Egyesült Államok - angol - NLM (National Library of Medicine)

american health packaging - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol tablets 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cholangitis (pbc). patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. risk summary available published data on the use of ursodiol in pregnant women derived from randomized controlled trials, observational studies, and case series collected over several decades have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. most of the reported exposures to ursodiol occurred in the second and third trimester of pregnancy. in animal reproduction studies, ursodiol had no adverse effects on embryo-fetal development when administered at doses greater than human therapeutic doses (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 defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data no adverse effects on embryo-fetal development were observed with oral administration of ursodiol to pregnant rats and rabbits during organogenesis at doses up to 22 and 7 times, respectively, the maximum recommended human dose (based on body surface area). risk summary ursodiol is naturally present in human milk. there are no reports of adverse effects of ursodiol on the breastfed child, but the reports are extremely limited. there are no data on the effects of ursodiol on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ursodiol and any potential adverse effects on the breastfed child from ursodiol or from the underlying maternal condition. the safety and effectiveness of ursodiol in pediatric patients have not been established.

Kanada - angol - Health Canada

boehringer ingelheim animal health canada inc. - firocoxib - tablet - 57mg - firocoxib 57mg - horses

Egyesült Államok - angol - NLM (National Library of Medicine)

strides pharma science limited - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol tablets, 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cholangitis (pbc). patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. risk summary available published data on the use of ursodiol in pregnant women derived from randomized controlled trials, observational studies, and case series collected over several decades have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. most of the reported exposures to ursodiol occurred in the second and third trimester of pregnancy. in animal reproduction studies, ursodiol had no adverse effects on embryo-fetal development when administered at doses greater than human therapeutic doses (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 defect, loss, or ot

Kanada - angol - Health Canada

merck canada inc - belzutifan - tablet - 40mg - belzutifan 40mg

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

osseo dental - 35310 - orthodontic appliance, retainer - clearcorrect retainers are clear, thin, plastic, thermoformed, removable orthodontic appliances used at the completion of orthodontically repositioned teeth as prescribed by a dentist or orthodontist. the retainers are indicated for the maintenance of teeth in their corrected positions following corrective orthodontic treatment. clearcorrect retainers can be used in conjunction with the clearcorrect orthodontic appliance system or prescribed by a dentist or orthodontist for the maintenance of teeth in their corrected positions following corrective orthodontic treatment using any other orthodontic procedure

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

byte au unit trust - 66722 - orthodontic aligner/retainer seater, reusable - a small cylindrical device intended to aid in positioning and seating an orthodontic progressive aligner or teeth retainer into place. this is a reusable device intended for single-patient use.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 35310 - orthodontic appliance, retainer - the products are intended for the creation of dental retainers.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

dentsply sirona pty ltd - 35310 - orthodontic appliance, retainer - orthodontic retainers are intended for use in retention and the prevention of relapse at the completion of orthodontic treatment.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

henry schein halas - 33204 - matrix band/strip retainer, dental - matrix retainer dental

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

cb healthcare consulting pty limited - 33204 - matrix band/strip retainer, dental - a dental device used to engage the ends of a matrix band or strip to hold it in position around a tooth that is being prepared for a dental restoration. it can be designed in various configurations: 1) a self-closing circular ring; or 2) a rod-like instrument, which tensions and locks the matrix in place. this device will remain attached to the matrix band during the dental procedure. this is a reusable device, and the retainer can be either of universal type, of contra-angled type etc.