IRINOTECAN WOCKHARDT irinotecan hydrochloride 40mg/2mL injection vial

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

irinotecan hydrochloride trihydrate, Quantity: 20 mg/mL

Disponible depuis:

Wockhardt Bio Pty Ltd

DCI (Dénomination commune internationale):

irinotecan hydrochloride trihydrate

forme pharmaceutique:

Injection, concentrated

Composition:

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

Mode d'administration:

Intravenous

Unités en paquet:

1 Vial per pack

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

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.

Descriptif du produit:

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

Statut de autorisation:

Licence status A

Date de l'autorisation:

2017-10-13

Notice patient

IRINOTECAN
1
IRINOTECAN
WOCKHARDT
_Irinotecan hydrochloride_
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
IRINOTECAN WOCKHARDT.
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 WOCKHARDT
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
WOCKHARDT IS USED
FOR
IRINOTECAN WOCKHARDT 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 WOCKHARDT
may be used once spread of cancer
beyond the bowel is first diagnosed.
At this time IRINOTECAN
WOCKHARDT will be given in
combination with other anticancer
medicines. Alternatively,
IRINOTECAN WOCKHARDT 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
WOCKHARDT HAS
BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed
it for another purpose.
_USE IN CHILDREN_
It is not known if IRINOTECAN
WOCKHARDT is safe and
effective in the treatment of
children.
BEFORE BEING TREATED
WITH IRINOTECAN
WOCKHARDT
_WHEN IRINOTECAN _
_WOCKHARDT MUST NOT BE _
_GIVEN_
IRINOTECAN WOCKHARDT
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 _
_WOCKHARDT_
You should be treated with
IRINOTECAN WOCKHARDT by
a doctor who is experienced in
treating patients with cancer.
Treatment will normally take place
in a hospital because of the need for
ho

Résumé des caractéristiques du produit

Irinotecan WOCKHARDT Concentrated Injection 4.4
1
AUSTRALIAN PRODUCT INFORMATION – IRINOTECAN WOCKHARDT
CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Irinotecan hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
IRINOTECAN
WOCKHARDT
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 WOCKHARDT 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 dos