DOCETAXEL KABI docetaxel anhydrous 20 mg/1 mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

docetaxel, Quantity: 20 mg

Available from:

Fresenius Kabi Australia Pty Ltd

INN (International Name):

Docetaxel

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: citric acid; polysorbate 80; ethanol absolute

Administration route:

Intravenous

Units in package:

Carton - 1's

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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 (ACTH) 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 firstline 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: Colourless to pale yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-10-21

Patient Information leaflet

                                CMI for Docetaxel Kabi
Feb, 2013
Page 1 of 4
DOCETAXEL KABI
Docetaxel
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Docetaxel Kabi.
It does not contain all the available
information. It does not take the
place
of
talking
to
your
doctor,
nurse or pharmacist.
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 KABI IS
USED FOR
Docetaxel
Kabi
is
used
to
treat
breast
cancer,
ovarian
cancer,
some types of lung cancer, head
and
neck
cancer
and
prostate
cancer.
Docetaxel Kabi works by stopping
cells from growing and multiplying.
Docetaxel Kabi 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
Kabi
for
another purpose.
ASK
YOUR
DOCTOR,
NURSE
OR
PHARMACIST
IF
YOU
HAVE
ANY
QUESTIONS ABOUT WHY DOCETAXEL
KABI
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 Docetaxel Kabi.
Docetaxel Kabi may be used alone
or
in
combination
with
other
medicines to treat cancer.
This medicine is only available with
a doctor’s prescription.
Docetaxel Kabi is not addictive.
BEFORE
YOU
ARE
GIVEN
DOCETAXEL KABI
_WHEN YOU MUST NOT BE GIVEN IT _
Docetaxel
Kabi
is
not
recommended for use in children.
DO NOT RECEIVE DOCETAXEL KABI IF
YOU HAVE AN ALLERGY TO DOCETAXEL
OR ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Symptoms of an allergic reaction
include:
•
shortness of breath, wheezing,
difficulty
breathing
or
a
tight
feeling in your chest
•
swelling of the face, lips, tongue
or other parts of the body
•
rash
                                
                                Read the complete document
                                
                            

Summary of Product characteristics

                                Page 1 of 40
PRODUCT INFORMATION
DOCETAXEL KABI
NAME OF MEDICINE
Docetaxel
DESCRIPTION
Chemical structure:
(docetaxel anhydrous)
CAS number 114977-28-5
DOCETAXEL
Docetaxel is: (2_R_,3_S_)-_N_-carboxy-3-phenylisoserine,
_N_-_tert_-butyl ester, 13-ester with 5_ß_,
20-epoxy-1, 2
α
_,_ 4, 7_ß_, 10_ß_, 13
α
-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate.
Docetaxel is a white to almost white powder with the empirical formula
C
43
H
53
NO
14
and a
molecular weight of 807.9. It is highly lipophilic and practically
insoluble in water.
Single-dose vials of Docetaxel Kabi concentrated injection containing
20, 80 or 160 mg
of docetaxel per 1.0, 4.0 or 8.0 mL, respectively, in 50/50 (v/v)
polysorbate 80/absolute
ethanol. The sterile pyrogen-free viscous solution contains 20 mg/mL
docetaxel.
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.
SITE AND MODE 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.
Page 2 of 40
PHARMACODYNAMICS
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 vivo_, docetaxel
is schedule independent and has a broad spectrum of experimental
antitumour activity
against advanced murine and human grafted tumours. Against
transplantable murine
tumours _ in vivo_, docetaxel was synergistic with vincristine
(administered at the same
time),
etoposide,
cyclophosphamide
or
                                
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