Enoxar

2000 IU/0.2 mL soln for inj: Clear colourless solution filled in a prefilled syringe.
Each 0.2 mL contains: Enoxaparin Sodium (porcine derived) 2000 IU Anti-Factor Xa (equivalent to 20 mg).
4000 IU/0.4 mL soln for inj: Enoxaparin sodium is a solution for injection in pre-filled syringes with colourless or faint yellow transparent liquid.
Each pre-filled syringe contains: Enoxaparin sodium (USP) obtained from Porcine Intestinal Mucosa 4000 Anti-Xa IU equivalent to 40 mg.
6000 IU/0.6 mL soln for inj: Clear colorless liquid.
Each 0.6 mL solution contains: Enoxaparin Sodium 6000 IU Anti-Factor Xa (equivalent to 60 mg).

Pharmacotherapeutic group: Antithrombotic agent, heparin group.
Pharmacology: Pharmacodynamics: 2000 IU/0.2 mL and 4000 IU/0.4 mL soln for inj: Enoxaparin sodium is an LMWH with a mean molecular weight of approximately 4,500 daltons, in which the antithrombotic and anticoagulant activities of standard heparin have been dissociated. The drug substance is sodium salt. In the in vitro purified system, enoxaparin sodium has high anti-Xa activity (approximately 100 IU/mg) and low anti-IIa or antithrombin activity (approximately 28 IU/mg), with a ratio of 3.6. These anticoagulant activities are mediated through anti-thrombin III (ATIII) resulting in anti-thrombotic activities in humans.
Beyond its anti-Xa/IIa activity, further antithrombotic and anti-inflammatory properties of Enoxaparin sodium have been identified in healthy subjects and patients as well as in non-clinical models. These include ATIII-dependent inhibition of other coagulation factors like factor VIIa, induction of endogenous Tissue Factor Pathway Inhibitor (TFPI) release as well as a reduced release of von Willebrand factor (vWF) from the vascular endothelium into the blood circulation. These factors are known to contribute to the overall antithrombotic effect of Enoxaparin sodium.
When used as a prophylactic treatment, Enoxaparin sodium does not significantly affect the aPTT.
When used as a curative treatment, aPTT can be prolonged by 1.5-2.2 times the control time at peak activity.
Pharmacokinetics: 2000 IU/0.2 mL and 6000 IU/0.6 mL soln for inj: Absorption and Distribution: Maximum anti-Factor Xa and anti-thrombin (anti-Factor) activities occur 3 to 5 hours after SC injection of Enoxaparin.
Mean peak anti-Factor Xa activity was 0.16 IU/mL (1.58 pg/mL) and 0.38 IU/mL (3.83 pg/mL) after the 20 mg and 40 mg clinically tested SC doses, respectively. Mean (n=46) peak anti-Factor Xa activity was 1.1 IU/mL at steady state in patients with unstable angina receiving 1 mg/kg SC every 12 hours for 14 days. Mean absolute bioavailability of Enoxaparin, after 1.5 mg/kg given SC, based on anti-Factor Xa activity is approximately 100% in healthy volunteers.
Enoxaparin pharmacokinetics appears to be linear over the recommended dosage ranges. After repeated subcutaneous administration of 40 mg once daily and 1.5 mg/kg once daily regimens in healthy volunteers, the steady state is reached on day 2 with an average exposure ratio about 15% higher than after a single dose. Steady-state Enoxaparin activity levels are well predicted by single-dose pharmacokinetics. After repeated subcutaneous administration of the 1 mg/kg twice daily regimen, the steady state is reached from 4 with mean exposure about 65% higher than after a single dose and mean peak and trough levels of about 1.2 and 0.52 IU/mL, respectively. Based on Enoxaparin sodium pharmacokinetics, this difference in steady state is expected and within the therapeutic range.
4000 IU/0.4 mL soln for inj: General characteristics: The pharmacokinetic parameters of enoxaparin sodium have been studied primarily in terms of the time course of plasma anti-Xa activity and also by anti-IIa activity, at the recommended dosage ranges after single and repeated SC administration and after single IV administration. The quantitative determination of anti-Xa and anti-IIa pharmacokinetic activities was conducted by validated amidolytic methods.
Absorption: The absolute bioavailability of enoxaparin sodium after SC injection, based on anti-Xa activity, is close to 100%.
Different doses and formulations and dosing regimens can be used.
The mean maximum plasma anti-Xa activity level is observed 3 to 5 hours after SC injection and achieves approximately 0.2, 0.4, 1.0 and 1.3 anti-Xa IU/mL following single SC administration of 2,000 IU, 4,000 IU, 100 IU/kg and 150 IU/kg (20 mg, 40 mg, 1 mg/kg and 1.5 mg/kg) doses, respectively.
A 3,000 IU (30 mg) IV bolus immediately followed by 100 IU/kg (1 mg/kg) SC every 12 hours provided initial maximum anti-Xa activity level of 1.16 IU/mL (n=16) and average exposure corresponding to 88% of steady-state levels. Steady-state is achieved on the second day of treatment.
After repeated SC administration of 4,000 IU (40 mg) once daily and 150 IU/kg (1.5 mg/kg) once daily regimens in healthy volunteers, the steady-state is reached on day 2 with an average exposure ratio about 15% higher than after a single dose. After repeated SC administration of the 100 IU/kg (1 mg/kg) twice daily regimen, the steady-state is reached from day 3 to 4 with mean exposure about 65% higher than after a single dose and mean maximum and trough anti-Xa activity levels of about 1.2 and 0.52 IU/mL, respectively.
