Vyhledávání

Léčba NovoSeven®

  • vysoce účinná

    • u spontánních krvácení
    • u ortopedických a invazivních výkonů

  • bezpečná

    • bez rizika přenosu virových infekcí
    • nízké riziko nežádoucích účinků

  • okamžitě dostupná

    • NovoSeven® stabilní při pokojové teplotě

  • jednoduchá a pohodlná

Správná volba pro kontrolu krvácení


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Reference


Charakteristika přípravku

  1. NovoSeven® SPC, Novo Nordisk A/S.
  2. Key NS, Aledort LM, Beardsley D, Cooper HA, Davignon G, Ewenstein BM, et al. Home treatment of mild to moderate bleeding episodes using recombinant factor VIIa (NovoSeven®) in haemophiliacs with inhibitors. Thromb Haemost. 1998 Dec;80(6):912-8.
  3. Shapiro AD, Gilchrist GS, Hoots WK, Cooper HA, Gastineau DA. Prospective, randomised trial of two doses of rFVIIa (NovoSeven®) in haemophilia patients with inhibitors undergoing surgery. Thromb Haemost. 1998 Nov;80(5):773-8.
  4. Lusher JM, Roberts HR, Davignon G, Joist JH, Smith H, Shapiro A, et al. A randomized, double-blind comparison of two dosage levels of recombinant factor VIIa in the treatment of joint, muscle and mucocutaneous haemorrhages in persons with haemophilia A and B, with and without inhibitors. rFVIIa Study Group. Haemophilia. 1998 Nov;4(6):790-8.
  5. Ingerslev J, Freidman D, Gastineau D, Gilchrist G, Johnsson H, Lucas G, et al. J. Major surgery in haemophilic patients with inhibitors using recombinant factor VIIa. Haemostasis. 1996;26 Suppl 1:118-23.
  6. McPherson J, Teague L, Lloyd J, Jupe D, Rowell J, Ockelford P, et al. Experience with recombinant factor VIIa in Australia and New Zealand. Haemostasis. 1996;26 Suppl 1:109-17.
  7. Arkin S, Cooper HA, Hutter JJ, Miller S, Schmidt ML, Seibel NL, et al. Activated recombinant human coagulation factor VII therapy for intracranial hemorrhage in patients with hemophilia A or B with inhibitors. Results of the NovoSeven® emergency-use program. Haemostasis. 1998 Mar-Apr;28(2):93-8.
  8. Liebman HA, Chediak J, Fink KI, Galvez AG, Shah PC, Sham RL. Activated recombinant human coagulation factor VII (rFVIIa) therapy for abdominal bleeding in patients with inhibitory antibodies to factor VIII. Am J Hematol. 2000 Mar;63(3):109-13.
  9. Varon D, Martinowitz U, Heim M (Guest editors). State of the art. Inhibitors of coagulation factors. Haemophilia. 1998;4:538-628.
  10. Ingerslev J, Knudsen L, Hvid I, Tange MR, Fredberg U, Sneppen O. Use of recombinant factor VIIa in surgery in factor-VII-deficient patients. Haemophilia. 1997 Jul; 3(3):215-8.
  11. Scharrer I. Recombinant factor VIIa for patients with inhibitors to factor VIII or IX or factor VII deficiency. Haemophilia. 1999 Jul;5(4):253-9.
  12. Mariani G, Testa MG, Di Paolantonio T, Molskov Bech R, Herder U. Use of recombinant activated factor VII in the treatment of congenital factor VII deficiencies. Vox Sang. 1999;77(3):131-6.
  13. He S, Ekman GJ, Hedner U. The effect of platelets on fibrin gel structure formed in the presence of recombinant factor VIIa in hemophilia plasma and in plasma from a patient with Glanzmann thrombasthenia. J Thromb Haemost. 2005 Feb;3(2):272-9.
  14. Poon MC, Demers C, Jobin F, Wu JW. Recombinant factor VIIa is effective for bleeding and surgery in patients with Glanzmann thrombasthenia. Blood. 1999 Dec 1;94(11):3951-3.
  15. d'Oiron R, Ménart C, Trzeciak MC, Nurden P, Fressinaud E, Dreyfus M, et al. Use of recombinant factor VIIa in 3 patients with inherited type I Glanzmann's thrombasthenia undergoing invasive procedures. Thromb Haemost. 2000 May;83(5):644-7.
  16. Poon MC, D'Oiron R, Von Depka M, Khair K, Négrier C, Karafoulidou A, et al. For members of the International Data Collection on Recombinant Factor VIIa and Congenital Platelet Disorders Study Group. Prophylactic and therapeutic recombinant factor VIIa administration to patients with Glanzmann's thrombasthenia: results of an international survey. J Thromb Haemost. 2004 Jul;2(7):1096-103.

