Poliart 2.5Ml Sir Intra-Articular

Description
Medical device based on polynucleotides at a concentration of 10 mg/ml and sodium hyaluronate at a concentration of 10 mg/ml.
It is available as a sterile, pyrogen-free, viscoelastic solution packaged in single-use syringes.
Polynucleotides are naturally derived substances, highly purified and reabsorbed, they have viscoelastic properties and promote trophic effects on the joint.
Hyaluronic acid is one of the fundamental components of synovial fluid, which confers viscosity and elasticity properties.
PoliArt, improving the characteristics of synovial fluid, exerts a trophic and protective action on the joints, promoting both the enhancement of joint function and reduction of painful symptoms.
Indicated in cases of joint pathologies with pain attributable to degenerative, post-traumatic conditions, or joint alterations. PoliArt is a temporary substitute for synovial fluid that, thanks to its trophic, viscoelastic, and lubricating properties, favors the restoration of the rheological conditions of the joints. The product, by improving the features of synovial fluid, exerts a protective action on the joints and supports the physiological repair mechanisms at the level of articular cartilage.
PoliArt acts at the level of the joint where it is injected.
The outer surface of the syringe is not sterile.

Components
Each pre-filled syringe contains isotonic gel composed of: sodium hyaluronate, polynucleotides, mannitol, disodium phosphate dodecahydrate, monobasic sodium phosphate dihydrate, water for injections.
The syringe contents are sterile and pyrogen-free.

Directions for use
PoliArt should be administered using a sterile needle with a diameter between 18G and 22G, generally 20G, injecting the solution intra-articularly. Due to the viscosity of the solution, to ensure a watertight seal and prevent, during administration, the product from leaking between the needle and syringe. Screw the needle securely onto the luer-type closure of the syringe.
Intra-articular injection must be performed by medical personnel, observing the aseptic techniques prescribed for this method of administration.
The product should be injected into the joint cavity. The injection site must be on healthy skin.
The recommended treatment regimen is three injections into the joint to be treated, spaced one to three weeks apart.

Warnings
The use of PoliArt is contraindicated in individuals with hypersensitivity to the components of the product or with a history of allergy to fish-derived products.
The efficacy and safety of PoliArt have not been established in pregnant or breastfeeding women or in children: treatment is not recommended in these cases.
The product must not be injected into an infected or severely inflamed joint. Injection should be avoided in case of ongoing infections or skin inflammatory conditions near the injection site, to avoid the risk of bacterial arthritis.
It should be used with particular caution in cases of lymphatic or venous stasis of the limb to be treated.
In case of joint effusion, aspiration is advised before injecting the product.
Do not inject into veins.
It is recommended to advise the patient, after intra-articular injection, to avoid strenuous activities involving the joint and to resume normal activities after a couple of days.
PoliArt is a single-use product, any residual should be disposed of.
Possible adverse events associated with intra-articular injections such as pain, heat sensation, redness, swelling may occur. These symptoms are usually transient and subside shortly. These manifestations can be alleviated by resting the joint and applying ice locally. If symptoms persist, consult a doctor. The doctor must ensure that patients report any adverse effects observed after treatment.
Keep out of reach of children.
Check the integrity of the syringe packaging before use: do not use the product if the packaging appears opened or damaged.
Do not disperse into the environment after use. Do not use after the expiration date indicated on the box.
Do not freeze.
Once opened, the product must be used immediately and discarded after use.
PoliArt must be administered only by authorized personnel in accordance with local legislation.
Since sodium hyaluronate can precipitate in the presence of quaternary ammonium salts, the simultaneous use of PoliArt and products containing such substances should be avoided. Therefore, before application, it is recommended to remove disinfectants with sterile saline solution.

Storage
Store in a closed place, protected from direct light and heat at room temperature (0°-40°C).

Format
Glass syringe pre-assembled and pre-filled with 2.5 ml.

Code MD041V