Bemiparin sodium

Thông tin thuốc gốc
Chỉ định và Liều dùng
Prophylaxis of clotting in the extracorporeal circulation during haemodialysis
Adult: For patients undergoing repeated haemodialysis sessions of <4 hours and with no bleeding risk: <60 kg: 2,500 IU; >60 kg: 3,500 IU. Dose is to be given into the arterial side of the dialyser at the start of dialysis session, in a single dose.

Prophylaxis of venous thromboembolism during surgical procedures
Adult: General surgery in moderate-risk patient: On the day of procedure, 2,500 IU anti-Xa given 2 hours before or 6 hours after surgery. On subsequent days, 2,500 IU anti-Xa given 24 hourly. Orthopaedic surgery in high-risk patient: On the day of procedure, 3,500 IU anti-Xa given 2 hours before or 6 hours after surgery. On subsequent days, 3,500 IU anti-Xa given 24 hourly. Continue prophylactic treatment for at least 7-10 days after the procedure and until the risk of thromboembolism is decreased or until the patient is fully ambulant.

Deep vein thrombosis
Adult: Treatment of acute established DVT with or without pulmonary embolism: 115 IU anti-Xa/kg once daily for 5-9 days. Refer to the detailed product guideline for further dosing instructions depending on the patient’s body weight.
Renal Impairment
Prophylaxis of venous thromboembolism during surgical procedures:
CrCl (mL/min) Dosage
<30 General surgery in moderate-risk patient: Close monitoring is recommended; Orthopaedic surgery in high-risk patient: Dose adjustment may be necessary with close monitoring.

Deep vein thrombosis:
CrCl (mL/min) Dosage
<30 Dose adjustment may be necessary with close monitoring.
Hepatic Impairment
Severe: Contraindicated.
Chống chỉ định
Hypersensitivity to bemiparin sodium, heparin, and substances of porcine origin. History of confirmed or suspected immunologically mediated heparin induced thrombocytopenia (HIT), active haemorrhage or increased risk of bleeding due to impaired haemostasis, severe pancreatic impairment, injuries to or operations on CNS, eyes, and ears (within the last 2 months); disseminated intravascular coagulation (DIC) associated with HIT, acute bacterial and slow endocarditis, organic lesions susceptible of bleeding (e.g. haemorrhagic stroke, active peptic ulcer, cerebral aneurysm or neoplasms). Severe hepatic impairment.
Thận trọng
Patient with uncontrolled arterial hypertension, history of gastro-duodenal ulcer disease, thrombocytopenia, nephrolithiasis or urethrolithiasis, choroid and retinal vascular disease; diabetes mellitus. Patient undergoing spinal or epidural anaesthesia and/or lumbar puncture. LMWHs are different and not necessarily equivalent; comply with the dosage regimen and specific method of use for each product. Hepatic and mild to moderate (CrCl 30-80 mL/min) renal impairment. Pregnancy and lactation.
Phản ứng phụ
Significant: Severe bleeding, hyperkalaemia (reversible), cutaneous necrosis, mild and transient thrombocytopenia (type I). Rarely, antibody-mediated severe thrombocytopenia (type II).
Blood and lymphatic system disorders: Bleeding complications (e.g. skin, mucous membranes, wounds, gastrointestinal and urogenital tracts).
General disorders and administration site conditions: Ecchymosis, haematoma, and pain at inj site.
Hepatobiliary disorders: Mild and transient increase of AST, ALT, and gamma-glutamyl transferase levels.
Immune system disorders: Cutaneous allergic reactions (e.g. urticaria, pruritus). Rarely, anaphylactic reactions (e.g. fever, nausea, vomiting, dyspnoea, bronchospasm, glottis oedema, hypotension).
Musculoskeletal and connective tissue disorders: Osteoporosis (long-term use).
Potentially Fatal: For patient undergoing epidural/spinal anaesthesia or lumbar puncture: Rarely, epidural and spinal haematoma leading to neurological impairment (e.g. prolonged or permanent paralysis).
Monitoring Parameters
Monitor serum electrolytes prior to therapy (in patient at risk of hyperkalaemia) and regularly thereafter in prolonged treatment; platelet counts prior to treatment, on the 1st day then regularly for 3-4 days, and at the end of therapy. Monitor for signs and symptoms of neurological impairment (e.g. back pain, numbness and weakness in lower limbs) and bowel or bladder dysfunction.
Quá liều
Symptoms: Bleeding. Management: Discontinue treatment depending on severity of haemorrhage and risk of thrombosis. Administration of protamine sulfate may be necessary for major haemorrhages.
Tương tác
Increased effects and risk of bleeding with vitamin K antagonists, other anticoagulants, aspirin, NSAIDs, ticlopidine, clopidogrel, other platelet inhibitors, systemic glucocorticoids, and dextran. May decrease the anticoagulant effect with glyceryl trinitrate. May increase the risk of hyperkalaemia with K-sparing diuretics.
Tác dụng
Description: Bemiparin sodium is a LMWH obtained by depolymerisation of heparin Na from porcine intestinal mucosa. Its anti-Xa activity ranges between 80-120 anti-Xa IU/mg and the anti-IIa activity ranges between 5-20 anti-IIa IU/mg. The anti-Xa/anti-IIa ratio is approx 8. Its high anti-Xa/IIa ratio may result to greater antithrombotic effect without increasing the bleeding risk.
Absorption: Rapidly absorbed following SC inj. Bioavailability: Approx 96%. Time to peak plasma concentration: 2-4 hours.
Excretion: Elimination half-life: 5-6 hours.
Bảo quản
Store below 30°C. Do not freeze.
Phân loại ATC
B01AB12 - bemiparin ; Belongs to the class of heparin group. Used in the treatment of thrombosis.
Chapman TM and Goa KL. Bemiparin: A Review of Its Use in the Prevention of Venous Thromboembolism and Treatment of Deep Vein Thrombosis. Drugs. 2003;63(21):2357-2377. doi: 10.2165/00003495-200363210-00009. Accessed 19/06/2020

