Interfyl® Human Connective Tissue Matrix

• These recommendations are designed to serve only as general guidelines. They are not intended to supersede institutional protocols or professional clinical judgment concerning patient care.
• lnterfyl® should not be applied until excessive exudate or bleeding, acute swelling, and infection are controlled.
• Each syringe/vial of Interfyl® is intended for use on a single patient on one occasion. Discard any unused material remaining after each treatment as per institutional procedures.
• Always handle lnterfyl® using aseptic techniques. Inspect all packaging integrity. Do not use if package seal is broken or the container has been violated. Discard material if mishandling has caused possible damage or contamination.

APPLICATION GUIDE FLOWABLE
Note: The product is supplied in a double-pouch configuration; the inner pouch and its contents are sterile. Always handle Interfyl® using aseptic technique. Once opened, use within two hours. After proper preparation of the treatment area site:
• Open product package and remove inner pouch containing the syringes and accessories.
• Using aseptic technique, peel open the inner pouch and present the syringes and accessories onto the sterile field.

Interfyl® 40mg Flowable
Package Contains: 3mL product syringe with 40mg Interfyl® (dry); (1) 1-mL syringe; (1) syringe adapter with double female luer locks; (1) flexible 1.5 inch cannula
• Fill the empty 1mL syringe with 0.3mL-0.4mL sterile saline or other sterile non-viscous fluid. Remove the needle from the syringe and attach the provided double female luer lock connection. Set syringe aside.
• Note: 0.3mL-0.4mL of liquid will achieve a toothpaste-like consistency. Based on physician preference and/or clinical application, the consistency can be altered by adding more or less liquid.

Interfyl® 1.5mL Flowable
Package Contains: 3mL product syringe with 1.5mL Interfyl® (dry); (1) 3mL syringe; (1) syringe adapter with double female luer locks; (1) flexible 1.5 inch cannula
• Fill the empty 3mL syringe with 1.5mL sterile saline or other sterile non-viscous fluid. Remove the needle from the syringe and attach the provided double female luer lock connection. Set syringe aside.
• Note: 1.5mL of liquid will achieve a toothpaste-like consistency. Based on physician preference and/or clinical application, the consistency can be altered by adding more or less liquid.

Notes on MIXING (Aseptic Technique):
• Interfyl® product syringe: Do not remove the cap. Pull back on the plunger slightly to create space and hold. Tap the syringe until the product particles are loosened.
• Connect the two syringes with the luer lock:
• Holding the connected syringes vertically (with the syringe containing the sterile fluid on top), push down on the plunger to release sterile fluid into the Interfyl® product syringe.
• Holding the two connected syringes horizontally, push both plungers back and forth a minimum of 15 times to create a homogeneous mix.
• Can use 18 gauge needle if desired.

Interfyl® Particulate 50mg and 100mg*
Package contains one (1) product vial.
Note: The product is supplied in a double-pouch configuration; the inner pouch and its contents are sterile. Always handle Interfyl® using aseptic technique. Once opened, use within two hours. After proper preparation of the treatment area site:
• Open product package and remove inner pouch containing the product vial.
• Unscrew the cap to open the vial.

Notes on MIXING (Aseptic Technique):
• The product may be used ‘dry.’ Placement of the product can be achieved by either tapping/sprinkling the contents out directly from the vial or by utilizing a non-traumatic forceps to pick-up the particulate for placement to the desired area.
• Sterile saline or other sterile fluid may be added to the particulate for a wet application. To achieve a paste-like consistency, add 0.6mL sterile fluid for the 100mg vial, and 0.3mL sterile fluid for the 50mg vial.
• The consistency can be altered by adding more or less liquid. The resulting wet particulate may be placed as desired.
NOTE: NOT to be used as an injectable.