Sinogel Intra-Articular Syringe 2.4% + 1.6% 3ml Needle Gauge 21

Medical device consisting of a buffered physiological solution of highly purified hyaluronic acid, with high molecular weight, and sodium chondroitin of biotechnological origin. The hyaluronic acid used in the device is obtained by fermentation and has not undergone chemical modification processes. This results in excellent tolerability.
Specifically designed for the viscosupplementation of large joints, for which a large volume of solution, with high concentration of hyaluronic acid, without high viscosity is recommended. The chains of hyaluronic acid and those of sodium chondroitin present in the device, thanks to a specific and patented treatment of the solution, interact with each other giving the solution rheological characteristics such as to obtain viscosity values lower than those of hyaluronic acid alone at the same concentration.< br /> It is indicated in cases of pain or reduced mobility due to degenerative or post-traumatic conditions or alterations of the joint and tendons.
Device for the integration of synovial fluid, which allows the physiological properties to be restored and rheology of arthritic joints. By restoring the viscoelastic properties of the synovial fluid, it reduces pain and restores joint and tendon motility, acting only at the level of the joint into which it is injected, without exerting any systemic action. It is particularly suitable for viscosupplementation of hip osteoarthritis.
The contents of the syringe are sterile.

How to use
Aspirate the any joint effusion before proceeding with the injection.
Carefully unscrew the cap of the syringe, holding the “Luer Lock” closing collar firmly between your fingers and paying particular attention to avoid contact with the opening. Insert the needle into the “Luer Lock” type closure collar of the syringe (insert an appropriate needle) screw firmly, until you feel a slight pressure, in order to ensure a watertight seal and prevent the liquid from leaking during administration, maintaining the “Luer Lock” closure collar firmly between the fingers.
Inject at room temperature and under strict aseptic conditions.
For viscosupplementation of hip osteoarthritis it is recommended to carry out the injection by means of a guide ultrasound.
Inject only inside the synovial space.

It is indicated to be injected only 1 time for each treatment cycle. If necessary, further injections may be performed. The opportunity and frequency with which the treatment cycle can be repeated must be assessed by the doctor for each individual patient, considering in any case the risk/benefit ratio of the treatment.

Components< /b>
Highly purified hyaluronic acid (high molecular weight), sodium chondroitin of biotechnological origin, sodium chloride, sodium phosphate and water for injections.

Warnings< /b>
The contents of the pre-filled syringe are sterile. The syringe is packaged in a sealed blister.
The external surface of the syringe is not sterile.
Do not use the device after the expiry date stated on the package.
Do not use the device if the packaging is opened or damaged.
Do not sterilize again. The device is intended for single use only.
Do not reuse to avoid any risk of contamination.
Once opened the device must be used immediately and discarded after use.
The injection site must be on healthy skin.
Do not inject vascularly. Do not inject outside the joint cavity.
Do not administer the device in the presence of a large intra-articular effusion.
After intra-articular injection, advise the patient to avoid all intense physical activities and to resume normal activities only after a few days.
Protect from sunlight.
Keep out of the reach and sight of children.
Do not mix the device with disinfectants such as quaternary ammonium salts or chlorhexidine as a precipitate may form.
Extra-articular infiltration may cause side effects locally. During use of 3 ml, symptoms such as pain, sensation of heat, redness or swelling may appear at the injection site. These secondary manifestations can be alleviated by applying ice to the treated joint. Normally they disappear after a short time. The doctor must ensure that patients inform him of any side effects that may occur after treatment.
Intra-articular injection can only be performed by a doctor.

Storage
Store between 0 °C and 25 °C, away from heat sources and sunlight. Do not freeze.
Shelf life with intact packaging: 36 months.

Format
Pack of 1 pre-filled syringe (72.0 mg of acid hyaluronic sodium salt and 48.0 mg of sodium chondroitin in 3 ml of sodium chloride buffered physiological solution) and 1 needle 21G x 1 ½' (0.8 x 40 mm).