Cathflo activase alteplase for injection is a sterile, white t. Alteplase activase calculator thrombolytic globalrph. Retavase is supplied as 10 units of lyophilized powder in singleuse vials for reconstitution, co. Activase alteplase in acute ischemic stroke american heart.
Dosing and administration poster and interactive downloadable pdf. A possible decrease in responsiveness to skin testing may occur in the presence of infections, viral infections measles, mumps, chickenpox, hiv, live virus vaccinations measles, mumps, rubella. It is a sterile, purified glycoprotein of 527 amino acids. It is synthesized using the complementary dna cdna for natural human tissuetype plasminogen activator obtained from a human melanoma cell line. Oct, 2020 using the transfer device provided, reconstitute by adding the contents of the accompanying 100 ml vial of swfi to the 100 mg vial of activase. Remove the protective flipcaps from the vial of alteplase and sterile water sw. Allina health alteplase rtpaactivase dosage administration.
Remove the protective cap from one end of the transfer device and keeping the vial of swfi. General catheter management brochure cathflo activase. Open the mix2vial package by peeling away the lid figure 1. Activase alteplase treatment for acute ischemic stroke ais. Learn about activase alteplase, a treatment for acute ischemic stroke ais. Cathflo activase alteplase is indicated for restoration of function to clotted central venous access devises as assessed by the inability to withdraw blood. Read all of this leaflet carefully before you start using this. Maximal dilution of activase pursuing a career in clinical pharmacy. Reconstitute cathflo activase to a final concentration of 1 mgml. Safety and efficacy of alteplase for restoring function of.
Important safety information contraindications cathflo activase should not be administered to patients with known hypersensitivity to alteplase or any component of the formulation. During and following activase administration for the treatment of acute ischemic stroke, frequently monitor and control blood pressure. It is synthesized using the complementary dna cdna for natural human tissue. See package insert for reconstitution instructions.
Highlights of prescribing information for intravenous. Appendix alteplase use in hemodialysis central venous. Remove the protective cap from one end of the transfer device and keeping the vial of sw upright, insert the piercing pin vertically. Highlights of prescribing information procrit epoetin alfa. Alteplase has been studied in patients from 2 to 16 years of age. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for invanz ertapenem. Administration fda package insert, specifically for the only tissuetype plasminogen activator licensed for use in acute ischemic stroke, alteplase. While recognizing that the alteplase package insert was updated in february 2015, our general practice is to follow the recommendations in the aha guidelines. Remove the protective cap from the other end of the transfer device. Alteplase cathflo activase, genentech, package insert fda. Highlights of prescribing information antiplatelet. A study of another alteplase product, actilyse, in acute ischemic stroke, suggested that doses greater. Please see full prescribing information for additional important safety. Instructions for administration preparation of solution.
Reconstitute activase immediately before administration, using aseptic technique at all times. Insert spike end of the infusion set through the same puncture site. Dobutamine was compatible at concentrations up to 4 mgml but incompatible at a concentration of 12. No study drug related adverse events were observed in these pediatric patients. Cathflo activase alteplase is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood. Alteplase for the treatment of central venous catheter occlusion in children.
Highlights of prescribing information these highlights do not. Patients with low body weights 10 kg and alteplase, with each dose equal to 110% of the internal lumen volume of the dysfunctional cvad to a maximum dose of 2 mg. Activase alteplase recombinant package insert, genentech inc, south san. Consult package insert for complete instructions on medication preparation. For a complete listing, see the dosage forms, composition and packaging section of the product monograph. Singleuse vial lytic thrombolytic cathflo activase. Remove the protective cap from one end of the transfer device and keeping the vial of sw upright, insert the piercing pin vertically into the center of the stopper of the vial of sw first. Dosing show first dosing slide the recommended dose of alteplase for treating acute ischemic stroke is 0.
Patients were to be excluded from the trial if they received gp iibiiia inhibitors within the previous 12 hours. In the national heart, lung and blood institutes cardiac arrhythmia suppression trial cast, a longterm, multicentered, randomized, doubleblind study in patients with asymptomatic nonlifethreatening ventricular arrhythmias who had a myocardial infarction more than six days but less than two years previously, an excessive mortality or nonfatal cardiac arrest rate 7. Open the package containing the transfer device by peeling the paper label off the package. Recent intracranial or intraspinal surgery or trauma see package insert for warnings.
Alteplase is an enzyme that has the property of fibrinenhanced conversion of plasminogen to plasmin. It is a sterile, purified 9 glycoprotein of 527 amino acids. Cipro ciprofloxacin hydrochloride tablets cipro ciprofloxacin oral suspension 08918468, r. Powder for reconstitution for use in central venous access. Remove the protective flipcaps from one vial of activase and one vial of swfi. Dailymed cathflo activase alteplase injection, powder. Learn more about tnkase tenecteplase administration, and tnkase dosing and reconstitution for acute myocardial infarction treatment. Alteplase%20use%20for%20occluded%20hemodialysis%20catheters. Jun 22, 2019 cathflo package insert pdf product monograph. In many cases, patients received concomitant angiotensinconverting enzyme inhibitors. Umhs inpatient acute ischemic stroke treatment guidelines. Alteplase is an enzyme that has the property of fibrinenhanced conversion of plasminogen. Reconstitute retavase only with the supplied sterile water for injection. Drug precipitates in the catheter may occur in conjunction with thrombus.
