Zeitschriftenartikel

Die nachfolgend genannten Zeitschriftenartikel bieten Fachinformationen zur laufenden Entwicklung von rekombinanten und aus Plasma gewonnenen Gerinnungstherapien sowie einen Einblick in Ereignisse in der Gemeinde der Blutgerinnungsstörungen:

James, Kouides, Abdul-Kadir, Edlund, Federici, Halimeh, Kamphuisen, Konkle, Martinez-Perez, McLintock, Peyvandi, and Winikoff. American Journal of Obstetrics & Gynecology 2009. Von Willebrand Disease and Other Bleeding Disorders in Women Experiencing Menorrhagia or Postpartum Hemorrhage. An Observational Study on Postpartum Levels of von Willebrand Factor in Women with and without von Willebrand Disease: Rationale and Study Design. This article is the result of a consensus conference on the diagnosis and management of von Willebrand Disease and other bleeding disorders in women with excessive reproductive tract bleeding as the initial symptom. As these bleeding disorders are underdiagnosed in women who experience abnormal bleeding, this publication provides clinical information and recommends strategies to guide practicing obstetricians and gynecologists.

Martinowitz, U.; Luboshitz, J; Bashari, D.; Ravid, B.; Gorina, E.; Regan, L.; Stass, H.; and Lubetsky, A. Haemophilia (May, 2009), 15, 676–685. Stability, efficacy, and safety of continuously infused sucrose-formulated recombinant factor VIII (rFVIII-FS) during surgery in patients with severe haemophilia. This article addresses the efficacy and safety of continuous infusion (CI) of recombinant factor VIII (rFVIII-FS) during surgery in hemophilia A patients. It summarizes the study results used for obtaining EMEA approval for CI. Helixate NexGen (Kogenate®) was approved in the EU on 29 January 2007. So far, Helixate NexGen/Kogenate® is the only EMEA-approved rFVIII product indicated for CI.

James, Andra H., 100 Questions & Answers about von Willebrand Disease (September, 2008). This guidebook provides a primer for patients and their families, and addresses questions and answers that help individuals better understand and cope with von Willebrand Disease (VWD). It includes current, practical, comprehensible information about types of VWD and how they affect the patient, as well as symptoms, diagnosis, treatment, and daily living.

Mauser-Bunschoten E.P., De Knecht-van Eekelen A., and Smit C. Aging with Hemophilia: Medical & Psychosocial Impact (2008). This book addresses the medical and social issues of aging hemophiliacs, including relationship of other diseases, avoiding complications, and recommendations and practical advice for daily living.

Berntorp E. et al. European Journal of Haematology 2008, Vol. 80 Suppl. 70:3-35. A systematic overview of the first pasteurized VWF/FVIII medicinal product, Haemate P/Humate-P: History and clinical performance. This article gives an overview on the history of Haemate® P/Humate-P® and presents previously unpublished clinical data, as well as clinical data already presented in previous publications. They include the product’s pharmacokinetic profile, a record regarding short- and long-term safety, its value on surgical interventions, and successful immune tolerance induction and dosing recommendations.

Frampton J.E. and Wagstaff A.J. Drugs 2008; 68 (6): 839-53. Sucrose-Formulated Octocog Alfa.This publication gives an overview of sucrose-formulated octocog alfa, including its pharmacological properties, therapeutic efficacy, tolerability, dosage and administration and the implications for hemophilia A treatment. It also presents a comparison with other currently available recombinant FVIII products in terms of characteristics.

Oldenburg J. and Santagostino E. Thieme Drug Report 2008; 5:4. Helixate® NexGen: A recombinant anti-haemophilic product for the treatment of haemophilia A. This article gives an introduction to haemophilia A, diagnosis and treatment options and presents a comparison between recombinant factor VIII concentrates in terms of characteristics and risk of inhibitor development. Also included is a detailed overview of Helixate® NexGen regarding product characteristics, efficacy and safety findings.

Budde U. et al. Seminars in Thrombosis & Hemostasis 2006;32:514–521. Comparative Analysis and Classification of VWF-FVIII Concentrates: Impact on Treatment of Patients with VWD. In this publication, Budde et al present a comparative study with 12 VWF/FVIII concentrates with focus on content, activities of FVIII and VWF and content of high molecular weight VWF multimers. Based on this analysis, the authors propose a classification of VWF/FVIII products.


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