Injection volume and dose concentration over the range 100-200 mg/mL does not affect pharmacokinetic parameters in healthy volunteers.
Enoxaparin sodium pharmacokinetics appears to be linear over the recommended dosage ranges. Intra-patient and inter-patient variability is low. Following repeated SC administration, no accumulation takes place.
Plasma anti-IIa activity after SC administration is approximately ten-fold lower than anti-Xa activity. The mean maximum anti-IIa activity level is observed approximately 3 to 4 hours following SC injection and reaches 0.13 IU/mL and 0.19 IU/mL following repeated administration of 100 IU/kg (1 mg/kg) twice daily and 150 IU/kg (1.5 mg/kg) once daily, respectively.
Distribution: The volume of distribution of enoxaparin sodium anti-Xa activity is about 4.3 liters and is close to the blood volume.
Biotransformation: Enoxaparin sodium is primarily metabolized in the liver by desulfation and/or depolymerization to lower molecular weight species with much reduced biological potency.
Elimination: Enoxaparin sodium is a low clearance drug with a mean anti-Xa plasma clearance of 0.74 L/h after a 150 IU/kg (1.5 mg/kg) 6-hour IV infusion.
Elimination appears monophasic with a half-life of about 5 hours after a single SC dose to about 7 hours after repeated dosing.
Renal clearance of active fragments represents about 10% of the administered dose and total renal excretion of active and non-active fragments is 40% of the dose.
Special populations: Elderly: Based on the results of a population pharmacokinetic analysis, the enoxaparin sodium kinetic profile is not different in elderly subjects compared to younger subjects when renal function is normal. However, since the renal function is known to decline with age, elderly patients may show reduced elimination of enoxaparin sodium.
Hepatic impairment: In a study conducted on patients with advanced cirrhosis treated with enoxaparin sodium 4,000 IU (40 mg) once daily, a decrease in maximum anti-Xa activity was associated with an increase in the severity of hepatic impairment (assessed by Child-Pugh categories). This decrease was mainly attributed to a decrease in ATIII level secondary to reduced synthesis of ATIII in patients with hepatic impairment.
Renal impairment: A linear relationship between anti-Xa plasma clearance and creatinine clearance at steady-state has been observed, which indicates decreased clearance of enoxaparin sodium in patients with reduced renal function. Anti-Xa exposure represented by AUC, at steady-state, is marginally increased in mild (creatinine clearance 50-80 mL/min) and moderate (creatinine clearance 30-50 mL/min) renal impairment after repeated SC 4,000 IU (40 mg) once daily doses. In patients with severe renal impairment (creatinine clearance <30 mL/min), the AUC at a steady state is significantly increased on average by 65% after repeated SC 4,000 IU (40 mg) once daily doses.
Hemodialysis: Enoxaparin sodium pharmacokinetics appeared similar than the control population, after a single 25 IU, 50 IU or 100 IU/kg (0.25, 0.50 or 1.0 mg/kg) IV dose however, AUC was two-fold higher than control.
Weight: After repeated SC 150 IU/kg (1.5 mg/kg) once daily dosing, the mean AUC of anti-Xa activity is marginally higher at a steady state in obese healthy volunteers (BMI 30-48 kg/m) compared to non-obese control subjects, while maximum plasma anti-Xa activity level is not increased. There is a lower weight-adjusted clearance in obese subjects with SC dosing.
When non-weight adjusted dosing was administered, it was found after a single-SC 4,000 IU (40 mg) dose, that anti-Xa exposure is 52% higher in low-weight women (<45 kg) and 27% higher in low-weight men (<57 kg) when compared to normal weight control subjects.
Pharmacokinetic interactions: No pharmacokinetic interactions were observed between enoxaparin sodium and thrombolytics when administered concomitantly.
Toxicology: 4000 IU/0.4 mL soln for inj: Preclinical safety data: Besides the anticoagulant effects of enoxaparin sodium, there was no evidence of adverse effects at 15 mg/kg/day in the 13-week SC toxicity studies both in rats and dogs and at 10 mg/kg/day in the 26-week SC and IV toxicity studies both in rats, and monkeys.
Enoxaparin sodium has shown no mutagenic activity based on in vitro tests, including the Ames test, mouse lymphoma cell forward mutation test, and no clastogenic activity based on an in vitro human lymphocyte chromosomal aberration test, and the in vivo rat bone marrow chromosomal aberration test. Studies conducted in pregnant rats and rabbits at SC doses of enoxaparin sodium up to 30 mg/kg/day did not reveal any evidence of teratogenic effects or fetotoxicity. Enoxaparin sodium was found to have no effect on fertility or reproductive performance of male and female rats at SC doses up to 20 mg/kg/day.

