ARTROSULFUR® MSM + HA LABOREST® 3 Pre-filled Syringes

ARTROSULFUR® MSM + HA LABOREST® Medical Device

Artrosulfur® MSM + HA solution of MSM (Methylsulfonylmethane 5%) and hyaluronic acid (16 mg / ml) for intra-articular injection, pre-filled syringe.

Indications

Artrosulfur® MSM + HA is a substitute for synovial fluid in joints affected by degenerative or mechanical arthropathy, which causes pain or reduced mobility.

Action

Acts as a substitute for synovial fluid in joints affected by degenerative arthropathy.

How does Artrosulfur® MSM + HA work?

Artrosulfur® MSM + HA is a CE marked medical device compliant with MDD 93/42 / EEC, containing 16 mg / ml of hyaluronic acid obtained by fermentation and not chemically modified and MSM. Artrosulfur® MSM + HA is a clear, sterile, non-pyrogenic and viscoelastic solution supplied in a 2 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. Artrosulfur® MSM + HA acts only at the level of the joint where it is injected, without exerting any systemic action.

Method of use and dosage

Remove any joint effusion before injecting Artrosulfur® MSM + HA; the same needle must be used for effusion removal and injection of Artrosulfur® MSM + HA. Remove the protective cap of the syringe taking special care to avoid contact with the opening. Firmly screw the needle with a diameter between 18 and 22 G to the Luer type locking collar following the instructions below. Before injection treat the site with suitable disinfectant. Inject Artrosulfur® MSM + HA using aseptic technique. Inject into the joint cavity only. It is advisable to carry out an initial cycle of three treatment sessions, at intervals of one week from each other, possibly followed by maintenance sessions, according to the medical prescription.
1.Carefully unscrew the cap from the tip of the syringe, paying particular attention to avoid contact with the opening;
2. Gently grasp the needle shield and mount the needle onto the luer-lock connector, screwing firmly until a slight back pressure is felt to ensure a tight seal and prevent gel from escaping during administration.

Warnings and Contraindications

Artrosulfur® MSM + HA is only indicated for intra-articular injections and should only be dispensed by a physician who has received specific training in intra-articular injection technique. Before use, check the integrity of the syringe and the expiration date. Do not use needles other than those indicated. The product should not be injected in the presence of an infected or severely inflamed joint. Infiltration should be avoided in case of ongoing infections or inflammatory conditions of the skin near the site of infiltration. Since no clinical data are available on the use of hyaluronate in children, treatment with Artrosulfur® MSM + HA is not recommended in these cases. It is recommended that the patient be advised, after the intra-articular injection, to avoid physical activities that are demanding for the joint and to resume normal activities after a couple of days. Artrosulfur® MSM + HA is a single use product, quality and sterility are only guaranteed if the syringe is sealed. Any residue must therefore be disposed of and not reused even after a new sterilization. Do not use the product if the packaging is already open or damaged. The syringe complete with needle should be discarded immediately after use, even if the solution has not been fully administered. After use, eliminate according to the regulations in force.
There are incompatibilities between sodium hyaluronate and quaternary ammonium compounds, such as benzalkonium chloride solutions. Therefore, avoid contact between Artrosulfur® MSM + HA and these substances.
Some transient side reactions may occur following the injection of Artrosulfur® MSM + HA, 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. Any other unwanted side effects associated with Artrosulfur® MSM + HA injection should be reported to your doctor.
Store Artrosulfur® MSM + HA at 2-25 ° C (36-77 ° F) in a dry place in the original box. Protect from light, heat and frost. Keep out of the reach of children.

Ingredients and Composition

Main component: hyaluronic acid sodium salt 1.6%. Other ingredients: MSM (methylsulfonylmethane) 5%, sodium chloride, sodium phosphate and water for injections (to taste).

Format

3 Pre-filled syringes containing 2 ml of non-pyrogenic gel, sterilized with moist heat. 3 Needles of type 21-G. The needles are CE0476 sterile class IIa medical devices manufactured by Meika group Srl