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

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

irinotecan hydrochloride trihydrate

Tilgængelig fra:

Alphapharm Pty Ltd

INN (International Name):

irinotecan hydrochloride trihydrate

Autorisation status:

Registered

Indlægsseddel

IRINOTECAN
ALPHAPHARM
_contains the active ingredient irinotecan hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE BEING TREATED WITH
IRINOTECAN ALPHAPHARM.
This leaflet answers some common
questions about IRINOTECAN
ALPHAPHARM.
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
ALPHAPHARM against the benefits
they expect it will have for you.
ASK YOUR DOCTOR OR PHARMACIST, IF
YOU HAVE ANY CONCERNS ABOUT BEING
TREATED WITH THIS MEDICINE.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT IRINOTECAN
ALPHAPHARM IS
USED FOR
IRINOTECAN ALPHAPHARM
contains the active ingredient,
irinotecan hydrochloride.
It 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 ALPHAPHARM
may be used once spread of cancer
beyond the bowel is first diagnosed.
At this time IRINOTECAN
ALPHAPHARM will be given in
combination with other anticancer
medicines. Alternatively,
IRINOTECAN ALPHAPHARM is
used alone when the cancer has not
responded or has returned after initial
treatment.
Your doctor may have prescribed
IRINOTECAN ALPHAPHARM for
another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
IRINOTECAN ALPHAPHARM
HAS BEEN PRESCRIBED FOR YOU.
_USE IN CHILDREN_
It is not known if IRINOTECAN
ALPHAPHARM is safe and effective
in the treatment of children.
BEFORE BEING TREATED
WITH IRINOTECAN
ALPHAPHARM
Some information is provided below.
However, always talk to your doctor
if you have concerns or questions
about your treatment.
_WHEN IRINOTECAN MUST NOT_
_BE GIVEN_
IRINOTECAN must not be given if
you:
•
are allergic to irinotecan
hydrochloride, or any of the other
ingredients listed at the end of
this lea

Produktets egenskaber

AUSTRALIAN PRODUCT INFORMATION
IRINOTECAN ALPHAPHARM
_Irinotecan hydrochloride concentrated injection _
_ _
_ _
1 NAME OF THE MEDICINE
Irinotecan hydrochloride
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Irinotecan Alphapharm contains 20mg irinotecan
hydrochloride.
For the full list of excipients, see
6.1 LIST OF EXCIPIENTS
3 PHARMACEUTICAL FORM
Concentrated injection.
Irinotecan injection is supplied as a sterile, light yellow or pale
yellow, clear, aqueous solution with pH 3.5. It is
intended for dilution with 5% Glucose Injection or 0.9% Sodium
Chloride Injection prior to infusion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Irinotecan is indicated as a component of first-line therapy for
patients with metastatic carcinoma of the colon or
rectum. Irinotecan is also indicated for patients with metastatic
carcinoma of the colon or rectum whose disease
has recurred or progressed following initial therapy.
4.2 DOSE 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 (refer to
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
).
_Combination Agent Therapy _
_DOSAGE REGIMENS _
_ _
Irinotecan injection in Combination with fluorouracil (5-FU) and
Leucovorin (LV)
Irinotecan should be administered as an intravenous infusion over 90
minutes (refer to Preparation of Infusion
Solution). For all regimens, the dose of LV should be administered
immediately after Irinotecan, with the
administration of 5-FU to follow immediately after the administration
of LV. The recommended regimens are
shown in Table 1.
IRINOTECAN ALPHAPHARM – Product Information
2
TABLE 1: COMBINATION AGENT DOSAGE REGIMENS & DOSE MODIFICATIONS
A
REGIMEN 1
6 week cycle
Treatment resumes
Day 43
Irinotecan
LV
5-FU
125mg/m
2
IV over 90 min on day 1, 8, 15, 22 then 2 wk rest
20mg/m
2
IV bolus injection day 1, 8, 15, 22 then 2 wk rest
500mg/m
2
IV bolus injection day 1, 8, 15