2000 IU/0.2 mL and 6000 IU/0.6 ml soln for inj: Prophylaxis of Deep Vein Thrombosis.
Treatment of Acute Deep Vein Thrombosis.
Prophylaxis of Ischaemic Complications of Unstable Angina and Non-Q-Wave Myocardial Infarction.
Treatment of Acute ST-Segment Elevation Myocardial Infarction (STEMI).
4000 IU/0.4 mL soln for inj: Enoxaparin sodium solution for injection is indicated in adults for: Prophylaxis of venous thromboembolic disease in moderate and high-risk surgical patients, in particular those undergoing orthopedic or general surgery including cancer surgery.
Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery.
Prevention of thrombus formation in extracorporeal circulation during hemodialysis.
Acute coronary syndrome.
Treatment of unstable angina and non-ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid.
Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).

2000 IU/0.2 mL and 6000 IU/0.6 mL soln for inj: All patients should be evaluated for a bleeding disorder before administration of Enoxaparin, unless the medication is needed urgently, or as prescribed by the physician.
Abdominal surgery: In patients undergoing abdominal surgery who are at risk for thromboembolic complications, the recommended dose of Enoxaparin is 40 mg once a day administered by SC injection with the initial dose given 2 hours prior to surgery.
The usual duration of administration is 7 to 10 days; up to 12 days of administration has been well tolerated in clinical trials.
Hip or Knee Replacement surgery: In patients undergoing hip or knee replacement surgery, the recommended surgery dose of Enoxaparin is 30 mg every 12 hours administered by SC injection. Provided that hemostasis has been established, the initial dose should be given 12 to 24 hours after surgery. For hip replacement surgery, a dose of 40 mg once a day SC is given initially 12 hours prior to surgery may be considered. In the initial phase of thromboprophylaxis in hip replacement surgery patients, continued prophylaxis with Enoxaparin 40 mg once a day administered by SC injection for 3 weeks is recommended.
The usual duration of administration is 7 to 10 days; up to 14 days of administration has been well tolerated in clinical trials.
Medical Patients During Acute Illness: In medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness, the recommended dose of Enoxaparin is 40 mg once a day administered by SC injection. The usual duration of administration is 6 to 11 days up to 14 days of Enoxaparin has been well tolerated in the controlled clinical trial.
Administration: Enoxaparin is a clear, colorless to pale yellow sterile solution, and as with other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration.
Enoxaparin is administered by SC injection. It must not be administered by intramuscular injection.
Enoxaparin is intended for use under the guidance of a physician. Patients may self-inject only if their physician determines that it is appropriate and with medical follow-up, as necessary. Proper training in subcutaneous injection technique (with or without the assistance of an injection device) should be provided.
Subcutaneous Injection Technique: Patients should be lying down and Enoxaparin administered by deep SC injection. To avoid the loss of the drug, do not expel the air bubble from the syringe before the injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. The whole length of the needle should be introduced into a skin fold held between the thumb and forefinger; the skin fold should be held throughout the injection. To minimize bruising, do not rub the injection site after completion of the injection.
4000 IU/0.4 mL soln for inj: Posology: Prophylaxis of venous thromboembolic disease in moderate and high-risk surgical patients: Individual thromboembolic risk for patients can be estimated using a validated risk stratification model. In patients at moderate risk of thromboembolism, the recommended dose of enoxaparin sodium is 2,000 IU (20 mg) once daily by subcutaneous (SC) injection. Pre-operative initiation (2 hours before surgery) of enoxaparin sodium 2,000 IU (20 mg) was proven effective and safe in moderate-risk surgery.
In moderate-risk patients, enoxaparin sodium treatment should be maintained for a minimum period of 7-10 days whatever the recovery status (e.g., mobility).
Prophylaxis should be continued until the patient no longer has significantly reduced mobility.
In patients at high risk of thromboembolism, the recommended dose of enoxaparin sodium is 4,000 IU (40 mg) once daily given by SC injection preferably started 12 hours before surgery. If there is a need for earlier than 12 hours of enoxaparin sodium pre-operative prophylactic initiation (e.g., high-risk patient waiting for a deferred orthopedic surgery), the last injection should be administered no later than 12 hours prior to surgery and resumed 12 hours after surgery.
For patients who undergo major orthopedic surgery an extended thromboprophylaxis for up to 5 weeks is recommended.
For patients with high venous thromboembolism (VTE) risk who undergo abdominal or pelvic surgery for cancer, an extended thromboprophylaxis for up to 4 weeks is recommended.
Prophylaxis of venous thromboembolism in medical patients: The recommended dose of enoxaparin sodium is 4,000 IU (40 mg) once daily by SC injection. Treatment with enoxaparin sodium is prescribed for at least 6 to 14 days whatever the recovery status (e.g., mobility). The benefit is not established for treatment longer than 14 days.
Treatment of DVT and PE: Enoxaparin sodium can be administered SC either as a once-daily injection of 150 IU/kg (1.5 mg/kg) or as twice-daily injections of 100 IU/kg (1 mg/kg).
The regimen should be selected by the physician based on an individual assessment including an evaluation of the thromboembolic risk and of the risk of bleeding. The dose regimen of 150 IU/kg (1.5 mg/kg) administered once daily should be used in uncomplicated patients with a low risk of VTE recurrence. The dose regimen of 100 IU/kg (1 mg/kg) administered twice daily should be used in all other patients such as those with obesity, symptomatic PE, cancer, recurrent VTE or proximal (vena iliaca) thrombosis.
Enoxaparin sodium treatment is prescribed for an average period of 10 days. Oral anticoagulant therapy should be initiated when appropriate.
Prevention of thrombus formation during hemodialysis: The recommended dose is 100 IU/kg (1 mg/kg) of enoxaparin sodium.
For patients with a high risk of hemorrhage, the dose should be reduced to 50 IU/kg (0.5 mg/kg) for double vascular access or 75 IU/kg (0.75 mg/kg) for single vascular access.
During hemodialysis, enoxaparin sodium should be introduced into the arterial line of the circuit at the beginning of the dialysis session. The effect of this dose is usually sufficient for a 4-hour session; however, if fibrin rings are found, for example after a longer than normal session, a further dose of 50 IU to 100 IU/kg (0.5 to 1 mg/kg) may be given.
No data are available on patients using enoxaparin sodium for prophylaxis or treatment and during hemodialysis sessions.
Acute coronary syndrome: treatment of unstable angina and NSTEMI and treatment of acute STEMI.
For treatment of unstable angina and NSTEMI, the recommended dose of enoxaparin sodium is 100 IU/kg (1 mg/kg) every 12 hours by SC injection administered in combination with antiplatelet therapy. Treatment should be maintained for a minimum of 2 days and continued until clinical stabilization. The usual duration of treatment is 2 to 8 days.
Acetylsalicylic acid is recommended for all patients without contraindications at an initial oral loading dose of 150-300 mg (in acetylsalicylic acid-naive patients) and a maintenance dose of 75-325 mg/day long-term regardless of the treatment strategy.
For treatment of acute STEMI, the recommended dose of enoxaparin sodium is a single intravenous (IV) bolus of 3,000 IU (30 mg) plus a 100 IU/kg (1 mg/kg) SC dose followed by 100 IU/kg (1 mg/kg) administered SC every 12 hours (maximum 10,000 IU (100 mg) for each of the first two SC doses). Appropriate antiplatelet therapy such as oral acetylsalicylic acid (75 mg to 325 mg once daily) should be administered concomitantly unless contraindicated. The recommended duration of treatment is 8 days or until hospital discharge, whichever comes first. When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific), enoxaparin sodium should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy.
For dosage in patients ≥75 years of age.
For patients managed with PCI, if the last dose of enoxaparin sodium SC was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last SC administration was given more than 8 hours before balloon inflation, an IV bolus of 30 IU/kg (0.3 mg/kg) enoxaparin sodium should be administered.
Pediatric population: The safety and efficacy of enoxaparin sodium in the pediatric population have not been established.
Elderly: For all indications except STEMI, no dose reduction is necessary for elderly patients, unless kidney function is impaired.
For treatment of acute STEMI in elderly patients ≥75 years of age, an initial IV bolus must not be used. Initiate dosing with 75 IU/kg (0.75 mg/kg) SC every 12 hours (maximum 7,500 IU (75 mg) for each of the first two SC doses only, followed by 75 IU/kg (0.75 mg/kg) SC dosing for the remaining doses).
Hepatic impairment: Limited data are available in patients with hepatic impairment and caution should be used in these patients.
Renal impairment: Severe renal impairment: Enoxaparin sodium is not recommended for patients with end-stage renal disease (creatinine clearance <15 mL/min) due to the lack of data in this population outside the prevention of thrombus formation in extracorporeal circulation during hemodialysis.
Dosage table for patients with severe renal impairment (creatinine clearance [15-30] mL/min): The recommended dosage adjustments do not apply to the hemodialysis indication. (See Table 1.)

