Indication

Hibor 2500 I.U. & 3500 I.U. Prevention of venous thromboembolism (VTE)

Hibor 5000 I.U., 7500 I.U., 10000 I.U. Treatment of venous thromboembolism (VTE)

Qualitative Quantitative Composition

Bemiparin sodium 2,500 IU (anti-Xa)/0.2 ml

Bemiparin sodium 3500 IU/0.2 ml

Bemiparin sodium 5,000 IU (anti-Xa)/0.2 ml

Bemiparin sodium 7,500 IU (anti-Xa)/0.3 ml

Bemiparin sodium 10,000 IU (anti-Xa)/0.4 ml

Pharmaceutical Dose Form

Solution for injection in pre-filled syringe

Dose And Administration

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.

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.

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 of venous thromboembolism (VTE)

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 correspondes, 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.

Contraindications

Hypersensitivity to bemiparin sodium, heparin or substances of porcine origin.

History of confirmed or suspected immunologically mediated heparin induced thrombocytopenia (HIT).

Active haemorrhage or increased risk of bleeding due to impairment of haemostasis.

Severe impairment of liver or pancreatic function.

Injuries to or operations on the central nervous system, eyes and ears within the last 2 months.

Disseminated Intravascular Coagulation (DIC) attributable to heparin-induced thrombocytopenia.

Acute bacterial endocarditis and slow endocarditis.

Organic lesions susceptible of bleed (e.g.: active peptic ulcer, haemorrhagic stroke, cerebral aneurysm or cerebral neoplasms).

Special Warnings Precautions

Do not administer by the intramuscular route.

Caution should be exercised in cases of liver or renal failure, uncontrolled arterial hypertension, history of gastro-duodenal ulcer disease, thrombocytopenia, nephrolithiasis and/or urethrolithiasis, choroid and retinal vascular disease, or any other organic lesion susceptible of bleed, or in patients undergoing spinal or epidural anaesthesia and/or lumbar puncture.

Interaction

The concomitant administration of bemiparin and the following medicinal products is not advisable:

Vitamin K antagonists and other anticoagulants, acetyl salicylic acid and other salicylates and NSAIDs, ticlopidine, clopidogrel and other platelet inhibitors systemic glucocorticoids and dextran.

License Name

บริษัท สตาดา (ประเทศไทย) จำกัด

Distributor Name

บริษัท ดีเคเอสเอช (ประเทศไทย) จำกัด

Marketing Authorisation Number

1C 16/61 (NB), 1C 17/61 (NB), 1C 18/61 (NB), 1C 19/61 (NB), 1C 20/61 (NB)