Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

breckenridge pharmaceutical, inc. - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - norepinephrine bitartrate injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. none. risk summary limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated. (see clinical considerations ). in animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see data ). increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approxim

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - norepinephrine bitartrate injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. none. risk summary limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated. (see clinical considerations). in animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see data). increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approxi

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

sagent pharmaceuticals - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - norepinephrine bitartrate injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. none. risk summary limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated. (see clinical considerations) . in animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see data). increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approxim

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - norepinephrine bitartrate injection, usp is indicated to raise blood pressure in adult patients with severe, acute hypotension. none. 8.1 pregnancy risk summary limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated. (see clinical considerations below). in animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see data below). increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approximately 2 times the maximum recommended dose on a mg/m3 basis for four days during organogenesis (see data below). the estimated background risk for 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 the clinically recognized pregnancies is 2-4% and 15−20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk hypotension associated with septic shock, myocardial infarction, and stroke are medical emergencies in pregnancy which can be fatal if left untreated. delaying treatment in pregnant women with hypotension associated with septic shock, myocardial infarction and stroke may increase the risk of maternal and fetal morbidity and mortality. life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of norepinephrine on the fetus. data animal data a study in pregnant sheep receiving high doses of intravenous norepinephrine (40 mcg/min, at approximately 10 times the average maintenance dose of 2-4 mcg/min in human, on a mg/kg basis) exhibited a significant decrease in maternal placental blood flow. decreases in fetal oxygenation, urine and lung liquid flow were also observed. norepinephrine administration to pregnant rats on gestation day 16 or 17 resulted in cataract production in rat fetuses. in hamsters, an increased number of resorptions (29.1% in study group vs. 3.4% in control group), fetal microscopic liver abnormalities and delayed skeletal ossification were observed at approximately 2 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day from gestation day 7-10). 8.2 lactation risk summary there are no data on the presence of norepinephrine in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. clinically relevant exposure to the infant is not expected based on the short half-life and poor oral bioavailability of norepinephrine. 8.4 pediatric use safety and effectiveness in pediatric patients have not been established. 8.5 geriatric use clinical studies of norepinephrine bitartrate injection 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. avoid administration of norepinephrine bitartrate injection into the veins in the leg in elderly patients [see warnings and precautions (5.1)].

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

baxter healthcare corporation - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - norepinephrine bitartrate injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. none. risk summary limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated. (see clinical considerations) . in animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see data). increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approximately 2 times the maximum recommended dose on a mg/m3 basis for four days during organogenesis (see data). the estimated background risk for 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 the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk hypotension associated with septic shock, myocardial infarction, and stroke are medical emergencies in pregnancy which can be fatal if left untreated. delaying treatment in pregnant women with hypotension associated with septic shock, myocardial infarction and stroke may increase the risk of maternal and fetal morbidity and mortality. life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of norepinephrine on the fetus. data animal data a study in pregnant sheep receiving high doses of intravenous norepinephrine (40 mcg/min, at approximately 10 times the average maintenance dose of 2 to 4 mcg/min in human, on a mg/kg basis) exhibited a significant decrease in maternal placental blood flow. decreases in fetal oxygenation, urine and lung liquid flow were also observed. norepinephrine administration to pregnant rats on gestation day 16 or 17 resulted in cataract production in rat fetuses. in hamsters, an increased number of resorptions (29.1% in study group vs. 3.4% in control group), fetal microscopic liver abnormalities and delayed skeletal ossification were observed at approximately 2 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day from gestation day 7 to 10). risk summary there are no data on the presence of norepinephrine in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. clinically relevant exposure to the infant is not expected based on the short half-life and poor oral bioavailability of norepinephrine. safety and effectiveness in pediatric patients have not been established. clinical studies of norepinephrine bitartrate 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. avoid administration of norepinephrine bitartrate into the veins in the leg in elderly patients [see warnings and precautions (5.1)] .

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

fresenius kabi usa, llc - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - norepinephrine bitartrate injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. none. risk summary limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated. (see clinical considerations ). in animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see data) . increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approxim

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

bioactive nutritional, inc. - norepinephrine (unii: x4w3enh1cv) (norepinephrine - unii:x4w3enh1cv) - norepinephrine 6 [hp_x] in 1 ml - for temporary relief of anxiety, mood swings, dizziness, skin rashes, fears, headaches, hives and hot flashes. for temporary relief of anxiety, mood swings, dizziness, skin rashes, fears, headaches, hives and hot flashes.

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - epinephrine bitartrate (unii: 30q7ki53ak) (epinephrine - unii:ykh834o4bh), lidocaine hydrochloride anhydrous (unii: ec2cnf7xfp) (lidocaine - unii:98pi200987) - xylocaine (lidocaine hcl) injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. lidocaine hcl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

physicians total care, inc. - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - epinephrine 0.3 mg in 0.3 ml - epipen® and epipen® jr auto-injectors are indicated in the emergency treatment of allergic reactions (type i) including anaphylaxis to stinging insects (e.g., order hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitos), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. epipen® and epipen® jr auto-injectors are intended for immediate administration in patients, who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. selection of the appropriate dosage strength is determined according to patient body weight (see dosage and administration section). such reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convu

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

lineage therapeutics inc - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - epinephrine 0.15 mg in 0.15 ml