Description
Donegal HA is a replacement for synovial fluid in joints affected by degenerative or mechanical arthropathy, causing pain or reduced mobility.
It is a medical device with CE marking compliant with MDD 93/42/EEC directive, containing 8 mg/ml of hyaluronic acid obtained by fermentation and not chemically modified.
Hyaluronic acid is a natural polysaccharide present in many human tissues, particularly in synovial fluid, and acts in the joints both as a lubricant for cartilage and ligaments and as a shock absorber. According to many studies, injections of hyaluronic acid in joints affected by osteoarthritis restore the viscosity and elasticity of the synovial fluid, with a consequent reduction in pain and an improvement in joint mobility. Donegal HA acts only at the level of the joint into which it is injected, without exerting any systemic action.

How to use
Remove any joint effusion before injecting Donegal HA; the same needle should be used for removal of the effusion and injection of Donegal HA.
Remove the protective cap from the syringe, taking special care to avoid contact with the opening.
Screw the 18 to 22G diameter needle firmly into the Luer-type locking collar to ensure a watertight seal.
Before injection, treat the site with an appropriate antiseptic solution.
Inject Donegal HA using aseptic technique.
Inject into the joint cavity only.
The product must be administered weekly for a total of 5 weeks or in any case according to the medical prescription.

Composition
Main component: hyaluronic acid sodium salt 0.8%; other components: sodium chloride, sodium phosphate and water for injections (quantum satis).

Warnings
The contents of the pre-filled syringe are sterile. The syringe is packaged in a sealed blister. The outer surface of the syringe is not sterile.
Do not use Donegal HA after the expiry date which is stated on the carton.
Do not use Donegal HA if the pack or syringe is opened or damaged.
The injection site must be on healthy skin.
Do not inject vascularly. Do not inject outside the joint cavity, into synovial tissues or capsules.
Donegal HA has not been tested in pregnant or breastfeeding women.
Donegal HA is single use only and does not require resterilization.
Intra-articular injection must be performed exclusively by a physician.
Avoid concomitant administration of Donegal HA with other products for intra-articular use in order to prevent any possible interaction.
Do not administer Donegal HA in the presence of large intra-articular effusion.
Once opened, Donegal HA must be used immediately and disposed of after use in accordance with local regulations.
Keep out of reach of children.
As with any invasive joint treatment, the patient is advised to avoid all strenuous physical activity for the first 2-3 days after the injection.
Donegal HA must not be administered: to patients with known sensitivity to hyaluronic acid and related compounds, in case of infection or skin disease in the vicinity of the injection site, if the joint is infected or severely inflamed.
Some transient side effects may occur following the injection of Donegal HA, such as pain, stiffness, warmth, redness or swelling. These secondary manifestations can be alleviated by applying ice to the treated joint.
Usually these disappear after a short time.
If symptoms persist, seek medical attention.
As with any invasive joint treatment, septic arthritis may occur if proper precautions are not observed during injection or the injection site is not aseptic.

Conservation
Store the product in its original packaging at a temperature between 0°C and 25°C, away from direct sunlight and frost.
The expiry date refers to the product stored correctly, in intact packaging.
Best before date from production date, in intact packaging: 36 months.

Format
Pack of 1 syringe containing 16 mg of hyaluronic acid in 2 ml of solution.

Cod. 0100000144