Description

EUFLEXXA solution injectable (3x2ml)

Viscoelastic solution for intra -articular injection :

Syringe (glass) with clamp luer -lock syringe with 2 ml single-use , ready to use , 1 box (ACL 3401042303468 ) and box 3 (ACL 3401042303529 ) .

composition

Buffered saline ( isotonic ) , highly purified sodium hyaluronate , viscoelastic , high molecular weight of about 3 million Daltons ( 2.4 to 3.6 million Daltons ) .

properties

Euflexxa is an issue saline bacterial fermentation using a medium containing no not derived from animal origin. The sodium hyaluronate is a polysaccharide composed of repeat disaccharide units of N- acetylglucosamine and sodium glucuronate linked by glycoside bonds beta -1 , 3 and beta -1 , 4 .

Hyaluronate is a key component of synovial fluid, aqueous humor and vitreous eye , skin and the umbilical cord. The contents of the syringe sterile ( aseptic filling ) and pyrogen free. Euflexxa is sterilized with ethylene oxide .

indications

Recommended in the treatment of pain associated with osteoarthritis of the knee and other synovial joints . Restoring the viscoelastic properties of synovial fluid , Euflexxa reduces joint pain and impairment improves the mobility and flexibility of the joint.
Duration of effects :

For patients who respond favorably to the treatment , the duration of the therapeutic effect is at least 26 weeks .

Instructions , Dosage

Euflexxa be injected into the synovial space . Euflexxa each syringe is for single use. The syringe should be used immediately after opening individual blister. Remove the cap from the syringe and attach a sterile needle of appropriate size and length, eg 17 to 21 gauge . Ensure the proper attachment of the needle to the syringe and check for air bubbles.

Generally, a dose of 1 ml or 2 ml is injected into the joint to be treated and repeated at weekly intervals for 3 weeks, a total of 3 injections. 3 injections must be administered to achieve an optimal effect . Euflexxa is injected at room temperature ( wait 20 to 30 minutes before use if Euflexxa was in a refrigerator) .

Methods apply strict asepsis during handling of the syringe and injection . Inject the contents of the syringe into the joint to be treated . Discard any unused portion of Euflexxa . If the treatment is administered more than one joint , use a different syringe for each joint .

Cons -indications

Do not use Euflexxa in patients with known hypersensitivity to hyaluronate preparations or to any of the constituents.

Do not use Euflexxa patients having a joint infection , an infection at the injection site , or a skin infection .

Precautions

Euflexxa should be administered by qualified medical personnel.

Aspirate effusion before each injection.

The efficacy and safety of injection associated with other intra-articular treatments are not established.

Euflexxa has not been studied in pregnant women or in patients under 18 years.

Euflexxa is a purified substance from bacterial fermentation , the presence of minute amounts of impurities can not be completely excluded. The physician should be aware of potential risks associated with the injection of organic products.

Do not inject intravenously.

Do not use if package is opened or damaged.
Side effects:

In clinical trials , the most common adverse events were arthralgia and joint swelling . Other effects observed were : effusion , nausea , fatigue, nonspecific painful tension , back pain , paresthesia , skin irritation, and nonspecific hypertension.

Events associated as itching, redness, pain and swelling may occur at the injection site . Applying ice to the treated joint can relieve such related events are usually transient.
incompatibilities:

When skin disinfection , not Euflexxa use with instruments using sterilized products based on quaternary ammonium salts as sodium hyaluronate can be precipitated in their presence.

Storage conditions

Store in a refrigerator between 2 ° C and 8 ° C , protected from light. Do not freeze. Can be kept outside of the refrigerator at ambient temperature ( between 15 ° C and 25 ° C) for six months .