HYADD 4 (sodium hyaluronate hexadecylamide).
Principal component: Hyadd4 (sodium hyaluronate hexadecylamide), 24 mg/3 mL.
HYMOVIS is a sterile, non pyrogenic, hydrogel manufactured with Hyadd4 (hexadecylamide of highly purified natural sodium hyaluronate obtained by bacterial fermentation) in isotonic buffered solution.
Thanks to the high viscosity and elasticity given by the hexadecylamide of sodium hyaluronate, HYMOVIS improves the lubricating and shock absorbing function of synovial fluid, protecting cartilage and soft tissues against mechanical injuries. These properties, together with the prolonged residence time in the articular joints, enable HYMOVIS to relieve pain and to improve joint function with a short treatment regimen.
Excipients/Inactive Ingredients: Sodium chloride, disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injection.
HYMOVIS is indicated for the treatment of pain in osteoarthritic joints and in the conservative treatment of the meniscal lesion of the knee and for the improvement of joint mobility through the enhancement of synovial fluid viscoelasticity.
A treatment cycle in osteoarthritic joints consists of two injections administered at one week interval.
A treatment cycle in joints with meniscal lesion consists of two injections administered at two week interval.
Administration: HYMOVIS is intended for intra-articular injection only.
Product administration should be performed exclusively by physicians.
The sterility also on the outer surface of the syringe allows to perform the intra-articular injection also in the operating room.
Given its viscosity, inject slowly HYMOVIS in the affected joint using a suitable sterile needle (18 or 20 gauge).
All the rules regarding aseptic administration technique must be strictly followed.
Remove any joint effusion, if present, before injecting HYMOVIS.
Do not administer to patients with ascertained individual hypersensitivity to the product components or in case of infections or skin diseases in the area of the injection site.
Treatment should be avoided if the joint shows evidence of acute inflammation.
The safety and efficacy of HYMOVIS in children and pregnant women have not been established.
The safety and efficacy of the use of HYMOVIS concomitantly with other intra-articular treatments have not been established.
The syringe is intended for single use; inject the contents in one joint only.
If this product is reprocessed and/or reused, Fidia Farmaceutici cannot guarantee performance, functionality, material structure, or cleanliness or sterility of the product. Reuse could lead to illness, infection and/or serious injury to the patient or user.
Do not use HYMOVIS if the package is opened or damaged.
The safety and efficacy of HYMOVIS in pregnant women have not been established.
Local undesirable effects such as pain, swelling/effusion, warmth and redness may occur at the injection site. Such symptoms are usually mild and transient.
More marked inflammatory reactions have been reported with sodium hyaluronate-based products for intra-articular use.
As for any intra-articular treatment, septic arthritis may occur on rare occasions if general precautions for aseptic injection are not observed.
Do not concomitantly use disinfectants containing quaternary ammonium salts, because sodium hyaluronate hexadecylamide may precipitate in their presence.
Avoid the contemporary administration of HYMOVIS with other intra-articular products in order to prevent any possible interaction.
Store in the original packaging not exceeding 25°C. Do not freeze.
M09AX01 - hyaluronic acid ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.
Inj (pre-filled syringe) 24 mg/3 mL x 2's.