Docefrez
Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
Lietošanas instrukcija
(PIL)
14-06-2012
Produkta apraksts
(SPC)
14-06-2012
Publiskā novērtējuma ziņojums
(PAR)
14-06-2012
Aktīvā sastāvdaļa:
docetaxel
Pieejams no:
Sun Pharmaceutical Industries Europe B.V.
ATĶ kods:
L01CD02
SNN (starptautisko nepatentēto nosaukumu):
docetaxel
Ārstniecības grupa:
Antineoplastic agents
Ārstniecības joma:
Stomach Neoplasms; Adenoma; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Prostatic Neoplasms
Ārstēšanas norādes:
Breast cancerDocetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.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 cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small cell lung cancerDocetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.Docetaxel 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 in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.Gastric adenocarcinomaDocetaxel 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 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.
Produktu pārskats:
Revision: 1
Autorizācija statuss:
Withdrawn
Autorizācija datums:
2010-05-10
Lietošanas instrukcija
Medicinal product no longer authorised
86
B. PACKAGE LEAFLET
Medicinal product no longer authorised
87
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOCEFREZ 20 MG POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
DOCETAXEL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or nurse.
IN THIS LEAFLET
:
1.
What Docefrez is and what it is used for
2.
Before you use Docefrez
3.
How to use Docefrez
4.
Possible side-effects
5.
How to store Docefrez
6.
Further information
1.
WHAT DOCEFREZ IS AND WHAT IT IS USED FOR
Docefrez contains the active substance docetaxel. Docetaxel, derived
from yew-tree needles, belongs to a
group of anti-cancer medicines called taxanes.
Docefrez is used, either alone or in combination with other medicines,
for the treatment of the following
kinds of cancer:
- advanced breast cancer, alone or with doxorubicin, or trastuzumab,
or capecitabine
- early breast cancer with or without lymph node involvement, with
doxorubicin and cyclophosphamide
- non-small cell lung cancer (NSCLC), alone or with cisplatin
- prostate cancer, with prednisone or prednisolone
- metastatic gastric cancer, with cisplatin and 5-fluorouracil
- head and neck cancer, with cisplatin and 5-fluorouracil.
2.
BEFORE YOU USE DOCEFREZ
DO NOT USE DOCEFREZ
-
if you are allergic (hypersensitive) to docetaxel or any of the other
ingredients of Docefrez
-
if your number of white blood cells is too low
-
if you have severe liver disease
-
TAKE SPECIAL CARE WITH DOCEFREZ
Tell your doctor if you have:
-
heart problems
-
liver problems
-
kidney problems
Before each Docefrez dose, you will have blood tests to check that
your blood cell counts and liver function
are adequate.
USING OTHER MEDICINES
Medicinal product no longer authorised
88
Please tell your doctor or nurse if
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Produkta apraksts
Medicinal product no longer authorised
1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Docefrez 20 mg powder and solvent for concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-dose vial of powder contains 20 mg docetaxel (anhydrous).
After reconstitution, 1 ml of concentrate contains 24 mg docetaxel.
Excipients: the solvent contains 35.4% (w/w) ethanol.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for concentrate for solution for infusion.
White lyophilised powder.
The solvent is a viscous, clear and colourless 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 cytotoxic chemotherapy.
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