Estats Units - anglès - 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

Estats Units - anglès - 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

Irlanda - anglès - HPRA (Health Products Regulatory Authority)

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

Irlanda - anglès - HPRA (Health Products Regulatory Authority)

meda health sales ireland limited - azelastine hydrochloride - eye drops solution - 0.5 mg/ml - other antiallergics

Irlanda - anglès - HPRA (Health Products Regulatory Authority)

brown & burk uk ltd - azelastine hydrochloride - eye drops solution - 0.5 mg/ml - other antiallergics

Estats Units - anglès - NLM (National Library of Medicine)

meda pharmaceuticals inc. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x), fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - azelastine hydrochloride 137 ug - dymista is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older . none. limited data from postmarketing experience with dymista in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. the individual components of dymista have been marketed for decades. while the data regarding the use of nasal preparations of fluticasone propionate in pregnancy are limited, data from clinical studies of inhaled fluticasone propionate do not indicate an increased risk of adverse maternal or fetal outcomes. animal reproduction studies with dymista are not available; however, studies are available with its individual components, azelastine hydrochloride and fluticasone propionate. in animal reproduction studies, there was no evidence of fetal harm in animals at oral doses of azelastine hydrochloride approximately 10 times the clinical daily dose. oral administration of azelast

Irlanda - anglès - HPRA (Health Products Regulatory Authority)

hospira uk limited - vinblastine sulfate - solution for inj/inf - 1 mg/ml - vinca alkaloids and analogues

Canadà - anglès - Health Canada

sandoz canada incorporated - vinblastine sulfate - solution - 1mg - vinblastine sulfate 1mg - antineoplastic agents

Canadà - anglès - Health Canada

pfizer canada ulc - vinblastine sulfate - solution - 1mg - vinblastine sulfate 1mg - antineoplastic agents

Canadà - anglès - Health Canada

teva canada limited - vinblastine sulfate - solution - 1mg - vinblastine sulfate 1mg - antineoplastic agents