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  • Replenine VF
    / Kamada


    Active Ingredient *
    Factor II 0.2 IU/ml
    Factor IX 50 IU/ml
    Factor X 1 IU/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 x 500 IU

    not in the basket chart 28170

    Vial

    1 x 1,000 IU

    not in the basket chart 28171

    Dosage

    The dosage and duration of the substitution therapy depend on the severity of the factor IX deficiency, on the location and extent of the bleeding and on the patient’s clinical condition. On demand treatment The number of units of factor IX administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products. Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an international standard for factor IX in plasma). One International Unit (IU) of factor IX activity is equivalent to that quantity of factor IX in one mL of normal human plasma. The calculation of the required dosage of factor IX is based on the empirical finding that 1 International Unit (IU) ReplenineVF per kg body weight raises the plasma factor IX activity by 1.16% of normal activity. The required dosage is determined using the following formula: Required units = body weight (kg) x desired factor IX rise (%) (IU/dL) x 0.85 The amount to be administered and the frequency of administration should always be orientated to the clinical effectiveness in the individual case. Factor IX products rarely require to be administered more than once daily.
    For full details see prescribing information.


    Indications

    Treatment of bleeding and prophylaxis in patients with hemophilia B (congenital factor IX deficiency).


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients. Patients showing signs of Disseminated Intravascular Coagulation (DIC). Patients suffering from acute liver failure, patients with impaired liver function require monitoring for signs of DIC.


    Special Precautions

    As with any intravenous protein product, allergic type hypersensitivity reactions are possible. Replenine-VF contains traces of human proteins other than FIX. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. If these symptoms occur, they should be advised to discontinue use of the product immediately and contact their physician. In case of shock, standard treatment for shocktreatment should be observed. Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens. The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19. It is strongly recommended that every time that Replenine-VF is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product. After repeated treatment with human coagulation factor IX products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing. There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions. Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor. It should be noted that patients with factor IX inhibitors may be at an increased risk of anaphylaxis with subsequent challenge with factor IX. Because of the risk of allergic reactions with factor IX concentrates, the initial administrations of factor IX should, according to the treating physician’s judgement, be performed under medical observation where proper medical care for allergic reactions could be provided. Since the use of factor IX complex concentrates has historically been associated with the development of thromboembolic complications, the risk being higher in low purity preparations, the use of factor IX containing products may be potentially hazardous in patients with signs of fibrinolysis and in patients with disseminated intravascular coagulation (DIC). Because of the potential risk of thrombotic complications, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thromboembolic phenomena or DIC. In each of these situations, the potential benefit of treatment with Replenine-VF should be weighed against the risk of these complications.


    Side Effects

    If there are any side effects these should be controlled by stopping the infusion, followed by specific treatment of the particular side effect. Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing.( Patients with hemophilia B may develop antibodies (inhibitors) to factor IX. If such inhibitors occur, the condition will manifest as an insufficient clinical response. There is a potential risk of thromboembolic episodes following the administration of factor IX products, with a higher risk for low purity preparations. The use of low purity factor IX products has been associated with instances of myocardial infarction, disseminated intravascular coagulation, venous thrombosis and pulmonary embolism. The use of high purity factor IX is rarely associated with such side effects.


    Drug interactions

    No interactions of human coagulation factor IX products with other medicinal products are known.


    Pregnancy and Lactation

    Animal reproduction studies have not been conducted with factor IX. Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breast-feeding is not available. Therefore, this product should be used during pregnancy and lactation only if clearly indicated.


    Overdose

    No case of overdose with human factor IX has been reported


    Manufacturer
    BPL, Bio Products Laboratory
    Licence holder
    CLOSE