IRINOTECAN-GA irinotecan hydrochloride trihydrate 100 mg / 5 mL injection vial

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Prenos Navodilo za uporabo (PIL)
24-08-2020
Prenos Javno poročilo o oceni (PAR)
30-11-2017

Aktivna sestavina:

irinotecan hydrochloride trihydrate, Quantity: 20 mg/mL

Dostopno od:

Medis Pharma Pty Ltd

INN (mednarodno ime):

irinotecan hydrochloride trihydrate

Farmacevtska oblika:

Injection

Sestava:

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

Pot uporabe:

Intravenous

Enote v paketu:

Vial 100 mg / 5 mL

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

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.

Povzetek izdelek:

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

Status dovoljenje:

Registered

Datum dovoljenje:

2008-06-04

Navodilo za uporabo

                                Irinotecan-GA CMI V2 100720
Page 1 of 5
IRINOTECAN-GA INJECTION
Irinotecan (eye-ri-noe-TEE-kan)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Irinotecan-GA Injection
.
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-GA
INJECTION 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
IRINOTECAN-GA
_WHEN YOU MUST NOT BE _
_GIVEN IT_
YOU MUST NOT BE GIVEN
IRINOTECAN INJECTION IF
YOU HAVE AN ALLERGY TO:
• any medicine containing
irinotecan
• 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;
swelling of the face, lips,
tongue or other parts of
the body; rash, itching or
hives on the skin.
YOU MUST NOT BE GIVEN
THIS MEDICINE IF YOU ARE
PREGNANT.
It may affect your
developing baby if you take
it d
                                
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