Docetaxel Teva Pharma
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
29-01-2014
Produktets egenskaber
(SPC)
29-01-2014
Offentlige vurderingsrapport
(PAR)
29-01-2014
Aktiv bestanddel:
docetaxel
Tilgængelig fra:
Teva Pharma B.V.
ATC-kode:
L01CD02
INN (International Name):
docetaxel
Terapeutisk gruppe:
Antineoplastic agents
Terapeutisk område:
Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Prostatic Neoplasms
Terapeutiske indikationer:
Breast cancerDocetaxel Teva Pharma 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.Non-small-cell lung cancerDocetaxel Teva Pharma is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Docetaxel Teva Pharma 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 Teva Pharma in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Produkt oversigt:
Revision: 6
Autorisation status:
Withdrawn
Autorisation dato:
2011-01-21
Indlægsseddel
70
B. PACKAGE LEAFLET
Medicinal product no longer authorised
71
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOCETAXEL TEVA PHARMA 20 MG 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 Docetaxel Teva Pharma is and what it is used for
2.
What you need to know before you use Docetaxel Teva Pharma
3.
How to use Docetaxel Teva Pharma
4.
Possible side effects
5.
How to store Docetaxel Teva Pharma
6.
Contents of the pack and other information
1.
WHAT DOCETAXEL TEVA PHARMA IS AND WHAT IT IS USED FOR
The name of this medicine is Docetaxel Teva Pharma. Docetaxel is a
substance derived from the
needles of yew trees.
Docetaxel belongs to the group of anti-cancer medicines called
taxoids.
Docetaxel Teva Pharma has been prescribed by your doctor for the
treatment of advanced breast
cancer, special forms of lung cancer (non-small cell lung cancer) and
prostate cancer:
-
For the treatment of advanced breast cancer, Docetaxel Teva Pharma
could be administered
alone.
-
For the treatment of lung cancer, Docetaxel Teva Pharma could be
administered either alone or
in combination with cisplatin.
-
For the treatment of prostate cancer, Docetaxel Teva Pharma is
administered in combination
with prednisone or prednisolone.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DOCETAXEL TEVA PHARMA
YOU MUST NOT BE GIVEN DOCETAXEL TEVA PHARMA IF
•
you are allergic (hypersensitive) to docetaxel or any of the other
ingredients of Docetaxel Teva
Pharma
•
the number of white blood cells is too low
•
you have a severe liver disease.
WARNINGS AND PRECAUTIONS
Before each treatment with Docetaxel
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Docetaxel Teva Pharma 20 mg concentrate and solvent for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-dose vial of Docetaxel Teva Pharma concentrate contains 20
mg docetaxel (anhydrous).
Each ml of concentrate contains 27.73 mg docetaxel.
Excipients with known effect
:
Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol.
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
Docetaxel Teva Pharma 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.
Non-small cell lung cancer
Docetaxel Teva Pharma is indicated for the treatment of patients with
locally advanced or metastatic
non-small cell lung cancer after failure of prior chemotherapy.
Docetaxel Teva Pharma 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 cancer
Docetaxel Teva Pharma in combination with prednisone or prednisolone
is indicated for the treatment
of patients with hormone refractory metastatic prostate cancer.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The use of docetaxel should be confined to units specialised in the
administration of cytotoxic
chemotherapy and it should only be administered under the supervision
of a physician qualified in the
use of anticancer chemotherapy (see section 6.6).
Recommended dose
For breast and non-small cell lung cancer, premedication consisting of
an oral corticost
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