Formats, Presentations of Sinovial One 2% - Sinovial One
Joint viscosupplementation device:
3 ml glass pre-filled syringe containing 2.5 ml of solution, single use + sterile needle type 21 G x 1½'' (0.8 x 40 mm), box of 1 syringe and 1 needle (EAN 3700640500072).
The pre-filled syringe is sterilized by moist heat. The contents of the syringe are sterile and non-pyrogenic.
The needle is sterilized with ethylene oxide.
Sinovial One 2% composition
Highly purified hyaluronic acid sodium salt (50.0 mg hyaluronic acid sodium salt in 2.5 ml physiological solution buffered with sodium chloride), sodium chloride, sodium phosphate and water for injection (qsp 100%).
Properties of Sinovial One 2%
Sinovial One is a physiological buffered solution of hyaluronic acid sodium salt, with viscoelastic properties.
Sinovial One contains 2.0% hyaluronic acid, with a molecular weight between 800 and 1200 kDalton.
Hyaluronic acid sodium salt (hyaluronan*) consists of iterative chains of N-acetylglucosamine disaccharide units and sodium glucuronate. It is an essential component of the synovial fluid to which it gives its viscoelastic properties.
The hyaluronic acid sodium salt contained in Sinovial One is obtained by fermentation and is not chemically modified.
*Another designation often used.
Indications Sinovial One 2% (2.0 %)
Sinovial One 2.0% is indicated for pain or mobility restrictions due to degenerative or post-traumatic diseases or damage to joints and tendons.
Sinovial One is a suitable joint fluid replacement agent that restores the physiological and rheological conditions of arthritic joints.
This therapeutic effect is based on the special properties of the hyaluronic acid used.
By restoring the viscoelastic properties of the joint fluid, Sinovial One reduces pain and restores joint and tendon mobility.
Sinovial One acts only on the joint in which it has been injected and has no systemic effect.
Instructions for use Sinovial One 2% is used as follows
Aspirate any joint effusion before injecting Sinovial One.
Remove the cap from the syringe, taking particular care not to touch the syringe opening.
Insert the 21 G diameter needle included in the box. Secure the needle into the Luer connector on the syringe to ensure a tight connection and to prevent fluid leakage during administration.
Inject Sinovial One at room temperature and under strict aseptic conditions. Inject only into the synovial space.
Sinovial One is a single dose preparation and should be injected only once per treatment cycle. Subsequent injections may be made if necessary. The appropriateness and frequency with which the treatment cycle can be repeated must be assessed by the physician for each individual patient, taking into consideration the benefit/risk ratio of the treatment in each case.
Contraindications Sinovial One 2%
Do not inject Sinovial One in the presence of an infected or severely inflamed joint or if the patient has a skin condition or infection at the injection site.
Precautions for use
Intra-articular injection should only be performed by a physician.
Do not mix Sinovial One with disinfectants such as quaternary ammonium salts or chlorhexidine because of the risk of precipitation of hyaluronic acid in the solution.
The injection site must be located on healthy skin.
Do not inject intravascularly. Do not inject outside the joint space, into the synovial tissue or into the joint capsule.
Do not administer Sinovial One in the presence of significant intra-articular effusion.
After intra-articular injection, the patient should be advised to refrain from physical exertion and to resume normal activities only after a few days.
The contents of the pre-filled syringe are sterile. The syringe is packaged in an airtight blister pack. The outer surface of the syringe is not sterile. Do not resterilize. The contents of the syringe are for single use only.
Do not reuse to avoid contamination.
The possible presence of an air bubble does not compromise the characteristics of the product.
Keep out of reach of children.
Adverse Reactions:
Extra-articular infiltration of Sinovial One may cause local adverse effects. During the use of Sinovial One, events such as pain, warmth, redness or swelling may occur at the injection site. These side effects can be relieved by applying ice to the treated joint. These usually subside within a short time.
The physician should ensure that patients inform him/her of any adverse events that occur after treatment.
Interactions :
No interactions of Sinovial One with other drugs have been reported to date.
Storage conditions
Do not use Sinovial One after the expiry date stated on the package.
Store at room temperature below 25°C and away from heat sources. Do not freeze.
Once opened, Sinovial One should be used immediately and disposed of after use.
Do not use Sinovial One if the package has been opened or damaged.
Administrative Information
Medical device, class III. CE mark 0373.
Responsible for CE marking: IBSA Farmaceutici Italia srl, via Martiri di Cefalonia, 2, 26900 Lodi, Italy.
Date of revision of the leaflet: February 2015.
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