Docetaxel Strides 40mg/ml concentrate and solvent for solution for infusion

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Malta Medicines Authority

Aktīvā sastāvdaļa:

DOCETAXEL

Pieejams no:

Strides Arcolab International Limited Unit 4, Metro Centre, Tolpits Lane, Watford, Hertfordshire, WD 189 SS, United Kingdom

ATĶ kods:

L01CD02

SNN (starptautisko nepatentēto nosaukumu):

DOCETAXEL 40 mg

Zāļu forma:

CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION

Kompozīcija:

DOCETAXEL 40 mg

Receptes veids:

POM

Ārstniecības joma:

ANTINEOPLASTIC AGENTS

Autorizācija statuss:

Withdrawn

Autorizācija datums:

2012-05-28

Lietošanas instrukcija

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 
DOCETAXEL STRIDES 40 MG/ML CONCENTRATE AND SOLVENT FOR SOLUTION FOR
INFUSION 

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 or your hospital
pharmacist. 
- 
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 hospital pharmacist. 

IN THIS LEAFLET: 
1. 
What Docetaxel Strides is and what it is used for 
2. 
Before you use  Docetaxel Strides 
3. 
How to use Docetaxel Strides  
4. 
Possible side-effects 
5. 
How to store Docetaxel Strides  
6. 
Further information 

1. 
WHAT DOCETAXEL STRIDES IS AND WHAT IT IS USED FOR 

The name of this medicine is Docetaxel Strides. Docetaxel is a
substance derived 
from the needles of yew trees. 
Docetaxel belongs to the group of anti-cancer medicines called
taxoids. 

Docetaxel Strides 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 Strides 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 Strides could be administered in combination
with 
doxorubicin and cyclophosphamide. 
- 
For the treatment of lung cancer, Docetaxel Strides could be
administered either 
alone or in combination with cisplatin. 
- 
For the treatment of prostate cancer, Docetaxel Strides is
administered in 
combination with prednisone or prednisolone. 
- 
For the treatment of metastatic gastric cancer, Docetaxel Strides is
administered 
in combination with cisplatin and 5-fluorouracil. 
- 
For the treatment of head and neck canc

Produkta apraksts

 
1. 
NAME OF THE MEDICINAL PRODUCT 

Docetaxel Strides 40 mg/ml concentrate and solvent for solution for
infusion 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each single-dose vial of Docetaxel concentrate contains
40mg/ml docetaxel (anhydrous). 

The concentrate vial is reconstituted with the solvent vial to
achieve a premix solution with a 
concentration of 10 mg/ml docetaxel (anhydrous). 

Excipient: Each single-dose vial of solvent contains 13% (w/w)
anhydrous ethanol in water for 
injection. 

For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Concentrate and solvent for solution for infusion. 
The concentrate is a clear colorless to pale yellow viscous
solution. 
The solvent is a colourless 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 overexpress HER2 and who previously have
not received 
chemotherapy for metastatic disease.