European Union - English - EMA (European Medicines Agency)

ultragenyx germany gmbh - vestronidase alfa - mucopolysaccharidosis vii - enzymes - mepsevii is indicated for the treatment of non-neurological manifestations of mucopolysaccharidosis vii (mps vii; sly syndrome).

European Union - English - EMA (European Medicines Agency)

ultragenyx germany gmbh - evinacumab - hypercholesterolemia - lipid modifying agents - evkeeza is indicated as an adjunct to diet and other low-density lipoprotein-cholesterol (ldl-c) lowering therapies for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolaemia (hofh).

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

ultragenyx pharmaceutical inc. - triheptanoin (unii: 2p6o7cfw5k) (triheptanoin - unii:2p6o7cfw5k) - dojolvi is indicated as a source of calories and fatty acids for the treatment of adult and pediatric patients with molecularly confirmed long-chain fatty acid oxidation disorders (lc-faod). none. risk summary there are no available data on triheptanoin use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies conducted in pregnant rats and rabbits administered triheptanoin during the period of organogenesis, the primary toxicological effect (reduced body weight gain) was considered to be specific to decreased food consumption related to taste aversion in animals, and therefore is not relevant to clinical use in the intended populations. there is a pregnancy safety study for dojolvi. if a patient becomes pregnant while receiving dojolvi, healthcare providers should report dojolvi exposure by calling ultragenyx pharmaceutical inc. at 1-888-756-8657. the 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 clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data embryofetal developmental studies have been conducted with triheptanoin in rats and rabbits following oral administration of 10% (3.2 g/kg), 30% (9.7 g/kg) and 50% (16 g/kg) dci in rats and 10% (1.2 g/kg), 20% (2.3 g/kg) and 30% (3.5 g/kg) dci in rabbits during the period of organogenesis. reduced body weight gain, associated with decreased food consumption, was observed in pregnant rats and rabbits following administration of triheptanoin food mixture and was attributed to taste aversion. the noael for this maternal toxicity (lack of body weight gain) was 10% dci for both rats and rabbits. administration of dietary triheptanoin to pregnant rats at doses approximately 2 times above, and pregnant rabbits approximately equal to the targeted clinical dose of 35% dci resulted in increased incidence of skeletal malformations and decreased litter weights in both species and reduced number of viable litters in rabbits. the adverse effects on rat and rabbit embryofetal development were associated with the reduced body weight gain observed in pregnant animals. the noael for embryofetal development toxicity was 30% and 20% dci for rats and rabbits, respectively. in a pre- and postnatal developmental study in rats, reduced birthweights and delayed sexual maturation in pups were observed at 50% dci and were considered secondary to the reductions in body weight gain in pregnant rats. risk summary there are no data on the presence of triheptanoin or its metabolites in human or animal milk, the effects on the breastfed infant, or the effects on milk production. medium-chain triglycerides and other fatty acids are normal components of breastmilk and the composition of breastmilk varies within feedings, over stages of lactation, and between mothers and populations due to maternal factors including genetics, environment, and diet. the developmental and health benefits of breastfeeding should be considered along with the clinical need for dojolvi and any potential adverse effect on the breastfed infant from dojolvi or from the underlying maternal condition. the safety and effectiveness of dojolvi have been established in pediatric patients [see adverse reactions (6.1), clinical studies (14)]. clinical studies of dojolvi did not include patients 65 years of age and older to determine if they respond differently from younger adult patients. this instructions for use contains information on how to take dojolvi. read this instructions for use before you start taking dojolvi and each time you get a refill. there may be new information. this instructions for use does not take the place of talking to your healthcare provider about your medical condition or treatment. important information you need to know before taking or giving dojolvi: - use an