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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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. The comparative efficacy of these two regimens has not been evaluated.

In this study, depending upon the scale, the favorable outcome of minimal or no disability occurred in at least 11 per more patients treated with Activase than those receiving placebo. There are two Activase dose regimens accelerated and 3-hour for use in the management of AMI; there are no controlled studies to compare clinical outcomes with these regimens [see Clinical Studies ].

Activase has not been shown to treat adequately underlying deep vein thrombosis in patients with PE. Many drugs are excreted in human milk.

Cerebral edema, cerebral herniation, seizure, new ischemic stroke.

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

Peel the clear plastic hanger from the vial label. Discard any apckage solution after administration is complete. There are no adequate and well-controlled studies in pregnant women.

Pulmonary Embolism Activase is indicated for the lysis of acute massive pulmonary embolismdefined as: Allergic Reactions Allergic-type reactions, e. Both studies enrolled patients with measurable neurological deficit who could complete screening and begin study treatment within 3 hours from symptom onset.

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Asymptomatic intracranial hemorrhage was defined as intracranial hemorrhage detected on a routine repeat CT scan without preceding clinical worsening. Because of the higher risk of intracranial hemorrhage in patients treated for acute ischemic stroke, limit inser to facilities that can provide timely access to appropriate evaluation and management of intracranial hemorrhage.

Acute Myocardial Infarction Arrhythmias, AV block, cardiogenic shock, heart failure, cardiac arrest, recurrent ischemia, myocardial reinfarction, myocardial rupture, electromechanical dissociation, pericardial effusion, xctivase, mitral regurgitation, cardiac tamponade, thromboembolism, pulmonary edema.

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. For acute massive pulmonary embolism, bleeding events were consistent with the general safety profile observed with Activase treatment of AMI patients receiving the 3-hour infusion regimen.

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

Insegt not add any other medication to infusion solutions containing Activase. To minimize bleeding from noncompressible sites, avoid internal jugular and subclavian venous punctures.

Cholesterol embolism has been reported rarely in patients treated with thrombolytic agents; the true incidence is unknown.

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: Alteplase in acute myocardial infarction AMI patients is rapidly cleared from the plasma with an initial half-life of less than 5 minutes. Because these reactions are reported atcivase from a population of uncertain size, it is not always possible to onsert estimate their frequency or establish a causal relationship to drug exposure.

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Click “OK” if you are a healthcare professional. Activase is supplied as a sterile, lyophilized powder in 50 mg vials containing vacuum and in mg vials without vacuum. Hypersensitivity Hypersensitivity, including urticaria, angioedema and anaphylaxis, has been reported in association with use of Cathflo Activase.

The New Alteplase (tPA) Package Insert: What Is the Potential Impact? (P) | Neurology

Monitor patients treated with Activase during and for several hours after infusion for orolingual angioedema. Web page addresses and e-mail addresses turn into links automatically. Contraindications Cathflo Activase should not be administered to patients with known hypersensitivity to alteplase or any component of the formulation.

If the mg vial is used, the needle should be inserted away from the puncture mark made by the transfer device. Last reviewed on RxList: I, the first and corresponding author, verify my disclosures and those of my co-authors are up to date at http: Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.

Activaze is for intravenous administration only. Pediatric Use Safety and effectiveness of Activase in pediatric patients have not been established.

Monitor patients treated with Cathflo Activase for signs of hypersensitivity and treat appropriately if necessary. Activase can cause significant, acgivase fatal, internal or external bleeding, especially at arterial and venous puncture sites.