ACTIVASE PACKAGE INSERT PDF

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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It is not known whether Activase is excreted in human milk. In the post-marketing setting, there have been reports of orolingual angioedema in patients primarily patients with AIS receiving concomitant angiotensin-converting enzyme inhibitors. Get useful tools to help you ensure and promote patency in your clinical practice.

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

Preparation Of Bolus Dose Prepare the bolus dose in one of the following ways: Pulmonary Embolism Activase is indicated for the lysis of acute massive pulmonary embolismdefined as: Long-term studies in animals have not been performed to evaluate the carcinogenic potential or the effect on fertility.

It is a sterile, purified glycoprotein of amino acids. Activaee 05, ; 86 16 Supplement April 17, Fatal cases of hemorrhage associated with traumatic intubation in patients administered Activase have been reported.

Acute Ischemic Stroke Cerebral edema, cerebral herniation, seizure, new ischemic stroke. Some received IV heparin on arrival cativase the emergency room prior to enrollment and randomization. Pregnancy There are no adequate and well-controlled studies in pregnant women. General Certain causes of catheter dysfunction should be considered before treatment with Cathflo Activase e.

Monitor patients treated with Activase during and for several hours after infusion for orolingual angioedema. Related Articles No related articles found. Aactivase a prespecified subgroup analysis of patients receiving aspirin prior to onset of stroke symptoms, the insfrt outcome for Activase-treated patients was preserved.

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

Lyerly has nothing to disclose. Limitation Of Use The risk of stroke may outweigh the benefit produced by activsse therapy in patients whose AMI puts them at low risk for death or heart failure. Remove the appropriate volume from a port second injection site on the infusion line after the infusion set is primed.

To minimize bleeding from noncompressible sites, avoid internal jugular and subclavian venous punctures. Last reviewed on RxList: Heparin SQ 12, U was administered 4 hours after initiation of SK therapy, followed by 12, U twice daily for 7 days or until dischargewhichever came first.

Open the package containing the transfer device innsert peeling the paper label off the package. The results comparing Activase- and placebo-treated patients for the four outcome scales together Generalized Estimating Equations and individually are presented in Table 7.

If serious bleeding occurs, terminate the Activase infusion. The following adverse reactions have been identified during post-approval use of Activase. Recently, a history of intracranial hemorrhage ICH and recent stroke within 3 months were removed as contraindications from the drug package insert, potentially increasing the number of patients eligible for tPA.

Infections Cathflo Activase should be used with caution in the presence of known or suspected infection in the catheter. Coagulation Tests May Be Unreliable During Activase Therapy Coagulation tests and measures of fibrinolytic activity may be unreliable during Activase therapy, unless specific precautions are taken to prevent in vitro artifacts.

Biological potency is determined by an in vitro clot lysis assay and is expressed in International Units IU. In this study, depending upon the scale, the favorable outcome of minimal or no inserf occurred in at least 11 per more patients treated with Activase than those receiving placebo.

Swirl gently to dissolve the Activase powder.

Advise patients to contact a health-care professional if they experience symptoms or signs consistent with bleeding e. There are no adequate and imsert studies in pregnant women. Short-term studies, which evaluated tumorigenicity of Activase and effect on tumor metastases in rodents, were negative.

The information contained in this section of the site is intended for U. 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 ]. Click “OK” if you are a healthcare professional. A favorable outcome was defined as minimal or no disability using four stroke assessment scales: The incidence of combined day mortality or nonfatal stroke for the Activase actovase infusion was 1.

Pharmacokinetics Alteplase in acute myocardial infarction AMI patients is rapidly cleared from the plasma with an initial half-life of less than 5 minutes. 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. Submit only on articles published within the last 8 weeks. All contributors’ disclosures must be entered and current in our database before comments can be posted.

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.

There is no difference in the dominant initial plasma half-life between the 3-hour and accelerated regimens for AMI. Efficacy results suggest a reduced but still favorable clinical outcome for Activase-treated elderly [see Clinical Studies ]. A prespecified secondary analysis suggested improved 3-month outcome associated with Activase inseft using the following stroke assessment scales: The following adverse reactions are discussed in greater detail in the other sections of the label:.

Discard any unused solution after administration is complete. The interaction of Cathflo Activase with other drugs has not been formally studied. Perform venipunctures carefully and only as required.