Indication:
ARTOSYAL40 M is a synovial fuid substitute 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 fuid of the knee, exerts a protective action of this joint with a consequent improvement of the functionality and reduction of pain symptoms.
ARTOSYAL 40 M acts only at the joint where it is injected, without exerting any systemic action.
Ingredients:
Sodium hyaluronate 20 mg/ml, sodium chloride, sodium dihydrogen phosphate dihydrate, dibasic sodium phosphate dodecahydrate, WFI grade water
PHARMACOLOGICAL & Pharmacodynamic properties:
ARTOSYAL40 M is a sterile, biodegradable, isotonic, injectable gel, for intra-articular use. ARTOSYAL40 M 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 bufer. ARTOSYAL40 M is characterised by viscoelastic properties, therefore allows to facilitate the normalisation of the viscosity of the synovial fuid present in the intra-articular cavity
Daily Dose:
Remove any joint efusion before injecting ARTOSYAL40 M; for the removal of the efusion and the injection of ARTOSYAL40 M 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 must be treated with appropriate disinfectant. Inject ARTOSYAL40 M adopting aseptic technique. Inject only into the joint cavity. It is recommended to perform an initial cycle of 2 to 3 treatments at a distance of not less than one week of each other depending on the needs of individual patients, possibly followed by maintenance sessions according to the medical prescription.
Contraindication:
ARTOSYAL40 M must not be used in patients under 18 years of age
Possible side effects:
There may be some temporary side reactions following injection of ARTOSYAL40 M, such as pain, stifness, warmth, redness or swelling. These secondary manifestations may be relieved by applying ice on the treated articulation. Usually these efects disappear after a short time. If symptoms persist, consult a physician. Any other unwanted side efects associated with the injection of ARTOSYAL40 M 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
warnings and precautions:
ARTOSYAL M is suitable only for intra-articular injections and must only be dispensed by a doctor who has received specifc 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 infamed joint. The infltration must be avoided in the case of infections in place or infammatory 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.
CAUTION: the exterior of the syringe is not sterile.
Since ARTOSYAL M has not been tested in pregnant or breastfeeding women, its use in such cases is not recommended.
ARTOSYAL M must not be used in patients under 18 years of age. Being ARTOSYAL M 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 syringe into a suitable container according to current legislation.
Drug Interaction:
There are incompatibilities between sodium hyaluronate and quaternary ammonium compounds, such as solutions of benzalkonium chloride. Contact between ARTOSYAL 40M and these substances must be therefore avoided.
Pregnancy and luctation:
Since ARTOSYAL 40 M has not been tested in pregnant or breastfeeding women, its use in such cases is not recommended.
Suitable for:
Patients above 18 years of age
Storage condition:
Store ARTOSYAL40 M 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
