Gemcitabine SUN gemcitabine hydrochloride 1200mg/120mL solution for infusion bag

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

gemcitabine hydrochloride, Quantity: 1200 mg

Disponível em:

Sun Pharma ANZ Pty Ltd

DCI (Denominação Comum Internacional):

Gemcitabine hydrochloride

Forma farmacêutica:

Injection, intravenous infusion

Composição:

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

Via de administração:

Intravenous

Unidades em pacote:

1 bag, 5 bags, 10 bags

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

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.

Resumo do produto:

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

Status de autorização:

Licence status A

Data de autorização:

2016-06-10