1 09-15. HIBOR . HIKMA PHARMACEUTICALS . (Bemiparin Sodium) The recommended dose of bemiparin is 2,500 IU/. Action day or 3,500 IU/day by subcutaneous route, HIBOR (Bemiparin sodium) belongs to a group of according to the set of risk factors of the patients, medicines called anticoagulants, which help to pre- whether defined as mild or high-risk thromboem- vent blood from clotting in the blood vessels. bolic patients. HIBOR is a second-generation low molecular weight Prophylactic treatment must be continued, accord- . heparin (LMWH). It has a very low mean molecular ing to the physician's criteria, during the risk period weight (3600 Dalton), a long half life ( hrs) and a or until the complete mobilisation of the patient.
2 Large anti Xa: anti IIa ratio (8:1). 3. Prevention of clotting during haemodialysis: Indications When used in haemodialysis, HIBOR 2,500 IU or HIBOR is indicated in the following cases: 3,500 IU is usually administered by injecting one To prevent blood clots in the veins after general bolus dose (the contents of the syringe) into the abdominal surgery in patients with a moderate risk arterial side of the dialysis machine. of venous thromboembolism. 4. To prevent blood clots in the veins after a major Prevention of the thromboembolic disease in non- orthopaedic surgery in patients with high risk venous surgical patients thromboembolism: Prevention of clotting in the extracorporeal circuit The recommended dose is an injection of during haemodialysis Bemiparin 3,500 IU/day administered by subcuta- To prevent blood clots in the veins after a major neous injection.
3 Orthopaedic surgery in patients with high risk Prophylactic treatment should be maintained for at venous thromboembolism. least 7-10 days after the surgical procedure and Secondary prevention of venous thromboembolism until the patient is fully mobile or the risk of throm- recurrence in patients with deep vein thrombosis botic disease has decreased. and transient high-risk The initial dose should be administered 2 hours Treatment of deep vein thrombosis before or 6 hours after surgery. Dosage and administration 5. Secondary prevention of venous thromboembo- 1. To prevent blood clots in the veins after general lism recurrence in patients with deep vein thrombo- abdominal surgery in patients with a moderate risk sis and transient high-risk.
4 Of venous thromboembolism HIBOR can be administered at a fixed dose of The recommended dose is an injection of 3,500 IU/day (up to a maximum of 3 months) in Bemiparin 2,500 IU/day administered by subcuta- patients who have received anticoagulant treat- neous injection ment for deep vein thrombosis with or without pul- Prophylactic treatment should be maintained for at monary embolism, as therapeutic alternative to the least 7-10 days after the surgical procedure and administration of oral anticoagulants or whenever until the patient is fully mobile or the risk of throm- they are contraindicated.
5 Botic disease has decreased. 6. Treatment of deep vein thrombosis Adults: The initial dose should be administered 2 hours As a general rule, HIBOR 5,000 IU, 7,500 IU. before or 6 hours after surgery or 10,000 IU should be administered by 2. Prevention of the thromboembolic disease in non- subcutaneous injection at the dose of 115 IU/. surgical patients: kg/day, once daily, for 7 2 days. This regimen HIKMA - HIBOR - HIKMA - HIBOR - corresponds - depending on the body weight - to In case of bacterial Endocarditis. the following ranges: In patients with active major bleeding ( active Body Weight Dosage stomach ulcer, stroke, brain tumours, or if you have <50 kg ml (5,000 IU) suffered from a brain haemorrhage).
6 50-70 kg ml (7,500 IU) In patients having an injury to or are about to have >70 kg ml (10,000 IU) an operation in the brain , spine, eyes and/or ears. Epidural or spinal anaesthesia during surgery are In patients weighing more than 100 kg body weight, contra-indicated if the patient is treated with HIBOR . the dose should be adjusted depending on the 5,000 IU/7,500 IU/10,000 IU. weight, at a level of 115 IU/kg/day. Warnings Usually oral anticoagulants will be commenced 3-5 Low molecular weight heparins should not be used days after the first administration of HIBOR 5,000 IU, interchangeably since they differ in their manufac- 7,500 IU or 10,000 IU, and the dose will be adjusted turing process, molecular weights, specific anti-Xa so as to keep a blood test level called the INR value activities, units and dosage.
7 Very careful attention between 2-3 times the control value. Oral anticoagu- and compliance with specific instructions on use of lation is usually continued for at least of 3 months. each product are absolutely essential. Injection technique Do not administer by intramuscular route. The pre-filled syringes are ready for use and must In case of Epidural anesthesia, HIBOR 2,500 IU or not be purged before the subcutaneous injection. 3,500 IU should be initiated 4 hours after removal The injection should be given into the subcutane- of the catheter. The next dose should be given after ous tissue of the waist, alternatively on the left and completion of the surgery.
8 Right sides. The needle should be completely intro- Children: The use of HIBOR is not recommended in duced perpendicularly but not tangentially, into the children. thick part of a skin fold held between the thumb Elderly: The same dosage should be used for elder- and the forefinger; the skin fold should be main- ly people as for any other adults. tained throughout the whole injection. Do not rub Renal and hepatic impairment: There are insufficient the injection site after administration. data to recommend a different dose of HIBOR in this HIBOR must not be injected into the muscle nor group of patients.
9 Mixed with any other injection. Pregnancy and lactation: There is not enough expe- HIBOR is usually administered by a doctor or a rience with HIBOR to recommend usage in pregnant nurse by subcutaneous injection. It is usually given or lactating women. once a day. Contraindications Precautions HIBOR must not be used in the following situations: Caution should be exercised in patients with liver or renal failure uncontrolled high blood pressure, a his- In patients who have allergic reaction after being given tory of gastroduodenal ulcer disease, thrombocyto- any medicine containing bemiparin sodium or heparin.
10 Penia or other conditions with an increased risk of In patients with a history of heparin-induced throm- bleeding or in patients undergoing spinal or epidural bocytopaenia (HIT). anaesthesia and/or lumbar puncture. In patients suffering from any condition which results in tendency to bleed excessively. Driving and using machines: In patients suffering from serious liver and/or pan- Bemiparin has no effect on the ability to drive and creas disease. use precision or dangerous machinery. In patients with disseminated Intravascular Drug interactions Coagulation (DIC) attributable to a heparin-induced The concomitant administration of Bemiparin and decrease in the number of platelets.