European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - arsenic trioxide - leukemia, promyelocytic, acute - antineoplastic agents - arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with:newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (apl) (white blood cell count, ≤ 10 x 103/μl) in combination with all-trans-retinoic acid (atra)relapsed/refractory acute promyelocytic leukaemia (apl)(previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (pml/rar-alpha) gene.the response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

European Union - English - EMA (European Medicines Agency)

mylan ireland limited - arsenic trioxide - leukemia, promyelocytic, acute - antineoplastic agents - arsenic trioxide mylan is indicated for induction of remission, and consolidation in adult patients with:- newly diagnosed low to intermediate risk acute promyelocytic leukaemia (apl) (white blood cell count, ≤ 10 x 103/μl) in combination with all trans retinoic acid (atra)- relapsed/refractory acute promyelocytic leukaemia (apl) (previous treatment should have included a retinoid and chemotherapy)characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic acid receptor alpha (pml/rar alpha) gene.the response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not beenexamined.

European Union - English - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - arsenic trioxide - leukemia, promyelocytic, acute - antineoplastic agents - arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with:newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (apl) (white blood cell count, ≤ 10 x 10³/μl) in combination with all-trans-retinoic acid (atra)relapsed/refractory apl (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukaemia/retinoic-acid-receptor-alpha (pml/rarα) gene.the response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

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

seroyal usa - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide 6 [hp_x] - indications for the temporary relief of symptoms associated with flu and indigestion indications for the temporary relief of symptoms associated with flu and indigestion directions adults: take five granules three times daily or as recommended by your healthcare practitioner. children: take three granules and follow adult directions.

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

sti 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 for injection 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, 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 2 basis ( see data ). a related trivalent arsenic, sodium arsenite, produced teratogenicity when

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

sagent pharmaceuticals - 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)

zydus lifesciences limited - 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 who are hypersensitive 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 d

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

zydus lifesciences limited - 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 who are hypersensitive 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 d

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