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

cardinal health 107, llc - enoxaparin sodium (unii: 8nz41mik1o) (enoxaparin - unii:e47c0nf7lv) - enoxaparin sodium injection, usp is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe): enoxaparin sodium injection, usp is indicated for: enoxaparin sodium injection, usp is indicated for the prophylaxis of ischemic complications of unstable angina and non-q-wave myocardial infarction, when concurrently administered with aspirin. enoxaparin sodium injection, usp, when administered concurrently with aspirin, has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute st-segment elevation myocardial infarction (stemi) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (pci). enoxaparin sodium injection is contraindicated in patients with: risk summary placental transfer of enoxaparin was observed in the animal studies. human data from a retrospective cohort study, which included 693 live births, suggest that enoxaparin sodium does not increase the risk of major developmental abnormalities (see data) . based on animal data, enoxaparin sodium is not predicted to increase the risk of major developmental abnormalities (see data ). adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. 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. clinical considerations pregnancy alone confers an increased risk for thromboembolism that is even higher for women with thromboembolic disease and certain high risk pregnancy conditions. while not adequately studied, pregnant women with mechanical prosthetic heart valves may be at even higher risk for thrombosis [seewarnings and precautions (5.7)anduse in specific populations (8.6) ]. pregnant women with thromboembolic disease, including those with mechanical prosthetic heart valves and those with inherited or acquired thrombophilias, have an increased risk of other maternal complications and fetal loss regardless of the type of anticoagulant used. all patients receiving anticoagulants, including pregnant women, are at risk for bleeding. pregnant women receiving enoxaparin sodium should be carefully monitored for evidence of bleeding or excessive anticoagulation. consideration for use of a shorter acting anticoagulant should be specifically addressed as delivery approaches [see boxed warning] . hemorrhage can occur at any site and may lead to death of mother and/or fetus. pregnant women should be apprised of the potential hazard to the fetus and the mother if enoxaparin sodium is administered during pregnancy. it is not known if monitoring of anti-factor xa activity and dose adjustment (by weight or anti-factor xa activity) of enoxaparin sodium injection affect the safety and the efficacy of the drug during pregnancy. data human data there are no adequate and well-controlled studies in pregnant women. a retrospective study reviewed the records of 604 women who used enoxaparin sodium during pregnancy. a total of 624 pregnancies resulted in 693 live births. there were 72 hemorrhagic events (11 serious) in 63 women. there were 14 cases of neonatal hemorrhage. major congenital anomalies in live births occurred at rates (2.5%) similar to background rates. there have been postmarketing reports of fetal death when pregnant women received enoxaparin sodium injection. causality for these cases has not been determined. insufficient data, the underlying disease, and the possibility of inadequate anticoagulation complicate the evaluation of these cases. a clinical study using enoxaparin sodium in pregnant women with mechanical prosthetic heart valves has been conducted [seewarnings and precautions (5.7) ]. animal data teratology studies have been conducted in pregnant rats and rabbits at subcutaneous doses of enoxaparin up to 15 times the recommended human dose (by comparison with 2 mg/kg as the maximum recommended daily dose). there was no evidence of teratogenic effects or fetotoxicity due to enoxaparin. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. risk summary it is unknown whether enoxaparin sodium is excreted in human milk. in lactating rats, the passage of enoxaparin or its metabolites in the milk is very limited. there is no information available on the effect of enoxaparin or its metabolites on the breastfed child, or on the milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for enoxaparin sodium injection and any potential adverse effects on the breastfed child from enoxaparin sodium injection or from the underlying maternal condition. safety and effectiveness of enoxaparin sodium injection in pediatric patients have not been established. enoxaparin sodium injection is not approved for use in neonates or infants. serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature neonates and low- birth- weight infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative. in these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/l). additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. preterm, low-birth-weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. the minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. prevention of deep vein thrombosis in hip, knee and abdominal surgery; treatment of deep vein thrombosis, prevention of ischemic complications of unstable angina and non-q-wave myocardial infarction over 2800 patients, 65 years and older, have received enoxaparin sodium injection in clinical trials. the efficacy of enoxaparin sodium injection in the geriatric (≥65 years) was similar to that seen in younger patients (<65 years). the incidence of bleeding complications was similar between geriatric and younger patients when 30 mg every 12 hours or 40 mg once a day doses of enoxaparin sodium injection were employed. the incidence of bleeding complications was higher in geriatric patients as compared to younger patients when enoxaparin sodium injection was administered at doses of 1.5 mg/kg once a day or 1 mg/kg every 12 hours. the risk of enoxaparin sodium injection -associated bleeding increased with age. serious adverse events increased with age for patients receiving enoxaparin sodium injection. other clinical experience (including postmarketing surveillance and literature reports) has not revealed additional differences in the safety of enoxaparin sodium injection between geriatric and younger patients. careful attention to dosing intervals and concomitant medications (especially antiplatelet medications) is advised. enoxaparin sodium injection should be used with care in geriatric patients who may show delayed elimination of enoxaparin. monitoring of geriatric patients with low body weight (<45 kg) and those predisposed to decreased renal function should be considered [seewarnings and precautions (2.6) and clinical pharmacology (12.3)] . treatment of acute st-segment elevation myocardial infarction in the clinical study for treatment of acute st-segment elevation myocardial infarction, there was no evidence of difference in