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Moderate and mild renal impairment: Although no dose adjustment is recommended in patients with moderate (creatinine clearance 30-50 mL/min) and mild (creatinine clearance 50-80 mL/min) renal impairment, careful clinical monitoring is advised.
Method of administration: Enoxaparin sodium injection should not be administered by the intramuscular route.
For the prophylaxis of venous thromboembolic disease following surgery, treatment of DVT and PE, treatment of unstable angina and NSTEMI, enoxaparin sodium should be administered by SC injection.
For acute STEMI, treatment is to be initiated with a single IV bolus injection immediately followed by an SC injection.
For the prevention of thrombus formation in the extracorporeal circulation during hemodialysis, it is administered through the arterial line of a dialysis circuit.
The pre-filled disposable syringe is ready for immediate use.
SC injection technique: Injection should be made preferably when the patient is lying down. Enoxaparin sodium is administered by deep SC injection.
Do not expel the air bubble from the syringe before the injection to avoid the loss of drug when using pre-filled syringes. When the quantity of drug to be injected requires to be adjusted based on the patient's body weight, use the graduated pre-filled syringes to reach the required volume by discarding the excess before injection. Be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe, and in such case, the volume shall be rounded up to the nearest graduation.
The administration should be alternated between the left and right anterolateral or posterolateral abdominal wall.
The whole length of the needle should be introduced vertically into a skin fold and gently held between the thumb and index finger. The skin fold should not be released until the injection is complete. Do not rub the injection site after administration.
Note for the pre-filled syringes fitted with an automatic safety system: The safety system is triggered at the end of the injection.
In case of self-administration, the patient should be advised to follow instructions provided in the patient information leaflet included in the pack of this medicine.
IV (bolus) injection (for acute STEMI indication only): For acute STEMI, treatment is to be initiated with a single IV bolus injection immediately followed by an SC injection.
For IV injection, either the multidose vial or pre-filled syringe can be used.
Enoxaparin sodium should be administered through an IV line. It should not be mixed or co-administered with other medications. To avoid the possible mixture of enoxaparin sodium with other drugs, the IV access chosen should be flushed with a sufficient amount of saline or dextrose solution prior to and following the IV bolus administration of enoxaparin sodium to clear the port of drug. Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.
Initial 3,000 IU (30 mg) bolus: For the initial 3,000 IU (30 mg) bolus, using an enoxaparin sodium graduated pre-filled syringe, expel the excessive volume to retain only 3,000 IU (30 mg) in the syringe. The 3,000 IU (30 mg) dose can then be directly injected into the IV line.
Additional bolus for PCI when last SC administration was given more than 8 hours before balloon inflation: For patients being managed with PCI, an additional IV bolus of 30 IU/kg (0.3 mg/kg) is to be administered if the last SC administration was given more than 8 hours before balloon inflation.
In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the drug to 300 IU/mL (3 mg/mL).
To obtain a 300 IU/mL (3 mg/mL) solution, it is recommended to use a 6,000 IU (60 mg) enoxaparin sodium pre-filled syringe, and a 50 mL infusion bag (i.e., using either normal saline solution (0.9%) or 5% dextrose in water) as follows: Withdraw 30 mL from the infusion bag with a syringe and discard the liquid. Inject the complete contents of the 6,000 IU (60 mg) enoxaparin sodium pre-filled syringe into the 20 mL remaining in the bag. Gently mix the contents of the bag. Withdraw the required volume of diluted solution with a syringe for administration into the IV line.
After dilution is completed, the volume to be injected can be calculated using the following formula [Volume of diluted solution (mL) = Patient weight (kg) x 0.1] or using the table as follows. It is recommended to prepare the dilution immediately before use.
Volume to be injected through IV line after dilution is completed at a concentration of 300 IU (3 mg)/mL.
Arterial line injection: It is administered through the arterial line of a dialysis circuit for the prevention of thrombus formation in the extracorporeal circulation during hemodialysis. Switch between enoxaparin sodium and oral anticoagulants.
Switch between enoxaparin sodium and vitamin K antagonists (VKA): Clinical monitoring and laboratory tests [prothrombin time expressed as the International Normalized Ratio (INR)] must be intensified to monitor the effect of VKA.
As there is an interval before the VKA reaches its maximum effect, enoxaparin sodium therapy should be continued at a constant dose for as long as necessary in order to maintain the INR within the desired therapeutic range for the indication in two successive tests.
For patients currently receiving a VKA, the VKA should be discontinued and the first dose of enoxaparin sodium should be given when the INR has dropped below the therapeutic range. (See Table 2.)

