The package label accompanying fdas approval letter did not contain the word rabbit. Embed pdf in word while working on your document, click insert object. Jan 17, 2020 acetazolamide is a potent carbonic anhydrase inhibitor, effective in the control of fluid secretion e. Keep the febridx test card in the sealed foil pouch until just before use. Pegloticase injection is used to treat chronic gout in adult patients who have already been treated with other medicines that did not work well. Additional copies of the febridx package insert can be found on the downloads page at. Krystexxa is not recommended for the treatment of asymptomatic hyperuricemia. Pegloticase is approved for the treatment of hyperuricemia in patients with. For prescription medications, the insert is technical, providing. For prescription medications, the insert is technical, providing information for medical professionals about how to prescribe the drug. Table of contents description clinical pharmacology indications and usage contraindications precautions adverse reactions dosage and administration how supplied storage references smallpox vaccine dried, calf lymph type dryvax dried smallpox vaccine rx.
Based on posthoc analyses of the clinical trial data, if krystexxa had been stopped when a patients uric acid level rose to greater than 6 mgdl on a single. Package insert definition of package insert by medical. Computing a group of characters, such as a number or a word, appended to a particular statement in a program to allow its unique identification 3. Has documentation of improvement in disease severity since initiating. Krystexxa is the firstever and only treatment approved by the fda for adult patients who suffer with chronic gout that is refractory to conventional therapy, paul hamelin. Package insert definition of package insert by the free.
Krystexxa is used to treat adult patients with severe chronic longterm tophaceous. Word will convert the pdf to editable text and you can then copy and paste that text into your office document. Visually inspect krystexxa for particulate matter and discoloration before administration, whenever solution and container permit. If youre looking to insert the contents of your pdf file into an office file, as opposed to simply inserting the pdf as an attachment, then your best bet is to open that pdf with word 20 or 2016. Observational study of the use of krystexxa pegloticase in adult. Vials may be held up to 12 months upon removal from refrigeration to room temperature. You should be given medications such as a corticosteroid and an. At the surgeons discretion, the following autologous fluids may also be used to hydrate the implant. This is how to insert pdf into word as an embedded object. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for zaroxolyn metolazone. The medicinal product should be administered in a healthcare setting and by healthcare professionals prepared. Pegloticase krystexxa injectable aetna precertification. Oral phytonadione is adequately absorbed from the gastrointestinal.
Dailymed krystexxa pegloticase injection, solution. Sep 05, 2018 krystexxa pegloticase is an enzyme that metabolizes uric acid into a harmless chemical that is eliminated from the body in urine. Against initiating longterm uratelowering therapy in most patients after a. Serious allergic reactions may happen in some patients who receive krystexxa.
The longterm risk of prophylactic medications to prevent infusion. Abraxane is 125 mgm2 intravenously over 3040 minutes on days 1, 8 and 15 of each 28day cycle. Experience the latest findings on gout progression through an. Do not use the febridx test card or the buffer solution past the expiration date. Inhibition of platelet aggregation by clopidogrel is achieved through an active metabolite. Krystexxa is a prescription medication used to treat chronic gout. Overall, the process is pretty much the same, so i only need to explain it once. Krystexxa pegloticase injection for intravenous infusion is an enzyme that metabolizes uric acid into a harmless chemical that is eliminated from the body in urine and is used to treat chronic. Please read carefully and keep this information for future use. The metabolism of clopidogrel to its active metabolite can be impaired by. These hig hlights do not include all the informatio n nee ded to use. They work by removing excess uric acid from the body. Graham mayor microsoft word mvp 20022019 for more word tips and downloads visit my web site. Oral phytonadione is adequately absorbed from the gastrointestinal tract only if bile salts are present.
In the object dialogue box, click create from file and then click browse to find the pdf document you want to insert. Call 1888krystexxa 18885797839 monday friday, 8 am to 8 pm et. The first thing the product website emphasizes is that this treatment can cause life threatening allergic reactions in some people. Upon request, a krystexxa team member can deliver you a compilation of current literature describing the use of immunomodulation with pegloticase, including. Collect whole blood into a lithium heparin blood collection tubes and store between 0 and 32 hours post venipuncture at 1825. Acetazolamide is a potent carbonic anhydrase inhibitor, effective in the control of fluid secretion e. For more information, go to edit pdf content in word. Krystexxa injection is a prescription medicine used in adults to help reduce the signs and symptoms of gout that are not controlled by other treatments. Package insert dryvax smallpox vaccine, dried, calf lymph. Use standard precautions for collecting and handling a blood sample. Gout is a condition that is caused by too much uric.
Sep 23, 2016 krystexxa is a prescription medication used to treat chronic gout. Rdea594, oral dosage form, phase 2 trials ongoing, ardea biosciences. This page further describes uses of this prescription drug, including possible offlabel uses. Pegloticase is an enzyme that metabolizes uric acid into a harmless chemical that is eliminated from the body in urine. A prospective observational, proofofconcept, case series. Sep 15, 2012 1 95% confidence interval for differences in responder rate between pegloticase group vs. This package insert is intended for the eyecare practitioner, but should be made. Experience the latest findings on gout progression through an interactive presentation, and see what processes can occur in gout independent of pain.
