Australia - English - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - gemcitabine hydrochloride, quantity: 1138.6 mg (equivalent: gemcitabine, qty 1000 mg) - injection, powder for - excipient ingredients: hydrochloric acid; sodium acetate; sodium hydroxide; mannitol - gemcitabine kabi is indicated for, the treatment of patients with locally advanced or metastatic non-small cell lung cancer. treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer. alone or in combination with cisplatin, for the treatment of patients with bladder cancer. 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. in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - gemcitabine hydrochloride, quantity: 227.72 mg (equivalent: gemcitabine, qty 200 mg) - injection, powder for - excipient ingredients: mannitol; sodium acetate; hydrochloric acid; sodium hydroxide - gemcitabine kabi is indicated for, the treatment of patients with locally advanced or metastatic non-small cell lung cancer. treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer. alone or in combination with cisplatin, for the treatment of patients with bladder cancer. 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. in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - gemcitabine hydrochloride (unii: u347pv74il) (gemcitabine - unii:b76n6sbz8r) - gemcitabine 2 g in 50 ml - gemcitabine for injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. gemcitabine for injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. gemcitabine for injection in combination with cisplatin is indicated for the first-line treatment of patients with inoperable, locally advanced (stage iiia or iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc). gemcitabine for injection is indicated as first-line treatment for patients with locally advanced (nonresectable stage ii or stage iii) or metastatic (stage iv) adenocarcinoma of the pancreas. gemcitabine for injection is indicated for patients previously treated with fluorouracil. gemcitabine for injection is contrain

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - emtricitabine, quantity: 200 mg; tenofovir disoproxil succinate, quantity: 300.6 mg - tablet, film coated - excipient ingredients: macrogol 3350; indigo carmine aluminium lake; magnesium stearate; isopropyl alcohol; polyvinyl alcohol; microcrystalline cellulose; titanium dioxide; lactose monohydrate; purified talc; croscarmellose sodium; purified water; pregelatinised maize starch - treatment of hiv-1 infection,tenofovir/emtricitabine sandoz is indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents.,pre-exposure prophylaxis,tenofovir/emtricitabine sandoz is indicated in combination with safer sex practices for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 in adults at high risk. this indication is based on clinical trials in men who have sex with men (msm) at high risk for hiv-1 infection and in heterosexual serodiscordant couples (see section 5.1 pharmacodynamic properties, clinical trials).

Australia - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - capecitabine -

Australia - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - capecitabine -

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - cytarabine 100 mg/ml - solution for injection - 100 mg/ml - active: cytarabine 100 mg/ml excipient: water for injection - cytarabine is indicated primarily for: · induction and maintenance of remission in acute myelocytic leukaemia of both adults and children. it has also been found to be useful in the treatment of other leukaemias such as · acute lymphocytic leukaemia · chronic myelocytic leukaemia (blast phase). cytarabine may be used alone or in combination with other antineoplastic agents, the best results are often obtained with combination therapy. children with non-hodgkin's lymphoma have benefited from a combination drug program (lsa2l2) that includes cytarabine. remissions induced by cytarabine not followed by maintenance treatment have been brief. maintenance therapy has extended these and provided useful and comfortable remissions with relatively little toxicity. cytarabine has been used intrathecally in meningeal leukaemia. focal leukaemic involvement of the central nervous system may not respond to intrathecal cytarabine and may better be treated with radiotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - cytarabine 20 mg/ml - solution for injection - 20 mg/ml - active: cytarabine 20 mg/ml excipient: sodium chloride water for injection - cytarabine is indicated primarily for: · induction and maintenance of remission in acute myelocytic leukaemia of both adults and children. it has also been found to be useful in the treatment of other leukaemias such as · acute lymphocytic leukaemia · chronic myelocytic leukaemia (blast phase). cytarabine may be used alone or in combination with other antineoplastic agents, the best results are often obtained with combination therapy. children with non-hodgkin's lymphoma have benefited from a combination drug program (lsa2l2) that includes cytarabine. remissions induced by cytarabine not followed by maintenance treatment have been brief. maintenance therapy has extended these and provided useful and comfortable remissions with relatively little toxicity. cytarabine has been used intrathecally in meningeal leukaemia. focal leukaemic involvement of the central nervous system may not respond to intrathecal cytarabine and may better be treated with radiotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - fludarabine phosphate 25 mg/ml - concentrate for injection - 25 mg/ml - active: fludarabine phosphate 25 mg/ml excipient: dibasic sodium phosphate dihydrate sodium hydroxide water for injection - fludarabine ebewe is indicated for the treatment of b-cell chronic lymphocytic leukaemia.

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi oncology plc - capecitabine - film coated tablet - 500 milligram - capecitabine