Monovisc 20mg/ml - intra-articular injection syringe 4 ml

Product Description

Pre-filled syringe for intra-articular use based on hyaluronic acid.

Indications

Monovisc is a CE medical device composed of ultrapure, high molecular weight sodium hyaluronate, produced by bacterial fermentation. Thanks to hyaluronic acid, a complex natural polysaccharide from the glycosaminoglycan family, Vita Research Monovisc is indicated as a viscoelastic supplement or substitute for synovial fluid in human joints and is also suitable for the treatment of symptoms of human joint dysfunctions such as osteoarthritis.

Directions for use and Dosage

• Inject the required amount of product through a sterile, disposable hypodermic needle of suitable diameter into the selected joint space;
• The sterile needle must be attached to the Monovisc syringe by medical personnel, using an aseptic technique approved by the clinical center;
• The larger diameters 18-21 gauges are used for knee injections;
• The final selection for any procedure must be determined by the physician;
• Before injecting the product, the physician must ensure adequate penetration into the synovial space of the joint.

Warnings

It is recommended that the usual precautions for injecting substances into joints be taken. Only medical personnel competent in the injection techniques accepted for the administration of agents into joint spaces should inject sodium hyaluronate for this application. The amount of product to be injected depends on the specific site and the patient's anatomy and must be defined by the physician performing the procedure. Do not use an excessive amount of sodium hyaluronate and keep the patient under close observation. Do not overfill the synovial space. If pain increases during the injection, stop the injection and withdraw the needle. For intra-articular use. Sterile contents. Single use only. Do not resterilize. Do not use if the internal packaging of the product is opened or damaged. Discard used needles or syringes after each injection. The sale and use of this device are restricted to a physician or under the supervision of a physician.

Contraindications

The product is composed of cross-linked sodium hyaluronate and may contain traces of gram-positive bacterial proteins. The following pre-existing conditions may constitute relative or absolute contraindications to the use of the product:

• known sensitivity to any of the materials contained in the product;
• pre-existing infections of the skin region at the intended injection site;
• known joint infection;
• known systemic bleeding abnormalities.

Storage

Store at 2°C - 25°C. Protect from freezing.

Format

Sterile viscoelastic preparation supplied in a 4.0 ml disposable glass syringe.