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Drug details for : ZIBOR® 2,500 IU anti-Xa/0.2 ml
| Drug class description : | Antithrombotic |
| Generic Name : | Bemiparin sodium |
| Drug description : | Solution for injection in pre-filled syringe. Colourless, clear solution free of visible particles. |
| Presentation : | Bemiparin sodium (INN): 2,500 IU (anti-Factor Xa*) per 0.2 ml pre-filled syringe (equivalent to 12500 IU (anti-Factor Xa*) per millilitre solution for injection). *Potency is described in International anti-Factor Xa activity units (IU) of the 1st International Low Molecular Weight Heparin Reference Standard. |
| Indications : | Prevention of thromboembolic disease in patients undergoing general surgery. Prevention of clotting in the extracorporeal circuit during haemodialysis. |
| Adult Dosage : | 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. Prevention General surgery with moderate risk of venous thromboembolism: On the day of the surgical procedure, Zibor 2,500 IU anti-Xa is to be administered by subcutaneous (sc) route, 2 hours before or 6 hours after surgery. On subsequent days, Zibor 2,500 IU anti-Xa sc is to be administered every 24 hours. Orthopaedic surgery with high risk of venous thromboembolism: On the day of the surgical procedure, Zibor 3,500 IU anti-Xa is to be administered by subcutaneous (sc) route, 2 hours before or 6 hours after surgery. On subsequent days, Zibor 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 clotting in the extracorporeal circuit during haemodialysis: For patients undergoing repeated haemodialysis of no longer than 4 hours in duration and with no risk of bleeding, the prevention of clotting in the extracorporeal circuit during haemodialysis 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 60kg, the dose will be 2,500 IU, whereas for patients weighing more than 60kg, the dose will be 3,500 IU. Treatment Treatment of deep vein thrombosis Zibor 25,000 IU anti-Factor Xa/ml solution for injection should be administered by the subcutaneous route at a dose of 115 IU anti-Xa/kg weight, once daily. The recommended duration of treatment is 7 ± 2 days. The daily dose generally corresponds - depending on the body weight range - to the following doses and volumes of the product in pre-filled syringes: < 50 kg, 0.2 ml (5,000 IU anti-Xa); 50-70 kg, 0.3 ml (7,500 IU anti-Xa),> 70 kg, 0.4 ml (10,000 IU anti-Xa). In patients weighing more than 100 kg body-weight, the dose should be calculated on the basis of 115 IU anti-Xa/kg/day, where the concentration of anti-Xa is 25,000 IU/ml. In the absence of any contra-indication, oral anticoagulation should be commenced 3-5 days after beginning Zibor 25,000 IU/ml first administration, and the dose adjusted so as to keep the International Normalized Ratio (INR) value between 2-3 times the control value. Bemiparin administration can be stopped as soon as the said INR value is achieved. Oral anticoagulation should be continued for at least 3 months. Renal and hepatic impairment: There are insufficient data to recommend a dose adjustment of bemiparin in this group of patients. Method of administration. Subcutaneous injection technique: The pre-filled syringes are ready for immediate use and must not be purged before the subcutaneous injection. When Zibor is administered subcutaneously, the injection should be given in the subcutaneous cell tissue of the anterolateral or posterolateral abdominal waist, alternately on the left and right sides. The needle should be fully inserted, perpendicularly and not tangentially, into the thick part of a skin fold held between the thumb and the forefinger; the skin fold should be held throughout the whole injection. Do not rub the injection site. |
| Child Dosage : | The safety and efficacy of the use of bemiparin in children has not been established, therefore the usage in children is not recommended. |
| Elderly Dosage : | Elderly: No dose adjustment required. |
| Contra Indications : | Hypersensitivity to bemiparin sodium, heparin or substances derived from pigs. History of confirmed or suspected immunologically mediated heparin induced thrombocytopenia (HIT) (See Special Precautions for use). Active haemorrhage or increased risk of bleeding due to impairment of haemostasis. Severe impairment of liver and pancreas function. Injuries to and 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 endocarditis lenta. Organic lesion with high risk of bleeding (e.g. active peptic ulcer, haemorrhagic stroke, cerebral aneurysm or cerebral neoplasms). In patients receiving heparin for treatment rather than for prophylaxis, locoregional anaesthesia in elective surgical procedures is contra-indicated. |
| Special Precautions : | Do not administer by the intramuscular route. Due to risk of haematoma during bemiparin administration the intramuscular injection of other agents should be avoided. Caution should be exercised in patients with 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 with an increased risk of bleeding complications, or in patients undergoing spinal or epidural anaesthesia and /or lumbar puncture. Bemiparin, like other LMWHs, can suppress adrenal secretion of aldosterone leading to hyperkalaemia, particularly in patients such as those with diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis, a raised plasma potassium or taking potassium sparing drugs. The risk of hyperkalaemia appears to increase with the duration of therapy but is usually reversible. Serum electrolytes should be measured in patients at risk before starting bemiparin therapy and monitored regularly thereafter particularly if treatment is prolonged beyond about 7 days. Occasionally a mild transient thrombocytopenia (type I) at the beginning of therapy with heparin with platelet counts between 100,000/mm3 and 150,000/mm3 