Dolatrox Hcc KolinPharma 3ml

Dolatrox Hcc KolinPharma Medical Device

Dolatrox hcchcc is a medical device with CE mark in compliance with the MDD 93/42 / EEC directive and subsequent amendments and additions, containing hyaluronic acid obtained by fermentation and not chemically modified, chondroitin sulphate of marine origin and cyclodextrin. Dolatrox hcchcc is a clear, sterile, non-pyrogenic and viscoelastic solution supplied in a 3 ml syringe. Hyaluronic acid is a natural polysaccharide present in many human tissues, in particular in the synovial fluid, and acts in the joints both as a lubricant of cartilages 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 of pain and an improvement in the mobility of the joint. Chondrotin sulfate is a high molecular weight glycosaminoglycan which is one of the essential building blocks of joint cartilage. In vitro, chondroitin sulfate has shown the ability to inhibit hyaluronidases, enzymes that degrade hyaluronic acid by hydrolyzing its bonds. Cyclodextrins are cyclic oligosaccharides capable of improving the water solubility of some substances by improving their stability and changing their state of aggregation from liquid to viscous. Thanks to the viscosifying capacity of the cyclodextrins, the solution of hyaluronic acid and chondroitin sulphate thus obtained has physical characteristics such as to guarantee better effectiveness. Dolatrox hcchcc acts only at the level of the joint where it is injected, without exerting any systemic action.

How to use

Remove any joint effusion before injecting Dolatrox hcchcc; the same needle must be used for effusion removal and injection of Dolatrox hcchcc. Remove the protective cap of the syringe taking special care to avoid contact with the opening. Firmly screw the 18 to 22 G diameter needle into the Luer-type locking collar to ensure a watertight seal. Before injection, treat the site with an appropriate antiseptic solution. Inject Dolatrox hcchcc using an aseptic technique. Inject into the joint cavity only.
Administration : Dolatrox hcchcc must be administered only once per therapy cycle; if necessary, the infiltration can be repeated. The doctor will evaluate the advisability of administering another infiltration based on the patient's situation.

Components

Hyaluronic acid sodium salt (20 mg / ml), chondrotin sulfate of marine origin (20 mg / ml), hydroxypropyl-betacyclodextrin (10 mg / ml), 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 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 by vascular route. Do not inject outside the joint cavity, into tissues or synovial capsules.
• Dolatrox hcchcc has not been tested in pregnant or lactating women.
• Dolatrox hcchcc is for single use only and must not be resterilized.
• Avoid the simultaneous administration of Dolatrox hcchcc with other products for intraarticular use in order to prevent any possible interaction.
• Do not administer Dolatrox hcchcc in the presence of profuse intraarticular effusion.
• Once the package has been opened, Dolatrox hcchcc must be used immediately and disposed of after use according to current regulations.
• Keep out of reach of children.
• As with any invasive joint treatment, the patient is recommended to avoid all strenuous physical activity for the first 2-3 days after the injection.

Contraindications

Dolatrox hcc must not be administered

• To patients with proven sensitivity to hyaluronic acid and its 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 the injection of Dolatrox hcchcc, such as pain, stiffness, warmth, redness or swelling. These secondary manifestations can be alleviated by applying ice to the treated joint. They usually 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 the injection or the injection site is not aseptic. Intra-articular injection should only be performed by a physician or in accordance with local legislation.

storage

Dolatrox hcc must be stored in the original packaging at a temperature between 0 and 25 ° C, away from direct sunlight and frost. The expiry date is indicated on the package.

Format

Glass syringe containing 3 ml of solution packed in a blister. The contents of the syringe are sterilized with moist heat.