Your healthcare provider hcp may give you advate when you have. Highlights of prescribing information these highlights do not include all the information needed to use kovaltry safely and effectively. Alphanate antihemophilic factorvon willebrand factor complex human 3051535 revised. Antihemophilic factor recombinant, plasmaalbuminfree method. Adynovate antihemophilic factor recombinant, pegylated is a prescription treatment for hemophilia a. Any federal regulatory requirements and the member specific benefit plan coverage may also impact coverage criteria. The product contains approximately 40 to 960 iu per ml octocog alfa. Please see accompanying advate full prescribing information available at. Insert the needle into the vein and remove the tourniquet. 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. Press down firmly on the package until the adapter snaps into place on. Monitor patients and discontinue rituxan infusion for severe reactions 5. Place the tip of the plunger rod into the end of the syringe.
Documentation of positive clinical response to advate therapy. Extravasation of etopophos may result in swelling, pain, cellulitis, and necrosis including skin necrosis. Advate antihemophilic factor recombinant, plasmaalbuminfree method for intravenous use, lyophilized powder for reconstitution initial u. Adynovate, the parent molecule advate, mouse or hamster protein. Please see adynovate detailed important risk information and full prescribing information. This document is provided in portable document format pdf. Supporting documents older than three years advate. You or someone else might also administer advate as an injection, but only after receiving adequate training. These highlights do not include all the information needed to use hemlibra safely and effectively. Antihemophilic factorvon willebrand factor complex human, humatep is approved to treat and prevent bleeding in adult patients with hemophilia a classical hemophilia. Advate 250 iu powder and solvent for solution for injection. Download leaflet view the patient leaflet in pdf format. In order to view pdf documents, you must have adobe reader software installed on your computer.
Highlights of prescribing information these highlights do not include all the information needed to use advate safely and effectively. Severe mucocutaneous reactions, some with fatal outcomes 5. Your healthcare provider may give you kogenate fs when you have surgery. Grip the baxject ii hiflow package at its edge and pull the.
Turn the system over, so that the diluent vial is on top. Insert the needle of the syringe into the histidine diluent vial. Parnate is not indicated for the initial treatment of mdd due to the potential forserious adverse reactions and drug interactions, and the need for dietary restrictions. Advate from the package and visually inspect the contents of the product and diluent. Prescribing information afstyla antihemophilic factor.
Advate with 5 ml of sterile water for injection, usp, usp is available as a lyophilized powder in singleuse vials containing nominally 250, 500, 1500, 2000 and 3000 iu. Sections or subsections omitted from the full prescribing information are not listed. Advate antihemophilic factor recombinant is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia a congenital factor viii deficiency for. Authorization of therapy will be issued for 12 months a state mandates may apply. Quickly insert the white plastic spike fully into the advate vial stopper by pushing straight down figure d. Proleukin, a lymphokine, is produced by recombinant dna technology using a genetically engineered e. Etopophos solutions may be administered at infusion rates up to 3. If chickenpox develops, treatment with antiviral agents may be considered. Antihemophilic factor recombinant, plasmaalbuminfree. Turn the package over and insert the clear plastic spike through the solvent stopper. Advate is used to prevent and control bleeding in adults and children 016 years with hemophilia a.
Page 2 of 21 full prescribing information 1 indications and usage 1. Instructions for use insert for detailed information on injection site selection and dose administration. Highlights of prescribing information these highlights do not include all the information needed to use enbrel safely and effectively. Download resources that can help you stay on track downloadable pdf. Remove advate from the package and verify that the expiration date on the label has not passed and the potency unit number is same as expected. Dailymed advate antihemophilic factor recombinant kit.
Please see the advate detailed important risk information and full prescribing information. Press straight down to fully insert the clear plastic spike through the diluents. See the respective package inserts for complete vzig and ig prescribing information. Allow the advate package to reach room temperature. The mean baselinecorrected serum calcium for the aredia 60mg and etidronate disodium groups were. 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. The us prescribing information for advate states that the lyophilized product. Parnatetranylcypromine sulfate is indicated forthe treatment of major depressive disorder mdd in adult patients who have not responded adequately to other antidepressants. Advate is usually injected into a vein intravenously by your doctor or nurse. Advate will be approved based on the following criterion.
Reconstitute and administer kovaltry with the components provided with each package. There are some things in life that work for you, like controlling and preventing bleeds with recombinate antihemophilic factor recombinant. Detailed instructions for self administration are given at the end of this package leaflet. Advate antihemophilic factor recombinant is a treatment for hemophilia a. Reconstitute with 10 ml sterile water for injection, usp. We would like to show you a description here but the site wont allow us.
Each advate vial is labelled with the strength expressed in iu international units per vial. Press straight down to fully insert the clear plastic spike. Kogenate fs is used to treat and control bleeding in adults and children with hemophilia a. Advate antihemophilic factor recombinant, plasmaalbumin free method description advate antihemophilic factor recombinant, plasmaalbumin free method is a purified glycoprotein consisting of 2,332 amino acids that is synthesized by a genetically engineered chinese hamster ovary. Corticosteroids should be used with caution, if at all, in patients with active or quiescent. Inject air into the vial and withdraw the quantity required for reconstitution. Highlights of prescribing information these highlights do not include all the information needed to use humatep safely and effectively. Inspect parenteral drug products for discoloration and particulate matter. Your doctor might also give you afstyla before surgical procedures. Advate is packaged with 5 ml or 2 ml of sterile water for injection, usp, a baxject ii needleless transfer device, one terumo microbore infusion set 2 ml only, one full prescribing physician insert, and one patient insert. See full prescribing information for complete boxed warning.
Used regularly prophylaxis, afstyla can reduce the number of bleeding episodes and the risk of joint damage due to bleeding. Follow applicable special handling and disposal procedures. Insert the needle on the infusion set tubing into the vein, and remove the tourniquet. The advate powder should be white to offwhite in color and the diluent free from foreign particles.
Lift the package cover away from the vial adapter and discard the cover. With one hand holding the advate in the baxject iii system, press down firmly on the solvent vial with the other hand until the system is fully collapsed and the solvent flows down into the advate vial fig. The clinical experience of this fulllength rfviii is the focus of this article. Download the complete prescribing information for kcentra. While holding the adapter in the package, place the vial adapter over the vial.
774 519 339 562 1393 830 692 18 122 1362 518 1064 1127 1020 262 675 1565 878 1526 320 1460 1580 1449 173 557 1339 1293 102 1010 388 796 805 500 625 997 381 852 993 1000 34 632