efficacy between patients ≥75 years of age (n = 1241) and patients less than 75 years of age (n = 9015). patients ≥75 years of age did not receive a 30 mg intravenous bolus prior to the normal dosage regimen and had their subcutaneous dose adjusted to 0.75 mg/kg every 12 hours [seedosage and administration (2.4)] . the incidence of bleeding complications was higher in patients ≥65 years of age as compared to younger patients (<65 years). the use of enoxaparin sodium injection has not been adequately studied for thromboprophylaxis in patients with mechanical prosthetic heart valves and has not been adequately studied for long-term use in this patient population. isolated cases of prosthetic heart valve thrombosis have been reported in patients with mechanical prosthetic heart valves who have received enoxaparin sodium for thromboprophylaxis. some of these cases were pregnant women in whom thrombosis led to maternal and fetal deaths. insufficient data, the underlying disease and the possibility of inadequate anticoagulation complicate the evaluation of these cases. pregnant women with mechanical prosthetic heart valves may be at higher risk for thromboembolism [see warnings and precautions ( 5.7) ] . in patients with renal impairment, there is an increase in exposure of enoxaparin sodium. all such patients should be observed carefully for signs and symptoms of bleeding. because exposure of enoxaparin sodium is significantly increased in patients with severe renal impairment (creatinine clearance <30 ml/min), a dosage adjustment is recommended for therapeutic and prophylactic dosage ranges. no dosage adjustment is recommended in patients with creatinine clearance 30 to<50 ml/min and creatinine clearance 50 to 80 ml/min [see dosage and administration ( 2.3) and clinical pharmacology ( 12.3) ]. in patients with renal failure, treatment with enoxaparin sodium has been associated with the development of hyperkalemia [see adverse reactions ( 6.2) ] . an increase in exposure of enoxaparin sodium with prophylactic dosages (non-weight adjusted) has been observed in low-weight women (<45 kg) and low-weight men (<57 kg). observe low-weight patients frequently for signs and symptoms of bleeding [see clinical pharmacology ( 12.3) ] . obese patients are at higher risk for thromboembolism. the safety and efficacy of prophylactic doses of enoxaparin sodium injection in obese patients (bmi >30 kg/m2 ) has not been fully determined and there is no consensus for dose adjustment. observe these patients carefully for signs and symptoms of thromboembolism. enoxaparin (en-ox-ah-par-in) sodium injection for subcutaneous use single-dose prefilled syringe this instructions for use contains information on how to prepare and inject enoxaparin sodium injection prefilled syringe. read this instructions for use before using the enoxaparin sodium injection prefilled syringe and each time you get a new prescription. there may be new information. do not inject yourself or someone else until you have been shown how to inject enoxaparin sodium injection. your healthcare provider can show you or your caregiver how to prepare and inject a dose of enoxaparin sodium injection. call your healthcare provider if you have any questions. important information: storing enoxaparin sodium injection prefilled syringes: parts of enoxaparin sodium injection prefilled syringe: preparing to inject enoxaparin sodium injection: step 1: gather the following supplies for your injection (see figure a): 1 items not included. step 2: wash your hands well with soap and water. step 3: preparing a dose of enoxaparin sodium injection take the prefilled syringe out of the package. open the packaging by peeling the lid at the arrow as directed. take the prefilled syringe out of the plastic container by holding the middle of the syringe body (see figure b). step 4: check the enoxaparin sodium injection prefilled syringe step 5: check the medicine step 6: choose your injection site step 7: clean the injection site clean the injection site with an alcohol wipe (see figure f). let your skin dry before injecting. step 8: remove the needle cap hold the prefilled syringe in the middle of the body with the needle pointing away from you. remove the needle cap by pulling it straight off the syringe (see figure g). step 9: injecting a dose that is less than the full amount in the prefilled syringe. if your prescribed dose is the same as the amount in the prefilled syringe, go to step 10. if your dose is based on your bodyweight, your healthcare provider may prescribe less than the full amount in the syringe. you will have to get rid of (discard) some of the medicine from the prefilled syringe before you inject enoxaparin sodium injection. to measure your prescribed dose, hold the prefilled syringe with the needle pointing down. carefully watch the numbers on the syringe as you push the plunger down until the amount left in the syringe is the same as your prescribed dose. the tip of the plunger should line up with the number for your prescribed dose (see figure h). step 10: injecting enoxaparin sodium injection hold the prefilled syringe like a pencil in your hand with the needle pointing down. with your other hand, pinch the cleaned stomach (abdomen) area between your forefinger and thumb to make a fold in the skin (see figure i). make sure you hold the skin fold during the entire injection. insert the full length of the needle straight into the skin fold at about a 90° angle (see figure j). push the plunger rod down slowly and steadily with your thumb until the enoxaparin sodium injection prefilled syringe is empty (see figure k). step 11: remove the needle remove the needle from the injection site by pulling it straight out while keeping your fingers on the plunger rod (see figure l). step 12: activate the safety system point the needle away from yourself and other people, and firmly push the plunger rod again to activate the safety system. the protective sleeve will automatically come down and cover the needle. you will hear a "click" when the protective sleeve is released (see figure m). step 13: dispose of used enoxaparin sodium injection prefilled syringes and needle caps put the used enoxaparin sodium injection prefilled syringe and needle cap in an fda-cleared sharps disposal container right away after use (see figure n). do not dispose of enoxaparin sodium injection prefilled syringes or needle caps in your household trash. if you do not have an fda-cleared sharps disposal container, you may use a household container that is: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles, syringes, and prefilled syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at http://www.fda.gov/safesharpsdisposal. manufactured by shenzhen techdow pharmaceutical co., ltd. for sandoz inc., princeton, nj 08540 distributed by: cardinal health dublin, oh 43017 l5741434-0224 l5741442-0224 l5741459-0224 l5741467-0224 l5741475-0224

