What is the active ingredient in BERIPLEX 1000IU Powder and solvent for solution for injection?

Prothrombinum multiplex humanum (Białko C, Białko S, Factor II coagulationis humanus, Factor IX coagulationis humanus, Factor VII coagulationis humanus, Factor X coagulationis humanus)

Is BERIPLEX 1000IU Powder and solvent for solution for injection OTC or prescription only?

BERIPLEX 1000IU Powder and solvent for solution for injection requires a doctor's prescription.

What are the side effects of BERIPLEX 1000IU Powder and solvent for solution for injection?

Summary of the safety profile Allergic or anaphylactic reactions have been observed uncommonly, including severe anaphylactic reactions (see section 4.4). Replacement therapy may lead to the formation of circulating antibodies inhibiting one or more of the human prothrombin complex factors. The presence of such inhibitors results in an inadequate clinical response to treatment. In such cases, it is recommended to contact a specialised haemophilia treatment centre. Anaphylactic

Who should NOT take BERIPLEX 1000IU Powder and solvent for solution for injection?

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. In cases of disseminated intravascular coagulation, prothrombin complex products may only be used after resolution of the consumptive state. Known history of heparin-induced thrombocytopenia.

Does BERIPLEX 1000IU Powder and solvent for solution for injection interact with other medications?

Human prothrombin complex products neutralise the effect of vitamin K antagonists, but no interactions with other medicinal products are known. When performing coagulation tests that are sensitive to heparin in patients receiving high doses of human prothrombin complex, the presence of heparin as a component of the administered product must be taken into account.

Can BERIPLEX 1000IU Powder and solvent for solution for injection be used during pregnancy?

Pregnancy and breast-feeding The safety of human prothrombin complex during pregnancy and breast-feeding has not been established. Animal studies are not suitable for assessing safety with regard to pregnancy, embryonal/foetal development, parturition, or postnatal development. Human prothrombin complex should therefore only be used during pregnancy and breast-feeding if clearly indicated. Fertility No data on fertility are available.

BERIPLEX 1000IU Powder and solvent for solution for injection

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

BERIPLEX 1000IU Powder and solvent for solution for injection — Description, Dosage, Side Effects | PillsCard

Pharmacotherapeutic group: antihemorrhagics, blood coagulation factors II, VII, IX and X in combination ATC code: B02BD01. Coagulation factors II, VII, IX and X, which are synthesised in the liver with the aid of vitamin K, are commonly referred to as the prothrombin complex.‍‍‍‍‍‍‍‍‍‍‍‍‍ In addition to the coagulation factors, Beriplex contains the vitamin K-dependent coagulation inhibitors protein C and protein S. Factor VII is the zymogen of the active serine protease factor VIIa, which initiates the extrinsic pathway of blood coagulation. The tissue factor–factor VIIa complex activates coagulation factors IX and X, resulting in the formation of factors IXa and Xa. With further activation of the coagulation cascade, prothrombin (factor II) is activated and converted to thrombin. Through the action of thrombin, fibrinogen is converted to fibrin, resulting in clot formation. Normal thrombin generation is also vitally important for platelet function as part of primary haemostasis. In isolated cases, severe factor VII deficiency leads to decreased thrombin generation and a bleeding tendency due to impaired fibrin formation and impaired primary haemostasis. Isolated factor IX deficiency is one of the classic forms of haemophilia (haemophilia B). Isolated factor II or factor X deficiency is very rare, but in severe forms may cause a bleeding tendency similar to that seen in classic haemophilia. Additional components include the coagulation inhibitors protein C and protein S, which are also synthesised in the liver. The biological activity of protein C is potentiated by its cofactor, protein S. Activated protein C inhibits coagulation by inactivating coagulation factors Va and VIIIa. Protein S, as a cofactor of protein C, promotes the inactivation of coagulation. Protein C deficiency is associated with an increased risk of thrombosis. Acquired deficiency of vitamin K-dependent coagulation factors occurs during treatment with vitamin K antagonists. When the deficiency becomes severe, it may lead to a serious bleeding tendency characterised by retroperitoneal or cerebrovascular haemorrhage rather than muscle or joint bleeding. Severe hepatic insufficiency also results in markedly reduced levels of vitamin K-dependent coagulation factors with a clinical bleeding tendency, which is, however, often complex due to simultaneous ongoing low-grade intravascular coagulation, low platelet counts, deficiency of coagulation inhibitors, and disturbed fibrinolysis. Administration of human prothrombin complex results in an increase in plasma levels of the vitamin K-dependent coagulation factors and thereby temporarily corrects the coagulation defect in patients with a deficiency of one or more of these factors.

