Synvisc-One48 mg/10 ml

Hylan G-F is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e.g., acetaminophen.

2.25 mL glass syringe containing one 2 mL (16 mg) dose of hylan G-F 20. The contents of the syringe are sterile and nonpyrogenic.

Drugs for Osteoarthritis

Joints contain a fluid, called synovial fluid, which acts as a lubricant and shock absorber. Patients with osteoarthritis have synovial fluid that is thinner than normal, and, therefore, it is less effective as a lubricant and shock-absorber. Synvisc-One 48 mg/10 ml is an elastic fluid that is made from a substance called hyaluronan, that is found in normal joint fluid. Hyaluronan is the key substance in joint fluid that provides the shock-absorbing quality to the fluid, and it is essential for the proper functioning of joints. When Synvisc-One 48 mg/10 ml is injected into the knee of a patient with osteoarthritis, the drug helps to restore the shock-absorbing effect of the fluid within the knee. This can reduce pain, resulting in a more active lifestyle.

Synvisc-One 48 mg/10 ml is administered by intra-articular injection once a week (one week apart) for a total of three injections. Strict aseptic administration technique must be followed. Using an 18- to 22-gauge needle, remove synovial fluid or effusion before each Synvisc-One 48 mg/10 ml injection. Do not use the same syringe for removing synovial fluid and for injecting Synvisc-One 48 mg/10 ml however the same 18- to 22-gauge needle should be used. Twist the tip cap before pulling it off, as this will minimize product leakage. To ensure a tight seal and prevent leakage during administration, secure the needle tightly while firmly holding the luer hub.

Synvisc-One 48 mg/10 ml is administered by intra-articular injection once a week (one week apart) for a total of three injections. Strict aseptic administration technique must be followed. Using an 18- to 22-gauge needle, remove synovial fluid or effusion before each Synvisc-One 48 mg/10 ml injection. Do not use the same syringe for removing synovial fluid and for injecting Synvisc-One 48 mg/10 ml however the same 18- to 22-gauge needle should be used. Twist the tip cap before pulling it off, as this will minimize product leakage. To ensure a tight seal and prevent leakage during administration, secure the needle tightly while firmly holding the luer hub.

No information provided.

Do not administer to patients with known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations. Do not inject Hylan G-F in the knees of patients having knee joint infections or skin diseases or infections in the area of the injection site

The most commonly reported adverse events associated with Synvisc-One 48 mg/10 ml are the following: Pain in the injected knee, Swelling in the injected knee, Joint effusion

Pregnancy: The safety and effectiveness of Synvisc-One 48 mg/10 ml have not been established in pregnant women.Nursing mothers: It is not known if Synvisc-One 48 mg/10 ml is excreted in human milk. The safety and effectiveness of Synvisc-One 48 mg/10 ml have not been established in lactating women.

The effectiveness of a single treatment cycle of less than three injections (2 mL each) of Synvisc-One 48 mg/10 ml has not been established. The safety and effectiveness of Synvisc-One 48 mg/10 ml 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 48 mg/10 ml concomitantly with other intra-articular injectables have not been established. Use caution when injecting Synvisc-One 48 mg/10 ml into patients who are allergic to avian proteins, feathers, and egg products. The safety and effectiveness of Synvisc-One 48 mg/10 ml 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 48 mg/10 ml. Do not use Synvisc-One 48 mg/10 ml 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-One 48 mg/10 ml injection. Synvisc-One 48 mg/10 ml should be used with caution when there is evidence of lymphatic or venous stasis in the leg to be injected. Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronan can precipitate in their presence. Do not inject Hylan G-F 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 Hylan G-F. Intravascular injections of Hylan G-F may cause systemic adverse events.

Do not use Synvisc-One 48 mg/10 ml if the package has been opened or damaged. Store in original packaging (protected from light) at room temperature below 86°F (30°C). DO NOT FREEZE.

Pediatrics: The safety and effectiveness of Hylan G-F have not been established in pediatric patients. Pediatric patients are defined as patients ≤ 21 years of age.

Drugs for Osteoarthritis

Joints contain a fluid, called synovial fluid, which acts as a lubricant and shock absorber. Patients with osteoarthritis have synovial fluid that is thinner than normal, and, therefore, it is less effective as a lubricant and shock-absorber. Synvisc-One 48 mg/10 ml is an elastic fluid that is made from a substance called hyaluronan, that is found in normal joint fluid. Hyaluronan is the key substance in joint fluid that provides the shock-absorbing quality to the fluid, and it is essential for the proper functioning of joints. When Synvisc-One 48 mg/10 ml is injected into the knee of a patient with osteoarthritis, the drug helps to restore the shock-absorbing effect of the fluid within the knee. This can reduce pain, resulting in a more active lifestyle.

Pregnancy: The safety and effectiveness of Synvisc-One 48 mg/10 ml have not been established in pregnant women.Nursing mothers: It is not known if Synvisc-One 48 mg/10 ml is excreted in human milk. The safety and effectiveness of Synvisc-One 48 mg/10 ml have not been established in lactating women.

Pediatrics: The safety and effectiveness of Hylan G-F have not been established in pediatric patients. Pediatric patients are defined as patients ≤ 21 years of age.