Prothromplex Adverse Reactions

Summary of the safety profile: Replacement therapy with human prothrombin complex concentrates, including therapy with Prothromplex TOTAL 600 IU, may result in the formation of circulating antibodies inhibiting one or more of the human prothrombin complex factors. If such inhibitors occur, the condition will manifest itself as a poor clinical response.
There is a risk of thromboembolic episodes, following the administration of human prothrombin complex (see Precautions).
For safety with regard to transmissible agents, see Precautions.
Tabulated list of adverse reactions: The acute myocardial infarction, venous thrombosis and pyrexia presented in the tabulated list of adverse reactions as follows have been reported in one clinical study with Prothromplex TOTAL 600 IU in oral anticoagulant reversal in patients (n=61) with acquired prothrombin complex coagulation factors (II, VII, IX, X) deficiency. The other adverse reactions included in the table have been reported from post-marketing experience only and the frequency category was assigned by statistics based on the assumption that each adverse reaction could have occurred in the clinical trial with 61 patients.
Adverse reactions to treatment with Prothromplex TOTAL 600 IU are classified by MedDRA System Organ Class (version 15.1). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data). (See Table 4.)

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Class reactions: Skin and subcutaneous tissue disorders: Angioedema, Paraesthesia.
General disorders and administrative site conditions: Infusion site reaction.
Nervous system disorders: Lethargy.
Psychiatric disorders: Restlessness.
Paediatric population: For information on paediatric population see statement in Dosage & Administration.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.