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)

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)

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)

orbicular pharmaceutical technologies private 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 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 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 equiv

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

cephalon, inc. - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide 1 mg in 1 ml - trisenox is indicated in combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (apl) whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. trisenox 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. trisenox is contraindicated in patients who are hypersensitive to arsenic. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animal studies, trisenox 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 arsen

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

cephalon, llc - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide 2 mg in 1 ml - trisenox is indicated in combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (apl) whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. trisenox 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. trisenox 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, trisenox 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 arsen

Canada - English - Health Canada

sterimax inc - arsenic trioxide - solution - 1mg - arsenic trioxide 1mg - antineoplastic agents

Canada - English - Health Canada

phebra pty ltd - arsenic trioxide - solution - 10mg - arsenic trioxide 10mg - antineoplastic agents

Canada - English - Health Canada

auro pharma inc - arsenic trioxide - solution - 2mg - arsenic trioxide 2mg

Australia - English - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - arsenic trioxide, quantity: 10 mg - injection, concentrated - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid - for the induction of remission and consolidation in patients with acute promyelocytic leukaemia (apl) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterised by the presence of the t(15:17) translocation or pml/rar-alpha gene expression.,for the induction of remission and consolidation in patients with previously untreated acute promyelocytic leukaemia (apl) in combination with all-trans retinoic acid (atra) and/or chemotherapy and whose apl is characterised by the presence of the t(15:17) translocation or pml/rar-alpha gene expression.