Taxotere 20mg1ml concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Docetaxel

Available from:

Sanofi

ATC code:

L01CD02

INN (International Name):

Docetaxel

Dosage:

20mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5000283653776

Patient Information leaflet

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TAXOTERE CONTAINS ETHANOL (ALCOHOL)
This medicinal product contains 50 vol %
ethanol anhydrous (alcohol), i.e. up to
395 mg ethanol anhydrous per vial,
equivalent to 10 ml of beer or 4 ml wine
per vial.
Harmful for those suffering
from alcoholism.
To be taken into account
if you are pregnant or if
you are breast-feeding
women, in children and
high-risk groups such as
patients with liver disease,
or epilepsy.
The amount of alcohol in this medicinal
product may have effects on the central
nervous system (the part of the nervous
system that includes the brain and spinal
cord).
The amount of alcohol in this medicinal product
may alter the effects of other medicines.
The amount of alcohol in this medicine may
impair your ability to drive or use machines.
3. HOW TO USE TAXOTERE
TAXOTERE will be administered to you by a
healthcare professional.
USUAL DOSE
The dose will depend on your weight and
your general condition. Your doctor will
calculate your body surface area in square
meters (m²) and will determine the dose you
should receive.
METHOD AND ROUTE OF ADMINISTRATION
TAXOTERE will be given by infusion into one
of your veins (intravenous use). The infusion
will last approximately one hour during
which you will be in the hospital.
FREQUENCY OF ADMINISTRATION
You should usually receive your infusion
once every 3 weeks.
Your doctor may change the dose and
frequency of dosing depending on your
blood tests, your general condition and your
response to TAXOTERE. In particular, please
inform your doctor in case of diarrhoea,
sores in the mouth, feeling of numbness or
pins and needles, fever and give her/him
results of your blood tests. Such information
will allow her/him to decide whether a dose
reduction is needed. If you have any further
questions on the use of this medicine, ask
your doctor, or hospital pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Your doctor will discuss these with yo

Summary of Product characteristics

TAXOTERE 20MG/1ML CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 03-Nov-2016 | SANOFI
1. Name of the medicinal product
TAXOTERE 20 mg/1 ml concentrate for solution for infusion
2. Qualitative and quantitative composition
Each ml of concentrate contains 20 mg docetaxel (as trihydrate).
One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Excipient with known effect:
Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395
mg).
For the 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
TAXOTERE 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).
TAXOTERE 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.
TAXOTERE 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.
TAXOTERE 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.
TAXOTERE in combination with capecitabine is indicated for the
treatment of patients with locally
advanced or metastatic breast cancer after failure of cytotoxic
chemotherapy. Previous the