Description
PolyArt 2.5 ml
Gel for intra-articular infiltrations
with polynucleotides and hyaluronic acid
Description
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 comes as a sterile, apyrogenic, viscoelastic solution packaged in disposable syringes.
Polynucleotides are substances of natural origin, highly purified and reabsorbable, have viscoelastic properties and perform a trophic action on the joint.
Hyaluronic acid is one of the fundamental components of synovial fluid, to which it gives properties of viscosity and elasticity.
PoliArt, improving the characteristics of the synovial fluid, exerts a trophic and protective action on the joints, promoting both the improvement of joint functionality and the reduction of painful symptoms.
Indicated in cases of joint pathologies pain attributable to degenerative conditions, post-traumatic or joint alterations. PoliArt is a temporary substitute for synovial fluid which, thanks to its trophic, viscoelastic and lubricating properties, promotes the restoration of the rheological conditions of the joints. The product, 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 outer surface of the syringe is not sterile.
Components
Each pre-filled syringe contains isotonic gel consisting of: hyaluronic acid sodium salt, polynucleotides, mannitol, sodium phosphate dibasic dodecahydrate, sodium phosphate monobasic dihydrate, water for injections.
The contents of the syringe are sterile and non-pyrogenic.
How to use
PoliArt should 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, during administration, the leakage of the product between the needle and the syringe. Screw the needle tightly to the luer-type closure collar of the syringe.
Intra-articular infiltration must be performed by medical personnel, observing the aseptic rules prescribed for this administration method.
The product should be injected into the joint cavity. The injection site should be on healthy skin.
The recommended treatment regimen is three injections into the joint to be treated, one to three weeks apart.
Warnings
The use of PoliArt is contraindicated in subjects with individual hypersensitivity to the components of the product or with a positive history of allergy to products of fish origin.
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 should not be injected in the presence of an infected or severely inflamed joint. Infiltration should be avoided in case of active infections or inflammatory conditions of the skin near the site of infiltration, in order to avoid the possibility of bacterial arthritis.
It must be used with particular caution in the presence of lymphatic or venous stasis in 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 the intra-articular injection, to avoid physical activities that are demanding for 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 intra-articular injections are possible with PoliArt, such as: pain, sensation of heat, redness, swelling. These symptoms are generally transitory and reduce after a short time. These manifestations can be contained by keeping the joint at rest and applying ice locally. If the symptoms persist, contact a doctor. The doctor must ensure that patients inform him of any adverse 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 package.
Do not freeze.
Once opened, the product must be used immediately and discarded after use.
PoliArt must be administered only by authorised 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 saline solution.
Conservation
Store in a closed place, away from direct light and heat at room temperature (0°-40°C).
Format
Pre-assembled and pre-filled 2.5ml glass syringe.
Cod. MD041V
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 comes as a sterile, apyrogenic, viscoelastic solution packaged in disposable syringes.
Polynucleotides are substances of natural origin, highly purified and reabsorbable, have viscoelastic properties and perform a trophic action on the joint.
Hyaluronic acid is one of the fundamental components of synovial fluid, to which it gives properties of viscosity and elasticity.
PoliArt, improving the characteristics of the synovial fluid, exerts a trophic and protective action on the joints, promoting both the improvement of joint functionality and the reduction of painful symptoms.
Indicated in cases of joint pathologies pain attributable to degenerative conditions, post-traumatic or joint alterations. PoliArt is a temporary substitute for synovial fluid which, thanks to its trophic, viscoelastic and lubricating properties, promotes the restoration of the rheological conditions of the joints. The product, 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 outer surface of the syringe is not sterile.
Components
Each pre-filled syringe contains isotonic gel consisting of: hyaluronic acid sodium salt, polynucleotides, mannitol, sodium phosphate dibasic dodecahydrate, sodium phosphate monobasic dihydrate, water for injections.
The contents of the syringe are sterile and non-pyrogenic.
How to use
PoliArt should 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, during administration, the leakage of the product between the needle and the syringe. Screw the needle tightly to the luer-type closure collar of the syringe.
Intra-articular infiltration must be performed by medical personnel, observing the aseptic rules prescribed for this administration method.
The product should be injected into the joint cavity. The injection site should be on healthy skin.
The recommended treatment regimen is three injections into the joint to be treated, one to three weeks apart.
Warnings
The use of PoliArt is contraindicated in subjects with individual hypersensitivity to the components of the product or with a positive history of allergy to products of fish origin.
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 should not be injected in the presence of an infected or severely inflamed joint. Infiltration should be avoided in case of active infections or inflammatory conditions of the skin near the site of infiltration, in order to avoid the possibility of bacterial arthritis.
It must be used with particular caution in the presence of lymphatic or venous stasis in 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 the intra-articular injection, to avoid physical activities that are demanding for 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 intra-articular injections are possible with PoliArt, such as: pain, sensation of heat, redness, swelling. These symptoms are generally transitory and reduce after a short time. These manifestations can be contained by keeping the joint at rest and applying ice locally. If the symptoms persist, contact a doctor. The doctor must ensure that patients inform him of any adverse 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 package.
Do not freeze.
Once opened, the product must be used immediately and discarded after use.
PoliArt must be administered only by authorised 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 saline solution.
Conservation
Store in a closed place, away from direct light and heat at room temperature (0°-40°C).
Format
Pre-assembled and pre-filled 2.5ml glass syringe.
Cod. MD041V
