Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
Hypersensitivity
Allergic type hypersensitivity reactions are possible with Mononine. The product contains traces of mouse protein (the murine monoclonal antibody used in its purification process).
While the levels of mouse protein are extremely low ( 50 ng mouse protein/100 IU), infusion of such proteins might theoretically induce hypersensitivity responses.

If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.

In case of shock, the current medical standards for shock-treatment should be observed.

A standard dose of 2000 IU Mononine contains up to 30.36 mg sodium. To be taken into consideration by patients on a controlled sodium diet.

Inhibitors
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.

Thromboembolism
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 Mononine should be weighed against the risk of these complications.

Cardiovascular events
In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk.

Catheter-related complications
If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.

Virus safety

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 human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) and for the non-enveloped hepatitis A (HAV) and parvovirus B19 viruses.

Appropriate vaccination (hepatitis A and B) should be generally considered for patients in regular/repeated receipt of human plasma-derived factor IX products.

It is strongly recommended that every time that Mononine 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.

Paediatric population
The listed warnings and precautions apply both to adults and children.
There is no safety and efficacy data for continuous infusion application in children, particularly the potential for development of inhibitors is unknown (see section 4.2).

Effects on Driving

4.7   Effects on ability to drive and use machines

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