Description
SYNOVIAL HL 64 2 ml
Hybrid 3.2% - 32 mg (H-HA) + 32 mg (L-HA)/2 ml
Description
Medical device designed to integrate synovial fluid, allowing the physiological and rheological properties of arthritic joints and tendons to be restored.
The HA chains with different molecular weights present in SINOVIAL HL 64 2 ml, thanks to a specific and patented treatment of the solution, interact with each other, giving SINOVIAL HL 32 1 ml unique rheological characteristics that allow for the administration of higher concentrations of hyaluronic acid at the same viscosity of the solution. The HA chains with different molecular weights of SINOVIAL HL 64 2 ml provide greater resistance to hyaluronidase 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 more suitable for in vivo applications in tissues. In vitro studies have been carried out to identify any incompatibilities and/or interactions between SINOVIAL HL 64 2 ml and platelet-rich plasma (PRP), used for the endoarticular infiltrative treatment of osteoarthritis. The results obtained demonstrate that PRP does not modify the rheological behavior of sodium hyaluronate, which therefore retains the viscosupplementation function; furthermore, the results of the studies conducted on cultures of human mesenchymal stem cells (MSC) differentiated into chondrocytes demonstrate that there is no cellular suffering, an indicator of toxicity: there is therefore no reason to believe that the biocompatibility of SINOVIAL HL 64 2 ml is modified by the simultaneous administration of PRP.
SINOVIAL HL 64 2 ml with its particular formula, belongs to the latest generation of treatments for osteoarthritis and is indicated in cases of pain or reduced mobility due to degenerative conditions (arthrosis), post-traumatic conditions and tendinopathies associated with joint disability.
SINOVIALHL 64 2 ml is also indicated in cases of acute and chronic tendinopathies and/or those associated with joint disability and in the tendon repair process, even following surgical interventions.
It reduces pain and promotes the recovery of associated joint and tendon mobility, acting only in the synovial cavity into which it is injected, without exerting any systemic action.
SINOVIAL HL 64 2 ml, furthermore, thanks to its lubricating and viscoelastic characteristics, acts at the level of the tendon sheath where it improves tendon gliding (“Tendon gliding”) and the physiological healing/repair processes, thus preventing the formation of adhesions in the post-operative period. The treatment can consist of up to three injections depending on the severity of the joint and/or tendon degeneration. The opportunity and frequency with which the treatment can be repeated must be assessed by the doctor for each individual patient, considering in each case the risk/benefit ratio of the treatment.
How to use
Aspirate any joint effusion before injecting SINOVIAL HL 64 2 ml.
Carefully unscrew the syringe cap, keeping the “Luer Lock” closure collar firmly between your fingers and paying particular attention to avoid contact with the opening. Insert the needle into the Luer Lock closure collar of the syringe (18 or 22G diameter needle included in the package) screwing it firmly, until you feel a slight pressure, so as to ensure a watertight seal and prevent the liquid from leaking during administration, keeping the “Luer Lock” closure collar firmly between your fingers.
Inject SINOVIAL HL 64 2 ml at room temperature and under conditions of strict aseptic conditions, into the synovial space of the joint or into the tendon sheath/peritendinous area, depending on the identified medical need.
Components
High molecular weight hyaluronic acid (H-HA) and low molecular weight hyaluronic acid (L-HA), sodium chloride, sodium phosphate and water for injections.
Warnings
SINOVIAL HL 64 2 ml can only be injected by a doctor.
The contents of the pre-filled syringe are 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 64 2 ml after the expiry date shown on the package.
Do not use SINOVIAL HL 64 2 ml if the packaging is open or damaged.
The injection site must be on healthy skin. Do not inject via the vascular route. Do not inject outside the joint cavity, into the synovial tissue or into the joint capsule. Do not administer SINOVIAL HL 64 2 ml in the presence of abundant intra-articular effusion.
Do not re-sterilize. The device is intended for single use only. Do not reuse to avoid any risk of contamination.
Once opened SINOVIAL HL 64 2 ml must be used immediately and discarded after use.
Keep out of the reach and sight of children.
After the injection, advise the patient to avoid all strenuous physical activity and to resume normal activities only after a few days.
The possible presence of an air bubble does not affect the characteristics of the product.
Do not mix SINOVIAL HL 64 2 ml with disinfectants such as quaternary ammonium salts or chlorhexidine as a precipitate may form.
HL 64 2 ml may cause local side effects. During the use of SINOVIAL HL 64 2 ml, symptoms such as pain, heat, redness or swelling may appear at the injection site. These secondary manifestations can be alleviated by applying ice to the treated area. They usually disappear after a short time. The doctor must ensure that patients inform him of any side effects that occur after treatment.
SINOVIAL HL 64 2 ml must not be injected if the joint is infected or severely inflamed or if the patient has a skin condition or infection in the area of the injection site.
To date, no interactions between SINOVIAL HL 64 2 ml and other drugs are known. Based on in-vitro data available to date, no chemical-physical and biological interactions are known between SINOVIAL HL 64 2 ml and Platelet-rich Plasma (PRP), used for the endo-articular infiltrative treatment of osteoarthritis.
Conservation
Store at room temperature and in any case below 25 °C and away from heat sources. Do not freeze.
Validity with intact packaging: 36 months.
Format
Pack of 1 pre-filled syringe of 2 ml [32 mg (H-HA) + 32 mg (L-HA) of hyaluronic acid sodium salt in 2 ml of sodium chloride buffered saline solution] and 1 needle 21G x 1 ½" (0.8 x 40 mm).
