Description
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.
With its particular formula and its high concentration of glycosaminoglycans (GAG), it belongs to the latest generation of intra-articular treatments and is specifically designed for the viscosupplementation of large joints for which a large volume of solution is recommended, with a high concentration of hyaluronic acid, without a high viscosity. 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.

How to use
We recommend 1 infiltration per treatment cycle.
The opportunity and frequency with which the treatment cycle can be repeated must be evaluated by the doctor, considering in each case the risk-benefit ratio for each individual patient.

Aspirate any joint effusion before injecting SINOGEL 3 ml. Carefully unscrew the syringe cap, holding the “luer lock” closure collar firmly between your fingers and paying particular attention to avoid contact with the opening. Insert the 21 G needle provided in the product package into the luer lock closure collar of the syringe (insert an appropriate needle) and screw it firmly until you feel a slight pressure, so as to ensure a watertight seal and prevent the liquid from leaking out during administration, holding the luer lock closure collar firmly between your fingers. Inject SINOGEL 3 ml at room temperature and under conditions of strict aseptic conditions.
For viscosupplementation of hip osteoarthritis, it is recommended to perform the injection under ultrasound guidance.
Inject SINOGEL 3 ml only into the synovial space.

At the end of the treatment, the doctor must fill out and give the patient the implant card, which can be found on the first page of the instructions for use contained in the package.

Components
Sodium hyaluronate 72 mg, sodium chondroitin 48 mg, sodium chloride 21 mg, sodium phosphate monobasic 0.135 mg, sodium phosphate dibasic 0.48 mg, water for injections qs 3.0 ml.

Warnings
The contents of the pre-filled syringe are sterile. The syringe is packaged in a sealed blister. The outer surface of the syringe is not sterile.
Do not use the device after the expiry date shown on the package.
Do not use the device if the packaging is open or damaged as sterility may be compromised.
The injection site must be on healthy skin.
Do not use in pregnant or breastfeeding women.
Do not use in patients with autoimmune diseases.
Do not inject vascularly. Do not inject outside the joint cavity, into the synovial tissue or into the joint capsule.
Do not administer the device in the presence of large intra-articular effusion.
Do not re-sterilize. The device is intended for single use only.
Do not reuse to avoid any risk of contamination.
SINOGEL 3 ml is indicated for adult patients.
Keep out of the reach and sight of children.
Do not use SINOGEL 3 ml in case of known hypersensitivity or allergies to the components of the product.
After intra-articular injection, advise the patient to avoid all strenuous physical activity and to resume normal activities only after a few days.
Protect from sunlight.
The possible presence of an air bubble does not affect the characteristics of the product.
Do not mix the device with disinfectants such as quaternary ammonium salts or chlorhexidine as a precipitate may form.
If you are undergoing therapy and/or taking medications in conjunction with treatment, consult your doctor for further information.
Extra-articular infiltration of SINOGEL 3 ml may cause local side effects. During the use of SINOGEL 3 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 joint. They usually disappear after a short time. The physician must ensure that patients inform him of any side effects that occur after treatment.
In case of accident, consult the Manufacturer or the competent authority.
Follow the indicated dosage and in case of side effects related to an overdose, contact your doctor or the nearest hospital.
SINOGEL 3 ml must not be injected if the joint is infected or severely inflamed or if the patient has a skin condition or infection at the injection site.

Conservation
Store at room temperature and in any case below 25 °C and away from heat sources. Do not freeze.
Once opened, the device must be used immediately and discarded after use.
Validity with intact packaging: 36 months.

Format
1 x 3ml pre-filled syringe and 1 x 21G x 1 &frac12" (0.8 x 40mm) needle.

Cod. 6000001266