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Dosage
The dosage and duration of the substitution therapy depend on the severity of the disorder, on the location and extent of bleeding and on the patient’s clinical condition.
The amount and the frequency of administration should be calculated on an individual patient basis. Dosage intervals must be adapted to the different circulating half-lives of the respective coagulation factors in the prothrombin complex. Individual dosage requirements can only be identified on the basis of regular determinations of the individual plasma levels of the coagulation factors of interest, or on global tests of the prothrombin complex levels (INR, Quick’s test), and a continuous monitoring of the clinical condition of the patient.
In case of major surgical interventions, precise monitoring of the substitution therapy by means of coagulation assays is essential (specific coagulation factor assays and/or global tests for prothrombin complex levels).
See prescribing information for full details.
Indications
Treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required.
Contra-Indications
Risk of thrombosis, angina pectoris, recent MI (exception: life-threatening hemorrhages following overdose of oral anticoagulants, and before induction of a fibrinolytic therapy). In the case of disseminated intravascular coagulation, prothrombin complex-preparations may only be applied after termination of the consumptive state. Known history of heparin-induced thrombocytopenia.
See prescribing information for full details.
Special Precautions
In patients with acquired deficiency of the vitamin K-dependent coagulation factors (e.g. as induced by treatment of vitamin K antagonists), Beriplex P/N 250/500 should only be used when rapid correction of the prothrombin complex levels is necessary, such as major bleedings or emergency surgery. Patients receiving a vitamin K antagonist may have an underlying hypercoaguable state and infusion of human prothrombin complex may exacerbate this. If allergic or anaphylactic-type reactions occur, administration has to be stopped immediately (e.g. discontinue injection) and an appropriate treatment has to be initiated. 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 half-lives, may accumulate to levels considerably higher than normal. Because of the risk of thromboembolic complications, close monitoring should be exercised when administering to patients with a history of coronary heart disease or MI, to patients with liver disease, to patients postoperatively, to neonates or to patients at risk of thromboembolic phenomena or disseminated intravascular coagulation or simultaneous inhibitor deficiency. In patients with disseminated intravascular coagulation, it may, under certain circumstances, be necessary to substitute the coagulation factors of the prothrombin complex. When used to normalize impaired coagulation, prophylactic administration of heparin should be considered. Contains up to 343 mg sodium (approximately 15 mmol) per 100 ml which should be taken into consideration by patients on a controlled sodium diet.
See prescribing information for full details.
Side Effects
Renal and urinary disorders, vascular disorders. Increase in body temperature is observed in very rare cases. Immune system disorders – very rare, development of heparin-induced thrombocytopenia.
See prescribing information for full details.
Drug interactions
See prescribing information for full details.