GLUture Topical Tissue Adhesive (Canada)

Description

GLUture topical tissue adhesive (60% 2-octyl and 40% N-butyl cyanoacrylate) contains a thickener and stabilisers. GLUture topical tissue adhesive is a purple formulation that has been demonstrated to be useful for skin closure in spays, neuters, and other soft tissue surgeries.

How Supplied

GLUture topical tissue adhesive (60% 2-octyl and 40% N-butyl cyanoacrylate) is supplied in individual packages, list number 32046-90-01, with each package containing:

● One 1.5 mL multi-use aluminium tube

● Self-piercing tip with purple cap

● Disposable pipette tips

● Package insert

STORAGE CONDITIONS:

Store GLUture topical tissue adhesive at room temperature (below 30°C, 86°F), away from moisture and direct heat.

GLUture Topical Tissue Adhesive Indications

GLUture topical tissue adhesive is indicated for Veterinary Use Only. GLUture topical tissue adhesive is indicated as a tissue bridge, provided that subcutaneous sutures are used (when appropriate), in the following procedures:

● Spays

● Neuters

● Incisions

● Tumor removals

● Lacerations

ADMINISTRATION:

1. The successful application of GLUture topical tissue adhesive requires proper preparation of the wound site. If antiseptic treatment is desired for the wound site, wash the area with a povidone or chlorhexidine gluconate (4%) solution. Do not use other topical ointments or salves as they may interfere with the formation of the GLUture topical tissue adhesive bandage.

2. Hold the tube in an upright position and screw on the self-piercing tip.

3. Remove purple cap and firmly push disposable pipette tip over the piercing tip.

4. AVOID PLACING THIS PRODUCT IN ANY SUBCUTANEOUS TISSUES. It metabolises very slowly, which could lead to the development of a foreign body reaction.

5. Topical Skin Closure

a. The normal surgical procedure should be followed with the exception of the skin-closing step. Subcutaneous tissue should be closed with absorbable suture, resulting in a tension-free wound. Incisions with high physical stress may require suturing.

b. Suture the subcutaneous tissue to approximate the skin edges as closely as possible minimising exposed subcutaneous tissue between skin edges. If gaps in the primary tissue closure are apparent, press the skin edges together with gloved fingers or sterile forceps while slowly applying the GLUture topical tissue adhesive. Remove as much blood as possible from the incision site by blotting.

c. Hold the pipette tip slightly above the incision line and gently squeeze the adhesive from the tube in a thin line to the surface of the approximated skin edges. The product will be clear when dry. DO NOT FILL THE WOUND CAVITY WITH THE PRODUCT.

d. The wound edges need to be manually apposed for approximately 1 minute or until adequate wound strength is achieved. Full polymerisation is expected when the top layer of GLUture topical tissue adhesive is no longer tacky.

6. DO NOT APPLY GLUture topical tissue adhesive OVER A POOL OF BLOOD OR FLUID. This will cause improper polymerisation and adherence to the skin, resulting in the premature sloughing of the GLUture topical tissue adhesive.

7. After use, wipe the tube with a non-cotton wipe prior to replacing cap.

Contraindications

GLUture topical tissue adhesive is contraindicated in the management of infected or deep puncture wounds. GLUture topical tissue adhesive is not intended to be used as a replacement for suture material that would normally be used subcutaneously (i.e. absorbable sutures).

PRECAUTIONS/WARNINGS:

● Placing this product in any subcutaneous tissues may lead to a foreign body reaction and potential wound separation.

● Avoid unintended placement on skin and eyes.

● Avoid contact with surgical instruments and apparatus (such as gloves).

● After use, remove disposable pipette tip and discard.

● Use a new disposable tip for each procedure.

● Before replacing the screw-top cap, wipe excess adhesive from the piercing tip with an absorbent lint-free wipe to prevent cap from sticking.

● The product should not be used beyond the indicated expiration date.

REMOVAL OF GLUture TOPICAL TISSUE ADHESIVE:

GLUture topical tissue adhesive can be removed from skin or other surfaces with acetone.

ACTION:

GLUture topical tissue adhesive is a 60% 2-octyl and 40% N-butyl cyanoacrylate formulation, which, upon contact with most bodily fluids or with an alkaline pH environment, polymerises to form a thin, flexible, waterproof bridge/bandage. When GLUture topical tissue adhesive is used along an approximated surgical incision, the initial contact of the product will rapidly polymerise at the tissue junction. The remaining material that forms the tissue bridge will polymerise at a slower rate. The formation of the tissue bridge holds the approximated wound edges together.

Tissue regeneration and wound healing occurs under the GLUture topical tissue adhesive layer and is sloughed naturally as the incision heals.

For technical service and customer support, please call Zoetis.

Manufactured for:

Zoetis Canada, Inc.

Kirkland QC H9H 4M7

Phone: 1-800-461-0917

44770002 Rev2 V11202015

CPN: 1198498.1