Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

unimedic pharma ab - phenylephrine hydrochloride 0,061 mg/ml - eq. phenylephrine 0,05 mg/ml - solution for injection - 0,05 mg/ml - phenylephrine hydrochloride 0.061 mg/ml - phenylephrine

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

unimedic pharma ab - phenylephrine hydrochloride 0,122 mg/ml - eq. phenylephrine 0,1 mg/ml - solution for injection - 0,1 mg/ml - phenylephrine hydrochloride 0.122 mg/ml - phenylephrine

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

unimedic pharma - phenylephrine hydrochloride - solution for injection - 0,1 mg/ml - phenylephrine hydrochloride 0.122 mg/ml - phenylephrine

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

unimedic pharma ab - phenylephrine hydrochloride 12,2 mg/ml - eq. phenylephrine 10 mg/ml - concentrate for solution for injection/infusion - 10 mg/ml - phenylephrine hydrochloride 12.2 mg/ml - phenylephrine

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

meitheal pharmaceuticals inc. - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. none risk summary data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride injection use in pregnant women during cesarean section have not established a drug-associated risk of major birth defects and miscarriage. these studies have not identified an adverse effect on maternal outcomes or infant apgar scores [see data] . there are no data on the use of phenylephrine hydrochloride during the first or second trimester. in animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine hydrochloride was administered during organogenesis via a 1-hour infusion at 1.2 times the human daily dose (hdd) of 10 mg/60 kg/day. decreased pup weights were noted in offspring of pregnant rats treated with 2.9 times the hdd [see data]. the estimated backgrou

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

meitheal pharmaceuticals inc. - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride injection 10 mg per ml is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the settings of anesthesia and septic shock. the use of phenylephrine hydrochloride injection 10 mg per ml is contraindicated in patients with: - hypersensitivity to the products or any of their components risk summary in animal reproductive and developmental studies, decreased fetal body weights were noted at 0.4 times the human daily dose (hdd) of 10 mg. no malformations were reported, however, an increased incidence of agenesis of the intermediate lobe of the lung, a visceral variation, was reported at levels as low as 0.08 times the hdd. 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 misca

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

laboratoire aguettant - phenylephrine hydrochloride 0,122 mg/ml - eq. phenylephrine 0,1 mg/ml - solution for injection/infusion - 100 µg/ml - phenylephrine hydrochloride 0.122 mg/ml - phenylephrine

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

ingenus pharmaceuticals, llc - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. none risk summary data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride injection use in pregnant women during cesarean section have not established a drug-associated risk of major birth defects and miscarriage. these studies have not identified an adverse effect on maternal outcomes or infant apgar scores [see data] . there are no data on the use of phenylephrine during the first or second trimester. in animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine was administered during organogenesis via a 1-hour infusion at 1.2 times the human daily dose (hdd) of 10 mg/60 kg/day. decreased pup weights were noted in offspring of pregnant rats treated with 2.9 times the hdd [see data]. the estimated background risk of major birth defec

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

fresenius kabi usa, llc - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride injection 10 mg/ml is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the settings of anesthesia and septic shock. the use of phenylephrine hydrochloride injection 10 mg/ml is contraindicated in patients with: - hypersensitivity to the product or any of its components risk summary in animal reproductive and developmental studies, decreased fetal body weights were noted at 0.4 times the human daily dose (hdd) of 10 mg. no malformations were reported, however, an increased incidence of agenesis of the intermediate lobe of the lung, a visceral variation, was reported at levels as low as 0.08 times the hdd. 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 no malformations were noted when normotensive pregnant rats were treated with a single daily intravenous bolus dose of 50 mcg, 150 mcg, or 300/200 mcg/kg phenylephrine hydrochloride from gestation day 6 to 17 (high dose is 0.3/0.2 times the human daily dose (hdd) of 10 mg/day based on body surface area). evidence of maternal toxicity, including mortality, was noted at the highest tested dose of 300/200 mcg/kg. decreased fetal body weights but no clear treatment-related malformations were reported when normotensive pregnant rabbits were treated with a single daily intravenous bolus dose of 40 mcg, 100 mcg and 200 mcg/kg (0.08, 0.2, and 0.4 times the hdd based on body surface area) phenylephrine hydrochloride from gestation day 7 to 19. maternal toxicity, as manifested by decreased food consumption and body weight gain at all doses. an increased incidence of agenesis of the intermediate lobe of the lung, a visceral variation, was noted in all treatment groups compared to controls. no adverse effects on the offspring were reported when pregnant rats were treated via a single daily intravenous bolus dose of up to 200 mcg/day phenylephrine hydrochloride (0.2 times the hdd based on body surface area) from gestation day 6 to lactation day 20. safety and effectiveness in pediatric patients have not been established. clinical studies of phenylephrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. in patients with liver cirrhosis [child pugh class a (n=3), class b (n=5) and class c (n=1)], dose-response data indicate decreased responsiveness to phenylephrine. consider using larger doses than usual in hepatic impaired subjects. in patients with end stage renal disease (esrd) undergoing hemodialysis, dose-response data indicates increased responsiveness to phenylephrine. consider using lower doses of phenylephrine hydrochloride in esrd patients.

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

gland pharma limited - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride injection, 10 mg/ml, is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. none risk summary data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride injection use in pregnant women during cesarean section have not established a drug-associated risk of major birth defects and miscarriage. these studies have not identified an adverse effect on maternal outcomes or infant apgar scores [see data] . there are no data on the use of phenylephrine during the first or second trimester. in animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine was administered during organogenesis via a 1-hour infusion at 1.2 times the human daily dose (hdd) of 10 mg/60 kg/day. decreased pup weights were noted in offspring of pregnant rats treated with 2.9 times the hdd [see data]