Humate p.

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)].Although not compared statistically, rVWF appears to have more HMWM VWF and a higher ratio of VWF:GPIbM to VWF:Ag than Humate-P and cryoprecipitate. The estimated acquisition cost for our hospital for treating one major bleeding episode was more than 4-fold higher with Humate-P and 7- to 10-fold higher with rVWF than with cryoprecipitate.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) sudden cough, coughing up blood; pain, swelling, warmth, or redness in one or both legs; pale or yellowed skin, dark colored urine, fever, confusion or weakness; bleeding from a wound or where the medicine was injected; or. bleeding that is not controlled. Common Wilate side effects may include: nosebleeds;

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® has a high degree of purity with a low amount of non-factor proteins. Each Humate-P® vial contains the labeled amount of Factor VIII and vWF:RCoF activity expressed in international units (IU). Reconstituted solution is clear or slightly opalescent. Available in 1000 RcoF IU, and 2000 RcoF IU single-use vials. 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.

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 ...Jul 3, 2023 · 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 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.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.The generic name of Humate-p is antihemophilic factor/von willebrand factor complex (human). The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 63833-617-02 1 kit in 1 carton * 15 ml in 1 vial (63833-627-01) * 15 ml in 1 vial, single-dose (63833-765-55). This page includes all the important ...The results of both trials revealed that Humate-P was effective in preventing excessive bleeding during and after surgery. 1. The most frequent adverse reactions to Humate-P include allergic reactions such as urticaria, chest tightness, rash, pruritus, edema, injection-site bleeding, and epistaxis. 1. The efficacy of Alphanate in preventing ...

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 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. Used for Hemophilia and Von Willebrand Disease. info. Specialty Drug + 1 more alert. MORE expand_more. ANTIHEMOPHILIC FACTOR prevents and treats bleeding ...This unique HUMATE-P Surgery Dosing Calculator makes individual dosing fast, easy, and convenient. The 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. (For guidance on loading dose recommendations ...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. 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 ...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.

Sep 4, 2023 · 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. 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 …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 Factor VIII ( FVIII) is an essential blood-clotting protein, also known as anti-hemophilic factor (AHF). In humans, factor VIII is encoded by the F8 gene. [5] [6] Defects in this gene result in hemophilia A, an X-linked coagulation disorder. [7] Factor VIII is produced in liver sinusoidal cells and endothelial cells outside the liver throughout ...Humate-P® SDS Revision Date: 06/04/2015 Page 3 of 7 administered as directed by a physician. In addition, no adverse health effects are anticipated as a result of incidental contact or exposure to this product by those handling it or administering it in a therapeutic setting. More detailed information is available in the product package insert.

Humate-P® has a high degree of purity with a low amount of non-factor proteins. Each Humate-P® vial contains the labeled amount of Factor VIII and vWF:RCoF activity expressed in international units (IU). Reconstituted solution is clear or slightly opalescent. Available in 1000 RcoF IU, and 2000 RcoF IU single-use vials. 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 · 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 Hemophilia A. Minor hemorrhage: Loading dose 15 IU/kg IV should achieve FVIII:C plasma level ~30% of normal. Moderate hemorrhage: Loading dose 25 IU/kg IV should achieve FVIII:C plasma level ~50% of normal. Life-threatening hemorrhage: 40-50 IU/kg IV initially, followed by 2-25 IU q8-12hr to maintain FVIII:C level at 80-100% of normal. 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.Anti-hemophilic factor/von Willebrand factor complex (Humate-P) is indicated for use in adult patients for treatment and prevention of bleeding in hemophilia A and in adult and pediatric patients for treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease and in mild and moderate von Willebrand disease ...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. 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: Riastap Tisseel Epoetin alfa (Epogen/Procrit) Albumin Cryoprecipitate Other(s): _____ Others ATryn Thrombate III

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 ...

None of the reported suspected virus transmission cases were confirmed to be associated with Humate-P. Reported results of company-sponsored studies showed a low incidence of adverse events possibly or probably related to Humate-P. Conclusions: More than 33 years of pharmacovigilance data continue to support the safety of Humate-P.

Aug 7, 2023 · With the HUMATE-P vial placed firmly on a flat surface, invert the diluent vial with the Mix2Vial transfer set attached and push the plastic spike of the transparent adapter firmly through the center of the stopper of the HUMATE-P vial (Fig. 4). The diluent will automatically transfer into the HUMATE-P vial. Factor VIII (plasma -derived)/von Willebrand Factor Complex (plasma -derived) [Alphanate or Humate -P], Factor VIII (plasma -derived) [Hemofil M or Koāte -DVI), and Factor VIII (recombinant) [Advate, Kogenate FS, Kovaltry, NovoEight, Nuwiq , or Recombinate ] are proven and medically necessary when both of the following c riteria are met: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. 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. 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.The generic name of Humate-p is antihemophilic factor/von willebrand factor complex (human). The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 63833-617-02 1 kit in 1 carton * 15 ml in 1 vial (63833-627-01) * 15 ml in 1 vial, single-dose (63833-765-55). This page includes all the important ... 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® has a high degree of purity with a low amount of non-factor proteins. Each Humate-P® vial contains the labeled amount of Factor VIII and vWF:RCoF activity expressed in international units (IU). Reconstituted solution is clear or slightly opalescent. Available in 1000 RcoF IU, and 2000 RcoF IU single-use vials.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 - 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 ...

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 ... 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 ... 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.Instagram:https://instagram. in house pharmacybangkok serviced apartments monthlyvictoria secret underwear sale 10 for dollar35man walking on i 8 in mission valley 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)]. paul lumber and supplythe great ha 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.Among 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 ... standard speaker obituaries today 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 therapySome 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 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 ...