Description
Medical device with CE mark compliant with the MDD 93/42/EEC directive, containing 20 mg/ml of hyaluronic acid obtained by fermentation and not chemically modified. Donegal HA 2.0 is a clear, sterile, non-pyrogenic, viscoelastic solution supplied in a 2ml syringe. Hyaluronic acid is a natural polysaccharide present in many human tissues, especially 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, hyaluronic acid injections 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 2.0 acts only on the joint where it is injected, without exerting any systemic action.

How to use
Remove any joint effusion before injecting Donegal HA 2.0, the same needle should be used for removal of the effusion and injection of Donegal HA 2.0. Remove the protective cap from the syringe taking special care to avoid contact with the opening. Firmly screw the needle with a diameter between 18 and 22 G to the Luer-type locking collar to ensure a watertight seal. Before injection, treat the site with an appropriate antiseptic solution. Inject Donegal HA 2.0 using aseptic technique. Inject only into the joint cavity.
Administration: Donegal HA 2.0 should be administered weekly for a total of 3 weeks or in any case as prescribed by the physician.

Components
Main component: hyaluronic acid sodium salt 2.0%. Other ingredients: sodium chloride, sodium phosphate and water for injections (to taste).

Warnings
The contents of the pre-filled syringe are sterile. The syringe is packed in a sealed blister. The external surface of the syringe is not sterile. Do not use Donegal HA 2.0 after the expiry date stated on the package. Do not use Donegal HA 2.0 if the package or syringe is open or damaged. The injection site must be on healthy skin. Do not inject vascularly. Do not inject outside the joint cavity, into tissues or synovial capsules. Donegal HA 2.0 has not been tested in pregnant or breastfeeding women. Donegal HA 2.0 is for single use only and must not be re-sterilised. Avoid the simultaneous administration of Donegal HA 2.0 with other products for intra-articular use in order to prevent any possible interaction. Do not administer DONEGAL HA 2.0 in the presence of an abundant intra-articular effusion. Once the package has been opened, DONEGAL HA 2.0 must be used immediately and discarded after use according to the regulations in force. Keep out of reach of children. As with any invasive treatment of the joint, the patient is recommended to avoid all strenuous physical activity for the first 2-3 days after the injection.
Contraindications: Donegal HA 2.0 should not be administered to patients with known sensitivity to hyaluronic acid and related compounds; if you have an infection or skin disease near the injection site; if the joint is infected or severely inflamed.
Side effects: Some transient side reactions may occur following injection of Donegal HA 2.0, such as pain, stiffness, warmth, redness or swelling. These secondary manifestations can be relieved by applying ice to the treated joint. Usually they disappear after a short time. If symptoms persist, consult a doctor. As with any invasive treatment of the joint, septic arthritis could develop if proper precautions are not observed during injection or the injection site is not aseptic.
Intra-articular injection must only be performed by a physician or in accordance with local legislation.

storage
Store in the original package at a temperature between 0 and 25°C, away from direct sunlight and frost. The expiration date is indicated on the package.

Format
available in packs of 1 and 3 syringes. Each glass syringe contains 40 mg of hyaluronic acid in 2 ml of sodium chloride buffered saline, packaged in a blister. The contents of the syringe are sterilized with moist heat.

Code0100000146