due to temporary platelet activation has been observed (See Adverse Reactions). As a rule, no complications occur, therefore treatment can be continued. In rare cases antibody-mediated severe thrombocytopenia (type II) with platelet counts clearly below 100,000/mm3 has been observed (See Adverse Reactions). This effect usually occurs within 5 to 21 days after the beginning of treatment; in patients with a history of heparin-induced thrombocytopenia this may occur sooner. Platelet counts are recommended before administration of bemiparin, on the first day of therapy and then regularly 3 to 4 days and at the end of therapy with bemiparin. In practice, treatment must be discontinued immediately and an alternative therapy initiated if a significantly reduced platelet count is observed (30 to 50%) associated with positive or unknown results of in-vitro tests for antiplatelet antibody in the presence of bemiparin or other LMWHs and/or heparins. As with other heparins, cases of cutaneous necrosis, sometimes preceded by purpura or painful erythematous blotches have been reported with bemiparin (See Adverse Reactions). In such cases, treatment should be discontinued immediately. In patients undergoing epidural or spinal anaesthesia or lumbar puncture, the prophylactic use of heparin may very rarely be associated with epidural or spinal haematoma, resulting in prolonged or permanent paralysis (See Adverse Reactions). The risk is increased by the use of an epidural or spinal catheter for anaesthesia, by the concomitant use of drugs affecting haemostasis such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors or anticoagulants (See Interactions), and by traumatic or repeated puncture. When reaching a decision as to the interval between the last heparin administration at prophylactic doses and the placement or removal of an epidural or spinal catheter, the product characteristics and the patient profile should be taken into account. The subsequent dose of bemiparin should not take place until at least four hours after removal of the catheter. The subsequent dose should be delayed until the surgical procedure is completed. Should a physician decide to administer anticoagulation treatment in the context of epidural or spinal anaesthesia, extreme vigilance and frequent monitoring must be exercised to detect any signs and symptoms of neurological impairment, such as back pain, sensory and motor deficits (numbness and weakness in lower limbs) and bowel or bladder dysfunction. Nurses should be trained to detect such signs and symptoms. Patients should be instructed to inform a nurse or a clinician immediately if they experience any of these symptoms. If signs or symptoms of epidural or spinal haematoma are suspected, urgent diagnosis and treatment including medullary/spinal cord decompression should be initiated. |
| Interactions : | Bemiparin interactions with other medicinal products have not been investigated and the information given on this section is derived from data available from other LMWH. 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. All these drugs increase the pharmacological effect of bemiparin by interfering with its action on coagulation and/or platelet function and increasing the risk of bleeding. If the combination cannot be avoided, it should be used with careful clinical and laboratory monitoring. Medicinal products that increase the serum potassium concentration should only be taken concomitantly under especially careful medical supervision. Interaction of heparin with intravenous nitroglycerine (which can result in a decrease in efficacy) cannot be ruled out for bemiparin. Pregnancy and lactation Pregnancy: No reproductive toxicity studies have been performed with bemiparin. Animal studies have not shown any evidence of teratogenic effects with the use of LMWHs. There are no data to evaluate the possible teratogenic or foetotoxic effect of bemiparin in pregnant women, so that the potential risk for humans is unknown. Therefore Zibor is not recommended for use in pregnancy unless clearly necessary. It is unknown whether bemiparin crosses placental barrier. Lactation: Insufficient information is available as to whether bemiparin passes into breast milk. Therefore, where it is necessary for lactating mothers to receive Zibor, they should be advised to avoid breast-feeding. |
| Adverse Reactions : | The most commonly reported adverse reaction is haematoma and/or ecchymosis at the injection site, occurring in approximately 15% of patients receiving Zibor. Osteoporosis has been associated with long-term heparin treatment. The frequency of adverse events (AEs) reported with bemiparin are similar to those reported with other LMWHs and is as follows: Very common (> 1/10): Ecchymosis at injection site. Common (> 1/100, <1/10): Haematoma and pain at injection site. Bleeding complications (skin, mucous membranes, wounds, gastro-intestinal tract, urogenital tract). Mild and transient elevations of transaminases (ASAT, ALAT) and gamma-GT levels. Uncommon (> 1/1000, <1/100): Cutaneous allergic reactions (urticaria, pruritus). Mild and transient thrombocytopenia (type I) (See Special Precautions for use). Rare (<1/1000): Anaphylactic reactions (nausea, vomiting, fever, dyspnoea, bronchospasm, glottis oedema, hypotension, urticaria, pruritus). Severe thrombocytopenia (type II) (See Special Precautions for use). Cutaneous necrosis at the injection site (See Special Precautions for use). Epidural and spinal haematoma following epidural or spinal anaesthesia and lumbar puncture. These haematomas have caused various degrees of neurological impairment, including prolonged or permanent paralysis (See Special Precautions for use). |
| Manufacturer : | Amdipharm |
| Drug Availability : | (POM) |
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