Prothromplex Special Precautions

Traceability: In order to improve the 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) Prothromplex TOTAL 600 IU should only be used when rapid correction of the prothrombin complex levels is necessary, such as major bleeding or emergency surgery. In other cases, reduction of the dose of vitamin K antagonist and/or administration of vitamin K is usually sufficient.
Patients receiving a vitamin K antagonist may have an underlying hypercoagulable state and infusion of human prothrombin complex may exacerbate this.
In congenital deficiency of any vitamin K-dependent factors, specific coagulation factor product should be used when available.
Allergic-type hypersensitivity reactions including anaphylactic reactions and anaphylactic shock have been reported with Prothromplex TOTAL 600 IU.
If allergic or anaphylactic-type reactions occur, the injection/infusion should be stopped immediately. In the case of shock standard medical treatment for shock should be implemented.
Thromboembolism, DIC, Fibrinolysis: There is a risk of thrombosis and disseminated intravascular coagulation (DIC) when patients, with either congenital or acquired deficiency are treated with human prothrombin complex concentrates, including Prothromplex TOTAL 600 IU, particularly with repeated dosing.
Arterial and venous thromboembolic events including myocardial infarction, cerebrovascular accident (e.g. stroke), pulmonary embolism as well as DIC have been reported with Prothromplex TOTAL 600 IU.
The risk may be higher in treatment of isolated F VII deficiency, since the other vitamin K-dependent coagulation factors, with longer half-lives, may accumulate to levels considerably higher than normal. Patients given human prothrombin complex concentrates should be observed closely for signs and symptoms of intravascular coagulation or thrombosis. Because of the risk of thromboembolic complications, particularly close monitoring should be exercised when administering prothrombin complex concentrates to: patients with a history of coronary heart disease; patients with liver disease; pre or post-operative patients; neonates, or; other 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.
Virus safety: Standard measures to prevent infections which can be transmitted by medicinal products made from human blood or plasma include donor selection, testing of individual donations and plasma pools for specific infection markers and the execution of effective manufacturing steps to inactivate/remove viruses. Nevertheless, when medicinal products prepared from human blood or plasma are administered, infectious diseases due to transmission of infective agents cannot be totally excluded.
This also applies to unknown or emerging viruses or other pathogens.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV as well as against the non-enveloped HAV virus.
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 (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).
When a medicinal product prepared from human blood or plasma is administered regularly/repeatedly, appropriate vaccinations (hepatitis A and B) must be considered.
Sodium: This medicinal product contains 81.7 mg sodium per vial or 0.14 mg sodium per International Unit equivalent to 4.1% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Heparin: Heparin may cause allergic reactions and reduced blood cell counts which may affect the blood clotting system. Patients with a history of heparin-induced allergic reactions should avoid the use of heparin-containing medicines.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.
Use in Children: There are insufficient data to recommend the administration of Prothromplex TOTAL 600 IU in children.