IRINOTECAN WKT irinotecan hydrochloride 100mg/5mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

irinotecan hydrochloride trihydrate, Quantity: 20 mg/mL

Available from:

Wockhardt Bio Pty Ltd

INN (International Name):

irinotecan hydrochloride trihydrate

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: water for injections; sodium hydroxide; hydrochloric acid; lactic acid; sorbitol

Administration route:

Intravenous

Units in package:

1 Vial per pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Irinotecan injection is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. Irinotecan injection is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

Product summary:

Visual Identification: Clear yellow solution; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-10-13

Patient Information leaflet

IRINOTECAN
1
v1.1
IRINOTECAN
WKT
_Irinotecan hydrochloride_
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
IRINOTECAN WKT.
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 treating you with
IRINOTECAN WKT against the
expected benefits it will have for
you.
ASK YOUR DOCTOR IF YOU HAVE ANY
CONCERNS ABOUT BEING TREATED
WITH THIS MEDICINE.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT IRINOTECAN
WKT IS USED FOR
IRINOTECAN WKT 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. One of the
options in this situation is treatment
with an anticancer medicine, known
as chemotherapy.
IRINOTECAN WKT may be used
once spread of cancer beyond the
bowel is first diagnosed. At this
time IRINOTECAN WKT will be
given in combination with other
anticancer medicines. Alternatively,
IRINOTECAN WKT 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 WKT
HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed
it for another purpose.
_USE IN CHILDREN_
It is not known if IRINOTECAN
WKT is safe and effective in the
treatment of children.
BEFORE BEING TREATED
WITH IRINOTECAN
WKT
_WHEN IRINOTECAN WKT _
_MUST NOT BE GIVEN_
IRINOTECAN WKT must not be
given if you:
•
are allergic to irinotecan
hydrochloride or any of the
ingredients listed at the end
of this leaflet
•
are or may become pregnant
•
are breastfeeding or intend
to breastfeed.
_BEFORE TREATMENT WITH _
_IRINOTECAN WKT_
You should be treated with
IRINOTECAN WKT by a doctor
who is experienced in treating
patients with cancer. Treatment will
normally take place in a hospital
because of the need for hospital
facilities and skilled personnel.
It is likely that your doctor will
give you one or

Summary of Product characteristics

Irinotecan WKT Concentrated Injection v4.4
1
AUSTRALIAN PRODUCT INFORMATION – IRINOTECAN WKT
CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Irinotecan hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
IRINOTECAN
WKT
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
that is slightly soluble in water and organic solvents.
IRINOTECAN WKT injection is supplied as a sterile, clear yellow
concentrated aqueous
solution with pH 3.5. It is intended for dilution with 5% Glucose
Injection or 0.9% Sodium
Chloride Injection prior to infusion. In addition to irinotecan
hydrochloride, the ingredients
are sorbitol, lactic acid, sodium hydroxide and hydrochloric acid.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Sterile concentrated solution for IV infusion
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Irinotecan injection is indicated as a component of first-line therapy
for patients with
metastatic carcinoma of the colon or rectum. Irinotecan injection is
also indicated for patients
with metastatic carcinoma of the colon or rectum whose disease has
recurred or progressed
following initial therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
It is recommended that patients receive premedication with antiemetic
agents. Prophylactic or
therapeutic
administration
of
atropine
should
be
considered
in
patients
experiencing
cholinergic symptoms (see
section 4.4 Special Warnings and Precautions For Use)
.
C
OMBINATION
A
GENT
T
HERAPY
D
OSAGE
R
EGIMENS
_I_
_RINOTECAN INJECTION IN _
_C_
_OMBINATION WITH _
_5-F_
_LUOROURACIL _
_(5-_
_FU)_
_ AND _
_L_
_EUCOVORIN _
_(LV) _
Irinotecan injection should be administered as an intravenous infusion
over 90 minutes (see
Preparation of Infusion Solution). For all regimens, the dose of LV
should be admi