Healonid Yellow

Fluorescein Sodium:

• Description:
• ​clinical pharmacology
• ​contraindications:
• ​adverse reactions:
• ​dosage and administration:
• Storage:
• How supplied:
• Healonid Yellow (Fluorescein Sodium) reviews

DESCRIPTION:

Healonid Yellow (Fluorescein Sodium) Sodium and Proparacaine Hydrochloride Ophthalmic Solution, USP (Sterile) is a sterile ophthalmic solution combining the disclosing action of Healonid Yellow (Fluorescein Sodium) with the anesthetic action of Proparacaine Hydrochloride.

The active ingredient, Healonid Yellow (Fluorescein Sodium) Sodium, has the chemical name Spiro [isobenzofuran-1 (3H), 9'-[9H]xanthene]-3-one, 3',6' dihydroxy-,disodium salt. It is represented by the following structural formula:

The active ingredient, Proparacaine Hydrochloride, has the chemical name Benzoic acid, 3-amino-4-propoxy-, 2-[diethylamino]ethyl ester monohydrochloride. It is represented by the following structural formula:

EACH mL CONTAINS: ACTIVES: Healonid Yellow (Fluorescein Sodium) Sodium, USP, 0.25% [2.5 mg]. Proparacaine Hydrochloride, USP, 0.5% [5mg]; INACTIVES: Povidone, Boric Acid, Water for Injection, Sodium Hydroxide, or/and Hydrochloric Acid may be added to adjust pH.

PRESERVATIVE: Methylparaben 0.1%.

The structural formula for Healonid Yellow (Fluorescein Sodium) Sodium The structural formula for Proparacaine Hydrochloride

​CLINICAL PHARMACOLOGY

This product is the combination of a disclosing agent with a rapidly acting anesthetic of short duration.

For procedures requiring a disclosing agent in combination with an anesthetic agent such as tonometry, gonioscopy, removal of corneal foreign bodies and other short corneal or conjunctival procedures.

​CONTRAINDICATIONS:

Known hypersensitivity to any component of this product.

WARNINGS:

Avoid contamination - do not touch tip of sterile dropper used to dispense solution to any surface. Replace container closure immediately after using. Prolonged use of a topical ocular anesthetic is not recommended. It may product permanent corneal opacification with accompanying visual loss.

PRECAUTIONS:

This product should be used cautiously and sparingly in patients with known allergies, cardiac disease, or hyperthyroidism. The long-term toxicity is unknown; prolonged use may possibly delay wound healing. Although exceedingly rare with ophthalmic application of local anesthetics, it should be borne in mind that systemic toxicity manifested by central nervous system stimulation followed by depression may occur. Protection of the eye from irritating chemicals, foreign bodies and rubbing during the period of anesthesia is very important. Tonometers soaked in sterilizing or detergent solutions should be thoroughly rinsed with sterile distilled water prior to use. Patients should be advised to avoid touching the eye until the anesthesia has worn off.

​ADVERSE REACTIONS:

Occasional temporary stinging, burning, and conjunctival redness have been reported after use of ocular anesthetics, as well as a rare, severe, immediate-type, apparent hyper-allergic corneal reaction, with acute, intense and diffuse epithelial keratitis, a gray, ground glass appearance, sloughing of large areas of necrotic epithelium, corneal filaments and sometimes, iritis with descementitis. Allergic contact dermatitis with drying and fissuring of the fingertips has been reported.

To report SUSPECTED ADVERSE REACTIONS, contact Altaire Pharmaceuticals, Inc. at (631) 722-5988.

​DOSAGE AND ADMINISTRATION:

Usual Dosage: Removal of foreign bodies and sutures, and for tonometry, 1 to 2 drops (in single instillations) in each eye before operating.

Deep Ophthalmic Anesthesia: 1 drop in each eye every 5 to 10 minutes for 5-7 doses.

NOTE: The use of an eye patch is recommended.

STORAGE:

Store in refrigerator at 2°-8°C (36°-46°F). Can be stored at room temperature for up to 1 month.

HOW SUPPLIED:

Healonid Yellow (Fluorescein Sodium) Sodium and Proparacaine Hydrochloride Ophthalmic Solution, USP (Sterile) is supplied in a glass or plastic bottle with a controlled tip applicator in the following sizes:

5 mL fill (glass bottle) with dropper

DO NOT USE IS IMPRINTED SEAL ON CAP IS BROKEN OR MISSING.

KEEP OUT OF REACH OF CHILDREN

FOR OPHTHALMIC USE ONLY

Manufactured By:

Altaire Phamacueticals, Inc.

