GEMCITABINE AN gemcitabine (as hydrochloride) 2 g powder for injection vial

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
23-11-2017

Aktivna sestavina:

gemcitabine hydrochloride, Quantity: 2.28 g (Equivalent: gemcitabine, Qty 2 g)

Dostopno od:

Juno Pharmaceuticals Pty Ltd

INN (mednarodno ime):

Gemcitabine hydrochloride

Farmacevtska oblika:

Injection, powder for

Sestava:

Excipient Ingredients: sodium hydroxide; sodium acetate; hydrochloric acid; mannitol

Pot uporabe:

Intravenous

Enote v paketu:

1 vial

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

Gemcitabine Injection is indicated for treatment of patients with locally advanced or metastatic non- small cell lung cancer.,Gemcitabine Injection is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Gemcitabine AN for Injection is also indicated for patients with 5-FU refractory pancreatic cancer.,Gemcitabine Injection, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer.,Gemcitabine Injection, 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 Injection, 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: White to off-white solid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Status dovoljenje:

Registered

Datum dovoljenje:

2012-04-17