Dailymed humatep antihemophilic factorvon willebrand. Pharmacovigilance at 18669156958 or fda at 1800fda1088 or. Alphanate is designed to meet the needs of a variety of patients. Recombinate is used to prevent and control bleeding in people with hemophilia a. Push the blue plastic cannula of the mix2vial firmly through the rubber stopper of the diluent vial fig. Page 2 of 21 full prescribing information 1 indications and usage 1. Pharmaceutical compounding sterile preparations, it is important to note that while fda states that compounding does not include products prepared according to package labeling, fdaapproved labeling i. Csl behring contraindications albumin human usp, 25%. Uconn health department of pharmacy procoagulant factor agent 1to maintain vwf. Prescribing information kcentra prothrombin complex. Aliqopa copanlisib for injection, for intravenous use. Recombinate antihemophilic factor recombinant official site. Humate p is made from human blood and could contain infectious agents. Place the humate p vial, diluent vial and mix2vial transfer set on a flat surface.
Lift the package away from the adapter and discard the package. Presentation carton ndc number component 20 ml 0053768001 one vial containing 5 grams of albumin ndc 0053768090 50 ml 0053768032 one vial containing 12. All 5 recombinate dosage strengths are packaged with the same lowvolume 5 ml sterile water for. Priftin is only recommended for the treatment of active pulmonary tuberculosis caused by drugsusceptible organisms as part of regimens consisting of a 2month initial phase followed by a 4month continuation phase. Advate is a medicine used to replace clotting factor factor viii or antihemophilic factor that is missing in people with hemophilia a also called classic hemophilia. Plasma products carry a risk of transmitting infectious agents, including viruses, and theoretically, the. Cd52 is expressed on the surface of normal and malignant b and t lymphocytes, nk cells, monocytes, macrophages, and tissues of the male reproductive system. Nephrotic syndrome has been reported following attempted immune tolerance induction with factor ix products in hemophilia b patients with factor ix inhibitors and a history of severe allergic reactions to factor ix. Antihemophilic factorvon willebrand factor complex fda. In order to view pdf documents, you must have adobe reader software installed on your computer. Dailymed retrovir zidovudine capsule retrovir zidovudine. Esophageal candidiasis serious fungal infections caused by scedosporium apiospermum and fusarium species including fusarium solani, in patients intolerant of, or refractory. Your doctor will monitor you for events related to abnormal blood clotting.
Benefix humate p given over 320 min max 4mlmin max rate of 2 unitskgmin. Humatep antihemophilic factorvon willebrand factor. In order to minimize the possibility of thrombogenic complications, dosing guidelines should be strictly followed. Aug 01, 2018 place the humate p vial, diluent vial and mix2vial transfer set on a flat surface. Federal law restricts this device to sale by or on the order of a physician. Your healthcare provider hcp may give you advate when you have. Supporting documents older than three years humatep. The recommended adult and adolescent starting regimen is every 7 or 10 days with the potential to extend to 14 days based on your response. Pharmacy medical policy human antihemophilic factor. Campath alemtuzumab is a recombinant dnaderived humanized monoclonal antibody campath1h that is directed against the 2128 kd cell surface glycoprotein, cd52. Product information humate p alberta health services. Hymovis is a sterile, nonpyrogenic, viscoelastic hydrogel contained in a singleuse syringe. Highlights of prescribing information take with food.
Prescribing information kogenate fs, antihemophilic factor. In clinical studies, adverse reactions included tingling in. C units, which were converted in the study analysis to vwf. Vfend is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with. Reconstitute and administer kovaltry with the components provided with each package. Riastap, fibrinogen concentrate human, is indicated for the. If you do not have adobe reader, download it from the adobe web site. Priftin should not be used in the treatment of active pulmonary tuberculosis caused by rifampinresistant strains. Highlights of prescribing information these highlights do. Antihemophilic factorvon willebrand factor complex human, humate p is approved to treat and prevent bleeding in adult patients with hemophilia a classical hemophilia. Many patients carry a factor first card with pertinent information about their.
Uconn health department of pharmacy procoagulant factor. Kcentra, prothrombin complex concentrate human, is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin k antagonist vkaeg, warfarin therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure. Highlights of prescribing information these highlights do not include all the information needed to use humate p safely and effectively. Open the mix2vial transfer set package by peeling away the lid fig. Cvs caremark is an independent company that provides pharmacy benefit management services to carefirst bluecross blueshield and carefirst bluechoice, inc.
