Description
Sterile hydrogel, produced with Hyadd4 (hexadecylamide of highly purified natural sodium hyaluronate obtained by bacterial fermentation) in buffered isotonic solution. Thanks to the high viscosity and elasticity provided by hexadecylamide of sodium hyaluronate, HYMOVIS improves the lubricating and shock-absorbing function of the synovial fluid, protecting cartilage and soft tissues from mechanical damage. These properties, together with its prolonged residence time in the joints, allow HYMOVIS to relieve pain and improve joint function for up to six months in mild or moderate osteoarthritis of any nature, affecting the hip and knee.
Indicated for the treatment of patients suffering from mild or moderate osteoarthritis of the knee and hip. The device is indicated for the treatment of osteoarthritis of any nature.
HYMOVIS is administered exclusively via intra-articular injection.
The product must be administered exclusively by specialized medical personnel (e.g., orthopedic surgeon, rheumatologist, physiatrist, radiologist, sports medicine physician, etc.).
Remove any joint effusion, if present, before administration. Inject only intra-articularly. Intra-articular injection must be performed according to standard usual technique, with precise anatomical localization. For the hip, ultrasound or fluoroscopic guidance is recommended. Strictly follow all rules of aseptic administration.
Due to its viscosity, inject HYMOVIS slowly into the joint using an appropriate sterile needle (18 or 20 G).
One treatment consists of a single injection. No clinical data is available for more than one injection with HYMOVIS.

Components
Main component: Hyadd4 (hexadecylamide of sodium hyaluronate), 32 mg/4 ml.
Other components: sodium chloride, disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injections.

Warnings
If venous or lymphatic stasis is present in the affected limb, HYMOVIS should not be injected into the joint.
Do not administer to patients with known individual hypersensitivity to the product components or in cases of infections or skin conditions in the injection area.
Treatment should be avoided if the joint shows signs of acute inflammation.
The safety and efficacy of using HYMOVIS with other intra-articular treatments have not been established.
For the first 48 hours after injection, the patient can perform all daily routine activities, but it is advisable not to overload the treated joint.
The syringe is for single use; inject the content into one joint only. The assembled syringe must be disposed of immediately after use, regardless of whether the hydrogel has been fully administered or not.
If the product is reprocessed and/or reused, Fidia farmaceutici cannot guarantee its performance, functionality, material structure, cleanliness or sterility. Reuse can lead to illness, infection, and/or serious harm to the patient or user.
Do not use HYMOVIS after the expiry date printed on the carton. The expiry date refers to the product correctly stored in its original packaging.
Do not use HYMOVIS if the package is open or damaged.
Keep out of reach of children.

Storage
Store in the original packaging between 2 °C and 25 °C. Do not freeze.

Format
Carton containing 1 pre-filled luer lock syringe.

Code 10001310