Sections or subsections omitted from the full prescribing information are not listed. Highlights of prescribing information these highlights do not include all the information needed to use kovaltry safely and effectively. While holding the adapter in the package, place the vial adapter over the vial. Advate antihemophilic factor recombinant, plasmaalbuminfree method for intravenous use, lyophilized powder for reconstitution initial u. Detailed instructions for self administration are given at the end of this package leaflet. The clinical experience of this fulllength rfviii is the focus of this article. Thirty patients were randomized to receive aredia and 35 to receive etidronate disodium. Your healthcare provider hcp may give you advate when you have. The chemical name is desalanyl1, serine125 human interleukin2. Download resources that can help you stay on track downloadable pdf. The product contains approximately 40 to 960 iu per ml octocog alfa. Your healthcare provider may give you kogenate fs when you have surgery. Please see the advate detailed important risk information and full prescribing information. Turn the system over, so that the diluent vial is on top.
Alphanate antihemophilic factorvon willebrand factor complex human 3051535 revised. Advate from the package and visually inspect the contents of the product and diluent. Download leaflet view the patient leaflet in pdf format ukemcfilespil. Severe mucocutaneous reactions, some with fatal outcomes 5. See the respective package inserts for complete vzig and ig prescribing information. 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. The vacuum will draw the diluent into the advate vial. Inspect parenteral drug products for discoloration and particulate matter.
Extravasation of etopophos may result in swelling, pain, cellulitis, and necrosis including skin necrosis. Insert the needle into the vein and remove the tourniquet. Highlights of prescribing information these highlights do not include all the information needed to use humatep safely and effectively. Authorization of therapy will be issued for 12 months a state mandates may apply. 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. Download leaflet view the patient leaflet in pdf format.
Grip the baxject ii hiflow package at its edge and pull the. Antihemophilic factor recombinant, plasmaalbuminfree. 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. Please see accompanying advate full prescribing information available at. Antihemophilic factorvon willebrand factor complex human, humatep is approved to treat and prevent bleeding in adult patients with hemophilia a classical hemophilia. Download the complete prescribing information for kcentra. Used regularly prophylaxis, afstyla can reduce the number of bleeding episodes and the risk of joint damage due to bleeding. We would like to show you a description here but the site wont allow us. Reconstitute and administer kovaltry with the components provided with each package.
Antihemophilic factor recombinant, plasmaalbuminfree method. Please see adynovate detailed important risk information and full prescribing information. Only use the diluent syringe provided in the alprolix package. Adynovate, the parent molecule advate, mouse or hamster protein. Press straight down to fully insert the clear plastic spike. Inject air into the vial and withdraw the quantity required for reconstitution. Lift the package cover away from the vial adapter and discard the cover. 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. 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. Press down firmly on the package until the adapter snaps into place on. Advate is used to prevent and control bleeding in adults and children 016 years with hemophilia a. You or someone else might also administer advate as an injection, but only after receiving adequate training. Page 2 of 21 full prescribing information 1 indications and usage 1.
These highlights do not include all the information needed to use hemlibra safely and effectively. Advate is usually injected into a vein intravenously by your doctor or nurse. Corticosteroids should be used with caution, if at all, in patients with active or quiescent. Instructions for use insert for detailed information on injection site selection and dose administration. If chickenpox develops, treatment with antiviral agents may be considered. Documentation of positive clinical response to advate therapy. Each advate vial is labelled with the strength expressed in iu international units per vial.
Allow the advate package to reach room temperature. Advate 250 iu powder and solvent for solution for injection. See full prescribing information for complete boxed warning. 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. This document is provided in portable document format pdf. Insert the needle on the infusion set tubing into the vein, and remove the tourniquet. If any component of the package is opened or damaged, do not use this component. Dailymed advate antihemophilic factor recombinant kit.
Advate antihemophilic factor recombinant is a treatment for hemophilia a. Quickly insert the white plastic spike fully into the advate vial stopper by pushing straight down figure d. Fatal infusionrelated reactions within 24 hours of rituxan infusion. Insert the needle of the syringe into the histidine diluent vial. Proleukin, a lymphokine, is produced by recombinant dna technology using a genetically engineered e. Advate will be approved based on the following criterion. Shire launches mypkfit for advate antihemophilic factor. Kogenate fs is used to treat and control bleeding in adults and children with hemophilia a. Monitor patients and discontinue rituxan infusion for severe reactions 5. Place the tip of the plunger rod into the end of the syringe. The mean baselinecorrected serum calcium for the aredia 60mg and etidronate disodium groups were. Press straight down to fully insert the clear plastic spike through the diluents. Follow applicable special handling and disposal procedures. Turn the package over and insert the clear plastic spike through the solvent stopper.
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. Supporting documents older than three years advate. The us prescribing information for advate states that the lyophilized product. Adynovate antihemophilic factor recombinant, pegylated is a prescription treatment for hemophilia a. There are some things in life that work for you, like controlling and preventing bleeds with recombinate antihemophilic factor recombinant. Highlights of prescribing information these highlights do not include all the information needed to use advate safely and effectively. The us prescribing information for advate states that the lyophilized product should be stored. Highlights of prescribing information these highlights do not include all the information needed to use enbrel safely and effectively.
In order to view pdf documents, you must have adobe reader software installed on your computer. 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. Reconstitute with 10 ml sterile water for injection, usp. Advate antihemophilic factor recombinant is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia a congenital factor viii deficiency for. Any federal regulatory requirements and the member specific benefit plan coverage may also impact coverage criteria. Parnatetranylcypromine sulfate is indicated forthe treatment of major depressive disorder mdd in adult patients who have not responded adequately to other antidepressants. The advate powder should be white to offwhite in color and the diluent free from foreign particles. Prescribing information afstyla antihemophilic factor. Etopophos solutions may be administered at infusion rates up to 3.
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