Docetaxel Hospira Concentrate for Soln for Inf 10mg/ml (16ml vial)

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

DOCETAXEL

Disponible des:

Hospira UK Limited

Codi ATC:

L01CD02

Designació comuna internacional (DCI):

DOCETAXEL

formulario farmacéutico:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composición:

DOCETAXEL 160 mg

tipo de receta:

POM

Área terapéutica:

ANTINEOPLASTIC AGENTS

Estat d'Autorització:

Authorised

Data d'autorització:

2009-11-23

Informació per a l'usuari

Page 1 of 9
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 redde

Fitxa tècnica

Page 1 of 44
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 vialOne 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).
Page 2 of 44
Docetaxel Hospira 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 Hospira 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 Hospira in combination with trastuzumab is indicated for the
treatment of patients
with metastatic breast cancer whose tumours ov