Humate p - HUMATE-P is a made in a multi-step process that provides purity and safety every step of the way. Plasma collection, processing, and packaging procedures are designed to retain the properties of the VWF and FVIII proteins. CSL Behring’s Integrated Safety System includes 3 steps specifically designed to identify and remove live viruses.

 
viral transmission. The primary viral reduction step of the Humate-P® manufacturing process is the heat treatment of the purified, stabilized aqueous solution at 60.0 +/ - 1°C for 10 hours. In addition, the purification procedure (several precipitation steps) used in the manufacture of Humate-P® also provides viral reduction capacity. . Gs 15 pay scale 2023

Some dosage forms listed on this page may not apply to the brand name Humate-P. Applies to antihemophilic factor/von willebrand factor: intravenous powder for solution. Serious side effects of Humate-P. Along with its needed effects, antihemophilic factor/von willebrand factor may cause some unwanted effects. Although not all of these side ...Use Humate-P (Antihemophilic And Von Willebrand Factor Complex) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than ...In studies, more than 5% of patients reported the following adverse reactions to HUMATE-P: allergic/anaphylactic reactions, including hives, chest tightness, rash, itching, and swelling. The most common adverse reactions after surgery were bleeding at the wound or infusion site, and nosebleeds. Please see full prescribing information.viral transmission. The primary viral reduction step of the Humate-P® manufacturing process is the heat treatment of the purified, stabilized aqueous solution at 60.0 +/ - 1°C for 10 hours. In addition, the purification procedure (several precipitation steps) used in the manufacture of Humate-P® also provides viral reduction capacity.Humate-P. Used for Hemophilia and Von Willebrand Disease. info. Specialty Drug + 1 more alert. MORE expand_more. ANTIHEMOPHILIC FACTOR prevents and treats bleeding ...HUMATE-P loading dose Make individualized HUMATE-P dosing fast, easy, and convenient. This calculator determines the correct HUMATE-P loading dose (measured in VWF:RCo units) needed to achieve the desired increase in circulating VWF, as defined in the product prescribing information. Humate-P® Humate-P ®, FDA approved in 1986, is an anti-hemophilic factor/von Willebrand factor complex (human) originally indicated for the treatment and prevention of bleeding in adults with hemo-philia A. In 1999, the FDA approved Humate-P® for adults and pediatric patients with VWD for the treatment of spontaneous and trauma-inducedviral transmission. The primary viral reduction step of the Humate-P® manufacturing process is the heat treatment of the purified, stabilized aqueous solution at 60.0 +/ - 1°C for 10 hours. In addition, the purification procedure (several precipitation steps) used in the manufacture of Humate-P® also provides viral reduction capacity. This Billing and Coding Article provides coding guidance for Hemophilia Factor Products. This article does not address payment determination for hemophilia factor products. Information on payment for the clotting factor as well as payment for a clotting factor furnishing fee may be found in CMS Internet-Only Manual (IOM) Publication 100-04 ...A. Alphanate, Humate-P ONLY Coverage is provided in the following conditions: Hemophilia A (congenital factor VIII deficiency) † • Diagnosis of congenital factor VIII deficiency has been confirmed by blood coagulation testing; AND Used as treatment for control and prevention of bleeding episodes (episodic treatmentHumate-P; Wilate; Descriptions. Antihemophilic factor VIII and von Willebrand factor injection is a combination product that is used to treat serious bleeding episodes in patients with a bleeding problem called von Willebrand disease (VWD). The bleeding episode may be related to an injury (trauma) or a surgical procedure.CSL Behring: Humate-P and Helixate using the Mix2Vial™ Grifols: Alphanate® and AlphaNine® S/D using the Mix2Vial™ (see the CSL Behring instructions for Humate-P) Novo Nordisk: NovoSeven® RT ; Octapharma: Wilate using the Mix2Vial™ (see the CSL Behring instructions for Humate-P) Aetna considers Alphanate, Humate-P or Koate medically necessary for treatment