Hymovis Mo.Re.

Sterile hydrogel, produced with Hyadd4 (highly purified natural sodium hyaluronate hexadecyl amide obtained from bacterial fermentation) in buffered isotonic solution. Thanks to the high viscosity and elasticity given by sodium hexadecyl amide hyaluronate, HYMOVIS MO.RE. improves the lubricating and shock-absorbing function of the synovial fluid, protecting the cartilage and soft tissues from mechanical injuries. These properties, combined with the prolonged stay in the joints, allow HYMOVIS MO.RE. to relieve pain and improve joint function for up to six months in osteoarthritis of any nature, mild or moderate, of the hip and knee.
Indicated for the treatment of patients suffering from mild or moderate osteoarthritis of the knee and hip. The device È indicated for the treatment of osteoarthritis of any nature.
Thanks to its properties; lubricants, it is used to reduce pain and improve functionality knee and hip joint.

Mode of use
It is administered exclusively by intra-articular injection. The administration of the product must be done exclusively by specialized medical personnel (e.g. orthopedic surgeon, rheumatologist, physiatrist, radiologist, sports doctor, etc.). Sterility of the external surface of the syringe allows the use of the product in the operating room. Remove any joint effusion, if present, before administration. Inject exclusively intra-articularly. The intra-articular injection must be performed according to the usual standard technique, with precise anatomical localization. In the hip, ultrasound or radioscopic guidance is recommended. Strictly follow all the rules of aseptic administration. Given its viscosity, inject HYMOVIS MO.RE. slowly into the joint using an appropriate sterile needle (18 or 20 G). One treatment consists of just one injection. There are no clinical data available with more of an injection with HYMOVIS MO.RE.

Components
Hyadd4 (sodium hexadecyl amide hyaluronate) 32 mg/4 ml. sodium chloride, disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injections.

Warnings
If È venous or lymphatic stasis present in the affected limb, HYMOVIS MO.RE. it must not be injected into the joint. Do not administer to patients with proven hypersensitivity. individual to the components of the product or in case of infections or skin pathologies in the injection area.
The safety and effectiveness of HYMOVIS MO.RE. on pregnant or breastfeeding women or on subjects under 18 years of age have not been ascertained and therefore use is contraindicated in these patient populations.
Treatment should be avoided if the joint shows signs of acute inflammation. The safety and effectiveness of using HYMOVIS MO.RE. with other intra-articular treatments it is not been ascertained. For the first 48 hours after the injection, the patient can carry out all the activities of daily routines, but it is advisable not to overload the treated joint. The syringe È single use; inject the contents into only one joint. The assembled syringe should be discarded immediately after use, regardless of whether or not the hydrogel has been completely administered. If the product is reworked 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 MO.RE. after the expiry date printed on the box. The expiry date refers to the product correctly stored in its original packaging. Do not use HYMOVIS MO.RE. if the packaging is open or damaged. Keep out of reach of children.
Local side effects such as pain, swelling/effusion, warmth and redness may occur at the injection site. These symptoms are generally mild and transient. After the intra-articular injection, the application of an ice pack on the treated joint for 5-10 minutes reduces the incidence of such events. Local or systemic allergic reactions may occur in individuals with hypersensitivity to to the components of the product. More inflammatory reactions marked have been reported with sodium hyaluronate-based products for intra-articular use. As with any intra-articular treatment, on rare occasions it may septic arthritis may occur if the injection is not carried out in compliance with general aseptic precautions.
Do not use together with disinfectants containing quaternary ammonium salts, because they sodium hexadecylamine hyaluronate can fall in their presence. Avoid simultaneous administration of HYMOVIS MO.RE. and other intra-articular products in order to prevent any possible interaction.
Do not freeze.

Storage
Store at a temperature between 2°C and 25°C.
Validity with unopened package: 48 months.
Validity after first opening: 12 months.

Format
1 luer lock syringe.