Docetaxel Ebewe concentrate for solution for infusion

Valsts: Armēnija

Valoda: angļu

Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktīvā sastāvdaļa:

docetaxel

Pieejams no:

EBEWE Pharma Ges. m.b.H. Nfg. KG

ATĶ kods:

L01CD02

SNN (starptautisko nepatentēto nosaukumu):

docetaxel

Deva:

10mg/ml

Zāļu forma:

concentrate for solution for infusion

Vienības iepakojumā:

glass vial 2ml

Receptes veids:

Prescription

Autorizācija statuss:

Registered

Autorizācija datums:

2016-12-19

Lietošanas instrukcija

11784194-04
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, 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 cancer, Doce

Produkta apraksts

m12 - en-spc-w - 814.doc
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Docetaxel Ebewe 10mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of the concentrate contains 10 mg docetaxel.
Each vial of 2ml 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 (10mg/ml).
Excipient with known effect: Each single-dose vial of concentrate for
solution contains 27% (w/w)
ethanol 96%_._
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Docetaxel Ebewe 10 MG/ml concentrate for solution for infusion IS A
CLEAR, COLOURLESS TO PALE YELLOW
SOLUTION; PH 3.0 – 4.5, FREE FROM VISIBLE PARTICLES.
_Docetaxel Ebewe is presented in clear glass vials containing 2 ml (20
mg/vial), 8 ml (80 mg/vial) or _
_16 ml (160mg/vial). _
_ _
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