United States - English - NLM (National Library of Medicine)

cardinal health - dextran 70 (unii: 7sa290yk68) (dextran 70 - unii:7sa290yk68), polyethylene glycol 400 (unii: b697894sgq) (polyethylene glycol 400 - unii:b697894sgq), povidones (unii: fz989gh94e) (povidone - unii:fz989gh94e), tetrahydrozoline hydrochloride (unii: 0yzt43hs7d) (tetrahydrozoline - unii:s9u025y077) - dextran 70 1 mg in 1 ml - uses - for the relief of redness of the eyes due to minor eye irritations - for use as a protectant against further irritation or to relieve dryness of the eye stop use and ask a doctor if - you feel eye pain - changes in vision occur - redness or irritation of the eye lasts - condition worsens or lasts more than 72 hours directions - put 1 to 2 drops in the affected eye(s) up to 4 times daily - children under 6 years of age: ask a doctor

United States - English - NLM (National Library of Medicine)

hospira, inc. - sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37, bicarbonate ion - unii:hn1zra3q20) - sodium bicarbonate 0.2 g in 5 ml - neut (4% sodium bicarbonate additive solution) is indicated for use as an additive to raise the ph of acid solutions administered intravenously to reduce the incidence of chemical phlebitis and patient discomfort due to vein irritation at or near the site of infusion. not for use as a systemic alkalizer. none known.

United States - English - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin sodium is indicated for: prophylaxis and treatment of venous thromboembolism and pulmonary embolism; atrial fibrillation with embolization; treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); prevention of clotting in arterial and cardiac surgery; prophylaxis and treatment of peripheral arterial embolism; anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. the use of heparin sodium in 0.45% sodium chloride injection or heparin sodium in 5% dextrose injection is contraindicated in patients with the following conditions: history of heparin-induced thrombocytopenia (hit) and heparin-induced thrombocytopenia and thrombosis (hitt) [see warnings and precautions ( 5.3)] known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see adverse reactions ( 6.1)] in whom suitable blood coagulation tests — e.g., the whole blood clotting time, partial thromboplastin time, etc., — cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin) [see warnings and precautions ( 5.5)] an uncontrolled bleeding state [see warnings and precautions ( 5.2)], except when this is due to disseminated intravascular coagulation. 8.1 pregnancy risk summary there are no available data on heparin sodium use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. in published reports, heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. no teratogenicity, but early embryo-fetal death was observed in animal reproduction studies with administration of heparin sodium to pregnant rats and rabbits during organogenesis at doses approximately 10 times the maximum recommended human dose (mrhd) of 40,000 units/24 hours infusion (see data). consider the benefits and risks of heparin sodium in 0.45% sodium chloride injection or heparin sodium in 5% dextrose injection to a pregnant woman and possible risks to the fetus when prescribing heparin sodium in 0.45% sodium chloride injection or heparin sodium in 5% dextrose injection to a pregnant woman. 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 human data the maternal and fetal outcomes associated with uses of heparin via various dosing methods and administration routes during pregnancy have been investigated in numerous studies. these studies generally reported normal deliveries with no maternal or fetal bleeding and no other complications. animal data in a published study conducted in rats and rabbits, pregnant animals received heparin intravenously during organogenesis at a dose of 10,000 usp units/kg/day, approximately 10 times the maximum human daily dose based on body weight. the number of early resorptions increased in both species. there was no evidence of teratogenic effects. 8.2 lactation risk summary there is no information regarding the presence of heparin sodium in 0.45% sodium chloride injection or heparin sodium in 5% dextrose injection in human milk, the effects on the breastfed infant, or the effects on milk production. due to its large molecular weight, heparin is not likely to be excreted in human milk, and any heparin in milk would not be orally absorbed by a nursing infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for heparin sodium in 0.45% sodium chloride injection or heparin sodium in 5% dextrose injection and any potential adverse effects on the breastfed infant from heparin sodium in 0.45% sodium chloride injection or heparin sodium in 5% dextrose injection or from the underlying maternal condition [see use in specific populations ( 8.4)]. 8.4 pediatric use there are no adequate and well-controlled studies on heparin use in pediatric patients. pediatric dosing recommendations are based on clinical experience [see dosage and administration ( 2.4)]. 8.5 geriatric use there are limited adequate and well-controlled studies in patients 65 years and older. however, a higher incidence of bleeding has been reported in patients over 60 years of age, especially women [see warnings and precautions ( 5.2)]. lower doses of heparin may be indicated in these patients [see clinical pharmacology (12.3)].

