Description
Dolatrox hcc is a medical device with CE mark in accordance with Directive MDD 93/42/EEC and subsequent modifications and additions, containing hyaluronic acid obtained by fermentation and not chemically modified, chondroitin sulphate of marine origin and cyclodextrin. Dolatrox hcchcc is a transparent, sterile, apirogenous and viscoelastic solution provided in a 3 ml syringe. Hyaluronic acid is a natural polysaccharide present in many human tissues, especially in the synovial liquid, and acts in the joints both as a lubricant of cartilage and ligaments and as a shock absorber. According to many studies the injections of hyaluronic acid in joints with osteoarthritis restore the viscosity and elasticity of the synovial fluid, resulting in pain attenuation and an improvement of the mobility of the joint. The sulphate chondroitin is a glycosaminoglycan with a high molecular weight that is one of the essential constituent components of articular cartilage. In vitro, sulphate chondroitin has demonstrated the ability to inhibit ialuronidasis, enzymes that degrade hyaluronic acid by hydrolyzing its bonds. Cyclodextrins are cyclic oligosaccharides able to improve water solubility of certain substances by improving stability and changing the state of aggregation from viscous liquid. Thanks to the viscosizing ability of cyclodextrins, the solution of hyaluronic acid and sulphate so obtained has physical characteristics to ensure better effectiveness. Dolatrox hcchcc acts only at the level of the joint in which it is injected, without exercising any systemic action.

Mode of use
Mode of use Remove any joint deposit before injecting Dolatrox hcchcc; for removal of the efffusion and injection of Dolatrox hccc must be used the same needle. Remove the protective syringe cap paying special attention to avoid contact with opening. Securely screw the diameter needle between 18 and 22 G to the Luer type locking collar to ensure a stagnant seal. Before injection treat the site with an appropriate antiseptic solution. Inject Dolatrox hcchcc by adopting a septic technique. Inject only in the joint cavity.
Administration: Dolatrox hcchcc should be administered only once per cycle therapy; if necessary, infiltration can be repeated. The doctor will assess the opportunity to administer another infiltration according to the patient's situation.

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

Warnings
The content of the pre-filled syringe is 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 shown on the package.
- Do not use Dolatrox hcchcc if the packaging or syringe are open or damaged.
- The injection point must be on healthy skin.
- Don't inject vascularly. Do not inject outside the joint cavity, tissues or synovial capsules.
- Dolatrox hcchcc has not been tested in pregnant women or breastfeeding.
- Dolatrox hcchcc is disposable and should not be resterilized.
- Avoid the contemporary administration of Dolatrox hcchcc with other intraarticular products to prevent any possible interaction.
- Do not administer Dolatrox hcchcc in the presence of abundant intraarticular deposit.
- Once the package is opened, Dolatrox hcchcc must be used immediately and eliminated after use according to the current rules.
- Keep away from the children's reach.
- As with every invasive treatment of jointing, it is recommended for the patient to avoid all intense physical activity for the first 2-3 days after injection.
Contraindications:
Dolatrox hcchcc should not be administered:
- patients with proven sensitivity to hyaluronic acid and its compounds;
- in case of infection or skin disease near the injection site;
- if the joint is infected or strongly inflamed.
Side effects:
Transitional side reactions may occur as a result of Dolatrox hcchcc injection, such as pain, stiffness, feeling of heat, redness or swelling. These secondary manifestations can be alleviated with the application of ice on the treated joint. They usually disappear after a short time. If symptoms persist, contact a doctor. As in any invasive treatment of jointing, a septic arthritis may occur if the appropriate precautions during injection or injection point are not observed. Intraarticular injection must be carried out exclusively by a doctor or in accordance with local legislation.

Conservation
Dolatrox hcchcc must be kept in the original packaging at a temperature between 0 and 25°C, sheltered from direct sunlight and frost. The expiry date is indicated on the packaging.

Format
Glass syringe containing 3 ml of solution packaged in a blister. The content of the syringe is sterilized with wet heat.