加拿大 - 英文 - Health Canada

sandoz canada incorporated - gemcitabine (gemcitabine hydrochloride) - solution - 40mg - gemcitabine (gemcitabine hydrochloride) 40mg - antineoplastic agents

加拿大 - 英文 - Health Canada

accord healthcare inc - gemcitabine (gemcitabine hydrochloride) - solution - 100mg - gemcitabine (gemcitabine hydrochloride) 100mg - antineoplastic agents

加拿大 - 英文 - Health Canada

apotex inc - gemcitabine (gemcitabine hydrochloride) - solution - 38mg - gemcitabine (gemcitabine hydrochloride) 38mg - antineoplastic agents

美国 - 英文 - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - capecitabine (unii: 6804dj8z9u) (capecitabine - unii:6804dj8z9u) - capecitabine 150 mg - capecitabine is indicated for the: capecitabine is indicated for the adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen. capecitabine is contraindicated in patients with history of severe hypersensitivity reaction to fluorouracil or capecitabine [see adverse reactions ( 6.1)] . risk summary: based on findings in animal reproduction studies and its mechanism of action [see clinical pharmacology (12.1)] , capecitabine can cause fetal harm when administered to a pregnant woman. available human data with capecitabine use in pregnant women is not sufficient to inform the drug-associated risk. in animal reproduction studies, administration of capecitabine to pregnant animals during the period of organogenesis caused embryolethality and teratogenicity in mice and embryolethality in monkeys at 0.2 and 0.6 times the exposure (auc) in patients receiving the recommended dose of 1,250 mg/m2 twice daily, respectively (see data) . advise pregnant women of the

美国 - 英文 - NLM (National Library of Medicine)

amneal pharmaceuticals llc - capecitabine (unii: 6804dj8z9u) (capecitabine - unii:6804dj8z9u) - capecitabine 150 mg - capecitabine tablets are indicated for the: - adjuvant treatment of patients with stage iii colon cancer as a single agent or as a component of a combination chemotherapy regimen. - perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. - treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. capecitabine tablets are indicated for the: - treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated. - treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy. capecitabine tablets are indicated for the: - treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen. - trea

美国 - 英文 - NLM (National Library of Medicine)

mylan institutional llc - gemcitabine hydrochloride (unii: u347pv74il) (gemcitabine - unii:b76n6sbz8r) - gemcitabine 200 mg in 5 ml - gemcitabine 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 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 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 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 is indicated for patients previously treated with fluorouracil. gemcitabine is contraindicated in patients with a known hypersensitivity to gemcitabine. reactions include a

美国 - 英文 - NLM (National Library of Medicine)

accord healthcare inc. - 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 contraind

美国 - 英文 - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - tiagabine hydrochloride (unii: dqh6t6d8oy) (tiagabine - unii:z80i64hmnp) - tiagabine hydrochloride 2 mg - tiagabine hcl is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures. tiagabine hcl is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. the abuse and dependence potential of tiagabine hcl have not been evaluated in human studies.

美国 - 英文 - NLM (National Library of Medicine)

mylan institutional inc. - capecitabine (unii: 6804dj8z9u) (capecitabine - unii:6804dj8z9u) - capecitabine 500 mg - - capecitabine tablets are indicated as a single agent for adjuvant treatment in patients with dukes’ c colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. capecitabine tablets were non-inferior to 5-fluorouracil and leucovorin (5-fu/lv) for disease-free survival (dfs). physicians should consider results of combination chemotherapy trials, which have shown improvement in dfs and os, when prescribing single-agent capecitabine tablets in the adjuvant treatment of dukes’ c colon cancer. - capecitabine tablets are indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. combination chemotherapy has shown a survival benefit compared to 5-fu/lv alone. a survival benefit over 5-fu/lv has not been demonstrated with capecitabine tablets monotherapy. use of capecitabine tablets instead of 5-fu/lv in combinations has not been adequately studied to

美国 - 英文 - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - capecitabine (unii: 6804dj8z9u) (capecitabine - unii:6804dj8z9u) - capecitabine 150 mg - capecitabine tablets are contraindicated in patients with severe renal impairment (creatinine clearance below 30 ml/min [cockroft and gault]) [see use in specific populations (8.7) and clinical pharmacology (12.3)] . capecitabine tablets are contraindicated in patients with known hypersensitivity to capecitabine or to any of its components. capecitabine tablets are contraindicated in patients who have a known hypersensitivity to 5-fluorouracil. based on findings in animal reproduction studies and its mechanism of action,capecitabine tablets can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . limited available human data are not sufficient to inform the drug-associated risk during pregnancy. in animal reproduction studies, administration of capecitabine to pregnant animals during the period of organogenesis caused embryo lethality and teratogenicity in mice and embryo lethality in monkeys at 0.2 and 0.6 times the exposure (auc) in patients receiving the recommended