Mechanismus účinku

  1. Monroe DM, Hoffman M, Oliver JA, Roberts HR. Platelet activity of high-dose factor VIIa is independent of tissue factor. Br J Haematol. 1997 Dec;99(3):542-7.
  2. Kjalke M, Ezban M, Monroe DM, Hoffman M, Roberts HR, Hedner U. High-dose factor VIIa increases initial thrombin generation and mediates faster platelet activation in thrombocytopenia-like conditions in a cell-based model system. Br J Haematol. 2001 Jul;114(1):114-20.
  3. Kjalke M, Monroe DM, Hoffman M, Oliver JA, Ezban M, Hedner U, Roberts HR. The effects of activated factor VII in a cell-based model for tissue factor-initiated coagulation. Blood Coagul Fibrinolysis. 1998 Mar;9 Suppl 1:S21-5.
  4. Galán AM, Tonda R, Pino M, Reverter JC, Ordinas A, Escolar G. Increased local procoagulant action: a mechanism contributing to the favorable hemostatic effect of recombinant FVIIa in PLT disorders. Transfusion. 2003 Jul;43(7):885-92.
  5. Kumar R, Béguin S, Hemker HC. The influence of fibrinogen and fibrin on thrombin generation-evidence for feedback activation of the clotting system by clot bound thrombin. Thromb Haemost. 1994 Nov;72(5):713-21.
  6. Lisman T, de Groot PG, Lambert T, Røjkjaer R, Persson E. Enhanced in vitro procoagulant and antifibrinolytic potential of superactive variants of recombinant factor VIIa in severe hemophilia A. J Thromb Haemost. 2003 Oct;1(10):2175-8.
  7. Lisman T, Adelmeijer J, Cauwenberghs S, Van Pampus EC, Heemskerk JW, De Groot PG. Recombinant factor VIIa enhances platelet adhesion and activation under flow conditions at normal and reduced platelet count. J Thromb Haemost. 2005 Apr;3(4):742-51.
  8. He S, Blombäck M, Jacobsson Ekman G, Hedner U. The role of recombinant factor VIIa (FVIIa) in fibrin structure in the absence of FVIII/FIX. J Thromb Haemost. 2003 Jun;1(6):1215-9.
  9. Butenas S, Brummel KE, Branda RF, Paradis SG, Mann KG. Mechanism of factor VIIa-dependent coagulation in hemophilia blood. Blood. 2002 Feb 1;99(3):923-30.
  10. He S, Ekman GJ, Hedner U. The effect of platelets on fibrin gel structure formed in the presence of recombinant factor VIIa in hemophilia plasma and in plasma from a patient with Glanzmann thrombasthenia. J Thromb Haemost. 2005 Feb;3(2):272-9.
  11. Lisman T, de Groot P. Mechanism of action of recombinant activated factor VII. TATM. 2003;5(5):S5-10.