oral syringe or measuring cup to measure your prescribed dose. ask your healthcare provider or pharmacist to show you how to measure your prescribed dose. - mix or give dojolvi using containers, oral syringes, or measuring cups made of materials such as stainless steel, glass, or high density polyethylene (hdpe), polypropylene, low density polyethylene, polyurethane, and silicone (types of plastic materials). - after use, rinse materials and containers well with cold water and wipe dry. - do not mix or give dojolvi using containers, oral syringes, or measuring cups made of polystyrene (a type of plastic that can be solid or foam) or polyvinyl chloride (pvc), a solid plastic material. - take dojolvi at least 4 times a day with meals or snacks, and always mix well with soft food or drink or medical food or formula before taking. - if you take dojolvi by mouth, mix well with soft food or drink such as: plain or artificially sweetened fat free yogurt fat free milk, formula, or cottage cheese whole grain hot cereal fat free low carbohydrate pudding, smoothies, applesauce, or baby food - plain or artificially sweetened fat free yogurt - fat free milk, formula, or cottage cheese - whole grain hot cereal - fat free low carbohydrate pudding, smoothies, applesauce, or baby food - if you give dojolvi by feeding tube, mix well with medical food or formula. - your healthcare provider should advise you on how to maintain a proper diet when taking dojolvi. - if you miss a dose, take the next dose as soon as possible. take the following doses 3 to 4 hours apart. if it is not possible to take all the doses for the day, skip the missed dose. taking dojolvi by mouth: - use an oral syringe or measuring cup made of the materials listed above to measure the prescribed amount of dojolvi from the bottle. - add the prescribed amount of dojolvi to a clean bowl, cup, or container, made of the materials listed above, containing the appropriate amount of soft food or drink as instructed by your healthcare provider. - mix dojolvi well into the soft food or liquid and swallow the mixture. - do not take dojolvi alone to avoid stomach upset. - you can store any unused dojolvi mixture for up to 24 hours in the refrigerator. - if not used within 24 hours, throw away (dispose of) the dojolvi mixture in the trash. do not pour down the sink. do not save for later. - check the items used to take dojolvi often to make sure they are working properly and are not breaking down. giving dojolvi by feeding tube: - you can give dojolvi by a feeding tube. - mix dojolvi with medical food or formula before giving by a feeding tube, y-connector, or feeding tube extension set. - only give dojolvi in a feeding tube made of silicone or polyurethane. - do not give dojolvi in a feeding tube made of polyvinyl chloride (pvc), a type of plastic. - do not give dojolvi alone to avoid stomach upset and to avoid breakdown of the feeding tube. - do not add dojolvi to the feeding bag because the feeding equipment may break down over time. - use an oral syringe or measuring cup made of the materials listed above to measure the prescribed amount of dojolvi from the bottle. - add the prescribed amount of dojolvi to a clean bowl, cup, or container, made of the materials listed above, containing the appropriate amount of medical food or formula as instructed by your healthcare provider. - mix dojolvi well into the medical food or formula and draw up the entire amount of the mixture into a slip tip syringe. - remove the air from the syringe and connect the syringe directly into the feeding tube port. - push the contents of the syringe (dojolvi mixture) into the feeding tube port using steady pressure until empty. - draw up about 5 ml to 30 ml of water with the slip tip syringe and flush the feeding tube feeding port with the water. - throw away (dispose of) any unused dojolvi mixture in the trash. do not pour down the sink. do not save for later use. - check the feeding tube and other items used to give dojolvi often to make sure they are working properly and are not breaking down. how should i store dojolvi? - store dojolvi at room temperature between 68°f to 77°f (20°c to 25°c). - do not freeze dojolvi. - when the bottle of dojolvi has been opened, use within 9 months or by the expiration date on the bottle, whichever comes first. - do not store dojolvi in containers made of polystyrene or polyvinyl chloride (pvc). keep dojolvi and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. revised: 10/2023

