Descrizione Clinica
HYMOVIS MO.RE.
Description
Sterile hydrogel, produced with Hyadd4 (highly purified natural hyaluronate sodium hexadecilamid obtained from bacterial fermentation) in a buffered isotonic solution. Thanks to the high viscosity and elasticity given by hyaluronate sodium hexadecilamid, HYMOVIS MO.RE. improves the lubricating and shock absorption function of the synovial liquid, protecting cartilage and soft tissues from mechanical injuries. These properties, together with the prolonged stay in the joints, allow to HYMOVIS MO.RE. to relieve pain and to improve up to six months the joint function in osteoarthritis of any mild or moderate nature, hip and knee.
Suitable for treating patients with mild or moderate osteoarthritis of the knee and hip. The device is indicated for the treatment of osteoarthritis of any kind.
HYMOVIS MO.RE. 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, physiologist, radiologist, sports doctor, etc.).
Remove any joint deposit, if present, before administration. Inject only intra-articularly. Intra-articular injection must be performed according to the usual standard technique, with a precise anatomical location. In the hip, we recommend the ultrasound or radioscopic guide. Strictly follow all rules of administration in asepsis.
Given its viscosity, inject HYMOVIS MO.RE. slowly in the joint using an appropriate sterile needle (18 or 20 G).
One treatment consists of one injection. Clinical data with more than one injection with HYMOVIS MO.RE.
Components
Main component: Hyadd4 (hyaluronate sodium hexadecilamyde), 32 mg/4 ml.
Other components: chloride sodium, disodium hydrogenphosphate dodecahydrate, sodium hydrogenphosphate dihydrate, water for injectable preparations.
Warnings
If there is venous or lymphatic stasis in the affected limb, HYMOVIS MO.RE. should not be injected into the joint.
Do not give patients with proven individual hypersensitivity to product components or in case of infections or skin diseases in the injection area.
Treatment should be avoided if the joint shows signs of acute inflammation.
The safety and effectiveness of use HYMOVIS MO.RE. with other intra-arctic treatments has not been established.
For the first 48 hours after injection, the patient can perform all daily routine tasks, but it is recommended not to overload the treated joint.
The syringe is disposable; inject the content into one joint. The assembled syringe must be eliminated immediately after use, regardless of whether or not the hydrogel was administered completely.
If the product is re-elaborated and/or reused, Pharmaceutical Fidia cannot guarantee its performance, functionality, material structure, cleaning or sterility. Reuse can lead to disease, infection and/or serious damage to the patient or user.
Do not use HYMOVIS MO.RE. after the expiry date printed on the case. The expiration date refers to the product correctly stored in its original packaging.
Do not use HYMOVIS MO.RE. if the package is open or damaged.
Keep away from the reach of children.
Conservation
Store in the original packaging between 2 °C and 25 °C. Don't freeze.
Format
Cap containing 1 luer lock pre-filled syringe.
Cod. 10001309
Sterile hydrogel, produced with Hyadd4 (highly purified natural hyaluronate sodium hexadecilamid obtained from bacterial fermentation) in a buffered isotonic solution. Thanks to the high viscosity and elasticity given by hyaluronate sodium hexadecilamid, HYMOVIS MO.RE. improves the lubricating and shock absorption function of the synovial liquid, protecting cartilage and soft tissues from mechanical injuries. These properties, together with the prolonged stay in the joints, allow to HYMOVIS MO.RE. to relieve pain and to improve up to six months the joint function in osteoarthritis of any mild or moderate nature, hip and knee.
Suitable for treating patients with mild or moderate osteoarthritis of the knee and hip. The device is indicated for the treatment of osteoarthritis of any kind.
HYMOVIS MO.RE. 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, physiologist, radiologist, sports doctor, etc.).
Remove any joint deposit, if present, before administration. Inject only intra-articularly. Intra-articular injection must be performed according to the usual standard technique, with a precise anatomical location. In the hip, we recommend the ultrasound or radioscopic guide. Strictly follow all rules of administration in asepsis.
Given its viscosity, inject HYMOVIS MO.RE. slowly in the joint using an appropriate sterile needle (18 or 20 G).
One treatment consists of one injection. Clinical data with more than one injection with HYMOVIS MO.RE.
Components
Main component: Hyadd4 (hyaluronate sodium hexadecilamyde), 32 mg/4 ml.
Other components: chloride sodium, disodium hydrogenphosphate dodecahydrate, sodium hydrogenphosphate dihydrate, water for injectable preparations.
Warnings
If there is venous or lymphatic stasis in the affected limb, HYMOVIS MO.RE. should not be injected into the joint.
Do not give patients with proven individual hypersensitivity to product components or in case of infections or skin diseases in the injection area.
Treatment should be avoided if the joint shows signs of acute inflammation.
The safety and effectiveness of use HYMOVIS MO.RE. with other intra-arctic treatments has not been established.
For the first 48 hours after injection, the patient can perform all daily routine tasks, but it is recommended not to overload the treated joint.
The syringe is disposable; inject the content into one joint. The assembled syringe must be eliminated immediately after use, regardless of whether or not the hydrogel was administered completely.
If the product is re-elaborated and/or reused, Pharmaceutical Fidia cannot guarantee its performance, functionality, material structure, cleaning or sterility. Reuse can lead to disease, infection and/or serious damage to the patient or user.
Do not use HYMOVIS MO.RE. after the expiry date printed on the case. The expiration date refers to the product correctly stored in its original packaging.
Do not use HYMOVIS MO.RE. if the package is open or damaged.
Keep away from the reach of children.
Conservation
Store in the original packaging between 2 °C and 25 °C. Don't freeze.
Format
Cap containing 1 luer lock pre-filled syringe.
Cod. 10001309
