Hymovis HYADD 4 For Intra-articular Use 2 Pre-filled Syringes 24mg/3ml

Hymovis Pre-Filled Syringe is a sterile, non-pyrogenic hydrogel produced with HYADD 4 (highly purified sodium hyaluronate hexadecylamide obtained from bacterial fermentation) in buffered isotonic solution.

Indications

Hymovis is a product indicated for the treatment of joint pain in osteoarthritis and for the improvement of joint mobility by increasing the viscoelasticity of the synovial fluid.

Action

Articulate

How does the Hymovis intra-articular pre-filled syringe work?

Hymovis syringes, thanks to the high viscosity and elasticity given by sodium hyaluronate hexadecylamide, improve the function of the synovial fluid for lubrication and shock absorption, protecting the cartilage and soft tissues from mechanical injuries. These properties, combined with the prolonged stay of the product in the joints, allow Hymovis to relieve pain and improve joint function with a short treatment regimen.

Method of use and administration

Hymovis should only be administered by intra-articular injection and for a treatment course that includes two infiltrations one week apart. The administration of the product must be done exclusively by the doctor.

Given its viscosity, inject Hymovis slowly into the joint using an appropriate sterile needle (18 or 20 G). All rules regarding the aseptic administration technique must be strictly followed.

Treatment should be avoided if the joint shows signs of acute inflammation. If there is an effusion, remove it from the joint before administering Hymovis.

Warnings and Contraindications

The contents of the syringe are sterile.
The safety and efficacy of Hymovis in children and pregnant women has not been established.
The safety and efficacy of using Hymovis with other intra-articular treatments has not been established.
The syringe is for single use only; administer the content only in one joint.
If the product is reprocessed and / or reused, the manufacturing company cannot guarantee its performance, functionality, material structure, cleanliness or sterility.
Reuse can lead to illness, infection and / or harm to the patient or user.
Do not use Hymovis after the expiry date printed on the carton. The expiry date refers to the product properly stored in its original packaging.
Do not use Hymovis if the package is opened or damaged.
Keep out of reach of children.
Localized side effects such as pain, swelling / effusion, warmth and redness may occur at the administration site. These symptoms are usually mild and transient.
More marked inflammatory reactions have been reported with sodium hyaluronate products for intra-articular use.
As with any intra-articular treatment, septic arthritis can occur on rare occasions if the injection is not given in accordance with general aseptic precautions.
Do not use together with disinfectants containing quaternary ammonium salts, as sodium hyaluronate hexadecylamide can precipitate in their presence.
Avoid the simultaneous administration of Hymovis with other intra-articular products in order to prevent any possible interaction.
Store in the original package at a temperature not exceeding 25 ° C. Do not freeze.
Do not administer to patients with known individual hypersensitivity to the components of the product or in case of skin infections or diseases in the administration area.

Ingredients and Composition

Main component: HYADD 4 (Sodium Hyaluronate Hexadecylamide), 24mg / 3ml. Other ingredients: sodium chloride, disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injections.

Format

2 luer lock syringes pre-filled with 3 ml of hydrogel

More information on the product can be found on the website of the manufacturer Fidia Farmaceutici