factor IX x F10

Octapharma is Committed to Supplying Hospitals and Medical Providers with New Prothrombin Complex Concentrate PARAMUS, N.J., Jan. 3, 2024 /PRNewswire/ -- Octapharma USA has announced Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) is now available. The new non-activated four factor prothrombin complex concentrate (4F-PCC), approved by the U.S. Food and Drug Administration (FDA) this summer, is indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures. Continue Reading Octapharma has the Balfaxar® production flexibility to ensure consistent supply for hospitals and medical providers. Post this Octapharma USA has announced Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) is now available. Balfaxar®, a lyophilized powder for reconstitution, will be provided with sterile water for injection and the new transfer device, nextaro®. "The availability of Balfaxar® brings a welcome new treatment option for medical providers around the country," said Josh Goldstein, MD, PhD, Professor of Emergency Medicine at Harvard Medical School and Massachusetts General Hospital. "More than 2.4 million U.S. patients are prescribed warfarin to prevent blood clots from forming in patients who are at high risk.1 Unfortunately, the main side effect of warfarin is an increased risk of bleeding, which can complicate urgent surgery or invasive procedures.2 Clinical research has demonstrated that Balfaxar® is extremely effective in restoring blood coagulation by replenishing the levels of clotting factors that are deficient in those patients on warfarin." Balfaxar® is a non-activated 4F-PCC containing vitamin K-dependent factors: Factor II (prothrombin), Factor VII, Factor IX and Factor X, as well as antithrombotic Proteins C and S. "We are excited to announce the availability of Balfaxar® and are committed to providing the medical community with a valuable life-saving therapy," said Octapharma USA President Flemming Nielsen. "Octapharma has the production flexibility to ensure consistent supply for hospitals and medical providers now and in the future. We look forward to working with our critical care medicine partners to ensure patients receive the absolute best treatments available." The FDA approval of Balfaxar® was supported by the clinical trial LEX-209 (ClinicalTrials.gov Identifier: NCT02740335), which compared the efficacy and safety of Balfaxar® head-to-head with a control 4F-PCC (Kcentra®). The Phase III, randomized, double-blind, multicenter study randomized 208 patients to Balfaxar® (N=105) or control 4F-PCC (N=103). Balfaxar® met the primary endpoint of hemostatic efficacy in patients on a vitamin K antagonist undergoing urgent surgery with significant bleeding risk. The primary objective was met at the prespecified interim analysis and the study was stopped due to statistically significant efficacy results. Balfaxar® demonstrated effective hemostasis in 94.6% of patients versus 93.5% of patients for Kcentra®. International Normalized Ratio (INR) reductions and vitamin K dependent coagulation factor increases supported the primary endpoint and PCC dosing and duration of infusion were also similar. The safety profile was similar between treatment arms and consistent with previous studies.3 To study Balfaxar® further in other clinical scenarios, Octapharma is recruiting for two additional Phase III studies: LEX-210: Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor (ClinicalTrials.gov Identifier: NCT04867837) LEX-211: Active-control Randomised Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery (ClinicalTrials.gov Identifier: NCT05523297) For more information on LEX-210 and LEX-211, please visit ClinicalTrials.gov. Kcentra® is a registered trademark of CSL Behring GmbH. For more information on Balfaxar®, please contact Octapharma customer service at 201-604-1130. About Balfaxar® Balfaxar® (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure. WARNING: ARTERIAL and VENOUS THROMBOEMBOLIC COMPLICATIONS Patients being treated with Vitamin K antagonists (VKA) therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the potential risks of thromboembolic events, especially in patients with the history of a thromboembolic event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with Balfaxar® in clinical trials and post marketing surveillance. Monitor patients receiving Balfaxar® for signs and symptoms of thromboembolic events. Balfaxar® may not be suitable in patients with thromboembolic events in the prior 3 months. For complete boxed warning and full prescribing information, please visit Balfaxar.com/pi. About the Octapharma Group Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than 11,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology, Immunotherapy and Critical Care. Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centers across Europe and the US. The company's American subsidiary, Octapharma USA, is located in Paramus, N.J. For more information, please visit octapharmausa.com. REFERENCES 1 - ClinCalc.com, Warfarin: Drug Usage Statistics, United States, 2013 - 2020, accessed June 19, 2023. 2 - Mayo Clinic, Warfarin side effects: Watch for interactions, accessed June 19, 2023. 3 - Ravi Sarode, Joshua N. Goldstein, Gregory Simonian, Truman J. Milling Jr; A Phase 3, Prospective, Randomized, Double-Blind, Multicenter, Non-Inferiority Study Comparing Two Four-Factor Prothrombin Complex Concentrates for Reversal of Vitamin K Antagonist-Induced Anticoagulation in Patients Needing Urgent Surgery with Significant Bleeding Risk. Blood 2022; 140 (Supplement 1): 352–353. doi: SOURCE Octapharma

