DOCETAXEL SEACROSS 20 MGML CONCENTRATE FOR SOLUTION FOR INFUSION

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

DOCETAXEL ANHYDROUS

Dostupné z:

A.L. MEDI-MARKET LTD.

ATC kód:

L01CD02

Forma lieku:

CONCENTRATE FOR SOLUTION FOR INFUSION

Zloženie:

DOCETAXEL ANHYDROUS 20 MG / 1 ML

Spôsob podávania:

I.V

Typ predpisu:

Required

Výrobca:

SICHUAN HUIYU PHARMACEUTICAL CO., LTD., CHINA

Terapeutické oblasti:

DOCETAXEL

Terapeutické indikácie:

Breast cancer : Docetaxel Seacross 20 mg/ml in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node- positive breast cancer .Docetaxel Seacross 20 mg/ml 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 Seacross 20 mg/ml 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 Seacross 20 mg/ml 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 Seacross 20 mg/ml 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 anthracycline. Doxorubicin and cyclophosphamide followed by Docetaxel Seacross 20 mg/ml in combination with trastuzumab (AC-TH) is indicated for the adjuvant treatment of patients with HER2 over-expressing, node-positive or high risk node-negative, breast cancer .Docetaxel Seacross 20 mg/ml in combination with trastuzumab, and carboplatin (TCH) is indicated for the adjuvant treatment of patients with HER2 over-expressing, node-positive or high risk node-negative, breast cancer.Non-small cell lung cancer : Docetaxel Seacross 20 mg/ml is indicated for the treatment of patients with advanced non-small cell lung carcinoma. Ovarian Cancer : Docetaxel Seacross 20 mg/ml is indicated for treatment of metastatic carcinoma of the ovary after failure of first line or subsequent chemotherapy .Prostate cancer : Docetaxel Seacross 20 mg/ml in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer . Esophageal cancer : Docetaxel Seacross 20 mg/ml for the treatment of esophageal cancer.Gastric cancer : Docetaxel Seacross 20 mg/ml for the treatment of advanced gastric cancer.Head and neck (SCCHN): Docetaxel Seacross 20 mg/ml as monotherapy in the treatment of patients with recurrent and/or metastasis squamos cell carcinoma of the head and neck after failure of a previous chemotherapy regimen.Docetaxel Seacross 20 mg/ml 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.

Dátum Autorizácia:

2022-08-23

Súhrn charakteristických

2
1.
NAME OF THE MEDICINAL PRODUCT
DOCETAXEL Seacross 20 MG/ML, Concentrate for solution for infusion
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/M2.
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 <1500 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
DISCONTINUATION OF THE DOCETAXEL INFUSION AND ADMINISTRATION OF
APPROPRIATE THERAPY.
DOCETAXEL MUST NOT BE GIVEN TO PATIENTS WHO HAVE A HISTORY OF SEVERE
HYPERSENSITIVITY
REACTIONS TO DOCE