Hymovis® 24mg / 3ml Fidia 2 pre-filled luer-lock syringes

Hymovis® 24mg / 3ml Fidia - MEDICAL DEVICE IN INTRA-ARTICULAR INJECTABLE SOLUTION

Class III medical device, rule 8 annex IX of MDD 93/42 / EEC and subsequent additions and amendments.

It is a sterile, non-pyrogenic hydrogel, produced with Hyadd4 (highly purified sodium hyaluronate hexadecylamide obtained from bacterial fermentation) in a buffered isotonic solution

Indications

It is indicated for the treatment of joint pain in osteoarthritis and for the improvement of joint mobility by increasing the viscoelasticity of the synovial fluid.

Steam sterilized + EtO To be administered by intra-articular injection only. The administration of the product must be done exclusively by the doctor. Sterility also on the external surface of the syringe allows intra-articular injection to be performed even in the operating room. A course of treatment consists of 2 injections administered at one week intervals from each other. Given its viscosity, slowly inject into the joint using an appropriate sterile needle (18 or 20 G). All rules regarding the aseptic administration technique must be strictly followed. If there is an effusion, remove it from the joint before administration.

No animal materials are included in the device nor are they used in the manufacturing process steps.

No human blood derivatives are included in the device nor are they used in the manufacturing process steps.

Main components

Hyadd4 (hexadecylamide disodium hyaluronate), 24 mg / 3 ml
Other ingredients: sodium chloride, disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injections.

Format

Pack with 2 pre-filled luer-lock syringes.