Vrozená hemofilie

  1. NovoSeven® SPC, Novo Nordisk A/S.
  2. Varon D, Martinowitz U, Heim M (Guest editors). State of the art. Inhibitors of coagulation factors. Haemophilia. 1998;4:538-628.
  3. Hedner U, Glazer S, Pingel K, Alberts KA, Blombäck M, Schulman S, et al. Successful use of recombinant factor VIIa in patient with severe haemophilia A during synovectomy. Lancet. 1988 Nov 19;2(8621):1193.
  4. Key NS, Aledort LM, Beardsley D, Cooper HA, Davignon G, Ewenstein BM, et al. Home treatment of mild to moderate bleeding episodes using recombinant factor VIIa (NovoSeven®) in haemophiliacs with inhibitors. Thromb Haemost. 1998 Dec;80(6):912-8.
  5. Shapiro AD, Gilchrist GS, Hoots WK, Cooper HA, Gastineau DA. Prospective, randomised trial of two doses of rFVIIa (NovoSeven®) in haemophilia patients with inhibitors undergoing surgery. Thromb Haemost. 1998 Nov;80(5):773-8.
  6. Lusher JM, Roberts HR, Davignon G, Joist JH, Smith H, Shapiro A, et al. A randomized, double-blind comparison of two dosage levels of recombinant factor VIIa in the treatment of joint, muscle and mucocutaneous haemorrhages in persons with haemophilia A and B, with and without inhibitors. rFVIIa Study Group. Haemophilia. 1998 Nov;4(6):790-8.
  7. Ingerslev J, Freidman D, Gastineau D, Gilchrist G, Johnsson H, Lucas G, et al. Major surgery in haemophilic patients with inhibitors using recombinant factor VIIa. Haemostasis. 1996;26 Suppl 1:118-23.
  8. McPherson J, Teague L, Lloyd J, Jupe D, Rowell J, Ockelford P, et al. Experience with recombinant factor VIIa in Australia and New Zealand. Haemostasis. 1996;26 Suppl 1:109-17.
  9. Arkin S, Cooper HA, Hutter JJ, Miller S, Schmidt ML, Seibel NL, et al. Activated recombinant human coagulation factor VII therapy for intracranial hemorrhage in patients with hemophilia A or B with inhibitors. Results of the NovoSeven® emergency-use program. Haemostasis. 1998 Mar-Apr;28(2):93-8.
  10. Liebman HA, Chediak J, Fink KI, Galvez AG, Shah PC, Sham RL. Activated recombinant human coagulation factor VII (rFVIIa) therapy for abdominal bleeding in patients with inhibitory antibodies to factor VIII. Am J Hematol. 2000 Mar;63(3):109-13.
  11. Von Depka M. NovoSeven®: mode of action and use in acquired haemophilia. Intensive Care Med. 2002 Oct;28 Suppl 2:S222-7.
  12. Ingerslev J, Knudsen L, Hvid I, Tange MR, Fredberg U, Sneppen O. Use of recombinant factor VIIa in surgery in factor-VII-deficient patients. Haemophilia. 1997 Jul; 3(3):215-8.
  13. Salaj P, Gurlich R, Svorcová V, Marková M, Cetkovský P. Prophylactic preparation and surgical extirpation of a very large abdominal blood cyst in a severe haemophilia A patient with inhibitors managed by rFVIIa. Haemophilia. 2009 Jan;15(1):380-2. Epub 2008 Oct 30.
  14. Green D. Complications associated with the treatment of haemophiliacs with inhibitors. Haemophilia. 1999 Sep;5 Suppl 3:11-7.
  15. Conlan MG, Hoots WK. Disseminated intravascular coagulation and hemorrhage in hemophilia B following elective surgery. Am J Hematol. 1990 Nov;35(3):203-7.
  16. Roberts HR. Clinical experience with activated factor VII: focus on safety aspects. Blood Coagul Fibrinolysis. 1998 Mar;9 Suppl 1:S115-8.
  17. Roberts HR. Recombinant factor VIIa: How safe is the stuff? Can J Anaesth. 2005 Jan;52(1):8-11.
  18. Abshire T, Kenet G. Safety update on the use of recombinant factor VIIa and the treatment of congenital and acquired deficiency of factor VIII or IX with inhibitors. Haemophilia. 2008 Sep;14(5):898-902. Epub 2008 Aug 4.
  19. Salaj P, Brabec P, Penka M, Pohlreichova V, Smejkal P, Cetkovsky P. Effect of rFVIIa dose and time to treatment on patients with haemophilia and inhibitors: analysis of HemoRec registry data from the Czech Republic. Haemophilia. 2009 May;15(3):752-9.

