Paclitaxel 6 mg/ml concentrate for solution for infusion

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Paclitaxel

Доступно од:

Fresenius Kabi Limited

АТЦ код:

L01CD; L01CD01

INN (Међународно име):

Paclitaxel

Дозирање:

6 milligram(s)/millilitre

Фармацеутски облик:

Concentrate for solution for infusion

Тип рецептора:

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

Терапеутска област:

Taxanes; paclitaxel

Статус ауторизације:

Marketed

Датум одобрења:

2009-04-03

Информативни летак

PACLITAXEL - PACKAGE INSERT - IRELAND+UK (BORDON)
(Travesh Sharma) \\fre-kp-fp01\PDD-Artworks\Travesh\Paclitaxel
(Bordan)\Ireland-UK\16 Sep 2016\Paclitaxel - Package Insert -
Ireland+UK (Bordon).indd
SIZE:
592 X 300 MM
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18 JANUARY 2017 1:27 PM
VER. 01
TIMES NEW ROMAN 10 PTS.
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THE FOLLOWING INFORMATION
IS INTENDED FOR HEALTHCARE
PROFESSIONALS ONLY:
HANDLING
: As with all antineoplastic
agents, caution should be exercised
when handling paclitaxel. Dilution
should be carried out under aseptic
conditions by trained personnel in a
designated area. Adequate protective
gloves should be worn. Precautions
should be taken to avoid contact with
the skin and mucous membranes. In
the event of contact with the skin, the
area should be washed with soap and
water. Following topical exposure,
tingling, burning and redness have
been observed. In the event of contact
with the mucous membranes, these
should be flushed thoroughly with
water. Upon inhalation, dyspnoea,
chest pain, burning throat and nausea
have been reported.
If unopened vials are refrigerated, a
precipitate may form that redissolves
with little or no agitation upon
reaching room temperature. Product
quality is not affected. If the solution
remains cloudy or if an insoluble
precipitate is noted, the vial should be
discarded.
Following multiple needle entries
and product withdrawals, the vials
maintain microbial, chemical and
physical stability for up to 28 days at
25°C. Other in-use storage times and
conditions are the responsibility of the
user.
The Chemo-Dispensing Pin device or
similar devices with spikes should not
be used since they can cause the vial
stopper to collapse, resulting in loss of
sterile integrity.
PREPARATION FOR IV ADMINISTRATION:
Prior to infusion, paclitaxel must
be diluted using aseptic techniques
in 5% Glucose solution, 0.9%
Sodium Chloride solution, 5%
Glucose solution in Ringer solution,
and 5% Glucose solution/0.9%
Sodium Chloride solution to a final
concentration of 0.3 to 1.2 mg/ml.
Chemical and physical in

Карактеристике производа

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.
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 with known effect:
Ethanol, anhydrous 393 mg/ml (49.7 % (v/v)
Macrogolglycerol ricinoleate, 530 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, slightly yellowish 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 wh