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Product:

SYNVISC ONE®

Manufacturer: Genzyme
Active Substance(s) : Hylan g-f 20
Strength: 8mg/ml
Pack Size: 1-6ml prefilled syringe
Accessories: Package insert, 2 traceability labels
 
 
 
 
 
You can save $24.00 if you add an additional 5 units to your cart.

Synvisc One Product specifications

Synvisc One is a viscosupplement formulated to aid in the management of symptoms associated with knee osteoarthritis. Made of hyaluronan derivatives called hylan, this gel-like substance supplements and restores the shock-absorbing and lubricating properties of synovial fluid that is diminished in patients with osteoarthritis. This is a single dose treatment that is delivered via intraarticular injection to the affected knee, making this a convenient treatment option for patients.

What Synvisc One is formulated to do

Synvisc One is an orthopedic injectable used to treat pain associated with knee osteoarthritis. Patients who have this chronic condition suffer from soreness or stiffness in the knees after inactivity or overuse, swelling around the knees, and/or knee pain that worsens with activity. In some instances, this may become a debilitating condition that negatively affects the quality of life. When this happens, it is important that the patient is able to manage the associated pain and discomfort effectively and effortlessly to maintain their desired lifestyle.

If conventional treatments, such as physical therapy and pain medications (e.g. ibuprofen, acetaminophen), can no longer provide sufficient knee pain relief, patients may consider viscosupplementation as a treatment option. This therapeutic method typically involves a series of injections of high concentrations of hyaluronan, a compound found in large quantities in the synovial fluid that provides lubrication and cushioning in the knee joint.

Synvisc One is unique in its class of viscosupplements in two regards: its composition, and its course of treatment. Unlike other viscosupplements, Synvisc One is made up of hylan, which are cross-linked derivatives of hyaluronan. In addition, Synvisc One is a single-dose treatment, meaning that multiple visits are not required for this treatment.

Manufacturer/Origin

The Synvisc One orthopedic injection is manufactured by Genzyme Biosurgery, a division of Genzyme Corporation, which is a subsidiary of Sanofi, a global pharmaceutical and biotech company.

Synvisc One has its origins in the United States of America.

What else you need to know

When can it cause side effects?

Synvisc One should not be used in patients with a known allergy to hyaluronan products. Allergic reactions, such as anaphylactic reactions, anaphylactoid reactions, anaphylactic shock, and angioedema, have been reported for this product. Additionally, exercise caution when treating patients allergic to avian proteins, feathers, or egg products, as this product is derived from an avian source.

Reported side effects with this treatment include joint pain or stiffness; joint swelling or effusion; injection site pain; arthritis; arthropathy; and gait disturbance, such as difficulty walking and limping. This may not be a complete list of side effects. Refer to the package insert for a full list of side effects, warnings, and contraindications. Patients should be informed of all possible side effects, contraindications, and precautions prior to treatment.

Is this product FDA approved?

This product has been approved by FDA.

Information about the packaging

This product is supplied in a 10ml glass syringe.

What are the differences between the product range?

A related product is Synvisc, which has a different treatment regimen requiring multiple doses.

Suggested usage

  • Synvisc One is meant to be administered as a single intra-articular injection. Hence, follow standard procedures for injections, such as following an aseptic technique.
  • Remove any joint effusion or synovial fluid before injecting Synvisc One using an 18- to 20-gauge needle. Do not reuse the syringe for administering Synvisc One; however, the same needle may be used.
  • Uncap the tip of the prefilled treatment syringe by twisting the tip and then pulling it off.
  • Secure the needle tightly while holding the Luer hub: this will ensure a tight seal and prevent leakages.
  • Inject the full 6ml dose into 1 knee.
  • Patients should avoid any type of strenuous or prolonged weight-bearing activities for approximately 48 hours after treatment.

Composition

Synvisc One is a viscoelastic, sterile, non-pyrogenic solution of hylan A and hylan B hydrated gel in a buffered physiological saline solution, with a pH of 7.2. Hylans are derivatives of hyaluronan, a polysaccharide present in large quantities in healthy synovial fluid. Synvisc One combines three 2ml doses (16mg each) of a complete Synvisc treatment course into a single 6ml dose contained in a 10ml syringe.

What is in the box

  • 1-6ml dose of Synvisc One supplied in a 10ml glass syringe
  • A package insert that has comprehensive information on this product’s side effects, contraindications, precautions, expiration date, and other important topics.

Duration of effect

Current evidence shows that Synvisc One’s effects can last for up to 26 weeks with a single injection.

Storage conditions

Store this product in an environment that has a temperature between 2℃–30℃. Do not freeze.

Expiry (shelf life)

Refer to the package insert for information on the expiry date.