May administer eptifibatide injection in the same intravenous line as alteplase, atropine, dobutamine, heparin, lidocaine, meperidine, metoprolol, midazolam, morphine, nitroglycerin, or verapamil. Cathflo alteplase dosing and administration flashcard. Recommended total dose for ami is based activase package insert patient weight, not to exceed mg, regardless of the selected administration regimen accelerated activase package insert 3 hr. Frequently asked questions about activase alteplase in. Begin by assembling the 50mg vial of activase, the vial of swfi usp, included with the activase package, a 50ml syringe, a largebore needle eg, 18gauge, and alcohol wipes. Activase therapy in patients with acute myocardial infarction or pulmonary embolism is contraindicated in the following situations because of an increased risk of bleeding.
Actilyse powder and solvent for solution for injection and infusion. Please see full prescribing information for additional important safety information. Alteplase rtpaactivase dosage administration allina health. Place the diluent vial upright on an even surface, hold the vial tightly, and pick up the mix2vial in its clear outer packaging. No consistent adverse fetal effects were observed in mice, rats, rabbits, dogs and monkeys at doses of 50 mg. Open the package containing the transfer device by peeling the paper label off the package 4. Compatibilitystability reconstituted vials are stable up to 24 hours at room temperature and in fridge. Highlights of prescribing information acute ischemic stroke.
Mar 29, 2016 reconstitute activase immediately before administration, using aseptic technique at all times. Acetylcysteine solution, usp description acetylcysteine is the nonproprietary name for the nacetyl derivative of the naturally occurring. Do not administer eptifibatide injection through the same intravenous line as furosemide. Compatibilitystability reconstituted vials are stable up to 24. Dec 24, 2019 assent2 was an international, randomized, doubleblind trial that compared 30day mortality rates in 16,949 patients assigned to receive an iv bolus dose of tnkase or an accelerated infusion of activase alteplase. Alteplase tpathrombolysis for acute stroke dosing chart. Monitor patients treated with activase during and for several hours after infusion for hypersensitivity. Mucomist respirator solution, acetylcysteine usp 200 mg ml solution for inhalation not for injection description mucomist respirator solution is a derivative of the amino acid, cysteine. Novaplus primacor milrinone lactate injection 200 mcgml in 5% dextrose injection description primacor, brand of milrinone lactate injection, is a member of a class of bipyridine. Dobutamine was compatible at concentrations up to 4 mgml but incompatible at.
Jan 02, 2021 cathflo package insert pdf product monograph. Activase rtpa alteplase for injection should not be administered to patients with known hypersensitivity to the active substance alteplase or to any ingredient in the formulation or components of the container. Remove one of the protective caps from the transfer device and insert the piercing. After intravenous administration in these same patients, the mean elimination halflife was 9. Insert the syringe needle into the vial through the dosage in adult kidney transplant recipients nulojix should be administered in combination with basiliximab induction, mycophenolate mofetil mmf, and corticosteroids. Reconstitute 100 mg vial with 100 ml sterile water provided, see package insert for detailed. Activase package insert pdf learn about activase alteplase treatment for acute ischemic stroke ais. Available as alteplase 50 and 100 mg vial, plus 50 or 100 ml sterile water for injection for reconstitution. Cathflo activase alteplase dosing and administration cathflo 2 mg is the standard of care for treatment of thrombotically occluded catheters please see indication and important safety information on reverse side. We did not include international guidelines or other international governmental restrictions on the use of alteplase because it.
Full prescribing information 1 indications and usage aggrenox is indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis. Alteplase is a tissue plasminogen activator approved for treating acute ischemic stroke ais, acute. Cathflo activase alteplase 2 cathflo activase 3 alteplase 4 powder for reconstitution for use in central venous access 5 devices 6 description 7 cathflo activase alteplase is a tissue plasminogen activator tpa 8 produced by recombinant dna technology. Alteplase is the only approved therapeutic agent for the treatment of ais acute ischemic stroke and is widely accepted as the standard of care for eligible patients 4. The package insert for activase alteplase, genen tech. We did not include international guidelines or other international governmental restrictions on the use of alteplase because it was beyond the scope of this document. Iron dextran has been shown to be teratogenic and embryocidal in mice, rats, rabbits, dogs, and monkeys when given in doses of about 3 times the maximum human dose. Activase alteplase is a tissue plasminogen activator produced by recombinant dna technology. Alteplase is administered first as a bolus over one minute, followed by an infusion of the remaining dose over 60 minutes. Please see accompanying full prescribing information for additional important safety information. While holding the diluent vial securely, push the blue end of the mix2vial vertically. Alteplase, given intravenously iv, binds to fibrin in a thrombus and converts. Please see full prescribing information on each of our product pages for fdaapproved indications and dosage.
The benefits of thrombolytic therapy vs placebo were sustained at 1 year. The only fixeddose fibrinolytic for acute stemino dosing calculations needed 1. Angioedema has been observed during and up to 2 hours after activase infusion in patients treated for acute ischemic stroke and acute myocardial infarction. Jun 22, 2020 cathflo package insert pdf product monograph. Activase fda prescribing information, side effects and uses. Each reconstituted vial will deliver 2 mg of cathflo activase, at a ph of approximately 7. Alteplase tpa, a recombinant analogue of human tissue plasminogen activator. Mucomist respirator solution acetylcysteine usp 200 mg.
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