Hospira Gemcitabine 200 mg Powder for Solution for Infusion

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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Download 공공 평가 보고서 (PAR)
29-11-2017

유효 성분:

gemcitabine hydrochloride, Quantity: 45.54 mg/mL

제공처:

Hospira Australia Pty Ltd

INN (국제 이름):

Gemcitabine hydrochloride

약제 형태:

Injection

구성:

Excipient Ingredients: mannitol; sodium acetate trihydrate; water for injections; sodium hydroxide; hydrochloric acid

관리 경로:

Intravenous Infusion

패키지 단위:

1 x 10 mL

수업:

Medicine Listed (Export Only)

처방전 유형:

(S1) This Schedule is intentionally blank

치료 징후:

Locally advanced or metastatic bladder cancer in combination with other cytostatic medicinal products. - Locally advanced or metastatic breast cancer in combination with paclitaxel in patients experiencing a relapse after adjuvant/neoadjuvant chemotherapy. The preceding chemotherapy should have included an anthracycline unless clinically contraindicated. - Locally advanced or metastatic non-small cell lung cancer in combination with other cytostatic medicinal products. Palliative treatment of adult patients with locally advanced or metastatic nonsmall cell lung cancer. - Locally advanced or metastatic adenocarcinoma of the pancreas in patients who are in good general condition with adequate bone marrow reserves. Patients with 5-fluorouracil refractory pancreatic cancer.

제품 요약:

Visual Identification: A clear solution practically free from foreign particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

승인 상태:

Licence status A

승인 날짜:

2009-07-10