Získaná hemofilie


Stručná charakteristika onemocnění

  1. Hay CR. Acquired haemophilia. Baillieres Clin Haematol. 1998 Jun;11(2):287-303.
  2. Delgado J, Jimenez-Yuste V, Hernandez-Navarro F, Villar A. Acquired haemophilia: review and meta-analysis focused on therapy and prognostic factors. Br J Haematol. 2003 Apr;121(1):21-35.
  3. Collins PW, Hirsch S, Baglin TP, Dolan G, Hanley J, Makris M, et al. Acquired hemophilia A in the United Kingdom: a 2-year national surveillance study by the United Kingdom Haemophilia Centre Doctors' Organisation. Blood. 2007 Mar 1;109(5):1870-7. Epub 2006 Oct 17.
  4. Collins P, Macartney N, Davies R, Lees S, Giddings J, Majer R. A population based, unselected, consecutive cohort of patients with acquired haemophilia A. Br J Haematol. 2004 Jan;124(1):86-90.
  5. Collins PW. Management of acquired haemophilia A - more questions than answers. Blood Coagul Fibrinolysis. 2003 Jun;14 Suppl 1:S23-7.
  6. Collins PW. Treatment of acquired hemophilia A. J Thromb Haemost. 2007 May;5(5):893-900.
  7. Brack A, Vögeler S, Hilpert J, Berger G, Buhr HJ, Koscielny J. Acquired Factor VIII Inhibitor. Anesthesiology. 2009 Nov;111(5):1151-4.

Incidence

  1. Hay CR. Acquired haemophilia. Baillieres Clin Haematol. 1998 Jun;11(2):287-303.
  2. Delgado J, Jimenez-Yuste V, Hernandez-Navarro F, Villar A. Acquired haemophilia: review and meta-analysis focused on therapy and prognostic factors. Br J Haematol. 2003 Apr;121(1):21-35.
  3. Collins PW. Treatment of acquired hemophilia A. J Thromb Haemost. 2007 May;5(5):893-900.

Etiologie onemocnění

  1. Hay CR. Acquired haemophilia. Baillieres Clin Haematol. 1998 Jun;11(2):287-303.
  2. Collins P, Macartney N, Davies R, Lees S, Giddings J, Majer R. A population based, unselected, consecutive cohort of patients with acquired haemophilia A. Br J Haematol. 2004 Jan;124(1):86-90.
  3. Ma AD, Carrizosa D. Acquired factor VIII inhibitors: pathophysiology and treatment. Hematology Am Soc Hematol Educ Program. 2006:432-7.
  4. Rosenthal N, Vogel P, Beres D. Acquired hemophilia in a female. Festschrift dedicated to Robert Tilden Frakn. St. Louis: CV Mosby, 1937. p. 320.
  5. Delgado J, Jimenez-Yuste V, Hernandez-Navarro F, Villar A. Acquired haemophilia: review and meta-analysis focused on therapy and prognostic factors. Br J Haematol. 2003 Apr;121(1):21-35.
  6. Kaloyannidis P, Sakellari I, Fassas A, Fragia T, Vakalopoulou S, Kartsios C, et al. Acquired hemophilia A in a patient with multiple sclerosis treated with autologous hematopoietic stem cell transplantation and interferon beta-1a. Bone Marrow Transplant. 2004 Jul;34(2):187-8.
  7. Nakauchi-Tanaka T, Sohda S, Someya K, Kono K, Hamada H, Yoshikawa H. Acquired haemophilia due to factor VIII inhibitors in ovarian hyperstimulation syndrome: case report. Hum Reprod. 2003 Mar;18(3):506-8.
  8. Collins PW. Management of acquired haemophilia A - more questions than answers. Blood Coagul Fibrinolysis. 2003 Jun;14 Suppl 1:S23-7.

