DOCETAXEL HOSPIRA

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

DOCETAXEL

Beschikbaar vanaf:

Hospira UK Limited

ATC-code:

L01CD02

INN (Algemene Internationale Benaming):

DOCETAXEL

Dosering:

10 Micromol

farmaceutische vorm:

Concentrate for Soln for Inf

Prescription-type:

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

Therapeutisch gebied:

docetaxel

Autorisatie-status:

Not Marketed

Autorisatie datum:

2009-12-22

Bijsluiter

DOCETAXEL HOSPIRA 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Docetaxel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist.
IN THIS LEAFLET:
1.
What Docetaxel Hospira is and what it is used for
2.
Before you are given Docetaxel Hospira
3.
How Docetaxel Hospira is used
4.
Possible side effects
5
How to store Docetaxel Hospira
6.
Further information
1.
WHAT DOCETAXEL HOSPIRA IS AND WHAT IT IS USED FOR
Docetaxel Hospira is an anti-cancer drug and is used either alone or
in combination
with other anti-cancer medicines to treat:

Early breast cancer with or without lymph node involvement; Docetaxel
Hospira is used in combination with doxorubicin and cyclophosphamide.

Advanced
breast
cancer;
Docetaxel
Hospira
is
used
either
alone
or
in
combination

with doxorubicin, capecitabine or trastuzumab.

Special forms of lung cancer (non-small cell lung cancer); Docetaxel
Hospira
is used either alone or in combination with cisplatin.

Prostate cancer; Docetaxel Hospira is used in combination with
prednisone or
prednisolone.

Gastric cancer; where the cancer has spread, Docetaxel Hospira is used
in
combination with cisplatin and 5-fluorouracil.

Head
and
neck
cancer;
Docetaxel
Hospira
is
used
in
combination
with
cisplatin and 5-fluorouracil.
2.
BEFORE YOU ARE GIVEN DOCETAXEL HOSPIRA
DO NOT USE DOCETAXEL HOSPIRA:

if you are hypersensitive (allergic) to docetaxel or any of the other
ingredients

if you already have a reduced number of white blood cells

if you have severe liver disease.
SPECIAL CARE WILL BE TAKEN WITH DOCETAXEL HOSPIRA:

if the number of white cells in your blood is too low. Your doctor
will check
this.

if you develop a hypersensitivity (allergic) reaction to this medicine

if you develop reddening or sw

Productkenmerken

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
1ml 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
20 mg/2 ml vial
Each 2 ml vial of concentrate contains 0.46 ml of ethanol anhydrous
(363 mg).
80 mg/8 ml vial
Each 8 ml vial of concentrate contains 1.84 ml of ethanol anhydrous
(1452 mg).
160 mg/16 ml vial
Each 16 ml vial of concentrate contains 3.68 ml of ethanol anhydrous
(2904 mg).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Concentrate for Solution for Infusion
A clear colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Breast Cancer
Docetaxel Hospira 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).
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