ARTROSULFUR® HA LABOREST® 3 Pre-filled Syringes

ARTROSULFUR® HA LABOREST® Medical Device

Artrosulfur® HA hyaluronic acid solution for intra-articular injection, 16 mg / ml, pre-filled syringe.

Indications

Useful in case of pain or reduced joint mobility due to osteoarthritis, degenerative or mechanical arthropathy.

Action

It works by counteracting joint pain and mobility caused by osteoarthritis, degenerative or mechanical arthropathies.

How does Artrosulfur® HA work?

Artrosulfur® HA is a class III medical device containing 16 mg / ml of hyaluronic acid obtained through a bio-fermentation process and not subjected to any chemical modification. Hyaluronic acid is a polysaccharide, formed by the succession of a disaccharide consisting of N-acetylglucosamine and glucuronic acid, with a high molecular weight and high viscosity that occurs naturally in our joints and is produced by our type B synoviocytes. hyaluronic is an important component of the synovial fluid present in the joints, both for their lubrication and to cushion the mechanical stresses to which they are subject, and to protect the cartilage from inflammatory cells and from the lytic enzymes that degrade it. Artrosulfur® HA, thanks to its particular formulation, acts only locally without exercising any systemic activity.

Method of use and dosage

Unless otherwise advised by the physician, infiltrate intra-articularly once a week for 3 weeks.
The medical device is for professional use and must be administered by medical or paramedical personnel as established by the legislation of the country in which it is used. The medical device should only be injected into the joint cavity.
Treat the affected part with an adequate antiseptic solution not made up of Quaternary ammonium salts. Remove any joint effusions. This activity is carried out by aspirating the liquid with a syringe other than that of this device having a needle with a diameter between 18 G and 22 G. Once the needle of the aforementioned syringe has been aspirated, it will not be removed but must be disconnected from its syringe. used to remove the effusion in order to later connect it to the Artrosulfur® HA syringe. Open the blister containing the Artrosulfur® HA syringe. Remove the protective cap of the aforementioned syringe avoiding any contact between it and the affected part as the external surface of the syringe is not sterile. Firmly screw the needle referred to in point 1 to the Luer type locking collar in order to ensure a watertight seal. Inject Artrosulfur® HA using aseptic technique.

Warnings and Contraindications
This product can only be used by expert personnel. Once the package has been opened, the device must be used immediately. Keep out of the reach and sight of children. Do not use the product if the package is not intact. Do not use the product after the expiration date. The expiry date refers to the intact and correctly stored product. Do not use in case of broken or damaged skin. Do not inject by vascular route. Do not inject outside the joint cavity, into tissues or synovial capsules. Disposable non resterilizable and reusable device; reuse of the same syringe can produce infections or in any case worsen the pathology for which it was used. Device not tested in pregnant or lactating women. Avoid the simultaneous administration of the device with other products for intra-articular use in order to prevent any possible interaction between them. Do not administer in the presence of abundant intraarticular effusion. After using the device, the patient is recommended to avoid strenuous physical activity for the next 3 days. The use, especially if prolonged, can give rise to sensitization phenomena; where this occurs, stop treatment and consult your doctor in order to establish appropriate therapy. It is important to report the appearance of undesirable effects not described in this package leaflet to the doctor or nurse.

Do not administer in case:

• sensitivity to hyaluronic acid and to the other components making up the device.
• if you have an infection or skin disease near the injection site
• of infections of the affected part
• strong inflammation of the affected part

Transient pain and stiffness; feeling of heat, redness and swelling. In such cases, the use of ice on the treated joint can alleviate and improve the aforementioned symptoms. If symptoms persist, seek medical attention. As in any invasive treatment, septic arthritis can occur if the appropriate precautions are not observed during the injection or the injection site is not aseptic.
Store the product in the original packaging at a temperature between 2 and 25 ° C, in a dry place and away from direct sunlight and frost. The expiry date is indicated on the package.

Ingredients and Composition

Sodium Salt Hyaluronic Acid [1.6%].

Format

Blister pack containing 3 sterile single-use pre-filled syringes for intra-articular injections.