Special Warning : אזהרת שימוש

4.4         Special warnings and precautions for use

•     As with any intravenous protein product, allergic type hypersensitivity reactions are possible. The product contains traces of human proteins other than factor IX and heparin (see also sections 4.3 and 4.8). 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 medical -treatment for shock should be implemented.
•     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 virus HAV. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).
•     Appropriate vaccination (hepatitis A and B) should be considered for patients in regular / repeated receipt of human plasma-derived factor IX concentrates.
•     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 products, 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 products 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 thrombotic phenomena or DIC. In each of these situations, the benefit of treatment with OCTANINE F should be weighed against the risk of these complications.
•     Up to now, not enough results have been obtained from ongoing studies on surgeries performed under continuous perfusion with OCTANINE F.
•     It is strongly recommended that every time that OCTANINE F 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.
•     This medicinal product contains up to 3 mmol (or 69 mg) sodium for 1 vial OCTANINE F 500 IU and up to 6 mmol (or 138 mg) sodium for 1 vial OCTANINE F 1000 IU per dose. To be taken into consideration by patients on a controlled sodium diet.

Effects on Driving

4.7         Effects on ability to drive and use machines

Octanine F has no influence on the ability to drive and use machines.