Each 1 ml of EUFLEXXA contains: Sodium hyaluronate 10mg; Sodium chloride 8.5 mg; Disodium hydrogen phosphate dodecahydrate 0.56 mg; Sodium dihydrogen phosphate dihydrate 0.05 mg; Water for injections q.s.
EUFLEXXA is a viscoelastic, sterile solution of highly purified, high molecular weight (2.4-3.6 million daltons) sodium hyaluronate in phosphate-buffered saline. Sodium hyaluronate is a physiological material found in both animal and human tissues. EUFLEXXA is a very highly purified product extracted from bacterial cells. It is a polysaccharide consisting of a repeating disaccharide of N-acetylglucosamine and sodium glucuronate, linked by alternating β-1,3 and β-1,4 glycosidic bonds. Hyaluronate can be found in synovial fluid, in the vitreous and aqueous humor of the eye, in skin and in the umbilical cord. The contents of the EUFLEXXA syringe are sterile (aseptic filling) and the external surface of the blister-packed syringe is sterilized by ethylene oxide sterilization.
EUFLEXXA is indicated for the treatment of pain caused by osteoarthritis of the knee.
EUFLEXXA aids in lubrication of the joint, allows for greater mobility and flexibility of the treated joint, and reduces pain in the affected knee.
EUFLEXXA is intended for injection into the synovial space. Each EUFLEXXA syringe is intended for single use only. The syringe should be used immediately after the individual syringe blister is opened. Usually a dose of 2 ml is injected into the affected knee at weekly intervals for three weeks, for a total of three injections. For the best effect, all three injections must be administered. Do not use EUFLEXXA if the package is opened or has been tampered with or damaged.
Bring the EUFLEXXA syringe to room temperature before use. Use aseptic technique when handling the syringe and administering the injection. See Instructions for Use for details of preparing the syringe for use.
If the patient presents with effusion, the effusion should be removed before EUFLEXXA is injected into the joint.
Inject the contents of the syringe (2 ml) into one knee only. Discard any unused EUFLEXXA. If treatment is being administered to both knees, use a separate syringe for each knee.
For patients who respond to treatment, the effect of treatment lasts for at least twenty-six weeks.
Instructions for Use: Remove joint effusion, if present.
Twenty to thirty minutes before use, remove the product box from the refrigerator, remove the blister pack from the box and allow the syringe to come to room temperature.
Peel off the blister backing.
While holding the blister open side down, bend the blister and allow the syringe to fall gently onto the sterile surface.
Alternatively, hold the blister open side up and bend back the blister until the barrel's Luer end is exposed.
Gripping the luer end of the barrel, remove the syringe from the blister.
Do not remove the syringe from the plunger end.
To remove the tip cap from the syringe: Hold the syringe upright on the ribbed part of the white closure.
With the other hand, take hold of the white cap of the closure system. Gently tilt back and forth carefully until the cap disconnects and can be pulled off after the seal is broken.
Do not rotate.
Remove the cap in a straight upward direction. Do not touch the syringe tip.
Attach an appropriately sized sterile needle, for example 17 to 21 mm gauge.
Attention: Do not apply pressure to the plunger rod while the needle is being affixed. Verify that the needle is properly locked to the Luer Lock Adaptor (LLA).
Do not overtighten the LLA; this can lead to loosening of the LLA from the barrel.
Apply gentle pressure to the plunger. In order to expel air from the syringe needle and to verify that the syringe is operating properly.
The syringe is ready for use.
Inject intra-articularly into the knee synovial capsule using strict aseptic injection procedures.
Three treatments, each of 2 ml per knee, should be administered, each one week apart.
Do not use EUFLEXXA to treat patients who have a known hypersensitivity to hyaluronate preparations.
Do not use EUFLEXXA to treat patients with knee joint infection, infections in the area of the injection site or skin disease.
EUFLEXXA is to be used only by qualified medical personnel.
Safety and effectiveness of injection in conjunction with other intra-articular treatments, or into joints other than the knee have not been established.
Remove any joint effusion before injecting.
EUFLEXXA has not been tested on pregnant women, lactating women, or children under 18 years.
Since EUFLEXXA is a substance purified from bacterial cells, the presence of exceedingly minute quantities of impurities cannot be totally excluded. The physician should be aware of potential risks associated with the injection of biological substances.
Transient pain or swelling of the injected joint may occur after intra-articular injection with EUFLEXXA.
EUFLEXXA has not been tested on pregnant women or lactating women.
In clinical trials, the most common events were arthralgia and joint swelling. Other events experienced were effusion, nausea, fatigue, non-specified tenderness, back pain, paraesthesia, skin irritation and non-specified hypertension. Associated symptoms such as itching, redness, swelling and pain may occur at the injection site. Application of ice to the treated joint may relieve these symptoms. These symptoms generally decrease within a short period.
Do not inject intravascularly. Protect from light. Do not re-use-dispose of the syringe after use. Do not use if the package is opened or damaged.
Incompatibilities: Mixing of quaternary ammonium salts such as benzalkonium chloride with sodium hyaluronate solutions results in formation of a precipitate. EUFLEXXA should not be administered through a needle previously used with medical solutions containing benzalkonium chloride. Do not use disinfectants for skin preparation that contain quaternary ammonium salts.
Store in a cold dark place (2-8°C). Do not freeze. May be removed from refrigeration within the product shelf life and stored at room temperature (15-25°C) for up to six (6) months.
Shelf-Life: 3 years.
M09AX01 - hyaluronic acid ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.
Inj (pre-filled syringe) 1% x 2 mL x 1's.