PACLITAXEL 6 Mg/Ml Concentrate for Soln for Inf

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PACLITAXEL

Available from:

Stragen Nordic A/S

ATC code:

L01CD01

INN (International Name):

PACLITAXEL

Dosage:

6 Mg/Ml

Pharmaceutical form:

Concentrate for Soln for Inf

Prescription type:

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

Therapeutic area:

Taxanes

Authorization status:

Authorised

Authorization date:

2013-11-29

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PACLITAXEL 6 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Paclitaxel
READ ALL OF THESE 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 nurse

If you get any side effects talk to your doctor 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 Paclitaxel is given to you
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 the leaflet
it will be called “Paclitaxel”.
Paclitaxel 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-line 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-line therapy for advanced disease or disease which has spread
to other parts of the body (metastatic
disease). Paclitaxel 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).

as an additional treatment with anthracycline and cyclophosphamide
(AC).

as a second-line treatment for patients who have not responded to
standard treatments using anthracyclines, or for
whom such treatment should not be used.
_Advanced non-small-cell lung cancer: _

in combination with

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paclitaxel 6mg/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 50 ml contains 300 mg of paclitaxel.
Excipients with known effect:
Polyoxyethylated castor oil (Macrogolglycerol ricinoleate), anhydrous
ethanol (396 mg/ml)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear colourless to slightly yellow solution with a pH in range of 3.0
– 7.0 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 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 pat