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  • Fraxiparin 5700 IU AXA / 0.6 ml
    / GSK

    Active Ingredient
    Nadroparin 5700 I.U AXa/0.6ml

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Syringe (solution for injection)

    0.6 ml

    partial basket chart


    S.C. route (apart from the kidney dialysis indication). Do not inject by I.M. route. S.C. injection technique: See prescribing information.
    Prevention of venous thrombo-embolic disease in surgery: 1 injection daily. Dose depends on individual risk level, the patient and the type of surgery. Situation of moderate thrombogenic risk: When the patient does not present a high thrombo-embolic risk, effective prevention is obtained by daily injection of 2,850 anti-factor Xa I.U. (0.3 ml), including an initial injection conducted 2 hours before surgery. Situation of high thrombogenic risk: Hip and knee surgery: According to the weight of the patient, at a dosage of 1 daily injection of 38 anti-factor Xa I.U./kg before surgery (i.e., 12 hours before the procedure), after surgery (i.e., from the 12th hour after the end of the procedure), then daily up to the 3rd day after surgery, inclusive. From the 4th day after surgery: 57 anti-factor Xa I.U./kg. Treatment, accompanied by the usual elastic lower limb compression techniques, must be maintained until complete active deambulation of the patient. In general surgery, the duration of LMWH treatment must be less than 10 days. If the venous thrombo-embolic risk persists beyond the recommended treatment duration, it is necessary to consider continuing preventive treatment, notably using oral anticoagulants.
    Prevention of coagulation of the extra-corporal circulation loop/kidney dialysis: Injection by the intravascular route (into the arterial line of the dialysis loop).
    Curative treatment of deep-vein thrombosis (DVT): 2 injections daily, given 12 hours apart. The dose per injection is 85 anti-factor Xa I.U./kg. Treatment must be quickly switched to oral anticoagulants, unless contraindicated. Treatment duration must not exceed 10 days. For full details see prescribing information.


    Prophylactic treatment of venous thromboembolic disease during surgery for patients presenting with a moderate or high risk, treatment of constituted deep vein thrombosis, prevention of coagulation in the extra corporeal circuit during haemodialysis.


    Hypersensitivity. History of severe type-II heparin-induced thrombopenia induced under unfractioned heparin or under low molecular weight heparin. Hemorrhagic signs or tendencies linked to hemostasis disorders (disseminated intravascular coagulations may be an exception to this rule if these are not related to heparin treatment). Organic lesion liable to bleed. At curative doses: Intracerebral hemorrhage. Severe kidney failure according to calculation using the Cockroft formula, apart from the specific situation of dialysis. Epidural or spinal anesthetic must never be given in the event of curative treatment with LMWH.

    Special Precautions

    At curative doses, this drug is not generally recommended in: Extensive ischemic celebrovascular accident in the acute phase, with or without impaired consciousness. When the stroke is of embolic origin, the period to be complied with is 72 hours. Acute infectious endocarditis (apart from certain emboligenic cardiopathies). Mild to moderate kidney failure (creatinine clearance >30 and At preventive doses, this drug is not recommended in: Severe kidney failure; within the first 24 hours following an intracerebral hemorrhage. In elderly subjects over the age of 65. It would be dangerous to substitute the dosage regimen of one LMWH for another. It is essential to follow the recommended treatment regimen. Serious hemorrhagic accidents have notably been observed in the elderly; in the event of kidney failure; in bodyweight under 40 kg; in treatment prolonged beyond the recommended mean duration of 10 days; in non-compliance with the recommended treatment conditions; in combination with drugs increasing the hemorrhagic risk. Specific monitoring is essential in the elderly and/or subjects with kidney failure, and in the event of long-term treatment for more than 10 days. Risk of heparin-induced thrombopenia (HIT). The use of LMWHs in children is not recommended. Administration of spinal/epidural anesthetics see prescribing information.
    Pregnancy and lactation: Avoid use at a preventative dose during the first trimester of pregnancy or at curative dose throughout pregnancy. Preventative dose during the 2nd and 3rd trimesters must only be used if necessary. If epidural anesthesia is envisaged, it is advisable to suspend heparin treatment at least 12 hours prior. Treatment is not contraindicated in breast-feeding women.
    For full details see prescribing information.

