Sign Out
Do not administer by the intramuscular route.
Due to the risk of haematoma during bemiparin administration, the intramuscular injection of other agents should be avoided.
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.
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 those taking potassium sparing drugs. The risk of hyperkalemia appears to increase with the duration of therapy but is usually reversible (see Adverse Reactions). Serum electrolytes should be measured in patients at risk before starting bemiparin therapy and monitored regularly thereafter particularly if treatment is prolonged beyond 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 general rule, no complications occur and 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 occur within 5th to 21st day after the beginning of treatment, although 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 anti-platelet antibody in the presence of bemiparin, other LMWHs and /or heparins.
As with other heparins, some 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 anesthesia or lumbar puncture, the administration of heparin with prophylactic use 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 anesthesia, by the concomitant administration of drugs with action in the coagulation 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 early 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 the previously mentioned symptoms.
If signs or symptoms of epidural or spinal haematoma are suspected, urgent diagnosis and treatment including spinal cord decompression should be initiated.
Effects on ability to drive and use machines: HIBOR has no influence on the ability to drive and use machines.