of VWD when any of the following criteria is met: Member has type 1, 2A, 2M, or 2N VWD and has had an insufficient response to desmopressin or a documented clinical reason for not using desmopressin (see Appendix B ); or Dec 6, 2019 · Surgical procedures represent a serious hemostatic challenge for patients with von Willebrand disease (VWD), and careful perioperative management is required to minimize bleeding risk. Risk stratification includes not only the nature of the surgery to be performed but the baseline plasma von Willebrand factor (VWF) levels, bleeding history, and ... Humate-P® Humate-P ®, FDA approved in 1986, is an anti-hemophilic factor/von Willebrand factor complex (human) originally indicated for the treatment and prevention of bleeding in adults with hemo-philia A. In 1999, the FDA approved Humate-P® for adults and pediatric patients with VWD for the treatment of spontaneous and trauma-induced Humate-P® Humate-P ®, FDA approved in 1986, is an anti-hemophilic factor/von Willebrand factor complex (human) originally indicated for the treatment and prevention of bleeding in adults with hemo-philia A. In 1999, the FDA approved Humate-P® for adults and pediatric patients with VWD for the treatment of spontaneous and trauma-inducedHUMATE-P is made from human blood and could contain infectious agents. The risk that these agents may transmit disease cannot be completely eliminated, but has been reduced by screening plasma donors and testing donated plasma for certain viruses, and by inactivating and/or removing viruses during manufacturing.Additionally, Humate-P has a potency that is a higher factor than cryoprecipitate preparations. Humate-P can also be used for pediatric patients with VWD in the treatment of spontaneous and trauma-induced bleeding episodes, and the prevention of excessive bleeding during and after surgery.viral transmission. The primary viral reduction step of the Humate-P® manufacturing process is the heat treatment of the purified, stabilized aqueous solution at 60.0 +/ - 1°C for 10 hours. In addition, the purification procedure (several precipitation steps) used in the manufacture of Humate-P® also provides viral reduction capacity.HUMATE-P Connect SM is here to help with co-pay assistance,* programs to help patients who experience a lapse in insurance or are unable to afford therapy, and peer-to-peer networking events. To get the guidance and support. your patients may need, call 1-800-676-4266. Monday-Friday, 8 AM to 8 PM ET.Humate P - J7190 or J7186 or J7187 . Profilate HP- J7190 . AHF M - J7190 . Alphanate - J7190 . Antihemophilic Factor (Porcine) Hyate:C - J7191 . Recombinate (Recombinant) - J7192 . Kogenate - J7192 . Bioclate - J7192 . Helixate - J7192 . Xyntha – J7185 . 3. Factor VIII inhibitors . Autoplex T (anti-inhibitor) - J7198 . Feiba VH (anti ...Haemate P/Humate-P is an intermediate-purity VWF/FVIII concentrate with extensive clinical experience in VWD. This concentrate has been shown to correct haemostatic defects of VWD, with efficacy ratings of good/excellent in nearly all patients treated for bleeding or surgical events.The platelet bridges and VWF form layers, known as the initial hemostatic plug, which stops the bleeding at the injury site. 1. Successful completion of both stages of hemostasis results in the final step of the clotting process, the formation of a stable hemostatic plug. HUMATE-P has 94% homology with normal human plasma (NHP). 2.Aug 28, 2023 · Humate-P: View Coupon: Humate-P Connect This program provides brand name medications at no or low cost: Provided by: CSL Behring: TEL: 800-676-4266 ALT PHONE: 844-727-2752 FAX: 844-727-2757: Languages Spoken: English. Program Website : Program Applications and Forms: Humate-P Connect Enrollment Form : Medications 1. Humate-P** Humate P is a factor VIII and von Willebrand factor concentrate product made from the purified cold insoluble fraction of pooled human fresh frozen plasma It is used to treat and prevent bleeding in patients with a history of hemophilia A; and treatment of trauma induced bleeding andImportant Safety Information for Humate-P. Antihemophilic Factor/von Willebrand Factor Complex (Human), HUMATE-P ® is indicated for treatment and prevention of bleeding in adult patients with hemophilia A (classical