Docetaxel "Ebewe" Concentrate for Soln for Inf 10mg/ml (8ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DOCETAXEL

Available from:

Ebewe Pharma GmbH Nfg. KG Mondseestrasse 11, 4866 Unterach, Austria

ATC code:

L01CD02

INN (International Name):

DOCETAXEL 10 mg/ml

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

DOCETAXEL 10 mg/ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2010-06-15

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DOCETAXEL EBEWE 10 MG/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 Ebewe is and what it is used for
2.
What you need to know before you use Docetaxel Ebewe
3.
How to use Docetaxel Ebewe
4.
Possible side effects
5.
How to store Docetaxel Ebewe
6.
Content of the pack and other information
1.
WHAT DOCETAXEL EBEWE IS AND WHAT IT IS USED FOR
The name of this medicine is Docetaxel Ebewe. 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 Ebewe 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 Ebewe 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
Ebewe could be administered in combination with doxorubicin and
cyclophosphamide.
•
for the treatment of lung cancer, Docetaxel Ebewe could be
administered either alone or in
combination with cisplatin.
•
for the treatment of prostate cancer, Docetaxel Ebewe is administered
in combination with
prednisone or prednisolone.
•
for
the
treatment
of
metastatic
gastric
cancer,
Docetaxel
Ebewe
is
administered
in
combination with cisplatin and 5-fluorouracil.
•
for the treatment of head and neck c

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Docetaxel Ebewe 10 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of the concentrate for solution for infusion contains 10 mg
docetaxel.
Each vial of 2 ml contains 20 mg docetaxel anhydrous (10 mg/ml).
Each vial of 8 ml contains 80 mg docetaxel anhydrous (10 mg/ml).
Each vial of 16 ml contains 160 mg docetaxel anhydrous (10 mg/ml).
Excipient with known effect
Each single-dose vial of concentrate for solution for infusion
contains 34% (w/w) ethanol
96%
_._
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless to pale
_,_
yellow solution; pH 3.0 – 4.5, free from visible particles.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Breast cancer
Docetaxel Ebewe 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 Ebewe 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 Ebewe 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 Ebewe 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.
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Docetaxel Ebewe in combination with capecitabine is indicated fo