DBL GEMCITABINE INJECTION gemcitabine (as hydrochloride) 2g/52.6mL solution for Injection vial

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

gemcitabine hydrochloride, Quantity: 2.277 g

Commercializzato da:

Pfizer Australia Pty Ltd

INN (Nome Internazionale):

Gemcitabine hydrochloride

Forma farmaceutica:

Injection, solution

Composizione:

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

Via di somministrazione:

Intravenous

Confezione:

Single

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

DBL Gemcitabine Injection is indicated: 1. For treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). 2. For treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. 3. For treatment of patients with FU refractory pancreatic cancer. 4. Alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. 5. In combination with paclitaxel, for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated. 6. In combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

Dettagli prodotto:

Visual Identification: A clear, colourless or light straw-coloured solution in a clear glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

2010-04-28

Foglio illustrativo

DBL
™
Gemcitabine Injection CMI.
Page 1
DBL™ GEMCITABINE INJECTION
(SOLUTION FOR INJECTION)
Gemcitabine Hydrochloride (_jem-SIGH-ta-been) _
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™
Gemcitabine Injection
(gemcitabine). 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 gemcitabine 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 GEMCITABINE IS
USED FOR
This medicine is used to treat the
following types of cancer:
•
lung cancer
•
pancreatic cancer
•
bladder cancer
•
breast cancer
•
ovarian cancer.
This medicine belongs to a group
of medicines called antineoplastic
or cytotoxic medicines. You may
also hear of these being called
chemotherapy medicines.
This medicine works by killing
cancer cells and stopping 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 may be used alone
or in combination with other
medicines to treat cancer.
This medicine is not addictive.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU ARE GIVEN
GEMCITABINE
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN
GEMCITABINE IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
gemcitabine hydrochloride
•
any of the ingredients listed at
the end of this leaflet
•
if the packaging is torn or
shows sign of tampering.
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

Scheda tecnica

Version: pfpgemsi10320
Supersedes: pfpgemsi10919
Page 1 of 20
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™ GEMCITABINE INJECTION (GEMCITABINE
HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Gemcitabine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains gemcitabine hydrochloride (38 mg/mL) and the
excipients, Water for
Injections, hydrochloric acid and/or sodium hydroxide. DBL Gemcitabine
Injection contains
no microbial agent or preservatives.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
DBL
Gemcitabine
Injection
is
a
clear,
colourless
to
light
straw-coloured
solution
for
intravenous use.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DBL Gemcitabine Injection is indicated:

for treatment of patients with locally advanced or metastatic
non-small cell lung cancer
(NSCLC).

for treatment of patients with locally advanced or metastatic
adenocarcinoma of the
pancreas.

for treatment of patients with 5-Fluorouracil refractory pancreatic
cancer.

alone or in combination with cisplatin, is indicated for treatment of
patients with
bladder cancer.

in combination with paclitaxel, for the treatment of patients with
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, for the treatment of patients with
recurrent epithelial
ovarian carcinoma, who have relapsed > 6 months following
platinum-based therapy
Version: pfpgemsi10320
Supersedes: pfpgemsi10919
Page 2 of 20
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
DBL Gemcitabine Injection contains no antimicrobial preservative.
Product is for single use in
one patient only. Discard any residue.
_NON-SMALL CELL LUNG CANCER: _
_Single-agent use: _
_Adults:_
The
optimum
dose
schedule
for
gemcitabine
has
not
been
determined.
The
recommended dose of gemcitabine is 1,000 mg/m
2
, given by 30 minute intravenous i