Hospira Gemcitabine for Injection 2 g/vial

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

gemcitabine hydrochloride, Quantity: 45.54 mg/mL

Dostupné z:

Hospira Australia Pty Ltd

INN (Medzinárodný Name):

Gemcitabine hydrochloride

Forma lieku:

Injection

Zloženie:

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

Spôsob podávania:

Intravenous Infusion

Počet v balení:

1 x 100 mL

Trieda:

Medicine Listed (Export Only)

Typ predpisu:

(S1) This Schedule is intentionally blank

Terapeutické indikácie:

Gemcitabine for Injection, USP (gemcitabine hydrochloride) is indicated for the: treatment of patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas to achieve a Clinical Benefit Response (a composite measure of clinical imporvement). Treatment of patients with locally advanced or metastatic non-small lung cancer (NSCLC) as either a single agent or in combination with Cisplatin. Treatment of patients with Stage IV (locally advanced or metastatic) transitional cell carcinoma (TCC) of the bladder in combination with Cisplatin. Treatment, in combination with Paclitaxel, of patients with inresectable, locally recurrent or metastatic breast cancer, who have good performance status and have relapsed following adjuvant anthracycline-based chemotherapy.

Prehľad produktov:

Visual Identification: A clear solution practically free from foreign particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store between 15-30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizácia:

Listed (Export Only)

Dátum Autorizácia:

2009-08-06