Monovisc 4ml

Monovisc

Orthopedic Injectable

Hyaluronic Acid Viscosupplement

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).

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.

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.