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - dextran 40 sodium chloride - solution for infusion - 10/0.9 %w/v %w/v

United States - English - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - fosinopril sodium (unii: nw2rth6t2n) (fosinoprilat - unii:s312ey6zt8) - fosinopril sodium 20 mg - fosinopril sodium tablets, usp are indicated for the treatment of hypertension. it may be used alone or in combination with thiazide diuretics. fosinopril sodium tablets, usp are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see dosage and administration ). in using fosinopril sodium, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. available data are insufficient to show that fosinopril sodium does not have a similar risk (see warnings ). in considering use of fosinopril sodium, it should be noted that in controlled trials ace inhibitors have an effect on blood pressure that is less in black patients than in non- blacks. in addition, ace inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black

United States - English - NLM (National Library of Medicine)

baxter healthcare corporation - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin 200 [usp'u] in 100 ml - heparin sodium in sodium chloride injection at a concentration of 2 units/ml is indicated as an anticoagulant to maintain catheter patency. the use of heparin sodium in sodium chloride injection is contraindicated in patients with the following conditions: risk summary there are no available data on heparin sodium in sodium chloride injection use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. in published reports heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans (see data) . consider the benefits and risks of heparin sodium in sodium chloride injection for the mother and possible risks to the fetus when prescribing heparin sodium in sodium chloride injection to a pregnant woman. the 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. however, the background ris

United States - English - NLM (National Library of Medicine)

b. braun medical inc. - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin 200 [usp'u] in 100 ml - heparin sodium in 0.9% sodium chloride injection at the concentration of 2 usp units/ml is indicated as an anticoagulant to maintain catheter patency. the use of heparin sodium in 0.9% sodium chloride injection is contraindicated in patients with the following conditions: - uncontrollable active bleeding state except when this is due to disseminated intravascular coagulation [see warnings and precautions (5.2)] - history of heparin-induced thrombocytopenia (hit) or heparin-induced thrombocytopenia and thrombosis (hitt) [see warnings and precautions (5.3)] - severe thrombocytopenia [see warnings and precautions (5.3, 5.4)] - known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see warnings and precautions (5.5) and adverse reactions (6.1)] in published reports, heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. no teratogenicity was observed in animal reproduction studies with administration of heparin sodium to pregnant rats and rabbits during organogenesis at doses, approximately 2777 times the recommended human dose (mrhd) for maintenance of catheter patency of heparin [see data] . in pregnant animals, doses up to 2777 times higher than the human daily dose of heparin resulted in increased resorptions. consider the benefits and risks of heparin sodium in 0.9% sodium chloride injection to a pregnant woman and possible risks to the fetus when prescribing heparin sodium in 0.9% sodium chloride injection. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. the maternal and fetal outcomes associated with uses of heparin via various dosing methods and administration routes during pregnancy have been investigated in numerous studies. these studies generally reported normal deliveries with no maternal or fetal bleeding and no other complications. in a published study conducted in rats and rabbits, pregnant animals received heparin intravenously during organogenesis at a dose of 10,000 usp units/kg/day, approximately 2777 times the human daily dose. the number of early resorptions increased in both species. there was no evidence of teratogenic effects. there is no information regarding the presence of heparin sodium in 0.9% sodium chloride injection in human milk, the effects on the breastfed infant, or the effects on milk production. due to its large molecular weight, heparin is not likely to be excreted in human milk, and any heparin in milk would not be orally absorbed by a nursing infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for heparin sodium in 0.9% sodium chloride injection and any potential adverse effects on the breastfed infant from heparin sodium in 0.9% sodium chloride injection or from the underlying maternal condition [see use in specific populations (8.4)] . there are no adequate and well controlled studies on heparin use in pediatric patients. there are limited adequate and well-controlled studies in patients 65 years and older. however, a higher incidence of bleeding has been reported in patients over 60 years of age, especially women [see warnings and precautions (5.2)] .

United States - English - NLM (National Library of Medicine)

cardinal health - sodium bicarbonate (unii: 8mdf5v39qo) (bicarbonate ion - unii:hn1zra3q20) - sodium bicarbonate 0.2 g in 5 ml - neut (4% sodium bicarbonate additive solution) is indicated for use as an additive to raise the ph of acid solutions administered intravenously to reduce the incidence of chemical phlebitis and patient discomfort due to vein irritation at or near the site of infusion. not for use as a systemic alkalizer. none known.

United States - English - NLM (National Library of Medicine)

sandoz inc - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin 5000 [usp'u] in 1 ml - heparin sodium injection is indicated for: the use of heparin sodium injection is contraindicated in patients with the following conditions: risk summary there are no available data on heparin sodium injection use in pregnant women to inform a drug- associated risk of major birth defects and miscarriage. in published reports, heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. no teratogenicity, but early embryo-fetal death was observed in animal reproduction studies with administration of heparin sodium to pregnant rats and rabbits during organogenesis at doses approximately 10 times the maximum recommended human dose (mrhd) of 45,000 units/ day (see data) . consider the benefits and risks of heparin sodium injection for the mother and possible risks to the fetus when prescribing heparin sodium injection to a pregnant woman. if available, preservative-free heparin sodium injection is recommended when heparin therapy is needed during pr

United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin 5000 [usp'u] in 100 ml - heparin sodium is indicated for: - prophylaxis and treatment of venous thromboembolism and pulmonary embolism; - atrial fibrillation with embolization; - treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); - prevention of clotting in arterial and cardiac surgery; - prophylaxis and treatment of peripheral arterial embolism; - anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. the use of heparin sodium in 0.45% sodium chloride injection or heparin sodium in 5% dextrose injection is contraindicated in patients with the following conditions: - history of heparin-induced thrombocytopenia (hit) and heparin-induced thrombocytopenia and thrombosis (hitt) [see warnings and precautions (5.3)] - known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see adverse reactions (6.1)] - in whom suitable blood coagulation tests — e.g., the whole blood clotting time, partial thro