Each ml contains:

Sodium hyaluronate 10 mg

Clear, colourless liquid.

See the "Qualitative and quantitative composition" section.

Horses.

For the treatment of lameness in horses due to non-infectious inflammation of joints

None known

This product does not contain an antimicrobial preservative. Any solution remaining in the vial following withdrawal of the required dose should be discarded.

See below under "Amounts to be administered and administration route" regarding special precautions in administration.

Not applicable.

Not applicable.

Horses:

1 After intraarticular injection.

2 Diffuse swelling lasting 23-48 hours resulting from irritation by the needle while in the joint space. These may be acute but will generally resolve without sequelae within a few days.

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.

Can be used during pregnancy and lactation.

None known.

Intravenous or intraarticular use.

The recommended dose is:

Three treatments at weekly intervals. Fewer treatments may be required if early improvement is observed.

Strict aseptic technique should be observed when injecting the veterinary medicinal product. As with any intraarticular procedure, proper injection site disinfection and animal restraint are very important. Excess synovial fluid should be aseptically removed prior to injection. Care should be taken not to scratch the cartilage surface with the point of the injection needle.

For best results, the horse should be given three days stable rest after intraarticular treatment before gradually resuming normal activity.

None.

For administration by a veterinarian or under their direct supervision.

Meat: zero days.

Milk: Not authorised for use in animals producing milk for human consumption.

ATC VetCode: QM09 AX01

Hyaluronic acid is extracted from the capsule of selected micro-organism and purified as a sodium salt. Hyaluronic acid is a component of all mammalian connective tissue and is widely distributed in body tissues and intracellular fluids.

Sodium hyaluronate is the naturally occurring sodium salt of hyaluronic acid. In the normal joint sodium hyaluronate is synthesised in the synoviocytes.

The high affinity of sodium hyaluronate for water is responsible for the known high viscosity of the synovial fluid.

Not appliacble.

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

Shelf life after first opening the container: Any solution remaining in the vial following withdrawal of the required dose should be discarded.

Do not store above 25 °C.

Protect from sunlight.

2ml of solution in a 2.5ml clear Type I glass vial with a chlorobutyl grey stopper or a grey butyl rubber stopper, teflon face with an aluminium overseal and plastic cap.

2ml solution in a 5ml clear Type I glass vial with a chlorobutyl grey stopper or a grey butyl rubber stopper, teflon face with an aluminium overseal and plastic cap.

Not all pack sizes may be marketed.

Medicines should not be disposed of via wastewater.

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.