311 West Lane

Aquebogue, NY 119311

Tel: 631-722-5988

image description package insert image description

Hyaluronate Sodium:

• Caution:
• Description:
• Chemistry:
• Clinical pharmacology:
• Indications:
• Dosage and administration:
• Contraindications:
• Warning:
• Human warnings:
• Animal safety warning:
• Precautions:
• Adverse reactions:
• Post-approval experience:
• Effectiveness:
• Animal safety:
• Storage:
• How supplied:
• References:
• Healonid Yellow (Hyaluronate Sodium) reviews

CAUTION:

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

DESCRIPTION:

Healonid Yellow (Hyaluronate Sodium)^TM (hyaluronate sodium) injectable solution is a clear, colorless solution of low viscosity. Healonid Yellow (Hyaluronate Sodium)^TM injectable solution is pyrogen free, sterile and does not contain a preservative. It is administered by intravenous injection. Hyaluronic acid, the conjugate acid of Healonid Yellow (Hyaluronate Sodium) sodium, is extracted from the capsule of Streptococcus spp. and purified, resulting in a form which is essentially free of protein and nucleic acids. Healonid Yellow (Hyaluronate Sodium)^TM injectable solution is supplied in 4 mL (40 mg) vials.

Each mL contains 10 mg Healonid Yellow (Hyaluronate Sodium) sodium, 8.5 mg sodium chloride, 0.223 mg sodium phosphate dibasic and 0.04 mg sodium phosphate monobasic. The pH is adjusted to between 6.5 and 8.0 with sodium hydroxide or hydrochloric acid.

CHEMISTRY:

Hyaluronic acid, a glycosaminoglycan, can exist in the following forms depending upon the chemical environment in which it is found: as the acid, hyaluronic acid; as the sodium salt, sodium Healonid Yellow (Hyaluronate Sodium) (hyaluronate sodium); or as the Healonid Yellow (Hyaluronate Sodium) anion. These terms may be used interchangeably but in all cases, reference is made to the glycosaminoglycan composed of repeating subunits of D-glucuronic acid and N-acetyl-Dglucosamine linked together by glycosidic bonds. Since this product originates from a microbial source, there is no potential for contamination with dermatan or chondroitin sulfate or any other glycosaminoglycan.

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 Healonid Yellow (Hyaluronate Sodium) 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, Healonid Yellow (Hyaluronate Sodium) sodium exerts an anti-inflammatory action by inhibiting the movement of granulocytes and macrophages.¹

Healonid Yellow (Hyaluronate Sodium) 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.

INDICATIONS:

Healonid Yellow (Hyaluronate Sodium)^TM (hyaluronate sodium) 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 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:

There are no known contraindications for the use of Healonid Yellow (Hyaluronate Sodium)^TM (hyaluronate sodium) injectable solution in horses.

WARNING:

Do not use in horses intended for human consumption.

HUMAN WARNINGS:

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

ANIMAL SAFETY WARNING:

Not for intra-articular use.

PRECAUTIONS:

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

The safety of Healonid Yellow (Hyaluronate Sodium)^TM injectable solution has not been evaluated in breeding stallions or in breeding, pregnant or lactating mares.

ADVERSE REACTIONS:

No local or systemic side effects were observed in the clinical field studies using Healonid Yellow (Hyaluronate Sodium) sodium injectable solution.

POST-APPROVAL EXPERIENCE:

While all adverse reactions are not reported, the following adverse reactions are based on voluntary post-approval reporting for Healonid Yellow (Hyaluronate Sodium) sodium injectable solution: Occasional depression, lethargy, and fever.

For medical emergencies or to report adverse reactions, call 1-888-549-4503.

EFFECTIVENESS:

Forty-six horses with lameness in either the carpal or fetlock joints were treated intravenously or intra-articularly with Healonid Yellow (Hyaluronate Sodium) 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 Healonid Yellow (Hyaluronate Sodium) sodium injectable solution.

ANIMAL SAFETY:

Healonid Yellow (Hyaluronate Sodium) 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 Healonid Yellow (Hyaluronate Sodium) 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:

Store below 25°C (77°F).

HOW SUPPLIED:

Healonid Yellow (Hyaluronate Sodium)^TM injectable solution is supplied in cartons containing twelve x 4 mL (40 mg) vials.

REFERENCES:

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

For customer service or to obtain product information, including a Material Safety Data Sheet, call:1-706-549-4503. After hours, call 1-706-353-2442 or 1-706-714-7373.

February 2011

ANADA 200-432, Approved by FDA