Canada - Tiếng Anh - Health Canada

acala pharmaceuticals inc. (a division of fernbank management corporation) - norepinephrine (norepinephrine bitartrate monohydrate) - solution - 1mg - norepinephrine (norepinephrine bitartrate monohydrate) 1mg - alpha-and beta-adrenergic agonists

Hoa Kỳ - Tiếng Anh - 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)] .

Hoa Kỳ - Tiếng Anh - 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

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

focus health group - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - epinephrine 1 mg in 1000 ml - epinephrine is used to relieve respiratory distress due to bronchospasm, to provide rapid relief of hypersensitivity reactions to drugs and other allergens, and to prolong the action of anesthetics. its cardiac effects may be of use in restoring cardiac rhythm in cardiac arrest due to various causes, but it is not used in cardiac failure or in hemorrhagic, traumatic, or cardiogenic shock. epinephrine is used as a hemostatic agent. it is also used in treating mucosal congestion of hay fever, rhinitis, and acute sinusitis; to relieve bronchial asthmatic paroxysms; in syncope due to complete heart block or carotid sinus hypersensitivity; for symptomatic relief of serum sickness, urticaria, angioneurotic edema; for resuscitation in cardiac arrest following anesthetic accidents; in simple (open angle) glaucoma; for relaxation of uterine musculature and to inhibit uterine contractions. epinephrine injection can be utilized to prolong the action of anesthetics used in local and regional anesthesia. epinephrine is co

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - adrenalin® is available as a single-use 1 ml vial and a multiple-use 30 ml vial for intramuscular and subcutaneous use. emergency treatment of allergic reactions (type i), including anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. the signs and symptoms associated with anaphylaxis include flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with hypotension, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, airway swelling, laryngospasm, bronchospasm, pruritus, urticaria or angioedema, swelling of the eyelids, lips, and tongue. none. 8.1 pregnancy teratogenic effects: pregnancy category c. there are no adequate and well-controlled studies in pregnant women. epinephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (fetal

New Zealand - Tiếng Anh - Medsafe (Medicines Safety Authority)

sterling winthrop (nz) ltd (now skb nz or sanofi winthrop) - phenylephrine hydrochloride - nasal spray solution - 0.25%, 0.5% - active: phenylephrine hydrochloride

Canada - Tiếng Anh - Health Canada

xediton pharmaceuticals inc - zolmitriptan - spray - 2.5mg - zolmitriptan 2.5mg - selective serotonin agonists

Canada - Tiếng Anh - Health Canada

xediton pharmaceuticals inc - zolmitriptan - spray - 5mg - zolmitriptan 5mg - selective serotonin agonists

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

baxter healthcare corporation - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - for blood pressure control in certain acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions). as an adjunct in the treatment of cardiac arrest and profound hypotension. norepinephrine bitartrate injection, usp should not be given to patients who are hypotensive from blood volume deficits except as an emergency measure to maintain coronary and cerebral artery perfusion until blood volume replacement therapy can be completed. if norepinephrine bitartrate injection, usp is continuously administered to maintain blood pressure in the absence of blood volume replacement, the following may occur: severe peripheral and visceral vasoconstriction, decreased renal perfusion and urine output, poor systemic blood flow despite "normal" blood pressure, tissue hypoxia, and lactate acidosis. norepinephrine bitartrate injection, usp should also not be given to patients with mesenteric or peripheral vascular thrombosis (because of the risk of increasing ischemia and extending the area of infarction) unless, in the opinion of the attending physician, the administration of norepinephrine bitartrate injection, usp is necessary as a life-saving procedure. cyclopropane and halothane anesthetics increase cardiac autonomic irritability and therefore seem to sensitize the myocardium to the action of intravenously administered epinephrine or norepinephrine. hence, the use of norepinephrine bitartrate injection, usp during cyclopropane and halothane anesthesia is generally considered contraindicated because of the risk of producing ventricular tachycardia or fibrillation. the same type of cardiac arrhythmias may result from the use of norepinephrine bitartrate injection, usp in patients with profound hypoxia or hypercarbia.

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

langford research institute - epinephrine (unii: ykh834o4bh) (epinephrine - unii:ykh834o4bh) - epinephrine 1 mg in 1 mg