HERCLON trastuzumab (rch) 150 mg powder for injection vial

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

Trastuzumab, Quantity: 150 mg

Disponible des:

Roche Products Pty Ltd

Designació comuna internacional (DCI):

Trastuzumab

formulario farmacéutico:

Injection, powder for

Composición:

Excipient Ingredients: histidine; histidine hydrochloride; trehalose dihydrate; polysorbate 20

Vía de administración:

Intravenous

Unidades en paquete:

1 vial

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Early Breast Cancer HERCLON is indicated for the treatment of patients with HER2-positive localised breast cancer following surgery, and in assocoation with chemotherapy and, if applicable, radiotherapy. Locally Advanced Breast Cancer HERCLON is indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant HERCLON. Metastatic Breast Cancer HERCLON is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2: a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease, b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or c) in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer. Advanced Gastric Cancer HERCLON is indicated in combinat

Resumen del producto:

Visual Identification: Lyophilised powder: white to pale yellow in colour. Reconstituted solution: colourless to pale yellow, clear to slightly opalescent liquid.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Estat d'Autorització:

Licence status A

Data d'autorització:

2017-09-15