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Switch between enoxaparin sodium and direct oral anticoagulants (DOAC): For patients currently receiving enoxaparin sodium, discontinue enoxaparin sodium and start the DOAC 0 to 2 hours before the time that the next scheduled administration of enoxaparin sodium would be due as per DOAC label.
For patients currently receiving a DOAC, the first dose of enoxaparin sodium should be given at the time the next DOAC dose would be taken.
Administration in spinal/epidural anesthesia or lumbar puncture: Should the physician decide to administer anticoagulation in the context of epidural or spinal anesthesia/analgesia or lumbar puncture, careful neurological monitoring is recommended due to the risk of neuraxial hematomas.
At doses used for prophylaxis: A puncture-free interval of at least 12 hours shall be kept between the last injection of enoxaparin sodium at prophylactic doses and the needle or catheter placement.
For continuous techniques, a similar delay of at least 12 hours should be observed before removing the catheter.
For patients with creatinine clearance [15-30] mL/min, consider doubling the timing of puncture/catheter placement or removal to at least 24 hours.
The 2 hours preoperative initiation of enoxaparin sodium 2,000 IU (20 mg) is not compatible with neuraxial anesthesia.
At doses used for treatment: A puncture-free interval of at least 24 hours shall be kept between the last injection of enoxaparin sodium at curative doses and the needle or catheter placement.
For continuous techniques, a similar delay of 24 hours should be observed before removing the catheter.
For patients with creatinine clearance [15-30] mL/min, consider doubling the timing of puncture/catheter placement or removal to at least 48 hours.
Patients receiving the twice daily doses (i.e., 75 IU/kg (0.75 mg/kg) twice daily or 100 IU/kg (1 mg/kg) twice daily) should omit the second enoxaparin sodium dose to allow a sufficient delay before catheter placement or removal.
Anti-Xa levels are still detectable at these time points, and these delays are not a guarantee that neuraxial hematoma will be avoided.
Likewise, consider not using enoxaparin sodium until at least 4 hours after the spinal/epidural puncture or after the catheter has been removed. The delay must be based on a benefit-risk assessment considering both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors.

2000 IU/0.2 mL and 6000 IU/0.6 mL soln for inj: Accidental overdosage following administration of Enoxaparin may lead to hemorrhagic complications.
Injected Enoxaparin may be largely neutralized by the slow I.V. injection of protamine sulfate (1% solution).
The dose of protamine sulfate should be administrated to neutralize 1 mg of Enoxaparin, if Enoxaparin Sodium was administered in the protamine administration, or if it has been determined that a second dose of protamine is required. The second infusion of 0.5 mg protamine sulfate per 1 mg of Enoxaparin may be administered if a PTT measured 2 to 4 hours after the first infusion remains prolonged.
After 12 hours of the Enoxaparin sodium injection, protamine administration may not be required. However, even with higher doses of protamine, the PTT may remain more prolonged than under normal conditions found following administration of heparin. In all cases, the anti-Factor Xa activity is never completely neutralized (maximum about 60%).
4000 IU/0.4 mL soln for inj: Signs and symptoms: Accidental overdose with enoxaparin sodium after IV, extracorporeal or SC administration may lead to hemorrhagic complications. Following oral administration of even large doses, it is unlikely that enoxaparin sodium will be absorbed.
Management: The anticoagulant effects can be largely neutralized by the slow IV injection of protamine. The dose of protamine depends on the dose of enoxaparin sodium injected; 1 mg protamine neutralizes the anticoagulant effect of 100 IU (1 mg) of enoxaparin sodium, if enoxaparin sodium was administered in the previous 8 hours. An infusion of 0.5 mg protamine per 100 IU (1 mg) of enoxaparin sodium may be administered if enoxaparin sodium was administered greater than 8 hours previous to the protamine administration, or if it has been determined that a second dose of protamine is required. After 12 hours of the enoxaparin sodium injection, protamine administration may not be required. However, even with high doses of protamine, the anti-Xa activity of enoxaparin sodium is never completely neutralized (maximum about 60%).

2000 IU/0.2 mL and 6000 IU/0.6 mL soln for inj: Enoxaparin is contraindicated in patients with active major bleeding, in patients with thrombocytopenia associated with a positive in vitro test for antiplatelet antibody in the presence of Enoxaparin Sodium, or in patients with hypersensitivity to Enoxaparin Sodium. Patients with known hypersensitivity.
4000 IU/0.4 mL soln for inj: Enoxaparin sodium is contraindicated in patients with: Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients present in the formulation.
History of immune-mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies.
Active clinically significant bleeding and conditions with a high risk of hemorrhage, including recent hemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intra spinal or intracerebral vascular abnormalities.
Spinal or epidural anesthesia or loco-regional anesthesia when enoxaparin sodium is used for treatment in the previous 24 hours.

