PACLITAXEL

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

PACLITAXEL

Disponível em:

Accord Healthcare Limited

Código ATC:

L01CD01

DCI (Denominação Comum Internacional):

PACLITAXEL

Dosagem:

6 Mg/Ml

Forma farmacêutica:

Concentrate for Soln for Inf

Tipo de prescrição:

Product subject to prescription which may not be renewed (A)

Área terapêutica:

paclitaxel

Status de autorização:

Marketed

Data de autorização:

2010-06-18

Folheto informativo - Bula

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
PACLITAXEL 6 MG/ML, CONCENTRATE FOR SOLUTION FOR INFUSION
Paclitaxel
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 further questions, ask your doctor, 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 Paclitaxel Injection is and what it is used for
2.
What you need to know before you use Paclitaxel Injection
3.
How Paclitaxel Injection is given to you
4.
Possible side effects
5.
How to store Paclitaxel Injection
6.
Contents of the pack and other information
1.
WHAT PACLITAXEL INJECTION IS AND WHAT IT IS USED FOR
The name of your medicine is ‘Paclitaxel 6 mg/ml, Concentrate for
Solution for Infusion’ but in the rest of
the leaflet it will be called “Paclitaxel Injection”.
Paclitaxel belongs to a group of anti-cancer medicines called taxanes.
These
_ _
agents inhibit the growth of
cancer cells.
Paclitaxel Injection is used to treat:
OVARIAN CANCER:

as first therapy (after initial surgery in combination with the
platinum-containing medicine cisplatin).

after standard platinum-containing medicines have been tried but did
not work.
BREAST CANCER:

as first therapy for advanced disease or disease which has spread to
other parts of the body (metastatic
disease). Paclitaxel Injection is either combined with an
_anthracycline_
(e.g. doxorubicin) or with a
medicine called
_trastuzumab_
(for patients for whom anthracycline is not suitable and whose cancer
cells
have a protein on their surface called HER 2, see package leaflet of
trastuzumab).

after initial surgery following treatment with anthracycline and
cyclophosphamide (AC) as an additional
treatment.

as a second-line treatment for patients who have not responded to
standard treatments usi

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paclitaxel 6 mg/ml, Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate for solution for infusion contains 6 mg of
paclitaxel.
A vial of 5 ml contains 30 mg of paclitaxel.
A vial of 16.7 ml contains 100 mg of paclitaxel.
A vial of 25 ml contains 150 mg of paclitaxel.
A vial of 50 ml contains 300 mg of paclitaxel.
A vial of 100 ml contains 600 mg of paclitaxel.
Excipient(s) with known effect:
Polyoxyl 35 castor oil (Macrogolglycerol ricinoleate 35) 527.0 mg/ml
and anhydrous ethanol 391 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Paclitaxel 6 mg/ml, concentrate for solution for infusion is a clear
colourless to slightly yellow solution free from
visible particles with a pH in range of 3.0 – 5.5 and an osmolarity
of > 4000 mOsm/l.
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 breast
carcinoma following anthracycline and cyclophosphamide (AC) therapy.
Adjuvant treatment with Paclitaxel should be
regarded as an alternative to extended AC therapy.
Paclitaxel 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 over-express HER-2 (human epidermal growth factor
receptor 2) at a 3+ level as determined by
immunohistochemistry and for whom an