Docetaxel 80mg4ml concentrate for solution for infusion vials

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Docetaxel

Disponibbli minn:

Dr Reddy's Laboratories (UK

Kodiċi ATC:

L01CD02

INN (Isem Internazzjonali):

Docetaxel

Dożaġġ:

20mg/1ml

Għamla farmaċewtika:

Solution for infusion

Rotta amministrattiva:

Intravenous

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF:

Fuljett ta 'informazzjoni

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.
•
For the treatment of metastatic gastric cancer,
docetaxel is administered in combination with cisplatin
and 5-fluorouracil.
•
For the treatment of head and neck cancer, docetaxel
is administered in combination with cisplatin and 5-
fluorouracil.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE

Karatteristiċi tal-prodott

DOCETAXEL DR. REDDYS 80 MG/4 ML CONCENTRATE
FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 17-Aug-2016 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Docetaxel Dr. Reddy's 80 mg/4 ml Concentrate For Solution For Infusion
2. Qualitative and quantitative composition
Each ml of concentrate contains 20 mg docetaxel (anhydrous).
One vial of 4 ml of concentrate contains 80 mg docetaxel.
Excipients:
Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
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 or metastatic breast cancer after failure of cytoto