PALAT 6 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSIO 6 Mg/Ml Concentrate for Soln for Inf
Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Данни за продукта
(SPC)
10-06-2024
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Активна съставка:
PACLITAXEL
Предлага се от:
Ebewe Pharma Ges.m.b.H Nfg. KG
INN (Международно Name):
PACLITAXEL
дозиране:
6 Mg/Ml
Лекарствена форма:
Concentrate for Soln for Inf
Вид предписание :
Product subject to prescription which may not be renewed (A)
Статус Оторизация:
Authorised
Дата Оторизация:
0000-00-00
Данни за продукта
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Palat 6 mg/ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml concentrate for solution for infusion contains 6 mg paclitaxel.
One 5 ml vial contains 30 mg paclitaxel.
One 16.7 ml vial contains 100 mg paclitaxel.
One 25 ml vial contains 150 mg paclitaxel.
One 50 ml vial contains 300 mg paclitaxel.
One 100 ml vial contains 600 mg paclitaxel.
Excipients:
Ethanol, anhydrous (401,7 mg/ml), polyoxyl castor oil (macrogolglycerol ricinoleate) (522,4 mg/ml)
For a full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Paclitaxel 6 mg/ml is a clear, colourless to slightly yellow viscous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ovarian carcinoma: in the first-line chemotherapy of ovarian cancer, Paclitaxel 6 mg/ml 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 6 mg/ml 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 6 mg/ml is indicated for the treatment of patients with node-
positive breast carcinoma following anthracycline and cyclophosphamide (AC) therapy. Adjuvant treatment with
Paclitaxel 6 mg/ml should be regarded as an alternative to extended AC therapy.
Paclitaxel 6 mg/ml is indicated for the initial treatment of locally advanced or metastatic breast cancer either in
combination with an anthracycline in patients for whom anthracycline therapy is suitable, or in combination with
trastuzumab, in patients who ove
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