Cofact (concentrate of 4 coagulations factors) is presented as a powder for solution for injection containing human pro - thrombin complex. The product nominally contains the following IU of the human coagulation factors tabled below:

Component Cofact 250 IU (factor IX) Cofact 500 IU (factor IX) After reconstitution(IU/ml)
Coagulation Factor II 140-350 280-700 14-35
Coagulation Factor VII 70-200 140-400 7-20
Coagulation Factor IX 250 500 25
Coagulation Factor X 140-350 280-700 14-35

The total protein content per vial is 130-350 mg (Cofact 250 IU) or 260-700 mg (Cofact 500 IU). The specific activity of the product is ? 0.6 IU/mg, expressed as factor IX activity. The actual value for each of the 4 coagulation factors in the vial is indicated on the outer carton and the vial label. This medicinal product contains 125-195 mmol/l sodium per dose. To be taken into consideration by patients on a controlled diet.




Treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonist, or in case of overdose of vitamin K antagonist, when rapid correction of the deficiency is required.

Treatment of bleeding and perioperative prophylaxis in congenital deficiency of any of the vitamin K dependent coagulation factors when purified specific coagulation product is not available.

Kontra Indikasi :

Hypercoagulability state

Efek Samping :

Immune system disorders : Replacement therapy may rarely lead to the formation of circulating antibodies inhibiting one or more of the human prothrombin complex factors. If such inhibition occurs, the condition will manifest itself as a poor clinical response. Allergic or anaphylactic-type reactions have been very rarely observed.
General disorders and administration site conditions: Increase in body temperatures has not been observed.
Vascular disorders : There is a risk of thrombo-embolic episodes following the administration of human prothrombin complex.

Peringatan :

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 of vitamin K antagonist), Cofact 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 the vitamin K antagonists and/or administration of vitamin K is usually sufficient. Patients receiving vitamin K antagonists may have an underlying hypercoaguable state and infusion of human pro - thrombin complex 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, standards 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. Depsite 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 effectives for enveloped viruses such as HIV, HBV and HCV. The measures taken care may be of limited value against non-enveloped viruses such as HAV and parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g haemolytic anaemia). Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma- derived prothrombin complex products. It is strongly recommended that every time that Cofact 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. The risk may be higher in treatment of isolated factor VII deficiency, since the other vitamin K dependent coagulation factors, with longer halflives, 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 per- or post-operative patients, to neonates or to patients at risk of thrombo-embolic events or disseminated intravascular coagulation. In each of these situations, the potentials benefit of treatment should be weighed against the risk of these complications. No data are available regarding the use of Cofact in case of perinatal bleeding due to vitamin K deficiency in the newborn.

Aturan Pakai :

Cara Penyimpanan :

Stored at 2°C to 8°C, protected from light

Kemasan :

No Reg :