PACLITAXIN paclitaxel 100 mg/16.7 mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

paclitaxel, Quantity: 100 mg

Available from:

Teva Pharma Australia Pty Ltd

INN (International Name):

Paclitaxel

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: PEG-35 castor oil; ethanol; citric acid

Administration route:

Intravenous Infusion

Units in package:

1 x 25 mL vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Primary treatment of ovarian cancer in combination with a platinum agent.. Treatment of metastatic carcinoma of the ovary and of the breast after failure of standard therapy.. Adjuvant treatment of node positive breast cancer administered sequentially to doxorubicin and cyclophosphamide.. Treatment of metastatic cancer of the breast, in combination with trastuzumab (Herceptin), in patients who have tumours that overexpress HER-2 and who have not received previous chemotherapy for their metatastic disease.. Paclitaxin, 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.. Treatment of non-small cell lung cancer (NSCLC).

Product summary:

Visual Identification: clear, colourless or slightly yellow, viscous solution, free from visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2009-11-17

Patient Information leaflet

PACLITAXIN
®
_Paclitaxel_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
The medicine your doctor has
prescribed for you is called
PACLITAXIN. The information in
this leaflet will answer some
questions you may have about
PACLITAXIN.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
PACLITAXIN 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.
This leaflet does not contain
everything about PACLITAXIN.
Your doctor has been provided with
full information and can answer any
questions you may have.
FOLLOW YOUR DOCTOR'S ADVICE EVEN IF
IT DIFFERS FROM WHAT IS IN THIS
LEAFLET.
YOU SHOULD READ THIS LEAFLET
CAREFULLY BEFORE STARTING
PACLITAXIN AND KEEP IT IN A SAFE
PLACE TO REFER TO LATER.
WHAT PACLITAXIN IS
USED FOR
PACLITAXIN is used to treat cancer
of:
•
the ovary,
•
the breast, and
•
non-small cell cancer of the lung.
PACLITAXIN may be used alone or
in combination with other anticancer
agents.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
PACLITAXIN WAS PRESCRIBED FOR
YOU. YOUR DOCTOR MAY HAVE
PRESCRIBED IT FOR ANOTHER REASON.
_HOW PACLITAXIN WORKS:_
PACLITAXIN is the first of a class
of anticancer agents known as
taxanes. They work by killing cancer
cells and stopping cancer cells from
growing and multiplying.
The use of PACLITAXIN to treat
your cancer can lead to side-effects,
which are discussed below.
BEFORE YOU ARE GIVEN
PACLITAXIN
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE PACLITAXIN IF YOU:
•
you have had an allergic reaction
to PACLITAXEL or any of the
ingredients listed at the end of
this leaflet
•
you have had an allergic reaction
to any medication containing
PEG 35 castor oil.
Some of the symptoms of an allergic
reaction may include severe skin
rash, itching, hives, swelling of the
face, lips, mouth or throat which may
cause difficulty in swallowing or
breathing and swelling of the hands,
feet or ankles.
DO NOT TAKE PACLITAXIN IF YOU
ARE PREGNANT.
It

Summary of Product characteristics

Teva Pharma Australia Pty Ltd Ver 2.0 1
AUSTRALIAN PI – PACLITAXIN (PACLITAXEL) INJECTION
1
NAME OF THE MEDICINE
Paclitaxin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Paclitaxel is a natural product with antitumour activity. It is a
white to off white crystalline powder
that is highly lipophilic and insoluble in water. It is the first of a
class of anticancer agents known as
taxanes.
Molecular formula: C
47
H
51
NO
14
MW: 853.929
Each mL of Paclitaxin contains paclitaxel 6 mg. For the full list of
excipients, see Section 6.1 List of
excipients.
3
PHARMACEUTICAL FORM
Solution (sterile, nonpyrogenic, nonaqueous, concentrate for
dilution).
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
•
Primary treatment of ovarian cancer in combination with a platinum
agent.
•
Treatment of metastatic carcinoma of the ovary and of the breast after
failure of standard
therapy.
•
Adjuvant treatment of node positive breast cancer administered
sequentially to doxorubicin
and cyclophosphamide.
•
Treatment of metastatic cancer of the breast, in combination with
trastuzumab (Herceptin),
in patients who have tumours that overexpress HER-2 and who have not
received previous
chemotherapy for their metastatic disease.
•
Paclitaxin, 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.
•
Treatment of non-small cell lung cancer (NSCLC).
Teva Pharma Australia Pty Ltd Ver 2.0 2
4.2
D
OSE AND METHOD OF ADMINISTRATION
Product is for single use in one patient only. Discard any residue.
ALL PATIENTS MUST BE PREMEDICATED PRIOR TO PACLITAXIN ADMINISTRATION
[TO PREVENT SEVERE
HYPERSENSITIVITY REACTIONS]. SUCH PREMEDICATION MAY CONSIST OF
DEXAMETHASONE 20 MG ORALLY (OR ITS
EQUIVALENT) APPROXIMATELY 12 AND 6 HOURS BEFORE PACLITAXIN;
PROMETHAZINE 25 MG OR 50 MG
INTRAVENOUSLY 30 TO 60 MINUTE