HERCLON trastuzumab (rch) 150 mg powder for injection vial

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

지금 구매하세요

공공 평가 보고서 공공 평가 보고서 (PAR)
23-11-2017

유효 성분:

Trastuzumab, Quantity: 150 mg

제공처:

Roche Products Pty Ltd

INN (International Name):

Trastuzumab

약제 형태:

Injection, powder for

구성:

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

관리 경로:

Intravenous

패키지 단위:

1 vial

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

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

제품 요약:

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

승인 상태:

Licence status A

승인 날짜:

2017-09-15