GETERO gemcitabine (as hydrochloride) 200 mg powder for injection vial

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Beli sekarang

Laporan Penilaian Awam Laporan Penilaian Awam (PAR)
27-11-2017

Bahan aktif:

gemcitabine hydrochloride, Quantity: 228 mg

Boleh didapati daripada:

Hetero Australia Pty Ltd

INN (Nama Antarabangsa):

Gemcitabine hydrochloride

Borang farmaseutikal:

Injection, powder for

Komposisi:

Excipient Ingredients: sodium acetate trihydrate; sodium hydroxide; mannitol

Laluan pentadbiran:

Intravenous Infusion

Unit dalam pakej:

1 vial

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

Gemcitabine is indicated for treatment of patients with locally advanced or metastatic non- small cell lung cancer.,Gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Gemcitabine is also indicated for patients with 5-FU refractory pancreatic cancer.,Gemcitabine, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer.,Gemcitabine, 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, 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

Ringkasan produk:

Visual Identification: White to off-white lyophilised powder to be reconstituted for intravenous use.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Status kebenaran:

Licence status A

Tarikh kebenaran:

2015-03-03