Klinické projevy a průběh

  1. Collins P, Macartney N, Davies R, Lees S, Giddings J, Majer R. A population based, unselected, consecutive cohort of patients with acquired haemophilia A. Br J Haematol. 2004 Jan;124(1):86-90.
  2. Boggio LN, Green D. Acquired hemophilia. Rev Clin Exp Hematol. 2001 Dec;5(4):389-404; quiz following 431.
  3. Collins PW. Management of acquired haemophilia A - more questions than answers. Blood Coagul Fibrinolysis. 2003 Jun;14 Suppl 1:S23-7.
  4. Delgado J, Jimenez-Yuste V, Hernandez-Navarro F, Villar A. Acquired haemophilia: review and meta-analysis focused on therapy and prognostic factors. Br J Haematol. 2003 Apr;121(1):21-35.
  5. Zavřelová J, Matýšková M, Buliková A, Smejkal P, Penka M. Inhibitory FVIII a FIX – patofyziologie a možné interference při jejich stanovení. Transfuze a hematologie dnes. 2008;14(1):35-7.
  6. Ma AD, Carrizosa D. Acquired factor VIII inhibitors: pathophysiology and treatment. Hematology Am Soc Hematol Educ Program. 2006:432-7.
  7. Frick PG. Hemophilia-like disease following pregnancy with transplacental transfer of an acquired circulation anticoagulant. Blood. 1953 Jul;8(7):598-608.
  8. Hay CR. Acquired haemophilia. Baillieres Clin Haematol. 1998 Jun;11(2):287-303.

Laboratorní diagnóza
Diferenciální diagnóza

  1. Zavřelová J, Matýšková M, Buliková A, Smejkal P, Penka M. Inhibitory FVIII a FIX – patofyziologie a možné interference při jejich stanovení. Transfuze a hematologie dnes. 2008;14(1):35-7.
  2. Hay CR. Acquired haemophilia. Baillieres Clin Haematol. 1998 Jun;11(2):287-303.
  3. Pruthi RK, Nichols WL. Autoimmune factor FVIII inhibitors. Curr Opin Hematol. 1999 Sep;6(5):314-22.
  4. Barthels M, Kraus M, Bohn U, Liese B, von Depka M, Eisert R. Factor VIII inhibitor-tests could be less sensitive than supposed. Vox Sang. 1999;77 Suppl 1:87-9.

