EASYAL 2ml-40mg İntra Articular İnjection

PRODUCT DESCRIPTION:

EASYAL is a sterile, biodegradable, isotonic, injectable gel, for intra-articular use. EASYAL consists of medium chain (1,0-1,5 x 106 Dalton) hyaluronic acid, obtained from Streptococcus equi bacteria, formulated to a concentration of 20 mg/ml in a physiologic buffer. EASYAL 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 EASYAL and a product leaflet. A set of two labels showing the batch number is contained in the box. One of these labels should be attached to the patient’s file and the other should be given to the patient to ensure traceability.

COMPOSITION: Sodium hyaluronate 20 mg/ml, sodium chloride, sodium dihydrogen phosphate dihydrate, dibasic sodium phosphate dodecahydrate, WFI grade water.

INDICATIONS: EASYAL is a synovial fluid substitute which, thanks to its viscoelastic and lubricant properties, promotes the restoration of rheological conditions of the joints, altered in degenerative or post-traumatic conditions. The product, improving the characteristics of the synovial fluid, exerts a protective action of the joints and helps the improvement of joint function and the reduction of pain symptoms. EASYAL acts only at the joint where it is injected, without exerting any systemic action.

WARNINGS - PRECAUTIONS FOR USE: EASYAL is suitable only for intra-articular injections and must only be dispensed by a doctor. Before use, check the integrity of the syringe and the expiration date. Do not use needles other than those listed. The product should not be injected in the presence of a 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 stress for the articulation and resume normal activities after a few days. EASYAL has not been tested in pregnant or lactating women. EASYAL is a disposable product, the quality and sterility are guaranteed only if the syringe is sealed. Any residue must be discarded and not reused even after new sterilisation. Do not use the product if the package is already opened or damaged. After use, dispose of the needle into a suitable container.

INCOMPATIBILITIES: There are incompatibilities between sodium hyaluronate and quaternary ammonium compounds, such as solutions of benzalkonium chloride. Contact between EASYAL and these substances should be therefore avoided.

SIDE EFFECTS: There may be some temporary side reactions following injection of EASYAL, such as pain, stiffness, warmth, redness or swelling. These secondary manifestations may be relieved 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 EASYAL should be reported to a doctor.

METHODS OF USE: Remove any joint effusion before injecting EASYAL; for the removal of the effusion and the injection of EASYAL the same needle must be used. Remove the protective cap of the syringe, with particular attention to avoid contact with the opening. Firmly screw the needle, of diameter between 18 and 22 g, at the collar of Luer lock, following the instruction given below. Before injection, the site should be treated with appropriate disinfectant. Inject EASYAL adopting aseptic technique. Inject only into the joint cavity. It is recommended to perform an initial cycle of 3 to 5 weekly treatments, possibly followed by maintenance sessions, according to the medical prescription.

STORAGE: Store EASYAL at 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 heat.

COMPOSITION: sodium hyaluronate, sodium chloride, sodium dihydrogen phosphate dihydrate, dibasic sodium phosphate dodecahydrate, WFI grade water..