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

fresenius kabi usa, llc - gemcitabine hydrochloride (unii: u347pv74il) (gemcitabine - unii:b76n6sbz8r) - gemcitabine 200 mg in 5.26 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 contraind

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

fresenius kabi usa, llc - gemcitabine hydrochloride (unii: u347pv74il) (gemcitabine - unii:b76n6sbz8r) - gemcitabine 200 mg in 5.26 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 contraind

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - gemcitabine hydrochloride 1140mg equivalent to 1000 mg gemcitabine;  ;   - powder for injection - 1000 mg - active: gemcitabine hydrochloride 1140mg equivalent to 1000 mg gemcitabine     excipient: mannitol nitrogen sodium acetate as sodium acetate trihydrate sodium hydroxide - non-small cell lung cancer: gemcitabine ebewe, alone or in combination with cisplatin, is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer.

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

pfizer australia pty ltd - gemcitabine hydrochloride, quantity: 2.277 g - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide - dbl gemcitabine injection is indicated: 1. for treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc). 2. for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. 3. for treatment of patients with fu refractory pancreatic cancer. 4. alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. 5. in combination with paclitaxel, 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. 6. 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)

pfizer australia pty ltd - gemcitabine hydrochloride, quantity: 1.139 g - injection, solution - excipient ingredients: hydrochloric acid; sodium hydroxide; water for injections - dbl gemcitabine injection is indicated: 1. for treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc). 2. for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. 3. for treatment of patients with fu refractory pancreatic cancer. 4. alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. 5. in combination with paclitaxel, 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. 6. 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)

pfizer australia pty ltd - gemcitabine hydrochloride, quantity: 227.7 mg - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide - dbl gemcitabine injection is indicated: 1. for treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc). 2. for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. 3. for treatment of patients with fu refractory pancreatic cancer. 4. alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. 5. in combination with paclitaxel, 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. 6. 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)

