HERCLON trastuzumab (rch) 150 mg powder for injection vial

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

Trastuzumab, Quantity: 150 mg

Commercializzato da:

Roche Products Pty Ltd

INN (Nome Internazionale):

Trastuzumab

Forma farmaceutica:

Injection, powder for

Composizione:

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

Via di somministrazione:

Intravenous

Confezione:

1 vial

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

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

Dettagli prodotto:

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

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

2017-09-15