MEDITAB IRINOTECAN irinotecan hydrochloride trihydrate 100 mg / 5 mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

irinotecan hydrochloride trihydrate, Quantity: 20 mg/mL

Available from:

Cipla Australia Pty Ltd

INN (International Name):

irinotecan hydrochloride trihydrate

Pharmaceutical form:

Injection

Composition:

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

Administration route:

Intravenous

Units in package:

Vial 100 mg / 5 mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

As a component of first line therapy for patients with metastatic carcinoma of the colon or rectum. Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

Product summary:

Visual Identification: Clear colourless to yellow solution; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2010-10-28

Patient Information leaflet

MEDITAB IRINOTECAN
Irinotecan hydrochloride
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
MEDITAB
IRINOTECAN.
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
MEDITAB
IRINOTECAN 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 MEDITAB
IRINOTECAN IS USED
FOR
MEDITAB IRINOTECAN
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.
MEDITAB IRINOTECAN
may be used once spread
of cancer beyond the
bowel is first diagnosed.
At this time MEDITAB
IRINOTECAN will be
given in combination with
other anticancer
medicines. Alternatively,
MEDITAB
IRINOTECAN 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 MEDITAB
IRINOTECAN has been
prescribed for you.
Your doctor may have
prescribed it for another
purpose.
USE IN CHILDREN
It is not known if
MEDITAB
IRINOTECAN is safe and
effective in the treatment
of children.
BEFORE BEING TREATED WITH
MEDITAB
IRINOTECAN
WHEN _MEDITAB _
_IRINOTECAN_ MUST NOT
BE GIVEN
MEDITAB IRINOTECAN
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 _
_MEDITAB _
_IRINOTECAN _
You should be treated with
MEDITAB
IRINOTECAN 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 lik

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - MEDITAB IRINOTECAN (IRINOTECAN
HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Irinotecan hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The 2 mL and 5 mL injection products contain 40 mg and 100 mg of
irinotecan respectively
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Concentrated injection
Meditab Irinotecan Injection is supplied as a sterile, clear,
colourless to pale yellow aqueous
solution with pH 3.5. It is intended for dilution with glucose 5%
injection (preferred) or 0.9%
Sodium Chloride injection prior to infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Meditab Irinotecan injection is indicated as a component of first line
therapy for patients with
metastatic carcinoma of the colon or rectum.
Meditab 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
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 (see
section 4.4 - Special warnings and precautions for
use).
COMBINATION AGENT THERAPY
_DOSAGE REGIMENS: _
_ _
_ Meditab Irinotecan Injection in Combination with 5-_
_Fluorouracil (5-FU) and Leucovorin (LV) _
Meditab 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
administered immediately after Meditab Irinotecan, with the
administration of 5-FU to follow
immediately after the administration of LV. The recommended regimens
are shown in Table 1.
_ _
_TABLE 1: COMBINATION AGENT DOSAGE REGIMENS & DOSE MODIFICATIONS_
_A_
_ _
REGIMEN 1
6 week cycle
Treatment
resumes Day 43
Meditab
Irinotecan
LV
5-FU
125 mg/m
2
IV over 90 min on Day 1, 8, 15, 22 then 2 wk rest
20 mg/m
2
IV bolus injection Day 1, 8, 15, 2