athenex pharmaceutical division, llc. - gemcitabine hydrochloride (unii: u347pv74il) (gemcitabine - unii:b76n6sbz8r) - gemcitabine 200 mg in 5 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 contraindicated in patients with a known hypersensitivity to gemcitabine. reactions include anaphylaxis [see adverse reactions ( 6.1)]. risk summary based on animal data and its mechanism of action, gemcitabine for injection can cause fetal harm when administered to a pregnant woman [see clinical pharmacology ( 12.1)] . there are no available data on the use of gemcitabine for injection in pregnant women. in animal reproduction studies, gemcitabine was teratogenic, embryotoxic, and fetotoxic in mice and rabbits (see data) . advise pregnant women of the potential risk to a fetus [see use in special populations ( 8.3)] . in the u.s. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively. data animal data gemcitabine is embryotoxic in mice. daily dosing of gemcitabine to pregnant mice increased the incidence of fetal malformation (cleft palate, incomplete ossification) at doses of 1.5 mg/kg/day [approximately 0.005 times the 1000 mg/m 2 clinical dose based on body surface area (bsa)]. gemcitabine was embryotoxic and fetotoxic in rabbits. daily dosing of gemcitabine to pregnant rabbits resulted in fetotoxicity (decreased fetal viability, reduced litter sizes, and developmental delays) and increased the incidence of fetal malformations (fused pulmonary artery, absence of gall bladder) at doses of 0.1 mg/kg/day (approximately 0.002 times the 1000 mg/m 2 clinical dose based on bsa). risk summary there is no information regarding the presence of gemcitabine for injection or its metabolites in human milk, or their effects on the breastfed infant or on milk production. due to the potential for serious adverse reactions in breastfed infants from gemcitabine for injection, advise women not to breastfeed during treatment with gemcitabine for injection and for at least one week following the last dose. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating gemcitabine for injection [see use in specific populations ( 8.1)] . contraception gemcitabine for injection can cause fetal harm when administered to a pregnant woman [see use in specific populations ( 8.1)]. females because of the potential for genotoxicity, advise females of reproductive potential to use effective contraception during treatment with gemcitabine for injection and for 6 months after the final dose of gemcitabine for injection. males because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with gemcitabine for injection and for 3 months after the final dose [see nonclinical toxicology ( 13.1)] . infertility males based on animal studies, gemcitabine for injection may impair fertility in males of reproductive potential [see nonclinical toxicology ( 13.1)] . it is not known whether these effects on fertility are reversible. the safety and effectiveness of gemcitabine for injection have not been established in pediatric patients. the safety and pharmacokinetics of gemcitabine were evaluated in a trial in pediatric patients with refractory leukemia. the maximum tolerated dose was 10 mg/m 2 /min for 360 minutes weekly for three weeks followed by a one-week rest period. the safety and activity of gemcitabine for injection were evaluated in a trial of pediatric patients with relapsed acute lymphoblastic leukemia (22 patients) and acute myelogenous leukemia (10 patients) at a dose of 10 mg/m 2 /min administered over 360 minutes weekly for three weeks followed by a one-week rest period. patients with m1 or m2 bone marrow on day 28 who did not experience unacceptable toxicity were eligible to receive a maximum of one additional four-week course. toxicities observed included myelosuppression, febrile neutropenia, increased serum transaminases, nausea, and rash/desquamation. no meaningful clinical activity was observed in this trial. in clinical studies which enrolled 979 patients with various malignancies who received single agent gemcitabine for injection, no overall differences in safety were observed between patients aged 65 and older and younger patients, with the exception of a higher rate of grade 3-4 thrombocytopenia in older patients as compared to younger patients. in a randomized trial in women with ovarian cancer (study 1), 175 women received gemcitabine for injection with carboplatin, of which 29% were age 65 years or older. similar effectiveness was observed between older and younger women. there was significantly higher grade 3-4 neutropenia in women 65 years of age or older [see dosage and administration ( 2.1)] . gemcitabine for injection clearance is affected by age; however, there are no recommended dose adjustments based on patients' age [see clinical pharmacology ( 12.3)]. gemcitabine for injection clearance is decreased in females [see clinical pharmacology ( 12.3)] . in single agent studies of gemcitabine for injection, women, especially older women, were more likely not to proceed to a subsequent cycle and to experience grade 3-4 neutropenia and thrombocytopenia [see dosage and administration ( 2.1, 2.2, 2.3, 2.4)] .

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

dr reddys laboratories australia pty ltd - gemcitabine hydrochloride, quantity: 227.71 mg (equivalent: gemcitabine, qty 200 mg) - injection, powder for - excipient ingredients: sodium acetate trihydrate; hydrochloric acid; sodium hydroxide; mannitol - gemcitabine drla is indicated for treatment of patients with locally advanced or metastatic non-small cell lung cancer. ,gemcitabine drla is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. ,gemcitabine drla is also indicated for patients with 5-fu refractory pancreatic cancer. ,gemcitabine, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. ,gemcitabine drla 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 drla 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.

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

dr reddys laboratories australia pty ltd - gemcitabine hydrochloride, quantity: 1138.52 mg (equivalent: gemcitabine, qty 1000 mg) - injection, powder for - excipient ingredients: hydrochloric acid; sodium hydroxide; sodium acetate trihydrate; mannitol - gemcitabine drla is indicated for treatment of patients with locally advanced or metastatic non-small cell lung cancer. ,gemcitabine drla is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. gemcitabine drla is also indicated for patients with 5-fu refractory pancreatic cancer. ,gemcitabine alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. ,gemcitabine drla 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 drla 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.

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

dr reddys laboratories australia pty ltd - gemcitabine hydrochloride, quantity: 2277 mg (equivalent: gemcitabine, qty 2000 mg) - injection, powder for - excipient ingredients: hydrochloric acid; mannitol; sodium hydroxide; sodium acetate trihydrate - gemcitabine drla is indicated for treatment of patients with locally advanced or metastatic non-small cell lung cancer. ,gemcitabine drla is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. ,gemcitabine drla is also indicated for patients with 5-fu refractory pancreatic cancer. ,gemcitabine, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. ,gemcitabine drla 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 drla 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.