PRODUCT DESCRIPTION
Hyalubrix è una soluzione sterile, apirogena, viscoelastica prodotta con acido ialuronico sale sodico,ottenuto per fermentazione batterica da una frazione ad alto peso molecolare (>1.500kDa). L'acido ialuronico, un polisaccaride della famiglia dei glicosamminoglicani,è naturalmente presente in molti tessuti umani come la cartilagine e il liquidosinoviale: è continuamente secreto nella cavità articolare e rappresenta ilmaggior componente liquido sinoviale, al quale fornisce la sua caratteristicaviscosità ed elasticità. Tali proprietà sono fondamentali perchè il fluido svolga le funzioni dilubrificante e ammortizzatore nelle articolazioni normali, al fine di proteggere lacartilagine e i tessuti molli da danni meccanici. In patologie traumatiche e degenerativedelle articolazioni la quantità di acido ialuronicodiminuisce e il liquidosinoviale perde viscosità, provocando una compromissione della funzione e unasintomatologia dolorosa.
Composition
Hyaluronic acid sodium salt 1.5%, sodium chloride, sodium phosphate bibasico12h2Or, sodium monobasic phosphate 2h2Or, water for preparationsinettable.
Methods of use
Inject Hyalubrix, using a suitable sterile needle (for example 18 or 20 g), in the articulation damaged at weekly intervals for a total of 3 weeks.Senecessary, further injections can be performed.The administration of the product would be performed exclusively by specialist doctors.The rules concerning Asepsi and injective techniques must be observed.If you present unversure, remove it before injecting Hyalubrix.The sterility also on the external hope of the syringe makes the product suitable for use in the operating room.
Warnings
Do not administer to patients with ascertained individual sensitivity to components produced in the case of infections or skin diseases in the injection area. If studies performed on laboratory animals indicate that the product has no toxicity toxicity on reproduction and development, Hyalubix was not testedIn pregnant women.Do not use if the package is damaged.Do not use the product after the date discharge shown on the package.The expiration date refers to the Productsconscious in its original packaging at a temperature not exceeding 25 ° C. Hyalubrix is disposable, which means that it is to be used once only an exuter of a single patient.The complete syringe of needle must be eliminated immediately after use, even if the solution has not been completely administered.If the prophilated is reworked and/or reused, Fidia pharmaceuticals cannot guarantee it performance, the functionality, the structure of the material, the foreign cleaning.The reuse can lead to illness, infection and/or damage or the user.After use delete according to current regulations.Keep out of reach of children.
Undesirable effects: localized pain, swelling, heat and redness can occur in the injection site.These symptoms are generally mild and transient. Overcoming more marked inflammatory with the presence of fodiopirofosphate crystals, they were occasionally reported in conjunction with hyaluroned injections.As with any intra -roundal treatment, you could rarely be a septic arthritis, if precautionaryly observed for injections or the point of injection are not aseptic.
Interactions: do not use in conjunction with disinfectants containing ammonium -sotone salts, because hyaluronic acid can precipitate in their presence. Esper the simultaneous administration of Hyalubrix with other products for use -articular use, in order to prevent any possible interaction.
storage
Store at a temperature not exceeding 25 ° C.
Integral packaging validity: 18 months.
Format: Case containing 1 pre-crushed syringe.