2000 IU/0.2 mL and 6000 IU/0.6 mL soln for inj: General: Enoxaparin should not be mixed with other injections for infusion.
Enoxaparin should be used with care in patients with a bleeding diathesis, uncontrolled arterial hypertension, or a history of recent gastrointestinal ulceration, diabetic retinopathy, and hemorrhage.
Enoxaparin should be used with care in elderly patients who may show delayed elimination of Enoxaparin.
If thromboembolic events occur despite Enoxaparin prophylaxis, appropriate therapy should be initiated.
4000 IU/0.4 mL soln for inj: General: Enoxaparin sodium cannot be used interchangeably (unit for unit) with other LMWHs. These medicinal products differ in their manufacturing process, molecular weights, specific anti-Xa and anti-IIa activities, units, dosage and clinical efficacy and safety. This results in differences in pharmacokinetics and associated biological activities (e.g., anti-thrombin activity, and platelet interactions). Special attention and compliance with the instructions for use specific to each proprietary medicinal product are therefore required.
History of HIT (>100 days): The use of enoxaparin sodium in patients with a history of immune-mediated HIT within the past 100 days or in the presence of circulating antibodies is contraindicated. Circulating antibodies may persist for several years.
Enoxaparin sodium is to be used with extreme caution in patients with a history (>100 days) of heparin-induced thrombocytopenia without circulating antibodies. The decision to use enoxaparin sodium in such a case must be made only after a careful benefit-risk assessment and after non-heparin alternative treatments are considered (e.g., danaparoid sodium or lepirudin).
Monitoring of platelet counts: The risk of antibody-mediated HIT also exists with LMWHs. Should thrombocytopenia occur, it usually appears between the 5 and the 21-day following the beginning of enoxaparin sodium treatment.
The risk of HIT is higher in postoperative patients and mainly after cardiac surgery and in patients with cancer.
Therefore, it is recommended that the platelet counts be measured before the initiation of therapy with enoxaparin sodium and then regularly thereafter during the treatment.
If there are clinical symptoms suggestive of HIT (any new episode of arterial and/or venous thromboembolism, any painful skin lesion at the injection site, any allergic or anaphylactoid reactions on treatment), the platelet count should be measured. Patients must be aware that these symptoms may occur and if so, that they should inform their primary care physician.
In practice, if a confirmed significant decrease of the platelet count is observed (30 to 50% of the initial value), enoxaparin sodium treatment must be immediately discontinued and the patient switched to another non-heparin anticoagulant alternative treatment.
Hemorrhage: As with other anticoagulants, bleeding may occur at any site. If bleeding occurs, the origin of the hemorrhage should be investigated and appropriate treatment instituted.
Enoxaparin sodium, as with any other anticoagulant therapy, should be used with caution in conditions with increased potential for bleeding, such as: impaired hemostasis, history of peptic ulcer, recent ischemic stroke, severe arterial hypertension, recent diabetic retinopathy, neuro- or ophthalmologic surgery, concomitant use of medications affecting hemostasis.
Laboratory tests: At doses used for prophylaxis of venous thromboembolism, enoxaparin sodium does not influence bleeding time and global blood coagulation tests significantly, nor does it affect platelet aggregation or binding of fibrinogen to platelets.
At higher doses, increases in activated partial thromboplastin time (aPTT), and activated clotting time (ACT) may occur. Increases in aPTT and ACT are not linearly correlated with increasing enoxaparin sodium antithrombotic activity and therefore are unsuitable and unreliable for monitoring enoxaparin sodium activity.
Spinal/Epidural anesthesia or lumbar puncture: Spinal/epidural anesthesia or lumbar puncture must not be performed within 24 hours of administration of enoxaparin sodium at therapeutic doses.
There have been cases of neuraxial hematomas reported with the concurrent use of enoxaparin sodium and spinal/epidural anesthesia or spinal puncture procedures resulting in long term or permanent paralysis. These events are rare with enoxaparin sodium dosage regimens 4,000 IU (40 mg) once daily or lower. The risk of these events is higher with the use of post-operative indwelling epidural catheters, with the concomitant use of additional drugs affecting hemostasis such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), with traumatic or repeated epidural or spinal puncture, or in patients with a history of spinal surgery or spinal deformity.
To reduce the potential risk of bleeding associated with the concurrent use of enoxaparin sodium and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of enoxaparin sodium. Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of enoxaparin sodium is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known. For patients with creatinine clearance [15-30 mL/minute], additional considerations are necessary because elimination of enoxaparin sodium is more prolonged.
Should the physician decide to administer anticoagulation in the context of epidural or spinal anesthesia/analgesia or lumbar puncture, frequent monitoring must be exercised to detect any signs and symptoms of neurological impairment such as midline back pain, sensory and motor deficits (numbness or weakness in lower limbs), bowel and/or bladder dysfunction. Instruct patients to report immediately if they experience any of the previously mentioned signs or symptoms. If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae.
Skin necrosis/cutaneous vasculitis: Skin necrosis and cutaneous vasculitis have been reported with LMWHs and should lead to prompt treatment discontinuation.
Percutaneous coronary revascularization procedures: To minimize the risk of bleeding following the vascular instrumentation during the treatment of unstable angina, NSTEMI and acute STEMI, adhere precisely to the intervals recommended between enoxaparin sodium injection doses. It is important to achieve hemostasis at the puncture site after PCI. In case a closure device is used, the sheath can be removed immediately. If a manual compression method is used, sheath should be removed 6 hours after the last IV/SC enoxaparin sodium injection. If the treatment with enoxaparin sodium is to be continued, the next scheduled dose should be given no sooner than 6 to 8 hours after sheath removal. The site of the procedure should be observed for signs of bleeding or hematoma formation.
Acute infective endocarditis: Use of heparin is usually not recommended in patients with acute infective endocarditis due to the risk of cerebral hemorrhage. If such use is considered absolutely necessary, the decision must be made only after a careful individual benefit risk assessment.
Mechanical prosthetic heart valves: The use of enoxaparin sodium has not been adequately studied for thromboprophylaxis in patients with mechanical prosthetic heart valves. Isolated cases of prosthetic heart valve thrombosis have been reported in patients with mechanical prosthetic heart valves who have received enoxaparin sodium for thromboprophylaxis. Confounding factors, including underlying disease and insufficient clinical data, limit the evaluation of these cases. Some of these cases were pregnant women in whom thrombosis led to maternal and fetal death.
Low weight: 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), which may lead to a higher risk of bleeding. Therefore, careful clinical monitoring is advised in these patients.
Obese Patients: Obese patients are at higher risk for thromboembolism. The safety and efficacy of prophylactic doses in obese patients (BMI >30 kg/m²) has not been fully determined and there is no consensus for dose adjustment. These patients should be observed carefully for signs and symptoms of thromboembolism.
Hyperkalemia: Heparins can suppress adrenal secretion of aldosterone leading to hyperkalemia, particularly in patients such as those with diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis, taking medicinal products known to increase potassium. Plasma potassium should be monitored regularly especially in patients at risk.
Traceability: LMWHs are biological medicinal products. In order to improve the LMWH traceability, it is recommended that health care professionals record the trade name and batch number of the administered product in the patient file.
Sodium: For patients receiving doses higher than 210 mg/day, this medicine contains more than 24 mg sodium in each dose. This is equivalent to 1.2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Renal impairment: In patients with renal impairment, there is an increase in exposure of enoxaparin sodium which increases the risk of bleeding. In these patients, careful clinical monitoring is advised, and biological monitoring by anti-Xa activity measurement might be considered. Enoxaparin sodium is not recommended for patients with end stage renal disease (creatinine clearance <15 mL/min) due to lack of data in this population outside the prevention of thrombus formation in extracorporeal circulation during hemodialysis.
In patients with severe renal impairment (creatinine clearance 15-30 mL/min), since exposure of enoxaparin sodium is significantly increased, a dosage adjustment is recommended for therapeutic and prophylactic dosage ranges.
No dose adjustment is recommended in patients with moderate (creatinine clearance 30-50 mL/min) and mild (creatinine clearance 50-80 mL/min) renal impairment.
Hepatic impairment: Enoxaparin sodium should be used with caution in patients with hepatic impairment due to an increased potential for bleeding. Dose adjustment based on monitoring of anti-Xa levels is unreliable in patients with liver cirrhosis and not recommended.
Use in Pregnancy & Lactation: Pregnant women with mechanical prosthetic heart valves: The use of enoxaparin sodium for thromboprophylaxis in pregnant women with mechanical prosthetic heart valves has not been adequately studied. In a clinical study of pregnant women with mechanical prosthetic heart valves given enoxaparin sodium (100 IU/kg (1 mg/kg) twice daily) to reduce the risk of thromboembolism, 2 of 8 women developed clots resulting in blockage of the valve and leading to maternal and fetal death. There have been isolated post-marketing reports of valve thrombosis in pregnant women with mechanical prosthetic heart valves while receiving enoxaparin sodium for thromboprophylaxis. Pregnant women with mechanical prosthetic heart valves may be at higher risk for thromboembolism.
Use in the Elderly: No increased bleeding tendency is observed in the elderly with the prophylactic dosage ranges. Elderly patients (especially patients eighty years of age and older) may be at an increased risk for bleeding complications with the therapeutic dosage ranges. Careful clinical monitoring is advised and dose reduction might be considered in patients older than 75 years treated for STEMI.

