Docetaxel Zentiva (previously Docetaxel Winthrop)

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

docetaxel

Available from:

Zentiva k.s.

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; Stomach Neoplasms; Breast Neoplasms

Therapeutic indications:

Breast cancerDocetaxel Winthrop 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 Winthrop 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 Winthrop 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 Winthrop 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 Winthrop in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small-cell lung cancerDocetaxel Winthrop is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Docetaxel Winthrop in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancerDocetaxel Winthrop in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer.Gastric adenocarcinomaDocetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.Head and neck cancerDocetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Product summary:

Revision: 30

Authorization status:

Withdrawn

Authorization date:

2007-04-20

Patient Information leaflet

157
B. PACKAGE LEAFLET
Medicinal product no longer authorised
158
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOCETAXEL ZENTIVA 20 MG/1 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, your 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 Zentiva is and what it is used for
2.
What you need to know before you use Docetaxel Zentiva
3.
How to use Docetaxel Zentiva
4.
Possible side effects
5.
How to store Docetaxel Zentiva
6.
Contents of the pack and other information
1.
WHAT DOCETAXEL ZENTIVA IS AND WHAT IT IS USED FOR
The name of this medicine is Docetaxel Zentiva. 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 Zentiva 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 Zentiva 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 Zentiva
could be administered in combination with doxorubicin and
cyclophosphamide.
- For the treatment of lung cancer, Docetaxel Zentiva could be
administered either alone or in
combination with cisplatin.
- For the treatment of prostate cancer, Docetaxel Zentiva is
administered in combination with
prednisone or prednisolone.
- For the treatment of metastatic gastric cancer, Docetaxel Zentiva is
administered in combinat

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 20 mg docetaxel (as trihydrate).
One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Excipient with known effect:
Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395
mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a pale yellow to brownish-yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Breast cancer
Docetaxel Zentiva 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 Zentiva 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 Zentiva 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 Zentiva in combination with trastuzumab is indicated for the
treatment of patients with
metastatic breast cancer whose tumours over express HER2 and who
previously have not received
chemotherapy for metastatic disease.
Docetaxel Zentiva in combination with capecitabine is indicated for
the treatment of patients with
locally advanced or metastatic breast cancer after failure of
cytotoxic chemot