SINOGEL® 3 ml – Instructions for use
Description
Osteoarthritis (OA) is a chronic degenerative disease characterized by progressive damage to the articular cartilage, narrowing of the joint space, remodeling of the subchondral bone, formation of marginal joint osteophytes, and synovitis. Optimal OA therapy consists of an intra-articular injection of exogenous hyaluronic acid, which can relieve symptoms by restoring the viscoelastic properties of synovial fluid.
Hyaluronic acid sodium salt is formed from repetitive chains of disaccharide units of N-acetylglucosamine and sodium glucuronate and is an essential component of synovial fluid, where it acts as a joint lubricant under shear stress and as a shock absorber under compressive load.
SINOGEL® 3 ml consists of a buffered saline solution of highly purified hyaluronic acid with high molecular weight and sodium chondroitin of biotechnological origin. The hyaluronic acid used in the medical device is obtained by fermentation and has not been chemically modified. This results in excellent tolerability.
Purpose
SINOGEL® 3 ml, with its special formula and high glycosaminoglycan concentration (GAG), belongs to the latest generation of intra-articular treatments and was specifically developed for viscosupplementation of large joints, where a large volume of solution with a high concentration of hyaluronic acid without high viscosity is recommended. Thanks to a special and patented treatment of the solution, the hyaluronic acid and sodium chondroitin chains present in the product interact with each other, giving the solution rheological properties so that the viscosity values are lower than those of pure hyaluronic acid at the same concentration.
Indications
SINOGEL® 3 ml is indicated for pain or movement restrictions due to degenerative diseases, post-traumatic disorders, or joint changes.
SINOGEL® 3 ml is a medical device designed to restore the physiological and rheological properties of synovial fluid in joints affected by osteoarthritis.
SINOGEL® 3 ml restores the viscoelastic properties of synovial fluid, relieves pain, and promotes the restoration of joint mobility.
Target groups and users
SINOGEL® 3 ml is indicated for adults of both sexes and may only be administered by qualified personnel via intra-articular injection.
SINOGEL® 3 ml is prescription-only.
Composition
SINOGEL® 3 ml consists of a pre-filled syringe with 3 ml solution and contains the following ingredients:
| Functional ingredient |
Quantity |
| Sodium hyaluronate |
72 mg |
| Sodium chondroitin |
48 mg |
| Other ingredients |
Quantity |
| Sodium chloride |
21.000 mg |
| Monosodium phosphate |
0.135 mg |
| Disodium phosphate |
0.48 mg |
| Water for injection purposes |
q.s. 3.0 ml |
Dosage
It is recommended to perform 1 infiltration per treatment cycle. The appropriateness and frequency with which the treatment cycle can be repeated must be individually assessed by the physician, considering the risk-benefit ratio for each patient.
Available packages
SINOGEL® 3 ml is available in packs containing 1 pre-filled syringe (72.0 mg sodium hyaluronate and 48.0 mg sodium chondroitin in 3 ml sodium chloride buffered saline) and a 21G x 1½” (0.8 x 40 mm) needle.
The contents of the syringe are sterile and pyrogen-free.
Pre-filled syringe steam sterilized.
Needle sterilized with ethylene oxide.
Manufacturer: Terumo Europe N. V. – Interleuvenlaan 40 – 3001 Leuven, Belgium
Instructions for use
Before injecting SINOGEL® 3 ml, joint effusions must be aspirated.
Carefully unscrew the syringe cap, holding the Luer-Lock collar between your fingers and taking special care not to touch the opening.
Screw the 21G needle (included in the package) firmly onto the Luer-Lock collar of the syringe until you feel slight resistance to ensure an airtight seal and prevent fluid leakage during administration.
Inject SINOGEL® 3 ml at room temperature and under strictly 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 cavity.
After use
Fill out the implant card and hand it over to the patient.
Note: Fill out one implant card for each prefilled syringe used for treatment (i.e., 1 prefilled syringe = 1 completed implant card).
The implant card is inside the box; to remove it, proceed as follows:
- Open the SINOGEL® 3 ml box.
- Remove all blister packs with prefilled syringes from the box.
- Remove the implant card from the box. Gently press down the blue-bordered area of the outer packaging (back) without breaking it.
Instructions for filling out the implant card
Fill in the fields marked with the following symbols with the specified information:
- Patient's name or patient ID
- Date of treatment
- Name and address of the implanting healthcare facility
- Doctor's name
Warnings
- The contents of the prefilled syringe are sterile. The syringe is contained in a sealed blister pack.
- The outer surface of the syringe is not sterile.
- Do not use the medical device after the expiration date printed on the package.
- Do not use the medical device if the packaging is opened or damaged, as the sterility of the product may be compromised.
- The injection must be performed 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 synovial tissue, or the joint capsule.
- Do not administer SINOGEL® 3 ml if there is a severe joint effusion.
- Do not resterilize. The medical device is intended for single use only.
- Do not reuse to avoid contamination risks.
- Store at room temperature below 25 °C and away from heat sources. Do not freeze.
- Once opened, the medical device must be used immediately and disposed of after use.
- SINOGEL® 3 ml is indicated for adult patients. Keep out of reach of children.
- Do not use SINOGEL® 3 ml in case of known hypersensitivity or allergies to any of the product's components.
- After the injection, instruct the patient to avoid any intense physical activity and to resume normal activities only after a few days.
- Protect from sunlight.
- Existing air bubbles do not affect the product properties.
Precautions for use
Do not mix the medical device with disinfectants such as quaternary ammonium salts or chlorhexidine, as this may cause the product to precipitate.
Interactions
Currently, no interactions between SINOGEL® 3 ml and drugs/other treatments are known. However, if you are using medications or other therapeutic measures simultaneously, consult your doctor for more information.
Side effects
Extra-articular infiltration of SINOGEL® 3 ml can cause local adverse effects.
During the use of SINOGEL® 3 ml, symptoms such as pain, warmth, redness, or swelling at the injection site may occur. These secondary complaints can be relieved by applying ice to the treated joint and usually subside after a short time. Doctors must ensure that patients inform them of any adverse effects that may occur after treatment.
In case of an adverse event, the manufacturer or the competent authority must be informed.
Overdose
Adhere to the specified dosage and contact your doctor or the nearest hospital if you notice side effects related to an overdose.
Contraindications
SINOGEL® 3 ml must not be injected if there is an infected or severely inflamed joint or if the patient has a skin condition or infection at the injection site.
Shelf life
Shelf life: 36 months.
The expiration date indicates the maximum shelf life of the medical device.
Disposal
Do not dispose of the product in the environment after use. Follow local regulations for product disposal.
Summary of Safety and Clinical Performance
You can download the Summary of Safety and Clinical Performance (SSCP) using the following link:
https://www.ibsa.it/en/chi-siamo/summary-of-safety-and-clinical-performance.html
https://www.ibsa.it/en/chi-siamo/sscp-area-riservata.html
Date of last revision of the package leaflet
February 2023
Joint injections
Dermafiller
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