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

bayer healthcare pharmaceuticals inc. - iopromide (unii: 712bac33mz) (iopromide - unii:712bac33mz) - iodine 240 mg in 1 ml - ultravist® injection is an iodinated contrast agent indicated for: *for information on the concentrations and doses for the pediatric population [see dosage and administration (2.3) and use in specific populations (8.4)]. risk summary there are no data on ultravist injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. iopromide crosses the placenta and reaches fetal tissues in small amounts (see data). in animal reproduction studies, intravenous administration of iopromide to pregnant rats and rabbits during organogenesis at doses up to 0.35 and 0.7 times, respectively, the maximum recommended human dose based on body surface area resulted in no relevant adverse developmental effects (see data). . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. in the u.s. general p

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

food and drug administration - iopromide (unii: 712bac33mz) (iopromide - unii:712bac33mz) -

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

bayer healthcare pharmaceuticals inc. - iopromide (unii: 712bac33mz) (iopromide - unii:712bac33mz) - ultravist® injection is an iodinated contrast agent indicated in adults pediatric patients for use only with an automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this imaging bulk package. risk summary there are no data on ultravist injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. iopromide crosses the placenta and reaches fetal tissues in small amounts (see data). in animal reproduction studies, intravenous administration of iopromide to pregnant rats and rabbits during organogenesis at doses up to 0.35 and 0.7 times, respectively, the maximum recommended human dose based on body surface area resulted in no relevant adverse developmental effects (see data). . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of

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

bayer healthcare pharmaceuticals inc. - iopromide (unii: 712bac33mz) (iopromide - unii:712bac33mz) - ultravist® injection is an iodinated contrast agent indicated for: ultravist is indicated for: ultravist is indicated for: † specific concentrations and presentations of ultravist are recommended for each type of imaging procedure [see dosage and administration ( 2.2, 2.3, 2.4)]. there are no data on ultravist use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. iopromide crosses the placenta and reaches fetal tissues in small amounts (see data) . in animal reproduction studies, intravenous administration of iopromide to pregnant rats and rabbits during organogenesis at doses up to0.35 and 0.7 times, respectively, the maximum recommended human dose based on body surface area resulted in no relevant adverse developmental effects (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defects, loss, or other advers

Israel - English - Ministry of Health

bayer israel ltd - iopromide - solution for injection - iopromide 623.4 mg / 1 ml - iopromide - iopromide - contrast enhancement in computerized tomography (ct) , digital subtraction angiography (dsa), intravenous urography, arteriography ,phlebography of the extremities, venography, visualization of body cavities (e.g. arthrography, hysterosalpingography,fistulography) with the exception of myelography, ventriculography, cisternography.

Israel - English - Ministry of Health

bayer israel ltd - iopromide - solution for injection - iopromide 768.86 mg/ml - iopromide - iopromide - contrast enhancement in computerized tomography (ct) , digital subtraction angiography (dsa), intravenous urography, arteriography and especially angiocardiography, visualization of body cavities (e.g. arthrography, fistulography) with the exception of myelography, ventriculography, cisternography.

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

bayer east africa limited, kenya - iopromide - injectable solution - iopromide 623 mg/ml equivalent to iodine 300 mg

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

bayer australia ltd - iopromide, quantity: 498.72 mg/ml - injection, solution - excipient ingredients: water for injections; trometamol; sodium calcium edetate; dilute hydrochloric acid; sodium hydroxide - indications: ultravist is indicted for all angiographic and urographic examinations and for contrast enhancements in computerised tomography. ultravist 240 is additionally indicated for lumbar myelography in adults.

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

bayer australia ltd - iopromide, quantity: 498.72 mg/ml - injection, solution - excipient ingredients: dilute hydrochloric acid; water for injections; trometamol; sodium calcium edetate; sodium hydroxide - indications: ultravist is indicated for all angiographic and urographic examinations and for contrast enhancements in computerised tomography. ultravist 240 is additionally indicated for lumbar myelography in adults.

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

bayer australia ltd - iopromide, quantity: 623.4 mg/ml - injection - excipient ingredients: trometamol; sodium calcium edetate; water for injections; dilute hydrochloric acid; sodium hydroxide - all angiographic and urographic examinations and for contrast enhancement in computerised tomography.