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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Select only one of the three options below: Genentech will not contact the individuals you share packqge with. It is associated with invasive vascular procedures e. April 05, ; 86 16 Supplement April 17, Activase is a sterile, white to off-white, lyophilized powder for intravenous administration after reconstitution with Sterile Water for Injection, USP. Lines and paragraphs break automatically. Hypersensitivity, including urticaria, angioedema and anaphylaxis, has been reported in association with use of Cathflo Activase.

Pulmonary Embolism Pulmonary reembolization, pulmonary edema, pleural effusion, thromboembolism, hypotension. If angioedema develops, discontinue the Activase infusion and promptly institute appropriate therapy e. Long-term studies in animals have not been performed to evaluate the carcinogenic potential or the effect on fertility.

A dose-finding study of Activase suggested that doses greater than 0. A cranial computerized tomography CT scan was performed prior to treatment to rule ibsert the presence of intracranial hemorrhage. Reconstitute using aseptic technique.

Avoid intramuscular injections and trauma to the patient while on Activase. Remove the protective cap from the other end of the transfer device.

Perform venipunctures carefully and only as required. Administration of anticoagulants and antiplatelet agents was prohibited for the first 24 hours following symptom onset. Consider the possible risk of reembolization due to inserg lysis of underlying deep venous thrombi in this setting. Infections Cathflo Activase should be used with caution in the presence of known or suspected infection in the catheter.

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It is synthesized using the complementary DNA cDNA for natural human tissue-type plasminogen activator obtained from a human melanoma cell line. Find Lowest Prices on. Aspirin and heparin have been administered concomitantly with and following infusions of Activase in the management of acute myocardial infarction and pulmonary embolism, but the concomitant administration of heparin and aspirin with and following infusions of Activase for the treatment of acute ischemic stroke during innsert first 24 hours after symptom onset has not been investigated.

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: All contributors’ disclosures must be entered and current in our database before comments can be posted.

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

Alert Me Alert me when this article is cited Alert me if a correction is posted Alert me when eletters are published. These data indicate a significant increase in intracranial hemorrhage following Activase treatment, particularly symptomatic intracranial hemorrhage within aftivase hours.

Cathflo Activase should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Subgroup analysis of patients by age, infarct location, time from symptom onset to thrombolytic activasw, and treatment in the U.

When introduced into the systemic circulation at pharmacologic concentration, alteplase binds to fibrin in a thrombus and converts the entrapped plasminogen to plasmin. Extravasation of Activase infusion can cause ecchymosis or inflammation. Discard any unused solution after administration is complete. A favorable outcome was defined as minimal inert no disability using four stroke assessment scales: A dose of mg or greater should not be used in the treatment of Pqckage because it has been associated with an increase in intracranial bleeding.

Nursing Mothers It is not known whether Activase is excreted in human milk.

Gropen has nothing to disclose. Such force could cause rupture of the catheter or expulsion of the clot into the circulation. National guidelines need updating to reflect these changes. Efficacy results suggest a reduced but still favorable clinical outcome for Activase-treated elderly [see Clinical Studies ]. There was no increase in the incidences of day mortality or severe disability in Activasetreated patients compared to placebo.

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

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.

Insert the spike end of an infusion set through the same puncture site created by the transfer device in the stopper of the vial of reconstituted Activase.

Accelerated infusion of Activase was studied in an international, multi-center trial that randomized 41, patients with AMI to four thrombolytic regimens Study 3. Using Cathflo Activase in patients with infected catheters may release a localized infection into the systemic circulation. Many drugs are excreted in human milk. Post-Marketing Experience The following adverse reactions have been identified during post-approval use of Activase. There are no adequate and well-controlled studies in pregnant women.

The following adverse reactions have been identified during post-approval use of Activase. Some received IV heparin on arrival to the emergency room prior to enrollment and pacmage. Certain causes of catheter dysfunction should be considered before insery with Cathflo Activase e. The incidence of combined day mortality or nonfatal stroke was The annual number of discharges with primary diagnosis of ischemic stroke in the U.

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.