    Side Effects

    Hemorrhagic signs. Cases of thrombopenia have been reported. Rare cases of cutaneous necrosis at injection site. Rare cutaneous or systemic allergic signs. Risk of osteoporosis in long-term treatment. Transient elevation in transaminase levels. A few cases of hyperkalemia.
    For full details see prescribing information.

    Drug interactions

    Acetylsalicylic acid (antipyretic and anti-inflammatory doses) and other salicylates. NSAIDs (systemic route), dextran 40 (parenteral route), oral anticoagulants, abciximab, acetylsalicylic acid at anti-aggregant doses in cardiological and neurological indications, beraprost, clopidogrel, eptifibatide, iloprost, ticlopidine, tirofiban.
    For full details see prescribing information.

    Pregnancy and Lactation

    Pregnancy: Studies conducted in animals have not revealed any teratogenic effect of nadroparinIn the absence of any teratogenic effect in animals, no malformative effect is expected in humans. In fact, to date, substances responsible for malformations in humans have been shown to be teratogenic in animals during properly conducted studies in two species.
    Preventive treatment in the 1st trimester: and curative treatment In a clinical context, there are not yet enough relevant data in order to evaluate a possible teratogenicor foetotoxic effect of nadroparin when administered at a preventive dose during the first trimester of pregnancy or at a curative dose throughout pregnancy. Consequently, as a precautionary measure, it is preferable to avoid use of nadroparin at a preventive dose during the first trimester of pregnancy or at a curative dose throughout pregnancy.
    Preventive treatment in the 2nd & 3rd trimesters: In a clinical context, the use of nadroparin during the 2nd and 3rdtrimesters of a limited number of pregnancies does not appear to have evidenced any teratogenic or foetotoxic effects to date. However, further studies are necessary in order to evaluate the consequences of exposure under these conditions. Consequently, the use of nadroparin at a preventive dose during the 2nd and 3rdtrimesters of pregnancy must only be envisaged during pregnancy if necessary. If epidural anaesthesia is envisaged, it is advisable to suspend heparin treatment at the latest within 12 hours prior to anaesthesia, insofar as possible, for preventive treatment.
    Lactation: There is limited information on the excretion of nadroparin in breast milk. Therefore, the use of nadroparin during breast feeding is not advised.


    Accidental overdose following the subcutaneous administration of massive doses of low molecular weight heparin could cause haemorrhagic complications. In the event of haemorrhage, treatment with protamine sulphate may be indicated in certain cases, taking into account the following facts:  its efficacy is significantly less than that reported in the event of overdose with unfractionated heparin;  due to its adverse events (in particular, anaphylactic shock), the benefit/risk ratio of protamine sulphate must be carefully assessed before it is prescribed. In this event, neutralisation is conducted by slow intravenous injection of protamine (sulphate or hydrochloride).
    The effective protamine dose depends on:
    the heparin dose injected (100 anti-heparin units of protamine can be used to neutralise the activity of 100 anti-factor Xa IU of low molecular weight heparin),
    the time elapsed since injection of the heparin, with possible reduction of the antidote doses.
    Nevertheless, it is not possible to totally neutralise the anti-factor Xa activity.
    Moreover, the absorption kinetics of low molecular weight heparin may make this neutralisation transient and require fragmentation of the total calculated protamine dose into several injections (2 to 4) divided over 24 hours.  In the event of ingestion – even massive – of low molecular weight heparin (no cases reported), no serious consequences are, in principle, expected, given the very low gastrointestinal absorption of the product.