Paclitaxel 6 mg/ml Concentrate for Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paclitaxel

Available from:

Riemser Pharma GmbH

ATC code:

L01CD; L01CD01

INN (International Name):

Paclitaxel

Dosage:

6 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Therapeutic area:

Taxanes; paclitaxel

Authorization status:

Not marketed

Authorization date:

2010-01-08

Patient Information leaflet

1
PATIENT INFORMATION LEAFLET
PACLITAXEL 6MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
(Paclitaxel)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE.
•
KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.
•
IF YOU HAVE ANY FURTHER QUESTIONS, ASK YOUR DOCTOR.
•
IF ANY OF THE SIDE EFFECTS GETS SERIOUS, OR IF YOU NOTICE ANY SIDE
EFFECTS NOT LISTED IN THIS LEAFLET,
PLEASE TELL YOUR DOCTOR.
In this leaflet:
1.
What paclitaxel is and what it is used for
2.
Before you are given paclitaxel
3.
How paclitaxel is given to you
4.
Possible side effects
5.
How to store paclitaxel
6.
Further information
_Paclitaxel concentrate for solution for infusion is given only by a
doctor or nurse. They can answer any _
_questions you may have after reading this packaging leaflet. _
1.
WHAT PACLITAXEL IS AND WHAT IT IS USED FOR
This medicinal product is used for treatment of cancer. It can be
cancer of the ovaries or breast cancer
(advanced or spreading ovarian cancer, advanced or spreading breast
cancer). This medicinal product
may also be used for a special cancer in the lungs (advanced non-small
cell lung cancer, NSCLC) in
patients who cannot be treated with surgery and/or radiotherapy.
Paclitaxel may also be used for a
special cancer, called Kaposi’s sarcoma, which may be associated
with AIDS (Acquired Immuno-
Deficiency Syndrome) where other treatments i.e. liposomal
anthracyclines have not worked. Paclitaxel
works by stopping cell division and is used to prevent the growth of
cancer cells.
2.
BEFORE YOU ARE GIVEN PACLITAXEL
YOU SHOULD NOT BE GIVEN PACLITAXEL:
•
if you are allergic (hypersensitive) to paclitaxel or any of the other
ingredients. One of the
ingredients, macrogolglycerol ricinoleate, can cause severe allergic
reactions
•
if you are pregnant or breast feeding
•
if the number of white blood cells (neutrophils) is too low. This is
measured by a doctor or
nurse
•
if you have Kaposi’s sarcoma and you have a serious uncontrolled
infection.
If you are unsure about anything, ask your doctor or

Summary of Product characteristics

Health Products Regulatory Authority
21 July 2020
CRN009NY2
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paclitaxel 6 mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml contains 6 mg of the active ingredient, paclitaxel
1 vial of 5 ml contains 30 mg of paclitaxel
1 vial of 16.7 ml contains 100 mg of paclitaxel
1 vial of 50 ml contains 300 mg of paclitaxel
Excipients:
1ml contains 525 mg of macrogolglycerol ricinoleate
1 vial of 5 ml contains 2.625 g of macrogolglycerol ricinoleate
1 vial of 16.7 ml contains 8.768 g of macrogolglycerol ricinoleate
1 vial of 50 ml contains 26.250 g of macrogolglycerol ricinoleate
1ml contains 497 mg of ethanol
1 vial of 5 ml contains 2.485 g of ethanol
1 vial of 16.7 ml contains 8.300 g of ethanol
1 vial of 50 ml contains 24.850 g of ethanol
For full list of excipients, see 6.1
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
A clear, colourless to pale yellow viscous solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
OVARIAN CARCINOMA: in the first-line chemotherapy of ovarian cancer,
paclitaxel infusion 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 infusion 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 infusion is
indicated for the treatment of patients with node-positive
breast carcinoma following anthracycline and cyclophosphamide (AC)
therapy. Adjuvant treatment with paclitaxel infusion
should be regarded as an alternative to extended AC therapy.
Paclitaxel infusion 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 wit