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

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

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

Διαθέσιμο από:

Juno Pharmaceuticals Pty Ltd

INN (Διεθνής Όνομα):

Gemcitabine hydrochloride

Φαρμακοτεχνική μορφή:

Injection, powder for

Σύνθεση:

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

Οδός χορήγησης:

Intravenous

Μονάδες σε πακέτο:

1 vial

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2012-04-17