Hospira Gemcitabine 1g Powder for solution for Infusion

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

gemcitabine hydrochloride, Quantity: 45.54 mg/mL

Mevcut itibaren:

Hospira Australia Pty Ltd

INN (International Adı):

Gemcitabine hydrochloride

Farmasötik formu:

Injection

Kompozisyon:

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

Uygulama yolu:

Intravenous Infusion

Paketteki üniteler:

1 x 50 mL

Sınıf:

Medicine Listed (Export Only)

Reçete türü:

(S1) This Schedule is intentionally blank

Terapötik endikasyonlar:

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.

Ürün özeti:

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

Yetkilendirme durumu:

Listed (Export Only)

Yetkilendirme tarihi:

2009-07-10