VETRIGEL

Description

INDICATIONS: VetriGel®  Wound Dressing is indicated for the management of wounds. The product provides moisture to the wound, physical protection and a barrier against microbial infection.

HOW SUPPLIED: VetriGel is a sterile Single use kit containing

1. Syringe with oxidized dextran solution
2. Syringe with cross linking agent and excipients
3. Luer Lock Connector

PRECAUTIONS: If there are obvious package defects do not  use the product, as sterility may be compromised. The product is supplied in a single-use kit. Once mixed, the product must be used or discarded. Thorough debridement of wounds is required prior to application of VetriGel.

DIRCTIONS FOR USE: Clean the wound. Avoid use of oil based cleansers. Connecting the syringes and making repeated reciprocations achieves mixing prior to application. As soon as the polymer solution contacts the powder in the second syringe the reaction begins, so it is important to mix and use promptly. During the first 60 seconds mixture will be in liquid form, after 90 seconds in gel form. Working time is about 2 minutes.

1.Peel open the product kit pouch.

2.Remove the protective caps from syringes.

3.Use the connector provided to couple the syringe which contains polymer solution with the syringe which contains excipients.

4.Perform 20 full reciprocation cycles.

5.Ensure that all the mixed materials are in one syringe. Detach the empty syringe and the connector.

6.Extrude directly onto the intended application site.

7.After application use a secondary dressing to secure the VetriGel.

COVERING/DRESSING CHANGE

Wounds and conditions vary. Inspect the wound periodically and change the dressing as required.

CAUTION: Concurrent use of antibiotics may accelerate the gelling time of this product, which may alter the safety or effectiveness of this product. The addition of antibiotics to VetriGel® has not been reviewed or approved by the FDA and Royer Biomedical does not promote such additions.

Laboratory testing has demonstrated:

• 250mg Amikacin Sulfate Powder
• 150mg Amikacin Sulfate Powder + 100mg Clindamycin HCl Powder
• 250mg Gentamicin Sulfate Powder
• 100mg Clindamycin HCl + 150mg GentamicinSulfate Powdereach accelerated gelling times by 40 –60 seconds, reducing working time to approximately 1 minute.

STORAGE: Store at room temperature away from light. Do not freeze or expose to temperatures over 30°C (90°F).

Discard any unused material.