PACLITAXEL ACCORD paclitaxel 100 mg/16.7 mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

paclitaxel

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Paclitaxel

Authorization status:

Registered

Patient Information leaflet

Version 4.0
Page 1 of 4
PACLITAXEL ACCORD
_Paclitaxel Concentrated Injection 30 mg/5 mL, 100 mg/16.7 mL and 300
mg/50 mL _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Paclitaxel Accord. It
does not contain all the available
information. It does not take the place of
talking to your doctor.
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 PACLITAXEL ACCORD
IS USED FOR
Paclitaxel Accord is used to treat cancer
of the ovary, the breast, and non small
cell cancer of the lung. Paclitaxel Accord
may be used alone or in combination with
other anticancer agents.
Paclitaxel Accord is not recommended
for use in children as its safety and
effectiveness in patients under 18 years
of age has not been established.
Ask your doctor if you have any
questions about why Paclitaxel Accord
was prescribed for you.
_HOW PACLITAXEL ACCORD WORKS _
Paclitaxel Accord belongs to a class of
anticancer agents known as taxanes.
These agents prevent the division of cells,
particularly cancer cells.
The use of Paclitaxel Accord to treat your
cancer can lead to side-effects, which are
discussed below.
BEFORE RECEIVING
PACLITAXEL ACCORD
_WHEN PACLITAXEL ACCORD MUST _
_NOT BE GIVEN _
YOU HAVE AN ALLERGY TO:
•
Any medicine containing paclitaxel or
other medicines similar to paclitaxel
called taxanes
•
Any of the ingredients listed at the
end of this leaflet
•
Any medicines containing PEG-35
castor oil such as cyclosporin
injection or teniposide injection.
•
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 HAVE A VERY LOW WHITE B

Summary of Product characteristics

Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
PACLITAXEL ACCORD (PACLITAXEL) CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Paclitaxel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains 6 mg paclitaxel.
1 vial of 5 mL concentrated injection for infusion contains 30 mg
paclitaxel.
1 vial of 16.7 mL concentrated injection for infusion contains 100 mg
paclitaxel.
1 vial of 50 mL concentrated injection for infusion contains 300 mg
paclitaxel.
Excipients with known effect: absolute ethanol (49.5% v/v). For the
full list of excipients, see
SECTION
6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Paclitaxel Accord Concentrate for Intravenous Infusion is supplied as
a nonaqueous solution intended
for dilution with 0.9% Sodium Chloride Injection or 5% Glucose
Injection prior to intravenous infusion.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
1.
Paclitaxel is indicated for the primary treatment of ovarian cancer in
combination with a platinum
agent.
2.
Paclitaxel is indicated for the treatment of metastatic carcinoma of
the ovary after failure of standard
therapy.
3.
Paclitaxel is indicated for the treatment of metastatic carcinoma of
the breast after failure of
standard therapy.
4.
Paclitaxel
is
indicated
for
adjuvant
treatment
of
node-positive
breast
cancer
administered
sequentially to doxorubicin and cyclophosphamide.
5.
Paclitaxel is indicated for the treatment of metastatic cancer of the
breast, in combination with
trastuzumab (Herceptin
®
), in patients who have tumours that over-express HER-2 and who have
not received previous chemotherapy for their metastatic disease.
6.
Paclitaxel, in combination with gemcitabine (Gemzar
®
), is indicated 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.
7.
Paclitaxel is indicated for the treatment of non-small cell lung
cancer (NSCLC).
4.2
D
OSE AND METHOD OF ADMINISTRATI