DOTAX docetaxel 80 mg/4 ml Concentrated Solution for Infusion vial
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
docetaxel, Quantity: 80 mg
Available from:
Dr Reddys Laboratories Australia Pty Ltd
INN (International Name):
Docetaxel
Pharmaceutical form:
Injection, concentrated
Composition:
Excipient Ingredients: ethanol absolute; citric acid; polysorbate 80
Administration route:
Intravenous Infusion
Units in package:
1 vial
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Breast Cancer,Metastatic Breast Cancer,DOTAX is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed.,DOTAX 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.,DOTAX 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,DOTAX in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer.,Doxorubicin and cyclophosphamide followed by DOTAX in combination with trastuzumab (AC-TH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2,DOTAX in combination with carboplatin and trastuzuma
Product summary:
Visual Identification: Sterile pale yellow to brownish yellow solution in 5 ml tubular glass vial stoppered with chlorobutyl rubberstopper and sealed with flip off seal.; 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:
2014-12-22
Patient Information leaflet
DOCETAXEL-DRLA
DOCETAXEL-RZ
DOCETERE DOTAX
_Contains the active ingredient docetaxel _
CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some of the
common questions about docetaxel.
It does not contain all the
information. It does not take the
place of talking to your doctor, nurse
or pharmacist.
All medicines have risks and
benefits. Your doctor will have
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 WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Docetaxel-DRLA Docetaxel-RZ
Docetere Dotax. It contains the active
ingredient docetaxel.
Docetaxel is used to treat breast
cancer, ovarian cancer, some types of
lung cancer, head and neck cancer
and prostate cancer.
Docetaxel works by stopping cells
from growing and multiplying.
Docetaxel 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 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 docetaxel.
Docetaxel may be used alone or in
combination with other medicines to
treat cancer.
This medicine is only available with
a doctor's prescription.
Docetaxel is not addictive.
Your doctor may prescribe this
medicine for another use. Ask your
doctor if you want more information.
Rosuvastatin is not addictive.
_USE IN CHILDREN _
Docetaxel is not recommended for
use in children.
BEFORE YOU GIVEN THIS
MEDICINE
_WHEN YOU MUST NOT BE GIVEN _
_IT _
DO NOT RECEIVE DOCETAXEL IF YOU
HAVE AN ALLERGY TO D
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Summary of Product characteristics
Product Information (v2, update 13/1/15)
DOCETAXEL-DRLA DOCETAXEL-RZ DOCETERE DOTAX CONCENTRATED INJECTION
NAME OF THE MEDICINE
Docetaxel
Chemical Name:
5β,20-Epoxy-1,7β,10β-trihydroxy-9-oxotax-11-ene-2α,4, 13α-triyl
4-acetate 2-
benzoate 13-[(2R,3S)-3-[[(l,1-dimethylethoxy)carbonyl]
amino]-2-hydroxy-3-
phenylpropanoate].
Structural Formula:
CAS Number:
114977-28-5
Molecular Formula: C
43
H
53
NO
14
Molecular Weight:
808
DESCRIPTION
Docetaxel is white or almost white, crystalline, hygroscopic powder.
Practically insoluble in water. Freely
soluble in anhydrous ethanol, soluble in methylene chloride.
Single-dose vials of Docetaxel-DRLA Docetaxel-RZ Docetere Dotax
concentrated injection containing 20
or 80 mg of docetaxel per 1.0 or 4.0 mL, respectively, in 50% (v/v)
mixture of polysorbate 80 (0.54 g or
2.16 g) and absolute ethanol (0.395 g or 1.58 g), citric acid
anhydrous (0.003 g or 0.012 g). The sterile
pyrogen-free viscous solution contains 20 mg/mL docetaxel (anhydrous).
PHARMACOLOGY
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
vivo, docetaxel is schedule independent and has a broad spectrum of
experimental antitumour activity
against advanced murine and human gra
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