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Abbreviated instructions for reconstitution, dosage,
and administration |
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One 50 mg vial of sterile, lyophilized TNKase powder |
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Sterile, graduated, disposable B-D® 10 mL syringe with TwinPak™ Dual Cannula Device |
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10 mL vial of Sterile Water for Injection, USP |
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TNKase full prescribing information |
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3 alcohol prep pads |
Wastage Replacement Program: For information about our wastage replacement program, please contact your local Genentech representative or call Genentech Customer Service at 1-800-551-2231.
Indication:
For use in mortality reduction associated with acute myocardial
infarction (AMI). Treatment should be initiated as soon as possible
after the onset of AMI symptoms.
Important
Safety Information:
TNKase therapy in patients with acute myocardial infarction is
contraindicated in the following certain situations (eg, active internal
bleeding, history of cerebrovascular accident, known bleeding diathesis,
severe uncontrolled hypertension) because of an increased risk of
bleeding [See CONTRAINDICATIONS in full prescribing information].
The most common complication encountered during
TNKase therapy is bleeding. Should serious bleeding (not controlled by
local pressure) occur, any concomitant heparin or antiplatelet agents
should be discontinued immediately.
In certain conditions (eg, recent major surgery,
cerebrovascular disease, hypertension) the risk of TNKase therapy may be
increased and should be weighed against the anticipated benefits. [See
WARNINGS in full prescribing information].
Cholesterol embolism has been reported rarely in
patients treated with all types of thrombolytic agents; the true
incidence is unknown.
Coronary thrombolysis may result in arrhythmias
associated with reperfusion. It is recommended that anti-arrhythmic
therapy for bradycardia and/or ventricular irritability be available
when TNKase is administered.
Please see full prescribing information for
additional important safety information.
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