Canada - English - Health Canada

ultragenyx pharmaceutical inc - triheptanoin - liquid - 100% - triheptanoin 100% - caloric agents

Canada - English - Health Canada

ultragenyx pharmaceutical inc - evinacumab - solution - 150mg - evinacumab 150mg

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

ultragenyx pharmaceutical inc. - vestronidase alfa (unii: 7xz4062r17) (vestronidase alfa - unii:7xz4062r17) - vestronidase alfa 2 mg in 1 ml - mepsevii is indicated in pediatric and adult patients for the treatment of mucopolysaccharidosis vii (mps vii, sly syndrome).  limitations of use the effect of mepsevii on the central nervous system manifestations of mps vii has not been determined. none. risk summary there are no available data on mepsevii use in pregnant women to determine a drug-associated risk of adverse developmental outcomes. in embryofetal development studies, vestronidase alfa-vjbk administered intravenously to pregnant rats and rabbits during the period of organogenesis showed no adverse developmental outcomes at doses up to 1.6 and 10 times, respectively for rats and rabbits, the exposure at the recommended human dose. in a pre- and post-natal development study in rats, an increased number of stillbirths were observed at exposures less than the recommended human dose (see data). the clinical relevance of these animal findings is uncertain. 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 clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in embryofetal development studies, vestronidase alfa-vjbk administered intravenously to pregnant rats (once a week) and rabbits (once every 3 days) during the period of organogenesis showed no adverse developmental outcomes at doses up to 20 mg/kg. the 20 mg/kg dose in rats and rabbits provides approximately 1.6 and 10 times the human exposure (auc) of 57.9 hr*mcg/ml at the 4 mg/kg dose administered once every other week, respectively. in a pre- and post-natal developmental study in rats, vestronidase alfa-vjbk was administered every 3 days from gestation day 7 through lactation day 20 at doses of 2 mg/kg, 6 mg/kg, and 20 mg/kg. mortality and adverse clinical signs were observed in the maternal animals at the 20 mg/kg dose (1.6 times the human exposure (auc) at the recommended human dose of 4 mg/kg). subsequently, the 20 mg/kg dose was reduced to 12 mg/kg. maternal toxicity with mortality in one animal was also observed at the 6 mg/kg dose (0.17 times the auc at the recommended human dose of 4 mg/kg). at the 2 mg/kg dose (0.01 times the auc at the recommended human dose of 4 mg/kg), no adverse effects were observed in the maternal animals; however, there was a statistically significant decrease in the number of live births and subsequent increase in the number of stillbirths at this dose. risk summary   there are no data on the presence of vestronidase alfa-vjbk in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for mepsevii and any potential adverse effects on the breastfed infant from vestronidase alfa-vjbk or from the underlying maternal condition. the safety and effectiveness of mepsevii have been established in pediatric patients less than 18 years of age [see adverse reactions ( 6 ) , clinical studies ( 14 )] . clinical trials of mepsevii did not include any patients aged 65 and over. it is not known whether elderly patients respond differently from younger patients.

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

ultragenyx pharmaceutical inc. - burosumab (unii: g9wjt6rd29) (burosumab - unii:g9wjt6rd29) - burosumab 10 mg in 1 ml - crysvita is indicated for the treatment of x-linked hypophosphatemia (xlh) in adult and pediatric patients 6 months of age and older. crysvita is indicated for the treatment of fgf23-related hypophosphatemia in tumor-induced osteomalacia (tio) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older. crysvita is contraindicated: - in concomitant use with oral phosphate and/or active vitamin d analogs (e.g. calcitriol, paricalcitol, doxercalciferol, calcifediol) due to the risk of hyperphosphatemia [see warnings and precautions (5.2) and drug interactions (7.1)] . - when serum phosphorus is within or above the normal range for age [see warnings and precautions (5.2)] . - in patients with severe renal impairment or end stage renal disease because these conditions are associated with abnormal mineral metabolism [see use in specific population (8.6)] . risk summary there are no available data on crysvita use in pregnan

Singapore - English - HSA (Health Sciences Authority)

fondaco pte ltd - dental - ultradent edta is an 18% colorless, low-viscosity, aqueous, dentin-chelating solution. it contains a surfactant to facilitate better cleaning. it assists in root canal preparation by decalcifying dentin and removing the smear layer.

Singapore - English - HSA (Health Sciences Authority)

fondaco pte ltd - dental - ultradent porcelain etch is designed to use for intraoral or extraoral porcelain etching and indicated to use etching porcelain or old macro-filled composites prior to bonding and repair. silane is for bonding after etching in preparation for bonding resin.

Singapore - English - HSA (Health Sciences Authority)

fondaco pte ltd - dental - ultradent etching materials are used prior to bonding of any composites, sealants or bonding adhesives.