"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-One extra-articularly or into the synovial tissues and capsule.
- Intravascular injections of Synvisc-One may cause systemic adverse events.
- The safety and efficacy of Synvisc-One 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-One concomitantly with other intra-articular injectables have not been established.
- Use caution when injecting Synvisc-One into patients who are allergic to avian proteins, feathers or egg products.
- The safety and efficacy of Synvisc-One 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-One.
- Do not use Synvisc-One 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 any synovial fluid or effusion before injecting Synvisc- One.
- Synvisc-One 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.
- Mild to moderate pain, swelling and/or effusion of the injected knee have been reported in clinical trials that were related to intra-articular injection of Synvisc-One. These events were typically transient and usually resolved on their own or with conservative treatment.
- As with any invasive joint procedure, it is recommended that the patient avoid strenuous activities (for example, high-impact 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
The safety and effectiveness of Synvisc-One have not been established in pregnant women.
It is not known if Synvisc-One is excreted in human milk. The safety and effectiveness of Synvisc-One have not been established in lactating women.
The safety and effectiveness of Synvisc-One have not been established in pediatric patients. Pediatric patients are defined as patients ≤ 21 years of age.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/6/2016
Additional Synvisc-One Information
Synvisc-One - User Reviews
Synvisc-One 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