SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

SynVet-50; 50 mg solution for injection for horses

(UK, IE, DE, AT, NL, BE,)

Synvet; 20 mg/ml solution for injection (NO, SE, FI, DK)

Synvet solution for injection for horses (FR)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Each 2.5 ml syringe contains:

Sodium Hyaluronate 50 mg

(equivalent to hyaluronic acid) 47 mg

Excipients:

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection

Clear colourless viscous solution

4. CLINICAL PARTICULARS

4.1 Target species

Horse

4.2 Indications for use, specifying the target species

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

4.3 Contraindications

Do not use in case of joint infections.

Do not use in case of known hypersensitivity to exogenous sodium hyaluronate

4.4 Special warnings for each target species:

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

4.5 Special precautions for use

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.

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

In case of accidental contact with skin, wash with soap and water.

In case of accidental contact with eyes, blurred vision may occur because of the viscous nature of the product. Rinse immediately with plenty of clean water.

In the event of accidental self injection, seek medical advice.

4.6 Adverse reactions (frequency and seriousness)

The most commonly reported adverse reaction are transient mild swelling and/or heat 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.

4.7 Use during pregnancy, lactation or lay

Safety in pregnant and lactating mares has not been documented. Use only according to the benefit/risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

No data available to the interaction with other medicinal products. 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.

4.9 Amounts to be administered and administration route

For single intra-articular injection: 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.

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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

None observed

4.11 Withdrawal period

Meat and offal: zero days

Milk: zero hours

5. PHARMACOLOGICAl IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group:sodium hyaluronate (hyaluronic acid – ATC Vet Code: QM09AX01.

5.1 Pharmacodynamic properties

A bacterial fermentation process produces the active substance in the 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 SynVet-50 sodium hyaluronate ranges from >1 million to 1.8 million Dalton.

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 HA moved into and disappeared from the circulation at a first-order rate.

Uptake is primarily via the lymphatic’s. 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 HA and monosaccharides.

Environmental properties

Not applicable

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium Chloride

Disodium Phosphate Dodecahydrate

Citric Acid Monohydrate

Water for Injections

6.2 Incompatibilities

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

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

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

6.4. Special precautions for storage

Do not store above 25°C

Store in the original container

Store in a dry place

6.5 Nature and composition of 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 in single cartons or packs of 6 single cartons overwrapped with plastic film.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Equimed Ltd

2 Hilliards Court

Chester Business Park

Chester

CH4 9PX

United Kingdom

8. MARKETING AUTHORISATION NUMBER

Vm 25297/4000

9. DATE OF FIRST AUTHORISATION

Date: 09 September 2010

10. DATE OF REVISION OF THE TEXT

Date: September 2014

Approved: 15 January 2015