Descrizione Clinica
Medical devices - medical devices Sinovial 16 sir 0.8% 2ml 1pz
SINOVIAL 16 2 ml
0,8% 16 mg/2 ml
Description
Substitute of the synovial fluid, which allows to restore the physiological and reological properties of the arthrosic joints. This therapeutic action is performed by the particular characteristics of hyaluronic acid used. Hyaluronic acid contained in SINOVIAL 16 2 ml, obtained by fermentation and not chemically modified, has an excellent tolerance. Restoring the viscoelastic properties of the synovial liquid, SINOVIAL 16 2 ml reduces pain and restores joint and tendon mobility.
SINOVIAL 16 2 ml acts only at the level of the area in which it is injected, without exercising any systemic action. The improvement is immediate: already after the first injection, the WOMAC global index decreases and from the third injection the decrease becomes statistically significant.
Indicated in case of acute and chronic tendinopathy and/or associated with joint disability and in the process of repairing tendons, also following surgery. SINOVIAL 16 2 ml is a medical device designed to integrate the synovial fluid, allowing to restore the physiological and reological properties of the arthrosic joints and tendons. In the articulation SINOVIAL 16 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. SINOVIAL 16 2 ml also, thanks to its lubricants and viscoelastic characteristics, acts at the level of the sheath, where it improves the flow of the tendon (“Tendon gliding”) and physiological processes of scarring/repair, thus preventing the formation of adhesions in the post-operator decorations.
How to use
Aspirate any joint deposit before proceeding to injection.
Carefully unscrew the cap of the siging, keeping firmly between the fingers the collar of "Luer Lock" closure and paying special attention in order to avoid contact with the opening. Insert the needle to the closing collar of the Luer Lock type of the syringe (diameter needle between 18 and 22G) by tightening it firmly, until it perceives a slight pressure in order to ensure a stagna seal and prevent liquid leakage during administration, keeping firmly between the fingers the closing collar "Luer Lock".
Inject SINOVIAL 16 2 ml at room temperature and under tight asepsis conditions, within the synovial space of the articulation or in the curtain/zone sheath peri-tendine, depending on the medical need identified.
Components
0.8% of hyaluronic acid, highly purified sodium salt (molecular weight between 800 and 1.200 KDalton), sodium chloride, sodium phosphate, water for injectable preparations.
Warnings
SINOVIAL 16 2 ml can only be injected by a doctor.
The content of the pre-filled syringe is sterile.
The syringe is packaged in a sealed blister. The outer surface of the syringe is not sterile.
Do not use after the expiry date shown on the package.
Do not use 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 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 it must be used immediately and eliminated after use.
Keep away from the reach and sight of children.
After intrarticular injection or in the curtain synovia, 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 with disinfectants of the type salts of ammonium quaternary or chlorhexidine since a precipitate can form.
The extra-articular infiltration of SINOVIAL 16 2 ml can cause locally unwanted effects. During the use of SINOVIAL 16 2 ml may appear in the injection point symptoms such as pain, feeling of heat, 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 16 2 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.
The product should not be used in case of hypersensitivity known to hyaluronate sodium or other components.
To date there are no known interactions between SINOVIAL 16 2 ml and other drugs.
Do not mix with disinfectants of the type salts of quaternary ammonium or chlorhexidine since a precipitate may form.
It 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. The product should not be used in case of hypersensitivity known to hyaluronate sodium or other components.
SINOVIAL 16 2 ml can only be injected by a doctor.
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 (16.0 mg of hyaluronic acid salt sodium in 2 ml of buffered physiological solution of sodium chloride).
Cod. 6000001294
Substitute of the synovial fluid, which allows to restore the physiological and reological properties of the arthrosic joints. This therapeutic action is performed by the particular characteristics of hyaluronic acid used. Hyaluronic acid contained in SINOVIAL 16 2 ml, obtained by fermentation and not chemically modified, has an excellent tolerance. Restoring the viscoelastic properties of the synovial liquid, SINOVIAL 16 2 ml reduces pain and restores joint and tendon mobility.
SINOVIAL 16 2 ml acts only at the level of the area in which it is injected, without exercising any systemic action. The improvement is immediate: already after the first injection, the WOMAC global index decreases and from the third injection the decrease becomes statistically significant.
Indicated in case of acute and chronic tendinopathy and/or associated with joint disability and in the process of repairing tendons, also following surgery. SINOVIAL 16 2 ml is a medical device designed to integrate the synovial fluid, allowing to restore the physiological and reological properties of the arthrosic joints and tendons. In the articulation SINOVIAL 16 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. SINOVIAL 16 2 ml also, thanks to its lubricants and viscoelastic characteristics, acts at the level of the sheath, where it improves the flow of the tendon (“Tendon gliding”) and physiological processes of scarring/repair, thus preventing the formation of adhesions in the post-operator decorations.
How to use
Aspirate any joint deposit before proceeding to injection.
Carefully unscrew the cap of the siging, keeping firmly between the fingers the collar of "Luer Lock" closure and paying special attention in order to avoid contact with the opening. Insert the needle to the closing collar of the Luer Lock type of the syringe (diameter needle between 18 and 22G) by tightening it firmly, until it perceives a slight pressure in order to ensure a stagna seal and prevent liquid leakage during administration, keeping firmly between the fingers the closing collar "Luer Lock".
Inject SINOVIAL 16 2 ml at room temperature and under tight asepsis conditions, within the synovial space of the articulation or in the curtain/zone sheath peri-tendine, depending on the medical need identified.
Components
0.8% of hyaluronic acid, highly purified sodium salt (molecular weight between 800 and 1.200 KDalton), sodium chloride, sodium phosphate, water for injectable preparations.
Warnings
SINOVIAL 16 2 ml can only be injected by a doctor.
The content of the pre-filled syringe is sterile.
The syringe is packaged in a sealed blister. The outer surface of the syringe is not sterile.
Do not use after the expiry date shown on the package.
Do not use 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 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 it must be used immediately and eliminated after use.
Keep away from the reach and sight of children.
After intrarticular injection or in the curtain synovia, 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 with disinfectants of the type salts of ammonium quaternary or chlorhexidine since a precipitate can form.
The extra-articular infiltration of SINOVIAL 16 2 ml can cause locally unwanted effects. During the use of SINOVIAL 16 2 ml may appear in the injection point symptoms such as pain, feeling of heat, 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 16 2 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.
The product should not be used in case of hypersensitivity known to hyaluronate sodium or other components.
To date there are no known interactions between SINOVIAL 16 2 ml and other drugs.
Do not mix with disinfectants of the type salts of quaternary ammonium or chlorhexidine since a precipitate may form.
It 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. The product should not be used in case of hypersensitivity known to hyaluronate sodium or other components.
SINOVIAL 16 2 ml can only be injected by a doctor.
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 (16.0 mg of hyaluronic acid salt sodium in 2 ml of buffered physiological solution of sodium chloride).
Cod. 6000001294
