Enoxaparin sodium Impact 4000 IU (40 mg)/0.4 ml, solutions for injection in pre-filled syringes.

1 Pre-filled Syringe

Sold by Shwe Myittar Pharmacy 

Each pre-filled syringe contains 4 000 IU of anti-Xa activity (equivalent to 40 mg) of enoxaparin sodium in 0.4 ml of water for injections.

THERAPEUTIC INDICATIONS:

Indicated in adults for Prophylactic treatment of venous thromboembolic disease in moderate and high risk surgical patients, medical patients with an

acute illness, Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery,

The prolonged treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of their recurrence in patients with active

cancer, Prevention of thrombus formation in extracorporeal circulation during haemodialysis, 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).

POSOLOGY: Prophylactic treatment for venous thromboembolic disease in surgery: In patients at moderate risk of thromboembolism, the recommended dose of Enoxaparin sodium is 2 000 IU (20 mg) once daily by SC injection for 7-10 days. In patients at high risk of thromboembolism, the recommended dose of Enoxaparin sodium is 4 000 IU (40 mg) once daily by SC injection for up to 4-5 weeks depending on the surgery. Prophylactic treatment in acute medical illness:recommended dose of Enoxaparin sodium is 4 000 IU (40 mg) once daily by SC injection for 6-14 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). 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 anti-platelet therapy until clinical stabilization usually 2-8 days. 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. The safety and efficacy of Enoxaparin sodium in the paediatric population have not been established. For all indications except STEMI, no dose reduction is necessary in the elderly patients, unless kidney function is impaired.

METHOD OF ADMINISTRATION: Enoxaparin sodium Impact should not be administered by the intramuscular route. For more information, refer to the full Summary of Product characteristics. When switching between Enoxaparin sodium and vitamin K antagonists (VKA), Clinical monitoring and laboratory tests [pro-thrombin time expressed as the

International Normalized Ratio (INR)] must be intensified to monitor the effect of VKA. Enoxaparin sodium therapy should be continued at a constant dose for as long as necessary to maintain the INR within the desired therapeutic range for the indication in two successive tests. 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.

CONTRA-INDICATIONS: Hypersensitivity to the active substance or to any of the excipients, History of immune-mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies, Active clinically significant bleeding or associated conditions with a high risk of hemorrhage. Spinal or epidural anesthesia or loco-regional anesthesia when Enoxaparin sodium is used for treatment in the previous 24 hours.

SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE: 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. 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. It is recommended that the platelet counts be measured before the initiation of therapy with Enoxaparin sodium and then regularly thereafter during the treatment. At doses used for prophylactic treatment 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 coagulation time (ACT) may occur. Increases in APTT and ACT are not linearly correlated with increasing Enoxaparin sodium anti thrombotic activity and therefore are unsuitable and unreliable for monitoring enoxaparin sodium activity. For more information, refer to the full SmPC.

INTERACTIONS:

It is recommended that some agents which affect haemostasis 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. Such agents include systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, and NSAIDs including ketorolac; thrombolytics (e.g. alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants. The following medicinal products may be administered with caution concomitantly with Enoxaparin sodium: Platelet aggregation inhibitors including acetylsalicylic acid used at antiaggregant dose (cardioprotection), clopidogrel, ticlopidine, and glycoprotein IIb/IIIa antagonists indicated in acute coronary syndrome due to the risk of bleeding; Dextran 40; Systemic glucocorti-coids. 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.

PREGNANCY AND LACTATION: 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. 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 haemorrhagic 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. 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.

UNDESIRABLE EFFECTS:

Enoxaparin sodium has been evaluated in more than 15000 patients in clinical trials: 1776 for prophylaxis of deep vein thrombosis following orthopedic or abdominal surgery in patients at risk for thromboembolic complications, 1169 prophylaxis of deep vein thrombosis in acutely ill medical patients

with severely restricted mobility, 559 for treatment of DVT with or without PE, 1578 for treatment of unstable angina and non-Q-wave myocardial infarction and 10176 for treatment of acute STEMI. In clinical studies, haemorrhages, thrombocytopenia and thrombocytosis were the most commonly reported reactions. The safety profile of enoxaparin for the prolonged treatment of DVT and PE in patients with active cancer is like its safety profile for the treatment of DVT and PE. Other adverse reactions are outlines in the full SmPC.

OVERDOSE: The anticoagulant effects of Enoxaparin Impact can be largely neutralised by the slow IV injection of protamine. The dose of protamine depends on the dose of Enoxaparin sodium injected: 1 mg protamine neutralises 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.