hemophilia). HUMATE-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for (1) treatment of ...Aug 17, 2020 · In many cases, HUMATE-P from a single request was used for several treatment courses in one subject. Therefore, there are more reported treatment courses than requests. HUMATE-P was administered to 97 subjects in 530 treatment courses: 73 for surgery, 344 for treatment of bleeding, and 20 for prophylaxis of bleeding. Humate P/Haemate P Plasma derived North America/internationally CSL Behring, Germany 2.4 Pasteurization (60°C for 10 h) Voncento Plasma derived Europe CSL Behring, Germany 2.4 SD, dry heat (80°C, 72 h) Biostate Plasma derived Australia/Asia CSL Behring, Australia 2 SD, dry heat (80°C,72 h) Wilstart Plasma derived FranceHumate P - J7190 or J7186 or J7187 . Profilate HP- J7190 . AHF M - J7190 . Alphanate - J7190 . Antihemophilic Factor (Porcine) Hyate:C - J7191 . Recombinate (Recombinant) - J7192 . Kogenate - J7192 . Bioclate - J7192 . Helixate - J7192 . Xyntha – J7185 . 3. Factor VIII inhibitors . Autoplex T (anti-inhibitor) - J7198 . Feiba VH (anti ... Jun 23, 2020 · Use Humate-P (Antihemophilic And Von Willebrand Factor Complex) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than ... What is HUMATE-P HUMATE-P is a VWF/FVIII replacement therapy that delivers results, patient after patient, treatment after treatment, decade after decade, as proven by a US study of the hemostatic efficacy of HUMATE-P. Based on this study, an independent Data Safety Monitoring Board judged hemostatic efficacy as "effective in 94.3% of the perioperative study subjects." Aug 28, 2023 · Humate-P: View Coupon: Humate-P Connect This program provides brand name medications at no or low cost: Provided by: CSL Behring: TEL: 800-676-4266 ALT PHONE: 844-727-2752 FAX: 844-727-2757: Languages Spoken: English. Program Website : Program Applications and Forms: Humate-P Connect Enrollment Form : Medications HUMATE-P provides reliable hemostatic control for all VWD types. HUMATE-P is also proven effective across multiple types of bleeds, including: All bleeding episodes, including spontaneous bleeding episodes (bleeding that occurs without an obvious cause) or after an injury, such as nosebleeds4. 97% of patients overall (100% Type 1, 100% Type 2 ... Uses for Humate-P. Antihemophilic factor VIII and von Willebrand factor injection is a combination product that is used to treat serious bleeding episodes in patients with a bleeding problem called von Willebrand disease (VWD). The bleeding episode may be related to an injury (trauma) or a surgical procedure.A. Alphanate, Humate-P ONLY Coverage is provided in the following conditions: Hemophilia A (congenital factor VIII deficiency) † • Diagnosis of congenital factor VIII deficiency has been confirmed by blood coagulation testing; AND Used as treatment for control and prevention of bleeding episodes (episodic treatmentAmong the 63 VWD subjects who received HUMATE-P for prevention of excessive bleeding during and after surgery, including one subject who underwent colonoscopy without the planned polypectomy, the most common adverse events were postoperative hemorrhage (35 events in 19 subjects with five subjects experiencing bleeding at up to three different sites), postoperative nausea (15 subjects), and ...HUMATE-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations. Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses.Humate-P. Used for Hemophilia and Von Willebrand Disease. info. Specialty Drug + 1 more alert. MORE expand_more. ANTIHEMOPHILIC FACTOR prevents and treats bleeding ...HUMATE-P, Antihemophilic Factor/von Willebrand Factor Complex (Human), is a purified, sterile, lyophilized concentrate of Factor VIII (FVIII) and von Willebrand Factor (VWF) (Human) for intravenous administration in the treatment of patients with classical hemophilia (hemophilia A) and VWD [see Clinical Pharmacology (12)].Antihemophilic factor/VWF complex (Alphanate ®, Humate-P ®, Wilate ®) Full length with VWF: Pooled human plasma: 12.2–17.9 hours: 1978 (Alphanate), 1986 (Humate-P), August 2009 (Wilate) Recombinant: first generation: Antihemophilic factor recombinant (Recombinate ®) Full length: BSA in culture and human albumin as stabilizer: 14.6 ± 4.9 ...The platelet bridges and VWF form layers, known as the initial hemostatic plug, which stops the bleeding at the injury site. 1. Successful completion of both stages of hemostasis results in the final step of the clotting process, the formation of a stable hemostatic plug. HUMATE-P has 94% homology with normal human plasma (NHP). 