Соединенные Штаты - английский - NLM (National Library of Medicine)

meda pharmaceuticals - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride 205.5 ug - astepro nasal spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older. none. limited data from postmarketing experience over decades of use with astepro in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 4 times the clinical daily dose. oral administration of azelastine hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 180 times and higher than the maximum recommended human daily intranasal dose (mrhdid) of 1.644 mg. however, the relevance of these findings in animals to pregnant women was considered questionable based

Соединенные Штаты - английский - NLM (National Library of Medicine)

physicians total care, inc. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride 137 ug - astelin® nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing, and nasal pruritus in adults and children 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis, such as rhinorrhea, nasal congestion and postnasal drip in adults and children 12 years and older. astelin® nasal spray is contraindicated in patients with a known hypersensitivity to azelastine hydrochloride or any of its components. for intranasal use only important: follow instructions carefully to ensure proper dosing. dosing: the dosage of astelin® nasal spray is 1 spray per nostril twice daily for pediatric patients (ages 5-11 years) with seasonal allergic rhinitis. for patients age 12 and older with seasonal allergic rhinitis the dosage is one or two sprays per nostril twice daily. for patients age 12 and older with nonallergic vasomotor rhinitis the dosage is two sprays per nostril twice daily. keep your head tilted downward when spraying. alternate s

Ирландия - английский - HPRA (Health Products Regulatory Authority)

mylan ire healthcare limited - azelastine hydrochloride - eye drops, solution - 0.5 milligram(s)/millilitre - other antiallergics; azelastine

Соединенные Штаты - английский - NLM (National Library of Medicine)

rpk pharmaceuticals, inc. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride ophthalmic solution, 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis. azelastine hydrochloride ophthalmic solution, 0.05% is contraindicated in persons with known or suspected hypersensitivity to any of its components.

Соединенные Штаты - английский - NLM (National Library of Medicine)

avkare - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride 137 ug in 0.137 ml - azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. none. risk summary limited data from postmarketing experience over decades of use with azelastine hydrochloride in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose. oral administration of azelastine hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than the maximum recommended human daily intranasal dose (mrhdid) of 1.096

Соединенные Штаты - английский - NLM (National Library of Medicine)

a-s medication solutions - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. none. risk summary limited data from postmarketing experience over decades of use with azelastine hydrochloride nasal spray in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose. oral administration of azelastine hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than the maximum recommended human daily intranasal dose (mrhd

Соединенные Штаты - английский - NLM (National Library of Medicine)

rpk pharmaceuticals, inc. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. none. risk summary limited data from postmarketing experience over decades of use with azelastine hydrochloride nasal spray in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose. oral administration of azelastine hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than the maximum recommended human daily intranasal dose (mrhd

Соединенные Штаты - английский - NLM (National Library of Medicine)

rpk pharmaceuticals, inc. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride nasal solution (nasal spray), 0.1% (137 mcg per spray) is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. none. risk summary limited data from postmarketing experience over decades of use with azelastine hydrochloride nasal solution in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose. oral administration of azelastine hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than the maximum

Соединенные Штаты - английский - NLM (National Library of Medicine)

rpk pharmaceuticals, inc. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. none. risk summary limited data from postmarketing experience over decades of use with azelastine hydrochloride in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose. oral administration of azelastine hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than the maximum recommended human daily intranasal dose (mrhdid) o

Ирландия - английский - HPRA (Health Products Regulatory Authority)

rowex ltd - azelastine hydrochloride; fluticasone propionate - nasal spray, suspension - fluticasone, combinations