Descrizione Clinica
Medical devices - medical devices health Sinovial hl sir 3.2% 1ml Sinovial
SINOVIAL HL 32 1 ml
Hybrid 3.2% - 16 mg (H-HA) + 16 mg (L-HA)/1 ml
Description
Medical device designed to integrate the synovial fluid, allowing to restore the physiological and reological properties of arthrosive joints and tendons.
HA chains to different molecular weight present in SINOVIAL HL 32 1 ml, thanks to a specific and patented solution treatment, interact with each other by giving SINOVIAL HL 32 1 ml unique rheological characteristics that allow to administer, at the same viscosity of the solution, greater concentrations of hyaluronic acid. HA chains to different molecular weight of SINOVIAL HL 32 1 ml provide greater resistance to hyaluronidasis since this enzyme is not able to recognize the conformation of these high and low molecular weight complexes, therefore, SINOVIAL HL 32 1 ml is most suitable for live applications in fabrics. In vitro studies have been carried out to identify any incompatibilities and/or interactions between SINOVIAL HL 32 1 ml and plasma rich in platelets (PRP), used for the endoarticular treatment of osteoarthritis. The results obtained show that the PRP does not change the rheological behaviour of the hyaluronate sodium, which thus retains the function of viscosupplementation; in addition, the results of studies conducted on crops of human stem cells (MSC) differentiated in chondrocytes show that there is no cellular suffering, toxicity index: there is therefore no reason to believe that biocompatibility SINOVIAL HL 32 1 ml is modified by the simultaneous administration of PRP.
SINOVIAL HL 32 1 ml with its particular formula, belongs to the last generation of osteoarthritis treatments and is indicated in case of reduced pain or mobility due to degenerative (artrosis), posttraumatic and tendinopathic diseases associated with joint disability.
SINOVIAL HL 32 1 ml is also indicated in case of acute and chronic tendinopathy and associated with joint disability and in the process of repairing tendons also following surgery.
It reduces pain and promotes recovery of joint mobility and associated tendon, acting only in the synovial cavity in which it is injected, without exercising any systemic action.
SINOVIAL HL 32 1 ml, also, thanks to its lubricants and viscoelastic characteristics, acts at the level of the curtain sheath where it improves the sliding of the tendon (“Tendon gliding”) and the physiological processes of healing \reparation thus preventing the formation of adhesions in the post-operative decorations. The treatment can reach up to three injections depending on the severity of joint degeneration and tendon. The opportunity and frequency with which the treatment can be repeated must be evaluated by the doctor for each individual patient, considering in any case the risk/benefit ratio of the treatment.
Mode of use
Aspirate any joint deposit before proceeding to injection SINOVIAL HL 32 1 ml.
Carefully unscrew the syringe cap, keeping the closing collar “Luer Lock” firmly between your fingers and paying special attention to avoid contact with the opening. Insert the needle to the closing collar of the Luer Lock type of the syringe (diameter needle of 22G or 29G included in the package) screwing it firmly, until it perceives a slight pressure, so as to ensure a stagnant seal and prevent the leakage of the liquid during administration, keeping firmly between the fingers the closing collar “Luer Lock”.
Inject SINOVIAL HL 32 1 ml at room temperature and in tight asepsis conditions, within the synovial space of the articulation or in the curtain/peritndineous zone sheath, depending on the medical need identified.
Components
Hyaluronic acid with high molecular weight (H-HA) and low molecular weight (L-HA), sodium chloride, sodium phosphate and water for injectable preparations.
Warnings
SINOVIAL HL 32 1 ml can only be injected by a doctor.
The content of the pre-filled syringe is sterile. The syringe and needles are packaged in a sealed blister. The outer surface of the syringe is not sterile.
Do not use SINOVIAL HL 32 1 ml after the expiry date shown on the package.
Do not use SINOVIAL HL 32 1 ml if the packaging is open or damaged.
