Gemcitabine SUN gemcitabine hydrochloride 2000mg/200mL solution for infusion bag
देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
सार्वजनिक आकलन रिपोर्ट
(PAR)
25-11-2017
अनुरोध भेजा।
सक्रिय संघटक:
gemcitabine hydrochloride, Quantity: 2000 mg
थमां उपलब्ध:
Sun Pharma ANZ Pty Ltd
INN (इंटरनेशनल नाम):
Gemcitabine hydrochloride
फार्मास्यूटिकल फॉर्म:
Injection, intravenous infusion
रचना:
Excipient Ingredients: sodium chloride; sodium hydroxide; hydrochloric acid; water for injections
प्रशासन का मार्ग:
Intravenous
पैकेज में यूनिट:
1 bag, 5 bags, 10 bags
प्रिस्क्रिप्शन प्रकार:
(S4) Prescription Only Medicine
चिकित्सीय संकेत:
Gemcitabine SUN 10mg/ml solution for infusion is indicated for treatment of patients with locally advanced or metastatic non-small cell lung cancer. Gemcitabine SUN 10mg/ml solution for infusion is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Gemcitabine SUN 10mg/ml solution for infusion is also indicated for patients with 5-FU refractory pancreatic cancer. Gemcitabine SUN 10mg/ml solution for infusion, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. Gemcitabine SUN 10mg/ml solution for infusion, 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 SUN 10mg/ml solution for infusion, 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.
उत्पाद समीक्षा:
Visual Identification: Clear colourless solution in infusion bag with Tube Polyolefins, and minitulip infusion bag stopper; Container Type: Bag; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
प्राधिकरण का दर्जा:
Licence status A
प्राधिकरण की तारीख:
2016-06-10
