HERCLON trastuzumab (rch) 150 mg powder for injection vial

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

Trastuzumab, Quantity: 150 mg

Disponible depuis:

Roche Products Pty Ltd

DCI (Dénomination commune internationale):

Trastuzumab

forme pharmaceutique:

Injection, powder for

Composition:

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

Mode d'administration:

Intravenous

Unités en paquet:

1 vial

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

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

Descriptif du produit:

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

Statut de autorisation:

Licence status A

Date de l'autorisation:

2017-09-15