Cod. 6000001389
Medical device designed to integrate synovial fluid, allowing the physiological and rheological properties of arthritic joints and tendons to be restored.
The HA chains with different molecular weights present in SINOVIAL HL 64 2 ml, thanks to a specific and patented treatment of the solution, interact with each other, giving SINOVIAL HL 32 1 ml unique rheological characteristics that allow for the administration of higher concentrations of hyaluronic acid at the same viscosity of the solution. The HA chains with different molecular weights of SINOVIAL HL 64 2 ml provide greater resistance to hyaluronidase 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 more suitable for in vivo applications in tissues. In vitro studies have been carried out to identify any incompatibilities and/or interactions between SINOVIAL HL 64 2 ml and platelet-rich plasma (PRP), used for the endoarticular infiltrative treatment of osteoarthritis. The results obtained demonstrate that PRP does not modify the rheological behavior of sodium hyaluronate, which therefore retains the viscosupplementation function; furthermore, the results of the studies conducted on cultures of human mesenchymal stem cells (MSC) differentiated into chondrocytes demonstrate that there is no cellular suffering, an indicator of toxicity: there is therefore no reason to believe that the biocompatibility of SINOVIAL HL 64 2 ml is modified by the simultaneous administration of PRP.
SINOVIAL HL 64 2 ml with its particular formula, belongs to the latest generation of treatments for osteoarthritis and is indicated in cases of pain or reduced mobility due to degenerative conditions (arthrosis), post-traumatic conditions and tendinopathies associated with joint disability.
SINOVIALHL 64 2 ml is also indicated in cases of acute and chronic tendinopathies and/or those associated with joint disability and in the tendon repair process, even following surgical interventions.
It reduces pain and promotes the recovery of associated joint and tendon mobility, acting only in the synovial cavity into which it is injected, without exerting any systemic action.
SINOVIAL HL 64 2 ml, furthermore, thanks to its lubricating and viscoelastic characteristics, acts at the level of the tendon sheath where it improves tendon gliding (“Tendon gliding”) and the physiological healing/repair processes, thus preventing the formation of adhesions in the post-operative period. The treatment can consist of up to three injections depending on the severity of the joint and/or tendon degeneration. The opportunity and frequency with which the treatment can be repeated must be assessed by the doctor for each individual patient, considering in each case the risk/benefit ratio of the treatment.
How to use
Aspirate any joint effusion before injecting SINOVIAL HL 64 2 ml.
Carefully unscrew the syringe cap, keeping the “Luer Lock” closure collar firmly between your fingers and paying particular attention to avoid contact with the opening. Insert the needle into the Luer Lock closure collar of the syringe (18 or 22G diameter needle included in the package) screwing it firmly, until you feel a slight pressure, so as to ensure a watertight seal and prevent the liquid from leaking during administration, keeping the “Luer Lock” closure collar firmly between your fingers.
Inject SINOVIAL HL 64 2 ml at room temperature and under conditions of strict aseptic conditions, into the synovial space of the joint or into the tendon sheath/peritendinous area, depending on the identified medical need.
Components
High molecular weight hyaluronic acid (H-HA) and low molecular weight hyaluronic acid (L-HA), sodium chloride, sodium phosphate and water for injections.
Warnings
SINOVIAL HL 64 2 ml can only be injected by a doctor.
The contents of the pre-filled syringe are 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 64 2 ml after the expiry date shown on the package.
Do not use SINOVIAL HL 64 2 ml if the packaging is open or damaged.
The injection site must be on healthy skin. Do not inject via the vascular route. Do not inject outside the joint cavity, into the synovial tissue or into the joint capsule. Do not administer SINOVIAL HL 64 2 ml in the presence of abundant intra-articular effusion.
Do not re-sterilize. The device is intended for single use only. Do not reuse to avoid any risk of contamination.
Once opened SINOVIAL HL 64 2 ml must be used immediately and discarded after use.
Keep out of the reach and sight of children.
After the injection, advise the patient to avoid all strenuous physical activity and to resume normal activities only after a few days.
The possible presence of an air bubble does not affect the characteristics of the product.
Do not mix SINOVIAL HL 64 2 ml with disinfectants such as quaternary ammonium salts or chlorhexidine as a precipitate may form.
HL 64 2 ml may cause local side effects. During the use of SINOVIAL HL 64 2 ml, symptoms such as pain, heat, redness or swelling may appear at the injection site. These secondary manifestations can be alleviated by applying ice to the treated area. They usually disappear after a short time. The doctor must ensure that patients inform him of any side effects that occur after treatment.
SINOVIAL HL 64 2 ml must not be injected if the joint is infected or severely inflamed or if the patient has a skin condition or infection in the area of the injection site.
To date, no interactions between SINOVIAL HL 64 2 ml and other drugs are known. Based on in-vitro data available to date, no chemical-physical and biological interactions are known between SINOVIAL HL 64 2 ml and Platelet-rich Plasma (PRP), used for the endo-articular infiltrative treatment of osteoarthritis.
Conservation
Store at room temperature and in any case below 25 °C and away from heat sources. Do not freeze.
Validity with intact packaging: 36 months.
Format
Pack of 1 pre-filled syringe of 2 ml [32 mg (H-HA) + 32 mg (L-HA) of hyaluronic acid sodium salt in 2 ml of sodium chloride buffered saline solution] and 1 needle 21G x 1 ½" (0.8 x 40 mm).
Cod. 6000001389
