DBL IRINOTECAN irinotecan 100mg/5mL (as hydrochloride) concentrated injection vial

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

irinotecan hydrochloride trihydrate, Quantity: 100 mg

Dostupno od:

Pfizer Australia Pty Ltd

Farmaceutski oblik:

Injection, concentrated

Sastav:

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

Administracija rute:

Intravenous

Jedinice u paketu:

Single Pack

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

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.

Proizvod sažetak:

Visual Identification: A clear, colourless to pale yellow solution free from visible particulate matter.; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Status autorizacije:

Licence status A

Datum autorizacije:

2005-02-15

Uputa o lijeku

DBL™
Irinotecan Injection Concentrate CMI
page 1
DBL™ IRINOTECAN INJECTION
CONCENTRATE
Irinotecan _(eye-ri-noe-TEE-kan)_ Hydrochloride trihydrate
CONSUMER MEDICINE INFORMATION _DATE OF DISPENSING_
_CONSUMER NAME _
_PHARMACIST NAME _
_CONSUMER ADDRESS _
_PHARMACIST ADDRESS _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about DBL™
Irinotecan Injection Concentrate.
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 you being
given irinotecan against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET._ _
You may need to read it again.
WHAT IRINOTECAN IS
USED FOR
This medicine is used to treat
cancer of the colon or rectum that
has:
•
spread to other parts of the
body, or
•
recurred or progressed
following initial therapy.
This medicine belongs to a group
of medicines called antineoplastic
or cytotoxic medicines. You may
also hear of these being called
chemotherapy medicines.
It works by killing cancer cells and
stopping cancer cells from
growing and multiplying. It may
be used alone or in combination
with other medicines to treat
cancer.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU
.
Your doctor may have prescribed
it for another reason.
This medicine is not addictive.
_ _
It is available only with a doctor’s
prescription.
There is not enough information
to recommend the use of this
medicine for children.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN DBL™
IRINOTECAN INJECTION
CONCENTRATE IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
irinotecan hydrochloride
trihydrate
•
any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty
breathing
�

Svojstava lijeka

Version pfpirini10319
Supersedes:8.0
Page 1 of 34
AUSTRALIAN PRODUCT INFORMATION DBL
™
IRINOTECAN
INJECTION
CONCENTRATE
(IRINOTECAN HYDROCHLORIDE TRIHYDRATE)
1.
NAME OF THE MEDICINE
Irinotecan hydrochloride trihydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The 2 mL and 5 mL injections contain 40 mg and 100 mg of irinotecan
hydrochloride
trihydrate respectively. In addition to irinotecan hydrochloride
trihydrate, the ingredients are
sorbitol and lactic acid. Sodium hydroxide and hydrochloric acid are
used for pH adjustment.
Irinotecan hydrochloride trihydrate is a semisynthetic derivative of
camptothecin, an alkaloid
extract from plants such as
_Camptotheca acuminata_
. It is a pale yellow to yellow crystalline
powder, with the empirical formula C
33
H
38
N
4
O
6
.HCl.3H
2
O and a molecular weight of
677.19. Irinotecan hydrochloride trihydrateis slightly soluble in
water and organic solvents.
EXCIPIENT(S) WITH KNOWN EFFECT
•
Sodium hydroxide
•
Sorbitol
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Concentrated injection.
DBL
™
Irinotecan Injection Concentrate is supplied as a sterile, pale
yellow, clear, aqueous
concentrated solution for injection of 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 _ _
DBL
™
Irinotecan Injection Concentrate is indicated as a component of
first-line therapy for
patients with metastatic carcinoma of the colon or rectum. DBL
™
Irinotecan Injection
Concentrate is also indicated for patients with metastatic carcinoma
of the colon or rectum
whose disease has recurred or progressed following initial therapy.
Version pfpirini10319
Supersedes:8.0
Page 2 of 34
4.2 DOSE AND METHOD OF ADMINISTRATION
It is recommended that patients receive premedication with anti-emetic
agents. Prophylactic
or therapeutic administration of atropine should be considered in
patients experiencing
cholinergic symptoms (see Section 4.4 S