Buckingham R (ed). Bemiparin Sodium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. Accessed 05/06/2020.

Hibor Pre-filled Syringes (Stada [Thailand] Co., Ltd). MIMS Thailand. Accessed 05/06/2020.

Zibor 2,500 IU Anti-Xa/0.2 mL Solution for Injection in Pre-filled Syringes (Frosst Ibérica S.A.). MHRA. Accessed 19/06/2020.

Zibor 25,000 IU Anti-Xa/mL Solution for Injection in Pre-filled Syringes (Frosst Ibérica S.A.). MHRA. Accessed 05/06/2020.

Zibor 3,500 IU Anti-Xa/0.2 mL Solution for Injection in Pre-filled Syringes (Frosst Ibérica S.A.). MHRA. Accessed 19/06/2020.

Thông báo miễn trừ trách nhiệm: Thông tin này được MIMS biên soạn một cách độc lập dựa trên thông tin của Bemiparin sodium từ nhiều nguồn tài liệu tham khảo và được cung cấp chỉ cho mục đích tham khảo. Việc sử dụng điều trị và thông tin kê toa có thể khác nhau giữa các quốc gia. Vui lòng tham khảo thông tin sản phẩm trong MIMS để biết thông tin kê toa cụ thể đã qua phê duyệt ở quốc gia đó. Mặc dù đã rất nỗ lực để đảm bảo nội dung được chính xác nhưng MIMS sẽ không chịu trách nhiệm hoặc nghĩa vụ pháp lý cho bất kỳ yêu cầu bồi thường hay thiệt hại nào phát sinh do việc sử dụng hoặc sử dụng sai các thông tin ở đây, về nội dung thông tin hoặc về sự thiếu sót thông tin, hoặc về thông tin khác. © 2021 MIMS. Bản quyền thuộc về MIMS. Phát triển bởi
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in