Verenigde Staten - Engels - NLM (National Library of Medicine)

anazaohealth corporation - dextran 75 (unii: jy83shx053) (dextran 75 - unii:jy83shx053) - dextran 75 10 mg - technetium tc99m dextran by intravenous administration is indicated as a cardiac blood pool imaging agent and as an adjunct in the diagnosis of pericardial effusion, ventricular aneurysm, or gi bleed

Verenigde Staten - Engels - NLM (National Library of Medicine)

allergan, inc. - iron dextran (unii: 95hr524n2m) (ferric cation - unii:91o4lml611) - ferric cation 50 mg in 1 ml - infed is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or have had an unsatisfactory response to oral iron. infed is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran [see warnings and precautions ( 5.1 ) ] . risk summary   parenteral iron administration may be associated with hypersensitivity reactions [see warnings and precautions ( 5.1 )] , which may have serious consequences, such as fetal bradycardia (see clinical considerations). advise pregnant persons of the potential risk to the fetus. available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. there are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy (see clinical considerations). iron dextran has been shown to be teratogenic and embryocidal in mice, rats, rabbits, dogs, and monkeys when given in doses of about 3 times the maximum human dose. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defects, 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 2-4% and 15-20%, respectively. clinical considerations   disease-associated maternal and/or embryo/fetal risk    untreated iron deficiency anemia (ida) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. adverse pregnancy outcomes associated with ida include increased risk for preterm delivery and low birth weight. fetal /neonatal adverse reactions severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant persons with intravenous iron administration (such as infed) which may have serious consequences on the fetus such as fetal bradycardia, especially during the second and third trimester. data animal data no consistent adverse fetal effects were observed in mice, rats, rabbits, dogs, and monkeys at doses of 50 mg iron/kg or less. fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. fetal abnormalities in rats and dogs were observed at doses of 250 mg iron/kg and higher. the animals used in these tests were not iron deficient. risk summary trace amounts of unmetabolized iron dextran are present in human milk. there are no data on the effects of iron dextran in breastfed infants or effects on milk production. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for infed in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. infed is not recommended for use in infants under 4 months of age [s ee dosage and administration ( 2.2 ) ]. reports in the literature from countries outside the united states (in particular, new zealand) have suggested that the use of intramuscular iron dextran in neonates has been associated with an increased incidence of gram-negative sepsis, primarily due to e. coli.

Ierland - Engels - HPRA (Health Products Regulatory Authority)

correvio (uk) ltd - tirofiban hydrochloride monohydrate - concentrate for soln for inf - 50 microgram/ml

Ierland - Engels - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - dextran 70 glucose - solution for infusion - 6/5 %w/v

Canada - Engels - Health Canada

pharmacia (canada) inc. - dextran; dextrose - liquid - 10g; 5g - dextran 10g; dextrose 5g - replacement preparations

Verenigde Staten - Engels - NLM (National Library of Medicine)

