The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.
Hylartil Vet. (Canada)This page contains information on Hylartil Vet. for veterinary use.
The information provided typically includes the following:
- Hylartil Vet. Indications
- Warnings and cautions for Hylartil Vet.
- Direction and dosage information for Hylartil Vet.
Hylartil Vet.This treatment applies to the following species:
sodium hyaluronate sterile solution
Veterinary Use Only
DESCRIPTION: Hylartil® Vet. sterile solution is a sterile, pyrogen-free solution of the sodium salt of hyaluronic acid extracted from rooster combs. Sodium hyaluronate is a high molecular weight (> 1X106) polymer made up of repeating disaccharide units linked by glycosidic bonds. Each mL of Hylartil Vet. sterile solution contains 10 mg of sodium hyaluronate as the medicinal ingredient, in a physiological sodium chloride-phosphate buffer with a pH of 7.0 - 7.5.
Hylartil Vet. Indications
For the treatment of non-infectious inflammatory joint dysfunction due to traumatic and degenerative arthritis in horses.
Dosage and AdministrationAdminister 20 mg of sodium hyaluronate (1 x 2 mL syringe of Hylartil Vet. sterile solution) intra-articularly into small and medium size joints (e.g. coffin, carpal, fetlock). For the treatment of larger joints (e.g. hock), the dosage may be increased to 40 mg of sodium hyaluronate (2 x 2 mL syringe of Hylartil Vet. sterile solution). The treatment may be repeated at weekly intervals for a total of three treatments. Administer under aseptic conditions. Sterile gloves should be worn when handling the glass syringe. Joint effusion should be removed prior to injection. When performing the injections, care should be taken not to scratch the cartilage surface, as this may result in diffuse swelling lasting for 24 to 48 hours. This transient swelling, however, will have no effect on the ultimate clinical result. For best results, the horse should be given two days stall rest before gradually being brought back into training.
Tear off the paper covering. Bend the plastic backwards at the central indentation so as to fully expose the white plastic cap. Dislodge syringe.
Press the vial completely into the holder so that the needle perforates the membrane.
Remove the plastic cap.
Screw the plastic cap into the blue plunger.
Connect the cannula and check for proper function.
FOR SINGLE USE ONLY
Clinical PharmacologySodium hyaluronate is a natural, physiological substance which occurs in the extracellular space in connective tissue in both animals and man and is chemically identical in different species. High concentrations (> 0.2 mg/mL) of hyaluronate are found in the synovial fluid, the vitreous of the eye and the umbilical cord. The injected hyaluronate is expected to have the same pharmacokinetic fate as normal endogenous hyaluronate, and will be eliminated within one week (Balazs 1982, Sakamoto et al. 1980). No toxic effects are expected from Hylartil Vet. sterile solution, because sodium hyaluronate is a normal component of connective tissue matrix, and it is applied therapeutically only to compartments where it constitutes a normal component, such as the joint cavity. The absence of toxic effects has also been shown in acute, subacute, and chronic toxicity studies, where no significant adverse reactions or sensitizations have been demonstrated in mice, rats, rabbits, dogs, monkeys and horses. In an acute toxicity study in horses (Stults & Smith 1976), Hylartil Vet. sterile solution was injected intra-articularly at dosages corresponding to five times the recommended dose per animal (200 mg total). In a subacute study (Stults et al. 1977), horses were injected intra-articularly with the recommended dose per joint (20 mg) at weekly intervals for nine weeks. The results of both investigations showed that Hylartil Vet. sterile solution does not cause any clinically significant hematologic or blood chemistry changes. In mice, the intravenous LD100 was found to be of the order of 50 mg/kg body weight (Campbell 1973). There is always a potential immunological risk with repeated parenteral administration of a biological material. However, Hylartil Vet. sterile solution appears to be free of immunogenic properties. As shown by Richter (1974) Hylartil Vet. sterile solution did not produce any antibodies after repeated administration, nor did intense stimulation of the immunization process, by coupling of protein to the hyaluronate and simultaneous administration of Freund’s adjuvant, give rise to antibodies. Thus, repeated administration of Hylartil Vet. sterile solution involves minimal risk of sensitization.
EFFICACY: Clinical studies with Thoroughbred and Standardbred race horses were undertaken by six investigators at four separate clinics. A total of 136 joints were injected with Hylartil Vet. sterile solution in these investigations. In one study (Asheim, A. and Lindblad, G., 1976) only horses which were conventional treatment failures were included and the overall improvement rate following Hylartil Vet. sterile solution treatment approached 90 percent. In the other studies, the improvement rate surpassed this figure. In still another study, (Grant, B. et al. 1977) electrogoniometry was used to objectively show that Hylartil Vet. sterile solution can improve the function of arthritic carpal and fetlock joints. Hylartil Vet. sterile solution brought about a return to symmetry with respect to timing and duration of various angular motions of the joints. In cases where Hylartil Vet. sterile solution was not able to achieve contralateral symmetry of the joint motion pattern, blocking of the joint with anesthetic also had no effect indicating that most probably mechanical damage was responsible for the joint dysfunction.
CAUTIONS: For intra-articular injection only. Must not be administered intravascularly.
WarningsThis drug is not to be administered to horses that are to be slaughtered for use in food.
Adverse ReactionsA slight transient inflammatory swelling has occasionally been observed during the first 24 hours after the injection.
StorageRefrigerate at 2 to 8°C. Do not freeze. Protect from light.
PRESENTATION: Available in single use 2 mL disposable sterile glass syringes.
References available on request.
Zoetis is a trademark and Hylartil is a registered trademark of Zoetis or its licensors, used under license by Zoetis Canada Inc.
Zoetis Canada Inc., Kirkland QC H9H 4M7
NAC No.: 1198287.5
16,740 TRANS-CANADA HIGHWAY, KIRKLAND, QC, H9H 4M7
|Technical Services Canada:||800-461-0917|
|Technical Services USA:||800-366-5288|
|Every effort has been made to ensure the accuracy of the Hylartil Vet. information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.|
Copyright © 2018 North American Compendiums. Updated: 2018-01-04