Pregnancy: In humans, there is no evidence that Enoxaparin crosses the placental barrier during the second and third trimester of pregnancy. There is no information available concerning the first trimester. Animal studies have not shown any evidence of fetotoxicity or teratogenicity. Animal data have shown that Enoxaparin passage through the placenta is minimal.
Enoxaparin sodium should be used during pregnancy only if the physician has established a clear need.
Pregnant women receiving Enoxaparin Sodium should be carefully monitored for evidence of bleeding or excessive anticoagulation and should be warned of the hemorrhagic risk. Overall, the data suggest that there is no evidence for an increased risk of hemorrhage, thrombocytopenia, or osteoporosis with respect to the risk observed in non-pregnant women, other than that observed in pregnant women with prosthetic heart valves. If epidural anesthesia is planned, it is recommended to withdraw Enoxaparin Sodium treatment before.
Breastfeeding: It is not known whether unchanged Enoxaparin is excreted in human breast milk. In lactating rats, the passage of Enoxaparin or its metabolites in milk is very low. The oral absorption of Enoxaparin Sodium is unlikely. Enoxaparin can be used during breastfeeding.
Fertility: There is no clinical data for Enoxaparin Sodium in fertility. Animal studies did not show any effect on fertility.

2000 IU/0.2 mL and 6000 IU/0.6 mL soln for inj: Hemorrhage: The incidence of major hemorrhagic complications during Enoxaparin treatment has been low.
Thrombocytopenia: Mild to moderate thrombocytopenia can occur with the administration of Enoxaparin.
Cases of heparin-induced thrombocytopenia with thrombosis have also been observed in clinical practices.
Some of these cases were complicated by organ infarction, limb ischemia, or death.
Since Aminotransferase determinations are important in the differential diagnosis of Myocardial Infarction, liver disease, and pulmonary emboli, elevations that might be caused by drugs like Enoxaparin should be interpreted with caution.
Local Reaction: Mild local irritation, pain, hematoma, ecchymosis, and erythema may follow SC Enoxaparin than in patients treated with I.V. heparin.
Adverse events in Enoxaparin-treated patients with unstable angina or Non-Q-wave Myocardial Infarction: Non-major hemorrhagic, primarily injection site ecchymosis and hematomas were more frequently reported in patients treated with I.V. heparin.
4000 IU/0.4 mL soln for inj: Summary of the safety profile: Enoxaparin sodium has been evaluated in more than 15,000 patients who received enoxaparin sodium in clinical trials. These included 1,776 for prophylaxis of deep vein thrombosis following orthopedic or abdominal surgery in patients at risk for thromboembolic complications, 1,169 for prophylaxis of deep vein thrombosis in acutely ill medical patients with severely restricted mobility, 559 for treatment of DVT with or without PE, 1,578 for treatment of unstable angina and non-Q-wave myocardial infarction and 10,176 for treatment of acute STEMI.
Enoxaparin sodium regimen administered during these clinical trials varies depending on indications. The enoxaparin sodium dose was 4,000 IU (40 mg) SC once daily for prophylaxis of deep vein thrombosis following surgery or in acutely ill medical patients with severely restricted mobility. In treatment of DVT with or without PE, patients receiving enoxaparin sodium were treated with either 100 IU/kg (1 mg/kg) SC dose every 12 hours or a 150 IU/kg (1.5 mg/kg) SC dose once a day. In the clinical studies for treatment of unstable angina and non-Q-wave myocardial infarction, doses were 100 IU/kg (1 mg/kg) SC every 12 hours, and in the clinical study for treatment of acute STEMI enoxaparin sodium regimen was a 3,000 IU (30 mg) IV bolus followed by 100 IU/kg (1 mg/kg) SC every 12 hours. In clinical studies, hemorrhages, thrombocytopenia and thrombocytosis were the most commonly reported.
Tabulated summary list of adverse reactions: Other adverse reactions observed in clinical studies and reported in post-marketing experience (* indicates reactions from post-marketing experience) are detailed as follows.
Frequencies are defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1,000); and very rare (<1/10,000) or not known (cannot be estimated from available data). Within each system organ class, adverse reactions are presented in order of decreasing seriousness.
Blood and the lymphatic system disorders: Common: Hemorrhage, hemorrhagic anemia, thrombocytopenia, thrombocytosis.
Rare: Eosinophilia, cases of immuno-allergic thrombocytopenia with thrombosis; in some of them thrombosis was complicated by organ infarction or limb ischemia.
Immune system disorders: Common: Allergic reaction.
Rare: Anaphylactic/Anaphylactoid reactions including shock*.
Nervous system disorders: Common: Headache*.
Vascular disorders: Rare: Spinal hematoma* (or neuraxial hematoma). These reactions have resulted in varying degrees of neurologic injuries including long-term or permanent paralysis.
Hepato-biliary disorders: Very common: Hepatic enzyme increases (mainly transaminases >3 times the upper limit of normality).
Uncommon: Hepatocellular liver injury*. Rare: Cholestatic liver injury".
Skin and subcutaneous tissue disorders: Common: Urticaria, pruritus, erythema.
Uncommon: Bullous dermatitis.
Rare: Alopecia*, cutaneous vasculitis*, skin necrosis* usually occurring at the injection site (these phenomena have been usually preceded by purpura or erythematous plaques, infiltrated and painful). Injection site nodules* (inflammatory nodules, which were not cystic enclosure of enoxaparin).
They resolve after a few days and should not cause treatment discontinuation.
Musculoskeletal, connective tissue and bone disorders: Rare: Osteoporosis* following long term therapy (greater than 3 months).
General disorders and administration site conditions: Common: Injection site hematoma, injection site pain, other injection site reaction (such as oedema, hemorrhage, hypersensitivity, inflammation, mass, pain, or reaction). Uncommon: Local irritation, skin necrosis at injection site.
Investigations: Rare: Hyperkalemia*.
Description of selected adverse reactions: Hemorrhages: These included major hemorrhages, reported at most in 4.2% of the patients (surgical patients). Some of these cases have been fatal. In surgical patients, hemorrhage complications were considered major: if the hemorrhage caused a significant clinical event, or if accompanied by hemoglobin decrease >2 g/dL or transfusion of 2 or more units of blood products. Retroperitoneal and intracranial haemorrhages were always considered major.
As with other anticoagulants, hemorrhage may occur in the presence of associated risk factors such as: organic lesions liable to bleed, invasive procedures or the concomitant use of medications affecting hemostasis. (See Table 3.)

