Description
Dolatrox hcc is a CE-marked medical device compliant with Directive MDD 93/42/EEC and subsequent amendments and additions, containing hyaluronic acid obtained by fermentation and not chemically modified, marine-derived chondroitin sulfate, and cyclodextrin. Dolatrox hcchcc is a transparent, sterile, pyrogen-free, viscoelastic solution supplied in a 3 ml syringe. Hyaluronic acid is a natural polysaccharide found in many human tissues, particularly synovial fluid, and acts in joints both as a lubricant for cartilage and ligaments and as a shock absorber. Numerous studies have shown that hyaluronic acid injections into joints affected by osteoarthritis restore the viscosity and elasticity of the synovial fluid, resulting in pain relief and improved joint mobility. Chondroitin sulfate is a high-molecular-weight glycosaminoglycan that is an essential component of articular cartilage. In vitro, chondroitin sulfate has demonstrated the ability to inhibit hyaluronidases, enzymes that degrade hyaluronic acid by hydrolyzing its bonds. Cyclodextrins are cyclic oligosaccharides that can improve the water solubility of certain substances, enhancing their stability and changing their state of aggregation from liquid to viscous. Thanks to the viscosity-enhancing properties of cyclodextrins, the resulting hyaluronic acid and chondroitin sulfate solution has physical characteristics that ensure greater efficacy. Dolatrox hcchcc acts only at the level of the joint into which it is injected, without exerting any systemic action.

How to use
Directions for use: Remove any joint effusion before injecting Dolatrox hcchcc; the same needle should be used for removing the effusion and injecting Dolatrox hcchcc. Remove the protective cap from the syringe, taking particular care to avoid contact with the opening. Tightly screw the 18- to 22-gauge needle onto the Luer-type locking collar to ensure a watertight seal. Before injection, treat the site with an appropriate antiseptic solution. Inject Dolatrox hcchcc using aseptic technique. Inject only into the joint cavity.
Administration : Dolatrox hcchcc should be administered only once per treatment cycle; the injection can be repeated if necessary. The physician will evaluate the need for another injection based on the patient's situation.

Components
Hyaluronic acid sodium salt (20 mg/ml), chondroitin sulphate of marine origin (20 mg/ml), hydroxypropyl-betacyclodextrin (10 mg/ml), sodium chloride, sodium phosphate and water for injections (qs).

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 Dolatrox hcchcc after the expiry date stated on the package.
- Do not use Dolatrox hcchcc if the package or syringe is open or damaged.
- The injection site must be on healthy skin.
- Do not inject intravascularly. Do not inject outside the joint cavity, into tissues, or into synovial capsules.
- Dolatrox hcchcc has not been tested in pregnant or breastfeeding women.
- Dolatrox hcchcc is single use and does not need to be resterilized.
- Avoid concomitant administration of Dolatrox hcchcc with other products for intra-articular use in order to prevent any possible interaction.
- Do not administer Dolatrox hcchcc in the presence of a large intra-articular effusion.
- Once opened, Dolatrox hcchcc must be used immediately and disposed of after use in accordance with current 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.
Contraindications :
Dolatrox hcchcc must 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 effects may occur following the injection of Dolatrox hcchcc, such as pain, stiffness, heat, redness, or swelling. These side effects can be relieved by applying ice to the treated joint. They usually disappear after a short time. If symptoms persist, consult a doctor. As with any invasive joint treatment, septic arthritis may occur if appropriate precautions are not observed during the injection or if the injection site is not aseptic. Intra-articular injections should be performed only by a physician or in accordance with local regulations.

Conservation
Dolatrox hcchcc should be stored in the original packaging at a temperature between 0 and 25°C, away from direct sunlight and frost. The expiration date is indicated on the packaging.

Format
Glass syringe containing 3 ml of solution packaged in a blister. The contents of the syringe are sterilized by moist heat.