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Monovisc 4ml

Monovisc 4ml

Monovisc

Orthopedic Injectable
  • FDA Approved single Injection viscosupplement for the treatment of pain due to osteoarthritis of the knee in adults (U.S. labelling).
  • CE Marked medical device (Class III) in multiple markets as a viscoelastic supplement or replacement for synovial fluid.
  • Manufactured according to applicable ISO quality management standards for medical devices (e.g. ISO 13485).
  • Non Avian, fermentation Derived sodium hyaluronate meeting pharmacopeial purity and endotoxin specifications for intra Articular use.
  • Supplied as a sterile, non Pyrogenic device with validated sterilisation and packaging integrity processes.
Hyaluronic Acid Viscosupplement

Description

Monovisc 4ml is a single-injection, high–molecular weight hyaluronic acid (sodium hyaluronate) viscosupplement indicated for the treatment of joint pain due to osteoarthritis. Supplied as a sterile, viscoelastic, lightly cross-linked sodium hyaluronate solution in a prefilled 4 mL syringe (nominal 88 mg HA), it is injected intra-articularly to supplement or replace synovial fluid, restoring lubrication and shock absorption, and thereby reducing pain and improving joint mobility.

Bnefits

  • Single 4 mL intra-articular injection protocol, avoiding multiple-injection courses.
  • High molecular weight, lightly cross-linked sodium hyaluronate designed for prolonged residence time in the joint.
  • Delivers one of the highest hyaluronic acid doses per single injection (nominal 88 mg HA in 4 mL).
  • Restores the viscoelastic properties of synovial fluid, improving lubrication and shock absorption in osteoarthritic joints.
  • Reduces pain and stiffness in osteoarthritis when conservative measures and simple analgesics are insufficient.
  • Can provide clinically meaningful pain relief for up to approximately six months in many patients.
  • Non-avian, ultra-pure, fermentation-derived sodium hyaluronate reduces risk of avian protein–related reactions.
  • Sterile, non-pyrogenic, biocompatible and resorbable formulation.
  • Administered via standard intra-articular technique by a healthcare professional in an outpatient setting.
  • Available with broad international regulatory approvals (e.g. FDA approval for knee OA, CE-marked in multiple markets).

Indications

  • Treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g. acetaminophen).
  • Viscoelastic supplement or replacement for synovial fluid in human knee joints.
  • In some markets and labelling, indicated as a viscoelastic supplement or replacement for synovial fluid in hip, shoulder and ankle joints affected by mild to moderate osteoarthritis.
  • Use as a viscosupplement to improve joint function and mobility by restoring the rheological properties of synovial fluid.

Composition

  • Sodium hyaluronate (hyaluronic acid) of non-avian origin, manufactured by bacterial fermentation.
  • Lightly cross-linked high molecular weight sodium hyaluronate at a nominal concentration of approximately 20–22 mg/mL.
  • Total fill volume 4 mL per prefilled syringe (nominal total HA content 80–88 mg, commonly labelled as 88 mg).
  • Phosphate-buffered saline at physiological pH and osmolality.
  • Sterile, non-pyrogenic, translucent viscoelastic solution.
  • No animal proteins; no added anesthetic (e.g. lidocaine) in the standard product.

Formulation

  • High molecular weight, lightly cross-linked sodium hyaluronate viscoelastic solution.
  • Sterile, non-pyrogenic, translucent gel supplied in a single-use prefilled syringe.
  • Physiological pH and osmolality suitable for intra-articular injection.
  • Non-avian, fermentation-derived HA, highly purified to remove protein and endotoxin contaminants.
  • Designed to provide long-lasting mechanical (lubrication, cushioning) and chondroprotective effects via viscoelastic supplementation.
  • Resorbable polymer that is gradually degraded and eliminated after exerting its intra-articular effect.

Packaging

  • Single-use, prefilled 5 mL syringe containing 4 mL of Monovisc sodium hyaluronate solution.
  • Supplied as 1 prefilled syringe per box (1 x 4 mL).
  • Each syringe is packaged in a sterile blister tray with a protective blister cover.
  • Outer carton labelled with product name, batch/lot number, expiry date, manufacturer and regulatory markings (e.g. CE mark, where applicable).
  • Includes package insert with full prescribing information and instructions for use.
  • Traceability labels may be included for patient records and documentation.

