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

leadiant biosciences, inc. - pegademase bovine (unii: hw3h7d91f6) (pegademase bovine - unii:hw3h7d91f6) - pegademase bovine 250 [iu] in 1 ml - adagen® (pegademase bovine) injection is indicated for enzyme replacement therapy for adenosine deaminase (ada) deficiency in patients with severe combined immunodeficiency disease (scid) who are not suitable candidates for – or who have failed – bone marrow transplantation. adagen® (pegademase bovine) injection is recommended for use in infants from birth or in children of any age at the time of diagnosis. adagen® (pegademase bovine) injection is not intended as a replacement for hla identical bone marrow transplant therapy. adagen® (pegademase bovine) injection is also not intended to replace continued close medical supervision and the initiation of appropriate diagnostic tests and therapy (e.g., antibiotics, nutrition, oxygen, gammaglobulin) as indicated for intercurrent illnesses. there is no evidence to support the safety and efficacy of adagen® (pegademase bovine) injection as preparatory or support therapy for bone marrow transplantation. since adagen® (pegademase bovine) injection is admin

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

astellas pharma us, inc. - regadenoson (unii: 2xln4y044h) (regadenoson anhydrous - unii:7axv542lz4) - regadenoson anhydrous 0.08 mg in 1 ml - lexiscan® (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 lexiscan 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 lexiscan 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 reduced fetal body

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

mylan institutional 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: 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 w

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

hf acquisition co llc, dba healthfirst - regadenoson (unii: 2xln4y044h) (regadenoson anhydrous - unii:7axv542lz4) - lexiscan® (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 lexiscan 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 ( 5-5.2)]. 8.1 pregnancy risk summary there are no available data on lexiscan 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 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. 8.2 lactation 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 lexiscan. 8.4 pediatric use safety and effectiveness in pediatric patients have not been established. 8.5 geriatric use of the 1,337 patients receiving lexiscan 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%). 8.6 renal impairment no dose adjustment is needed in patients with renal impairment including patients with end stage renal disease and/or dependent on dialysis [see pharmacokinetics ( 12-12.3)].

European Union - English - EMA (European Medicines Agency)

ge healthcare as  - regadenoson - myocardial perfusion imaging - cardiac therapy - this medicinal product is for diagnostic use only.rapiscan is a selective coronary vasodilator for use as a pharmacological stress agent for radionuclide myocardial perfusion imaging (mpi) in adult patients unable to undergo adequate exercise stress.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

fmc australasia pty ltd - bifenthrin - suspension concentrate - bifenthrin pyrethroid active 100.0 g/l - insecticide - bowling green | carnation | commercial area - general | commercial building/structure - external | commercial building/structure - african black beetle | ants (except red imported fire ant) | aphid | argentine stem weevil | banana flower thrips | bill bug | biting midge | black or black house ant | caterpillar | coastal brown ant | cockroach | corn earworm | cutworm - agrotis spp. | flea | fly | funnel ant | geranium plume moth | greenhouse whitefly | helicoverpa spp. | lawn armyworm | light brown apple moth | longtailed mealy bug | looper | meat ant | mosquito | native budworm or bollworm | paper nest wasp | plague thrips | poinsettia whitefly | sod webworm | spider | stinging ant | subterranean termite | sugar ant | thrips simplex | tick | tick - except paralysis tick | two spotted mite | adult mosquitoes | banded sugar ant | billbug | budworm | corn earworm | cotton bollworm | cotton whitefly | ctenocephalides spp. | gladiolus thrips | grass caterpillar | grass grub | ground fleas | heliothis | la plata weevil | large cockroach | lawn caterpillar | looper | looper caterpillars | madeira ant | native bollworm | native budworm | ochetel

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

rapidscan pharma solutions eu ltd - regadenoson - solution for injection - 80microgram/1ml

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis australia pty ltd - cpcv 1-2 inactivated suspension - misc. vaccines or anti sera - cpcv 1-2 inactivated suspension vaccine-virus active 0.0 undefined - immunotherapy

Singapore - English - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - the brigade standalone system is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (ddd) at one or two contiguous levels in the lumbar spine (l2 to s1). ddd is defined as back pain of dicogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. ddd patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved level(s).the brigade standalone system is intended for use with autograft. the brigade standalone system (lordotic angles 8◦ to 12◦) is a standalone system.patients must have undergone a regimen of at least six(6) months of non-operative treatment prior to being treated with the brigade standalone system.

Singapore - English - HSA (Health Sciences Authority)

nuvasive southeast asia pte. ltd. - orthopaedics - the nuvasive brigade alif plate system is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (t1-l5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (l1-s1) spine instability as a result of: 1. fracture (including dislocation and subluxation) 2. tumor 3. degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 4. scoliosis 5. kyphosis 6. lordosis 7. spinal stenosis 8. failed previous spine surgery