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

meitheal pharmaceuticals inc. - enoxaparin sodium (unii: 8nz41mik1o) (enoxaparin - unii:e47c0nf7lv) - enoxaparin sodium injection is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe): - in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see clinical studies (14.1)] - in patients undergoing hip replacement surgery, during and following hospitalization - in patients undergoing knee replacement surgery - in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness enoxaparin sodium injection is indicated for: - the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism , when administered in conjunction with warfarin sodium - the outpatient treatment of acute deep vein thrombosis without pulmonary embolism , when administered in conjunction with warfarin sodium enoxaparin sodium injection is indicated for the prophylaxis of ischemic complications of unstable angina and non-q-wave myocardial infarction, when concurrently admin

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

meitheal pharmaceuticals inc. - enoxaparin sodium (unii: 8nz41mik1o) (enoxaparin - unii:e47c0nf7lv) - enoxaparin sodium injection is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe): - in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see clinical studies (14.1)] - in patients undergoing hip replacement surgery, during and following hospitalization - in patients undergoing knee replacement surgery - in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness enoxaparin sodium injection is indicated for: - the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism , when administered in conjunction with warfarin sodium - the outpatient treatment of acute deep vein thrombosis without pulmonary embolism , when administered in conjunction with warfarin sodium enoxaparin sodium injection is indicated for the prophylaxis of ischemic complications of unstable angina and non-q-wave myocardial infarction, when concurrently admin

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

meitheal pharmaceuticals inc. - enoxaparin sodium (unii: 8nz41mik1o) (enoxaparin - unii:e47c0nf7lv) - enoxaparin sodium injection is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe): - in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see clinical studies (14.1)] - in patients undergoing hip replacement surgery, during and following hospitalization - in patients undergoing knee replacement surgery - in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness enoxaparin sodium injection is indicated for: - the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism , when administered in conjunction with warfarin sodium - the outpatient treatment of acute deep vein thrombosis without pulmonary embolism , when administered in conjunction with warfarin sodium enoxaparin sodium injection is indicated for the prophylaxis of ischemic complications of unstable angina and non-q-wave myocardial infarction, when concurrently admin

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

hepalink usa inc. - enoxaparin sodium (unii: 8nz41mik1o) (enoxaparin - unii:e47c0nf7lv) - enoxaparin sodium injection is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe): - in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see clinical studies (14.1) ] - in patients undergoing hip replacement surgery, during and following hospitalization - in patients undergoing knee replacement surgery - in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness enoxaparin sodium injection is indicated for: - the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism , when administered in conjunction with warfarin sodium - the outpatient treatment of acute deep vein thrombosis without pulmonary embolism , when administered in conjunction with warfarin sodium enoxaparin sodium injection is indicated for the prophylaxis of ischemic co

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

northstar rxllc - enoxaparin sodium (unii: 8nz41mik1o) (enoxaparin - unii:e47c0nf7lv) - enoxaparin sodium injection is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe): - in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see clinical studies (14.1) ] - in patients undergoing hip replacement surgery, during and following hospitalization - in patients undergoing knee replacement surgery - in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness enoxaparin sodium injection is indicated for: - the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism , when administered in conjunction with warfarin sodium - the outpatient treatment of acute deep vein thrombosis without pulmonary embolism , when administered in conjunction with warfarin sodium enoxaparin sodium injection is indicated for the prophylaxis of ischemic co

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

be pharmaceuticals inc. - enoxaparin sodium (unii: 8nz41mik1o) (enoxaparin - unii:e47c0nf7lv) - enoxaparin sodium injection is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe):     •     in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see clinical studies (14.1)]     •      in patients undergoing hip replacement surgery, during and following hospitalization      •     in patients undergoing knee replacement surgery      •     in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness  enoxaparin sodium injection is indicated for: • the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism , when administered in conjunction with warfarin sodium  • the outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium enoxaparin sodium injection is indicated for the prophylaxis of ischemic complications of unstable angina and no

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - enoxaparin sodium -

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - enoxaparin sodium -

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - enoxaparin sodium -