Description
DOLATROX hcc
Description
Dolatrox hcc is a CE marked medical device compliant with MDD 93/42/EEC 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 transparent, sterile, apyrogenic and 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, injections of hyaluronic acid 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. Chondroitin sulphate is a high molecular weight glycosaminoglycan that is one of the essential constituents 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 solubility in water of some substances, improving their stability and changing their state of aggregation from liquid to viscous. Thanks to the viscosity capacity of cyclodextrins, the solution of hyaluronic acid and chondroitin sulfate thus obtained 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.
How to use
Directions for use Remove any joint effusion before injecting Dolatrox hcchcc; the same needle should be used for removal of the effusion and injection of Dolatrox hcchcc. Remove the protective cap from the syringe, taking special care to avoid contact with the opening. Screw the 18-22 gauge needle firmly onto the Luer-type locking collar to ensure a watertight seal. Treat the site with an appropriate antiseptic solution prior to injection. 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 can be repeated. The doctor will evaluate the opportunity to administer another infiltration based on the patient's situation.
Components
Hyaluronic acid sodium salt (20 mg/ml), marine chondroitin sulphate (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 via the vascular route. Do not inject outside the joint cavity, into the tissues or into the 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 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, warmth, redness or swelling. These side effects can be alleviated by applying ice to the treated joint. They usually disappear after a short time. If symptoms persist, seek medical advice. As with any invasive joint treatment, septic arthritis may occur if proper precautions are not observed during the injection or if the injection site is not aseptic. Intra-articular injection should only be performed by a physician or in accordance with local legislation.
Conservation
Dolatrox hcchcc should 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 package.
Format
Glass syringe containing 3 ml of solution packed in a blister. The contents of the syringe are sterilized by moist heat.
Dolatrox hcc is a CE marked medical device compliant with MDD 93/42/EEC 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 transparent, sterile, apyrogenic and 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, injections of hyaluronic acid 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. Chondroitin sulphate is a high molecular weight glycosaminoglycan that is one of the essential constituents 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 solubility in water of some substances, improving their stability and changing their state of aggregation from liquid to viscous. Thanks to the viscosity capacity of cyclodextrins, the solution of hyaluronic acid and chondroitin sulfate thus obtained 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.
How to use
Directions for use Remove any joint effusion before injecting Dolatrox hcchcc; the same needle should be used for removal of the effusion and injection of Dolatrox hcchcc. Remove the protective cap from the syringe, taking special care to avoid contact with the opening. Screw the 18-22 gauge needle firmly onto the Luer-type locking collar to ensure a watertight seal. Treat the site with an appropriate antiseptic solution prior to injection. 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 can be repeated. The doctor will evaluate the opportunity to administer another infiltration based on the patient's situation.
Components
Hyaluronic acid sodium salt (20 mg/ml), marine chondroitin sulphate (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 via the vascular route. Do not inject outside the joint cavity, into the tissues or into the 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 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, warmth, redness or swelling. These side effects can be alleviated by applying ice to the treated joint. They usually disappear after a short time. If symptoms persist, seek medical advice. As with any invasive joint treatment, septic arthritis may occur if proper precautions are not observed during the injection or if the injection site is not aseptic. Intra-articular injection should only be performed by a physician or in accordance with local legislation.
Conservation
Dolatrox hcchcc should 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 package.
Format
Glass syringe containing 3 ml of solution packed in a blister. The contents of the syringe are sterilized by moist heat.
