Cathflo® Activase® (alteplase) Preparation and Dosing

Reconstitute Cathflo immediately before use

Review these general guidelines for preparing and dosing Cathflo 8

Cathflo is available for reconstitution in a single-use 2-mg vial. 8

After WASHING hands using aseptic technique, reconstitute Cathflo to a final concentration of 2 mg/2 mL:

 

1. Aseptically WITHDRAW 2.2 mL of Sterile Water for Injection, USP (diluent is not provided). Do not use Bacteriostatic Water for Injection, USP.

 

 

2. 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.

 

 

3. 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 at a pH of approximately 7.3.

 

 

FDA-approved dosing with Cathflo 8

If catheter function is not restored at 120 minutes after 1 dose of Cathflo, a second dose may be instilled (see Instructions for Administration). There is no efficacy or safety information on dosing in excess of 2 mg per dose for this indication. Studies have only evaluated up to two 2-mg doses.

No other medication should be added to solutions containing Cathflo.

Lyophilized Cathflo should be stored at refrigerated temperatures (2°C-8°C/36°F-46°F). Cathflo should be reconstituted immediately before use. The solution may be used within 8 hours if stored at 2°C to 30°C (36°F-86°F).

CVAD=central venous access devices; INS=Infusion Nurses Society.

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The INS Infusion Therapy Standards of Practice state that the instillation of alteplase 2 mg (Cathflo Activase) is safe and effective in restoring catheter patency in patients. 2