Gemcitabine SUN gemcitabine hydrochloride 2200mg/200mL solution for infusion bag

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

지금 구매하세요

공공 평가 보고서 공공 평가 보고서 (PAR)
25-11-2017

유효 성분:

gemcitabine hydrochloride, Quantity: 2200 mg

제공처:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Gemcitabine hydrochloride

약제 형태:

Injection, intravenous infusion

구성:

Excipient Ingredients: sodium chloride; sodium hydroxide; hydrochloric acid; water for injections

관리 경로:

Intravenous

패키지 단위:

1 bag, 5 bags, 10 bags

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Gemcitabine SUN 10mg/ml solution for infusion is indicated for treatment of patients with locally advanced or metastatic non-small cell lung cancer. Gemcitabine SUN 10mg/ml solution for infusion is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Gemcitabine SUN 10mg/ml solution for infusion is also indicated for patients with 5-FU refractory pancreatic cancer. Gemcitabine SUN 10mg/ml solution for infusion, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. Gemcitabine SUN 10mg/ml solution for infusion, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated. Gemcitabine SUN 10mg/ml solution for infusion, in combination with carboplatin, is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

제품 요약:

Visual Identification: Clear colourless solution in infusion bag with Tube Polyolefins, and minitulip infusion bag stopper; Container Type: Bag; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Licence status A

승인 날짜:

2016-06-10