EBETAXEL Concentrate for Soln for Inf 6 Mg/Ml
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-03-2023
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Active ingredient:
PACLITAXEL
Available from:
Ebewe Pharma Ges.m.b.H Nfg. KG
Dosage:
6 Mg/Ml
Pharmaceutical form:
Concentrate for Soln for Inf
Authorization date:
2007-04-27
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Ebetaxel 6mg/ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of concentrate for solution for infusion contains 6mg paclitaxel
A vial of 5ml contains 30mg paclitaxel
A vial of 16.7ml contains 100mg paclitaxel
A vial of 25ml contains 150mg paclitaxel
A vial of 50ml contains 300mg paclitaxel
Excipients: Polyoxyl castor oil (macrogolglycerol ricinoleate) (522.4mg/ml), ethanol anhydrous (401.7 mg/ml) (see
4.4).
For a full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, light yellow solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Ovarian carcinoma: In the first-line chemotherapy of ovarian cancer, paclitaxel is indicated for the treatment of
patients with advanced carcinoma of the ovary or with residual disease (
>
1 cm) after initial laparotomy, in
combination with cisplatin.
In the second-line chemotherapy of ovarian cancer, paclitaxel is indicated for the treatment of metastatic carcinoma of
the ovary after failure of standard, platinum containing therapy.
Breast carcinoma: In the adjuvant setting, paclitaxel is indicated for the treatment of patients with node-positive
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