Important Drug Information:
Some vials of Cathflo® Activase® (alteplase) have been found to contain rubber-stopper particulate matter after reconstitution. This does not impact the efficacy of Cathflo Activase, as the drug itself has not been compromised. Filtration through a 5-micron filter needle is sufficient to remove any potential particulate matter; therefore, effective March 22, 2013, Cathflo Activase should be filtered with a 5-micron filter needle during withdrawal of the reconstituted solution to remove potential rubber-stopper particulate matter.
To use a filter needle with Cathflo Activase, you should follow these simple instructions:
- Follow all recommended steps for reconstitution of Cathflo Activase.
- Carefully inspect the reconstituted product prior to withdrawal for foreign matter and discoloration. Reconstituted product is a colorless to pale yellow transparent solution.
- Do not administer Cathflo Activase if particulate matter is discovered.
- After inspection for foreign matter and discoloration, filter the reconstituted solution using the following protocol:
- Attach a 5-micron filter needle to an appropriately sized syringe
- Withdraw 2 mL (2 mg) of solution from the reconstituted vial
- Remove the filter needle from the syringe
Cathflo Activase plays a key role in helping to restore function to catheters with thrombotic occlusions.1,2 Cathflo Activase is the only lytic FDA-approved for the restoration of function to central venous access devices.
Please see Instructions for Administration in the accompanying full Prescribing Information for a complete guide to preparation and instillation of Cathflo Activase.
You can also find more information about Cathflo Activase at www.cathflo.com.
