PoliArt Gel for intra-articular infiltrations 2.5ml

Medical device based on polynucleotides at a concentration of 10 mg/ml and hyaluronic acid sodium salt at a concentration of 10 mg/ml.
It is presented as a sterile, non-pyrogenic, viscoelastic solution packaged in disposable syringes.
Polynucleotides are substances of natural origin, highly purified and reabsorbable, they have viscoelastic properties and perform a trophic action on the joint.
Hyaluronic acid is one of the fundamental components of the synovial fluid, to which it confers properties of viscosity and elasticity.
PoliArt, by improving the characteristics of the synovial fluid, exerts a trophic and protective action on the joints, favoring both the improvement of joint function and the reduction of painful symptoms.
Indicated in cases of joint pathologies pain attributable to degenerative, post-traumatic conditions or alterations of the joints. PoliArt is a temporary substitute for synovial fluid which, thanks to its trophic, viscoelastic and lubricating properties, favors the restoration of the rheological conditions of the joints. The product, by improving the characteristics of the synovial fluid, exerts a protective action on the joints and promotes the physiological repair mechanisms at the level of the articular cartilage.
PoliArt acts at the level of the joint into which it is injected.
The external surface of the syringe is not sterile.

Components
Each pre-filled syringe contains isotonic gel consisting of: hyaluronic acid sodium salt, polynucleotides, mannitol, sodium dibasic phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injections.
The contents of the syringe are sterile and non-pyrogenic.

How to use
PoliArt must be administered using a sterile needle with a diameter between 18G and 22G, generally 20G, injecting the solution intra-articularly. Given the viscosity of the solution, to ensure a watertight seal and prevent the product from leaking between the needle and syringe during administration. Screw the needle firmly onto the luer-type closure collar of the syringe.
Intra-articular infiltration must be performed by medical personnel, observing the asepsis rules prescribed for this method of administration.
The product it must be injected inside the joint cavity. The injection point must be on healthy skin.
The recommended treatment regimen is three infiltrations into the joint to be treated, one to three weeks apart.

Warnings
The use of PoliArt is contraindicated in subjects with individual hypersensitivity towards the components of the product or with a positive history of allergy to products of fish origin.
The efficacy and The safety of PoliArt has not been established in pregnant or breastfeeding women or in children: treatment, in these cases, is not recommended.
The product must not be injected in the presence of an infected or severely inflamed joint. The infiltration must be avoided in case of ongoing infections or inflammatory conditions of the skin near the site of the infiltration, to avoid the possibility of the onset of bacterial arthritis.
It must be used with particular attention in the presence of lymphatic stasis or venous vein of the leg to be treated.
In the presence of joint effusion, aspiration is recommended before injecting the product.
Do not inject into a vein.
It is advisable to advise the patient, after intra-articular injection, to avoid physical activities that are demanding on the joint and to resume normal activities after a couple of days.
PoliArt is a disposable product, any residue must be eliminated.
Adverse events associated with the practice of intra-articular injections are possible with PoliArt, such as: pain, sensation of heat, redness, swelling. These symptoms are generally transient and reduce after a short time. These manifestations can be contained by keeping the joint at rest and applying ice locally. If symptoms persist, contact a doctor. The doctor must ensure that patients inform him of any side effects that appear 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 is already open or damaged.
Do not dispose of in the environment after use. Do not use after the expiry date indicated on the carton.
Do not freeze.
Once opened, the product must be used immediately and discarded after use.
PoliArt must only be administered by authorized personnel in accordance with local legislation.
Since hyaluronic acid sodium salt can precipitate in the presence of quaternary ammonium salts, the simultaneous use of PoliArt and products containing these substances should be avoided. Therefore, before application, it is recommended to remove the disinfectant with sterile physiological solution.

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

Format
Pre-assembled and pre-filled glass syringe of 2.5 ml.
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