Hy-50 Vet.
PACKAGE LEAFLET
HY-50 Vet 17 mg/ml solution for injection
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder:
Dechra Limited
Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW
United Kingdom
Manufacturer for the batch release:
Dales Pharmaceuticals
Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW
United Kingdom
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
HY-50 Vet 17 mg/ml solution for injection
Sodium hyaluronate
3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
HY-50 Vet is a sterile, colourless, clear solution containing:
Active Substance
Sodium Hyaluronate 17 mg/ml
Excipients
Sodium Chloride 7.57 mg/ml
Disodium Phosphate Heptahydrate 3.78 mg/ml
Sodium Dihydrogen Phosphate Monohydrate 0.45 mg/ml
Water for Injection qs to 1 ml
4. INDICATION(S)
For intra-articular and intravenous treatment of lameness caused by joint dysfunction associated with non-infectious synovitis.
5. CONTRAINDICATIONS
Do not use in cases of joint infection.
6. ADVERSE REACTIONS
Transient mild swelling and/or heat has been reported in treated joints (2,7%). These self-limiting local signs resolve spontaneously within 48 hours, and do not negate a successful therapeutic outcome.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
7. TARGET SPECIES
Horse.
8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Intravenous use: 3 ml intravenously repeated at weekly intervals for a total of three treatments.
For single intra-articular injection: 3 ml (51 mg) intra-articularly into medium sized and large joints. Smaller joints such as intertarsal, tarsometatarsal and interphalangeal joints can be treated with a 1.5 ml (25.5 mg) dose.
More than one joint may be treated at the same time.
9. ADVICE ON CORRECT ADMINISTRATION
Excess synovial fluid should be removed whenever possible prior to injection.
Remove product from refrigerator approximately 10 minutes before performing injection. The injection should be administered under strict aseptic conditions. Ensure removal of dirt, hair, topical medicaments and soap/antiseptic residues. Intra-articular injections should not be made through overlying skin that is infected, blistered, scurfed or otherwise compromised. A sterile dressing and clean bandage should be applied after injection, as appropriate for the particular joint treated.
10. WITHDRAWAL PERIOD
Meat and offal – zero days
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Store in a refrigerator (2 C – 8 C)
Do not freeze
Do not use after the expiry date stated on the label and carton.
Single dose syringes made ready for injection shall be used immediately. Any unused portion of a syringe is to be discarded.
12. SPECIAL WARNING(S)
Radiographic evaluation should be carried out in cases of acute, severe lameness to ensure that the joints are free from serious fractures.
Use during pregnancy and lactation:
Safety in pregnant and lactating mares has not been documented. Use only according to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction: No data available.
Do not mix with any other product.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Any unused product or waste material should be disposed in accordance with national requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
2016-02-25
15. OTHER INFORMATION