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

meitheal pharmaceuticals inc. - regadenoson (unii: 2xln4y044h) (regadenoson anhydrous - unii:7axv542lz4) - regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (mpi) in patients unable to undergo adequate exercise stress. do not administer regadenoson to patients with: - second- or third-degree av block, or - sinus node dysfunction unless these patients have a functioning artificial pacemaker [see warnings and precautions (5.2)]. risk summary there are no available data on regadenoson use in pregnant women to inform a drug-associated risk. in animal reproduction studies, adverse developmental outcomes were observed with the administration of regadenoson to pregnant rats and rabbits during organogenesis only at doses that produced maternal toxicity (see data ). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data reproductive studies in rats showed that regadenoson doses 10 and 20 times the maximum recommended human dose (mrh

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

hospira, inc. - regadenoson anhydrous (unii: 7axv542lz4) (regadenoson anhydrous - unii:7axv542lz4) - regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (mpi) in patients unable to undergo adequate exercise stress. do not administer regadenoson injection to patients with: unless these patients have a functioning artificial pacemaker [see warnings and precautions (5.2)] . risk summary there are no available data on regadenoson injection use in pregnant women to inform a drug-associated risk. in animal reproduction studies, adverse developmental outcomes were observed with the administration of regadenoson to pregnant rats and rabbits during organogenesis only at doses that produced maternal toxicity (see data ). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. data animal data reproductive studies in rats showed that regadenoson doses 10 and 20 times the maximum recommended human dose (mrhd) based on body surface area caused reduce

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

apotex corp. - regadenoson (unii: 2xln4y044h) (regadenoson anhydrous - unii:7axv542lz4) - regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (mpi) in patients unable to undergo adequate exercise stress. do not administer regadenoson injection to patients with: unless these patients have a functioning artificial pacemaker [see warnings and precautions (5.2) ]. risk summary there are no available data on regadenoson use in pregnant women to inform a drug-associated risk. in animal reproduction studies, adverse developmental outcomes were observed with the administration of regadenoson to pregnant rats and rabbits during organogenesis only at doses that produced maternal toxicity (see data). 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.   data animal data reproductive studies in rats showed that regadenoson doses 10 and 20 times the maximum recommended human dose (mrhd) based on body surface area caused reduced

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

international medication systems, limited - regadenoson anhydrous (unii: 7axv542lz4) (regadenoson anhydrous - unii:7axv542lz4) - regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (mpi) in patients unable to undergo adequate exercise stress. do not administer regadenoson injection to patients with: - second- or third-degree av block, or - sinus node dysfunction unless these patients have a functioning artificial pacemaker [see warnings and precautions (5.2) ]. risk summary there are no available data on regadenoson injection use in pregnant women to inform a drug-associated risk. in animal reproduction studies, adverse developmental outcomes were observed with the administration of regadenoson to pregnant rats and rabbits during organogenesis only at doses that produced maternal toxicity (see data ). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data reproductive studies in rats showed that regadenoson doses 10 and 20 times the maximu

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

dr. reddy's laboratories inc. - regadenoson anhydrous (unii: 7axv542lz4) (regadenoson anhydrous - unii:7axv542lz4) - regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (mpi) in patients unable to undergo adequate exercise stress.   do not administer regadenoson injection to patients with: - second- or third-degree av block, or - sinus node dysfunction unless these patients have a functioning artificial pacemaker [see warnings and precautions (5.2)]. risk summary there are no available data on regadenoson use in pregnant women to inform a drug-associated risk. in animal reproduction studies, adverse developmental outcomes were observed with the administration of regadenoson to pregnant rats and rabbits during organogenesis only at doses that produced maternal toxicity (see data). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.   data animal data reproductive studies in rats showed that regadenoson doses 10 and 20 times the maximum recommended h

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

hikma pharmaceuticals usa inc. - regadenoson anhydrous (unii: 7axv542lz4) (regadenoson anhydrous - unii:7axv542lz4) - regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (mpi) in patients unable to undergo adequate exercise stress. do not administer regadenoson injection to patients with: - second- or third-degree av block, or - sinus node dysfunction unless these patients have a functioning artificial pacemaker [see warnings and precautions (5.2) ]. risk summary there are no available data on regadenoson injection use in pregnant women to inform a drug-associated risk. in animal reproduction studies, adverse developmental outcomes were observed with the administration of regadenoson to pregnant rats and rabbits during organogenesis only at doses that produced maternal toxicity (see data ). 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. data animal data reproductive studies in rats showed that regadenoson doses 10 and 20 times the maximum

