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WARNING: The different low molecular weight heparins are not necessarily equivalent. Therefore compliance with the dosage regimen and the specific method of use for each of these medicinal products is required.
Adults: General surgery with moderate risk of venous thromboembolism: On the day of the surgical procedure, 2,500 IU anti-Xa is to be administered by subcutaneous route (sc), 2 hours before or 6 hours after surgery. On subsequent days, 2,500 IU anti-Xa sc is to be administered every 24 hours.
Orthopedic surgery with high risk of venous thromboembolism: On the day of the surgical procedure, 3,500 IU anti-Xa is to be administered by sc route, 2 hours before or 6 hours after surgery. On subsequent days, 3,500 IU anti-Xa sc is to be administered every 24 hours.
Prophylactic treatment must be followed in accordance with the physician's opinion during the period of risk or until the patient is mobilised. As a general rule, it is considered necessary to maintain prophylactic treatment for at least 7 - 10 days after the surgical procedure and until the risk of thromboembolic disease has decreased.
Prevention of thromboembolic disease in non-surgical patients: The recommended posology of bemiparin is 2,500 IU/day or 3,500 IU/day by sc route, according to whether the set of risk factors of the patient defines as mild or high thromboembolic risk.
Prophylactic treatment should be continued, in accordance with the physician’s opinion, during the period of risk or until the patient is mobilised.
Secondary prevention of the venous thromboembolism recurrences in patients with deep venous thrombosis and transitory risk factors: HIBOR may be administered at the fixed dose of 3,500 IU / day, up to a maximum period of 3 months, in patients who have received anticoagulant treatment for deep vein thrombosis with or without pulmonary embolism, as therapeutic alternative to oral anticoagulant administration or in cases of contraindication of its use.
Prevention of clotting in the extracorporeal circulation circuit during haemodialysis: For patients undergoing repeated haemodialysis sessions of no longer than 4 hours in duration and with no risk of bleeding, the prevention of clotting in the extracorporeal circulation circuit is obtained by injecting a single dose in the form of bolus into the arterial line at the beginning of the dialysis session. For patients weighing less than 60 kg, the dose to be administered will be 2,500 IU, whereas for patients weighing more than 60 kg, the dose to be administered will be 3,500 IU.
Treatment deep vein thrombosis: HIBOR should be administered by subcutaneous route at the fixed dose of 115 IU anti-Xa/kg weight/day, during 7 ± 2 days as a general rule. This daily dose generally corresponds, depending on the body weight, to the ranges: <50 kg, 0.2 ml (5,000 IU anti-Xa); 50-70 kg, 0.3 ml (7,500 IU anti-Xa); 70-100 kg, 0.4 ml (10,000 IU anti-Xa) and 100-120 kg, 0.5 ml (12,500 IU anti-Xa). In patients of > 120 kg of weight, the dose to be administered must be adjusted to the weight, at a rate of 115 IU anti-Xa/kg/day, considering the concentration of 25,000 IU / ml.
Unless contraindicated, oral anticoagulant treatment will be initiated between days 3-5 after starting the administration of HIBOR, in doses adjusted to maintain the INR between 2 and 3 on the control value. The administration of bemiparin may be discontinued once reached the mentioned value of INR. Oral anticoagulation should be continued during a minimum of 3 months.
In patients with deep vein thrombosis and transitory risk factors, as a therapeutic alternative to oral anticoagulant administration or in cases of contraindication of its use, HIBOR may be administered at the fixed dose of 3,500 IU / day, up to a maximum of 3 months.
Children: HIBOR is not recommended for use in children under 18 years due to a lack of data on safety and efficacy.
Elderly: No dose adjustment required.
Renal and hepatic impairment: There are insufficient data to recommend a dose adjustment of bemiparin in this group of patients.
Method of administratio: Subcutaneous injection technique: The patient should follow these steps: Wash hands thoroughly. The patient should be sitting or lying in a comfortable position at the time of Hibor administration.
The administration of HIBOR by subcutaneous route is performed by injecting the syringe in the subcutaneous cell tissue of the anterolateral or posterolateral abdominal waist, to 5 centimetres from the navel and any scar or bruise. Clean the skin in that area.
Use different places for the injection on different days, for example, first on the left hand side, next time on the right.
Pull the needle cap off the HIBOR syringe.
To keep the needle sterile, make sure it doesn't touch anything.
This pre-filled syringe is now ready for use.
Before injecting, do not push the plunger to get rid of any air bubbles, because the patient might lose the medicine.
Hold the syringe in one hand and with the other hand, using the forefinger and thumb, gently pinch the area of skin which the patient has cleaned and make a skin fold.
Insert the whole needle into the folded skin keeping the syringe as straight as possible on the body surface at a 90° angle.
Press down on the plunger, making sure the patient holds the skin fold in position throughout the injection.
Remove the syringe from the injection site keeping the finger on the plunger rod and syringe straight. Let go of the skin fold.
Immediately discard the syringe throwing it into the sharps bin closest (the needle in), close the container lid tightly and place it out of reach of children.
Warnings: Do not reuse the needle shield after injection.
Do not rub the skin where the patient has put the injection in. This will help to avoid bruises.
