HY-50 (SODIUM HYALURONATE STERILE INJECTION 17MG/ML)

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

Buy It Now

Active ingredient:
SODIUM HYALURONATE
Available from:
DECHRA LTD
INN (International Name):
sodium hyaluronate(17mg/mL)
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
SODIUM HYALURONATE UNGROUPED Active 17.0 mg/ml
Units in package:
1 x 3mL
Class:
VM - Veterinary Medicine
Therapeutic group:
HORSE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT STUD | MARE | PACER | POL
Therapeutic area:
MUSCULOSKELETAL SYSTEM
Therapeutic indications:
INFLAMMATORY JOINT DISEASE | NON-INFECTIOUS JOINT DISEASE
Product summary:
Poison schedule: 4; Withholding period: WHP:Not to be used in horses intended for human consumption.; Host/pest details: HORSE: [INFLAMMATORY JOINT DISEASE]; An aid to the management of non-infectious inflammatory joint diseases in horses only - for intra-articular administration.NOT TO BE USED in horses intended for human consumption
Authorization status:
Registered
Authorization number:
53840
Authorization date:
2020-07-01

For Official Use Only

e-Label Application (DRAFT)

Company Name:

DECHRA LTD

Product Name:

HY-50 (SODIUM HYALURONATE STERILE INJECTION 17MG/ML)

eLabel Application No:

DC12-6673502E134

APVMA Approval No:

53840-102807

Product No:

53840

Version No:

Application Started:

2015-May-06 00:29:49

Version Created:

2015-Nov-03 13:42:38

Started By:

Susan Scanlan

Printed:

2015-Nov-11 11:08:16

Label Name:

HY-50 (SODIUM HYALURONATE STERILE INJECTION 17MG/ML)

Signal Headings:

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Constituent

Statements:

17 mg/mL SODIUM HYALURONATE

Claims:

For intra-articular administration, is an aid in the management of non-infectious

inflammatory joint diseases in horses only.

Net Contents:

1 x 3mL

Directions for Use:

To be used by, or under the supervision of, a registered veterinary surgeon.

Restraints:

DO NOT USE in horses intended for human consumption.

Contraindications:

This product should not be administered to horses with a history of hypersensitivity to

sodium hyaluronate. This product should not be administered when joint sepsis and/or

fractures are present or suspected. In cases of severe acute lameness, radiographic

evaluation should be carried out prior to HY-50 treatment to ensure that the joints are free

from serious intra-articular fractures.

Precautions:

Effects on fertility and reproductive function in breeding mares and stallions have not been

evaluated.

Side Effects:

Transient, mild swelling and/or heat were observed in 2.7% of treated joints in an open

field trial. These self-limiting local signs resolve spontaneously within 48 hours, and do not

negate a successful therapeutic outcome.

RLP

APPROVED

For Official Use Only

Dosage and

Administration:

Dosage and Administration: Use the contents within 24 hours of first broaching the

vial. Discard the unused portion. The recommended dose of HY-50 is 50 mg (3 mL)

intra-articularly into medium sized and large joints. Smaller joints such as intertarsal,

tarsometatarsal and interphalangeal joints can be treated with a 2 mL dose. More than one

joint may be treated at the same time. Treatment may be repeated after one or more weeks

if necessary, but not to exceed four consecutive weekly injections in the same joint.

HY-50 should be administered using strict aseptic technique. The site should be surgically

prepared to ensure removal of all dirt, hair, topical medicaments, and soapy residues. Intra-

articular injections should not be made through skin that has been recently fired or blistered

or that has been scurfed by the use of counterirritants. After introducing the needle into

the joint, excess synovial fluid should be allowed to drain, or should be aspirated, when

possible, prior to attaching the syringe and injecting HY-50. Discard any unused portion

of a syringe. A sterile dressing and clean bandage should be applied after injection, as

appropriate for the particular joint treated. Hand walk for at least 2 days after treatment.

Return to strenuous exercise will depend on the severity of each case and the regression of

clinical signs.

General Directions:

Withholding

Periods:

DO NOT USE in horses intended for human consumption.

Trade Advice:

Safety Directions:

First Aid

Instructions:

If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia

131126

First Aid Warnings:

Additional User

Safety:

Environmental

Statements:

Disposal:

Discarded needles/sharps should immediately be placed in a designated and appropriately

labelled "sharps" container. Dispose of empty container by wrapping with paper and placing

in garbage.

Storage:

Store between 2C and 8C (refrigerate, do not freeze). Discard any unused portion of a

syringe.

Similar products

Search alerts related to this product

View documents history

Share this information