Regne Unit - anglès - MHRA (Medicines & Healthcare Products Regulatory Agency)

kent pharma (uk) ltd - phenylephrine hydrochloride - solution for injection - 10mg/1ml

Regne Unit - anglès - MHRA (Medicines & Healthcare Products Regulatory Agency)

aguettant ltd - phenylephrine hydrochloride - solution for injection - 50microgram/1ml

Regne Unit - anglès - MHRA (Medicines & Healthcare Products Regulatory Agency)

martindale pharmaceuticals ltd - phenylephrine hydrochloride - solution for injection - 100microgram/1ml

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

hikma pharmaceuticals usa inc. - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - immphentiv injection 100 mcg/ml is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. 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 immphentiv 100 mcg/ml and phenylephrine hydrochloride injection 10 mg/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 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. animal reproduction studies have not been conducted with phenylephrine. it is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. phenylephrine should be given to a pregnant woman only if clearly needed. however, the safety of its use for the management of hypotension associated with neuraxial anesthesia in cesarean deliveries is well established.71   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.

Irlanda - anglès - HPRA (Health Products Regulatory Authority)

bausch & lomb uk limited - phenylephrine hydrochloride - eye drops, solution - 2.5 percent weight/volume - sympathomimetics used as decongestants; phenylephrine

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

bausch & lomb australia pty ltd - phenylephrine hydrochloride, quantity: 100 mg/ml - eye drops, solution - excipient ingredients: sodium metabisulfite; disodium edetate; purified water - phenylephrine is a directly acting sympathomimetic agent used topically in the eye as a mydriatic. minims phenylephrine hydrochloride eye drops are indicated to dilate the pupil for diagnostic or therapeutic procedures.

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

bausch & lomb (nz) ltd - phenylephrine hydrochloride 10%;  ;   - eye drops, solution - 10 % - active: phenylephrine hydrochloride 10%     excipient: disodium edetate dihydrate sodium metabisulfite water for injection

Malta - anglès - Malta Medicines Authority

p & d pharmaceuticals limited 38 woolmer way, bordon hampshire gu35 9qf, united kingdom - phenylephrine hydrochloride - solution for injection - phenylephrine hydrochloride 10 mmol/ml - cardiac therapy

Malta - anglès - Malta Medicines Authority

beacon pharmaceuticals limited the bower 4 roundwood avenue, stockley park, heathrow, ub11 1af, united kingdom - phenylephrine hydrochloride - solution for infusion or injection - phenylephrine hydrochloride 10 mg/ml - cardiac therapy

Canadà - anglès - Health Canada

pharma stulln inc. - phenylephrine hydrochloride - solution - 2.5% - phenylephrine hydrochloride 2.5% - mydriatics