Taxotere

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

docetaxel

Διαθέσιμο από:

Sanofi Mature IP

Φαρμακολογική κατηγορία (ATC):

L01CD02

INN (Διεθνής Όνομα):

docetaxel

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

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

Θεραπευτικές ενδείξεις:

Breast cancerTaxotere 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.Taxotere 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.Taxotere monotherapy is indicated for the treatment of patients with locally advanced ormetastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.Taxotere 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.Taxotere 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 cancerTaxotere is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Taxotere 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 cancerTaxotere in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.Gastric adenocarcinomaTaxotere 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 cancerTaxotere 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.

Περίληψη προϊόντος:

Revision: 50

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

1995-11-27

Φύλλο οδηγιών χρήσης

258
B. PACKAGE LEAFLET
259
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAXOTERE 20 MG/0.5 ML CONCENTRATE AND SOLVENT 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 TAXOTERE is and what it is used for
2.
What you need to know before you use TAXOTERE
3.
How to use TAXOTERE
4.
Possible side effects
5.
How to store TAXOTERE
6.
Contents of the pack and other information
1.
WHAT TAXOTERE IS AND WHAT IT IS USED FOR
The name of this medicine is TAXOTERE. 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.
TAXOTERE 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, TAXOTERE 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, TAXOTERE
could be administered in combination with doxorubicin and
cyclophosphamide.
- For the treatment of lung cancer, TAXOTERE could be administered
either alone or in combination
with cisplatin.
- For the treatment of prostate cancer, TAXOTERE is administered in
combination with prednisone or
prednisolone.
- For the treatment of metastatic gastric cancer, TAXOTERE is
administered in combination with
cisplatin and 5-fluorouracil.
- For the treatment of head and neck cancer, TAXOTERE is administered
in combination with
cisplatin and

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-dose vial of TAXOTERE 20 mg/0.5 ml concentrate contains
docetaxel (as trihydrate)
corresponding to 20 mg of docetaxel (anhydrous). The viscous solution
contains 40 mg/ml docetaxel
(anhydrous).
Excipients with known effect:
Each single-dose vial of solvent contains 13% (w/w) ethanol 95% v/v in
water for injection (252 mg of
ethanol 95% v/v).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate and solvent for solution for infusion.
The concentrate is a clear viscous, yellow to brown-yellow solution.
The solvent is a colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Breast cancer
TAXOTERE 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).
TAXOTERE 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.
TAXOTERE 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.
TAXOTERE 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.
TAXOTERE in combination with capecitabine is indicated for the
treatment of patients w