Docetaxel Actavis 20mg/0.5ml concentrate and solvent for solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DOCETAXEL

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

L01CD02

INN (International Name):

DOCETAXEL 40 mg/ml

Pharmaceutical form:

CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION

Composition:

DOCETAXEL 40 mg/ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2010-12-21

Patient Information leaflet

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOCETAXEL ACTAVIS 20 MG/0.5 ML CONCENTRATE AND SOLVENT FOR SOLUTION
FOR INFUSION
DOCETAXEL ACTAVIS 80 MG/2 ML CONCENTRATE AND SOLVENT 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 or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Docetaxel Actavis is and what it is used for
2.
What you need to know before you use Docetaxel Actavis
3.
How to use Docetaxel Actavis
4.
Possible side effects
5.
How to store Docetaxel Actavis
6.
Contents of the pack and other information
1.
WHAT DOCETAXEL ACTAVIS IS AND WHAT IT IS USED FOR
The name of this medicine is Docetaxel Actavis. 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 Actavis 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 Actavis 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 Actavis
could be administered in combination with doxorubicin and
cyclophosphamide.
-
For the treatment of lung cancer, Docetaxel Actavis could be
administered either alone or in
combination with cisplatin.
-
For the treatment of prostate cancer, Docetaxel Actavis is
adminis

Summary of Product characteristics

Page 1 of 39
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Docetaxel Actavis 20 mg/0.5 ml concentrate and solvent for solution
for infusion
Docetaxel Actavis 80 mg/2 ml concentrate and solvent for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single dose vial contains docetaxel 20 mg/0.5 ml or 80 mg/2 ml.
Each single dose vial contains 40 mg/ml of docetaxel.
Each single dose vial contains 10 mg/ml of docetaxel after
reconstitution with the accompanying solvent.
Excipients with known effect
Each single dose 20 mg/0.5 ml vial of concentrate contains 50 mg
ethanol absolute.
Each single dose 80 mg/2 ml vial of concentrate contains 200 mg
ethanol absolute.
Each single dose vial of solvent contains 9.53% (w/w) ethanol
absolute.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate and solvent for solution for infusion.
The concentrate is a clear, oily, yellow solution.
The solvent is a clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Breast cancer
Docetaxel Actavis 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 Actavis 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 Actavis 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 Actavis in combination with trastuzumab is indicated fo