Léčba krvácivých komplikací

  1. 1. Collins P, Macartney N, Davies R, Lees S, Giddings J, Majer R. A population based, unselected, consecutive cohort of patients with acquired haemophilia A. Br J Haematol. 2004 Jan;124(1):86-90.
  2. Hay CR, Brown S, Collins PW, Keeling DM, Liesner R. The diagnosis and management of factor VIII and IX inhibitors: a guideline from the United Kingdom Haemophilia Centre Doctors Organisation. Br J Haematol. 2006 Jun;133(6):591-605.
  3. Huth-Kühne A, Baudo F, Collins P, Ingerslev J, Kessler CM, Lévesque H. International recommendations on the diagnosis and treatment of patients with acquired hemophilia A. Haematologica. 2009 Apr;94(4):566-75.
  4. Collins PW. Treatment of acquired hemophilia A. J Thromb Haemost. 2007 May;5(5):893-900.
  5. Hedner U. Factor VIIa in the treatment of haemophilia. Blood Coagul Fibrinolysis. 1990 Aug;1(3):307-17.
  6. Hedner U, Glazer S, Falch J. Recombinant activated factor VII in the treatment of bleeding episodes in patients with inherited and acquired bleeding disorders. Transfus Med Rev. 1993 Apr;7(2):78-83.
  7. Hay CR, Negrier C, Ludlam CA. The treatment of bleeding in acquired haemophilia with recombinant factor VIIa: A multicentre study. Thromb Haemost. 1997 Dec;78(6):1463-7.
  8. NovoSeven® SPC, Novo Nordisk A/S.
  9. Delgado J, Jimenez-Yuste V, Hernandez-Navarro F, Villar A. Acquired haemophilia: review and meta-analysis focused on therapy and prognostic factors. Br J Haematol. 2003 Apr;121(1):21-35.
  10. Baudo F, de Cataldo F, Gaidano G; Italian registry of acquired hemophilia. Treatment of acquired factor VIII inhibitor with recombinant activated factor VIIa: data from the Italian registry of acquired hemophilia. Haematologica. 2004 Jun;89(6):759-61.
  11. Von Depka M. NovoSeven®: mode of action and use in aquired haemophilia. Intensive Care Med. 2002 Oct;28 Suppl 2:S222-7.
  12. Scharrer I. Recombinant factor VIIa for patients with inhibitors to factor VIII or IX or factor VII deficiency. Haemophilia. 1999 Jul;5(4):253-9.
  13. Roberts HR. Recombinant factor VIIa: How safe is the stuff? Can J Anaesth. 2005 Jan;52(1):8-11.
  14. Abshire T, Kenet G. Safety update on the use of recombinant factor VIIa and the treatment of congenital and acquired deficiency of factor VIII or IX with inhibitors. Haemophilia. 2008 Sep;14(5):898-902. Epub 2008 Aug 4.
  15. Negrier C, Goudemand J, Sultan Y, Bertrand M, Rothschild C, Lauroua P. Multicenter retrospective study on the utilization of FEIBA in France in patients with factor VIII and factor IX inhibitors. French FEIBA Study Group. Factor Eight Bypassing Activity. Thromb Haemost. 1997 Jun;77(6):1113-9.
  16. Nemes L, Pitlik E. New protocol for immune tolerance induction in acquired hemophilia. Haematologica. 2000 Oct;85(10 Suppl):64-8.
  17. Zeitler H, Ulrich-Merzenich G, Hess L, Konsek E, Unkrig C, Walger P, et al. Treatment of acquired hemophilia by the Bonn-Malmö Protocol: documentation of an in vivo immunomodulating concept. Blood. 2005 Mar 15;105(6):2287-93. Epub 2004 Nov 12.

Eradikace inhibitoru

  1. Hay CR. Acquired haemophilia. Baillieres Clin Haematol. 1998 Jun;11(2):287-303.
  2. Delgado J, Jimenez-Yuste V, Hernandez-Navarro F, Villar A. Acquired haemophilia: Review and meta-analysis focused on therapy and prognostic factors. Br J Haematol. 2003 Apr;121(1):21-35.
  3. Collins P, Macartney N, Davies R, Lees S, Giddings J, Majer R. A population based, unselected, consecutive cohort of patients with acquired haemophilia A. Br J Haematol. 2004 Jan;124(1):86-90.
  4. Collins PW. Treatment of acquired hemophilia A. J Thromb Haemost. 2007 May;5(5):893-900.
  5. Zavřelová J, Matýšková M, Buliková A, Smejkal P, Penka M. Inhibitory FVIII a FIX – patofyziologie a možné interference při jejich stanovení. Transfuze a hematologie dnes. 2008;14(1):35-7
  6. Green D, Lechner K. A survey of 215 non-hemophilic patients with inhibitors to factor VIII. Thromb Haemost. 1981 Jun 30;45(3):200-3.
  7. Green D, Rademaker AW, Briët E. A prospective, randomized trial of prednisone and cyclophosphamide in the treatment of patients with factor VIII autoantibodies. Thromb Haemost. 1993 Nov 15;70(5):753-7.
  8. Struillou L, Fiks-Sigaud M, Barrier J, Blat E. Acquired haemophilia and rheumatoid arthritis: success of immunoglobulin therapy. J Intern Med. 1993 Mar;233(3):304-5.
  9. Ma AD. Carrizosa D. Acquired factor VIII inhibitors: pathophysiology and treatment. Hematology Am Soc Hematol Educ Program. 2006:432-7.
  10. Franchini M. Rituximab in the treatment of adult acquired hemophilia A: a systematic review. Crit Rev Oncol Hematol. 2007 Jul;63(1):47-52. Epub 2007 Jan 19.
  11. Aggarwal A, Grewal R, Green RJ, Boggio L, Green D, Weksler BB, et al. Rituximab for autoimmune haemophilia: a proposed treatment algorithm. 2005 Jan;11(1):13-9.
  12. Lian EC, Larcada AF, Chiu AY. Combination immunosupressive therapy after factor VIII infusion for acquired factor VIII inhibitor. Ann Intern Med. 1989 May 15;110(10):774-8.
  13. Huth-Kühne A, Baudo F, Collins P, Ingerslev J, Kessler CM, Lévesque H, et al. International recommendations on the diagnosis and treatment of patients with acquired hemophilia A. Haematologica. 2009 Apr;94(4):566-75.
  14. Zeitler H, Ulrich-Merzenich G, Hess L, Konsek E, Unkrig C, Walger P, et al. Treatment of acquired hemophilia by the Bonn-Malmö Protocol: documentation of an in vivo immunomodulating concept. Blood. 2005 Mar 15;105(6):2287-93. Epub 2004 Nov 12.

