Simple dosing and administration
To prepare the solution
Reconstitute Cathflo to a final concentration of 1 mg/mL.
- Aseptically WITHDRAW 2.2 mL of Sterile Water for Injection, USP (diluent is not provided). Do not use Bacteriostatic Water for Injection.
- INJECT the 2.2 mL of Sterile Water for Injection, USP, into the Cathflo vial, directing the diluent stream into the powder. Slight foaming is not unusual; let the vial stand undisturbed to allow large bubbles to dissipate.
- Mix by gently SWIRLING until the contents are completely dissolved. Complete dissolution should occur within 3 minutes. DO NOT SHAKE. The reconstituted preparation results in a colorless to pale yellow transparent solution containing
1 mg/mL Cathflo at a pH of approximately 7.3. - Cathflo contains no antibacterial preservatives and should be reconstituted immediately before use. The solution may be used for intracatheter instillation within 8 hours following reconstitution when stored at 2–30°C (36–86°F).
No other medication should be added to solutions containing Cathflo.
To instill the solution:
- INSPECT the product prior to administration for foreign matter and discoloration. Solution should be inspected immediately before use.
- WITHDRAW 2 mL (2 mg) of reconstituted solution from the vial.
- INSTILL the appropriate dose of Cathflo into the occluded catheter using a 10- to 12-cc syringe. Smaller syringes should not be used as they are associated with greater infusion pressures and may cause damage to the catheter or blood vessels.
- After 30 minutes of DWELL time, assess the catheter function by attempting to aspirate blood. If the catheter is functional, go to step 10; If not functional,
go to step 9. - ASSESS catheter function after 120 minutes of dwell time by attempting to aspirate blood. If catheter is functional, go to step 10. If catheter is still occluded, a second dose of equal amount may be instilled. Repeat steps 1 through 8.
- If catheter function has been restored, ASPIRATE 4 to 5 mL of blood in patients >10 kg or 3 mL in patients <10 kg to remove Cathflo and residual clot. Then gently irrigate the catheter with 0.9% Sodium Chloride, USP. Any unused solution should be discarded.
Indication
Cathflo Activase (Alteplase) is indicated for the restoration of function to central venous access devices (CVADs) as assessed by the ability to withdraw blood.
Safety Information
Cathflo Activase should not be administered to patients with known hypersensitivity to Alteplase or any component of the formulation.
In clinical trials, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding, and venous thrombosis.
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