PARAMUS, N.J., July 26, 2023 /PRNewswire/ -- Octapharma USA today announced that Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) has received U.S. Food and Drug Administration (FDA) approval for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures. Continue Reading Balfaxar® helps restore blood coagulation by replenishing the levels of clotting factors that are deficient due to warfarin therapy. Balfaxar® is a non-activated four factor prothrombin complex concentrate (4F-PCC) containing vitamin K-dependent factors: Factor II (prothrombin), Factor VII, Factor IX and Factor X, as well as antithrombotic Proteins C and S. We are confident Balfaxar® will be a welcomed treatment for physicians who need to quickly restore patients' coagulation Tweet this The FDA approval is supported by the clinical trial LEX-209 (ClinicalTrials.gov Identifier: NCT02740335), which compared the efficacy and safety of Balfaxar® head-to-head with a control 4F-PCC (Kcentra®). The Phase III, randomized, double-blind, multicenter study was performed at 24 sites in the U.S. and Europe and randomized 208 patients to Balfaxar® (N=105) or control 4F-PCC (N=103). "Balfaxar® met the primary endpoint of hemostatic efficacy and was non-inferior to the comparator, Kcentra®, in patients on a vitamin K antagonist undergoing urgent surgery with significant bleeding risk," said LEX-209 Principal Investigator Ravi Sarode, M.D. "The primary objective was met at the prespecified interim analysis and the study was stopped due to statistically significant efficacy results indicating that Balfaxar® was non-inferior to Kcentra®. Balfaxar® demonstrated effective hemostasis in 94.6% of patients versus 93.5% of patients for Kcentra®. International Normalized Ratio (INR) reductions and vitamin K dependent coagulation factor increases supported the primary endpoint and PCC dosing and duration of infusion were also similar. The safety profile was similar between treatment arms and consistent with previous studies."1 More than 2.4 million U.S. patients are prescribed warfarin to prevent blood clots from forming following a heart attack, heart valve surgery, stroke, deep vein thrombosis/pulmonary embolism, or for certain types of irregular heartbeat (atrial fibrillation).2 The main side effect of warfarin is an increased risk of bleeding particularly for patients undergoing urgent surgery or invasive procedures.3 "The FDA approval of Balfaxar® establishes a new therapy for medical providers when their patients need a 4F-PCC product," said Octapharma USA President Flemming Nielsen. "Octapharma is committed to providing patients with life-saving and life-enhancing therapies for critical care medicine. We are confident Balfaxar® will be a welcomed treatment for physicians who need to quickly restore patients' coagulation." Balfaxar®, a lyophilized powder for reconstitution, will be provided with sterile water for injection and the new transfer device, nextaro®. The transfer device includes an optimized vial housing that enables precentering of the vial during mounting, and optimized contamination protection with two integrated filters. Nextaro® was preferred by healthcare professionals versus a widely used, competitive transfer device in an Octapharma user preference study.4 To study Balfaxar® further in other clinical scenarios, Octapharma is recruiting for two additional Phase III studies: LEX-210: Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor (ClinicalTrials.gov Identifier: NCT04867837) LEX-211: Active-control Randomised Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery (ClinicalTrials.gov Identifier: NCT05523297) For more information on LEX-210 and LEX-211, please visit ClinicalTrials.gov. Kcentra® is a registered trademark of CSL Behring GmbH. Nextaro® is a registered trademark of sfm medical devices GmbH. About Balfaxar® Balfaxar® (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure. WARNING: ARTERIAL and VENOUS THROMBOEMBOLIC COMPLICATIONS Patients being treated with Vitamin K antagonists (VKA) therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the potential risks of thromboembolic events, especially in patients with the history of a thromboembolic event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with Balfaxar® in clinical trials and post marketing surveillance. Monitor patients receiving Balfaxar® for signs and symptoms of thromboembolic events. Balfaxar® may not be suitable in patients with thromboembolic events in the prior 3 months. For complete boxed warning and full prescribing information, please visit Balfaxar.com. About the Octapharma Group Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than 11,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology, Immunotherapy and Critical Care. Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centers across Europe and the US. The company's American subsidiary, Octapharma USA, is located in Paramus, N.J. For more information, please visit octapharmausa.com. REFERENCES 1 - Ravi Sarode, Joshua N. Goldstein, Gregory Simonian, Truman J. Milling Jr; A Phase 3, Prospective, Randomized, Double-Blind, Multicenter, Non-Inferiority Study Comparing Two Four-Factor Prothrombin Complex Concentrates for Reversal of Vitamin K Antagonist-Induced Anticoagulation in Patients Needing Urgent Surgery with Significant Bleeding Risk. Blood 2022; 140 (Supplement 1): 352–353. doi: 2 - ClinCalc.com, Warfarin: Drug Usage Statistics, United States, 2013 - 2020, accessed June 19, 2023. 3 - Mayo Clinic, Warfarin side effects: Watch for interactions, accessed June 19, 2023. 4 - Data on file, Octapharma USA, Oct. 22, 2018. BALF-0101-PPROctapharma USA, Inc. • 117 West Century Road • Paramus • NJ 07652 • 201-604-1130 • SOURCE Octapharma USA

LACHEN, Switzerland, June 6, 2023 /PRNewswire/ -- Octapharma to present new clinical and scientific findings for wilate®, Nuwiq®, octaplex® and atenativ® at the upcoming ISTH 2023 Congress New data and clinical study developments will be presented in nine posters and during two Supported Symposia The most recent developments from Octapharma's Haematology and Critical Care portfolios will be presented at the 31st Congress of the International Society on Thrombosis and Haemostasis (ISTH) on June 24–28, 2023, in Montréal, Canada. The data will be featured in nine poster presentations and two Supported Symposia during this key international meeting. Octapharma is a proud Silver Supporter of the ISTH 2023 Congress. There will also be a promotional booth focusing on modern approaches to bleeding and coagulation management. People with inherited bleeding disorders, such as haemophilia A and von Willebrand disease, are at risk of recurrent and prolonged bleeds placing a heavy burden on patients' lives. In addition to the risk of potentially life-threatening bleeds, increased bleeding is associated with long-term consequences that severely impair patients' quality of life. Patients with a deficiency of the prothrombin complex of coagulation factors are also at increased risk of bleeding. Such deficiencies may be inherited but can also be acquired and may be induced by the use of vitamin K antagonists (VKA) for anticoagulation therapy. During urgent surgery, rapid correction of the deficiency is required and can be achieved through the use of four-factor prothrombin complex concentrates (4F-PCC). 4F-PCC can also be used to control major bleeding associated with the use of direct oral anticoagulant (DOAC) therapy in patients with factor Xa inhibitors. The presentations at ISTH 2023 reflect Octapharma's long-term commitment to improving patient care and addressing unmet clinical needs. "We are proud to showcase our new data and provide updates of studies from across Octapharma's haematology and critical care portfolios at ISTH 2023," said Olaf Walter, Board Member at Octapharma. "Despite advances in the field, people with bleeding and coagulation disorders still face considerable challenges surrounding bleed management. At Octapharma, we strive to address such challenges head-on with the goal to improve the day-to-day lives of patients." Poster Presentations The WIL-31 study investigated the efficacy and safety of prophylaxis with wilate® in patients with von Willebrand disease (VWD) of any gender with VWD type 1, type 2 (except 2N) or type 3. The results of the study show that wilate® prophylaxis is highly effective at reducing the number of bleeds in children and adults, and provides compelling evidence to support the use of regular prophylaxis in patients with severe VWD. Further data on the efficacy and safety of wilate® prophylaxis is being collected in the WIL-33 study in children under six years of age. The goals and design of this study will be presented. Prophylaxis is already the standard of care for people with haemophilia A. The results of an indirect comparison show that fewer patients experienced bleeds when receiving personalised prophylaxis with Nuwiq® rather than prophylaxis with a comparator factor VIII (FVIII) product. New data exploring differences in the binding of different recombinant FVIII products to platelets in vitro will be shared in a separate poster. Although haemophilia A mainly affects