Docetaxel Accord

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

docetaxel

Available from:

Accord Healthcare S.L.U.

ATC code:

L01CD02

INN (International Name):

docetaxel

Therapeutic group:

Antineoplastic agents,

Therapeutic area:

Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Breast Neoplasms

Therapeutic indications:

Breast cancerDocetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.Docetaxel Accord in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.Docetaxel Accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.Docetaxel Accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer w

Product summary:

Revision: 13

Authorization status:

Authorised

Authorization date:

2012-05-22

Patient Information leaflet

59
B. PACKAGE LEAFLET
60
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOCETAXEL ACCORD 20 MG/1 ML CONCENTRATE FOR SOLUTION FOR INFUSION
DOCETAXEL ACCORD 80 MG/4 ML CONCENTRATE FOR SOLUTION FOR INFUSION
DOCETAXEL ACCORD 160 MG/8 ML CONCENTRATE FOR SOLUTION FOR INFUSION
docetaxel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, hospital
pharmacist or nurse.

If you get any side effects talk to your doctor, hospital pharmacist
or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Docetaxel Accord is and what it is used for
2.
What you need to know before you use Docetaxel Accord
3.
How to use Docetaxel Accord
4.
Possible side effects
5.
How to store Docetaxel Accord
6.
Contents of the pack and other information
1.
WHAT DOCETAXEL ACCORD IS AND WHAT IT IS USED FOR
The name of this medicine is Docetaxel Accord. Its common name is
docetaxel. Docetaxel is a
substance derived from the needles of yew trees.
Docetaxel belongs to the group of anti-cancer medicines called
taxoids.
Docetaxel Accord has been prescribed by your doctor for the treatment
of breast cancer, special forms
of lung cancer (non-small cell lung cancer), prostate cancer, gastric
cancer or head and neck cancer:
-
For the treatment of advanced breast cancer, docetaxel could be
administered either alone or in
combination with doxorubicin, or trastuzumab, or capecitabine.
-
For the treatment of early breast cancer with or without lymph node
involvement, docetaxel could
be administered in combination with doxorubicin and cyclophosphamide.
-
For the treatment of lung cancer, docetaxel could be administered
either alone or in combination
with cisplatin.
-
For the treatment of prostate cancer, docetaxel is administered in
combination with prednisone or
prednisolone.
-
For the treatment of metastatic gastric c

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion
Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion
Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 20 mg docetaxel.
Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion
One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion
One vial of 4 ml of concentrate contains 80 mg of docetaxel.
Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion
One vial of 8 ml of concentrate contains 160 mg of docetaxel.
Excipient with known effect
_Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion_
Each vial of 1ml of concentrate contains 0.5 ml of ethanol anhydrous
(395 mg).
_Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion_
Each vial of 4ml of concentrate contains 2 ml of ethanol anhydrous
(1.58 g).
_Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion_
Each vial of 8ml of concentrate contains 4 ml of ethanol anhydrous
(3.16 g).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear pale yellow to brownish-yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Breast cancer
Docetaxel Accord in combination with doxorubicin and cyclophosphamide
is indicated for the
adjuvant treatment of patients with:

operable node-positive breast cancer

operable node-negative breast cancer .
For patients with operable node-negative breast cancer, adjuvant
treatment should be restricted to
patients eligible to receive chemotherapy according to internationally
established criteria for primary
therapy of early breast cancer (see section 5.1).
Docetaxel Accord in combination with doxorubicin is indicated for the
treatment of patients wi