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Product:

ORTHOVISC®

Manufacturer: Anika Therapeutics
Active Substance(s) : Sodium hyaluronate
Strength: 15mg/ml
Pack Size: 1-2ml prefilled syringe
Accessories: Package insert, 3 traceability labels
 
 
 
 
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Product: ORTHOVISC® Non-English
Manufacturer: Anika Therapeutics
Active Substance(s) : Sodium hyaluronate
Strength: 15mg/ml
Pack Size: 1-2ml prefilled syringe
Accessories: Package insert, 3 traceability labels

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Orthovisc® Product Specifications

If a patient is suffering from knee pain, Orthovisc may be the solution. Made of a substance consisting of high molecular weight hyaluronic acid, Orthovisc is designed to closely mimic synovial fluid that is normally lost with the advent of osteoarthritis of the knee, restoring support and lubrication around the joint, thus alleviating discomfort and pain. The treatment consists of a series of orthopedic injections to the affected knee and is meant as a treatment in patients who have not responded to conventional treatment for pain due to knee osteoarthritis.

What Orthovisc is formulated to do

Orthovisc, also known as hyaluronan or hyaluronic acid, is a series of orthopedic injections used for pain management of osteoarthritis, referred to as viscosupplementation.

Viscosupplementation is a therapeutic method used to treat osteoarthritis pain in patients who have not adequately responded to conventional treatments like physical therapy and pain medication. It involves replacing or supplementing synovial fluid surrounding the affected joint with a substance designed to match the rheological and physiological properties of healthy synovial fluid. With that, the cushioning and lubricating properties of synovial fluid are restored, minimizing the symptoms related to osteoarthritis.

Reported benefits from treatment using Orthovisc include a reduction in joint pain and improvement in functionality, duration of effects of up to 26 weeks, and no reported pseudoseptic reactions.

Manufacturer/Origin

Orthovisc is manufactured by Anika Therapeutics, a medical technology company based in Massachusetts, USA that specializes in the development of products for pain management, tissue regeneration and wound healing.

What else you need to know

When it can cause side effects

Do not use Orthovisc injections to treat patients who are allergic to hyaluronan or are hypersensitive to Gram positive bacteria proteins.

Do not administer to patients with infections or skin diseases in the area of injection site.

Incidence of adverse effects with treatment include joint pain, headache, and temporary pain at injection site. Advise patients of all possible side effects and contraindications prior to treatment. Refer to the product leaflet for a complete list of precautions and other information.

Information about packaging

This filler is packaged in prefilled syringes. Keep this viscosupplement in the original packaging until ready to use. Needles are not sold with this product.

Is this filler FDA approved?

This product is FDA approved for use. In the United States and Canada, Orthovisc is approved solely for use in the knee. In the European Economic Area and other parts of the world, Orthovisc is approved for use in all synovial joints.

Suggested usage

  • For optimal results, treatment should consist of a series of intra-articular injections 1 week apart for a total of 3–4 injections.
  • Site preparation should be undertaken according to standard procedures. Avoid using disinfectants that contain quaternary ammonium salts, as precipitation may occur.
  • Attach a small gauge needle (18- to 21-gauge) to the uncapped syringe tip and inject Orthovisc into the knee joint with proper injection technique.
  • Contents of syringe are intended for one knee only. Used a separate syringe for bilateral treatment.
  • Repeat courses of Orthovisc may be administered if symptoms return.

Composition

Orthovisc is a viscoelastic, clear fluid made up of highly purified hyaluronan, a high molecular weight polysaccharide, in physiologic saline. Each dose comprises hyaluronan (30mg), sodium chloride (18mg), and sterile water. The hyaluronan is derived from a non-avian source.

What is in the box?

  • 1-2ml syringe sealed in a sterile pouch.
  • Information leaflet

Duration of effect

Clinical studies have shown that Orthovisc can provide pain relief for up to 26 weeks with 3–4 injections. This duration will be affected by the severity of the condition and individual physiological factors.

Storage conditions

Store at 2°C–25°C. Do not freeze. Keep out of reach of children. Do not remove the viscosupplement from the packaging until ready to use.

Expiry (shelf life)

  • Refer to product packaging for expiry date.
  • Do not use this injectable past the specified expiration date.

Disclaimer: Raskel Medical offers only genuine products made by their original manufacturer. All brands are trademarks of their respective owners. Raskel Medical is not operated by, supported by, or affiliated with the manufacturer in any way. Product packaging may not be exactly as shown.