USA - engelsk - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - levoleucovorin calcium (unii: 778xl6vbs8) (levoleucovorin - unii:990s25980y) - levoleucovorin 50 mg in 5 ml - levoleucovorin for injection 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 levoleucovorin for injection 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. levoleucovorin for injection 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 for injection use in pregnant women. animal reproduction studies have not been conducted with levoleucovorin. levoleucovorin is administered in combination

USA - engelsk - NLM (National Library of Medicine)

amneal pharmaceuticals llc - levoleucovorin calcium (unii: 778xl6vbs8) (levoleucovorin - unii:990s25980y) - levoleucovorin 50 mg - levoleucovorin for injection 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 levoleucovorin for injection 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. levoleucovorin for injection 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 methotr

USA - engelsk - NLM (National Library of Medicine)

mylan institutional llc - levoleucovorin calcium pentahydrate (unii: wa16a5y52x) (levoleucovorin - unii:990s25980y) - levoleucovorin 10 mg in 1 ml - levoleucovorin injection is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid. animal reproduction studies have not been conducted with levoleucovorin. it is not known whether levoleucovorin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. levoleucovorin should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from levoleucovorin, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. [see clinical studies (14).] clinical studies of levoleucovorin in the treatment of osteosarcoma did not include subjects aged 65 and over to determine whether they respond differently from younger subjects. in the ncctg clinical trial of levoleucovo

USA - engelsk - NLM (National Library of Medicine)

amneal pharmaceuticals llc - levoleucovorin calcium (unii: 778xl6vbs8) (levoleucovorin - unii:990s25980y) - levoleucovorin 10 mg in 1 ml - levoleucovorin injection 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 levoleucovorin injection 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. levoleucovorin injection 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 flu

USA - engelsk - NLM (National Library of Medicine)

actavis pharma, inc. - levoleucovorin calcium (unii: 778xl6vbs8) (levoleucovorin - unii:990s25980y) - levoleucovorin 10 mg in 1 ml - levoleucovorin for injection is indicated for: - rescue after high-dose methotrexate therapy in patients with osteosarcoma [see clinical studies ( 14 )] .  - diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination. limitation of use levoleucovorin for injection is not indicated for the treatment of pernicious anemia or megaloblastic anemia secondary to lack of vitamin b12 , because of the risk of progression of neurologic manifestations despite hematologic remission. levoleucovorin 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, which can cause embryo-fetal harm.  refer to methotrexate prescribing information for additional inform

USA - engelsk - NLM (National Library of Medicine)

dr.reddy's laboratories inc - levoleucovorin calcium (unii: 778xl6vbs8) (levoleucovorin - unii:990s25980y) - levoleucovorin injection is a folate analog. levoleucovorin injection rescue is indicated after high-dose methotrexate therapy in osteosarcoma. levoleucovorin injection is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. levoleucovorin injection is indicated for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer. · levoleucovorin injection is not approved for pernicious anemia and megaloblastic anemias secondary to the lack of vitamin b12 .improper use may cause a hematologic remission while neurologic manifestations continue to progress. levoleucovorin injection is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid. pregnancy category c. animal reproduction studies have not been conducted with levoleucovori

USA - engelsk - NLM (National Library of Medicine)

meitheal pharmaceuticals inc - levoleucovorin calcium (unii: 778xl6vbs8) (levoleucovorin - unii:990s25980y) - levoleucovorin for injection 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 levoleucovorin for injection 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. levoleucovorin 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 fluor

USA - engelsk - NLM (National Library of Medicine)

meitheal pharmaceuticals inc. - levoleucovorin calcium (unii: 778xl6vbs8) (levoleucovorin - unii:990s25980y) - levoleucovorin injection 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 levoleucovorin injection 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. levoleucovorin 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 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 levoleucovorin 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 levoleucovorin 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 and over to determine whether they respond differently from younger patients. in the ncctg clinical trial of levoleucovorin 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.

USA - engelsk - NLM (National Library of Medicine)

sandoz inc - levoleucovorin calcium pentahydrate (unii: wa16a5y52x) (levoleucovorin - unii:990s25980y) - levoleucovorin injection is indicated for: limitations of use levoleucovorin injection 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. levoleucovorin 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 injection 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

USA - engelsk - NLM (National Library of Medicine)

ingenus pharmaceuticals, llc - levoleucovorin calcium pentahydrate (unii: wa16a5y52x) (levoleucovorin - unii:990s25980y) - levoleucovorin injection 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 levoleucovorin injection is not indicated for pernicious anemia and megaloblastic anemia secondary to lack of vitamin b12 , because of the risk of progression of neurologic manifestations despite hematologic remission. levoleucovorin 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 injection use in pregnant women. animal reproduction studies have not been conducted with levoleucovorin. levoleucovorin is administered in combination with methotrexate or f