Presentation and Status in Health Basket
5 ml x 250 IU
10 ml x 500 IU
10 ml x 1000 IU
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia. The dosage and duration of treatment depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient‘s clinical condition. The number of administered units of factor VIII is expressed in International Units (IU), which are standardised by the World Health Organisation (WHO). The factor VIII activity in the plasma is expressed either in percent (relative to normal human plasma) or in International Units (referred 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 finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 1 % to 2 % of normal activity. The required dosage is determined using the following formula: Required units = body weight (kg) x desired factor VIII rise (%) x 0.5 How much of Haemoctin® SDH 250 should the patient use, and how often should he use it? The physician must take account of how effective Haemoctin SDH 250 is for the patient personally when deciding how much and how often it should be administered. Haemoctin SDH 250 must rarely be administered more than once per day. In the event of occurrence of any haemorrhagic events such as listed in the following table, the factor VIII activity should not fall below the given activity level.
For full details see prescribing information.
Treatment and prophylaxis of bleeding in patients with hemophilia A (congenital factor VIII deficiency) in patients with acquired factor VIII deficiency.
Hypersensitivity to the active substance or to any of the excipients.
As with every protein-containing product for intravenous administration, allergic hypersensitivity reactions are possible. If early signs of an allergic reaction are observed, immediately interrupt the treatment with Haemoctin SDH 250. After repeatedly receiving treatment with factor VIII concentrates, it is possible that the body may develop antibodies (inhibitors) to factor VIII. The patient should be checked regularly using a biological test (the Bethesda test) for the formation of inhibitors. The appearance of such factor VIII inhibitors manifests itself as a lack of therapeutic success. The amount of inhibitors in the body is expressed in Bethesda units (BU) per ml of blood plasma. The risk of developing inhibitors depends on the administration of factor VIII, and is greatest during the first 20 days of administration. Inhibitors rarely form after more than 100 days of administration. When medicinal products are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections. The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for nonenveloped hepatitis A virus. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19. UhrParvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia). Consider vaccinating against hepatitis A and B in patients regularly or repeatedly receiving human plasma derived factor VIII products. It is strongly recommended that every time a dose of Haemoctin SDH 250 is given the name and batch number of the product are recorded in order to maintain a record of the batches used. What should be observed in road traffic, when operating machinery or working in potentially hazardous situations. The ability to drive or operate machinery is not impaired. For full details see prescribing information.
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed infrequently, and may in some cases progress to severe anaphylaxis (including shock). On rare occasions, fever has been observed. Patients with haemophilia A may develop neutralising antibodies (inhibitors) to factor VIII. If such inhibitors occur, the condition will manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted. From introduction in the market until January 2006 a total of about 500 000 standard dosages of Haemoctin® SDH 250, 500 and 1000 were applied. In total 12 cases of suspected development of inhibitors were received from clinical trials, spontaneous reporting and non interventional studies. This corresponds to a reporting frequency of 1 case on 40 864 applications.
For full details see prescribing information.
Interactions between Haemoctin SDH 1000 and other medicinal products are unknown. Haemoctin SDH 1000 should not be mixed with other medicinal products. Only the supplied infusion set should be used because treatment failure can occur as a consequence of factor VIII adsorption to the internal surfaces of some infusion equipment.
Pregnancy and Lactation
Because of the rare occurrence of haemophilia A in women, there is no experience available on the use of Haemoctin SDH 250 during pregnancy or while breastfeeding. No animal experiments have been performed during pregnancy and nursing. Haemoctin® SDH 250 should only be used if clearly needed during pregnancy or lactaction.
No case of overdose has been reported.