HIALUROM
Sodium hyaluronate 30 mg 2 ml, sterile solution for injection in a prefilled syringe
For intraarticular injection
DESCRIPTION:
Hialurom is a sterile, viscoelastic solution of sodium hyaluronate. Hialurom contains 30 mg in 2 ml of sterile sodium hyaluronate with a molecular weight of 1.5 - 2.4 million Daltons, dissolved in physiological saline with an average osmolarity of 335 milliosmols, in a prefilled syringe. The sodium hyaluronate is obtained by bacterial fermentation of a Streptococcus strain and subsequently purified.
Each milliliter of Hialurom contains 15 mg sodium hyaluronate, sodium chloride, and water for injection.
Sterile by moist heat.
INDICATIONS:
Hialurom is indicated as a viscoelastic supplement or replacement of synovial fluid in the human knee joint.
Hialurom is indicated for the symptomatic treatment of knee osteoarthritis. Hialurom acts as a lubricant and mechanical support.
CONTRAINDICATIONS:
The following pre-existing conditions may represent relative or absolute contraindications for the use of Hialurom:
- allergies (hypersensitivity) to any of the components of Hialurom,
- existing skin infections at the injection site,
- known infection in the index finger joint,
- known systemic bleeding disorders.
Hialurom may contain traces of proteins from gram-positive bacteria and is contraindicated for patients with known allergies of this type.
POSSIBLE SIDE EFFECTS:
Sodium hyaluronate is a natural component of human tissue. Since sodium hyaluronate is classified as non-inflammatory, all inflammatory reactions are attributed to the injection procedure itself. Occasionally, mild to moderate temporary swelling and discomfort have been observed after intraarticular injection of sodium hyaluronate preparations. There are minimal risks associated with the injection procedure, primarily infections and bleeding.
ADMINISTRATION AND DOSAGE:
Hialurom may only be administered by medical professionals trained in intraarticular injection techniques.
Hialurom may only be administered intraarticularly.
It must not be administered intravenously.
Strict aseptic administration techniques must be followed.
The injection site must be properly disinfected (70% alcohol or another disinfectant). Disinfectants containing quaternary ammonium salts should not be used for skin disinfection, as this may cause a failure reaction of the hyaluronic acid. Hialurom is administered once weekly into the affected joint over three consecutive weeks. For bilateral treatment, a separate syringe should be used for each knee. Each joint may only undergo one treatment cycle within a 6-month period.
Any joint effusion must be removed by joint aspiration before injecting Hialurom. The joint space must not be overfilled. Hialurom is available as a prefilled syringe and must not be diluted. The contents of the Hialurom prefilled syringe are sterile and must be used immediately once the package is opened. Hialurom must be slowly injected into the joint space using a standard intra-articular injection technique.
Remove the prefilled syringe from the packaging. Break the visible seal before use and remove the cap from the prefilled syringe. Attach the hypodermic needle of a suitable size (gauge) and length (inch) and ensure it is properly secured by gently twisting. Prime the syringe before injection.
Common needle sizes for injections into the knee are between 18 and 21 G (1.2-0.8 mm).
The final choice of needle for each treatment is made by the doctor,
PRECAUTIONS:
General precautions for intraarticular injections must be observed. Hialurom must only be injected into the joint space by trained medical personnel. If pain increases during the injection, the injection must be stopped and the needle withdrawn.
Patients must be carefully examined for signs of acute inflammation before administration, and the doctor must decide whether treatment with Hialurom should be started in such cases.
As with any invasive joint procedure, it is recommended not to overload the joint immediately after the intraarticular injection.
Patients who experience abnormal follow-up complications after administration of Hialurom must see a doctor immediately. There is insufficient data to recommend use in children and adolescents, pregnant and breastfeeding women. Hialurom must not be administered simultaneously or mixed intraarticularly with other products.
WARNINGS:
The product Hialurom is intended for single use!
Do not reuse.
Each Hialurom prefilled syringe is intended for use on a single patient only.
Do not use the syringe if the seal is opened or damaged.
The product must not be re-sterilized as this may damage or alter the product.
The product should only be used if the solution is clear.
Used needles and syringes must be disposed of after each injection and must not be kept for other administrations.
Reusing already used needles and syringes can lead to the transmission of infectious agents (including HIV and hepatitis).
Hialurom should be brought to room temperature before use by storing it, if necessary, for about 20-45 minutes at appropriate temperatures before administration.
Keep out of reach of children.
Do not use after the expiration date on the label.
PROPERTIES AND MODE OF ACTION:
The sodium hyaluronate in Hialurom is a polysaccharide consisting of sodium glucuronate and N-acetylglucosamine.
Sodium hyaluronate is ubiquitous in human tissue and is found in high concentrations in certain tissues such as the vitreous body, synovial fluid, umbilical cord, and dermis. In synovial joints, sodium hyaluronate acts as a lubricant and shock absorber, enabling normal movements without joint pain. In degenerative joint diseases (osteoarthritis), the viscoelasticity of synovial fluid is impaired, which greatly increases mechanical stress on the joint and destruction of joint cartilage, leading to restricted and painful joint movement.
The lubricating and shock-absorbing properties of sodium hyaluronate reduce pain and improve joint mobility when administered intra-articularly.
This effect can last for 6 months after a treatment cycle of 1-3 intra-articular injections.
Viscosupplementation with hyaluronic acid is an effective and well-tolerated therapy for knee osteoarthritis. Viscosupplementation is also a well-tolerated therapy for osteoarthritis of other joints, but a consensus on the effectiveness of viscosupplementation with hyaluronic acid for other joint osteoarthritis has not yet been reached worldwide.
COMPOSITION:
Each milliliter of Hialurom contains 15 mg sodium hyaluronate, 9 mg sodium chloride, and water for injection. Each syringe contains 2 ml of sterile, viscoelastic solution of 30 mg sodium hyaluronate. Hialurom is available in a carton box with the following contents:
- one blister with a disposable prefilled syringe and instructions for use,
- three blisters with disposable prefilled syringes and instructions for use.
STORAGE:
The product should be stored in its original packaging. The storage temperature should not exceed 25°C. Do not freeze.
Information status: February 2019
Joint injections
Dermafiller
Supplements
