Docetaxel Venus Pharma 20 mg/1 ml concentrate for solution for infusion (4ml vial)

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Διαθέσιμο από:

Venus Pharma GmbH Am Bahnhof 1-3, Werne, D 59368, Germany

Φαρμακολογική κατηγορία (ATC):

L01CD02

INN (Διεθνής Όνομα):

DOCETAXEL 20 mg/ml

Φαρμακοτεχνική μορφή:

CONCENTRATE FOR SOLUTION FOR INFUSION

Σύνθεση:

DOCETAXEL 20 mg/ml

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2024-01-09

Φύλλο οδηγιών χρήσης

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DOCETAXEL VENUS PHARMA 20 MG/1 ML CONCENTRATE FOR SOLUTION FOR
INFUSION
DOCETAXEL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, please ask your doctor,
pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same as yours.
- If you get any side effects, tell your doctor, 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 Venus Pharma is and what it is used for
2.
What you need to know before you use Docetaxel Venus Pharma
3.
How to use Docetaxel Venus Pharma
4.
Possible side effects
5.
How to store Docetaxel Venus Pharma
6.
Contents of the pack and other information
1. WHAT DOCETAXEL VENUS PHARMA IS AND WHAT IT IS USED FOR
The name of this medicine is Docetaxel Venus Pharma. 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 me

Αρχείο Π.Χ.Π.

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Docetaxel Venus Pharma 20 mg/1 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 326 mg of ethanol anhydrous.
Each vial of 4 ml of concentrate contains 1.304 g of ethanol
anhydrous.
Each vial of 8 ml of concentrate contains 2.608 g of ethanol
anhydrous.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A yellow to pale yellow 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.
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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.
Docetaxel in combina