Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - capecitabine, quantity: 500 mg - tablet, film coated - excipient ingredients: lactose; magnesium stearate; microcrystalline cellulose; hypromellose; croscarmellose sodium; titanium dioxide; purified talc; iron oxide yellow; iron oxide red - colon cancer ,capecitabine is indicated for the adjuvant treatment of patients with dukes? stage c and high-risk stage b, colon cancer, either as monotherapy or in combination with oxaliplatin.,colorectal cancer,capecitabine is indicated for the treatment of patients with advanced or metastatic colorectal cancer.,oesophagogastric cancer,capecitabine is indicated for the first-line treatment of patients with advanced oesophagogastric cancer in combination with a platinum-based regimen.,breast cancer,capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen unless therapy with these and other standard agents are clinically contraindicated ,capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.

Amerikas Savienotās Valstis - angļu - 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

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

avpak - 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

Amerikas Savienotās Valstis - angļu - 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

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - capecitabine -

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

northstar rxllc - capecitabine (unii: 6804dj8z9u) (capecitabine - unii:6804dj8z9u) - capecitabine 150 mg - - capecitabine tablets, usp 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 was 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 in the adjuvant treatment of dukes' c colon cancer. - capecitabine tablets, usp 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 monotherapy. use of capecitabine tablets, usp instead of 5-fu/lv in combinations has not been adequately studied to assure sa

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

ascend laboratories, 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

Eiropas Savienība - angļu - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - capecitabine - stomach neoplasms; breast neoplasms; colonic neoplasms; colorectal neoplasms - capecitabine - capecitabine is indicated for the adjuvant treatment of patients following surgery of stage-iii (dukes’ stage-c) colon cancer.capecitabine is indicated for the treatment of metastatic colorectal cancer.capecitabine is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. previous therapy should have included an anthracycline. capecitabine is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

Amerikas Savienotās Valstis - angļu - 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

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - 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.