EBETAXEL 6 MGML

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

PACLITAXEL

Disponible des:

NOVARTIS ISRAEL LTD

Codi ATC:

L01CD01

formulario farmacéutico:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composición:

PACLITAXEL 6 MG/ML

Vía de administración:

I.V

tipo de receta:

Required

Fabricat per:

EBEWE PHARMA GES.M.B.H NFG.KG, AUSTRIA

Grupo terapéutico:

PACLITAXEL

Área terapéutica:

PACLITAXEL

indicaciones terapéuticas:

Paclitaxel is indicated alone or in combination, for the treatment of advanced carcinoma of the ovary. For the treatment of metastatic breast cancer after failure of combination chemotherapy. Prior therapy should have included an anthracycline unless clinically containdicated. Paclitaxel is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. Advanced non small cell lung cancer: Paclitaxel associated with cisplatinum is indicated for the treatment of non small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Kaposis's sarcoma: Paclitaxel is indicated in the second-line treatment of AIDS related Kaposi's sarcoma

Data d'autorització:

2014-05-31

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ebetaxel 6mg/ml Concentrate for Solution for Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml contains 6mg of the active ingredient, paclitaxel
1 vial of 5ml contains 30mg of paclitaxel
1 vial of 16.7ml contains 100mg of paclitaxel
1 vial of 25ml contains 150mg of paclitaxel
1 vial of 50ml contains 300mg of paclitaxel
1 vial of 100ml contains 600mg of paclitaxel
1ml contains 522.4mg of the excipient, polyoxyl castor oil (macrogol
glycerol
ricinolate)
For full list of excipients, see 6.1
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion
A clear, colourless to pale yellow solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Paclitaxel is indicated alone or in combination, for the treatment of
advanced carcinoma of
the ovary.
•
For the treatment of metastatic breast cancer after failure of
combination chemotherapy.
Prior therapy should have included an anthracycline unless clinically
containdicated.
•
Paclitaxel is indicated for the adjuvant treatment of node-positive
breast cancer administered
sequentially to standard doxorubicin-containing combination
chemotherapy.
•
Advanced non small cell lung cancer: paclitaxel associated with
cisplatinum is indicated for
the treatment of non small cell lung cancer in patients who are not
candidates for potentially
curative surgery and/or radiation therapy.
•
Kaposis's sarcoma: paclitaxel is indicated in the second-line
treatment of AIDS related
Kaposi's sarcoma.
4.2
Dosage and Method of Administration
_ _
_FIRST-LINE CHEMOTHERAPY OF OVARIAN CANCER _
Since other dosage regimens have not yet been evaluated, the
recommended first- line treatment of
ovarian cancer is 135 mg/m
2
of paclitaxel as an infusion over 24 hours, followed by 75 mg/m
2
of cisplatin
and a therapy-free interval of three weeks (see
_“Interactions with Other Medicinal Products”)._
SECOND-LINE CHEMOTHERAPY OF OVARIAN AND METASTATIC BREAST CANCER
The recommended dosage is 175 mg/m
2
of paclitaxel, given as a