DOCETAXEL WOCKHARDT docetaxel 20mg/1mL concentrated solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

docetaxel, Quantity: 20 mg

Available from:

Wockhardt Bio Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: ethanol absolute; citric acid monohydrate; polysorbate 80

Administration route:

Intravenous Infusion

Units in package:

One vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Docetaxel concentrate for solution for infusion is indicated for;,Breast Cancer -,Metastatic Breast Cancer : Docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. ,Docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. ,Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. ,Adjuvant Treatment of Breast Cancer : Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer. ,Doxorubicin and cyclophosphamide followed by Docetaxel in combination with trastuzumab (AC-TH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2. ,Docetaxel in combination with carboplatin and trastuzumab (TCH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2. ,Docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of ? 1cm and < 7cm. ,Non Small Cell Lung Cancer -,Docetaxel is indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer, including those who have failed platinum-based chemotherapy. ,Ovarian Cancer - Docetaxel is indicated for the treatment of metastatic carcinoma of the ovary after failure of first-line or subsequent chemotherapy. ,Prostate Cancer -,Docetaxel is indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer. ,Head and Neck Cancer -,Docetaxel, in combination with cisplatin and fluorouracil is indicated as induction treatment prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the tumour is technically unresectable.

Product summary:

Visual Identification: Clear viscous, colourless to yellowish or greenish-yellow sterile solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 12 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2017-12-04

Patient Information leaflet

DOCETAXEL WOCKHARDT
1
DOCETAXEL WOCKHARDT
(
_Docetaxel_
)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Docetaxel
WOCKHARDT.
It does not contain all the available
information. It does not take the place
of talking to your doctor, nurse or
pharmacist.
The information in this leaflet was last
updated on the date shown on the final
page. More recent information on this
medicine may be available. Make sure
you speak to your pharmacist, nurse or
doctor to obtain the most up to date
information on this medicine.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you being given this medicine against
the benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DOCETAXEL
WOCKHARDT IS USED FOR
DOCETAXEL WOCKHARDT is
used to treat breast cancer, ovarian
cancer, some types of lung cancer,
head and neck cancer and prostate
cancer.
DOCETAXEL WOCKHARDT works
by stopping cells from growing and
multiplying.
DOCETAXEL WOCKHARDT
belongs to a group of medicines
called antineoplastic or cytotoxic
medicines. You may also hear of
these being called chemotherapy
medicines.
Your doctor, however, may prescribe
DOCETAXEL WOCKHARDT for
another purpose.
ASK YOUR DOCTOR, NURSE OR
PHARMACIST IF YOU HAVE ANY QUESTIONS
ABOUT WHY THIS MEDICINE HAS BEEN
PRESCRIBED FOR YOU.
You
may
have
probably
taken
another medicine to treat your breast,
ovarian,
lung,
head
and
neck
or
prostate cancer. However, your doctor
has now decided to
treat
you
with
D O C E T A X E L
WOCKHARDT
may
be
used
alone
or
in
combination
with
other medicines to
treat cancer.
This medicine is only available with
a doctor's prescription.
D O C E T A X E L
WOCKHARDT
is
not
addictive. BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN IT _
DOCETAXEL WOCKHARDT is not
recommended for use in children.
DO NOT RECEIVE
DOCETAXEL
WOCKHARDT IF YOU HAVE AN
ALL

Summary of Product characteristics

DOCETAXEL
Version 1.1
Page 1
PRODUCT INFORMATION
DOCETAXEL WOCKHARDT
AUSTRALIAN APPROVED NAME
Docetaxel
CHEMICAL STRUCTURE
Molecular Formula: C
43
H
53
NO
14
Molecular Weight: 807.88
Chemical Name: (2R,3S)-N-carboxy-3-phenylisoserine, N-tert-butyl
ester, 13-ester with 5β, 20
epoxy 1, 2α , 4, 7β, 10β, 13α -hexahydroxytax-11-en-9-one
4-acetate 2-
benzoate
CAS REGISTRY NUMBER
114977-28-5
DOCETAXEL
Version 1.1
Page 2
DESCRIPTION
DOCETAXEL
Docetaxel is a white to almost white powder. It is highly lipophilic
and practically insoluble in
water.
Single-dose vials of DOCETAXEL WOCKHARDT concentrated injection
containing 20 or 80 or
160mg of docetaxel per 1.0 or 4.0 or 8.0mL.
In each DOCETAXEL WOCKHARDT 20mg/1mL concentrate vial, contains 2 mg
citric acid, 457
mg of absolute ethanol (96%) and 450 mg of polysorbate 80.
In each DOCETAXEL WOCKHARDT 80mg/4mL concentrate vial, contains 8mg
citric acid, 1828
mg of absolute ethanol (96%) and 1800 mg of polysorbate 80.
In each DOCETAXEL WOCKHARDT 160mg/8mL concentrate vial, contains 16 mg
citric acid,
3656 mg of absolute ethanol (96%) and 3600 mg of polysorbate 80.
PHARMACOLOGY
CLASS
Docetaxel is an antineoplastic agent which acts by promoting the
assembly of tubulin into stable
microtubules and inhibits their disassembly which leads to a marked
decrease of free tubulin. The
binding of docetaxel to microtubules does not alter the number of
protofilaments.
PHARMACODYNAMICS
MECHANISM OF ACTION
Docetaxel has been shown in vitro to disrupt the microtubular network
in cells which is essential
for vital mitotic and interphase cellular functions.
_PRECLINICAL DATA _
Docetaxel was found to be cytotoxic
_in vitro _
against various murine and human tumour cell lines
and against freshly excised human tumour cells in clonogenic assays.
Docetaxel achieves high
intracellular concentrations with a long cell residence time. In
addition, docetaxel was found to be
active on some, but not all, cell lines overexpressing the
p-glycoprotein which is encoded by the
multidrug resistance gene. In viv