Dolatrox hcc - hyaluronic acid syringe for joints 3 ml

Product Description

Dolatrox hcchcc 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 chondroitin sulfate, and cyclodextrin.

Indications

Dolatrox hcchcc is a transparent, sterile, pyrogen-free, viscoelastic solution supplied in a 3 ml syringe.
Hyaluronic acid is a natural polysaccharide present in many human tissues, particularly in synovial fluid, and acts in 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, resulting in pain relief and improved joint mobility.
Chondroitin sulfate is a high molecular weight glycosaminoglycan that is one of the essential building blocks 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 capable of improving the water solubility of certain substances, improving their stability and changing their aggregation state from liquid to viscous.
Thanks to the viscosity-increasing capacity of cyclodextrins, the solution of hyaluronic acid and chondroitin sulfate thus becomes more viscous. The resulting solution has physical characteristics that guarantee better efficacy.
Dolatrox hcchcc acts only at the level of the joint into which it is injected, without exerting any systemic action.

Composition

Hyaluronic acid sodium salt (20 mg/ml), marine chondrotin sulfate (20 mg/ml), hydroxypropyl-betacyclodextrin (10 mg/ml), sodium chloride, sodium phosphate and water for injections (q.s.).

Directions for use and Dosage

Remove any joint effusion before injecting Dolatrox hcchcc; The same needle must be used for removal of the effusion and injection of Dolatrox hcchcc.
Remove the protective cap from the syringe, taking particular care to avoid contact with the opening.
Firmly 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 must be administered only once per therapy cycle; if necessary, the infiltration may be repeated.
The doctor will evaluate the need for another injection based on the patient's situation.

Warnings

The contents of the pre-filled syringe are sterile.
The syringe is packaged in a sealed blister. The external surface of the syringe is not sterile.

• Do not use Dolatrox hcchcc after the expiry date shown on the packaging.
• Do not use Dolatrox hcchcc if the packaging or syringe is open or damaged.
• The injection site must be on healthy skin.
• Do not inject into a vascular system. Do not inject outside the joint cavity, into synovial tissues or capsules.
• Dolatrox hcchcc has not been tested in pregnant or breastfeeding women.
• Dolatrox hcchcc is for single use only and must not be resterilized.
• Avoid concomitant administration of Dolatrox hcchcc with other products for intra-articular use to prevent any possible interaction.
• Do not administer Dolatrox hcchcc in the presence of a large intra-articular effusion.
• Once the package is 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;
• in case of infection or skin disease in the vicinity of 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, sensation of heat, redness or swelling.
These secondary manifestations can be alleviated by applying ice to the treated joint.
They usually disappear after a short time.
If the symptoms persist, consult a doctor.
As in Any invasive treatment of the joint may result in septic arthritis if appropriate precautions are not observed during the injection or if the injection site is not aseptic. Intra-articular injection should be performed only by a physician or in accordance with local legislation.

Storage

Dolatrox hcchcc must be stored in the original packaging at a temperature between 0 and 25°C, protected 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 contents of the syringe are sterilized by moist heat.