"The US Food and Drug Administration's (FDA's) Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee voted yesterday to recommend premarket approval of the Cartiva Synthetic Cartilage Implant for use in pati"...
- Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronan can precipitate in their presence.
- Do not inject SYNVISC (hylan g-f 20) extra-articularly or into the synovial tissues and capsule. Local and systemic adverse events, generally in the area of the injection, have occurred following extra-articular injection of SYNVISC (hylan g-f 20) .
- Intravascular injections of SYNVISC (hylan g-f 20) may cause systemic adverse events.
- The effectiveness of a single treatment cycle of less than three injections (2 mL each) of SYNVISC (hylan g-f 20) has not been established.
- The safety and effectiveness of SYNVISC (hylan g-f 20) in locations other than the knee and for conditions other than osteoarthritis have not been established.
- The safety and effectiveness of the use of SYNVISC (hylan g-f 20) concomitantly with other intra-articular injectables have not been established.
- Use caution when injecting SYNVISC (hylan g-f 20) into patients who are allergic to avian proteins, feathers, and egg products.
- The safety and effectiveness of SYNVISC (hylan g-f 20) in severely inflamed knee joints have not been established.
- Strict aseptic administration technique must be followed.
- STERILE CONTENTS. The syringe is intended for single use. The contents of the syringe must be used immediately after its packaging is opened. Discard any unused SYNVISC (hylan g-f 20) .
- Do not use SYNVISC (hylan g-f 20) if package is opened or damaged. Store in original packaging (protected from light) at room temperature below 86°F (30°C). DO NOT FREEZE.
- Remove synovial fluid or effusion before each SYNVISC (hylan g-f 20) injection.
- SYNVISC (hylan g-f 20) should be used with caution when there is evidence of lymphatic or venous stasis in the leg to be injected.
Information for Patients
- Provide patients with a copy of the Patient Labeling prior to use.
- Transient pain, swelling and/or effusion of the injected joint may occur after intra-articular injection of SYNVISC (hylan g-f 20) . In some cases the effusion may be considerable and can cause pronounced pain; cases where swelling is extensive should be discussed with the physician.
- As with any invasive joint procedure, it is recommended that the patient avoid any strenuous activities (for example, highimpact sports such as soccer, tennis or jogging) or prolonged weight-bearing activities for approximately 48 hours following the intra-articular injection. The patient should consult his or her physician regarding the appropriate time to resume such activities.
Use in Specific Populations
- Pregnancy: The safety and effectiveness of SYNVISC (hylan g-f 20) have not been established in pregnant women.
- Nursing mothers:It is not known if SYNVISC (hylan g-f 20) is excreted in human milk. The safety and effectiveness of SYNVISC (hylan g-f 20) have not been established in lactating women.
- Pediatrics: The safety and effectiveness of SYNVISC (hylan g-f 20) have not been established in pediatric patients. Pediatric patients are defined as patients” 21 years of age.
Last reviewed on RxList: 7/22/2010
Additional Synvisc Information
Synvisc - User Reviews
Synvisc User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options