Gemcitabine SUN gemcitabine hydrochloride 2000mg/200mL solution for infusion bag

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

gemcitabine hydrochloride, Quantity: 2000 mg

זמין מ:

Sun Pharma ANZ Pty Ltd

INN (שם בינלאומי):

Gemcitabine hydrochloride

טופס פרצבטיות:

Injection, intravenous infusion

הרכב:

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

מסלול נתינה (של תרופות):

Intravenous

יחידות באריזה:

1 bag, 5 bags, 10 bags

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

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.

leaflet_short:

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

מצב אישור:

Licence status A

תאריך אישור:

2016-06-10