Paclitaxel 6mg/ml concentrate for solution for infusion

Land: Malta

Sprache: Englisch

Quelle: Malta Medicines Authority

Wirkstoff:

PACLITAXEL

Verfügbar ab:

Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom

ATC-Code:

L01CD01

INN (Internationale Bezeichnung):

PACLITAXEL 6 mg

Darreichungsform:

CONCENTRATE FOR SOLUTION FOR INFUSION

Zusammensetzung:

PACLITAXEL 6 mg

Verschreibungstyp:

POM

Therapiebereich:

ANTINEOPLASTIC AGENTS

Berechtigungsstatus:

Withdrawn

Berechtigungsdatum:

2015-07-03

Gebrauchsinformation

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 any further questions, ask your doctor or pharmacist.
-
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 IS and what it is used for
2.
What you need to know before you use PACLITAXEL
3.
How to use PACLITAXEL
4.
Possible side effects
5.
How to store PACLITAXEL
6.
Contents of the pack and other information
1.
WHAT PACLITAXEL 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
leaflet it will be called ‘Paclitaxel’. Paclitaxel is available as
vials containing 30 mg, 100 mg, or 300 mg
paclitaxel in a 6 mg/ml solution which has to be diluted before being
given to you.
This medicine belongs to a group of anti-cancer medicines called
taxanes. These agents inhibit the growth
of cancer cells.
Paclitaxel 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 spred to
other parts of the body
(metastatic disease). Paclitaxel is either in combination with an
anthracyclines (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 HER2, see package
of trastuzumab).
•
after initial surgery following treatment with anthracycline and
cyclophosphamide (AC) as an
additional treatment.
•
As second-line treatment for patients who have not res

Fachinformation

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
paclitaxel.
Each vial of 5 ml contains 30 mg of paclitaxel.
Each vial of 16.7 ml contains 100 mg of paclitaxel.
Each vial of 50 ml contains 300 mg of paclitaxel.
Excipients with known effect:
Ethanol, 392.133 mg per ml (49.7%v/v)
Macrogolglycerol Ricinoleate (polyoxyl castor oil), 527.33 mg per ml.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
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 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 anthracycline is not suitable (see section 4.4 and 5.1).
As a single agent, paclitaxel is indicated for the treatment of
metastatic carcinoma of the breast
in patients who have failed, or are not