Sinovial 2 ml: 2-ml single-use pre-filled syringes (steam-sterilized), ready for use, + sterile single-use 21G x 1½ needles (ethylene oxide-sterilized), box of 3 syringes + 3 needles
SYNOVIALE ARTICULAIRE by Boiron: Homeopathic Granules and Oral Drops
BORIUM 4CH, 5CH, 9CH Granules by Boiron Homeopathy
For warnings, precautions, and contraindications, please refer to the package insert.
SINOVIAL® 2 ml, SINOVIAL® MINI
Updated: Thursday, March 21, 2013.
Indications: Viscoelastic injectable products
Forms, Presentations
Viscoelastic solution for intra-articular injection:
Sinovial 2 ml: 2-ml single-use pre-filled syringes (steam-sterilized), ready for use, plus sterile single-use 21G x 1½ needles (ethylene oxide-sterilized), box of 3 syringes + 3 needles (ACL 3401094747517).
Sinovial Mini: 1-ml single-use pre-filled syringes (steam-sterilized), ready to use, box of 1 (ACL 3401099169826).
The contents of the syringes are sterile and nonpyrogenic.
Composition
Highly purified sodium hyaluronate (sodium salt of hyaluronic acid) at 0.8% (8 mg of hyaluronic acid per 1 mL of buffered physiological sodium chloride solution), sodium chloride, sodium phosphate, and water for injection (qsp 100%).
Properties
Sinovial is a buffered physiological hyaluronic acid solution with viscoelastic properties. Sinovial contains hyaluronic acid with a molecular weight ranging from 800 to 1200 kDalton.
Sodium hyaluronate (hyaluronan*) consists of repeating disaccharide units composed of N-acetylglucosamine and sodium glucuronate. It is an essential component of synovial fluid and imparts its viscoelastic properties.
*
Another commonly used term.
Indications
Sinovial 2 ml is indicated for pain or reduced mobility to restore the physiological and rheological properties of arthritic joints.
Sinovial Mini is suitable for viscosupplementation of small joints: all joints of the wrist and hand, including the interphalangeal, intercarpal, metacarpophalangeal, carpometacarpal, distal radioulnar joints, and the radiocarpal joint; all joints of the foot and the temporomandibular joint; and tendon sheaths (for example, in cases of tenosynovitis of the flexor tendons or trigger finger).
Sinovial is a suitable joint fluid replacement agent. It restores the physiological and rheological conditions of the arthritic joint. Its therapeutic action is based on the special properties of its hyaluronic acid. The hyaluronic acid in Sinovial, obtained through fermentation and chemically unmodified, is very well tolerated. By restoring the viscoelastic properties of the synovial fluid, Sinovial reduces pain and restores joint mobility.
Sinovial acts only in the joints into which it has been injected; it has no systemic effect.
Directions for Use, Dosage
It is recommended to administer 2 mL of Sinovial according to a dosing regimen of 3 injections, spaced 1 week apart.
It is recommended to administer Sinovial Mini according to a dosing regimen of 2 to 3 treatments per year, with intervals of 4 to 6 months, as directed by a doctor.
Aspirate any joint effusion before injecting Sinovial. Do not use Sinovial if the packaging is open, damaged, or incomplete. Check the packaging for damage before use. Inject Sinovial at room temperature, strictly observing aseptic technique. Take special care not to touch the syringe tip when removing the cap. Use the supplied needle (Sinovial 2 mL) or an appropriately sized 18- to 22-Gauge needle (Sinovial Mini). To ensure a tight connection and prevent leakage during administration, securely attach the needle to the syringe connector.
Contraindications
Sinovial must not be injected into an infected or severely inflamed joint, or in patients with a skin condition or infection at the injection site.
Precautions
Intra-articular injection may only be performed by a physician.
Do not use disinfectants containing quaternary ammonium salts, such as benzalkonium chloride, as there is a known incompatibility with hyaluronic acid.
The possible presence of an air bubble does not compromise the product’s characteristics.
The injection site must be on healthy skin. Inject only into the joint space. Do not inject intravascularly. Do not inject outside the joint space, into the synovial tissue, or into the joint capsule. Extra-articular infiltration of Sinovial may cause local adverse effects. Do not use Sinovial in the presence of significant intra-articular effusion.
Do not re-sterilize. The syringe and needles are for single-use only. Do not reuse to avoid any risk of contamination.
As with any invasive procedure involving a joint, patients are advised to refrain from physical exertion after the joint injection and to resume normal activities only after a few days.
It may be helpful to use a topical anti-inflammatory medication for temporary relief.
Adverse effects:
Related symptoms, such as pain, a sensation of warmth, redness, or swelling, may occur at the injection site after using Sinovial.
Applying ice to the treated joint can help relieve these side effects. They usually subside within a short time.
The patient should inform the doctor of any adverse effects that may occur later.
Storage Conditions
Do not use after the date printed on the packaging.
Store at a temperature between 4 °C and 25 °C, away from any source of heat.
Do not freeze.
Sinovial must be used immediately after opening and discarded after use.
Administrative Information
Suggested retail price:
Sinovial Mini:
€23.00 (not covered by LPPR; available only by prescription).
CE Mark 0373 (ISTISAN).
Medical device, Class III.
Date of package insert revision: June 2012.
GENÉVRIER SA Laboratories
ZI Les 3-Moulins. 280 Goa Street
Sophia-Antipolis Park
06901 Sophia-Antipolis
Phone: 04 92 91 15 60. Fax: 04 92 91 15 30
Please note: Medications are not like other products. Read the medication insert carefully before ordering. Keep medications out of the reach of children. If symptoms persist, consult your doctor or pharmacist. Be aware of potential interactions with your current medications.
Please inform your online pharmacist of any current treatments to identify potential interactions. The order confirmation form includes a custom message field for this purpose.
Click here to view the package insert for this medication on the website of the French National Agency for Medicines and Health Products Safety.
Pharmacovigilance: Report one or more adverse effects related to the use of a medication