amneal pharmaceuticals llc - benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - benazepril hydrochloride 5 mg - benazepril hcl tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs.  control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). these considerations may guide selection of therapy. it may be used alone or in combination with thiazide diuretics. benazepril hcl tablets are contraindicated in patients: - who are hypersensitive to benazepril or to any other ace inhibitor - with a history of angioedema with or without previous ace inhibitor treatment benazepril hcl is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). do not administer benazepril hcl within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see warnings and precautions (5.2)]. do not co-administer aliskiren with angiotensin receptor blockers, ace inhibitors; including benazepril hcl tablets in patients with diabetes [see drug interactions (7.4)]. risk summary benazepril hcl can cause fetal harm when administered to a pregnant woman. use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. when pregnancy is detected, discontinue benazepril hcl as soon as possible. the estimated background risk of major birth defects and miscarriage for the indicated population are unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the general u.s. population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. pregnant women with hypertension should be carefully monitored and managed accordingly. fetal/neonatal adverse reactions oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia and skeletal deformations, including skull hypoplasia, hypotension, and death. in the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. perform serial ultrasound examinations to assess the intra-amniotic environment. fetal testing may be appropriate, based on the week of pregnancy. patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. closely observe infants with histories of in utero exposure to benazepril hcl for hypotension, oliguria, and hyperkalemia. if oliguria or hypotension occur in neonates with a history of in utero exposure to benazepril hcl, support blood pressure and renal perfusion. exchange transfusions or dialysis may be required as a means of reversing hypotension and substituting for disordered renal function. minimal amounts of unchanged benazepril and of benazeprilat are excreted into the breast milk of lactating women treated with benazepril. a newborn child ingesting entirely breast milk would receive less than 0.1% of the mg/kg maternal dose of benazepril and benazeprilat. the antihypertensive effects of benazepril hcl have been evaluated in a double-blind study in pediatric patients 7 to 16 years of age [see clinical pharmacology (12.3)]. the pharmacokinetics of benazepril hcl have been evaluated in pediatric patients 6 to 16 years of age [see clinical pharmacology (12.3)]. infants below the age of 1 year should not be given benazepril hcl because of the risk of effects on kidney development. safety and effectiveness of benazepril hcl have not been established in pediatric patients less than 6 years of age or in children with glomerular filtration rate < 30 ml/min/1.73 m² [see dosage and administration (2.1) and clinical pharmacology (12.3)]. of the total number of patients who received benazepril in u.s. clinical studies of benazepril hcl, 18% were 65 or older while 2% were 75 or older. no overall differences in effectiveness or safety were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. benazepril and benazeprilat are substantially excreted by the kidney. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see dosage and administration (2.2)] . ace inhibitors, including benazepril hcl, as monotherapy, have an effect on blood pressure that is less in black patients than in non-blacks.  dose adjustment of benazepril hcl is required in patients undergoing hemodialysis or whose creatinine clearance is ≤ 30 ml/min. no dose adjustment of benazepril hcl is required in patients with creatinine clearance > 30 ml/min [see dosage and administration (2.2) and clinical pharmacology (12.3)].

Verenigde Staten - Engels - NLM (National Library of Medicine)

international laboratories, llc - benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - benazepril hydrochloride 20 mg - benazepril hydrochloride tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from

Verenigde Staten - Engels - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - amlodipine 2.5 mg - amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. - do not coadminister aliskiren with angiotensin receptor blockers (arbs), ace inhibitors, including amlodipine besylate and benazepril hydrochloride in patients with diabetes. - amlodipine and benazepril hydrochloride capsules are contraindicated in patients with a history of angioedema, with or without previous ace inhibitor treatment, or patients who are hypersensitive to benazepril, to any other ace inhibitor, to amlodipine, or to any of the excipients of amlodipine and benazepril hydrochloride capsules. - amlodipine and benazepril hydrochloride capsules are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). do not administer amlodipine and benazepril hydrochloride capsules within 36 hours of switching to or from a neprilysin inhibitor, e.g., sacubitril/valsartan [see warnings and precautions (5.1) ]. pregnancy

Verenigde Staten - Engels - NLM (National Library of Medicine)

golden state medical supply inc. - lisinopril (unii: e7199s1ywr) (lisinopril anhydrous - unii:7q3p4bs2fd) - lisinopril 2.5 mg - lisinopril tablets are indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than 1 drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety

Verenigde Staten - Engels - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - enalapril maleate (unii: 9o25354epj) (enalaprilat anhydrous - unii:q508q118jm) - enalapril maleate 2.5 mg - enalapril maleate tablets are indicated for the treatment of hypertension. enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. the blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive. enalapril maleate tablets are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. in these patients enalapril maleate tablets improve symptoms, increase survival, and decrease the frequency of hospitalization (see clinical pharmacology , heart failure, mortality trials for details and limitations of survival trials). in clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤ 35 percent), enalapril maleate tablets decrease the rate of development of overt heart failure and decrease the incidence of hospitalization for heart failure (see clinical pharmacology , heart failure, mortality tria