SynVet-50; 50 mg Solution for Injection for Horses

Composition

Each 2.5 ml syringe contains:

Active substance:

Excipients:

Qualitative composition of excipients and other constituents

Sodium chloride

Disodium phosphate dodecahydrate

Citric acid monohydrate

Water for injections

Clear, colourless, viscous solution.

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Pharmacological properties

4.1 ATCvet code: QM09AX01

4.2 Pharmacodynamics

A bacterial fermentation process produces the active substance in the veterinary medicinal product. Sodium hyaluronate is extracted from the capsule of Streptococcus spp. and purified, resulting in a form which is free of protein, pyrogen and nucleic acids.

Sodium hyaluronate is the sodium salt of hyaluronic acid, a non-sulphated acid, high- viscosity mucopolysaccharide or glycosaminoglycan of high molecular weight composed of equimolar amounts of D- glucuronic acid and N-acetylglucosamine linked by glycosidic bonds.

Hyaluronate is a physiological natural substance of connective tissues in all mammals and its chemical structure is the same in all species. High concentrations of hyaluronate are especially found in the synovial fluid, the vitreous of the eye and the umbilical cord. Hyaluronic acid is also found in the articular cartilage matrix.

Apart from its physical and rheological properties, hyaluronic acid has anti-inflammatory, analgesic, lubricant and anti-oxidant activities. Its biochemical activities are distinct from its physical and rheological properties. It is an effective free radical scavenger, a potent inhibitor of leucocytes and macrophage migration and aggregation, and enhances healing of connective tissue.

Intra-articularly administered sodium hyaluronate alleviates aseptic joint inflammation and enhances joint lubrication. The mechanism of action of the active substance is not fully understood. The molecular weight of the active ingredient in the veterinary medicinal product sodium hyaluronate ranges from >1 million to 1.8 million Dalton.

4.3 Pharmacokinetics

Studies with radio labelled hyaluronic acid in rabbit and sheep indicate that hyaluronic acid is cleared from the joint within 4 to 5 days after intra-articular injection.

Elimination half-life from synovial fluid after intra-articular injection of any joint was highly variable, however the mean t1/2, determined in only a few horses, was approximately 8- 24 hours.

Intra-articular administered hyaluronic acid moved into and disappeared from the circulation at a first- order rate.

Uptake is primarily via the lymphatics. Hyaluronate is taken up and metabolized in liver endothelial cells, where it is broken down into C1 units of the carbon cycle before being re- utilised in the body. The main metabolites are H2O, CO2, lactate, D-glucosamine-N-acetyl- D-glucosamine, low weight hyaluronic acid and monosaccharides.

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Target species

Horses

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Indications

For adjunctive intra-articular treatment of joint disease associated with non-infectious synovitis in horses.

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Dosage

Intra-articular use.

A single injection of 2.5 ml intra-articularly into medium sized and large joints. More than one joint may be treated at the same time.

A sterile dressing and clean bandage should be applied after injection, as appropriate for the particular joint treated.

Suggested needle size for intra-articular use: 20G 1,5 inch needle (0,9 x 40 mm)

If necessary, re-treatment of the joint can be considered at 2-3 weeks after the first- treatment.

Single dose syringes made ready for injection shall be used immediately; any unused portion of a syringe is to be discarded.

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Contraindications

Do not use in cases of joint infections.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

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Adverse reactions

Horse:

1 Occurring in approximately 2.7% of the treated joints. These self-limiting local signs typically resolve spontaneously within 48 hours. However, since the early signs of septic arthritis may be similar, it is advised that a thorough clinical examination and monitoring are carried out if these clinical signs occur. Consideration should be given to appropriate further investigations.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Excess synovial fluid should be removed whenever possible prior to injection. The injection should be administered under strict aseptic conditions through healthy undamaged skin.

Appropriate investigations should be carried out in cases of acute, severe lameness to ensure that the joints are free from fractures, OCD fragments and infections.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

In case of accidental spillage onto skin, wash the affected area with soap and water. In case of accidental contact with eyes, blurred vision may occur because of the viscous nature of the veterinary medicinal product. Rinse immediately with plenty of clean water. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Use only accordingly to the benefit-risk assessment by the responsible veterinarian.

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Interactions

No data available.

It is described that hyaluronic acid competes with other high molecular weight polysaccharides such as chondroitin sulphate for receptor binding and thus for uptake in the articular cartilage tissue.

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Overdose

Not applicable.

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Special warnings

The treated horse should be box-rested for 2 days before gradually resuming a normal exercise pattern.

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Withdrawal period

Meat and offal: zero days.

Milk: zero hours.

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

Single-dose glass syringe barrel with luer tip and rigid tip cap.

Type 1 glass syringe, lubricated with dimethicone.

Styrene-butadiene rubber cap.

Bromobutyl rubber plunger.

Available as single dose syringe in a sealed translucent plastic blister packed in one carton folding box.

Available as multipack with six single dose cartons aggregated and overwrapped with plastic foil and label.

Not all pack sizes may be marketed.

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Storage

Do not store above 25 °C.

Store in the original package.

Store in a dry place.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 4 years

Any solution remaining in the syringe following withdrawal of the required dose should be discarded.

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Disposal of unused product

Medicines should not be disposed of via wastewater or household waste.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 25297/5000

8 DATE OF FIRST AUTHORISATION

09 September 2010

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

July 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved 06 August 2026

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Registration holder

Equimed Europe Ltd

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