2.HUMATE-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations. Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses.Jun 4, 2023 · Some dosage forms listed on this page may not apply to the brand name Humate-P. Applies to antihemophilic factor/von willebrand factor: intravenous powder for solution. Serious side effects of Humate-P. Along with its needed effects, antihemophilic factor/von willebrand factor may cause some unwanted effects. Although not all of these side ... 1. Humate-P** Humate P is a factor VIII and von Willebrand factor concentrate product made from the purified cold insoluble fraction of pooled human fresh frozen plasma It is used to treat and prevent bleeding in patients with a history of hemophilia A; and treatment of trauma induced bleeding andThe reported VWF:RCo average and terminal t1/2 of 10.4 and 15.8 hours (h), respectively, for Wilate and 9.3 h and 12.8 h for Humate-P, were not statistically different. Also, the mean VWF:RCo in vivo recoveries (Wilate 1.89, Humate-P 1.99 IU/dl per IU/kg) were similar between the two replacement therapies. Jan 17, 2012 · Humate-P, Wilate) Reference Number: ERX.SPA.185 Effective Date: 01.11.17 Last Review Date: 11.17 Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description The following are factor VIII/von Willebrand factor complexes (human) requiring prior authorization: The densitometric analysis shows that, like normal human plasma, HUMATE-P contains a high percentage of high molecular weight von Willebrand factor (HMW-VWF) multimers, and it is capable of correcting the hemostatic defect in patients with VWD. View an animated densitometric analysis comparing various VWF/FVIII concentrates and normal human plasma.Dec 6, 2019 · Surgical procedures represent a serious hemostatic challenge for patients with von Willebrand disease (VWD), and careful perioperative management is required to minimize bleeding risk. Risk stratification includes not only the nature of the surgery to be performed but the baseline plasma von Willebrand factor (VWF) levels, bleeding history, and ... (Humate-P) VWD – control and prevention of bleeding episodes Type 1 VWD, mild disease Minor or major episodes: 40-60 IU/kg IV loading dose followed by 40- 50 IU/kg IV every 8-12 hours : Type 1 VWD, moderate or severe disease Minor episodes: 40-50 IU/kg IV as one or two doses . Major episodes: 50-75 IU/kg loading doseThe reported VWF:RCo average and terminal t1/2 of 10.4 and 15.8 hours (h), respectively, for Wilate and 9.3 h and 12.8 h for Humate-P, were not statistically different. Also, the mean VWF:RCo in vivo recoveries (Wilate 1.89, Humate-P 1.99 IU/dl per IU/kg) were similar between the two replacement therapies. Lillicrap D, Poon M-C, Walker I, Xie F, Schwartz BA, and members of the Association of Hemophilia Clinic Directors of Canada. Efficacy and safety of the factor VIII/von Willebrand factor concentrate, Haemate-P/HUMATE-P: ristocetin cofactor unit dosing in patients with von Willebrand disease. Thromb Haemost. 2002;87 (2):224-230.May 25, 2022 · Examples of plasma-derived product brand names include Humate P, Alphanate, Koate, and Wilfactin. An example of a product manufactured in the laboratory is Vonvendi. These treatments are injected into a vein, often in the hospital or in a health care provider's office, but some patients are taught how to self-inject this treatment at home. Humate-P and Alphanate are currently the only plasma-derived VWF concentrates approved by the U.S. Food and Drug Administration for the treatment of VWD. These products also contain factor VIII ...viral transmission. The primary viral reduction step of the Humate-P® manufacturing process is the heat treatment of the purified, stabilized aqueous solution at 60.0 +/ - 1°C for 10 hours. In addition, the purification procedure (several precipitation steps) used in the manufacture of Humate-P® also provides viral reduction capacity.HUMATE-P, Antihemophilic Factor/von Willebrand Factor Complex (Human), is indicated for treatment and prevention of bleeding in adults with hemophilia A (classical hemophilia). 