Docetaxel Hospira 10mg/ml concentrate for Solution for Infusion (8ml vial)

Country: Malta

Bahasa: Inggeris

Sumber: Medicines Authority

Bahan aktif:

DOCETAXEL

Boleh didapati daripada:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

Kod ATC:

L01CD02

INN (Nama Antarabangsa):

DOCETAXEL 10 mg/ml

Borang farmaseutikal:

CONCENTRATE FOR SOLUTION FOR INFUSION

Komposisi:

DOCETAXEL 10 mg/ml

Jenis preskripsi:

POM

Kawasan terapeutik:

ANTINEOPLASTIC AGENTS

Status kebenaran:

Authorised

Tarikh kebenaran:

2009-11-23

Risalah maklumat

PACKAGE LEAFLET
Package leaflet: Information for the patient
Docetaxel Hospira 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 Hospira is and what it is used for
2.
What you need to know before you use Docetaxel Hospira
3.
How to use Docetaxel Hospira
4.
Possible side effects
5.
How to store Docetaxel Hospira
6.
Contents of the pack and other information
1.
What Docetaxel Hospira is and what it is used for
The name of this medicine is Docetaxel Hospira. 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 Hospira 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, this medicine 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, this
medicine could be administered in combination with doxorubicin and
cyclophosphamide.
-
For the treatment of lung cancer, this medicine could be administered
either alone or in
combination with cisplatin.
-
For the treatment of prostate cancer, this medicine is administered in
combination with
prednisone or prednisolone.
-
For the treatment of metastatic gastric cancer, this medicine is
administered in combination
with cisplatin and 5-fluorouracil.
-
For the treatment of head and neck cancer, this medicin

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Docetaxel Hospira 10 mg/mL concentrate for solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL concentrate for solution for infusion contains 10 mg docetaxel.
20 mg/2 mL vial
One vial of 2 mL contains 20 mg docetaxel.
80 mg/8 mL vial
One vial of 8 mL contains 80 mg docetaxel.
160 mg/16 mL vial
One vial of 16 mL contains 160 mg docetaxel.
Excipient with known effect
1 mL concentrate for solution for infusion contains 182 mg ethanol.
20 mg/2 mL vial
This product contains 364 mg anhydrous ethanol in each 2 mL vial of
concentrate which is equivalent
to 182 mg/mL (23% v/v).
80 mg/8 mL vial
This product contains 1455 mg anhydrous ethanol in each 8 mL vial of
concentrate which is
equivalent to 182 mg/mL (23% v/v).
160 mg/16 mL vial
This product contains 2911 mg anhydrous ethanol in each 16 mL vial of
concentrate which is
equivalent to 182 mg/mL (23% v/v).
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 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
anthr