Docetaxel 20mg1ml concentrate for solution for infusion vials

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Docetaxel

Dostupné z:

Accord Healthcare Ltd

ATC kód:

L01CD02

INN (Medzinárodný Name):

Docetaxel

Dávkovanie:

20mg/1ml

Forma lieku:

Solution for infusion

Spôsob podávania:

Intravenous

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: ; GTIN: 5055565700389

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOCETAXEL ACCORD 20 MG/1 ML CONCENTRATE FOR SOLUTION FOR INFUSION
DOCETAXEL ACCORD 80 MG/4 ML CONCENTRATE FOR SOLUTION FOR INFUSION
DOCETAXEL ACCORD 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 Accord is and what it is used for
2.
What you need to know before you use Docetaxel Accord
3.
How to use Docetaxel Accord
4.
Possible side effects
5.
How to store Docetaxel Accord
6.
Contents of the pack and other information
1.
WHAT DOCETAXEL ACCORD IS AND WHAT IT IS USED FOR
The name of this medicine is Docetaxel Accord. Its common name is
docetaxel. Docetaxel is a substance
derived from the needles of yew trees.
Docetaxel belongs to the group of anti-cancer medicines called
taxoids.
Docetaxel Accord 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
admin

Súhrn charakteristických

OBJECT 1
DOCETAXEL ACCORD CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 24-Jan-2018 | Accord
Healthcare Limited
1. Name of the medicinal product
Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion
Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion
Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion
2. Qualitative and quantitative composition
Each ml of concentrate contains 20 mg docetaxel.
Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion
One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion
One vial of 4 ml of concentrate contains 80 mg of docetaxel.
Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion
One vial of 8 ml of concentrate contains 160 mg of docetaxel.
Excipient with known effect
_Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion _
Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395
mg).
_Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion _
Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
_Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion _
Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear pale yellow to brownish-yellow solution.
4. Clinical particulars
4.1 Therapeutic indications
Breast cancer
Docetaxel Accord 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 Ac