Deficit koagulačního faktoru VII

  1. NovoSeven® SPC, Novo Nordisk A/S.
  2. Ingerslev J, Knudsen L, Hvid I, Tange MR, Fredberg U, Sneppen O. Use of recombinant factor VIIa in surgery in factor-VII-deficient patients. Haemophilia. 1997 Jul; 3(3):215-8.
  3. Scharrer I. Recombinant factor VIIa for patients with inhibitors to factor VIII or IX or factor VII deficiency. Haemophilia. 1999 Jul;5(4):253-9.
  4. Mariani G, Testa MG, Di Paolantonio T, Molskov Bech R, Hedner U. Use of recombinant, activated factor VII in the treatment of congenital factor VII deficiencies. Vox Sang. 1999;77(3):131-6.

Glanzmannova trombastenie

  1. NovoSeven® SPC, Novo Nordisk A/S.
  2. Lisman T, Moschatsis S, Adelmeijer J, Nieuwenhuis HK, De Groot PG. Recombinant factor VIIa enhances deposition of platelets with congenital or acquired alpha IIb beta 3 deficiency to endothelial cell matrix and collagen under conditions of flow via tissue factor-independent thrombin generation. Blood. 2003 Mar 1;101(5):1864-70. Epub 2002 Oct 31.
  3. Galán AM, Tonda R, Pino M, Reverter JC, Ordinas A, Escolar G. Increased local procoagulant action: a mechanism contributing to the favorable hemostatic effect of recombinant FVIIa in PLT disorders. Transfusion. 2003 Jul;43(7):885-92.
  4. Osdiot S, Rosa JP. Polymeric fibrin interacts with platelets independently from integrin alpha-IIb-beta-3 [Abstract]. Blood. 2001;98:518a.
  5. He S, Ekman GJ, Hedner U. The effect of platelets on fibrin gel structure formed in the presence of recombinant factor VIIa in hemophilia plasma and in plasma from a patient with Glanzmann thrombasthenia. J Thromb Haemost. 2005 Feb;3(2):272-9.
  6. Poon MC, D'Oiron R, Von Depka M, Khair K, Négrier C, Karafoulidou A, et al. For members of the International Data Collection on Recombinant Factor VIIa and Congenital Platelet Disorders Study Group. Prophylactic and therapeutic recombinant factor VIIa administration to patients with Glanzmann's thrombasthenia: results of an international survey. J Thromb Haemost. 2004 Jul;2(7):1096-103.
  7. Poon MC, Demers C, Jobin F, Wu JW. Recombinant factor VIIa is effective for bleeding and surgery in patients with Glanzmann thrombasthenia. Blood. 1999 Dec 1;94(11):3951-3.
  8. Tengborn L, Petruson B. A patient with Glanzmann thrombasthenia and epistaxis successfully treated with recombinant factor VIIa. Thromb Haemost. 1996 Jun;75(6):981-2.
  9. Poon M-C, Katsarou O, Huth-Kuehne A, Petrini P, Hann I, Demers C, et al. Recombinant factor VIIa in congenital platelet bleeding disorders [Abstract]. Blood. 2000;96 Suppl 1:256a.
  10. d'Oiron R, Ménart C, Trzeciak MC, Nurden P, Fressinaud E, Dreyfus M, et al. Use of recombinant factor VIIa in 3 patients with inherited type I Glanzmann's thrombasthenia undergoing invasive procedures. Thromb Haemost. 2000 May;83(5):644-7.

