Egyesült Államok - angol - NLM (National Library of Medicine)

acrotech biopharma inc - levoleucovorin calcium (unii: 778xl6vbs8) (levoleucovorin - unii:990s25980y) - fusilev is indicated for: • rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. • diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. • the treatment of adults with metastatic colorectal cancer in combination with fluorouracil. limitations of use fusilev is not indicated for pernicious anemia and megaloblastic anemia secondary to the lack of vitamin b12 , because of the risk of progression of neurologic manifestations despite hematologic remission. fusilev is contraindicated in patients who have had severe hypersensitivity to leucovorin products, folic acid or folinic acid [see adverse reactions (6.2)]. risk summary there are limited data with fusilev use in pregnant women. animal reproduction studies have not been conducted with levoleucovorin. levoleucovorin is administered in combination with methotrexate or fluorouracil, which can cause embryo-fetal harm. refer to methotrexate and fluorouracil prescribing information for additional information. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary there are no data on the presence of levoleucovorin in human milk or its effects on the breastfed infant or on milk production. levoleucovorin is administered in combination with methotrexate or fluorouracil. refer to methotrexate and fluorouracil prescribing information for additional information. the safety and effectiveness of fusilev have been established in pediatric patients for rescue after high-dose methotrexate therapy in osteosarcoma and diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination. use of levoleucovorin in pediatric patients is supported by open-label clinical trial data in 16 pediatric patients 6 years of age and older, with additional supporting evidence from literature [see clinical studies (14.1) ]. the safety and effectiveness of fusilev have not been established for the treatment of pediatric patients with advanced metastatic colorectal cancer. - clinical studies of fusilev in the treatment of osteosarcoma did not include patients aged 65 and over to determine whether they respond differently from younger patients.  - in the ncctg clinical trial of fusilev in combination with fluorouracil for the treatment of metastatic colorectal cancer, no overall differences in safety or effectiveness were observed between patients age 65 years and older and younger patients.

Egyesült Államok - angol - NLM (National Library of Medicine)

acrotech biopharma inc - levoleucovorin disodium (unii: 5txq76k65t) (levoleucovorin - unii:990s25980y) - khapzory is indicated for: - rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. - diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination adult and pediatric patients. - the treatment of adults with metastatic colorectal cancer in combination with fluorouracil. limitations of use khapzory is not indicated for pernicious anemia and megaloblastic anemia secondary to lack the of vitamin b12 because of the risk of progression of neurologic manifestations despite hematologic remission. khapzory is contraindicated in patients who have had severe hypersensitivity to leucovorin products, folic acid, or folinic acid [see adverse reactions (6.2)] . risk summary there are limited data with levoleucovorin use in pregnant women. animal reproduction studies have not been conducted with levoleucovorin. levoleucovorin is administered in combination with methotrexate or fluorouracil, which can cause embryo-fetal harm.  refer to methotrexate or fluorouracil prescribing information for additional information. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary there are no data on the presence of levoleucovorin in human milk or its effects on the breastfed infant or on milk production. levoleucovorin is administered in combination with methotrexate or fluorouracil. refer to methotrexate or fluorouracil prescribing information for additional information. the safety and effectiveness of khapzory have been established in pediatric patients for rescue after high-dose methotrexate therapy in osteosarcoma and diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination. use of levoleucovorin in pediatric patients is supported by open-label clinical trial data in 16 pediatric patients 6 years of age and older, with additional supporting evidence from literature [see clinical studies (14.1)] . the safety and effectiveness of khapzory have not been established for the treatment of pediatric patients with advanced metastatic colorectal cancer. clinical studies of levoleucovorin in the treatment of osteosarcoma did not include patients aged 65 years and over to determine whether they respond differently from younger patients. in the ncctg clinical trial of levoleucovorin in combination with fluorouracil in the treatment of metastatic colorectal cancer, adverse reactions were consistent with fluorouracil related toxicity and were similar for patients age 65 years and older and patients younger than 65 [see clinical studies (14.2)] .

Kanada - angol - Health Canada

lederle cyanamid canada inc. - leucovorin (leucovorin calcium) - tablet - 5mg - leucovorin (leucovorin calcium) 5mg - antidotes

Kanada - angol - Health Canada

david bull laboratories (pty) ltd. - leucovorin (leucovorin calcium) - liquid - 10mg - leucovorin (leucovorin calcium) 10mg - antidotes

Kanada - angol - Health Canada

generic medical partners inc - leucovorin (leucovorin calcium) - solution - 200mg - leucovorin (leucovorin calcium) 200mg - antidotes

Kanada - angol - Health Canada

generic medical partners inc - leucovorin (leucovorin calcium) - solution - 1000mg - leucovorin (leucovorin calcium) 1000mg - antidotes

Chile - spanyol - ISPC (Instituto de Salud Pública de Chile)

fresenius kabi chile ltda. - leucovorina - leucovorina calcica 350 mg - el tratamiento con leucovorina está indicado en: -tratamiento de reacciones adversas a drogas e intoxicaciones inducidas por antagonistas de ácido fólico (solamente para inyección). después de terapia con altas dosis de metotrexato, para la protección de células sanas de los efectos tóxicos del metotrexato. -tratamiento de anemia megaloblástica causada por deficiencia de ácido fólico. -tratamiento de cáncer colorrectal avanzado en combinación con 5-fluorouracilo

Chile - spanyol - ISPC (Instituto de Salud Pública de Chile)

fresenius kabi chile ltda. - leucovorina - leucovorina calcica 350 mg - el tratamiento con leucovorina está indicado en: -tratamiento de reacciones adversas a drogas e intoxicaciones inducidas por antagonistas de ácido fólico (solamente para inyección). después de terapia con altas dosis de metotrexato, para la protección de células sanas de los efectos tóxicos del metotrexato. -tratamiento de anemia megaloblástica causada por deficiencia de ácido fólico. -tratamiento de cáncer colorrectal avanzado en combinación con 5-fluorouracilo.

Vietnam - vietnami - BỘ Y TẾ (CỤC QUẢN LÝ DƯỢC)

công ty tnhh dược phẩm việt pháp - leucovorin calcium - dung dịch tiêm - 500mg leucovorin/50ml

Peru - spanyol - DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)

medifarma s.a. - droguerÍa - leucovorina de calcio; - polvo para solucion inyectable - por vial 1.00 vial - - folinato de calcio