The injection point must be on healthy skin. Don't inject vascularly. Do not inject outside the joint cavity, in the synovial tissue or in the joint capsule. Do not administer SINOVIAL HL 32 1 ml in the presence of abundant intrarticular deposit.
Do not sterilize again. The device is only intended for use. Do not reuse to avoid any risk of contamination.
Once opened SINOVIAL HL 32 1 ml must be used immediately and eliminated after use.
Keep away from the reach and sight of children.
After injection, recommend to the patient to avoid all intense physical activity and resume normal activity only after a few days.
The presence of an air bubble does not affect the characteristics of the product.
Do not mix SINOVIAL HL 32 1 ml with disinfectants of the type salts of quaternary ammonium or chlorhexidine as a precipitate may form.
HL 32 1 ml can cause locally unwanted effects. During the use of SINOVIAL HL 32 1 ml may appear in the injection point symptoms such as pain, feeling of warmth, redness or swelling. These secondary events can be alleviated with the application of ice on the treated area. They usually disappear after a short time. Your doctor must ensure that patients inform you of any side effects that have occurred after treatment.
SINOVIAL HL 32 1 ml should not be injected in the presence of infectious or severely inflamed joints or if the patient has a skin affection or infection in the injection point area.
To date there are no known interactions between SINOVIAL HL 32 1 ml and other medicines. Based on the in-vitro data available today, there are no known chemical-physical and biological interactions between SINOVIAL HL 32 1 ml and Plasma rich in Piastrine (PRP), used for the endoarticular treatment of osteoarthritis.
Conservation
Store at room temperature and still under 25 °C and away from heat sources. Don't freeze.
Validity of whole packaging: 36 months.
Format
Packaging:
- 1 pre-filled syringe [16 mg (H-HA + 16 mg (L-HA) di acido ialuronico sale sodico in 1 ml di soluzione fisiologica tamponata di cloruro di sodio];
- 1 needle 29 G x 1⁄2" TW (0,3 x 12 mm), for small joints;
- 1 needle 22 G x 1 1⁄2" (0,7 x 40 mm), for large joints.
Cod. 6000001359
Medical device designed to integrate the synovial fluid, allowing to restore the physiological and reological properties of arthrosive joints and tendons.
HA chains to different molecular weight present in SINOVIAL HL 32 1 ml, thanks to a specific and patented solution treatment, interact with each other by giving SINOVIAL HL 32 1 ml unique rheological characteristics that allow to administer, at the same viscosity of the solution, greater concentrations of hyaluronic acid. HA chains to different molecular weight of SINOVIAL HL 32 1 ml provide greater resistance to hyaluronidasis since this enzyme is not able to recognize the conformation of these high and low molecular weight complexes, therefore, SINOVIAL HL 32 1 ml is most suitable for live applications in fabrics. In vitro studies have been carried out to identify any incompatibilities and/or interactions between SINOVIAL HL 32 1 ml and plasma rich in platelets (PRP), used for the endoarticular treatment of osteoarthritis. The results obtained show that the PRP does not change the rheological behaviour of the hyaluronate sodium, which thus retains the function of viscosupplementation; in addition, the results of studies conducted on crops of human stem cells (MSC) differentiated in chondrocytes show that there is no cellular suffering, toxicity index: there is therefore no reason to believe that biocompatibility SINOVIAL HL 32 1 ml is modified by the simultaneous administration of PRP.
SINOVIAL HL 32 1 ml with its particular formula, belongs to the last generation of osteoarthritis treatments and is indicated in case of reduced pain or mobility due to degenerative (artrosis), posttraumatic and tendinopathic diseases associated with joint disability.
SINOVIAL HL 32 1 ml is also indicated in case of acute and chronic tendinopathy and associated with joint disability and in the process of repairing tendons also following surgery.
It reduces pain and promotes recovery of joint mobility and associated tendon, acting only in the synovial cavity in which it is injected, without exercising any systemic action.
