OCTAPLEX

Posology Only general dosage guidelines are given below. Treatment should be initiated under the supervision of a physician experienced in the treatment of coagulation disorders. The dosage and duration of the substitution therapy depend on the severity of the disorder, on the location and extent of the bleeding and on the patient’s clinical condition.

The amount and the frequency of administration should be calculated on an individual patient basis. 2). 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 (prothrombin time, INR), and 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). Bleeding and perioperative prophylaxis of bleeding during vitamin K antagonist treatment: The dose will depend on the INR before treatment and body weight.

In the following table approximate doses (units/kg body weight of the reconstituted product) are given. Pre-treatment INR 2 - < 4 4 - 6 > 6 Dose of Octaplex (units† of factor IX) / kg body weight 25 35 50 † Units refer to International Units.

Dose is based on body weight up to, but not exceeding 100 kg. For patients weighing more than 100 kg, the maximum single dose (IU of factor IX) should therefore not exceed 2500 IU for an INR of 2 - < 4, 3500 IU for an INR of 4 - 6 and 5000 IU for an INR of > 6.

The correction of the vitamin K antagonist induced impairment of haemostasis persists for approximately 6-8 hours. However, the effects of vitamin K, if administered simultaneously, are usually achieved within 4-6 hours. Thus, repeated treatment with human prothrombin complex is not usually required when vitamin K has been administered.

As these recommendations are empirical and recovery and the duration of effect may vary, monitoring of INR during treatment is mandatory. 017 IU/mL, respectively. The dose of a specific factor administered is expressed in International Units (IU), which are related to the current WHO standard for each factor.

Summary of Safety Profile Replacement therapy may lead to 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.

Allergic or anaphylactic-type reactions may rarely occur (≥ 1/10,000 to < 1/1,000) including severe anaphylactic reactions. Increase in body temperature has been observed very rarely (<1/10,000). 4). Tabulated List of adverse reactions of Octaplex The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).

Frequencies have been based on clinical trial data, according to the following convention: 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) or not known (cannot be estimated from the available data).

MedDRA Standard System Organ Class Adverse reactions Frequency Psychiatric Disorders Anxiety uncommon Vascular disorders Deep vein thrombosis common Thrombosis uncommon Hypertension uncommon Respiratory, thoracic and Pulmonary embolism uncommon mediastinal disorders Bronchospasm uncommon Hemoptysis uncommon Epistaxis uncommon MedDRA Standard System Organ Class Adverse reactions Frequency General disorders and administration site conditions Immune system disorders Anaphylactic shock, hypersensitivity Nervous system disorders Tremor Cardiac disorders Cardiac arrest, tachycardia Vascular disorders Circulatory collapse, hypotension Respiratory, thoracic and mediastinal disorders Dyspnoea, respiratory failure Gastrointestinal disorders Nausea Skin and subcutaneous tissue disorders Urticaria, rash General disorders and administration site conditions Chills Injection site burning uncommon Investigations Fibrin D-dimer increased uncommon Blood thrombin increased uncommon Hepatic Function Abnormal uncommon Injury, poisoning and procedural complications Thrombosis in device uncommon The following adverse reactions have been reported during post-marketing use of Octaplex.

Traceability In order to improve 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.

g. as induced by treatment with vitamin K antagonists), Octaplex should only be used when rapid correction of prothrombin complex levels is necessary, such as major bleeding or emergency surgery. In other cases, reduction of the dose of the 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 prothrombin complex concentrate may exacerbate this. If allergic or anaphylactic-type reactions occur, the infusion should be stopped immediately.

In case of shock, standard 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.

Despite 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 effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV). The measures taken may be of limited value against non-enveloped viruses such as hepatitis A virus (HAV) and parvovirus B19.

g. haemolytic anaemia). Appropriate vaccination (hepatitis A and B) is recommended for patients in regular/repeated receipt of human plasma-derived prothrombin complex products. It is strongly recommended that every time Octaplex 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.

1. - Known allergy to heparin or history of heparin induced thrombocytopenia. - Individuals who have IgA deficiency with known antibodies against IgA.