Hospira Gemcitabine 200 mg Powder for Solution for Infusion

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

ダウンロード 公開評価報告書 (PAR)
29-11-2017

有効成分:

gemcitabine hydrochloride, Quantity: 45.54 mg/mL

から入手可能:

Hospira Australia Pty Ltd

INN(国際名):

Gemcitabine hydrochloride

医薬品形態:

Injection

構図:

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

投与経路:

Intravenous Infusion

パッケージ内のユニット:

1 x 10 mL

クラス:

Medicine Listed (Export Only)

処方タイプ:

(S1) This Schedule is intentionally blank

適応症:

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.

製品概要:

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

認証ステータス:

Licence status A

承認日:

2009-07-10