Docetaxel 160mg/8ml Concentrate For Solution For Infusion

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

docetaxel

Available from:

Dr. Reddy’s Laboratories (UK) Ltd

ATC code:

L01CD02

INN (International Name):

docetaxel

Dosage:

20mg/ml

Pharmaceutical form:

Concentrate for solution for infusion (sterile concentrate)

Administration route:

infusion

Units in package:

Each box contains one vial

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Dr. Reddy’s Laboratories (UK) Ltd

Therapeutic group:

Taxanes

Therapeutic indications:

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.

Authorization status:

Authorised

Authorization date:

2015-03-31

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

DOCETAXEL 20 MG/1 ML, 80 MG/4 ML, 160 MG/8 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, hospital pharmacist or
nurse. 
• 
If you get any side effects talk to
your doctor, hospital 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 IS AND WHAT IT IS USED FOR 
2.  WHAT YOU NEED TO KNOW BEFORE YOU USE 
DOCETAXEL 
3.  HOW TO USE DOCETAXEL 
4.  POSSIBLE SIDE EFFECTS 
5.  HOW TO STORE DOCETAXEL 
6.  CONTENTS OF THE PACK AND OTHER INFORMATION 

1.    WHAT DOCETAXEL IS AND WHAT IT IS USED FOR  

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

Docetaxel 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 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 could be 
administered in combination with doxorubicin and 
cyclophosphamide. 
• 
For the treatment of lung cancer, docetaxel could be 
administered either alone or in combination with 
cisplatin. 
• 
For the treatment of prostate cancer, docetaxel is 
administered in combination with prednisone or 
prednisolone

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Docetaxel 160 mg/8 ml Concentrate For Solution For Infusion 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each ml of concentrate contains 20 mg docetaxel (anhydrous). 
One vial of 8 ml of concentrate contains 160 mg docetaxel. 

Excipients: 
Each vial of concentrate contains 3.16 g ethanol anhydrous. 

For a full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Concentrate for solution for infusion (sterile concentrate). 

The concentrate is a pale yellow to brownish-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 anthracycline or an
alkylating 
agent. 

Docetaxel in combination with trastuzumab is indicated for
the treatment of 
patients with metastatic breast cancer whose tumours over express
HER2 and 
who previously have not received chemotherapy for
metastatic disease. 

Docetaxel in combination with capecitabine is indicated for the
treatment of 
patients with locally advanced