Gemcitabine SUN gemcitabine hydrochloride 1600mg/160mL solution for infusion bag

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

gemcitabine hydrochloride, Quantity: 1600 mg

Disponible des:

Sun Pharma ANZ Pty Ltd

Designació comuna internacional (DCI):

Gemcitabine hydrochloride

formulario farmacéutico:

Injection, intravenous infusion

Composición:

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

Vía de administración:

Intravenous

Unidades en paquete:

1 bag, 5 bags, 10 bags

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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.

Resumen del producto:

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

Estat d'Autorització:

Licence status A

Data d'autorització:

2016-06-10