| Step 2 |
Aseptically WITHDRAW 10 mL of Sterile Water for Injection, USP, using the B-D 10 mL syringe with TwinPakTM Dual Cannula Device included in the kit. Do not use Bacteriostatic Water for Injection, USP.
 |
| Step 3 |
INJECT entire contents (10 mL) into the TNKase vial, directing the diluent into the powder.
Slight foaming upon reconstitution is not unusual; any large bubbles will
dissipate if the product is allowed to stand undisturbed for several minutes.
 |
| Step 4 |
GENTLY SWIRL until contents are completely dissolved.
DO NOT SHAKE. Solution should be colorless or pale yellow and transparent. Once the appropriate dose of TNKase is drawn into the syringe, stand the shield vertically and recap the red tab cannula.
|
| Step 5 |
USE UPON RECONSTITUTION. If not used immediately, refrigerate solution at 2–8°C (36–46°F) and use within 8 hours. DO NOT FREEZE. Final concentration of TNKase is 5 mg/mL. |
Click here to view entire Reconstitution Animation. |
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.
Safety Information: TNKase therapy is contraindicated in the following conditions due to an increased risk of bleeding: active internal bleeding, history of cerebrovascular accident, intracranial or intraspinal surgery or trauma within 2 months, intracranial neoplasm, arteriovenous malformation, or aneurysm, known bleeding diathesis, and severe uncontrolled hypertension.
All thrombolytic agents increase the risk of bleeding, including intracranial bleeding, and should be used only in eligible patients. In addition, thrombolytic therapy increases the risk of stroke, including hemorrhagic stroke, particularly in elderly patients. In patients with large ST segment elevation myocardial infarction, physicians should choose either thrombolysis or percutaneous coronary intervention (PCI) as the primary treatment strategy for reperfusion. Rescue PCI or subsequent elective PCI may be performed after administration of thrombolytic therapies if medically appropriate.
|
