"The U.S. Food and Drug Administration today approved the Impella 2.5 System, a miniature blood pump system intended to help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary interventio"...
DOSAGE AND ADMINISTRATION
TNKase® (Tenecteplase) is for intravenous administration only. The recommended total dose should not exceed 50 mg and is based upon patient weight.
A single bolus dose should be administered over 5 seconds based on patient weight.Treatment should be initiated as soon as possible after the onset of AMI symptoms (see Clinical Studies).
Dose Information Table
|Patient Weight (kg)||TNKase (mg)||Volume TNKase* to be administered (mL)|
|≥ 60 to <70||35||7|
|≥ 70 to <80||40||8|
|≥ 80 to <90||45||9|
|*From one vial of TNKase reconstituted with 10 mL SWFI.|
THE 10 mL SYRINGE WITH TWINPAK™ DUAL CANNULA DEVICE
NOTE: Read all instructions completely before beginning reconstitution and administration.
- Remove the shield assembly from the supplied B-D® 10 mL syringe with
TwinPak™ Dual Cannula Device (see figure) and aseptically withdraw
10 mL of Sterile Water for Injection (SWFI), USP, from the supplied diluent
vial using the red hub cannula syringe filling device. Do not use Bacteriostatic
Water for Injection, USP.
Note: Do not discard the shield assembly.
- Inject the entire contents of the syringe (10 mL) into the TNKase (tenecteplase) vial directing the diluent stream 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.
- Gently swirl until contents are completely dissolved. DO NOT SHAKE. The reconstituted preparation results in a colorless to pale yellow transparent solution containing TNKase (tenecteplase) at 5 mg/mL at a pH of approximately 7.3. The osmolality of this solution is approximately 290 mOsm/kg.
- Determine the appropriate dose of TNKase (tenecteplase) (see Dose Information Table) and withdraw this volume (in milliliters) from the reconstituted vial with the syringe. Any unused solution should be discarded.
- Once the appropriate dose of TNKase (tenecteplase) is drawn into the syringe, stand the shield vertically on a flat surface (with green side down) and passively recap the red hub cannula.
- Remove the entire shield assembly, including the red hub cannula, by twisting counterclockwise. Note: The shield assembly also contains the clear-ended blunt plastic cannula; retain for split septum IV access.
- The product should be visually inspected prior to administration for particulate matter and discoloration. TNKase (tenecteplase) may be administered as reconstituted at 5 mg/mL.
- Precipitation may occur when TNKase (tenecteplase) is administered in an IV line containing dextrose. Dextrose-containing lines should be flushed with a saline-containing solution prior to and following single bolus administration of TNKase (tenecteplase) .
- Reconstituted TNKase (tenecteplase) should be administered as a single IV bolus over 5 seconds.
- Because TNKase (tenecteplase) contains no antibacterial preservatives, it should be reconstituted immediately before use. If the reconstituted TNKase (tenecteplase) is not used immediately, refrigerate the TNKase (tenecteplase) vial at 2–8°C (36–46°F) and use within 8 hours.
- Although the supplied syringe is compatible with a conventional needle,
this syringe is designed to be used with needleless IV systems. From the information
below, follow the instructions applicable to the IV system in use.
Split septum IV system:
- Remove the green cap.
- Attach the clear-ended blunt plastic cannula to the syringe.
- Remove the shield and use the blunt plastic cannula to access the split septum injection port.
- Because the blunt plastic cannula has two side ports, air or fluid expelled through the cannula will exit in two sideways directions; direct away from face or mucous membranes.
Luer-Lok® system: Connect syringe directly to IV port.
Conventional needle (not supplied in this kit): Attach a large bore needle, e.g.,18 gauge, to the syringe's universal Luer-Lok®.
- Dispose of the syringe, cannula and shield per established procedures.
TNKase® (Tenecteplase) is supplied as a sterile, lyophilized powder in a 50 mg vial under partial vacuum. Each 50 mg vial of TNKase (tenecteplase) is packaged with one 10 mL vial of Sterile Water for Injection,USP for reconstitution,the B-D® 10 mL syringe with TwinPak™ Dual Cannula Device, and three alcohol prep pads.NDC 50242-038-61.
Stability and Storage
Store lyophilized TNKase (tenecteplase) at controlled room temperature not to exceed 30°C (86°F) or under refrigeration 2–8°C (36–46°F). Do not use beyond the expiration date stamped on the vial.
Manufactured by: Genentech, Inc. 1 DNA Way, South San Francisco, CA 94080-4990. Code revision January 2008. FDA approval June 2000. FDA Rev date: 6/2/2000This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/6/2008
Additional Tnkase Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options.