HYADD® 4 for intra-articular injection
Pre-filled syringe
Product description
HYMOVIS is a sterile, pyrogen-free hydrogel made with Hyadd4 (highly pure, naturally derived hexadecylamine sodium hyaluronate obtained by bacterial fermentation) in an isotonic buffered solution. Thanks to the high viscosity and elasticity of hexadecylamine sodium hyaluronate, HYMOVIS improves the lubricating function and shock absorption of synovial fluid and protects joint cartilage and soft tissues from mechanical injuries. Due to these properties, combined with an extended residence time in the joint, HYMOVIS relieves pain and simultaneously improves joint function within a short treatment regimen.
Composition
Main ingredient: Hyadd4 (sodium hyaluronate-hexadecylamide), 24 mg/3 ml.
Other ingredients: sodium chloride, disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injection.
Indications
HYMOVIS is indicated for the treatment of pain in osteoarthritis and for the conservative treatment of meniscus injuries of the knee, as well as to improve joint mobility by increasing the viscoelasticity of the synovial fluid.
Method of administration
HYMOVIS is intended for intra-articular injection only.
The product must only be administered by a physician.
Since the syringe is also sterile on the outside, it may be used for intra-articular injection in the operating room.
Due to its viscosity, HYMOVIS must be injected slowly into the affected joint using a suitable sterile needle (18 or 20 G).
All regulations for sterile administration must be strictly observed.
Joint effusions must be removed before injecting HYMOVIS.
Dosage
In case of osteoarthritis, a treatment cycle consists of two injections administered one week apart.
In case of meniscus injury, a treatment cycle consists of two injections administered two weeks apart.
Contraindications
The product must not be administered to patients with known hypersensitivity to any of the ingredients of the medicinal product or with infections or skin diseases at the injection site.
Warnings and precautions
Treatment must be discontinued in case of signs of acute inflammation.
The safety and efficacy of HYMOVIS in children and pregnant women have not been established.
The safety and efficacy of using HYMOVIS simultaneously with other intra-articular treatments have not been established.
The syringe is intended for single use; its contents must be injected into only one joint.
In case of reprocessing and/or reuse, Fidia Farmaceutici cannot guarantee the efficacy, functionality, material structure, purity, or sterility of the medicine. Reuse may lead to illness, infections, and/or serious injury to the patient or user.
HYMOVIS must not be used after the expiration date indicated on the packaging. The expiration date refers to the product properly stored in the original packaging.
HYMOVIS must not be used if the packaging is opened or damaged.
Keep medicines out of reach of children.
Side effects
Localized side effects such as pain, swelling/effusion, warmth, and redness may occur at the injection site. Such symptoms are usually mild and temporary.
More pronounced inflammatory reactions have been reported in connection with intraarticular injections of hyaluronate.
As with any intraarticular treatment, septic arthritis may rarely occur if general sterility precautions for the injection are not observed.
Interactions
The product must not be used together with disinfectants containing quaternary ammonium salts, as sodium hyaluronate hexadecylamide may precipitate in their presence.
To avoid potential interactions, HYMOVIS should not be used simultaneously with other products administered intraarticularly.
Storage
Store in the original packaging. Do not store above 25 °C. Do not freeze.
Type and content of the container
- Package with 1 Luer Lock prefilled syringe
- Package with 2 Luer Lock prefilled syringes
Each syringe has a backstop and is sealed in an ethylene oxide-sterilized blister pack.
Each syringe contains 3 ml of hydrogel and is steam sterilized. The instruction manual is included in every package.
Manufacturer:
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica 3/A
35031 Abano Terme (Padua), Italy
Distribution:
Fidia Pharma GmbH
Opladener Straße 149
40789 Monheim am Rhein, Germany
Phone: +49 2173 8954 200
Fax: +49 2173 8954 100
Email: medical@fidiapharma.de
Information status:
This instruction manual was last revised in December 2015.
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