BLOOD-DERIVED MEDICINES

A blood-derived medicine is any medicine made from human blood or plasma. To produce medicines, blood plasma undergoes fractionation, a procedure used to extract individual protein plasma components.

To produce blood-derived medicines, fresh frozen plasma is used that has been prepared from whole blood or through plasmapheresis, donated by unpaid voluntary donors, and that has not been used for clinical treatment of patients. The plasma collected in the Republic of Slovenia for the purposes of producing medications is processed at the selected provider abroad pursuant to the procedures laid down. Blood-derived medicines made from human plasma that is donated by Slovenian donors are registryed and produced pursuant to GMP and Ph. Eur. All medications made from the plasma collected in the Republic of Slovenia are always returned in full to treat patients (with inherited blood clotting disorders, immune deficiencies, etc.) in Slovenia.

Within the frame of the self-sufficiency programme, ZTM currently supplies the market with coagulation factor VIII, coagulation factor IX, a combination of coagulation factors IX, II, VII and X, the human normal immunoglobulin for intravenous administration and albumin.

The Centre for the supply and marketing of medicinal products and medical devices at ZTM has been verified and pursues wholesale marketing of blood-derived and recombinant medicines.

For additional information, please contact the Centre for the supply and marketing of medicinal products and medical devices at the Blood Transfusion Centre of Slovenia at the following telephone numbers: 01/54 38 214 and 01/54 38 209.

Blood clotting factors:

• Coagulation factor VIII (F VIII) is a lyophilised, virally inactivated and purified concentrate of human blood clotting factor VIII that is intended to treat and prevent haemorrhage in patients with a blood clotting disorder (haemophilia A) and patients with an acquired Factor VIII deficiency; in various concentrations and forms.
• Coagulation factor IX (F IX) is a lyophilised, virally inactivated and purified concentrate of human blood clotting factor IX that is intended to treat and prevent haemorrhage in patients with a blood clotting disorder (haemophilia B); in various concentrations and forms.
• A combination of von Willebrand factor and coagulation factor VIII is a lyophilised, virally inactivated and purified concentrate of human factor VIII and vWF that is intended to treat and prevent haemorrhage or bleeding during surgery in patients with von Willebrand disease or to treat and prevent haemorrhage in patients with haemophilia A; in various concentrations and forms.
• A combination of coagulation factors IX, II, VII and X is a lyophilised, virally inactivated and purified concentrate of human factors IX, II, VII and X that is intended for the treatment of haemorrhage and perioperative protection of haemorrhage in acquired deficiency of the prothrombin complex coagulation factors as well as in acquired deficiency of vitamin K-dependent clotting factors II and X; in various concentrations and forms.
• Fibrinogen is a lyophilised, virally inactivated and purified concentrate of human blood clotting factor I that is intended to treat an acute stage of haemorrhage in patients with inherited fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia; in various concentrations and forms.

Immunoglobulins:

• Human normal immunoglobulin for intravenous administration is a virally inactivated and purified human normal immunoglobulin that contains a wide spectrum of antibodies against various infectious disease agents and is intended for replacement therapy in patients with primary immunodeficiency syndromes, myeloma or chronic lymphatic leukaemia and repeated infections as well as in children with congenital AIDS; in various concentrations and forms.
• Human normal immunoglobulin for extravascular administration is a virally inactivated and purified human normal immunoglobulin that is intended for replacement therapy in patients with a primary immunodeficiency syndrome, myeloma or chronic lymphatic leukaemia and repeated infections; in various concentrations and forms.
• Human anti-D immunoglobulin is a virally inactivated and purified human specific immunoglobulin that contains antibodies against the Rhesus factor and is intended for prenatal and postnatal prevention of RhD immunisation at RhD-negative women and for the treatment of RhD-negative persons after the transfusion of RhD-positive blood; in various concentrations and forms.
• Human immunoglobulin against hepatitis B is a virally inactivated and purified human immunoglobulin against hepatitis B surface antigen that is intended to provide immediate and long-term immunity and prevent infection with the hepatitis virus after liver transplant; in various concentrations and forms.
• Human immunoglobulin against chickenpox/shingles (varicella/herpes zoster) is a virally inactivated and purified human immunoglobulin against the varicella/herpes zoster virus that is intended to provide immediate and long-term immunity; in various concentrations and forms.
• Human immunoglobulin against cytomegalovirus (CMV) is a virally inactivated and purified human immunoglobulin against cytomegalovirus that is intended to provide immediate and long-term immunity; in various concentrations and forms. 

Albumin:

• Albumin is a virally inactivated and purified human albumin that is intended to replace and sustain a volume of blood in circulation in case a decreased volume of blood has been proven; in various concentrations and forms.