Výzkumný ústav včelařský s.r.o. - search results

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

(s)-methoprene

vyzkumny ustav organickych zyntez a.s. - (s)-methoprene - unknown - (s)-methoprene terpene active 0.0 - active constituent

European Union - English - EMA (European Medicines Agency)

halagon

emdoka bvba - halofuginone lactate - halofuginone, other antiprotozoal agents - calves, newborn - in newborn calves:prevention of diarrhoea due to diagnosed cryptosporidium parvum infection, in farms with history of cryptosporidiosis. administration should start in the first 24 to 48 hours of age.reduction of diarrhoea due to diagnosed cryptosporidium parvum infection. administration should start within 24 hours after the onset of diarrhoea. in both cases, the reduction of oocysts excretion has been demonstrated.

European Union - English - EMA (European Medicines Agency)

emdocam

emdoka bvba - meloxicam - oxicams - horses; pigs; cattle - cattlefor use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs. for use in diarrhoea in combination with oral rehydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle. for adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.pigsfor use in noninfectious locomotor disorders to reduce the symptoms of lameness and inflammation. for adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitits-metritis-agalactia syndrome) with appropriate antibiotic therapy.horsesfor use in the alleviation of inflammation and relief of pain in both acute and chronic musculoskeletal disorders. for the relief of pain associated with equine colic.dogs: alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.cats:reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.

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

vyzulta- latanoprostene bunod solution/ drops

bausch & lomb incorporated - latanoprostene bunod (unii: i6393o0922) (latanoprost acid - unii:ej85341990) - vyzulta ® (latanoprostene bunod ophthalmic solution) 0.024% is indicated for the reduction of intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. none. risk summary there are no available human data for the use of vyzulta during pregnancy to inform any drug associated risks. latanoprostene bunod has caused miscarriages, abortion, and fetal harm in rabbits. latanoprostene bunod was shown to be abortifacient and teratogenic when administered intravenously (iv) to pregnant rabbits at exposures ≥ 0.28 times the clinical dose. doses ≥ 20 mcg/kg/day (23 times the clinical dose) produced 100% embryofetal lethality. structural abnormalities observed in rabbit fetuses included anomalies of the great vessels and aortic arch vessels, domed head, sternebral and vertebral skeletal anomalies, limb hyperextension and malrotation, abdominal distension and edema. latanoprostene bunod was not teratogenic in the rat when administered iv at 150 mcg/kg/day (87 times the clinical dose) [see data] . the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. data animal data embryofetal studies were conducted in pregnant rabbits administered latanoprostene bunod daily by intravenous injection on gestation days 7 through 19, to target the period of organogenesis. the doses administered ranged from 0.24 to 80 mcg/kg/day. abortion occurred at doses ≥ 0.24 mcg/kg/day latanoprostene bunod (0.28 times the clinical dose, on a body surface area basis, assuming 100% absorption). embryofetal lethality (resorption) was increased in latanoprostene bunod treatment groups, as evidenced by increases in early resorptions at doses ≥ 0.24 mcg/kg/day and late resorptions at doses ≥ 6 mcg/kg/day (approximately 7 times the clinical dose). no fetuses survived in any rabbit pregnancy at doses of 20 mcg/kg/day (23 times the clinical dose) or greater. latanoprostene bunod produced structural abnormalities at doses ≥ 0.24 mcg/kg/day (0.28 times the clinical dose). malformations included anomalies of sternum, coarctation of the aorta with pulmonary trunk dilation, retroesophageal subclavian artery with absent brachiocephalic artery, domed head, forepaw hyperextension and hindlimb malrotation, abdominal distention/edema, and missing/fused caudal vertebrae. an embryofetal study was conducted in pregnant rats administered latanoprostene bunod daily by intravenous injection on gestation days 7 through 17, to target the period of organogenesis. the doses administered ranged from 150 to 1500 mcg/kg/day. maternal toxicity was produced at 1500 mcg/kg/day (870 times the clinical dose, on a body surface area basis, assuming 100% absorption), as evidenced by reduced maternal weight gain. embryofetal lethality (resorption and fetal death) and structural anomalies were produced at doses ≥ 300 mcg/kg/day (174 times the clinical dose). malformations included anomalies of the sternum, domed head, forepaw hyperextension and hindlimb malrotation, vertebral anomalies and delayed ossification of distal limb bones. a no observed adverse effect level (noael) was established at 150 mcg/kg/day (87 times the clinical dose) in this study. risk summary there are no data on the presence of vyzulta in human 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 vyzulta, and any potential adverse effects on the breastfed infant from vyzulta. use in pediatric patients aged 16 years and younger is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. no overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.