Descrizione Clinica
Medical devices - medical devices Sinovial hl 64 sir 2ml 1pz
SINOVIAL HL 64 2 ml
3.2% - 32 mg (H-HA) + 32 mg (L-HA)/2 ml
Description
Visco-supplementary device of the joints.
The sodium salt of hyaluronic acid is formed by repeated chains of N-acetylglucosamine and sodium glucuronate dysaccharide units and represents a fundamental component of the synovial fluid, which gives the particular viscoelastic properties.
Composed of a buffered physiological solution of high molecular weight hyaluronic acid (H-HA) and low molecular weight (L-HA). Hyaluronic acid with high and low molecular weight used in the device, is obtained by fermentative means and has not undergone chemical modification processes. This entails excellent tolerance. Also HA chains to different molecular weight present in SINOVIAL HL 64 2 ml, thanks to a specific and patented solution treatment, interact with each other by giving SINOVIAL HL 64 2 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 64 2 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 64 2 ml is most suitable for live applications in fabrics.
Indicated in case of acute and chronic tendinopathy and/or associated with joint disability and in the process of repairing tendons also following surgery.
Designed to integrate the synovial fluid, allowing to restore the physical and reological properties of arthrosic joints and tendons. In the articulation SINOVIAL HL 64 2 ml 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.
Thanks to its lubricating and viscoelastic characteristics, it acts at the level of the tendon where it improves the flow of the tendon ("Tendon gliding") and the physiological processes of scarring/repair thus preventing the formation of adhesions in the post-operator decor. The treatment can reach up to three injections depending on the severity of joint degeneration and/or 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 64 2 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 of 18 or 22G included in the package) screwing it firmly, until it perceives a slight pressure, so as to ensure a stagna seal and prevent the leakage of the liquid during administration, keeping firmly between the fingers the closing collar “Luer Lock”.
Inject SINOVIAL HL 64 2 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
- The contents of the pre-filled syringe are sterile. The syringe and the needle are packaged in a sealed blister.
The outer surface of the syringe is not sterile.
- Do not use SINOVIAL HL 64 2 ml after expiry date.
- Do not use SINOVIAL HL 64 2 ml if packing 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.
- Don't administer SINOVIAL HL 64 2 ml in the presence of abundant intrarticular deposit.
- Don't sterilize again. The device is disposable.
- Do not reuse to avoid any risk of contamination.
- Once opened, it 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 activities and resume normal activities only after a few days.
- The presence of an air bubble does not affect the characteristics of the product.
- NON mix the product with disinfectants of the type salts of quaternary ammonium or chlorhexidine since a precipitate can form.
- The product should not be injected in the presence of an infected or severely inflamed joint or if the patient has a skin affection or infection in the injection point area.
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
Pack of 1 pre-filled syringe of 2 ml [32 mg (H-HA) + 32 mg (L-HA) di acido ialuronico sale sodico in 2 ml di soluzione fisiologica tamponata di cloruro di sodio] and 1 needle 21G x 1 1⁄2" (0,8 x 40 mm).
Cod. 6000001389
Visco-supplementary device of the joints.
The sodium salt of hyaluronic acid is formed by repeated chains of N-acetylglucosamine and sodium glucuronate dysaccharide units and represents a fundamental component of the synovial fluid, which gives the particular viscoelastic properties.
Composed of a buffered physiological solution of high molecular weight hyaluronic acid (H-HA) and low molecular weight (L-HA). Hyaluronic acid with high and low molecular weight used in the device, is obtained by fermentative means and has not undergone chemical modification processes. This entails excellent tolerance. Also HA chains to different molecular weight present in SINOVIAL HL 64 2 ml, thanks to a specific and patented solution treatment, interact with each other by giving SINOVIAL HL 64 2 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 64 2 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 64 2 ml is most suitable for live applications in fabrics.
Indicated in case of acute and chronic tendinopathy and/or associated with joint disability and in the process of repairing tendons also following surgery.
Designed to integrate the synovial fluid, allowing to restore the physical and reological properties of arthrosic joints and tendons. In the articulation SINOVIAL HL 64 2 ml 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.
Thanks to its lubricating and viscoelastic characteristics, it acts at the level of the tendon where it improves the flow of the tendon ("Tendon gliding") and the physiological processes of scarring/repair thus preventing the formation of adhesions in the post-operator decor. The treatment can reach up to three injections depending on the severity of joint degeneration and/or 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 64 2 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 of 18 or 22G included in the package) screwing it firmly, until it perceives a slight pressure, so as to ensure a stagna seal and prevent the leakage of the liquid during administration, keeping firmly between the fingers the closing collar “Luer Lock”.
Inject SINOVIAL HL 64 2 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
- The contents of the pre-filled syringe are sterile. The syringe and the needle are packaged in a sealed blister.
The outer surface of the syringe is not sterile.
- Do not use SINOVIAL HL 64 2 ml after expiry date.
- Do not use SINOVIAL HL 64 2 ml if packing 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.
- Don't administer SINOVIAL HL 64 2 ml in the presence of abundant intrarticular deposit.
- Don't sterilize again. The device is disposable.
- Do not reuse to avoid any risk of contamination.
- Once opened, it 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 activities and resume normal activities only after a few days.
- The presence of an air bubble does not affect the characteristics of the product.
- NON mix the product with disinfectants of the type salts of quaternary ammonium or chlorhexidine since a precipitate can form.
- The product should not be injected in the presence of an infected or severely inflamed joint or if the patient has a skin affection or infection in the injection point area.
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
Pack of 1 pre-filled syringe of 2 ml [32 mg (H-HA) + 32 mg (L-HA) di acido ialuronico sale sodico in 2 ml di soluzione fisiologica tamponata di cloruro di sodio] and 1 needle 21G x 1 1⁄2" (0,8 x 40 mm).
Cod. 6000001389
