Sinovial 2 ml: 2 ml pre-filled syringes for single use (steam sterilized water), ready to use, sterile disposable + Type 21G x 1 ½ needles (sterilized by ethylene oxide) box 3 + 3 syringes needles (ACL 3401094747517).
Sinovial ® 2 ml sinovial ® MINI
Updated: Thursday, March 21, 2013.
Applications: viscoelastic Injectables
Forms, Presentations
Viscoelastic solution for intraarticular injection:
Sinovial 2 ml: 2 ml pre-filled syringes for single use (steam sterilized water), ready to use, sterile disposable + Type 21G x 1 ½ needles (sterilized by ethylene oxide) box 3 + 3 syringes needles (ACL 3401094747517).
Sinovial Mini: Prefilled syringes of 1 ml disposable (sterilized water vapor), ready to use, 1 box (ACL 3401099169826).
The contents of the syringe are sterile and non-pyrogenic.
Composition
Sodium hyaluronate (the sodium salt of hyaluronic acid) 0.8% highly purified (8 mg hyaluronic acid / 1 ml of physiological sodium chloride buffered), sodium chloride, sodium phosphate and water for injections injectables (qs 100%).
Properties
Sinovial is a hyaluronic acid physiological solution buffered with visco-elastic properties. Sinovial contains hyaluronic acid having a molecular weight between 800 and 1200 kDalton.
Sodium hyaluronate (hyaluronan *) consists of repeated disaccharide units made of N-acetylglucosamine and sodium glucuronate. It is an essential component of synovial fluid and gives it its visco-elastic properties.
*
Another name often used.
Indications
Sinovial 2 ml is indicated in cases of pain or decreased mobility for a restoration of physiological and rheological properties of osteoarthritic joints.
Sinovial Mini is suitable for viscosupplementation small joints: All joints of the wrist and hand, including the interphalangeal joints, intercarpal, metacarpophalangeal, carpometacarpal, radio-ulnar distal and radiocarpal joint, all joints of the foot and temporomandibular joint and tendon sheaths (eg in case of tenosynovitis of the flexor tendons or trigger finger).
Sinovial agent is a suitable replacement joint fluid. It restores the physiological and rheological conditions of the osteoarthritic joint. The therapeutic action based on the special properties of the hyaluronic acid. Hyaluronic acid Sinovial obtained by fermentation and chemically unmodified, is very well tolerated. Restoring the viscoelastic properties of synovial fluid, Sinovial reduces pain and restores joint mobility.
Is only in the synovial joints where it was injected; it has no systemic effect.
Instructions, Dosage
It is recommended to administer Sinovial 2 ml according to a regimen of three injections, 1 week apart.
It is recommended to administer Sinovial Mini on a regimen February-March treatments per year, with intervals of 4 to 6 months, depending on the doctor's advice.
Suck a possible joint effusion before injecting Sinovial. Do not use Sinovial if the package is opened, damaged or incomplete. Check the integrity of the packaging before use. Inject Sinovial at room temperature and strictly observing the rules of asepsis. Be particularly careful not to touch the opening of the syringe by removing the cap. Use needle provided (Sinovial 2 ml) or appropriately sized needle of 18-22 G (Sinovial Mini). To ensure a tight connection and prevent leakage during administration, securely fit the needle to the syringe connector.
Cons-indications
Should not inject Sinovial in an infected or acutely inflamed joint, or in patients with skin disease or infection at the site of injection.
Precautions
Intra-articular injection can only be made by a physician.
Do not use disinfectants quaternary ammonium salts such as benzalkonium chloride because it is a known incompatibility with hyaluronic acid.
The possible presence of an air bubble does not affect the characteristics of the product.
The injection site should be located in healthy skin. Only inject into the joint space. Do not inject intravascularly. Do not inject outside the joint space in the synovial tissue or joint capsule. An extra-articular infiltration Sinovial may cause local adverse effects. Do not use Sinovial in the presence of a significant 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 at a joint, it is recommended the patient to refrain from physical exertion after articular injection and not resume normal activities after a few days.
Side effects:
Events associated, such as pain, a feeling of warmth, redness or swelling may occur at the injection site after using Sinovial.
Applying ice to the treated joint can relieve such events associated. These usually resolve in a short time.
The patient should inform the doctor about any side effect may occur later.
Storage conditions
Do not use beyond the date shown on the packaging.
Store at a temperature between 4 ° C and 25 ° C, away from any heat source.
Do not freeze.
Sinovial should be used immediately after opening and discarded after use.
Administrative Information
List Price:
Sinovial Mini:
€ 23.00 (no support ISL, can not be supplied on medical prescription).
EC 0373 (ISTISAN) marking.
Medical device, Class III.
Revision Date of record: June 2012.
JUNIPER Laboratories SA
ZI Les 3 Moulins. 280, rue de Goa
Park of Sophia-Antipolis
06901 Sophia-Antipolis
Tel: 04 92 91 15 60 Fax:. 04 92 91 15 30
Email: mail@laboratoires-genevrier.com
Viscoelastic solution for intra-articular injection:
Sinovial 2 ml: Syringes (glass) pre-filled with 2 ml disposable solution (steam sterilized), ready to use, + sterile, single use needles type 21G x 1½ [0.8 mm × 40 mm] (sterilized with ethylene oxide), box of 3 syringes + 3 needles (ACL 34010 9474751 7 ) or box of 1 syringe + 1 needle (ACL 34010 6029722 0 ).