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

baxter healthcare corporation - regadenoson (unii: 2xln4y044h) (regadenoson anhydrous - unii:7axv542lz4) - regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (mpi) in patients unable to undergo adequate exercise stress. do not administer regadenoson injection to patients with: unless these patients have a functioning artificial pacemaker [see warnings and precautions (5.2) ]. risk summary there are no available data on regadenoson injection use in pregnant women to inform a drug-associated risk. in animal reproduction studies, adverse developmental outcomes were observed with the administration of regadenoson to pregnant rats and rabbits during organogenesis only at doses that produced maternal toxicity (see data ). 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. data animal data reproductive studies in rats showed that regadenoson doses 10 and 20 times the maximum recommended human dose (mrhd) based on body surface area cause

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

almaject, inc. - regadenoson (unii: 2xln4y044h) (regadenoson anhydrous - unii:7axv542lz4) - regadenoson injection  is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (mpi) in patients unable to undergo adequate exercise stress. do not administer regadenoson injection to patients with: ·       second- or third-degree av block, or ·       sinus node dysfunction  unless these patients have a functioning artificial pacemaker [see warnings and precautions (5.2) ] . risk summary there are no available data on regadenoson injection use in pregnant women to inform a drug-associated risk. in animal reproduction studies, adverse developmental outcomes were observed with the administration of regadenoson to pregnant rats and rabbits during organogenesis only at doses that produced maternal toxicity (see data ). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data reproductive studies in rats showed that regadenoson dos

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

gland pharma limited - regadenoson (unii: 2xln4y044h) (regadenoson anhydrous - unii:7axv542lz4) - regadenoson injection  is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (mpi) in patients unable to undergo adequate exercise stress. do not administer regadenoson injection to patients with: ·       second- or third- degree av block, or ·       sinus node dysfunction  unless these patients have a functioning artificial pacemaker [see warnings and precautions (5.2) ]. risk summary there are no available data on regadenoson injection use in pregnant women to inform a drug-associated risk. in animal reproduction studies, adverse developmental outcomes were observed with the administration of regadenoson to pregnant rats and rabbits during organogenesis only at doses that produced maternal toxicity (see data ). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data reproductive studies in rats showed that regadenoson dos

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

eugia us llc - regadenoson (unii: 2xln4y044h) (regadenoson anhydrous - unii:7axv542lz4) - regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (mpi) in patients unable to undergo adequate exercise stress. do not administer regadenoson to patients with: - second- or third-degree av block, or - sinus node dysfunction unless these patients have a functioning artificial pacemaker [see warnings and precautions (5.2)] . risk summary there are no available data on regadenoson use in pregnant women to inform a drug-associated risk. in animal reproduction studies, adverse developmental outcomes were observed with the administration of regadenoson to pregnant rats and rabbits during organogenesis only at doses that produced maternal toxicity (see data ). 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. data animal data reproductive studies in rats showed that regadenoson doses 10 and 20 times the maximum recommended human dose (mrhd) based on body surface area caused reduced fetal body weights and significant ossification delays in fore- and hind limb phalanges and metatarsals; maternal toxicity also occurred at these doses. skeletal variations were increased in all treated groups. in rabbits, maternal toxicity occurred at regadenoson doses administered during organogenesis at 4 times the mrhd; however, there were no teratogenic effects in offspring at this dose. at higher doses, 12 and 20 times the mrhd, maternal toxicity occurred along with increased embryo-fetal loss and fetal malformations. risk summary there is no information on the presence of regadenoson in human milk, the effects on the breastfed infant, or the effects on milk production. because of the potential risk of serious cardiac reactions in the breastfed infant, advise the nursing mother to pump and discard breast milk for 10 hours after administration of regadenoson. safety and effectiveness in pediatric patients have not been established. of the 1,337 patients receiving regadenoson in studies 1 and 2, 56% were 65 years of age and over and 24% were 75 years of age and over. older patients (≥ 75 years of age) had a similar adverse event profile compared to younger patients (< 65 years of age), but had a higher incidence of hypotension (2% vs. ≤ 1%). no dose adjustment is needed in patients with renal impairment including patients with end stage renal disease and/or dependent on dialysis [see pharmacokinetics (12.3)].