DOCETAXEL EBEWE 10 MG1 ML

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

DOCETAXEL

متاح من:

NOVARTIS ISRAEL LTD

ATC رمز:

L01CD02

الشكل الصيدلاني:

CONCENTRATE FOR SOLUTION FOR INFUSION

تركيب:

DOCETAXEL 10 MG / 1 ML

طريقة التعاطي:

I.V

نوع الوصفة الطبية :

Required

المصنعة من قبل:

EBEWE PHARMA GES.M.B.H NFG.KG, AUSTRIA

المجموعة العلاجية:

DOCETAXEL

المجال العلاجي:

DOCETAXEL

الخصائص العلاجية:

Breast cancer: docetaxel 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 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 tumors overexpress HER2 and who previously have not received chemotherapy for metastatic disease. docetaxel in combination with capecitabine is indicated for the treatment of patients with metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an an

تاريخ الترخيص:

2016-07-31

نشرة المعلومات

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_ הרמחה לע העדוה_
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_אפורל ןולעב תוחיטב עדימ_
ךיראת
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12.
: :תילגנאב רישכת םש
DOCETAXEL EBEWE 10 MG/1ML
:םושיר רפסמ 146-55-33269-00 : םושירה לעב םש
PHARMALOGIC LTD.
! דבלב תורמחהה טורפל דעוימ הז ספוט
!!תורמחה קרו ךא בוהצב םינמוסמ
)םיחפסנכ ופרוצ תואלבט(
תושקובמ תורמחה
שדח טסקט
ןשי טסקט
ןולעב קרפ
Special poulation
Paediatric population
The safety and efficacy of docetaxel in
nasopharyngeal carcinoma in children aged 1 month
to less than 18 years have not yet been established.
There is no relevant use of docetaxel in the paediatric
population in the indications breast cancer, non-small
cell lung cancer, prostate cancer, gastric carcinoma
and head and neck cancer, not
including type II and III less differentiated
nasopharyngeal carcinoma.
_CHILDREN AND ADOLESCENTS _
Docetaxel Ebewe is not recommended
for use in children due to insufficient data
on safety and efficacy.
POSOLOGY AND
METHOD OF
ADMINISTRATION
2
Respiratory disorders:
Acute respiratory distress syndrome, interstitial
pneumonia/pneumonitis, interstitial lung disease,
pulmonary
fibrosis and respiratory failure have been reported
and may be associated with fatal outcome. Cases of
radiation pneumonitis have been reported in patients
receiving concomitant radiotherapy.
If new or worsening pulmonary symptoms develop,
patients should be closely monitored, promptly
investigated, and appropriately treated. Interruption of
docetaxel therapy is recommended until diagnosis is
available. Early use of supportive care measures may
help improve the condition. The benefit of resuming
docetaxel treatment must be carefully evaluated.
EYE DISORDERS
Cystoid macular oedema (CMO) has been reported in
patients treated with docetaxel. Patients with impaired
vision should undergo a prompt and complete
ophthalmologic examination. In case CMO is
diagnosed, docetaxel treatment should be
disconti

خصائص المنتج

1.
NAME OF THE MEDICINAL PRODUCT
DOCETAXEL EBEWE
10 MG/ML
CONCENTRATE FOR SOLUTION FOR INFUSION
WARNINGS_ _
DOCETAXEL EBEWE CONCENTRATE FOR SOLUTION FOR INFUSION SHOULD BE
ADMINISTERED UNDER THE SUPERVISION OF A PHYSICIAN
EXPERIENCED IN THE USE OF ANTINEOPLASTIC AGENTS.
WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY
REACTIONS, AND FLUID RETENTION
THE INCIDENCE OF TREATMENT-RELATED MORTALITY ASSOCIATED WITH DOCETAXEL
THERAPY IS INCREASED IN PATIENTS WITH ABNORMAL
LIVER FUNCTION, IN PATIENTS RECEIVING HIGHER DOSES, AND IN PATIENTS
WITH NON-SMALL CELL LUNG CARCINOMA AND A HISTORY OF PRIOR
TREATMENT WITH PLATINUM-BASED CHEMOTHERAPY WHO RECEIVE DOCETAXEL AS A
SINGLE AGENT AT A DOSE OF 100 MG/M
2
.
DOCETAXEL SHOULD NOT BE GIVEN TO PATIENTS WITH BILIRUBIN > UPPER LIMIT
OF NORMAL (ULN), OR TO PATIENTS WITH AST AND/OR
ALT > 1.5 × ULN CONCOMITANT WITH ALKALINE PHOSPHATASE > 2.5 × ULN.
PATIENTS WITH ELEVATIONS OF BILIRUBIN OR ABNORMALITIES
OF TRANSAMINASE CONCURRENT WITH ALKALINE PHOSPHATASE ARE AT INCREASED
RISK FOR THE DEVELOPMENT OF GRADE 4 NEUTROPENIA,
FEBRILE NEUTROPENIA, INFECTIONS, SEVERE THROMBOCYTOPENIA, SEVERE
STOMATITIS, SEVERE SKIN TOXICITY, AND TOXIC DEATH. PATIENTS
WITH ISOLATED ELEVATIONS OF TRANSAMINASE > 1.5 × ULN ALSO HAD A
HIGHER RATE OF FEBRILE NEUTROPENIA GRADE 4 BUT DID NOT HAVE
AN INCREASED INCIDENCE OF TOXIC DEATH. BILIRUBIN, AST OR ALT, AND
ALKALINE PHOSPHATASE VALUES SHOULD BE OBTAINED PRIOR TO
EACH CYCLE OF DOCETAXEL THERAPY.
DOCETAXEL THERAPY SHOULD NOT BE GIVEN TO PATIENTS WITH NEUTROPHIL
COUNTS OF < 1,500 CELLS/MM. IN ORDER TO MONITOR THE
OCCURRENCE OF NEUTROPENIA, WHICH MAY BE SEVERE AND RESULT IN
INFECTION, FREQUENT BLOOD CELL COUNTS SHOULD BE PERFORMED
ON ALL PATIENTS RECEIVING DOCETAXEL.
SEVERE HYPERSENSITIVITY REACTIONS CHARACTERIZED BY GENERALIZED
RASH/ERYTHEMA, HYPOTENSION AND/OR BRONCHOSPASM, OR
VERY RARELY FATAL ANAPHYLAXIS, HAVE BEEN REPORTED IN PATIENTS WHO
RECEIVED A 3-DAY DEXAMETHASONE PREMEDICATION.
HYPERSENSITIVITY REACTIONS REQUIRE IMMEDIATE DISCONTINUAT