1.2 Von Willebrand Disease (VWD) HUMATE-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for: (1) (2)HUMATE-P (represented in the graph by the blue line) had the highest content of HMW-VWF multimers among VWF products tested, and its multimer pattern was most like that of NHP The multimer patterns of products A, G, H, and E (represented in the densitometric analysis by the red, green, orange, and yellow lines, respectively) differ from that of NHPSee full list on drugs.com Jun 23, 2020 · Use Humate-P (Antihemophilic And Von Willebrand Factor Complex) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than ... A. Alphanate, Humate-P ONLY Coverage is provided in the following conditions: Hemophilia A (congenital factor VIII deficiency) † Diagnosis of congenital factor VIII deficiency has been confirmed by blood coagulation testing; AND Used as treatment for control and prevention of bleeding episodes (episodic treatment Humate-P • If patient needs FEIBA • If patient needs rFVIIa • If patient needs dose of DDAVP! Goal for factor replacement is 30 minutes or less for suspected head bleeds and 60 minutes or less for suspected bleeding in areas other than the head. Pearls: P1: When in doubt, administer clotting factor replacement therapy What is HUMATE-P HUMATE-P is a VWF/FVIII replacement therapy that delivers results, patient after patient, treatment after treatment, decade after decade, as proven by a US study of the hemostatic efficacy of HUMATE-P. Based on this study, an independent Data Safety Monitoring Board judged hemostatic efficacy as "effective in 94.3% of the perioperative study subjects."Humate-P is a combination medicine used to treat or prevent bleeding episodes in people with von Willebrand disease. Humate-P is also used to treat or prevent bleeding episodes in people with hemophilia A. Humate-P may also be used for purposes not listed in this medication guide.At CSL Behring, we believe everyone should have access to therapy. For HUMATE-P we provide support services to help you get the treatment you need. Co-pay Assistance: Patients meeting eligibility requirements* may receive up to $12,000 in Co-Pay support. *Patient must have coverage for HUMATE-P under a private, commercial plan.Humate-P. Used for Hemophilia and Von Willebrand Disease. info. Specialty Drug + 1 more alert. MORE expand_more. ANTIHEMOPHILIC FACTOR prevents and treats bleeding ... Important Safety Information for Humate-P. Antihemophilic Factor/von Willebrand Factor Complex (Human), HUMATE-P ® is indicated for treatment and prevention of bleeding in adult patients with hemophilia A (classical hemophilia). HUMATE-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for (1) treatment of ...Tradename: Humate-P. Manufacturer: CSL Behring GmbH, License #1765. Indication: In adult and pediatric patients with von Willebrand disease for (1) treatment of spontaneous and trauma-induced ... Humate-P. Used for Hemophilia and Von Willebrand Disease. info. Specialty Drug + 1 more alert. MORE expand_more. ANTIHEMOPHILIC FACTOR prevents and treats bleeding ... Jun 23, 2020 · Use Humate-P (Antihemophilic And Von Willebrand Factor Complex) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than ... Possible side effects of Human Factor VIII with von Willebrand factor. Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing. Pain, itching, swelling, burning, or a lump under your skin where the needle was placed. Haemate P/Humate-P, the first plasma-derived von Willebrand factor (VWF)/factor VIII (FVIII)-containing concentrate that was pasteurized to reduce the risk of virus infection, was developed in the 1970s and approved for use in Germany in 1981. Today, Haemate P is marketed in over 35 countries worldw …Possible side effects of Human Factor VIII with von Willebrand factor. Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing. Pain, itching, swelling, burning, or a lump under your skin where the needle was placed.HUMATE-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations. Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses. Adjust dose based on clinical response. Intravenous dosage (Humate-P): Adults: 15 International Units/kg/dose IV to achieve a peak postinfusion factor VIII activity concentration of 30% of normal; most minor bleeds can be treated with 1 dose. If needed, half of the dose may be given 1 to 2 times daily for 1 to 2 days.Jun 4, 2023 · Some dosage forms listed on this page may not apply to the brand name Humate-P. Applies to antihemophilic factor/von willebrand factor: intravenous powder for solution. Serious side effects of Humate-P. Along with its needed effects, antihemophilic factor/von willebrand factor may cause some unwanted effects. Although not all of these side ... Humate P - J7190 or J7186 or J7187 . Profilate HP- J7190 . AHF M - J7190 . Alphanate - J7190 . Antihemophilic Factor (Porcine) Hyate:C - J7191 . Recombinate (Recombinant) - J7192 . Kogenate - J7192 . Bioclate - J7192 . Helixate - J7192 . Xyntha – J7185 . 3. Factor VIII inhibitors . Autoplex T (anti-inhibitor) - J7198 . Feiba VH (anti ... What is HUMATE-P HUMATE-P is a VWF/FVIII replacement therapy that delivers results, patient after patient, treatment after treatment, decade after decade, as proven by a US study of the hemostatic efficacy of HUMATE-P. Based on this study, an independent Data Safety Monitoring Board judged hemostatic efficacy as "effective in 94.3% of the perioperative study subjects."Important Safety Information for Humate-P. Antihemophilic Factor/von Willebrand Factor Complex (Human), HUMATE-P ® is indicated for treatment and prevention of bleeding in adult patients with hemophilia A (classical hemophilia). HUMATE-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for (1) treatment of ...The reported VWF:RCo average and terminal t1/2 of 10.4 and 15.8 hours (h), respectively, for Wilate and 9.3 h and 12.8 h for Humate-P, were not statistically different. Also, the mean VWF:RCo in vivo recoveries (Wilate 1.89, Humate-P 1.99 IU/dl per IU/kg) were similar between the two replacement therapies. Dose: individualize dose IV q8-24h until hemostasis; Info: estimated dose (units) = [wt (kg) x desired factor VIII level (%) x 0.5] where desired factor VIII level = 80-100%; 1 unit/kg will incr. factor VIII level approx. 2%; dose, duration varies by site/severity of bleeding, severity of deficiency, and presence of inhibitors.Adjust dose based on clinical response. Intravenous dosage (Humate-P): Adults: 15 International Units/kg/dose IV to achieve a peak postinfusion factor VIII activity concentration of 30% of normal; most minor bleeds can be treated with 1 dose. If needed, half of the dose may be given 1 to 2 times daily for 1 to 2 days. Important Safety Information for Humate-P. Antihemophilic Factor/von Willebrand Factor Complex (Human), HUMATE-P ® is indicated for treatment and prevention of bleeding in adult patients with hemophilia A (classical hemophilia). HUMATE-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for (1) treatment of ...Berirab® P | Rabies Immunoglobulin. Evogam® | Human Normal Immunoglobulin 16% (16g/100mL) – Subcutaneous Infusion. HAEGARDA® | C1-Esterase Inhibitor Subcutaneous, (Human) Hepatitis B Immunoglobulin P | Human Hepatitis B Immunoglobulin. Hizentra® | Immune Globulin Subcutaneous (Human) 20% Liquid. Intragam® P | Human Normal Immunoglobulin.Dose: individualize dose IV q8-24h until hemostasis; Info: estimated dose (units) = [wt (kg) x desired factor VIII level (%) x 0.5] where desired factor VIII level = 80-100%; 1 unit/kg will incr. factor VIII level approx. 2%; dose, duration varies by site/severity of bleeding, severity of deficiency, and presence of inhibitors.Dec 6, 2019 · Humate P/Haemate P Plasma derived North America/internationally CSL Behring, Germany 2.4 Pasteurization (60°C for 10 h) Voncento Plasma derived Europe CSL Behring, Germany 2.4 SD, dry heat (80°C, 72 h) Biostate Plasma derived Australia/Asia CSL Behring, Australia 2 SD, dry heat (80°C,72 h) Wilstart Plasma derived France Tradename: Humate-P. Manufacturer: CSL Behring GmbH, License #1765. Indication: In adult and pediatric patients with von Willebrand disease for (1) treatment of spontaneous and trauma-induced ... The densitometric analysis shows that, like normal human plasma, HUMATE-P contains a high percentage of high molecular weight von Willebrand factor (HMW-VWF) multimers, and it is capable of correcting the hemostatic defect in patients with VWD. View an animated densitometric analysis comparing various VWF/FVIII concentrates and normal human plasma.

