DOCETAXEL ACCORD 80 mg/4 mL docetaxel concentrated injection 80 mg/4 mL glass vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

docetaxel, Quantity: 80 mg

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Docetaxel

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: polysorbate 80; ethanol absolute; citric acid

Administration route:

Intravenous

Units in package:

Pack of 1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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 = 1 cm and < 7 cm. 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: Supplied in single-dose vials as a sterile, pyrogen-free, non-aqueous,pale yellow to brownish-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:

2015-02-17

Patient Information leaflet

Version 3.0
Page 1 of 4
DOCETAXEL ACCORD
_Docetaxel Concentrated Injection 20 mg/1 mL, 80 mg/4 mL and 160 mg/8
mL _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Docetaxel Accord.
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 ACCORD
IS USED FOR
Docetaxel Accord is used to treat breast
cancer, ovarian cancer, some types of
lung cancer, head and neck cancer and
prostate cancer.
Docetaxel Accord works by stopping
cells from growing and multiplying.
Docetaxel Accord 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 Accord for another purpose.
ASK YOUR DOCTOR, NURSE OR
PHARMACIST IF YOU HAVE ANY QUESTIONS
ABOUT WHY DOCETAXEL ACCORD 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 Accord.
Docetaxel Accord may be used alone
or in combination with other medicines
to treat cancer.
This medicine is only available with a
doctor's prescription.
Docetaxel Accord is not addictive.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE _
_GIVEN IT _
Docetaxel Accord is not recommended
for use in children.
DO NOT RECEIVE DOCETAXEL ACCORD IF
YOU HAVE AN ALLERGY TO DOCETAXEL,
PACLITAXEL 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
•

Summary of Product characteristics

Page 1 of 39
AUSTRALIAN PRODUCT INFORMATION
DOCETAXEL ACCORD (DOCETAXEL) CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Docetaxel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of docetaxel solution contains 20 mg docetaxel.
Docetaxel is a white to off white powder and it is highly lipophilic
and practically insoluble in water.
Single-dose vials of Docetaxel Concentrated Injection containing 20 mg
or 80 mg or 160 mg of docetaxel
per 1.0 mL, 4.0 mL or 8.0 mL respectively. The sterile pyrogen-free
viscous solution contains 20 mg/mL
docetaxel (anhydrous).
Each mL of docetaxel solution also contains 395 mg absolute ethanol.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Docetaxel Accord is a sterile pyrogen-free non-aqueous pale yellow to
brownish-yellow solution for
injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
BREAST CANCER
Docetaxel Accord is indicated for the treatment of patients with
locally advanced or metastatic breast
cancer in whom previous chemotherapy has failed.
Docetaxel Accord 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 Accord 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 Accord 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 Accord in
combination with trastuzumab
(AC-TH) is indicated for the adjuvant treatment of patients with
operable breast cancer whose tumours
overexpress HER2.
Docetaxel Accord in combination with carboplatin and trastuzumab (TCH)
is indicated for the adjuvant
treatment of patients with operable breast cancer whose tum