males, female carriers may also have reduced levels of FVIII and be at increased risk of bleeding, especially during traumatic events such as surgery. Data from a retrospective case series of female haemophilia A carriers who were prescribed Nuwiq® during surgery at the Bonn Haemophilia Centre will provide an insight into the effective treatment of females. MOTIVATE is an ongoing, international investigator-initiated study made possible through funding from Octapharma AG, evaluating the management of haemophilia A patients with inhibitors. The Coordinating investigators, Drs Carmen Escuriola Ettingshausen and Robert F. Sidonio Jr., will provide an update on the study status as a poster at the Congress. The LEX-210 study will evaluate the haemostatic efficacy of octaplex® in patients with acute major bleeding receiving factor Xa inhibitors. As anti-factor Xa (anti-Xa) activity levels will be measured in these patients, the correlation between heparin-calibrated and specific factor Xa inhibitor assays has been analysed and will be presented. The results from the first head-to-head, phase 3, randomised, controlled trial (LEX-209) comparing two 4F-PCCs in patients on VKA anticoagulation who need urgent surgery will be presented, with a focus on dosing and haemostatic efficacy results. The results show that octaplex® was non-inferior to control 4F-PCC for rapid vitamin K antagonist reversal in patients undergoing urgent surgeries with significant bleeding risk. The posters will be presented at the following times: Sunday June 25, 18:30–19:30 ET PB0163. Differential binding of recombinant FVIII products to platelets, and impact of FVIII on VWF expression and platelet contractility in vitro. Presenting author: Viola Vogel. PB0235. Phase 3 study of the efficacy, pharmacokinetics, immunogenicity and safety of von Willebrand factor/factor VIII concentrate in patients with severe von Willebrand disease under 6 years of age. Presenting author: Akshat Jain. PB0238. Prospective, phase III study of the efficacy, safety, and pharmacokinetics of a human antithrombin III concentrate in congenital antithrombin deficiency during surgery or childbirth. Presenting author: Craig Kessler. Monday June 26, 18:30–19:30 ET PB0840. Efficacy of prophylaxis with a plasma-derived von Willebrand factor/factor VIII concentrate in patients with von Willebrand disease: Subgroup analysis by age and VWD type. Presenting Author: Robert F. Sidonio Jr. PB0681. German experience with simoctocog alfa during surgery in female haemophilia A carriers. Presenting author: Natascha Marquart. PB0584. Using heparin-calibrated assays to assess anti-factor Xa activity of factor Xa inhibitors (FXaI): a literature correlation analysis. Presenting author: Ravindra Sarode. PB1032. Four-factor prothrombin complex concentrates for vitamin K antagonist reversal before urgent surgery: dosing and hemostatic efficacy in a double-blind randomized study. Presenting author: Ravindra Sarode. Tuesday June 27, 18:30–19:30 ET PB1261. Matching adjusted indirect comparisons between personalized prophylaxis with simoctocog alfa versus standard prophylaxis with turoctocog alfa in adults with severe haemophilia A. Presenting author: Fernando F. Corrales-Medina. PB1288. Immune tolerance induction (ITI) strategies in haemophilia A patients with inhibitors – data from the MOTIVATE study. Presenting author: Carmen Escuriola Ettingshausen. Wednesday June 28, 13:00–14:00 ET PO11. Impact of simoctocog alfa prophylaxis on bleeding and joint health in Spanish patients with severe haemophilia A. Presenting author: María Teresa Alvarez-Román. Supported Symposia New clinical and scientific data, as well as updates on ongoing and new studies, will be shared during two Supported Symposia during the Congress. Final Results of the WIL-31 Study – A New Treatment Standard for von Willebrand Disease Patients with Severe Bleeding? Monday June 26, 13:15–14:30 ET, Room 511 Chair: Alok Srivastava, Christian Medical College, Vellore, India The symposium will focus on new data regarding the use of wilate® prophylaxis in children and adults to improve the lives of people with VWD. Topics presented will include the importance of prophylaxis, including current guidelines on the management of VWD and how to identify patients who may benefit from prophylactic treatment. Key learnings from the WIL-31 VWD prophylaxis study will be shared and case presentations of select WIL-31 patient cases from across the globe will be discussed. Bringing Together Two Worlds – Scientific and Clinical Insights for All-Round Bleed Protection in Haemophilia A Tuesday June 27, 13:15–14:30 ET, Room 511 Chair: Davide Matino, McMaster University, Hamilton, Ontario, Canada Octapharma's symposium on haemophilia A this year is dedicated to both, scientists and clinicians. The speakers will present data from the NuPreviq trial and the matching adjusted indirect comparisons (MAIC) analyses of