Description
Sterile hydrogel, manufactured with Hyadd4 (hexadecylamide of highly purified natural sodium hyaluronate obtained from bacterial fermentation) in buffered isotonic solution. Thanks to the high viscosity and elasticity provided by hexadecylamide of sodium hyaluronate, HYMOVIS MO.RE. improves the lubricating and shock-absorbing function of the synovial fluid, protecting cartilage and soft tissues from mechanical damage. These properties, combined with its prolonged residence in the joints, allow HYMOVIS MO.RE. to relieve pain and improve joint function for up to six months in mild or moderate osteoarthritis of any nature, in 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 MO.RE. is administered exclusively by intra-articular injection.
The product must be administered exclusively by specialized medical personnel (e.g., orthopedic surgeon, rheumatologist, physiatrist, radiologist, sports physician, etc.).
Remove any joint effusion, if present, before administration. Inject only intra-articularly. Intra-articular injection should be performed according to the usual standard 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 MO.RE. slowly into the joint using an appropriate sterile needle (18 or 20 G).
A treatment consists of a single injection. No clinical data are available with more than one HYMOVIS MO.RE. injection.

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 MO.RE. should not be injected into the joint.
Do not administer to patients with known individual hypersensitivity to the product components or in case 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 MO.RE. with other intra-articular treatments has not been established.
For the first 48 hours after the injection, the patient can carry out all daily routine activities, but it is advisable not to overload the treated joint.
The syringe is for single use; inject the content into only one joint. 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 may lead to illness, infection and/or serious harm to the patient or user.
Do not use HYMOVIS MO.RE. after the expiration date printed on the carton. The expiration date refers to the product stored correctly in its original packaging.
Do not use HYMOVIS MO.RE. 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
Box containing 1 pre-filled luer lock syringe.

Code 10001309