MONOVISC®

Name: MONOVISC®.
Ingredients: Cross-Linked Sodium Hyaluronate, 22mg/ml.
Size: 1x4mL pre-filled syringe.
Manufacturer: Anika Therapeutics, Inc.
Origin: Europe.
Also Included: Package leaflet only. A set of patients label is provided to ensure traceability.
Storage: It should be stored at 2℃ to 25℃. Protect from freezing.
Remarks: Sterile packaging.

Monovisc is a single-treatment orthopedic injectable manufactured by Anika Therapeutics and indicated for treatment of osteoarthritis of the knees. It consists of sterile, viscoelastic cross-linked sodium hyaluronate gel at a concentration of 22mg/mL. The sodium hyaluronate is derived from bacterial fermentation, so is of non-animal origin. A box of Mnovisc is sold with a single 4mL syringe prefilled with implant gel and accompanied with some traceability labels and product manual. All the contents are sterilised and must be kept in a well-regulated room with temperature ranging from 2°C to 25°C. Do not freeze this item.

Monovisc is intended to be used as a viscosupplement for patients suffering from painful symptoms of knee joint osteoarthritis. During this progressive joint disease, the protective tissues and fluid wear off causing the bones to rub together very painfully. Once injected, the gel protects and lubricates the bones from further friction. So, movements are much smoother. Monovisc can also be used in addition to or completely substitute other osteoarthritis management therapies, like weight loss, consuming analgesics and supplements, and even wearing rehabilitation gears. Patients may also delay the need for corrective joint surgery.

Osteoarthritis is a progressive and irreversible disorder of the joints that occurs when the cartilage in between the joints break down. Usually, this is commonly experienced by older patients. A strong family history may also contribute to the onset of this joint disorder. A healthy synovial knee joint consists of bones covered by a layer of articular cartilage which provides smooth motion. Besides that, cartilage manufactures lubricating synovial fluid in between the bones. The fluid absorbs sudden impacts and provide more lubrication for proper and normal joint action. However, joints affected by osteoarthritis often have worn out and damaged articular cartilage. Hence, bones will grind against each other with greater friction. Osteoarthritis sufferers often experience agonizing pain and swelling coupled by loss of joint movement.

Monovisc has been designed for patients who are still unable to manage their osteoarthritis symptoms with other pharmacological (e.g. over-the-counter drugs like acetaminophen and prescribed drugs like celecoxib) and non-pharmacological (e.g. diet change, weight loss, appropriate exercise, physical therapy, wearing mobility support gears) treatments. This high molecular weight sodium hyaluronate gel replaces the lost synovial fluid in the damaged joints. The implant gel forms a protective and slippery layer on the exposed bones. Hence, the bones can move effortlessly without painful frictions. Patients can regain joint movability and good quality of life.

This viscosupplement is intended to be injected intra-articularly only after determining a patient’s suitability to receive Monovisc treatments. If there is any fluid accumulation on the proposed joint, remove it completely and discard the needle used. Ensure that the prefilled syringe is still in its original packaging and within its shelf life. Remove the syringe aseptically from its packaging and attach a suitable needle (18G to 21G) to it. Then, inject the orthopaedic implant gel into the joint synovial space only after meticulous sanitisation of skin. Discard any leftover gel and used needles as they impose a biological hazard.

Monovisc is a very convenient treatment as only a single dose is necessary for symptoms improvement instead of multiple injections weekly. The amount of gel needed depends on the site of injection and severity of joint damage. Since this is a medical procedure, only certified medical practitioners with experience in intra-articular injections should perform the procedures via strict aseptic techniques. Do not administer the gel into blood vessels or surrounding joint tissues. Failure to do so will result in life threatening reactions like blood clots, stroke, and severe inflammation. Refer to the product manual for a detailed list of instructions and precautions.

A single Monovisc treatment can deliver pain-relief effects for up to 6 months. However, results may vary on an individual basis.

Monovisc is a very safe viscosupplement that has been purified to be free from harmful endotoxins, animal proteins and pyrogens. The gel content—high molecular weight hyaluronan—is actually found naturally in synovial fluid. The gel has been designed to share the same viscoelastic properties as the slippery synovial fluid. Hence, patients’ risk of developing foreign body reactions is very marginal. Since it is derived via bacterial fermentation process, this implant is contraindicated in some individuals due to risk of allergies.

As well, patients sporting skin infections or inflammation on the joint area as well as joint infections are also contraindicated from using this implant. The safety profile still remains untested in pregnant and breastfeeding mothers as well as in children. Exercise extra caution if your patients have any systemic bleeding disorders. Refer to the product manual for a detailed list of contraindications.

Patients usually face some mild reactions due to injection process itself.

• Arthralgia (joint pain)
• Temporary joint swelling
• Pain at treated site

These reactions should abate within a few days. Just with any other non-invasive viscosupplementation procedure, patients should rest the treated joint by not participating in strenuous exercises like jogging and tennis. They should also avoid activities that last longer than an hour.

• Allergic reaction

If patients do not recover from these reactions or develop allergic attacks (e.g. swollen tongue and mouth, breathing difficulties, nausea, vomiting, fever, dizziness, body aches), urge them to get immediate medical treatment. Refer to the product manual for a detailed list of adverse reactions.

Monovisc is a sodium hyaluronate viscosupplement derived via bacterial fermentation. The molecules are highly purified and extracted before being partially cross-linked to produce an elastic and viscous gel. The gel is biocompatible and biodegradable. After administering, the gel covers and lubricates the bones for better motion and support.