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

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
25-11-2017

Aktivna sestavina:

gemcitabine hydrochloride, Quantity: 2000 mg

Dostopno od:

Sun Pharma ANZ Pty Ltd

INN (mednarodno ime):

Gemcitabine hydrochloride

Farmacevtska oblika:

Injection, intravenous infusion

Sestava:

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

Pot uporabe:

Intravenous

Enote v paketu:

1 bag, 5 bags, 10 bags

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

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.

Povzetek izdelek:

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 dovoljenje:

Licence status A

Datum dovoljenje:

2016-06-10