Docetaxel Mylan
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
12-03-2015
Charakterystyka produktu
(SPC)
12-03-2015
Sprawozdanie z oceny publicznego
(PAR)
12-03-2015
Składnik aktywny:
docetaxel
Dostępny od:
Mylan S.A.S.
Kod ATC:
L01CD02
INN (International Nazwa):
docetaxel
Grupa terapeutyczna:
Antineoplastic agents
Dziedzina terapeutyczna:
Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Wskazania:
Treatment of breast cancer, special forms of lung cancer (non-small-cell lung cancer), prostate cancer, gastric cancer, or head and neck cancer.
Podsumowanie produktu:
Revision: 6
Status autoryzacji:
Withdrawn
Data autoryzacji:
2012-01-31
Ulotka dla pacjenta
129
B. PACKAGE LEAFLET
Medicinal product no longer authorised
130
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOCETAXEL MYLAN 20 MG/1 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 hospital
pharmacist.
-
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 Mylan 20 MG/1 ML is and what it is used for
2.
What you need to know before you use Docetaxel Mylan 20 MG/1 ML
3.
How to use Docetaxel Mylan 20 MG/1 ML
4.
Possible side effects
5.
How to store Docetaxel Mylan 20 MG/1 ML
6.
Contents of the pack and other information
1.
WHAT DOCETAXEL MYLAN 20 MG/1 ML IS AND WHAT IT IS USED FOR
Docetaxel is a substance derived from the needles of yew trees.
Docetaxel belongs to the group of anti-cancer medicines called
taxoids.
Docetaxel Mylan 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, docetaxe
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Docetaxel Mylan 20 mg/1 ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate for solution for infusion contains 20 mg of
docetaxel (anhydrous).
One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Excipient with known effect:
Each ml of concentrate for solution for infusion contains 395 mg of
ethanol anhydrous.
One vial of 1 ml of concentrate contains 395 mg of ethanol anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
The concentrate is pale yellow to brownish-yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Breast cancer
Docetaxel Mylan 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 Mylan 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 Mylan 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 Mylan 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 Mylan in combination with capecitabine is indicated for the
treatment of patient
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