Nuwiq® vs extended half-life (EHL) products as well as introduce the PROVE study. Topics discussed during this symposium will also include the role of platelets in FVIII binding, impact of prophylaxis on microRNA expression (biomarkers of joint and bone health) and how to utilise the power of RNASeq to understand inhibitor development. Both symposia will be open to congress participants in Montréal and will be streamed live for participants not attending the Congress. The opportunity to ask questions will be available at both symposia. Larisa Belyanskaya, Head of IBU Haematology at Octapharma commented: "We are delighted to showcase new data from WIL-31, which supports the importance of prophylaxis in people with von Willebrand disease, and to discuss scientific and clinical questions that need to be address to advance the management of people with haemophilia A." About Octapharma Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than11,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centres across Europe and the US. Octapharma has 40 years of experience in patient care. About Nuwiq® Nuwiq® (simoctocog alfa) is a 4th generation recombinant factor VIII (rFVIII) protein, produced in a human cell line without chemical modification or fusion with any other protein[1]. It is cultured without additives of human or animal origin, is devoid of antigenic non-human protein epitopes and has a high affinity for von Willebrand factor[1]. Nuwiq® treatment has been assessed in nine[1-3] completed clinical trials which included 201 previously treated patients (190 individuals)[1] and 108 previously untreated patients[2] with severe haemophilia A. Nuwiq® is available in 250 IU, 500 IU, 1,000 IU, 1,500 IU, 2,000 IU, 2,500 IU, 3,000 IU and 4,000 IU presentations[4]. Nuwiq® is approved for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital FVIII deficiency) across all age groups[4]. About wilate wilate® is a high-purity human von Willebrand factor/factor VIII (VWF/FVIII) concentrate, that undergoes two virus inactivation steps during its production[5]. No albumin is added as a stabiliser[5]. The purification processes result in a 1:1 ratio of VWF to FVIII that is similar to normal plasma[5]. wilate® contains a VWF triplet structure and content of large high molecular weight multimers similar to normal human plasma[5]. wilate® is exclusively derived from large pools of human plasma collected in approved plasma donation centres[6]. wilate® is available in 500 IU and 1,000 IU presentations. wilate® is indicated for the prevention and treatment of haemorrhage or surgical bleeding in von Willebrand disease (VWD), when desmopressin (DDAVP) alone is ineffective or contra-indicated, and for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)[6]. About octaplex® octaplex® is a human four factor prothrombin complex concentrate (4F-PCC) containing Factors II, VII, IX and X, as well as inhibitor protein C and its cofactor protein S. octaplex® is indicated for the treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required. It can also be used in the treatment of bleeding and perioperative prophylaxis in congenital deficiency of the vitamin K dependent coagulation factors II and X when purified specific coagulation factor product is not available. octaplex® is presented in vials containing 500 IU and 1000 IU of human prothrombin complex. The total protein content per vial is 260–820 mg (500 IU vial)/ 520–1640 mg (1000 IU vial). The specific activity of the product is ≥ 0.6 IU/mg proteins, expressed as factor IX activity. Do not store above 25°C, do not freeze. Store in the original package in order to protect from light. The product shelf life is three years.[7] About atenativ® atenativ® is a human antithrombin III concentrate (AT III), which is presented in vials containing 500 IU and 1000 IU of human antithrombin III as lyophilised powder for infusion. After reconstitution with 10 mL water for injection (WFI), the solution provides 50 IU/mL or 100 IU/mL of human antithrombin III. Store in the refrigerator (2-8 °C) Keep the vials in the outer carton in order to protect from light. The shelf life is three years. It has been indicated for treatment of patients with congenital and acquired antithrombin deficiency including prophylaxis for the prevention of deep vein thrombosis and thromboembolism in clinical risk situations (especially in surgery, pregnancy and childbirth), in combination with heparin, if indicated, as well as prevention of the progression of deep venous thrombosis and thromboembolism associated with heparin as indicated.[8] atenativ® is currently not registered in Canada. 1. Lissitchkov T et al. Ther Adv Hematol 2019; 10:2040620719858471. 2. Liesner RJ et al. Thromb Haemost 2021; 121:1400-8. 3. Octapharma AG; Data on file. 4. Nuwiq® Summary of Product Characteristics. 5. Stadler M et al. Biologicals 2006; 34:281-8. 6. wilate® Summary of Product Characteristics.