Octaplex Special Precautions

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 (eg, as induced by treatment with vitamin K antagonists), Octaplex 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.
In congenital deficiency of any of the vitamin K dependent factors, specific coagulation factor product should be used when available.
If allergic or anaphylactic-type reactions occur, the injection/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 applies to unknown viruses and other known and unknown pathogens.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV. The measures taken may be of limited value against non-enveloped viruses such as HAV or parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals with immunodeficiency or increased red cell production (eg, haemolytic anaemia).
It is strongly recommended that every time that Octaplex is administered to a patient, the name and batch number of the product are recorded.
Appropriate vaccination (hepatitis A and B) is recommended for patients in regular/repeated receipt of human plasma-derived prothrombin complex products.
Treatment with plasma derived products that contain factors II, VII, IX, and X has been associated with thrombosis.
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. The risk may be higher in treatment of isolated factor VII deficiency, since the other vitamin K dependant coagulation factors, with longer half-lives, may accumulate to levels considerably higher than normal. 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 in case of perinatal bleeding due to vitamin K deficiency in the new born.
Effects on Ability to Drive and Use Machines: No studies on the effects on the ability to drive and use machines have been performed.