Docetaxel 20mg/ml concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Docetaxel

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

L01CD; L01CD02

INN (International Name):

Docetaxel

Dosage:

20 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Therapeutic area:

Taxanes; docetaxel

Authorization status:

Marketed

Authorization date:

2010-09-24

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOCETAXEL 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Docetaxel
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.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Docetaxel is and what it is used for
2.
What you need to know before you use Docetaxel
3.
How to use Docetaxel
4.
Possible side effects
5.
How to store Docetaxel
6.
Contents of the pack and other information
1.
WHAT DOCETAXEL IS AND WHAT IT IS USED FOR
The name of this medicine is Docetaxel. Its common name is docetaxel.
Docetaxel is a substance derived
from the needles of yew trees.
Docetaxel belongs to the group of anti-cancer medicines called
taxoids.
Docetaxel has been prescribed by your doctor for the treatment of
breast cancer, special forms of lung cancer
(non-small cell lung cancer), prostate cancer, gastric cancer or head
and neck cancer:
- For the treatment of advanced breast cancer, Docetaxel could be
administered either alone or in
combination with doxorubicin, or trastuzumab, or capecitabine.
- For the treatment of early breast cancer with or without lymph node
involvement, Docetaxel could be
administered in combination with doxorubicin and cyclophosphamide.
- For the treatment of lung cancer, Docetaxel could be administered
either alone or in combination with
cisplatin.
- For the treatment of prostate cancer, Docetaxel is administered in
combination with prednisone or
prednisolone.
- For the treatment of metastatic gastric cancer, Docetaxel is
administered in combination with cisplatin and
5-fluorouracil.
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Summary of Product characteristics

Health Products Regulatory Authority
15 June 2020
CRN009NHL
Page 1 of 39
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Docetaxel 20mg/ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single dose vial contains docetaxel 20 mg/ml
Each 1 ml single dose vial contains 20 mg docetaxel
Each 4 ml single dose vial contains 80 mg docetaxel
Each 7 ml single dose vial contains 140 mg docetaxel
Each 8 ml single dose vial contains 160 mg docetaxel
Excipients with known effect: Ethanol absolute 400 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
The concentrate is a clear, pale yellow solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Breast cancer
Docetaxel in combination with doxorubicin and cyclophosphamide is
indicated for the adjuvant treatment of patients with:
• operable node-positive breast cancer
• operable node-negative breast cancer
For patients with operable node-negative breast cancer, adjuvant
treatment should be restricted to patients eligible to receive
chemotherapy according to internationally established criteria for
primary therapy of early breast cancer (see section 5.1).
Docetaxel in combination with doxorubicin is indicated for the
treatment of patients with locally advanced or metastatic breast
cancer who have not previously received cytotoxic therapy for this
condition.
Docetaxel monotherapy is indicated for the treatment of patients with
locally advanced or metastatic breast cancer after failure
of cytotoxic therapy. Previous chemotherapy should have included an
anthracycline or an alkylating agent.
Docetaxel in combination with trastuzumab is indicated for the
treatment of patients with metastatic breast cancer whose
tumors over express HER2 and who previously have not received
chemotherapy for metastatic disease.
Docetaxel in combination with capecitabine is indicated for the
treatment of patients with locally advanced or metastatic breast
cancer after failure o