Sinovial Mini: Syringe (glass) pre-filled with 1 ml of disposable solution (steam sterilized), ready to use, unitary box (ACL 34010 9916982 6 ).
The contents of the syringes are sterile and not pyrogenic.
Sodium hyaluronate (sodium salt of hyaluronic acid) highly purified to 0.8% (8 mg of hyaluronic acid / 1 ml of buffered physiological sodium chloride solution), sodium chloride, sodium phosphate and water for preparations injectables (qs 100%).
Sinovial is a buffered physiological hyaluronic acid solution with viscoelastic properties. Sinovial contains hyaluronic acid with a molecular weight between 800 and 1200 kDaltons.
Sodium hyaluronate ( hyaluronan * ) consists of iterative disaccharide units made of N-acetylglucosamine and sodium glucuronate. It constitutes an essential component of the synovial fluid and confers on it its viscoelastic properties.
Sinovial 2 ml is indicated for pain or decreased mobility due to degenerative diseases (osteoarthritis), post-traumatic diseases or changes in joints and tendons. The improvement is instantaneous: the overall WOMAC index decreases with the first injection and, from the third injection, the reduction becomes statistically significant.
Sinovial Mini is suitable for the viscosupplementation of small joints: all joints of the wrist and hand, including the interphalangeal, intercarpal, metacarpophalangeal, carpometacarpal, distal radioulnar joints and radiocarpal joints, all joints of the foot and shoulder. temporomandibular joint, and tendinous sheaths (for example, tenosynovitis of the flexor tendons or protruding finger).
Sinovial is a replacement agent for the appropriate joint fluid. It restores the physiological and rheological conditions of the osteoarthritic joint. The therapeutic action is based on the special properties of its hyaluronic acid. Sinovial's hyaluronic acid, obtained by fermentation and chemically unmodified, is very well tolerated.
Sinovial acts only in the joints in which it was injected; it has no systemic effect.
It is recommended to administer Sinovial 2 ml according to a dosage schedule of 3 - 5 injections given one week apart to reduce pain and swelling, and improve function, which can last up to 24 weeks.
It is recommended to administer Sinovial Mini in a dosage schedule of 2 to 3 treatments per year, with intervals of 4 to 6 months, according to the physician's advice.
Aspirate any joint effusion before injecting Sinovial. Do not use Sinovial if the packaging is opened or damaged. Inject Sinovial at room temperature and strictly observe the rules of asepsis. Be particularly careful not to touch the syringe opening by removing the cap. Use the supplied needle (Sinovial 2 ml) or a needle of appropriate size from 18 to 22 G (Sinovial Mini). To ensure a tight connection and prevent leakage during administration, securely attach the needle to the syringe connector.
Do not inject Sinovial into an infected or heavily inflamed joint, or in patients with a skin condition or infection at the site of the injection.
Intra-articular injection can only be done by a doctor.
Do not use at the same time as disinfectants containing quaternary ammonium salts or chlorhexidine to prepare the skin, because a precipitation of hyaluronic acid is possible in their presence.
The possible presence of an air bubble does not compromise the characteristics of the product.
The injection site should be located on healthy skin. Inject only in the joint space. Do not inject intravascularly or outside the tendon sheath. Do not inject outside the joint space, in the synovial tissue or joint capsule. Extra-articular infiltration of Sinovial, or outside the tendon sheath, may cause local adverse effects. Do not use Sinovial in the presence of significant intra-articular effusion.
Do not resterilize. The syringe and needles are for single use only. Do not reuse to avoid any risk of contamination.
The contents of the pre-filled syringe are sterile. The syringe and needle are supplied in sealed blister pack. The outer surface of the syringe is not sterile.
As with any invasive procedure at the joint, the patient is advised to abstain from physical exertion after joint injection and to resume normal activities only after a few days.
Associated manifestations, such as pain, feeling hot, redness or swelling, may occur at the injection site after Sinovial use.
The application of ice on the treated joint relieves such associated manifestations. These usually decline in a short time.
The patient should inform the doctor of any undesirable effects that may occur later.
No interactions with other drugs have been reported to date.
Do not use beyond the date on the packaging.
Store at a temperature between 0 ° C and 25 ° C, away from any source of heat.
Do not freeze.
Sinovial should be used immediately after opening and discarded after use.
Medical devices, class III. Marking THIS 0373.
CE Marking Manager: IBSA Farmaceutici Italia srl, via Martiri di Cefalonia, 2, 26900 Lodi, Italy.
Revision date of the package leaflet: February 2017 (Sinovial 2 ml), November 2014 (Sinovial Mini).
ZI Les 3-Moulins. 280 Goa Street
Park Sophia-Antipolis
06901 Sophia-Antipolis
Tel: 04 92 91 15 60. Fax: 04 92 91 15 30
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