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Animal NDC 17030-098-12 Nexha

Hyaluronate Sodium

Animal Product Information

Field Name Field Value
Animal NDC Code 17030-098-12
Proprietary Name Nexha What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Hyaluronate Sodium What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Vetoquinol Usa, Inc.
Product Type Prescription Animal Drug
Usage Information
    INDICATIONS: NexHA™ injectable solution is indicated in the treatment of joint dysfunction of the carpus or fetlock in horses due to non-infectious synovitis associated with equine osteoarthritis.
Active Ingredient(s)
  • Hyaluronate Sodium
Inactive Ingredient(s)
  • SODIUM CHLORIDE (451W47IQ8X)
  • SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (E1W4N241FO)
  • SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (5QWK665956)
  • SODIUM CHLORIDE (451W47IQ8X)
  • SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (E1W4N241FO)
  • SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (5QWK665956)
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200432 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Nexha Images

Nexha Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Injectable Solution 10 mg/mL
For Intravenous Use In Horses Only

4 mL

Manufactured for:
Vetoquinol USA, Inc.
4250 N. Sylvania Ave.
Ft. Worth, TX (USA) 76137
www.vetoquinolusa.com

Approved by FDA under ANADA # 200-432

Made in France

439313
11/2022
100409B

vetoquinol


Warnings And Precautions



CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.


Description



DESCRIPTION: NexHA™ injectable solution is a clear, colorless solution of low viscosity.

NexHA™ injectable solution is pyrogen free, sterile and does not contain a preservative. It is administered by intravenous injection. Hyaluronic acid, the conjugate acid of hyaluronate sodium, is extracted from the capsule of Streptococcus spp. and purified, resulting in a form which is essentially free of protein and nucleic acids. NexHA™ injectable solution is supplied in 4 mL (40 mg) vials. Each mL contains 10 mg hyaluronate sodium, 8.5 mg sodium chloride, 0.223 mg sodium phosphate dibasic acid and 0.04 mg sodium phosphate monobasic. The pH is adjusted to between 6.5 and 8.0 with sodium hydroxide or hydrochloric acid.


Clinical Pharmacology



CLINICAL PHARMACOLOGY: Hyaluronic acid is a naturally occurring substance present in connective tissue, skin, vitreous humor and the umbilical cord in all mammals. High concentrations of hyaluronic acid are also found in the synovial fluid. It also constitutes the major component of the capsule of certain microorganisms. The hyaluronic acid produced by bacteria is the same structure and configuration as that found in mammals.

The actual mechanism of action for hyaluronate sodium in the healing of degenerative joint disease is not completely understood. One major function appears to be the regulation of normal cellular constituents. This effect decreases the impact of exudation, enzyme release and subsequent degradation of joint integrity. Additionally, hyaluronate sodium exerts an anti-inflammatory action by inhibiting the movement of granulocytes and macrophages.1

Hyaluronate molecules are long chains which form a filter network interspersed with normal cellular fluids. It is widely accepted that injection directly into the joint pouch enhances the healing of inflamed synovium by restoring lubrication of the joint fluid. This further supplements the visco-elastic properties of normal joint fluid.


Veterinary Indications



INDICATIONS: NexHA™ injectable solution is indicated in the treatment of joint dysfunction of the carpus or fetlock in horses due to non-infectious synovitis associated with equine osteoarthritis.


Dosage & Administration



DOSAGE AND ADMINISTRATION: 4 mL (40 mg) injected intravenously. Treatment may be repeated at weekly intervals for a total of three treatments. Use aseptic technique and inject slowly into the jugular vein. Horses should be given stall rest after treatment before gradually resuming normal activity.

Discard any unused portion of the drug and the empty vial after opening.


Contraindications



CONTRAINDICATIONS: There are no known contraindications for the use of NexHA™ injectable solution in horses.


Warnings



WARNING: Do not use in horses intended for human consumption.


User Safety Warnings



HUMAN WARNINGS: Not for use in humans. Keep this and all other drugs out of reach of children.


General Precautions



ANIMAL SAFETY WARNING: Not for intra-articular use.


Precautions



PRECAUTIONS: Radiographic evaluation should be carried out in cases of acute lameness to ensure that the joint is free from serious fracture.

The safety of NexHA™ injectable solution has not been evaluated in breeding stallions or in breeding, pregnant or lactating mares.


Adverse Reactions



ADVERSE REACTIONS: No local or systemic side effects were observed in the clinical field studies using hyaluronate sodium injectable solution.


Other Safety Information



POST-APPROVAL EXPERIENCE: While all adverse reactions are not reported, the following adverse reactions are based on voluntary post-approval reporting for hyaluronate sodium injectable solution: Occasional depression, lethargy, and fever.

To report suspected adverse events, contact Vetoquinol USA, Inc. at 1-800-835-9496. For technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Vetoquinol USA, Inc. at 1-800-267-5707. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.


Pharmacodynamics



EFFECTIVENESS: Forty-six horses with lameness in either the carpal or fetlock joints were treated intravenously or intra-articularly with hyaluronate sodium injectable solution in a well controlled clinical field trial conducted at four locations. One, two or three injections were given based on clinical improvement. Overall clinical improvement was judged as excellent or good in 90% of the cases treated intravenously and 96% of those treated intra-articularly with hyaluronate sodium injectable solution.


Animal Pharmacology & Or Toxicology



ANIMAL SAFETY: Hyaluronate sodium injectable solution was administered to normal horses at one, three and five times the recommended intra-articular dosage of 20 mg and the intravenous dosage of 40 mg. Treatments were given once weekly for nine consecutive weeks (three times the maximum duration). No systemic clinical signs were observed nor were there any adverse effects upon hematology or clinical chemistry parameters. A transient, slight to mild post-injection swelling of the joint capsule occurred in some of the animals treated intra-articularly with hyaluronate sodium injectable solution as it did in the saline treated control horses. No gross or histological lesions were observed in the soft tissues or the surface areas of the treated joint.


Storage And Handling



STORAGE: Store below 25°C (77°F).


How Supplied



HOW SUPPLIED: NexHA™ injectable solution is supplied in cartons containing twelve × 4 mL (40 mg) vials.


References



REFERENCES: 1Swanstrom, O.G. 1978. Hyaluronate (hyaluronic acid) and its use, Proc. American Assoc. Equine Pract., 24th annual convention, pp. 345-348.


Principal Display Pane - 4 Ml Vial Label



NDC 17030-098-12

NexHA™
(hyaluronate sodium)

INJECTABLE SOLUTION
10 MG/ML

Approved by FDA under
ANADA # 200-432

vetoquinoL

4mL


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.