⚠️ Warnings

Seek the advice of a specialist experienced in the treatment of coagulation disorders. In patients with acquired deficiency of vitamin K-dependent coagulation factors (e.g.‍‍‍‍‍‍‍‍‍‍‍‍‍ deficiency induced by treatment with vitamin K antagonists), Beriplex should only be used when rapid correction of prothrombin complex levels is necessary, such as in major bleeding or emergency surgery. In other cases, reduction of the vitamin K antagonist dose and/or administration of vitamin K is usually sufficient. Patients receiving vitamin K antagonists have an underlying hypercoagulable state, which may be exacerbated by infusion of human prothrombin complex. In congenital deficiency of any vitamin K-dependent factor, a specific coagulation factor product should be used when available. If an allergic or anaphylactic reaction occurs, administration of Beriplex should be stopped immediately (e.g. stop injection) and appropriate treatment must be initiated. Treatment depends on the nature and severity of the adverse reaction. In case of shock, standard anti-shock treatment must be initiated immediately. There is a risk of thrombosis or disseminated intravascular coagulation when patients with congenital or acquired deficiency are treated with human prothrombin complex, especially with repeated dosing. The risk may be higher in the treatment of isolated factor VII deficiency, since the other vitamin K-dependent coagulation factors with longer half-lives may accumulate to levels substantially above normal. Patients receiving human prothrombin complex concentrates should be closely monitored for signs of intravascular coagulation or thrombosis. Due to the risk of thromboembolic complications, close monitoring is recommended when administering Beriplex, particularly in patients with a history of coronary heart disease, patients with liver disease, peri- and postoperative patients, neonates, or other patients at risk of thromboembolic events or disseminated intravascular coagulation, or with concurrent inhibitor deficiency. In each of these situations, the potential benefit of treatment with Beriplex should be weighed against the risk of these complications. In patients with disseminated intravascular coagulation, replacement of prothrombin complex coagulation factors may be necessary under certain circumstances. However, such replacement should only be carried out after resolution of the consumptive state (e.g. treatment of the underlying cause, sustained normalisation of antithrombin III levels). Reversal of vitamin K antagonist therapy exposes patients to the thromboembolic risk of the underlying disease. Resumption of anticoagulation should be carefully considered as soon as possible. Adverse reactions may include the development of heparin-induced thrombocytopenia type II (HIT type II). The characteristic features of HIT are a platelet count decrease of > 50 percent and/or the occurrence of new or unexplained thromboembolic complications during heparin therapy. The onset is usually 4 to 14 days after initiation of heparin therapy, but may occur within 10 hours in patients who have recently received heparin (within the past 100 days). Nephrotic syndrome has been reported in isolated cases following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reaction. No data are available on the use of Beriplex in cases of perinatal bleeding due to vitamin K deficiency in neonates. Beriplex contains up to 343 mg sodium (approximately 15 mmol) per 100 ml. This should be taken into consideration in patients on a sodium-restricted diet. Viral safety 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 these measures, 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 any unknown or emerging viruses or other pathogens. The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV), and for the non-enveloped hepatitis A virus (HAV) and parvovirus B19. Appropriate vaccination (against hepatitis A and B) should be considered for patients receiving regular or repeated administration of prothrombin complex products derived from human plasma. It is strongly recommended that every time Beriplex 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.

BERIPLEX 1000IU Powder and solvent for solution for injection

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