Docetaxel Kabi

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

docetaxel

Tillgänglig från:

Fresenius Kabi Deutschland GmbH

ATC-kod:

L01CD02

INN (International namn):

docetaxel

Terapeutisk grupp:

Antineoplastic agents

Terapiområde:

Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms

Terapeutiska indikationer:

Breast cancerDocetaxel Kabi 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.Docetaxel Kabi 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 Kabi 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 Kabi in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.Docetaxel Kabi in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small-cell lung cancerDocetaxel Kabi is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Docetaxel Kabi in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancerDocetaxel Kabi in combination with prednisone or prednisolone is indicated for the treatment of patients with castration-resistant metastatic prostate cancer.Docetaxel Kabi in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer.Gastric adenocarcinomaDocetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.Head and neck cancerDocetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Produktsammanfattning:

Revision: 15

Bemyndigande status:

Authorised

Tillstånd datum:

2012-05-22

Bipacksedel

251
B. PACKAGE LEAFLET
252
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOCETAXEL KABI 20 MG/1 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 KABI
is and what it is used for
2.
What you need to know before you use DOCETAXEL KABI
3.
How to use DOCETAXEL KABI
4.
Possible side effects
5.
How to store DOCETAXEL KABI
6.
Contents of the pack and other information
1.
WHAT DOCETAXEL KABI IS AND WHAT IT IS USED FOR
The name of this medicine is DOCETAXEL KABI.
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 KABI
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 KABI
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
KABI
could be administered in combination with doxorubicin and
cyclophosphamide.
-
For the treatment of lung cancer, DOCETAXEL KABI
could be administered either alone or in
combination with cisplatin.
-
For the treatment of prostate cancer, DOCETAXEL KABI
is administered in combination with
prednisone or prednisolone.
-
For the treatment of metastatic gastric cancer, DOCETAXEL KABI is
administered in
combination with cisplatin and 5-fluorouracil.
-
For the treatment of head and neck cancer

Produktens egenskaper

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 20 mg docetaxel anhydrous.
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 clear, colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BREAST CANCER
DOCETAXEL KABI 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 KABI 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 KABI 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 KABI 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 KABI in combination with capecitabine is indicated for the
treatment of patients with
locally advanced or metastatic breast cancer after failure of
cytotoxic chemotherapy. Previous therapy
should have included an anthracycline.