Special Warning : אזהרת שימוש

4.4     Special warnings and precautions for use
Traceability
In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

The advice of a specialist experienced in the management of coagulation disorders should be sought.

In patients with acquired deficiency of the vitamin K dependent coagulation factors (e.g. as induced by treatment with vitamin K antagonists), Octaplex 500 IU should only be used when rapid correction of prothrombin complex levels is necessary, such as major bleeding or emergency surgery. In other cases, reduction of the dose of the vitamin K antagonist and/or administration of vitamin K is usually sufficient.

Patients receiving a vitamin K antagonist may have an underlying hypercoaguable state and infusion of prothrombin complex concentrate may exacerbate this.
If allergic or anaphylactic-type reactions occur, the infusion should be stopped immediately. 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 human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV).
The measures taken may be of limited value against non-enveloped viruses such as hepatitis A virus (HAV) and parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).

Appropriate vaccination (hepatitis A and B) is recommended for patients in regular/repeated receipt of human plasma-derived prothrombin complex products.

It is strongly recommended that every time Octaplex 500 IU 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.

There is a risk of thrombosis or disseminated intravascular coagulation when patients, with either congenital or acquired deficiency are treated with human prothrombin complex particularly with repeated dosing. Patients given human prothrombin complex should be observed closely for signs or symptoms of intravascular coagulation or thrombosis. Because of the risk of thromboembolic complications, close monitoring should be exercised when administering human prothrombin complex to patients with a history of coronary heart disease, to patients with liver disease, to peri- or postoperative patients, to neonates, or to patients at risk of thromboembolic events or disseminated intravascular coagulation. In each of these situations, the potential benefit of treatment should be weighed against the risk of these complications.

No data are available regarding the use of Octaplex 500 IU in case of perinatal bleeding due to vitamin K deficiency in the new-born.

Octaplex 500 IU contains 75 – 125 mg sodium per vial, equivalent to 3.8 – 6.3 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

In congenital deficiency of any of the vitamin K dependent factors, specific coagulation factor product should be used when available.

Effects on Driving

4.7   Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.