ClotIt Vet Hemostatic Powder

Company: Protégé Biomedical

Stops Bleeding Faster*

Sterile, all-natural, easy-to-use

Clotting Powder

For surgical procedures and minor-to-severe animal wounds

Instructions for Use

1. Open foil pouch.

2. Shake bottle well.

3. Apply powder freely with nozzle, covering entire wound. (To remove white cap, snap cap to one side. If top clogs during application, flick the clogged tip to dislodge the clog.)

4. Apply moderate pressure for 10 - 20 seconds (longer for severe wounds).

5. Repeat as needed.

6. If using in internal surgery, irrigate treated area to remove all ClotIt powder before closing surgical site. ClotIt powder can be left on external wounds, but should not be left internally.

Severe wounds may require multiple applications. Use caution when applying in direct contact with large vessels and seek veterinary care before closing wound site, as potential for arterial or venous occlusion may exist.

Description

ClotIt VET is a medical device designed for application to wound sites as a hemostat. ClotIt VET is an all-natural mineral based technology that incorporates hydrophilic particles that work to rapidly absorb plasma at the wound site. Its patent-pending technology rapidly initiates clotting and stops bleeding. This product does not contain any human or animal components. It is a sterilized white powder and is non-pyrogenic, non-cytotoxic, and biocompatible.

Action

ClotIt VET consists of hydrophilic molecules that enhances natural hemostasis by ionically attracting blood particles such as platelets, red blood cells, and blood proteins and activating factor XII of the coagulation cascade to greatly speed up the body’s own natural clotting process. The fine mineral particles of ClotIt VET form as part of the clot, creating a solid, absorbable plug at the wound site.

ClotIt Vet Hemostatic Powder Indications

ClotIt VET is indicated in external medical procedures (except ophthalmic) as an adjunctive hemostatic device to assist when control of venous or capillary bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.

Contraindications

● Do not inject ClotIt VET into blood vessels as potential for embolization and death may exist.

Warnings

● ClotIt VET is not intended as a substitute for meticulous surgical technique and proper application of ligatures or other conventional procedures for hemostasis.

● Once hemostasis is achieved, ClotIt VET should be removed from the site of application by irrigation and aspiration. Excess ClotIt VET may cause drying of surrounding tissue due to the absorption of fluids around the wound site.

● Wound site and surrounding tissue may darken after the use of ClotIt VET due to oxidation of hemoglobin resulting in the formation of met-hemoglobin, which is harmless.

USE CAUTION WHEN APPLYING IN DIRECT CONTACT WITH LARGE VESSELS AS POTENTIAL FOR ARTERIAL OR VENOUS OCCLUSION MAY EXIST.

● ClotIt VET should be used with caution in the presence of infection or in contaminated areas of the body. If signs of infection or abscess develop where ClotIt VET has been applied, additional treatment may be necessary in order to allow drainage.

● Safety and effectiveness in ophthalmic procedures have not been established.

● ClotIt VET should not be used for controlling post-partum bleeding or menorrhagia.

Precautions

● When using ClotIt VET to treat hemorrhaging in large vessels, ensure blood flow is restored prior to closing the wound site, as potential for arterial or venous occlusion may exist.

● ClotIt VET is supplied as a sterile product and cannot be re-sterilized. Unused, open containers of ClotIt VET should be discarded.

● When ClotIt VET is used in conjunction with autologous blood salvage circuits, carefully follow the instructions in the administration section regarding proper filtration and cell washing.

● ClotIt VET is not recommended for the primary treatment of coagulation disorders.

● No testing has been performed on the use of ClotIt VET on bone surfaces to which prosthetic materials are to be attached with adhesives and is therefore not recommended.

● In urological procedures, ClotIt VET should not be left in the renal pelvis or ureters to eliminate the potential foci for calculus formation.

Adverse Reactions That Have been Attributed To Other Hemostatic Agents

Note that ClotIt VET is a unique hemostatic agent consisting of natural minerals, and absorption rate has not been verified at this time. The following adverse events have been reported for other hemostatic agents and may apply to the use of ClotIt VET:

● Paralysis and nerve damage have been reported when hemostatic agents are used in or in proximity to foramina in bone, areas of boney confine, the spinal cord, and/with laminectomy, reports of paralysis have also been received in connection with other procedures.

● Compression of the brain and spinal cord resulting from the accumulation of sterile fluid has been observed.

www.clotitvet.com

* Stops bleeding faster than the leading competition.

Comparison data available upon request.

MADE IN U.S.A.

Manufactured by: Protégé Biomedical, LLC, 10909 Valley View Road, Eden Prairie, MN 55344

Patents pending.

STERILE R

PRO-013-January 2016

©2016 Protégé Biomedical, LLC. All Rights Reserved

CPN: 1838000.0