GEMCITABINE SANDOZ gemcitabine (as hydrochloride) 1000 mg/100 mL concentrated solution for infusion vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gemcitabine hydrochloride, Quantity: 1139 mg (Equivalent: gemcitabine, Qty 1000 mg)

Available from:

Sandoz Pty Ltd

INN (International Name):

Gemcitabine

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: sodium hydroxide; water for injections; sodium acetate trihydrate

Administration route:

Intravenous

Units in package:

1 x 100mL vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

GEMCITABINE SANDOZ is indicated for treatment of patients with:. - locally advanced or metastatic non-small cell lung cancer (NSCLC). - locally advanced or metastatic adenocarcinoma of the pancreas . - Fluorouracil refractory pancreatic cancer. - (alone or in combination with cisplatin) bladder cancer. - (in combination with paclitaxel) unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated.. - (in combination with carboplatin) recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

Product summary:

Visual Identification: Clear colourless solution in a clear glass vial with a grey rubber stopper; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2008-12-02

Patient Information leaflet

Gemcitabine Ebewe
®
1
GEMCITABINE EBEWE
GEMCITABINE HYDROCHLORIDE CONCENTRATED INJECTION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Gemcitabine Ebewe.
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 taking
this medicine against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT GEMCITABINE EBEWE IS USED FOR
This medicine is used to treat patients with
•
lung cancer
•
pancreatic cancer
•
bladder cancer
•
breast cancer
•
ovarian cancer.
It contains the active ingredient gemcitabine hydrochloride.
Gemcitabine hydrochloride
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
preventing
cancer
cells
from
growing
and
multiplying.
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.
Gemcitabine Ebewe may be used in combination with other cytotoxic
medicines to treat
cancer.
Gemcitabine Ebewe
®
2
This medicine is not addictive.
BEFORE YOU ARE GIVEN GEMCITABINE EBEWE
_WHEN YOU MUST NOT BE GIVEN IT _
YOU MUST NOT BE GIVEN THIS MEDICINE IF YOU HAVE AN ALLERGY TO:
•
gemcitabine hydrochloride, the active ingredient, or to any of the
other ingredients
listed at the end of this leaflet under Product Description.
•
any other similar medicines.
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 AFTER THE EXPIRY DATE PRINTED ON
THE PACK OR IF
THE PAC