Соединенные Штаты - английский - 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.

Соединенные Штаты - английский - NLM (National Library of Medicine)

american health packaging - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - carefully consider the potential benefits and risks of ketorolac tromethamine tablets usp and other treatment options before deciding to use ketorolac tromethamine tablets usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. ketorolac tromethamine tablets usp are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with iv or im dosing of ketorolac tromethamine and ketorolac tromethamine tablets usp are to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine tablets usp and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings, precautions, dosage and administration, and adverse reactions ).

Новая Зеландия - английский - Medsafe (Medicines Safety Authority)

baxter healthcare ltd - dextran 40 10%; glucose monohydrate 5% - solution for infusion - active: dextran 40 10% glucose monohydrate 5%

Соединенные Штаты - английский - NLM (National Library of Medicine)

gland pharma limited - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine 15 mg in 1 ml - carefully consider the potential benefits and risks ketorolac tromethamine and other treatment options before deciding to use ketorolac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). acute pain in adult patients ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings, precautions, dosage and administration , and adverse reactions ). pa

Канада - английский - Health Canada

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

Соединенные Штаты - английский - NLM (National Library of Medicine)

avpak - 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

Соединенные Штаты - английский - NLM (National Library of Medicine)

fresenius kabi usa, llc - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine 30 mg in 1 ml - carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings, precautions, dosage and administration, and adverse reactions ). patients should be switched to alter

Соединенные Штаты - английский - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - lisinopril (unii: e7199s1ywr) (lisinopril anhydrous - unii:7q3p4bs2fd) - lisinopril tablets usp are indicated for the treatment of hypertension 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 including lisinopril. 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 of pharmacologic classes and with differe

Соединенные Штаты - английский - NLM (National Library of Medicine)

pharmacosmos, inc - iron dextran (unii: 95hr524n2m) (ferric cation - unii:91o4lml611) -

Египет - английский - EDA (Egyptian Drug Authority)

otsuka egypt - infusion - 10 %