NovoSeven® stabilní při pokojové teplotě

  1. World Federation of Hemophilia. Guidelines for the Management of Hemophilia. 2005. Available from: http://www.wfh.org/2/docs/Publications/Diagnosis_and_Treatment/ Guidelines_Mng_Hemophilia.pdf.
  2. Colvin BT, Astermark J, Fischer K, Gringeri A, Lassila R, Schramm W, et al. European principles of haemophilia care. Haemophilia. 2008 Mar;14(2):361-74. Epub 2008 Jan 30.
  3. Salaj P, Smejkal P, Komrska V, Blatný J, Penka M. Standardy péče o nemocné s hemofilií. Český národní hemofilický program. 2009.
  4. Santagostino E, Gringeri A, Mannucci PM. State of care for hemophilia in pediatric patients. Paediatr Drugs. 2002;4(3):149-57.
  5. Santagostino E, Mancuso ME, Rocino A, Mancuso G, Scaraggi F, Mannucci PM. A prospective randomized trial of high and standard dosages of recombinant factor VIIa for treatment of hemarthroses in hemophiliacs with inhibitors. J Thromb Haemost. 2006 Feb;4(2):367-71.
  6. Rodriguez-Merchan EC. Management of musculoskeletal complications of hemophilia. Semin Thromb Hemost. 2003 Feb;29(1):87-96.
  7. Rodriguez-Merchan EC, Heim M. Hemophilia orthopedic management with emphasis on developing countries. Semin Thromb Hemost. 2005 Nov;31(5):518-26.
  8. Salek SZ, Benson GM, Elezović I, Krenn V, Ljung RC, Morfini M, et al. The need for speed in the management of haemophilia patients with inhibitors. Haemophilia. 2011 Jan;17(1):95-102. Epub 2010 Apr 12.
  9. Santagostino E, Gringeri A, Mannucci PM. Home treatment with recombinant activated factor VII in patients with factor VIII inhibitors: the advantages of early intervention. Br J Haematol. 1999 Jan;104(1):22-6.
  10. Salaj P, Brabec P, Penka M, Pohlreichova V, Smejkal P, Cetkovsky P, et al. Effect of rFVIIa dose and time to treatment on patients with haemophilia and inhibitors: analysis of HemoRec registry data from the Czech Republic. Haemophilia. 2009 May;15(3):752-9.
  11. Kavakli K, Makris M, Zulfikar B, Erhardtsen E, Abrams ZS, Kenet G, et al. Home treatment of haemarthroses using a single dose regimen of recombinant activated factor VII in patients with haemophilia and inhibitors. A multi-centre, randomised, double-blind, cross-over trial. Thromb Haemost. 2006 Apr;95(4):600-5.
  12. Kavakli K, Yesilipek A, Antmen B, Aksu S, Balkan C, Yilmaz D, et al. Kavakli K et al. The value of early treatment in patients with haemophilia and inhibitors. Haemophilia. 2010 May;16(3):487-94. Epub 2010 Jan 18.
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  15. NovoSeven® SPC, Novo Nordisk A/S.

Bezpečnost a snášenlivost

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