Usage

  • For intra-articular use only; must be administered by a qualified healthcare professional experienced in joint injections.
  • Indicated dose is a single intra-articular injection of the full 4 mL content into one affected knee joint.
  • If both knees require treatment, use a separate 4 mL prefilled syringe for each knee; do not split one syringe between joints.
  • Under aseptic conditions, remove any joint effusion or excess synovial fluid prior to injection, as per product labelling.
  • Attach an appropriate sterile needle (commonly 18–21G, length according to joint and patient habitus) securely to the syringe luer lock; avoid over-tightening to prevent damage to the syringe tip.
  • Inject via standard intra-articular approach (e.g. medial or lateral parapatellar approach for the knee) using anatomical landmarks or imaging guidance when indicated.
  • Inject the full 4 mL slowly into the joint space; do not overfill the joint.
  • Do not inject intravascularly or extra-articularly; ensure correct needle placement in the joint space before administration.
  • After injection, advise the patient to avoid strenuous or high-impact activities for 48 hours; gentle walking is generally permitted if comfortable.
  • Monitor the patient for any immediate post-injection reactions; instruct them to report persistent or severe pain, swelling, redness or warmth in the injected joint.
  • Repeat injection schedule should follow local labelling and clinical judgement; Monovisc is designed as a single-injection course rather than a multi-injection series.

Contraindications

  • Do not inject Monovisc in patients with infections or skin diseases in the area of the injection site or joint.
  • Do not administer to patients with known systemic bleeding disorders.
  • Do not inject into joints that are severely inflamed or infected (e.g. septic arthritis).
  • Contraindicated in patients with known hypersensitivity to hyaluronan preparations.
  • Contraindicated in patients with known hypersensitivity to gram-positive bacterial proteins, as the sodium hyaluronate is derived from bacterial fermentation.
  • Not indicated for use in pregnant or breastfeeding women, or in children and adolescents (typically ≤21 years), as safety and efficacy have not been established in these populations according to many labels.
  • Do not inject intravascularly; improper technique with intra-vascular injection is contraindicated due to risk of systemic adverse events.
  • Avoid use in patients with acute systemic illness or uncontrolled comorbidities that would make intra-articular procedures inappropriate, according to clinician judgement.

Adverse Effects

  • Transient pain, stiffness or discomfort in the injected joint following injection.
  • Joint swelling or effusion at or shortly after injection.
  • Injection-site pain or local reaction at the needle entry point.
  • Local warmth or redness around the joint.
  • Exacerbation of arthritic symptoms shortly after injection in a minority of patients (usually self-limiting).
  • Rare hypersensitivity or allergic-type reactions to hyaluronate or formulation components.
  • Very rare cases of pseudoseptic reactions or severe inflammatory response in the joint.
  • As with any intra-articular procedure, there is a small risk of joint infection (septic arthritis), bleeding, synovitis or damage to surrounding structures if technique is suboptimal.
  • Post-marketing experience has also reported arthralgia, back pain and muscle pain in some patients.

Storage Conditions

  • Store at controlled room temperature within the range specified in the package insert (commonly between 2 °C and 25 °C).
  • Do not freeze the product.
  • Keep the prefilled syringe in its original blister and outer carton to protect from light and physical damage until use.
  • Do not use after the expiry date printed on the syringe label and outer carton.
  • Do not use if the sterile blister packaging is damaged or opened.
  • Single-use only; once the sterile packaging is opened and the syringe used, any unused portion must be discarded and not resterilised or reused.

Duration

Clinical studies and product information generally report pain relief and functional improvement lasting up to approximately 6 months after a single 4 mL intra-articular injection, with duration varying based on disease severity, joint treated and patient-specific factors.

Onset

Many patients begin to notice improvement within several days, with typical onset of clinically meaningful pain relief occurring within approximately 1\u20132 weeks; some sources note early benefit emerging within 24\u201348 hours, and progressive improvement over subsequent weeks as joint biomechanics and inflammation are modified.

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