DOCETAXEL SANDOZ

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

docetaxel, Quantity: 20 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Docetaxel

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: polysorbate 80; citric acid; ethanol; nitrogen

Administration route:

Intravenous Infusion

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Docetaxel Sandoz is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. Docetaxel Sandoz 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 Sandoz 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. Docetaxel Sandoz 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 Sandoz in combination with trastuzumab (AC-TH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2. Docetaxel Sandoz 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. Docetaxel Sandoz 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. Docetaxel Sandoz is indicated for the treatment of metastatic carcinoma of the ovary after failure of firstline or subsequent chemotherapy. Docetaxel Sandoz is indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer. Docetaxel Sandoz, 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: A clear pale yellow solution free from visible particles within a glass vial; 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:

2011-04-20

Patient Information leaflet

Docetaxel Sandoz

1
DOCETAXEL SANDOZ
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_ _
DOCETAXEL CONCENTRATED INJECTION FOR INFUSION_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Docetaxel Sandoz.
It does not contain all the available information. It does not take
the place of talking to your doctor or
pharmacist.
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 DOCETAXEL SANDOZ IS USED FOR
The name of the medicine is called Docetaxel Sandoz. It contains the
active ingredient docetaxel.
Docetaxel belongs to a group of medicines called antineoplastic or
cytotoxic medicines. These may also
be called chemotherapy medicines. It works by killing cancer cells and
stopping cancer cells from
growing and multiplying.
This medicine is used to treat_ _

breast cancer_ _

ovarian cancer_ _

some types of lung cancer_ _

head and neck cancer_ _

prostate cancer._ _
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed Docetaxel Sandoz for another reason.
Docetaxel Sandoz may be used alone or in combination with other
medicines to treat cancer.
This medicine is not addictive.
This medicine is available only with a doctor’s prescription.
There is not enough information to recommend the use of this medicine
for children.
Docetaxel Sandoz

2
BEFORE YOU ARE GIVEN DOCETAXEL SANDOZ
_WHEN YOU MUST NOT BE GIVEN DOCETAXEL SANDOZ _
DO NOT RECEIVE THIS MEDICINE IF YOU HAVE AN ALLERGY TO:

Docetaxel, the active ingredient, or to any of the other ingredients
listed at the end of this leaflet under
Product Description.
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 p

Summary of Product characteristics

_Product Information_
Page 1 of 43
_Docetaxel Sandoz 20mg/2ml & 80mg/8ml concentrated injection for
infusion _
_02/2014 _
_Sandoz Pty Ltd _
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_ _
PRODUCT INFORMATION
DOCETAXEL SANDOZ
®
20MG/2ML & 80MG/8ML CONCENTRATED INJECTION FOR INFUSION
NAME OF THE MEDICINE
_ _
Generic name:
Docetaxel
Chemical name:
1,7β, 10β-Trihydroxy-9-oxo-5β,20-epoxytax-11-ene-2α,4,13α-triyl
4-
acetate 2-benzoate 13-[(2_R_,3_S_)-3-[[(1,1-
dimethylethoxy)carbonyl]amino]-2-hydroxy-3-phenylpropanoate]
CAS: 114977-28-5
Empirical formula: C
43
H
53
NO
14
MW: 807.88
DESCRIPTION
Docetaxel is a white to almost white powder. It is highly lipophilic
and practically insoluble
in water. The concentrated injection for infusion is a sterile clear,
colourless to pale yellow
solution free from visible particulates.
Docetaxel Sandoz Concentrated Injection for Infusion
Single-dose vials of Docetaxel Sandoz concentrated injection for
infusion contain either 20mg
or 80mg of docetaxel, in 2.0mL or 8.0mL of solvent, respectively. The
sterile pyrogen-free
viscous solution contains a concentration of 10mg/mL docetaxel. Each
mL of Docetaxel
Sandoz concentrated injection for infusion contains the inactive
ingredients ethanol
590.85mg, polysorbate 80 268.25mg and citric acid, anhydrous 1mg.
_Product Information_
Page 2 of 43
_Docetaxel Sandoz 20mg/2ml & 80mg/8ml concentrated injection for
infusion _
_02/2014 _
_Sandoz Pty Ltd _
_ _
_ _
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.
Docetaxel has been shown _in vitro _to disrupt the microtubular
network in cells which is
essential for vital mitotic and interphase cellular functions.
Pharmacodynamics
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. Doceta