Acute ST-segment elevation myocardial infarction (STEMI)

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 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.

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 a SC injection.

Enoxaparin sodium should be administered through an IV line. It should not be mixed or co-administered with other medicinal products. To avoid the possible mixture of enoxaparin sodium with other medicinal products, the IV access chosen should be flushed with a sufficient amount of sodium chloride 9 mg/ml (0.9%) or 5% glucose in water for injections prior to and following the IV bolus administration of enoxaparin sodium to clear the port of the medicinal product. Enoxaparin sodium may be safely administered with normal sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose in water for injections.

Initial 3,000 IU (30 mg) bolus

For the initial 3,000 IU (30 mg) bolus, using an enoxaparin sodium graduated pre-filled syringe, the excessive volume has to be expelled 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 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 medicinal product to 300 IU/mL (3 mg/mL).

To obtain a 300 IU/mL (3 mg/mL) solution, using a 6,000 IU (60 mg) enoxaparin sodium pre-filled syringe, it is recommended to use a 50 mL infusion bag (i.e. using either sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose in water for injections) 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 below. 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.