT will be given in
combination with other anticancer
medicines. Alternatively,
Irinotecan ACT is used alone when
the cancer has not responded or
has returned after initial
treatment.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IRINOTECAN
ACT HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
It is not known if Irinotecan ACT is
safe and effective in the treatment
of children.
Before being treated with
Irinotecan ACT
_WHEN IRINOTECAN ACT MUST NOT BE _
_GIVEN _
IRINOTECAN ACT MUST NOT BE GIVEN
IF YOU ARE ALLERGIC TO MEDICINES
CONTAINING IRINOTECAN OR ANY OF
THE INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
IRINOTECAN ACT MUST NOT BE GIVEN
IF YOU ARE, OR MAY BE, PREGNANT.
IRINOTECAN ACT MUST NOT BE GIVEN
IF YOU ARE BREASTFEEDING OR INTEND
TO BREASTFEED.
_BEFORE TREATMENT WITH IRINOTECAN _
_ACT _
You should be treated with
Irinotecan ACT by a doctor who is
experienced i

Đặc tính sản phẩm

Irinotecan ACT
injections
PRODUCT INFORMATION
NAME OF THE MEDICINE
Irinotecan hydrochloride. The chemical name for irinotecan
hydrochloride is
(4_S_)-4,11-diethyl-
4-hydroxy-9- [(4-piperidinopiperidino) carbonyloxy]-1_H_- pyrano
[3',4':6,7] indolizino [1,2-
_b_]quinolone- 3,14(4_H_,12_H_)dione hydrochloride trihydrate.
. Its structural formula is:
HCL•3H
2
0
C
33
H
38
N
4
O
6
.HCl.3H
2
0
Molecular weight: 677.19
CAS No.: 136572-09-3
DESCRIPTION
Irinotecan ACT injection (irinotecan hydrochloride injection) is an
antineoplastic agent of the
topoisomerase I inhibitor class.
Irinotecan hydrochloride is a semisynthetic derivative of
camptothecin, an alkaloid extract from
plants such as _Camptotheca acuminata_. It is a pale yellow to yellow
crystalline powder, slightly
soluble in water and organic solvents.
Irinotecan ACT injection is supplied as a sterile, light yellow or
pale yellow, clear, aqueous
solution with pH 3.5. It contains 20 mg irinotecan hydrochloride/mL
and comes in three sizes
containing 40 mg/2 mL, 100 mg/5 mL or 500 mg/25 mL. The solution also
contains sorbitol, (s)-
lactic acid, sodium hydroxide and hydrochloric acid. The concentrated
solution is intended for
dilution with 5% Glucose Injection or 0.9% Sodium Chloride Injection
prior to infusion.
PHARMACOLOGY
Irinotecan hydrochloride is a derivative of camptothecin.
Camptothecins interact specifically
with the enzyme topoisomerase I, which relieves torsional strain in
DNA by inducing reversible
single-strand breaks. Irinotecan hydrochloride and its active
metabolite SN-38 bind to the
topoisomerase I - DNA complex and prevent religation of these
single-strand breaks. Current
research suggests that the cytotoxicity of irinotecan hydrochloride is
due to double-strand DNA
damage produced during DNA synthesis when replication enzymes interact
with the ternary
complex
formed
by
topoisomerase
I,
DNA,
and
either
irinotecan
hydrochloride
or
SN-38.
Mammalian cells cannot efficiently repair these double-strand breaks.
Irinotecan hydrochloride serves as a water-