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0.C.ART is a sterile injectable, biodegradable and isotonic gel. for intra-articular use. O.C. ART consists of a medium molecular weight hyaluronic acid, produced by Streptococcus equi bacteria, formulated at a concentration of 20 mg/ml in a physiological buffer. O.C. ART is characterized by viscoelastic properties, therefore it allows to favor the normalization of the viscosity of the synovial fluid present in the intra-articular cavity. Each pack contains a vial-syringe of O.C.ART and a leaflet. There are two labels showing the batch number and the expiry date. One of these labels must be applied to the patient's medical record and the other must be given to the patient to ensure traceability.
20 mg/ml sodium hyaluronate, sodium chloride, monobasic sodium phosphate dihydrate, dibasic sodium phosphate dedecahydrate, water p.p.i. One syringe contains 2.0 ml of non-pyrogenic gel, sterilized with moist heat.
O.C. ART is a substitute for synovial fluid which, thanks to its viscoelastic and lubricating properties, favors the restoration of the rheological conditions of altered joints in the case of degenerative or post-traumatic conditions. The product, by improving the characteristics of the synovial fluid, exerts a protective action on the joints and promotes the improvement of joint function and the reduction of painful symptoms. 0.C.ART acts only at the level of the joint into which it is injected, without exerting any systemic action.
PRECAUTIONS FOR USE
0.C.ART is indicated only for intra-articular injections and must be administered exclusively by a doctor. 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 must be avoided in case of active infections or inflammatory conditions of the skin near the site of infiltration. It is advisable to recommend to the patient. after the intra-articular injection, to avoid physical activities that are demanding on the joint and to resume normal activities after a couple of days. 0.C.ART has not been tested in pregnant or breastfeeding women. 0.C.ART is a disposable product, quality and sterility are guaranteed only if the syringe is sealed. Any residue must therefore be disposed of and not reused even following new sterilization. Do not use the product if the packaging is already open or damaged. After use, dispose of the needle in a suitable container.
Incompatibilities exist between d sodium hyaluronate and quaternary ammonium compounds, such as benzalkonium chloride solutions. Therefore, avoid contact between 0.C.ART and these substances.
Store o.c.art 80 MG at 2-25 °C (36-37 °F) in a dry place in the original box.
Protect from light, heat and frost and handle with care.
CE mark registration number 1014
FOR DOCTOR USE ONLY
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