“Directions
By restoring the viscoelastic properties of the synovial fluid, the preparation reduces pain and restores mobility of joints and tendons, acting only at the level of the joint into which it is injected, without having a systemic effect.
A pre-filled syringe consisting of a buffered physiological solution of highly purified hyaluronic acid with a high molecular weight and sodium chondroitin obtained by biotechnological means.
The hyaluronic acid used in the device is obtained by fermentation and has not undergone chemical modification processes.
This ensures excellent tolerability.
Specially designed for viscous replenishment of large joints, for which a large volume of solution is recommended, with a high concentration of hyaluronic acid, without high viscosity.
Indicated for pain or limited mobility due to degenerative or post-traumatic conditions or changes in joints and tendons.
The needle is sterilized with ethylene oxide.
Directions for use and dosage
Before injection, remove all joint effusion.
Carefully unscrew the syringe cap, hold the Luer Lock firmly between your fingers, and be especially careful not to touch the opening.
Insert the needle into the Luer Lock cap of the syringe (insert the appropriate needle) and tighten firmly until you feel slight pressure to ensure watertightness and prevent fluid from leaking out during injection, holding the Luer Lock cap firmly with your fingers.
Injections should be performed at room temperature and under strict aseptic conditions. To restore viscosity in osteoarthritis of the hip, it is recommended to inject under ultrasound guidance.
Inject only into the synovial space.
The product should be administered only once per treatment cycle.
Additional injections may be given if necessary.
The possibility and frequency of repeating the treatment cycle should be assessed by the physician individually for each patient, taking into account the risk/benefit ratio of the treatment in each case.
Warnings
Intra-articular injection may only be performed by a physician.
Do not mix the device with disinfectants such as quaternary ammonium salts or chlorhexidine, as a precipitate may form.
To date, there are no known interactions between SINOGEL 3 ml and other medicinal products.
Extra-articular infiltration may cause local side effects.
During application, symptoms such as pain, heat, redness or swelling may occur at the injection site.
Such secondary manifestations can be alleviated by applying ice to the treated joint.
They usually disappear after a short time.
The physician should ensure that patients inform the physician of any side effects that occur after treatment.
The product should not be administered if the joint is infected or severely inflamed, or if the patient has a skin disease or infection at the injection site.
The outer surface of the syringe is not sterile.
Do not use the device after the expiration date printed on the package.
Do not use the device if the package is opened or damaged.
Do not re-sterilize.
The device is intended for single use only.
Do not reuse to avoid the risk of infection.
Once opened, the device must be used immediately and discarded after use.
The injection site must be on healthy skin.
Do not inject into the vascular network.
Do not inject outside the joint cavity, into the synovial tissue or into the joint capsule.
Do not use the device if there is a large intra-articular effusion.
After intra-articular injection, advise the patient to avoid any heavy physical activity and resume normal activities only after a few days.
Do not freeze.
Keep out of reach of children.
Storage
Store at a temperature of 0°C to 25°C, away from heat and sunlight.
Shelf life in unopened packaging: 36 months.
Format
1 pre-filled syringe and 1 needle G21 x 1 ½” (0.8 x 40 mm) 3 ml”
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