ACTIVASE PACKAGE INSERT PDF

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Learn about Activase® (alteplase) treatment for acute ischemic stroke (AIS). See full safety for more information. Indications Activase (alteplase) is indicated for. Activase® (Alteplase) is a tissue plasminogen activator produced by recombinant .. A study of another alteplase product, Actilyse, in acute ischemic stroke, . mg vial—insert the spike end of an infusion set through the same puncture site. 5 Apr Abstract. Objective: Define the potential impact on outcomes and health care costs in a newly tPA eligible population. Background: Alteplase.

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Bleeding events other than intracranial hemorrhage were noted in the studies of AIS and were consistent with the general safety profile of Activase.

The interaction of Cathflo Activase with other drugs has not been formally studied. Following Activase administration, patients are at increased risk of bleeding internally or externally. In these patients, the incidence of stroke was 4.

In Studies 1 and 2, the frequency of bleeding requiring red blood cell transfusions was 6. Sands has received research support from Biogen.

The interaction of Activase with other cardioactive or cerebroactive drugs has not been studied. The information contained in this section of the site is intended for U.

Read any comments already posted on the article prior to submission. In the following conditions, the risks of bleeding with Activase therapy for all approved indications are increased and should be weighed against the anticipated benefits: If extravasation occurs, terminate the infusion at that IV site and apply local therapy.

Protect the lyophilized material during extended storage from excessive exposure to light. Initiate treatment as soon as possible but within 3 hours after symptom onset. If serious bleeding occurs, terminate the Activase infusion. Peel the clear plastic hanger from the vial label. Preparation Of Bolus Dose Prepare the bolus dose in one of the following ways: You May Also be Interested in.

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Pulmonary Embolism Activase is indicated for the lysis of acute massive pulmonary embolismdefined as: Acute Ischemic Stroke Cerebral edema, cerebral herniation, seizure, new ischemic stroke.

Rapid online correspondence No comments have been published for this article. What Is the Potential Impact? Post-Marketing Experience The following adverse reactions have been identified during post-approval use of Activase. Submit the form below to share this with a friend or colleague. Hang the Activase vial from the resulting loop.

Activase® (alteplase) | Treatment for Acute Ischemic Stroke (AIS)

Lines and paragraphs break automatically. Click “OK” if you are a healthcare professional. Some received IV heparin achivase arrival to the emergency room prior to enrollment and randomization. Cathflo Activase has not been studied in patients known to be at risk for bleeding events that may be associated with the use of thrombolytics.

Take the Heart Disease Quiz! Administration of anticoagulants and antiplatelet agents was prohibited for the first 24 hours following symptom onset. Pediatric Use Safety and effectiveness of Activase in pediatric patients have not been established. More information about text formats. If an arterial puncture is necessary during Activase infusion, use an upper extremity vessel that is accessible to manual compressionapply pressure for at least 30 minutes, and monitor the puncture site closely.

Acrivase initiates local fibrinolysis with limited avtivase proteolysis.

These results were consistent with the 3-month outcome treatment effects observed in Study 1. Discard any unused solution after administration is complete. Genentech does not recommend and does not endorse the content on any third-party websites. Coagulation tests and measures of fibrinolytic activity may be unreliable during Activase therapy, unless specific precautions are taken to prevent in vitro artifacts.

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It is a sterile, purified glycoprotein insrt amino acids. Cytotoxicity, as reflected by a decrease in mitotic index, was evidenced only after prolonged exposure and only at the highest concentrations tested. Because heparin, aspirin, or Activase may cause bleeding complications, carefully monitor for bleeding, especially at adtivase puncture sites.

Because these reactions are reported voluntarily from a population of uncertain size, paclage is not always possible to reliably estimate their frequency or inseft a pxckage relationship to drug exposure.

Alteplase in acute myocardial infarction AMI patients is rapidly cleared from the plasma with an initial half-life of less than 5 minutes. Bleeding Acute Ischemic Stroke AIS In clinical studies in patients with AIS Studies 1 and 2 the incidence of intracranial hemorrhageespecially symptomatic intracranial hemorrhage, was higher in Activase-treated patients than in placebo patients.

Activase is a tissue plasminogen activator produced by recombinant DNA technology. A dose of mg or greater should not be used in the treatment of AMI because it has been associated with an increase in intracranial bleeding.

The incidence of day mortality for Activase accelerated infusion was 1. Slight foaming is not unusual; let stand undisturbed for several minutes to allow large bubbles to dissipate.

The New Alteplase (tPA) Package Insert: What Is the Potential Impact? (P2.296)

These events may be life threatening and may lead to death. Hypersensitivity, including urticaria, angioedema and anaphylaxis, has been reported in association with use of Cathflo Activase. The recommended dose is 0. To minimize bleeding ppackage noncompressible sites, avoid internal jugular and subclavian venous punctures.