Docetaxel Pfizer 10 mg/mL concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Docetaxel

Available from:

Pfizer Healthcare Ireland

ATC code:

L01CD; L01CD02

INN (International Name):

Docetaxel

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Prescription type:

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

Therapeutic area:

Taxanes; docetaxel

Authorization status:

Not marketed

Authorization date:

2012-11-16

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOCETAXEL PFIZER 10 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, pharmacist or
nurse.
-
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 Docetaxel Pfizer is and what it is used for
2.
What you need to know before you use Docetaxel Pfizer
3.
How to use Docetaxel Pfizer
4.
Possible side effects
5.
How to store Docetaxel Pfizer
6.
Contents of the pack and other information
1.
WHAT DOCETAXEL PFIZER IS AND WHAT IT IS USED FOR
The name of this medicine is Docetaxel Pfizer. 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 Pfizer 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 Pfizer 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
Pfizer could be administered in combination with doxorubicin and
cyclophosphamide.
-
For the treatment of lung cancer, Docetaxel Pfizer could be
administered either alone or in
combination with cisplatin.
-
For the treatment of prostate cancer, Docetaxel Pfizer is administered
in combination with
prednisone or prednisolone.
-
For the treatment of metastatic gastric cancer, Docetaxel Pfizer is
administered in combination
with cisplatin and 5-fluorouracil.
-
For the treatment of head and neck can

Summary of Product characteristics

Health Products Regulatory Authority
21 December 2023
CRN00DT7P
Page 1 of 46
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Docetaxel Pfizer 10 mg/mL concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL concentrate for solution for infusion contains 10 mg docetaxel.
One vial of 2 mL contains 20 mg docetaxel
One vial of 8 mL contains 80 mg docetaxel
One vial of 13 mL contains 130 mg docetaxel
One vial of 20 mL contains 200 mg docetaxel
Excipients with known effect
1 mL concentrate for solution for infusion contains 317 mg ethanol and
374 mg propylene glycol.
One vial of 2 mL contains 634 mg ethanol which is equivalent to 317
mg/mL (40% v/v) and 748 mg propylene glycol which is
equivalent to 374 mg/mL.
One vial of 8 mL contains 2536 mg ethanol which is equivalent to 317
mg/mL (40% v/v) and 2992 mg propylene glycol which
is equivalent to 374 mg/mL.
One vial of 13 mL contains 4121 mg ethanol which is equivalent to 317
mg/mL (40% v/v) and 4862 mg propylene glycol which
is equivalent to 374 mg/mL.
One vial of 20 mL contains 6340 mg ethanol which is equivalent to 317
mg/mL (40% v/v) and 7480 mg propylene glycol which
is equivalent to 374 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, colourless to brown-yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Breast cancer
Docetaxel Pfizer 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).
Health Products Regulatory Authority
21 December 2023
CRN00DT7P
Page 2 of 46
Docetaxel Pfizer in combination with doxorubicin is indica