SINOVIAL HL 32 1 ml, also, thanks to its lubricants and viscoelastic characteristics, acts at the level of the curtain sheath where it improves the sliding of the tendon (“Tendon gliding”) and the physiological processes of healing \reparation thus preventing the formation of adhesions in the post-operative decorations. The treatment can reach up to three injections depending on the severity of joint degeneration and tendon. The opportunity and frequency with which the treatment can be repeated must be evaluated by the doctor for each individual patient, considering in any case the risk/benefit ratio of the treatment.
Mode of use
Aspirate any joint deposit before proceeding to injection SINOVIAL HL 32 1 ml.
Carefully unscrew the syringe cap, keeping the closing collar “Luer Lock” firmly between your fingers and paying special attention to avoid contact with the opening. Insert the needle to the closing collar of the Luer Lock type of the syringe (diameter needle of 22G or 29G included in the package) screwing it firmly, until it perceives a slight pressure, so as to ensure a stagnant seal and prevent the leakage of the liquid during administration, keeping firmly between the fingers the closing collar “Luer Lock”.
Inject SINOVIAL HL 32 1 ml at room temperature and in tight asepsis conditions, within the synovial space of the articulation or in the curtain/peritndineous zone sheath, depending on the medical need identified.
Components
Hyaluronic acid with high molecular weight (H-HA) and low molecular weight (L-HA), sodium chloride, sodium phosphate and water for injectable preparations.
Warnings
SINOVIAL HL 32 1 ml can only be injected by a doctor.
The content of the pre-filled syringe is sterile. The syringe and needles are packaged in a sealed blister. The outer surface of the syringe is not sterile.
Do not use SINOVIAL HL 32 1 ml after the expiry date shown on the package.
Do not use SINOVIAL HL 32 1 ml if the packaging is open or damaged.
The injection point must be on healthy skin. Don't inject vascularly. Do not inject outside the joint cavity, in the synovial tissue or in the joint capsule. Do not administer SINOVIAL HL 32 1 ml in the presence of abundant intrarticular deposit.
Do not sterilize again. The device is only intended for use. Do not reuse to avoid any risk of contamination.
Once opened SINOVIAL HL 32 1 ml must be used immediately and eliminated after use.
Keep away from the reach and sight of children.
After injection, recommend to the patient to avoid all intense physical activity and resume normal activity only after a few days.
The presence of an air bubble does not affect the characteristics of the product.
Do not mix SINOVIAL HL 32 1 ml with disinfectants of the type salts of quaternary ammonium or chlorhexidine as a precipitate may form.
HL 32 1 ml can cause locally unwanted effects. During the use of SINOVIAL HL 32 1 ml may appear in the injection point symptoms such as pain, feeling of warmth, redness or swelling. These secondary events can be alleviated with the application of ice on the treated area. They usually disappear after a short time. Your doctor must ensure that patients inform you of any side effects that have occurred after treatment.
SINOVIAL HL 32 1 ml should not be injected in the presence of infectious or severely inflamed joints or if the patient has a skin affection or infection in the injection point area.
To date there are no known interactions between SINOVIAL HL 32 1 ml and other medicines. Based on the in-vitro data available today, there are no known chemical-physical and biological interactions between SINOVIAL HL 32 1 ml and Plasma rich in Piastrine (PRP), used for the endoarticular treatment of osteoarthritis.
Conservation
Store at room temperature and still under 25 °C and away from heat sources. Don't freeze.
Validity of whole packaging: 36 months.
Format
Packaging:
- 1 pre-filled syringe [16 mg (H-HA + 16 mg (L-HA) di acido ialuronico sale sodico in 1 ml di soluzione fisiologica tamponata di cloruro di sodio];
- 1 needle 29 G x 1⁄2" TW (0,3 x 12 mm), for small joints;
- 1 needle 22 G x 1 1⁄2" (0,7 x 40 mm), for large joints.
Cod. 6000001359