Feb 1, 2023 · Humate-P; Wilate; Descriptions. Antihemophilic factor VIII and von Willebrand factor injection is a combination product that is used to treat serious bleeding episodes in patients with a bleeding problem called von Willebrand disease (VWD). The bleeding episode may be related to an injury (trauma) or a surgical procedure. . Why did draco

humate p

HUMATE-P provides bleed control across all VWD types, including Type 3—the most severe. “Excellent” or “Good” overall clinical response demonstrated across the majority of treatment events in a retrospective study (N=97) *2. 424/437. treatment events. 332/344 nonsurgical.What is HUMATE-P HUMATE-P is a VWF/FVIII replacement therapy that delivers results, patient after patient, treatment after treatment, decade after decade, as proven by a US study of the hemostatic efficacy of HUMATE-P. Based on this study, an independent Data Safety Monitoring Board judged hemostatic efficacy as "effective in 94.3% of the perioperative study subjects." Aug 17, 2020 · In many cases, HUMATE-P from a single request was used for several treatment courses in one subject. Therefore, there are more reported treatment courses than requests. HUMATE-P was administered to 97 subjects in 530 treatment courses: 73 for surgery, 344 for treatment of bleeding, and 20 for prophylaxis of bleeding. Haemate P/Humate-P is an intermediate-purity VWF/FVIII concentrate with extensive clinical experience in VWD. This concentrate has been shown to correct haemostatic defects of VWD, with efficacy ratings of good/excellent in nearly all patients treated for bleeding or surgical events.HUMATE-P is made from human blood and could contain infectious agents. The risk that these agents may transmit disease cannot be completely eliminated, but has been reduced by screening plasma donors and testing donated plasma for certain viruses, and by inactivating and/or removing viruses during manufacturing.HUMATE-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations. Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses.The reported VWF:RCo average and terminal t1/2 of 10.4 and 15.8 hours (h), respectively, for Wilate and 9.3 h and 12.8 h for Humate-P, were not statistically different. Also, the mean VWF:RCo in vivo recoveries (Wilate 1.89, Humate-P 1.99 IU/dl per IU/kg) were similar between the two replacement therapies.HUMATE-P, Antihemophilic Factor/von Willebrand Factor Complex (Human), is indicated for treatment and prevention of bleeding in adults with hemophilia A (classical hemophilia). 1.2 Von Willebrand Disease (VWD) HUMATE-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for: (1) (2)Humate-P® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated. Although few adverse reactions have been reported in patients receiving Humate-P®, the most commonly reported viral transmission. The primary viral reduction step of the Humate-P® manufacturing process is the heat treatment of the purified, stabilized aqueous solution at 60.0 +/ - 1°C for 10 hours. In addition, the purification procedure (several precipitation steps) used in the manufacture of Humate-P® also provides viral reduction capacity. CSL Behring: Humate-P and Helixate using the Mix2Vial™ Grifols: Alphanate® and AlphaNine® S/D using the Mix2Vial™ (see the CSL Behring instructions for Humate-P) Novo Nordisk: NovoSeven® RT ; Octapharma: Wilate using the Mix2Vial™ (see the CSL Behring instructions for Humate-P) Humate P - J7190 or J7186 or J7187 . Profilate HP- J7190 . AHF M - J7190 . Alphanate - J7190 . Antihemophilic Factor (Porcine) Hyate:C - J7191 . Recombinate (Recombinant) - J7192 . Kogenate - J7192 . Bioclate - J7192 . Helixate - J7192 . Xyntha – J7185 . 3. Factor VIII inhibitors . Autoplex T (anti-inhibitor) - J7198 . Feiba VH (anti ... Oct 27, 2016 · Humate P is the only product available for patients with von Willebrand Disease (VWD). Dose is based on VWF:RCo units only for VWD. VWF units varies in ratio to Factor VIII units with an average of 2.4:1. *Per Pharmacy & Therapeutics committee, Pharmacy can adjust dose within +/- 10% based on current dosage vial sizes in pharmacy to prevent waste. Possible side effects of Human Factor VIII with von Willebrand factor. Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing. Pain, itching, swelling, burning, or a lump under your skin where the needle was placed. Important Safety Information for Humate-P. Antihemophilic Factor/von Willebrand Factor Complex (Human), HUMATE-P ® is indicated for treatment and prevention of bleeding in adult patients with hemophilia A (classical hemophilia). HUMATE-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for (1) treatment of ...In studies, more than 5% of patients reported the following adverse reactions to HUMATE-P: allergic/anaphylactic reactions, including hives, chest tightness, rash, itching, and swelling. The most common adverse reactions after surgery were bleeding at the wound or infusion site, and nosebleeds. Please see full prescribing information.HUMATE-P is made from human blood and could contain infectious agents. The risk that these agents may transmit disease cannot be completely eliminated, but has been reduced by screening plasma donors and testing donated plasma for certain viruses, and by inactivating and/or removing viruses during manufacturing. .

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