GETERO gemcitabine (as hydrochloride) 200 mg powder for injection vial

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

公開評価報告書 公開評価報告書 (PAR)
27-11-2017

有効成分:

gemcitabine hydrochloride, Quantity: 228 mg

から入手可能:

Hetero Australia Pty Ltd

INN(国際名):

Gemcitabine hydrochloride

医薬品形態:

Injection, powder for

構図:

Excipient Ingredients: sodium acetate trihydrate; sodium hydroxide; mannitol

投与経路:

Intravenous Infusion

パッケージ内のユニット:

1 vial

処方タイプ:

(S4) Prescription Only Medicine

適応症:

Gemcitabine is indicated for treatment of patients with locally advanced or metastatic non- small cell lung cancer.,Gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Gemcitabine is also indicated for patients with 5-FU refractory pancreatic cancer.,Gemcitabine, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer.,Gemcitabine, 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, 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

製品概要:

Visual Identification: White to off-white lyophilised powder to be reconstituted for intravenous use.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

認証ステータス:

Licence status A

承認日:

2015-03-03