Description
A synovial fluid substitute that, thanks to its viscoelastic and lubricating properties, promotes the restoration of impaired joint function in patients with degenerative osteoarthritis. By improving the properties of synovial fluid, the product protects joints, resulting in improved joint function and a reduction in pain. Focusial intra M acts only on the joint into which it is injected, without exerting any systemic effect.
Sterile, biodegradable, isotonic injectable gel for intra-articular use. Focusial intra M consists of a medium molecular weight hyaluronic acid, produced by Sterptococcus equi bacteria, formulated at a concentration of 20 mg/ml in a physiological buffer. Focusial intra M is characterized by viscoelastic properties, thus promoting normalization of the viscosity of the synovial fluid present in the intra-articular cavity.

How to use
Remove any joint effusion before injecting Focusial intra M.
Remove the protective cap from the syringe, taking particular care to avoid contact with the opening. Tightly screw the 18-22 gauge needle onto the Luer collar following the instructions below. Before injection, treat the site with a suitable disinfectant. Inject Focusial intra M using aseptic technique. Inject only into the intra-articular cavity. The use of Focusial intra M is at the discretion of the physician. Focusial intra M should be used according to the needs of individual patients, the area, and the pathology being treated.
A. Carefully unscrew the cap from the tip of the syringe, taking special care to avoid contact with the opening.
B. Gently grasp the needle shield and attach the needle to the Luer-Lock fitting, screwing firmly until you feel slight back pressure to ensure a watertight seal and prevent gel leakage during administration.

Components
Sodium hyaluronate 20 mg/ml, sodium chloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dodecahydrate, water for injections.

Warnings
Focusial intra M is indicated only for intra-articular injections and should be used exclusively by physicians specifically trained 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 into an infected or severely inflamed joint. Injection should be avoided in cases of active infection or inflammatory conditions of the joint, and normal activities should be resumed after a few days.
The outside of the syringe is not sterile.
Focusial intra M has not been tested in pregnant or breastfeeding women, so its use is not recommended in these cases. It should not be used in patients under 18 years of age. As it is a single-use product, quality and sterility are guaranteed only if the syringe is originally sealed. Any residue must therefore be disposed of and not reused, even after re-sterilization. Do not use the product if the packaging is already opened or damaged. After use, dispose of the syringe in a suitable container in accordance with current regulations. Keep out of reach of children. For medical use only.

Conservation
Store at 2-25°C in a dry place in the original packaging. Protect from light, heat, and frost.

Format
A syringe and a leaflet.

Code 1212