Krystexxa is part of the uricosuric drugs class and treats gout. Anaphylaxis and infusion reactions see full prescribing information for complete boxed warning. Lift the package away from the adapter and discard the package. Krystexxa fda prescribing information, side effects and uses. These highlights do not include all the information needed to use. Serious infections and malignancies 1 indications and usage 1. Sep 17, 2010 krystexxa is the firstever and only treatment approved by the fda for adult patients who suffer with chronic gout that is refractory to conventional therapy, paul hamelin, rph, president of. Discard any unused portion of product remaining in the 2 ml vial.
See 17 for patient counseling information and fdaapproved patient labeling. Krystexxa is a prescription medicine used in adults to help reduce the signs and symptoms of gout that are not controlled by other treatments. Krystexxa is supplied as a clear, colorless, sterile solution in phosphate buffered saline intended for intravenous infusion after dilution. Is prescribed a dose that is consistent with fdaapproved package labeling. Feb 06, 2020 pegloticase is an enzyme that metabolizes uric acid into a harmless chemical that is eliminated from the body in urine. Now lets go through the process of inserting pdf files into word 2007, 2010 and 20 for the pc.
Krystexxa definition of krystexxa by medical dictionary. Offlabel uses for krystexxa on occasion, your healthcare provider may recommend krystexxa for something other than refractory gout this would be known as an offlabel use. Aetna precertification notification 503 sunport lane, orlando, fl. Introduction of potent smallpox vaccine containing infectious vaccinia viruses into the superficial layers of the skin results in viral multiplication, immunity, and cellular hypersensitivity. Place implant into a sterile bowl and reconstitute with sterile isotonic solution. Mephyton precautions phytonadione vitamin k1 description. Colestipol is an insoluble, high molecular weight basic anionexchange copolymer of diethylenetriamine and 1chloro2, 3epoxypropane, with approximately 1 out of 5 amine nitrogens protonated chloride form. Dosage the recommended dose and regimen of krystexxa for adult patients is 8 mg uricase protein given as an intravenous infusion every two weeks.
Read the medication guide provided by your pharmacist before you start using pegloticase and each time you get a refill. However, this will only insert the text without the original formatting or graphics if any from the pdf file, so it wont look. Krystexxa is a clear, colorless, sterile 8 mgml solution of pegloticase in a 2 ml singledose vial, expressed as amounts of uricase protein. Gout is a common arthritis caused by deposition of monosodium urate crystals within joints.
Withdraw 1 ml of krystexxa from the vial into a sterile syringe. Package insert dryvax smallpox vaccine, dried, calf lymph type wyeth laboratories, inc. Krystexxa pegloticase is proven for the treatment of chronic gout refractory to. The optimal treatment duration with krystexxa has not been established. Gout is a common arthritis caused by deposition of monosodium urate crystals within joints that can also deposit in tissues and the kidneys. The following list does not include adverse reactions. What is the most important information i should know about krystexxa pegloticase. A package insert is a document included in the package of a medication that provides information about that drug and its use. Has documentation of improvement in disease severity since initiating treatment with krystexxa pegloticase. After absorption, phytonadione is initially concentrated in the liver, but the concentration declines rapidly.
You are encouraged to report negative side effects of prescription drugs to the. Krystexxa pegloticase injection for intravenous infusion is an enzyme that metabolizes uric acid into a harmless chemical that is eliminated from the body in urine and is used to treat chronic gout. This will insert the pdf first page only as objects cannot span pages just as in earlier versions, without converting the pdf. Side effects of krystexxa pegloticase injection, warnings, uses. Pegloticase is usually given after other gout medications have been tried without successful treatment of symptoms. The active ingredient in colestid tablets is micronized colestipol hydrochloride, which is a lipid lowering agent for oral use.
Here are two steps to insert pdf into word document as an object. Pretreatment and coadministration with methotrexate improved durability of pegloticase response. You can also import a portion of text from the pdf file using the insert object tool, and drop it into the word document. Krystexxa pegloticase that was previously approved will take into account whether the beneficiary. For further information on the use of krystexxa see the package leaflet. Please see the medication guide and prescribing information for more information. Aetna precertification notification 503 sunport lane, orlando, fl 32809 phone. Krystexxa, innpegloticase european medicines agency. You should be given medications such as a corticosteroid and an antihistamine before each dose of krystexxa to help prevent allergic reactions and infusion reactions. Vials may be held up to 12 months upon removal from refrigeration to room temperature storage conditions 20c to 25c 68f to 77f. Krystexxa is usually given after other gout medications have been tried without successful treatment of symptoms.
Chronic hyperuricemia is the most important risk factor for. Approved with an orphan drug status in the united states, pegloticase is. Click insert to insert the images into the word document. 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. Crealtas krystexxa is the first and only fdaapproved medicine for chronic refractory gout, which is an orphan disease and a type of arthritis that occurs when uric acid build up in the blood remains high and inflammation persists even after treatment with conventional therapies. Package insert article about package insert by the free. Krystexxa dosage for gout the recommended krystexxa dosage is 8 mg given intravenously by iv once every two weeks. Connect the diluent syringe to the vial adapter by inserting the tip of the syringe into the. As explained in this emedtv article, krystexxa is used for preventing gout attacks in people who have not adequately responded to other gout medications. Krystexxa pegloticase is an enzyme that metabolizes uric acid into a harmless chemical that is eliminated from the body in urine. Plavix is contraindicated in patients with hypersensitivity e. To get started, click on the insert tab on the ribbon. Krystexxa pegloticase is not recommended for the treatment of asymptomatic hyperuricemia.
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