DOCETAXEL AN docetaxel 80mg/2mL concentrated solution for injection vial with diluent vial

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

docetaxel, Quantity: 80 mg

Доступно од:

Juno Pharmaceuticals Pty Ltd

INN (Међународно име):

Docetaxel

Фармацеутски облик:

Injection, concentrated

Састав:

Excipient Ingredients: water for injections; ethanol absolute; citric acid; polysorbate 80

Пут администрације:

Intravenous Infusion

Јединице у пакету:

80mg/2ml vial

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

1. Breast Cancer a) Metastatic Breast Cancer,DOCETAXEL AN is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. DOCETAXEL AN in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. DOCETAXEL AN 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.,b). Adjuvant Treatment of Breast Cancer,DOCETAXEL AN in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer. Doxorubicin and cyclophosphamide followed by DOCETAXEL AN in combination with trastuzumab (AC- TH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2. DOCETAXEL AN in combination with carboplatin and trastuzumab (TCH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2. DOCETAXEL AN in combination with cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of greater than or equal to 1cm and < 7cm.,2. Non Small Cell Lung Cancer, DOCETAXEL AN is indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer, including those who have failed platinum-based chemotherapy.,3.Ovarian Cancer, DOCETAXEL AN is indicated for the treatment of metastatic carcinoma of the ovary after failure of first- line or subsequent chemotherapy.,4.Prostate Cancer,DOCETAXEL AN is indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer.,5. Head and Neck Cancer,DOCETAXEL AN, in combination with cisplatin and fluorouracil is indicated as induction treatment prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the tumour is technically unresectable.

Резиме производа:

Visual Identification: Clear, colorless to pale yellow viscous solution free from visible particles.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус ауторизације:

Licence status A

Датум одобрења:

2012-10-23