Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

In pathological conditions in which tissue factor may be expressed more extensively than considered normal, there may be a risk of development of thrombotic events or induction of Disseminated Intravascular Coagulation (DIC) in association with NovoSeven RT treatment.

Such situations may include patients with advanced atherosclerotic disease, crush injury, septicaemia or DIC. Because of the risk of thromboembolic complications, caution should be exercised when administering NovoSeven RT to patients with a history of coronary heart disease, to patients with liver disease, to post-operative patients, to pregnant or peripartum women, to neonates, or to patients at risk of thromboembolic events or DIC. In each of these situations, the potential benefit of treatment with NovoSeven RT should be weighed against the risk of these complications.

In severe postpartum haemorrhage and pregnancy, the clinical conditions (delivery, severe haemorrhage, transfusion, DIC, surgery/invasive procedures and coagulopathy) are known contributing factors to the thromboembolic risk; and in particular venous thromboembolic risk associated with the administration of NovoSeven RT (see section 4.8).

As recombinant coagulation factor VIIa NovoSeven RT may contain trace amounts of mouse IgG, bovine IgG and other residual culture proteins (hamster and bovine serum proteins), the remote possibility exists that patients treated with the product may develop hypersensitivity to these proteins.
In such cases treatment with antihistamines i.v. should be considered.

If allergic or anaphylactic-type reactions occur, the administration should be discontinued immediately. In case of shock, standard medical treatment for shock should be implemented. Patients should be informed of the early signs of hypersensitivity reactions. If such symptoms occur, the patient should be advised to discontinue use of the product immediately and contact their physician.

In case of severe bleeds the product should be administered in hospitals preferably specialised in treatment of haemophilia patients with coagulation factor VIII or IX inhibitors, or if not possible, in close collaboration with a physician specialised in haemophilia treatment.

If bleeding is not kept under control hospital care is mandatory. Patients/carers should inform the physician/supervising hospital at the earliest possible opportunity about all usages of NovoSeven RT.

Factor VII deficient patients should be monitored for prothrombin time and factor VII coagulant activity before and after administration of NovoSeven RT. In case the factor VIIa activity fails to reach the expected level or bleeding is not controlled after treatment with the recommended doses, antibody formation may be suspected and analysis for antibodies should be performed. Thrombosis has been reported in FVII deficient patients receiving NovoSeven RT during surgery but the risk of thrombosis in factor VII deficient patients treated with NovoSeven RT is unknown (see section 5.1).

Sodium content
The medicinal product contains less than 1 mmol sodium (23 mg) per injection, indicating that it is essentially ‘sodium free’.

Traceability
In order to improve the traceability of biological medicinal products, the name of the administered product should be clearly recorded. It is recommended to record the batch number as well.

Effects on Driving

4.7    Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.