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ORTHOVISC 2 ml

ORTHOVISC 2 ml

ORTHOVISC

Medical device
  • Classified and marketed as an intra Articular hyaluronic acid viscosupplement medical device for osteoarthritis pain relief in accordance with applicable regulatory frameworks.
  • High Purity, non Animal Sourced sodium hyaluronate manufactured under Good Manufacturing Practice (GMP) for medical devices.
  • In many markets ORTHOVISC carries a CE mark as a viscoelastic supplement or replacement for synovial fluid in human joints.
  • Subject to national regulatory approvals (for example, FDA premarket approval as an intra Articular HA device for knee OA in the United States).
Intra-articular hyaluronic acid viscosupplement

Description

ORTHOVISC 2 ml is a high molecular weight, ultra-pure hyaluronic acid (sodium hyaluronate) injection used as a viscosupplement to relieve joint pain caused by osteoarthritis, particularly in the knee. It is supplied as a sterile, prefilled 2 ml syringe containing a concentrated solution of non-animal-sourced sodium hyaluronate (15 mg/ml) in physiological saline. Injected directly into the affected joint, ORTHOVISC supplements the degraded synovial fluid, improving lubrication and shock absorption, and helping to reduce pain and improve joint function in patients who have not responded adequately to simple analgesics and conservative non-pharmacologic therapies.

Bnefits

  • Provides clinically proven relief of knee pain due to osteoarthritis when conservative treatments and simple analgesics are insufficient.
  • High molecular weight, highly purified sodium hyaluronate (15 mg/ml) formulated for optimal viscoelastic and lubricating properties in the joint.
  • Non-animal-sourced hyaluronic acid in physiological saline, offering excellent biocompatibility and resorbability.
  • Multi-injection treatment course (typically 3–4 intra-articular injections) can provide pain relief and functional improvement for up to 6 months.
  • Improves joint lubrication and shock absorption, helping to reduce friction and mechanical stress on articular cartilage.
  • Can delay or reduce the need for more invasive interventions such as joint replacement in some patients.
  • Favourable safety and tolerability profile when administered by appropriately trained clinicians.
  • Single-use, prefilled 2 ml syringe presentation simplifies preparation, reduces contamination risk and supports accurate dosing.

Indications

  • Treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy (e.g. physiotherapy, weight reduction) and to simple analgesics (e.g. paracetamol/acetaminophen).
  • In many markets outside the US, indicated as a viscoelastic supplement or replacement for synovial fluid in human synovial joints affected by osteoarthritis, where its actions are lubrication and mechanical support.

Composition

  • Active component: Highly purified sodium hyaluronate (hyaluronic acid) 15 mg/ml.
  • Concentration per syringe: 30 mg sodium hyaluronate in 2 ml solution.
  • Molecular weight: high molecular weight hyaluronan (in the range typically used for viscosupplementation).
  • Vehicle: Physiological saline solution (sodium chloride solution) with water for injection.
  • Non-animal-sourced hyaluronic acid produced by bacterial fermentation.

Formulation

  • Sterile, non-pyrogenic, viscoelastic solution of sodium hyaluronate in physiological saline.
  • High molecular weight hyaluronic acid (HA) formulated for intra-articular injection (viscosupplementation).
  • Prepackaged in a single-use, prefilled 2 ml glass syringe with a luer connection for attachment of a sterile needle.
  • Intended exclusively for intra-articular administration by a qualified healthcare professional.

Packaging

  • Standard presentation: 1 prefilled sterile syringe containing 2 ml of ORTHOVISC solution (30 mg sodium hyaluronate).
  • Each syringe is individually blister-packed or boxed, supplied sterile and ready for use after attachment of a suitable needle.
  • Multi-syringe packs may contain 3 or 4 x 2 ml syringes to complete a full course of treatment depending on the regimen used in a given market.
  • Outer carton labelled with product name, volume, batch number, expiry date and storage conditions; instructions for use are provided in an enclosed leaflet.

Usage

  • For intra-articular use only; must be administered by a physician or appropriately trained healthcare professional experienced in joint injection techniques.
  • Confirm indication and exclude active joint infection or significant joint effusion prior to injection; aspirate excess synovial fluid if necessary before administering ORTHOVISC.
  • Using aseptic technique, attach an appropriate sterile needle to the prefilled 2 ml syringe and remove air bubbles if present.
  • Inject the full 2 ml contents of the syringe into the joint space (typically the knee joint) via an appropriate approach, following local clinical guidelines for intra-articular injections.
  • Do not inject intravascularly or extra-articularly; ensure correct needle placement within the joint space before injection.
  • Typical regimen: one 2 ml intra-articular injection per week for three consecutive weeks; a fourth weekly injection may be given according to local product information and clinical judgement.
  • Do not reuse any remaining solution; each syringe is for single use only and must be discarded after use, even if not completely emptied.
  • After injection, the patient should avoid strenuous activities involving the treated joint (e.g. jogging, heavy lifting, prolonged standing) for 48 hours, then gradually resume normal activities as tolerated.
  • Follow local and manufacturer’s instructions for potential retreatment intervals (commonly after 4–6 months if symptoms recur).
  • Dispose of used syringes and needles in approved sharps containers in accordance with local regulations.

Contraindications

  • Known hypersensitivity to hyaluronan (hyaluronic acid), sodium hyaluronate or any component of the formulation.
  • Patients with known hypersensitivity to gram-positive bacterial proteins (given the fermentation-derived HA source).
  • Presence of infection or severe inflammation at the intended injection site or in the joint to be treated.
  • Intra-articular injection into a joint where there is a significant venous or lymphatic stasis in the limb.
  • Do not inject intravascularly or extra-articularly; ORTHOVISC is intended strictly for intra-articular administration.
  • Use with caution or avoid in patients with bleeding disorders or those receiving anticoagulant therapy, following local clinical guidance.

Adverse Effects

  • Local injection-site reactions such as pain, discomfort, warmth or swelling in the treated joint shortly after injection.
  • Transient joint effusion, stiffness or feeling of fullness in the injected joint.
  • Mild redness, bruising or tenderness around the injection site.
  • Infrequent inflammatory reactions, including pseudoseptic-like responses (acute painful swelling and inflammation in the joint), which usually resolve with appropriate management.
  • Very rare systemic hypersensitivity reactions (e.g. rash, pruritus, or more severe allergic responses).
  • As with any intra-articular procedure, there is a small risk of infection, haemorrhage or trauma to local structures if aseptic technique and proper injection practices are not followed.
  • Patients should be advised to report severe or persistent pain, swelling, redness or fever following injection for prompt evaluation.

Storage Conditions

  • Store in the original packaging at a controlled room or refrigerator temperature as specified in the local product labelling (commonly between 2°C and 25°C; do not freeze).
  • Protect from direct sunlight and excessive heat.
  • Do not use if the packaging or syringe is damaged, if the solution is cloudy, contains particles, or if the expiry date has passed.
  • Keep out of the reach of children.
  • Do not resterilise; syringes are supplied sterile and are intended for single use only.

Duration

A standard treatment course typically consists of 3 intra-articular injections of 2 ml ORTHOVISC administered at weekly intervals; in some protocols a 3\u20134 injection series is used. Clinical benefit may last for up to 6 months following a course of treatment, after which the series may be repeated if clinically indicated.

Onset

Symptom improvement is usually gradual, with some patients reporting pain relief after the first or second injection; maximal benefit is often observed several weeks after completion of the full injection series and can be maintained for up to approximately 26 weeks, although individual responses vary.

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