SUMMARY OF PRODUCT CHARACTERISTICS

QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Substance 

Hyaloronate Sodium 17 mg per ml
Excipients
Sodium Chloride 7.57 mg per mL
Sodium Phosphate Dibasic 3.78 mg per mL
Sodium Phosphate Monobasic 0.45mg per mL
Water for Injection qs to 1mL
PHARMACEUTICAL FORM
Sterile solution for injection
PHARMACOLOGICIAL PROPERTIES
Pharmacodynamics
The active substance in HY-50®, hyaluronate sodium, is produced by a bacterial fermentation process.  Hyaluronate sodium is the sodium salt of hyaluronic acid, a non-sulphated acid mucopolysaccharide or glycosaminoglycan of high molecular weight composed of equimolar amounts of D-glucuronic acid and N-acetylglucosamine linked together by glycosidic bonds.
Hyaluronic acid is a natural constituent of connective tissues in all mammals and its chemical structure is the same in all species.  Vitreous humour, umbilical cord and synovial fluids are especially rich in hyaluronic acid.  Hyaluronic acid is also found in the articular cartilage matrix.
Hyaluronic acid has biochemical activities which are distinct from its physical and rheological properties.  It is an effective free radical scavenger, a potent inhibitor of leukocyte and macrophage migration and aggregration, and enhances healing of connective tissue.
Intra-articularly administered hyaluronate sodium alleviates aseptic joint inflammation and enhances joint function.  The mechanism of action involved in the beneficial effects of hyaluronate sodium are not fully understood.
Pharmacokinetics
Not studied.
CLINICAL PARTICULARS
Target Species
Horse
Indications
Local treatment of non-infectious joint inflammation.
Contraindications
Joint infection.
Undesirable Effects
Transient mild swelling and/or heat has reported in treated joints (2.7%).  These self-limiting local signs resolve spontaneously within 48 hours, and do not negate a successful therapeutic outcome.
Special Precautions for Use
No special precautions.
Use During pregnancy and lactation
Treatment of pregnant or lactating mares has not been documented.
Interaction with other medicaments
Not studied.
Posology and method of administration
3 mL 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 dose.
More than one joint may be treated at the same time.  Injections may be repeated at weekly intervals if necessary, but not to exceed a total of four injections.
Excess synovial fluid should be removed whenever possible prior to injection.
A sterile dressing and clean bandage should be applied after injection, as appropriate for the particular joint treated.
Overdose
Not applicable.
Special Warnings
No special warnings.
Withdrawal Periods
Meat and organs 0 days.
Special Precautions
Special precautions are not necessary.
PHARMACEUTICAL PARTICULARS
Shelf-Life
2 years.  Single dose syringes made ready for injection shall be used immediately.  Any unused portion of a syringe is to be discarded.
Special Precautions for Storage
Store at 2º-8ºC.  Do not freeze.
Nature and Contents of Container
HY-50® is a sterile, colourless, clear, visco-elastic solution for injection packaged in pre-loaded 3 mL single-dose glass syringes.
Special Precautions for Disposal
Unused medication shall be left in a pharmacy to be destroyed.  Empty syringes shall be discarded in a safe way.

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Sound choice for intraarticular treatment of traumatic joint disease in horses.

 

FOR MORE INFORMATION PLEASE EMAIL US AT:

info@hy-50.com