Spryng for Equine

1.2 Storage

Spryng particles are recommended to be kept at approximately 40°-90°F. Use of Spryng particles is recommended within 26 months of the manufacture date on the package.

2. Intended Use and Indications for Use

Spryng particles for intra-articular injection are intended for cartilage reinforcement and/or augmentation. It is indicated to aid in the management of joint pain from loss of cartilage or tissue-bone mechanical malfunction caused by joint dysfunction not associated with infection (e.g., lameness, osteoarthritis, degenerative joint disease). Spryng matrices restore proper joint mechanics by adding natural, viscosolid matrices to the joint’s synovial fluid.

For use in horses to maintain and/or improve articulation.

3. Contraindications

Spryng is contraindicated in the following conditions:

● If there is an infection.

● If significant inflammation is present in the joint (i.e. swollen, tenderness, erythema).

Note: Spryng particles can be injected if there is no or mild inflammation in the joint or if the inflammation has been effectively treated with an anti-inflammatory agent. If inflammation exists, prior effective treatment with anti-inflammatory agents is recommended.

4. Warnings

Spryng particles must not be injected into blood vessels. Injection of Spryng particles into blood vessels can interfere with local circulation, resulting in vessel laceration, occlusion, infarction, embolic phenomena, and/or abscess at injection site.

Not for use in humans. Keep this device out of the reach of children.

5. Precautions

Using drugs that reduce coagulation (e.g., NSAIDs) may cause increased bruising or bleeding at the injection site. Injection should be performed only by a licensed veterinarian skilled in the delivery of intra-articular (IA) injections.

6. Directions for Use

Spryng material is sterilized and aseptically filled in syringes containing 2 cc of material. It is intended for single-use, intra-articular injection (Figure 1). Use clinical judgement pertaining to volume needed. Some joints may require more or less than 2 cc of material. The amount of Spryng particles injected should represent an appropriate volume as determined by the veterinarian.

Preparation for use

● The injection site should be thoroughly disinfected.

● Follow aseptic techniques.

● Animal restraint and sedation is recommended.

● The injection technique, location, amount of synovial fluid removal, depth of injection, needle type, and the administered quantity of Spryng, may vary based on veterinarian clinical judgment and the joint selected.

● Spryng particles should be administered using a sterile needle (e.g., 18-23G). The needle should be inserted based on the veterinarian’s assessment of the needle tip location.

● Settling of Spryng particles in the buffer solution during storage is normal; injection in the settled state will not impact its efficacy. Shaking to disperse particles may be performed.

● Inject Spryng particles by applying even pressure on the plunger rod.

● Route of administration is via intra-articular injection. Multiple joints may be injected as a part of the same treatment.

● Spryng is recommended for repeat administration depending on the veterinarian’s assessment, animal activity levels, and age of the animal. In case studies, Spryng particles provided beneficial effect for greater than one year.

● There is no maximum annual administration frequency.

● Each syringe is for a single use only. Do not use if the package is open or the syringe is damaged.

Disposal

The syringe and any unused material must be discarded after a single treatment visit. Follow national, local, or institutional guidelines for use and disposal of medical sharp devices.

7. Potential Adverse Reactions

Mild, short-term injection-site swelling has been observed. Adverse events should be reported to PetVivo at 844-PET-VIVO (738-8486) or info1@petvivo.com

MADE IN THE USA

Manufactured, marketed, and distributed by PetVivo, Inc., 5251 Edina Industrial Blvd., Minneapolis, MN 55439

844-PET-VIVO (738-8486)

www.petvivo.com

email: info1@petvivo.com

Spryng™ and OsteoCushion™ are trademarks of PetVivo Holdings, Inc.

This product is covered by U.S. Patent Nos. (US 8,153,591; US 9,107,937; US 9,999,705; US 10,850,006; CA 2,537,315; CA 2,583,561) and other pending applications and foreign patents. ©2022 PetVivo, Inc. All rights reserved.

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SEIFU-2-1122

Presentation: 5 mL syringe with 2 cc of product.

CPN: 2127001.0