Hospira Gemcitabine 1g Powder for solution for Infusion

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

gemcitabine hydrochloride, Quantity: 45.54 mg/mL

Tersedia dari:

Hospira Australia Pty Ltd

INN (Nama Internasional):

Gemcitabine hydrochloride

Bentuk farmasi:

Injection

Komposisi:

Excipient Ingredients: mannitol; sodium acetate trihydrate; water for injections; hydrochloric acid; sodium hydroxide

Rute administrasi :

Intravenous Infusion

Unit dalam paket:

1 x 50 mL

Kelas:

Medicine Listed (Export Only)

Jenis Resep:

(S1) This Schedule is intentionally blank

Indikasi Terapi:

Locally advanced or metastatic bladder cancer in combination with other cytostatic medicinal products. - Locally advanced or metastatic breast cancer in combination with paclitaxel in patients experiencing a relapse after adjuvant/neoadjuvant chemotherapy. The preceding chemotherapy should have included an anthracycline unless clinically contraindicated. - Locally advanced or metastatic non-small cell lung cancer in combination with other cytostatic medicinal products. Palliative treatment of adult patients with locally advanced or metastatic nonsmall cell lung cancer. - Locally advanced or metastatic adenocarcinoma of the pancreas in patients who are in good general condition with adequate bone marrow reserves. Patients with 5-fluorouracil refractory pancreatic cancer.

Ringkasan produk:

Visual Identification: A clear solution practically free from foreign particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status otorisasi:

Listed (Export Only)

Tanggal Otorisasi:

2009-07-10