Solution with the sodium salt of hyaluronic acid for intraarticular use
Pre-filled syringe
Product description
HYALUBRIX is a sterile, viscoelastic solution containing the sodium salt of hyaluronic acid, obtained by bacterial fermentation from a high molecular weight fraction.
Hyaluronic acid is an endogenous polysaccharide of the glycosaminoglycan family found in cartilage and joint fluid. It is continuously released into the joint and is one of the main components of joint fluid, giving it its characteristic viscosity and elasticity. These properties are crucial for the lubricating and shock-absorbing function of the fluid in healthy joints to protect cartilage and soft tissues from mechanical injury.
Traumatic and degenerative joint changes lead to a deficiency of hyaluronic acid and a loss of viscosity in the joint fluid, which in turn impairs joint function and causes painful symptoms. Numerous data in the literature show that intraarticular injection of hyaluronic acid can restore the viscoelastic properties of the joint fluid.
HYALUBRIX serves as a temporary replacement of joint fluid in patients with degenerative or mechanical joint disease that causes changes in the functional properties of the joint fluid. Weekly intraarticular injections of HYALUBRIX provide pain relief and improvement of joint function for up to six months in patients with degenerative or mechanical joint changes.
Composition
Main ingredient: sodium salt of hyaluronic acid 1.5%
Other ingredients: sodium chloride, disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injection.
Areas of application
HYALUBRIX is indicated for the treatment of pain and improvement of joint function in patients with degenerative or mechanical joint changes of the knee, hip, shoulder, ankle, and thumb saddle joint.
The product is indicated for the treatment of persistent pain after initial failure of analgesics or failure or intolerance of nonsteroidal anti-inflammatory drugs.
Intended use
HYALUBRIX is a temporary joint fluid substitute and must be injected intraarticularly.
Dosage and method of administration
HYALUBRIX is intended exclusively for intra-articular injection.
The product may only be used by licensed physicians (e.g., orthopedists, rheumatologists, specialists in physical and rehabilitative medicine, radiologists, sports medicine doctors, etc.).
The injection must be strictly intra-articular. The intra-articular injection must be performed according to the usual standard technique, taking anatomical conditions into account. For the hip, shoulder, and other less accessible joints, sonographic or fluoroscopic guidance is recommended.
Inject HYALUBRIX into the affected joint at weekly intervals over three weeks using a suitable sterile needle (e.g., 18 or 20 G).
If necessary, treatment can be repeated. However, no systematically collected data are available for this.
Clinical data demonstrate the efficacy of HYALUBRIX for up to six months. If clinically necessary, treatment can be repeated from three months after the first treatment cycle.
All rules of aseptic technique and injection procedure must be observed.
Any joint effusion must be removed before use.
Contraindications
Do not administer to patients with known hypersensitivity to any of the product components.
Do not administer if infections or skin diseases are present at the injection site.
Do not administer to patients with active synovitis.
Use in certain patient groups
The safety and efficacy of HYALUBRIX in pregnant or breastfeeding women or patients under 18 years of age have not been studied. Therefore, use in these patient groups is contraindicated.
Warnings and precautions
Do not use if the packaging is damaged.
Do not use the product after the expiration date indicated on the packaging. The expiration date applies to the product stored in the original packaging at a temperature not exceeding 25 °C.
The syringe is intended for single use only, i.e., for one injection in one patient. Inject the syringe contents into only one joint.
In the first 24 hours after the injection, patients can carry out all daily activities. However, it is recommended not to overload the treated joint.
The prepared syringe must be disposed of immediately after each use, regardless of whether the entire solution has been administered.
When reprocessing and/or reusing this product, Fidia Farmaceutici can no longer guarantee the effectiveness, functionality, material structure, purity, or sterility of the product. Reuse may lead to illness, infection, and/or serious injury to the patient or user.
After use, dispose of the product according to national regulations.
Keep out of reach of children.
Side effects
At the injection site, local pain, swelling, a feeling of warmth, and redness may occasionally occur. Such symptoms are generally mild and subside. After the intra-articular injection, applying an ice pack to the treated joint for five to ten minutes may reduce the frequency of these symptoms.
In people with hypersensitivity to the product components, local or systemic allergic reactions may occur.
Occasionally, stronger inflammatory reactions (sometimes with sodium pyrophosphate crystals) have been reported in connection with intra-articular injections of hyaluronate.
As with any intra-articular treatment, septic arthritis may rarely occur if general precautions for injections are not observed or if the injection site is not sterile.
Interactions
The product must not be used together with disinfectants containing quaternary ammonium salts, as hyaluronic acid may precipitate in their presence.
To avoid possible interactions, the simultaneous use of HYALUBRIX with other products administered intra-articularly should be avoided.
Storage
Store at a temperature not exceeding 25 °C.
Dosage forms
Box with one prefilled syringe containing a solution of 30 mg/2 ml sodium salt of hyaluronic acid.
The heat-sterilized syringe has a protective device and is airtight packed in a blister pack.
Available package sizes:
- Box with one prefilled syringe in a blister pack
- Box with three prefilled syringes, each in a blister pack.
- Box with 50 prefilled syringes (for healthcare facilities only)
- Box with 100 prefilled syringes (for healthcare facilities only)
The package does not contain needles.
Manufacturer
FIDIA Farmaceutici S.p.A.
Via Ponte della Fabbrica 3/A
35031 Abano Terme (PD), Italy
Status of the information in the instructions for use:
March 2021
Joint injections
Dermafiller
Supplements