Product must be ordered by clinical hematologist or hemophilia clinic nurse. Alprolix coagulation factor ix recombinant, fc fusion. If any component of the package is opened or damaged, do not use this component. Humate p is not known to prevent spontaneous bleeding episodes. Used regularly prophylaxis, afstyla can reduce the number of bleeding episodes and the risk of joint damage due to bleeding. Connect the diluent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening while firmly pushing and turning the syringe clockwise until the connection is secured. Koatedvi is indicated for the treatment of classical hemophilia hemophilia a in which there is a demonstrated deficiency of activity of the plasma clotting factor, factor viii. While holding onto the diluent vial, carefully remove the outer package from the mix2vial, being careful to leave the mix2vial attached firmly to the diluent vial fig. Recombinate is a prescription medicine used to replace clotting factor factor viii or antihemophilic factor that is missing in people with hemophilia a also called classic hemophilia. Allergictype reactions may result from the administration of antihemophilic factor human preparations. Dosage must be individualized based on patientspecific factors i. Each humatep vial contains the labeled amount of factor viii and. Product monograph template schedule d octapharma canada.
See boxed warning for information about the following. Wipe the stoppers with an alcohol swab and allow the stoppers to dry prior to opening the mix2vial transfer set package. For any questions about the handling, reconstitution and administration of kovaltry, contact bayer medical communications at 188884bayer 18888422937. Advate is used to prevent and control bleeding in adults and children 016 years with hemophilia a. More detailed information is available in the product package insert. Available in 5 dosage strengths, ranging from 250 iu to 2000 iu, recombinate offers 5 options that come with singlevial dosing. Kogenate fs antihemophilic factor recombinant is a medicine used to replace clotting factor factor viii or antihemophilic factor that is missing in people with hemophilia a. While holding onto the diluent vial, carefully remove the outer package from the mix2vial, being careful to leave the mix2vial attached firmly to. Humatep antihemophilic factorvon willebrand factor complex human lyophilized powder for reconstitution for intravenous use only. Your healthcare provider may give you kogenate fs when you have surgery. Jan 20, 2020 see boxed warning for information about the following. Afstyla, antihemophilic factor recombinant, single chain, is used to treat and control bleeding episodes in people with hemophilia a. Esperoct antihemophilic factor recombinant, glycopegylatedexei 3 hepatic, renal, or cardiac function, and of concomitant disease and other drug therapy. Instructions for use 1 information for prescribers hymovis high molecular weight viscoelastic hyaluronan caution.
Highlights of prescribing information these highlights. Antihemophilic factorvon willebrand factor complex. Qtern dapagliflozin and saxagliptin is indicated as an adjunct to diet and exercise to. You are encouraged to report negative side effects of prescription drugs to the fda. Alprolix is the only extended halflife factor ix therapy chosen by over 1,100 people in the us, and proven over 4 years of realworld experience. Place the humatep vial, diluent vial and mix2vial transfer set on a flat surface. Your doctor might also give you afstyla before surgical procedures. Reconstitute kovaltry with the components provided with each package. Dosing your life is bigger than hemophilia a, and your factor viii helps keep it that way.
Remove protective cover from the spike end of the filter. Factor viiivon willebrand alphanate, humatep, wilate. Filter the reconstituted product to remove potential particulate matter in the solution. Highlights of prescribing information these highlights do not include all the information needed to use humalog safely and effectively. Peel cover from microaggreg ate filter package and securely install the syringe into the exposed luer inlet of the filter, using a slight clockwise twisting motion.
Highlights of prescribing information these highlights do not include all the information needed to use humatep safely and effectively. Fdaapproved unapproved type of bleed dose interval duration goal factor concentration benefix factor ix recombinant 2000 iu vials. Sections or subsections omitted from the full prescribing information are not listed. This document is provided in portable document format pdf. Insert the needle of the syringe into the histidine diluent vial. Antihemophilic factorvon willebrand factor complex human, dried. Overview of esperoct package overview vial with esperoct powder vial adapter prefilled syringe with diluentp lunger rod plastic cap syringe cap syringe tip under syringe cap scale rubber plunger rubber stopper under plastic cap thread wide top end protective cap spike under protective paper protective r reconstitution 1. Insert the syringe needle containing the diluent into the novoseven rt vial through the center of the rubber stopper, aiming the needle against the side so that the stream of liquid. Antihemophilic factorvon willebrand factor complex human. Factor viiivon willebrand factor complex human alphanate, humatep, wilate reference number. Indefinite authorizationof advate, adynovate, afstyla, alphanate, eloctate, helixate fs, hemofil m, humate p, koate, kogenate fs, kovaltry, monoclatep, novoeight. Discontinue aliqopa if lifethreatening aliqoparelated toxicity occurs. Invasive aspergillosis candidemia in nonneutropenics and other deep tissue candida infections. Prescribing information afstyla antihemophilic factor.
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