Orthovisc® 2 ml is a sterile, viscoelastic sodium hyaluronate solution for intra-articular administration.
For supplementation or replacement of synovial fluid in human joints. For use by healthcare professionals only and in accordance with the current instructions for use.
Orthovisc® is a sterile viscosupplement for human joints. The 2 ml pre-filled syringe contains high-molecular-weight sodium hyaluronate in physiological saline and is intended for intra-articular administration by appropriately trained healthcare professionals.
In the European Economic Area, Orthovisc® is described as a viscoelastic supplement or replacement for synovial fluid in human joints. The functions stated in the instructions for use are lubrication and mechanical support. It is used for symptoms associated with impaired synovial-joint function, such as osteoarthritis. The indication and joint selection are the physician’s responsibility.
Orthovisc® is neither a dermal filler nor an aesthetic skin booster. Intended purpose, formulation and injection site differ fundamentally from products injected into the skin. The European intended purpose does not promise regeneration or rebuilding of articular cartilage.
Sodium hyaluronate is a natural component of synovial fluid and contributes to its viscoelastic properties. Orthovisc® contains 15 mg/ml sodium hyaluronate with a molecular weight above one million daltons. The solution is sterile, non-pyrogenic and formulated in physiological saline.
| Product | Orthovisc® Sodium Hyaluronate |
|---|---|
| Product type | Sterile viscoelastic sodium hyaluronate solution |
| Concentration | 15 mg sodium hyaluronate per ml |
| Syringe content | 2 ml |
| Total amount | 30 mg sodium hyaluronate |
| Other ingredients | 9 mg/ml sodium chloride and sterile water for injection |
| Molecular weight | Above 1,000,000 daltons according to the IFU |
| Kinematic viscosity | 20,000–70,000 centistokes according to the IFU |
| Administration | Intra-articular |
| Pack contents | 1 sterile single-use glass pre-filled syringe |
| Storage | 2–25 °C; protect from freezing |
| Manufacturer | Anika Therapeutics, Inc., USA |
| prpmed item number | 100411 |
These details reproduce the manufacturer’s information and are not an individual treatment recommendation. The physician’s decision and the current instructions supplied with the product are authoritative.
Do not use in cases of known hypersensitivity to product components, infection or skin disease at the intended injection site, known infection of the target joint, systemic bleeding disorders or known allergy to gram-positive bacterial proteins.
After administration
Temporary mild to moderate swelling or discomfort has occasionally been observed after intra-articular hyaluronate injections. General risks of intra-articular injections include infection and bleeding. Seek medical advice immediately in the event of unusual symptoms.
In the EEA, the IFU describes use in human joints. A maximum of 2 ml is intended for large joints and 1 ml for small joints. The physician determines the joint and volume.
Three injections at one-week intervals per treatment cycle. No more than one cycle per joint should be administered within six months.
The manufacturer describes the hyaluronate as non-animal in origin and produced by bacterial fermentation.
No. Clinical outcomes and the duration of possible symptom relief vary. No fixed duration can be derived from the intended purpose.
Orthovisc® is an Anika Therapeutics brand of sterile hyaluronic acid products for intra-articular use. In the European Economic Area, Orthovisc is described as a viscoelastic supplement or replacement for synovial fluid in human joints. Its intended physical functions are joint lubrication and mechanical support.
Orthovisc® belongs to the group of hyaluronic acid viscosupplements intended for intra-articular administration. It contains high molecular weight sodium hyaluronate in physiological saline. Hyaluronic acid is naturally present in synovial fluid and contributes to its viscoelastic properties.
With degenerative joint disease, the composition and physical properties of synovial fluid may change. Viscosupplementation addresses the joint fluid itself. Orthovisc® is administered directly into the joint space; European manufacturer information describes its actions as lubrication and mechanical support. This should not be confused with structural cartilage regeneration.
