ARTOSYAL H 2ml.
2% Hyaluronic acid sodium salt for intra-articular use
INDICATIONS:
ARTOSYAL H is a synovial which, thanks to its viscoelastic and lubricant properties, promotes the restoration of rheological conditions of the joints, altered in patients with degenerative osteoarthritis of the knee. The product, improving the characteristics of the synovial fluid of the knee, exerts a protective action of this joint with a consequent improvement of the functionality and reduction of pain symptoms. ARTOSYAL H acts only at the joint where it is injected, without exerting any systemic action.
PRODUCT DESCRIPTION:
ARTOSYAL H is a sterile, biodegredable, isotonic, injectable gel, for intra-articular use, ARTOSYAL H consists of hyaluronic acid with a medium molecular weight, obtained from Streptococcus equi bacteria, formulated to a concentration of 20 mg/ml in a physiologic buffer. ARTOSYAL H is characterised by viscoelastic properties, therefore allows to facilitate the normalisation of the viscosity of the synovial fluid present in the intra-articular cavity. Each box contains one syringe of ARTOSYAL H and a product leaflet. A set of two labels showing the batch number is contained in the box. One of these labels must be attachede to the patient’s file and the other must be given to the patient to ensure traceability.
COMPOSITION:
Sodium hyaluronate 20 mg/m, sodium chloride, sodium dihydrogen phosphate dihydrate, dibasic sodium phosphate dodecahydrate,WFI grade water.
METHODS OF USE:
Remove any joint effusion before injecting ARTOSYAL H ; fort he removal of the effusion and the injection of ARTOSYAL H the same needle must be used. Remove the protective cap of the syringe, with particularattention to avoid contact with the opening. Firmly screw the needle, of diameter betwen 18 and 22 g, at the collar of Luer lock, following the instruction given below. Before injection the sitemust be treated with appropriate disinfectant. Inject ARTOSYAL H adopting aseptic technique. Inject only into the joint cavity. It is recommended to perform an initial cycle of 2-3 treatments ar a distance of not less than one week of each other depending on the needs of individual patients, possibly followed by maintenance sesions according to the medical prescription. .
INSTRUCTIONS FOR ASSEMBLY OF THE SYRINGE NEEDLE:
A.Carefully unscrew the cap of the syringe, being particularly careful to avoid contact with the opening.
B.Gently grip the needle guard and mount the needle on the luer-lock mount, screwing it tight until a slight counterpressure is felt in order to ensure an airtight grip and prevent leakage of the liquid during administration.
WARNINGS – PRECAUTIONS FOR USE:
ARTOSYAL H is suitable only for intra-articular injevtions and must only be dispensed by a doctor who hasreceived specific training on the intra-articular injection technique. Before use, check the integrity of the syringe and the expiration date. Do not use needles other than those listed. The product must not be injected in the presence of an infected or severely inflamed joint. The infiltration must be avoided in the case of infections in place or inflammatory conditions of the skin in proximity of the injection. After the intra-articular injection it is advisable to recommend to the patient to avoid physical activities demanding stres fort he articulation and rsume normal activities after a few days.
CAUTİON:
The exterior of the syringe is not sterile.
Since ARTOSYAL H has not been tested in pregnant or breastfeeding women, its use in such cases is not recommended.
ARTOSYAL H ARTOSYAL H has not been tested in patients under 18 years of age. Being ARTOSYAL H a disposable product; the quality and sterility are guaranteed only if the syringe is sealed. Any resudie must be discarded and not reused evn after new sterilisation.
Do not use the product if the package is already opened or damaged. After use, dispose of the syringe into a suitable container according to current legislation.
SIDE EFFECTS:
There may be some temporary side reactions following injection of ARTOSYAL H, such as pain, stiffness, warmth, redness or swelling. These secondary manifestations may be relived by applying ice on the treated articulation. Usually these effects disappear after a short time. If symptoms persist, consult a physician. Any other unwanted side effects associated with the injection of ARTOSYAL H must be reported to a doctor. As for any intra-articular treatment, septic arthritis may rarely occur when general precautions for injections are not observed or the site of injection is not aseptic.
INCOMPATIBILITIES:
There are incompatibilitiesbetween sodium hyaluronate and quaternary ammonium compounds, such as solutions of benzalkonium chloride. Contact between ARTOSYAL H and these substances must be therefore avoided.
STORAGE:
Store ARTOSYAL H at 2-2.25°C (36-77°F) in a dry place in the original box. Protect from light, heat and frost. Keep out of reach of children.
CONTENTS OF THE PACK:
Pre-filled syringe containing 2 ml or 4 ml of non pyrogenic gel, sterilised using moist heath.
