DOSAGE AND ADMINISTRATION
Dosage
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 |
30 |
6 |
≥60 to <70 |
35 |
7 |
≥70 to <80 |
40 |
8 |
≥80 to <90 |
45 |
9 |
≥90 |
50 |
10 |
The safety and efficacy of TNKase have only been
investigated with concomitant administration of heparin and
aspirin as described in CLINICAL STUDIES.
THE
® 10 mL SYRINGE WITH
TWINPAK™ DUAL CANNULA DEVICE
Reconstitution
NOTE: Read all
instructions completely before beginning reconstitution and
administration.
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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 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 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 (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 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.
Administration
-
1.The product should be visually inspected prior to administration for particulate matter and discoloration. TNKase may be administered as reconstituted at 5 mg/mL.
-
2.Precipitation may occur when TNKase 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.
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3.Reconstituted TNKase should be administered as a single IV bolus over 5 seconds.
-
4.Because TNKase contains no antibacterial preservatives, it should be reconstituted immediately before use. If the reconstituted TNKase is not used immediately, refrigerate the TNKase vial at 2–8°C (36–46°F) and use within 8 hours.
-
5.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:
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- 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.
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Luer-Lok® system:
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Connect syringe directly to IV port. |
Conventional needle (not supplied in this kit):
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Attach a large bore needle, e.g., 18 gauge, to the syringe's universal Luer‑Lok®. |
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6.Dispose of the syringe, cannula and shield per established procedures.
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HOW SUPPLIED
TNKase® (Tenecteplase) is supplied as a sterile, lyophilized powder in a 50 mg vial under partial vacuum. Each 50 mg vial of TNKase 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 50242-120-01.
Stability and Storage
Store lyophilized TNKase 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.
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