Orthovisc® is therefore not a dermal filler or an aesthetic skin booster. Although all of these products may involve hyaluronic acid, their intended purpose, formulation, injection site and clinical context are fundamentally different.
Anika describes Orthovisc® as a sterile, ultra-pure, non-animal-derived hyaluronic acid product. Its sodium hyaluronate is produced by bacterial fermentation, distinguishing the raw material source from hyaluronates derived from animal tissue.
For the 2 mL Orthovisc® prefilled syringe, the manufacturer specifies 15 mg of sodium hyaluronate per millilitre, giving a total of 30 mg per syringe. Concentration alone does not define the product: Orthovisc® is classified as high molecular weight hyaluronan and is used for its viscoelastic properties within the joint.
Searches such as “Orthovisc hyaluronic acid”, “hyaluronic acid for joints”, “viscosupplement” or “Orthovisc 2 mL” refer to a joint-care product category, not to aesthetic hyaluronic acid fillers.
This brand information does not replace the IFU. Indication, joint selection, injection volume, treatment schedule, contraindications and aseptic technique are governed by the current regional IFU and the treating physician’s decision.
For the European Economic Area, Anika describes Orthovisc® as a viscoelastic supplement or replacement for synovial fluid in human joints. Approvals differ in other markets; in the United States, for example, Orthovisc is indicated for the knee only. Regional differences matter, so product information from one country should not automatically be applied to another.
The manufacturer brochure for territories outside North America describes a treatment course of three injections given one week apart. This is product information rather than individual treatment advice. The current IFU supplied with the specific product and the clinical situation always determine the appropriate procedure.
| Product type | Sterile viscoelastic sodium hyaluronate solution for intra-articular use |
|---|---|
| Manufacturer / brand | Anika Therapeutics · Orthovisc® |
| Concentration | 15 mg sodium hyaluronate per mL |
| Syringe volume | 2 mL |
| Total amount | 30 mg sodium hyaluronate per 2 mL syringe |
| Hyaluronate source | Bacterial fermentation, non-animal source |
| EEA classification | Viscoelastic supplement or replacement for synovial fluid in human joints |
| Use | Intra-articular; for appropriately qualified medical professionals in accordance with the IFU |
Synovial fluid reduces friction between joint surfaces and helps distribute mechanical loads. Hyaluronic acid contributes substantially to the fluid’s viscosity and elasticity. In osteoarthritis the joint environment changes, and viscosupplementation therefore follows a physical and mechanical approach within the joint space.
For accurate product communication, this distinction is more useful than broad claims about “cartilage rebuilding” or guaranteed duration of pain relief. Such promises do not follow from the intended purpose, and clinical outcomes may vary with the patient, joint, disease stage and accompanying treatment.
No. Orthovisc® is a viscosupplement for intra-articular use and is not intended for aesthetic volume correction in the skin.
According to the manufacturer, the 2 mL prefilled syringe contains 15 mg/mL sodium hyaluronate in physiological saline, giving 30 mg in total.
No. Anika states that the hyaluronate is produced by bacterial fermentation.
In the EEA, the manufacturer describes Orthovisc® as a viscoelastic supplement or replacement for synovial fluid in human joints. The specific use depends on the regional IFU and medical indication.
Orthovisc® is administered intra-articularly. Administration should be performed by appropriately qualified medical professionals in accordance with the current IFU.
The current manufacturer brochure for territories outside North America describes three injections at one-week intervals. This is not general treatment advice; the regional IFU remains decisive.
The intended purpose and site of use are different. Orthovisc® is designed for the joint space, whereas aesthetic fillers are intended for other tissues and treatment objectives.
Technical basis: current Orthovisc® product information from Anika Therapeutics, Orthovisc® Product Brochure AML-900-682 REV 01 and regional manufacturer information. If information differs, the IFU supplied with the specific product takes precedence.
Anika Therapeutics S.r.l.
Via della Ricerca Scientifica 4
35127 Padova (PD) – Italy
+39-049-295-8311
Fax: +39-049-295-8380
