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1 x 500 IU
1 x 1,000 IU
The dosage and duration of the substitution therapy depend on the severity of the FVIII defi ciency, on the location and extent of the bleeding and on the patient’s clinical condition.
On demand treatment: The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO standard for factor VIII products. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an international standard for factor VIII in plasma).
One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one mL of normal human plasma. The calculation of the required dosage of factor VIII is based on the empirical fi nding that 1 IU factor VIII per kg body weight raises the plasma factor VIII activity by 2.2% – 2.7% of normal activity (2.2-2.7 IU/dL). The required dosage is determined using the following formula: Required units = body weight (kg) x desired factor VIII rise (%) (IU/dL) x 0.4.
The amount to be administered and the frequency of administration should always be orientated to the clinical effectiveness in the individual case.
In the case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma activity level (in % of normal; IU/dL) in the corresponding period. The following table can be used to guide dosing in bleeding episodes and surgery: See prescribing information.
Prophylaxis: For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of factor VIII per kg body weight at intervals of 2 to 3 days. In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary. During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions. In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable. Individual patients may vary in their response to factor VIII, achieving different levels of in vivo recovery and demonstrating different half-lives.
Paediatric patients: Optivate is indicated for use in children, including those less than 6 years of age. The usual dose is 17 to 30 IU/kg. This can be given up to 3 times a week to prevent bleeding. In the clinical trials the median doses in children ≤6 years of age were 24.7 IU/kg for routine prophylaxis and 27.6 IU/kg to treat a bleed. Patients should be monitored for the development of factor VIII inhibitors. If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a factor VIII inhibitor is present. In patients with high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should be considered. Management of such patients should be directed by physicians with experience in the care of patients with haemophilia.
Method of administration: Dissolve the preparation as described in the attach product data sheet. The product should be administered via the intravenous route at a rate not exceeding 3 mL per minute (note that increasing the rate of administration may result in side effects).
Treatment and prophylaxis of bleeding in patients with hemophilia A (congenital factor VIII deficiency).
Hypersensitivity to the active substance or to any of the excipients.
As with any intravenous protein product, allergic type hypersensitivity reactions are possible. The product contains traces of human proteins other than factor VIII and VWF. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. If these symptoms occur, they should be advised to discontinue use of the product immediately and contact their physician. In case of shock, standard medical treatment for shock should be implemented In case of shock, standard medical treatment for shock should be implemented.Standard measures are implemented 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 HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19. for full details see prescribing information.
Pregnancy and lactation: Should be used only if clearly indicated.
Common: Headache , Somnolence, Vertigo (dizziness), Rash, Pruritus, Muscle and joint stiffness, Infusion site erythema, rash or pain, Oedema peripheral, Shivering (rigors), Fever (pyrexia).
for full details see prescribing information.
No interactions of human coagulation factor VIII products with other medicinal products have been reported.
Pregnancy and Lactation
Animal reproduction studies have not been conducted with factor VIII. Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast-feeding is not available. Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.
No case of overdose has been reported.