FRAXIPARINE 5700 IU AXa/0.6ml Injection
nadroparin
9500 IU/ml
Glaxo Wellcome Production
| Pack size | 0.6ml Prefilled Syringe x 2 |
|---|---|
| Dispensing mode | POM |
| Source | FRANCE |
| Agent | GULF DRUG EST. |
| Retail Price | 68.50 AED |
Available as:
Indications
FRAXIPARINE 5700 IU AXa/0.6ml Injection is used for:
Nadroparin is a low molecular weight heparin (LMWH) anticoagulant medication. It is used for prevention and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as prophylaxis of DVT in patients undergoing surgery. It may also be used for the treatment of unstable angina and non-Q-wave myocardial infarction (NQMI), as well as to prevent blood clots in patients with certain types of cancer.
Adult Dose
Intra-arterial
Prophylaxis of clotting in the extracorporeal circulation during haemodialysis
Adult: In haemodialysis sessions lasting <4 hours: As 9,500 anti-Xa IU/mL inj in patients weighing <50 kg: 2,850 anti-Xa IU; 50-69 kg: 3,800 anti-Xa IU; ≥70 kg: 5,700 anti-Xa IU. Doses are administered as a single dose into the arterial line of the circuit at the start of dialysis. May give additional dose if session last for >4 hours. Adjust dose in subsequent dialysis sessions as necessary according to patient response. In patients at high risk of haemorrhage: Reduce dose to half.
Intravenous, Subcutaneous
Non-Q wave myocardial infarction, Unstable angina
Adult: As 9,500 anti-Xa IU/mL inj in combination with aspirin: Initially, 86 anti-Xa IU/kg given via IV bolus inj. Subsequent doses are given via SC inj 12 hourly. Usual treatment duration: 6 days. Dosage may be adjusted according to individual bodyweight (refer to detailed product guidelines).
Subcutaneous
Prophylaxis of thromboembolic disorder
Adult: As 9,500 anti-Xa IU/mL inj: For general surgery: Initially, 2,850 anti-Xa IU given 2-4 hours prior to surgery, then once daily on subsequent days for at least 7 days or until the patient is ambulant. For orthopaedic surgery: Initially, 38 anti-Xa IU/kg given 12 hours before, and 12 hours after surgery, then once daily until Day 3 post-op. Then, increase dose by 50% or up to 57 anti-Xa IU/kg once daily starting Day 4 post-op. Continue treatment until the patient is ambulant for at least 10 days. For high-risk patients weighing ≤70 kg: 3,800 anti-Xa IU once daily; >70 kg: 5,700 anti-Xa IU once daily. Continue treatment throughout the risk period.
Elderly: For high-risk patients: May reduce dose to 2,850 anti-Xa IU once daily.
Subcutaneous
Thromboembolic disorders
Adult: As 9,500 anti-Xa IU/mL inj: 86 anti-Xa IU/kg 12 hourly. As 19,000 anti-Xa IU/mL inj: 171 anti-Xa IU/kg once daily. Usual treatment duration: 10 days. Dosage is adjusted according to individual bodyweight (refer to detailed product guidelines).
Child Dose
Renal Dose
Renal Impairment
Prophylaxis of thromboembolic disorder:
CrCl (mL/min) ≥30 to <50 and <30; Reduce dose by 25-33%.
Thromboembolic disorders; Unstable angina; Non-Q wave myocardial infarction:
CrCl (mL/min) ≥30 to <50; Reduce dose by 25-33%.
CrCl (mL/min) < 30; Contraindicated.
Administration
subcutaneously (under the skin) once or twice daily
Contra Indications
Nadroparin should not be used in individuals with active bleeding, increased risk of bleeding due to disorders of blood clotting (with the exception of disseminated intravascular coagulation that is not caused by heparin), history of bleeding strokes, conditions that increase the likelihood of bleeding (such as active peptic ulcers), or a history of low platelet count while using nadroparin. Additionally, it should not be used in individuals with severe kidney impairment (CrCl less than 30 mL/min) when used to treat blood clots, unstable angina, or non-Q wave heart attack.
Precautions
Patient with severe arterial hypertension, history of gastrointestinal ulceration, vascular disorder of chorio-retina, hepatic failure, risk factors for hyperkalaemia (e.g. diabetes mellitus, metabolic acidosis, haematoma in body tissues, use of ACE inhibitors, NSAIDs, K-sparing diuretics or K supplements). Patients who are undergoing knee surgery, spinal puncture, or receiving neuraxial anaesthesia (spinal or epidural anaesthesia); postoperative period after brain, spinal cord or eye surgery. Not interchangeable (unit for unit) with any other LMWHs or heparin. Not intended for IM administration. Hepatic and moderate renal (CrCl ≥30 to <50 mL/min) impairment. Elderly. Pregnancy and lactation.
Pregnancy-Lactation
Interactions
Nadroparin may interact with other medications, including:
Antiplatelet agents, such as aspirin and clopidogrel, which may increase the risk of bleeding
Anticoagulants, such as warfarin, which may increase the risk of bleeding
Fibrinolytic agents, such as alteplase, which may increase the risk of bleeding
Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, which may increase the risk of bleeding
Potassium-sparing diuretics, such as spironolactone, which may increase the risk of hyperkalemia (elevated potassium levels)
ACE inhibitors and angiotensin receptor blockers (ARBs), which may increase the risk of hyperkalemia
Adverse Effects
Side effects of nadroparin :
Significant:
Haemorrhage at any site, thrombocytopenia with thrombosis, heparin-induced thrombocytopenia, hyperkalaemia, prosthetic valve thrombosis;
epidural or spinal haematomas including subsequent chronic or permanent paralysis (in patients receiving neuraxial anaesthesia or undergoing spinal puncture). Rarely, cutaneous necrosis (preceded by purpura, infiltrated or painful erythematous blotches).
Blood and lymphatic system disorders:
Rarely, eosinophilia (reversible).
General disorders and administration site conditions:
Inj site haematoma and reaction.
Immune system disorders:
Rarely, hypersensitivity reactions.
Investigations:
Increased transaminases (transient).
Nervous system disorders:
Headache, migraine.
Reproductive system and breast disorders:
Rarely, priapism.
Skin and subcutaneous tissue disorders:
Rarely, rash, erythema, urticaria, pruritus.
Mechanism of Action
Note
FRAXIPARINE 5700 IU AXa/0.6ml 9500 IU/ml Injection manufactured by Glaxo Wellcome Production. Its generic name is nadroparin. FRAXIPARINE 5700 IU AXa/0.6ml is availble in United Arab Emirates.
Farmaco UAE drug index information on FRAXIPARINE 5700 IU AXa/0.6ml Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.
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