Hospira Gemcitabine 200 mg Powder for Solution for Infusion

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

gemcitabine hydrochloride, Quantity: 45.54 mg/mL

Dostupné s:

Hospira Australia Pty Ltd

INN (Mezinárodní Name):

Gemcitabine hydrochloride

Léková forma:

Injection

Složení:

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

Podání:

Intravenous Infusion

Jednotky v balení:

1 x 10 mL

Třída:

Medicine Listed (Export Only)

Druh předpisu:

(S1) This Schedule is intentionally blank

Terapeutické indikace:

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.

Přehled produktů:

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

Stav Autorizace:

Licence status A

Datum autorizace:

2009-07-10