Paclitaxel 6 mg/ml concentrate for solution for infusion

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Paclitaxel

থেকে পাওয়া:

Cipla (EU) Limited

এটিসি কোড:

L01CD

INN (International Name):

Paclitaxel

ডোজ:

6 milligram(s)/millilitre

ফার্মাসিউটিকাল ফর্ম:

Concentrate for solution for infusion

প্রশাসন রুট:

Intravenous infusion

প্যাকেজ ইউনিট:

1 vial containing 5 ml, 16.7 ml, or 50 ml

প্রেসক্রিপশন টাইপ:

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

Manufactured by:

Cipla (EU) Limited

Therapeutic group:

Plant alkaloids and other natural products, taxanes

Therapeutic area:

Taxanes

থেরাপিউটিক ইঙ্গিত:

It is indicated for the treatment of patients with carcinoma. See SPC for all therapeutic indications

অনুমোদন অবস্থা:

Not marketed

অনুমোদন তারিখ:

2015-06-26

তথ্য লিফলেট

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 spread 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 no

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
16 November 2018
CRN008L51
Page 1 of 27
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.
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 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 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.
Health Products Regulatory Authority
16 November 2018
CRN008L51
Page 2 of 27
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