SINOGEL 3 ml

Description
Medical device consisting of a buffered physiological solution of highly purified, high molecular weight hyaluronic acid and biotechnologically derived sodium chondroitin. The hyaluronic acid used in the device is obtained by fermentation and has not undergone chemical modification. This results in excellent tolerability.
With its unique formula and high concentration of glycosaminoglycans (GAGs), it belongs to the latest generation of intra-articular treatments and is specifically designed for viscosupplementation of large joints, requiring a large volume of solution with a high concentration of hyaluronic acid, without high viscosity. Thanks to a specific and patented solution treatment, the hyaluronic acid and sodium chondroitin chains present in the device interact with each other, giving the solution rheological characteristics that achieve lower viscosity values ​​than those of hyaluronic acid alone at the same concentration.

How to use
We recommend 1 infiltration per treatment cycle.
The appropriateness 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 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 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 leakage of the liquid during administration, holding the Luer lock collar firmly between your fingers. Inject SINOGEL 3 ml at room temperature and under 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 complete 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, monobasic sodium phosphate 0.135 mg, dibasic sodium phosphate 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 intravascularly. 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 the 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 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 concomitantly 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 side effects can be alleviated by applying ice to the treated joint. They usually disappear after a short time. Physicians should ensure that patients are informed 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, below 25°C, away from heat sources. Do not freeze.
Once opened, the device must be used immediately and discarded after use.
Shelf life in intact packaging: 36 months.

Format
1 x 3ml pre-filled syringe and 1 x 21G x 1 ½" (0.8 x 40mm) needle.

Cod. 6000001266