Docetaxel 20mg/ml concentrate for solution for infusion

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Docetaxel anhydrous

Verfügbar ab:

Seacross Pharmaceuticals Limited

ATC-Code:

L01CD; L01CD02

INN (Internationale Bezeichnung):

Docetaxel anhydrous

Dosierung:

20 milligram(s)/millilitre

Darreichungsform:

Concentrate for solution for infusion

Verschreibungstyp:

Product subject to prescription which may not be renewed (A)

Therapiebereich:

Taxanes; docetaxel

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2011-08-26

Gebrauchsinformation

_ie-pl-v5.0-20170928 1 / 8_
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOCETAXEL 20 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 or 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 is and what it is used for
2. What you need to know before you use Docetaxel
3. How to use Docetaxel
4. Possible side effects
5. How to store Docetaxel
6. Contents of the pack and other information
1. WHAT DOCETAXEL IS AND WHAT IT IS USED FOR
The name of this medicine is Docetaxel. 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 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 cancer, Docetaxel is
administered in
combination with cisplatin and 5-fluorouracil.
-
For the treatment of head and neck cancer, Docetaxel is administered
in
combination with cisplatin and

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Docetaxel 20mg/ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 20 mg docetaxel anhydrous.
One vial of 1 ml of concentrate contains 20 mg of docetaxel.
One vial of 4 ml of concentrate contains 80 mg of docetaxel.
One vial of 8 ml of concentrate contains 160 mg of docetaxel.
Excipients with known effect:
Each vial of 1 ml of concentrate contains 0.5 ml of ethanol anhydrous
(395 mg).
Each vial of 4 ml of concentrate contains 2 ml of ethanol anhydrous
(1.58 g).
Each vial of 8 ml 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.
The concentrate is a clear viscous, colourless to brownish-yellow
sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BREAST CANCER
Docetaxel 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 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 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 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.