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

ingenus pharmaceuticals, llc - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with apl who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide injection is contraindicated in patients with hypersensitivity to arsenic. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animal studies, arsenic trioxide injection can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m  basis (see data) . a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m  basis and in hamsters at an intravenous dose approximat

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

zydus pharmaceuticals usa inc. - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (apl) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide is contraindicated in patients with hypersensitivity to arsenic. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animal studies, arsenic trioxide can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m2 basis (see data) . a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m2 basis and in hamsters at an intravenous do

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

nexus pharmaceuticals inc - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with apl who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide injection is contraindicated in patients with hypersensitivity to arsenic. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animal studies, arsenic trioxide injection can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m² basis (see data). a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m² basis and in hamsters at an intravenous dose approximat

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

amring pharmaceuticals inc. - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with apl who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide is contraindicated in patients with hypersensitivity to arsenic. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animal studies, arsenic trioxide can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m2 basis (see data). a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m2 basis and in hamsters at an intravenous dose approximately equivalent to

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

zydus pharmaceuticals usa inc. - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (apl) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide is contraindicated in patients with hypersensitivity to arsenic. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animal studies, arsenic trioxide can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m2 basis (see data) . a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m2 basis and in hamsters at an intravenous do

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

ingenus pharmaceuticals, llc - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with apl who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide injection is contraindicated in patients with hypersensitivity to arsenic.   risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animal studies, arsenic trioxide injection can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m2 basis (see data) . a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m2 basis and in hamsters at an intravenous dose approx

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

gland pharma limited - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with apl who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide is contraindicated in patients with hypersensitivity to arsenic. risk summary based on the mechanism of action [see clinical pharmacology (12.1)]  and findings in animal studies, arsenic trioxide can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m² basis (see data ). a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m² basis and in hamsters at an intravenous dose approximately equivalent to th

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

auromedics pharma llc - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with apl who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide is contraindicated in patients with hypersensitivity to arsenic. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animal studies, arsenic trioxide can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m² basis (see data ). a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m² basis and in hamsters at an intravenous dose approximately equivalen

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

sandoz inc - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (apl) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide is contraindicated in patients with hypersensitivity to arsenic. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animal studies, arsenic trioxide can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m² basis (see data) . a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m² basis and in hamsters at an intravenous dose

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

zydus pharmaceuticals usa inc. - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (apl) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide is contraindicated in patients with hypersensitivity to arsenic. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animal studies, arsenic trioxide can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m2 basis (see data) . a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m2 basis and in hamsters at an intravenous do