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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Bleeding events other than intracranial hemorrhage were noted in the studies of AIS and were consistent with the general safety profile of Activase. Because heparin, aspirin, or Activase may cause bleeding complications, carefully monitor for bleeding, especially pqckage arterial puncture sites.

These types of conditions should be considered before treatment with Cathflo Activase.

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

Demographics and tPA exclusions were recorded. Institute parenteral anticoagulation near the end of or acrivase following the Activase infusion when the partial thromboplastin time or thrombin time returns to twice normal pacckage less. Reconstitute using aseptic technique. Study results demonstrated consistent functional and neurological improvement within all four stroke scales as indicated by median scores. Cholesterol embolism has been reported rarely in patients treated with thrombolytic agents; the true incidence is unknown.

Enter and update disclosures at http: A dose-finding study of Activase suggested that doses greater than 0. If extravasation occurs, terminate the infusion at that IV site and apply local therapy. Cholesterol Embolization Cholesterol embolism has been reported rarely in patients treated with thrombolytic agents; the true incidence is unknown.

Pulmonary Embolism Activase is indicated for the lysis of acute massive pulmonary embolismdefined as: Two placebo-controlled, double-blind trials Studies 1 and 2 were conducted in patients with AIS.

Single-Use Vial Lytic Thrombolytic – Cathflo® Activase® (alteplase)

Hang the Activase vial from the resulting loop. Cytotoxicity, as reflected by a decrease in mitotic index, was evidenced only after prolonged exposure and only at the highest concentrations tested. Inspect parenteral drug products for particulate matter and discoloration prior to administration whenever solution and container packgae. Activase can cause significant, sometimes fatal, internal or external bleeding, especially at arterial and venous puncture sites.

Acute Myocardial Infarction Activase is indicated for use in acute myocardial infarction AMI for the reduction of mortality and reduction of the incidence of heart failure.

The risk of stroke may acitvase the benefit produced by thrombolytic therapy in patients whose AMI puts them at low risk for death or heart failure.

Among these patients, 11 excluded had history of ICH, 15 with recent strokes, and 1 both. Recent major surgery or procedure, e. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug actiavse be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Shiue has nothing acivase disclose. Allergic Reactions Allergic-type reactions, e. Arrhythmias, AV block, cardiogenic shock, heart failure, cardiac arrest, recurrent ischemia, myocardial reinfarction, myocardial rupture, electromechanical dissociation, pericardial effusion, pericarditis, mitral regurgitation, cardiac tamponade, thromboembolism, pulmonary edema.

If angioedema develops, discontinue the Activase infusion and promptly institute appropriate therapy e. Open the package containing the transfer device by peeling the paper label off the package.

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.

Insedt Mothers It is not known whether Activase is excreted in human milk. Last reviewed on RxList: Consider the possible risk of reembolization due to the lysis of underlying deep venous thrombi in this setting.

The following adverse reactions are discussed in greater detail in the other sections of the label:. General Certain causes of catheter dysfunction should be considered before treatment with Cathflo Activase e. All patients received mg chewable aspirin administered as soon as possible, followed by mg daily.

It is synthesized using the complementary DNA cDNA for natural human tissue-type actiavse activator obtained from a human melanoma cell line.

Patients with prior aspirin use were included. The information contained in this section of the site is intended for U. The results comparing Activase- and placebo-treated patients for the four outcome scales together Generalized Estimating Equations and individually are presented in Table 7.

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

The first author must also be the corresponding author of the comment. In exploratory, multivariate analyses of Studies 1 and 2, age greater than 77 years was one of several interrelated baseline characteristics associated with an increased risk of intracranial hemorrhage.

Recently, a history pacckage intracranial hemorrhage ICH and recent stroke within 3 months were removed as contraindications from acttivase drug package insert, potentially increasing the number of patients eligible for tPA. Avoid intramuscular injections and trauma to the patient while on Activase.

Advise patients to contact a health-care professional if they experience symptoms or signs consistent with bleeding e. Select only one of the three options below: Efficacy results suggest a reduced but still favorable clinical outcome for Activase-treated elderly [see Clinical Pwckage ].

Subgroup analysis of patients by age, infarct location, time from symptom actjvase to thrombolytic treatment, and treatment in the U. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites. Such force could cause rupture of the catheter or expulsion of the clot into the circulation. The incidence of day mortality for Activase accelerated infusion was 1.

There are no adequate and well-controlled studies in pregnant women. Extravasation of Activase infusion can cause ecchymosis or inflammation.

Accelerated infusion of Activase was studied in an international, multi-center trial that randomized 41, patients with AMI to four thrombolytic regimens Study 3. It is associated with invasive vascular procedures e. Adverse Reactions In clinical trials, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding, and venous thrombosis.

As with all catheterization procedures, care should be used to maintain aseptic technique.

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