Haimovis 24mg/3ml syringe

Haimovis® is a hydrogel that is produced according to Good Manufacturing Practice (GMP) and contains HYADD®4, a new molecule patented by Fidia, at a concentration of 8 mg/ml. HYADD®4 is a new hyaluronic acid derivative: partial hyaluronic acid hexadecylamide (partial due to the very low level of hyaluronic acid modification, at approximately 3% molar concentration to maintain biocompatibility).

This structure gives Haimovis® special properties including a long retention time and visco-elastic properties in addition to the excellent lubricating properties of the preparation.

Restoration of elasticity. In contrast to cross-linked hyaluronic acid, Haimovis® exhibits complete restoration of its elasticity after repeated mechanical stress, which translates into a more pronounced ability to absorb shock caused by mechanical loading to better protect the joint.

Excellent biotribological properties. The biotribological properties are related to the ability of the substance to lubricate the cartilage surfaces upon mutual contact and thus protect them from the friction and mechanical stress caused by movement.

Hydrogels may have similar viscosity-elasticity coefficients but that does not mean they have the same lubricating effects inside the joint.
The Chemovis preparation shows the best lubricating properties among natural and cross-linked polymers both in healthy cartilage simulation and in degraded cartilage. The physicochemical and biological properties described for Haimovis form the basis of the clinical efficacy that has been found for this drug in the treatment of osteoarthritis and makes it the drug of choice for the treatment of acute and traumatic chondropathy in professional and amateur athletes.

Restoration of synovial fluid viscosity by Haimovis® effectively reduces pain, restores and preserves joint function in patients with osteoarthritis of the shoulder joint Biomechanical and biological features of Haimovis® create prerequisites for expanding indications for its use in diseases caused by sports activities.

Indications

For intra-articular administration for injuries and sports medicine

Pharmacological effect

Hymovis® is a hydrogel that is manufactured in accordance with Good Manufacturing Practice (GMP) requirements and contains HYADD®4, a new molecule patented by Fidia, at a concentration of 8 mg/ml. HYADD®4 is a new hyaluronic acid derivative: partial hyaluronic acid hexadecylamide (partial due to the very low level of modification of hyaluronic acid, approximately 3% molar concentration to maintain biocompatibility).

This structure gives Hymovis® special properties, including a long retention time, as well as visco-elastic properties in addition to the excellent lubricating properties of the drug.

Restoring elasticity. Unlike cross-linked hyaluronic acid, Hymovis® exhibits complete restoration of its elasticity after repeated mechanical stress, which translates into a more pronounced ability to absorb shock caused by mechanical stress, for better joint protection.

Excellent biotribological properties. Biotribological properties are associated with the ability of a substance to lubricate the surfaces of cartilage upon mutual contact and, thus, protect them from friction and mechanical stress that occurs during movement.

Hydrogels may have the same viscosity-elasticity coefficients, but this does not mean that they have the same lubricating effects inside the joint.
The drug Hymovis shows the best lubricating properties among natural polymers and cross-linked polymers, both in conditions of simulating healthy cartilage and cartilage with degradation. The physicochemical and biological properties described for the drug Hymovis are the basis for the clinical effectiveness that has been identified in this drug in the treatment of osteoarthritis, and make it the drug of choice in the treatment of acute and traumatic chondropathy in professional and amateur athletes.

Restoring the viscosity of synovial fluid with Hymovis® effectively reduces pain, restores and preserves joint function in patients with osteoarthritis of the shoulder joint. The biomechanical and biological features of Hymovis® create the prerequisites for expanding the indications for its use in diseases caused by sports.

Composition

The main component of the medical device Hymovisa 24 mg / 3 ml pre-filled syringe is sodium hyaluronate hexadecylamide (HYADD®4), obtained by amidation of the carboxyl group of sodium hyaluronate with hexadecylamine.

List of starting materials: – HYADD®4 (sodium hyaluronate hexadecylamide) – 24 mg;

– sodium chloride -25.5 mg;

– sodium hydrogen phosphate dodecahydrate (Na2HP04 x 12H20) – 1.35 mg;

– sodium dihydrogen phosphate dihydrate (Na2HP04 x 2H20) – 0.33 mg;

– water for injection up to 3 ml (q.s.).

Contraindications

Do not administer to patients with established individual hypersensitivity to the components of the product or in case of infection or skin diseases in the area of ​​the injection site.

Side Effects

Local pain, swelling, heat and redness may rarely appear at the injection site; such symptoms are usually mild and transitory.

More severe inflammatory reactions, with precipitation of sodium pyrophosphate crystals, have been reported with intra-articular administration of sodium hyaluronate solutions, although no relationship has been identified.

If general precautions are not observed and the injection site is not properly aseptically treated, septic arthritis may occur in rare cases, as with any intra-articular treatment.

Recommendations for use

The medical product “Haimovis” is injected using a sterile needle (18 or 20 gauge) into the affected joint (see Figure 1) once a week, the course of treatment does not exceed 3 weeks.

If necessary, repeated courses can be conducted.

A one-time procedure usually consists of introducing the Hymovis medical device into 1 large, or 2 medium, or 3-5 small joints.

The frequency is determined individually: the results of each previous procedure are assessed, indications for its repetition are established

Storage conditions

– The medical device should be stored in its original packaging at a temperature of 2 to 25°C.
– Do not freeze.

Shelf life

36 months.

Manufacturer

Fidia Pharmaceutical S.p.A., Italy