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Such as hematoma, ecchymosis other than at injection site, wound hematoma, hematuria, epistaxis and gastrointestinal hemorrhage.
Thrombocytopenia and thrombocytosis: See Table 4.

Click on icon to see table/diagram/image

2000 IU/0.2 mL and 6000 IU/0.6 mL soln for inj: Unless really needed, agents which may enhance the risk of hemorrhage should be discontinued prior to initiation of Enoxaparin therapy.
These agents include medications such as: anticoagulants, platelet inhibitors including acetylsalicylic acid, salicylates, NSAIDS (including ketorolac, tromethamine), dipyridamole, or sulfinpyrazone. If coadministration, conduct close clinical and laboratory monitoring.
Heparin-induced thrombocytopenia: Enoxaparin should be used with extreme caution in patients with a history of heparin-induced thrombocytopenia.
Hemorrhage: Enoxaparin, like other anticoagulants, should be used with extreme caution in conditions with increased risk of hemorrhage, such as bacterial endocarditis, congenital or acquired bleeding disorders, active ulcerative and angiodysplastic gastrointestinal disease, hemorrhagic stroke, or shortly after brain, spinal, or ophthalmological surgery, or in patients treated concomitantly with platelet inhibitors. Cases of epidural or spinal hematomas have been reported with the associated use of Enoxaparin and spinal/epidural anesthesia or spinal puncture resulting in long-term or permanent paralysis. The risk of these events is higher with the use of post-operative in-dwelling epidural catheters or by the concomitant use of additional drugs affecting homeostasis such as NSAIDs.
Major hemorrhages including retroperitoneal and intracranial bleeding have been reported. Some of these cases have been fatal.
Bleeding can occur at any site during therapy with Enoxaparin. An unexplained fall in hematocrit or blood pressure should lead to a search for a bleeding site.
Low-weight patients: An increase in exposure of Enoxaparin with sodium with prophylactic dosage (Non-weight adjusted) has been observed in low-weight (<45 kg) and low-weight men (<57 kg), which may lead to a higher risk of bleeding. Therefore, careful clinical monitoring is advised. All such patients should be observed carefully for signs and symptoms of bleeding.
Use in Pregnancy: Enoxaparin is not predicated to increase the risk of development and abnormalities.
Enoxaparin does not cross the placenta based on human and animal studies and shows no evidence of teratogenic effects of fetotoxicity. Since there are no adequate and well-controlled studies in pregnant women, Enoxaparin should be used during pregnancy only if clearly needed. Pregnant women should be apprised of the potential hazard to the fetus and the mother if Enoxaparin is administered during pregnancy.
4000 IU/0.4 mL soln for inj: Concomitant use not recommended: Medicinal products affecting hemostasis: It is recommended that some agents which affect hemostasis should be discontinued prior to enoxaparin sodium therapy unless strictly indicated. If the combination is indicated, enoxaparin sodium should be used with careful clinical and laboratory monitoring when appropriate. These agents include medicinal products such as: Systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, and NSAIDS including ketorolac.
Other thrombolytics (e.g., alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants.
Concomitant use with caution: The following medicinal products may be administered with caution concomitantly with enoxaparin sodium: Other medicinal products affecting hemostasis such as: Platelet aggregation inhibitors including acetylsalicylic acid used at antiaggregant dose (cardio protection), clopidogrel, ticlopidine, and glycoprotein IIb/Illa antagonists indicated in acute coronary syndrome due to the risk of bleeding.
Dextran 40.
Systemic glucocorticoids.
Medicinal products increasing potassium levels: Medicinal products that increase serum potassium levels may be administered concurrently with enoxaparin sodium under careful clinical and laboratory monitoring.

4000 IU/0.4 mL soln for inj: Incompatibilities: SC injection.
Do not mix with other products.
IV (Bolus) Injection (for acute STEMI indication only): This medicinal product must not be mixed with other medicinal products except those mentioned in dosage & route of administration.
Special Precautions for Handling and Disposal: Pre-filled syringes are ready for immediate use. For method of administration refer to dosage and method of administration. Use only clear, colourless to yellowish solutions.
Pre-filled syringes are supplied with or without an automatic safety system. The instructions for use are presented in the package leaflet.
Each syringe is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Store at temperatures not exceeding 30°C.
4000 IU/0.4 mL soln for inj: Do not freeze pre-filled syringes.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

B01AB05 - enoxaparin ; Belongs to the class of heparin group. Used in the treatment of thrombosis.

Rx