Hyaluronic Acid Sodium Salt Solution for Intraarticular Injection
Pre-filled syringe 60 mg/4 ml
Product Description
HYALONE® is a sterile, pyrogen-free, viscoelastic hyaluronic acid sodium salt solution obtained by bacterial fermentation from a high molecular weight fraction. Hyaluronic acid, a polysaccharide of the glycosaminoglycan family, is found in many human tissues, such as cartilage or joint fluid (synovial fluid); it is continuously released into the joint space and constitutes a main component of synovial fluid, giving it its characteristic viscosity and elasticity. These properties are essential for the lubricating and shock-absorbing functions that synovial fluid performs in a healthy joint to protect cartilage and soft tissues from mechanical injury. In traumatic and degenerative joint damage, there is an insufficient supply of hyaluronic acid to the synovial fluid and a loss of viscosity. This leads to impaired joint function and painful symptoms. Extensive data in the literature show that the viscoelastic properties of synovial fluid can be restored by intraarticular administration of hyaluronic acid, resulting in pain relief and improved joint mobility.
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.
Indications
HYALONE® is a temporary synovial fluid substitute for patients with degenerative or mechanical arthropathy of the hip or knee joint, causing a functional alteration of the synovial fluid without acute synovitis.
Dosage Instructions and Method of Administration
Application must only be performed by qualified physicians.
All rules regarding asepsis and injection technique must be followed.
If necessary, remove exudate before injecting HYALONE®.
After the first application, further treatments may be necessary to maintain the treatment effect. This depends on the individual patient. Inject HYALONE® with a suitable sterile needle (e.g., 18 – 20 G).
For hip joint application, ultrasound-guided injection is recommended. This is not necessary when HYALONE® is used in the knee joint.
The outer surface of the syringe is sterile, making the product suitable for use in operating rooms.
Contraindications
HYALONE® must not be administered to patients with known individual hypersensitivity to any components of the preparation or in cases of infections or skin diseases at the injection site.
There is no evidence of contraindications for repeated treatment.
Warnings and Precautions
Preclinical studies in laboratory animals show that the product has no potential reproductive or developmental toxicity. HYALONE® has not been tested in pregnant women. Do not use if the packaging is damaged.
Do not use the product after the expiration date indicated on the packaging.
The expiration date refers to storage of the product in the original packaging at a temperature not exceeding 25°C.
HYALONE® is intended for single use only; after use, the syringe must be disposed of according to the regulations applicable in the respective country.
This product is a single-use syringe, meaning the syringe should only be used on the same patient. The pre-filled syringe must be disposed of immediately after use, even if the injection solution has not been completely used up.
If the product is reprocessed and/or reused, Fidia Farmaceutici cannot guarantee the efficacy, function, material structure, purity, or sterility of the product. Reuse may lead to illness, infection, and/or serious injury to the patient. Disposal of the pre-filled syringe after use must comply with national guidelines.
Keep out of reach of children.
Adverse Reactions
Occasionally, local pain, swelling, warmth, and redness may occur at the injection site. Such symptoms are generally mild and temporary.
More pronounced inflammatory reactions, as sometimes seen with sodium pyrophosphate crystals, have occasionally been reported in connection with intraarticular injections of hyaluronate.
As with any intraarticular treatment, septic arthritis may rarely occur if general precautions for injections are not observed or if the injection site is not aseptic.
Interactions
Do not use HYALONE® together with disinfectants containing quaternary ammonium salts, as hyaluronic acid may precipitate in their presence. To avoid possible interactions, HYALONE® must not be administered simultaneously with other agents intended for intraarticular use.
Storage
Store at a temperature not exceeding 25°C.
Package Size
Each syringe is packaged in a blister and sterilized with ethylene oxide. One syringe contains 60 mg hyaluronic acid sodium salt in 4 ml solution, steam sterilized.
Manufacturer
Fidia Farmaceutici S.p.A. - Via Ponte della Fabbrica 3/A - 35031 Abano Terme (Padua) Italy
For further information, please contact Fidia Pharma GmbH, Germany:
Phone: +49 2173 8954 200 - Fax: +49 2173 8954 100 - Email: medical@fidiapharma.de
Information Date:
April 2012
Joint injections
Dermafiller
Supplements
