HIALUROM HONDRO
Sodium hyaluronate 60 mg/3 ml and chondroitin sodium sulfate 90 mg/3 ml, solution for injection in a prefilled syringe.
For intra-articular injection
DESCRIPTION:
Hialurom Hondro is a sterile, viscoelastic solution containing two highly purified cross-linked biological polymers, sodium hyaluronate and chondroitin sodium sulfate. Hialurom Hondro consists of sodium hyaluronate derived from bacterial fermentation of a Streptococcus strain and chondroitin sodium sulfate derived from bovine cartilage.
Hialurom Hondro is a sterile, viscoelastic solution obtained using aseptic processing techniques and supplied in a single-use glass syringe containing 3 ml of solution.
COMPOSITION:
Each prefilled syringe contains 60 mg sodium hyaluronate, 90 mg chondroitin sodium sulfate, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate dodecahydrate, sodium hydroxide and/or hydrochloric acid (for pH adjustment), and water for injection.
INDICATIONS:
Hialurom Hondro is indicated as a viscoelastic supplement or replacement for synovial fluid in the human knee joint.
Hialurom Hondro is indicated for the symptomatic treatment of mild to severe knee osteoarthritis. Hialurom Hondro acts as a lubricant and mechanical support.
CONTRAINDICATIONS:
Hialurom Hondro must not be used in:
- known allergies (hypersensitivity) to
sodium hyaluronate, chondroitin sulfate, or any other component of Hialurom
- Hondro,
- pre-existing skin infections at the injection site,
- known infection in the index finger joint,
- known systemic bleeding disorders, bleeding, or tendency to bleed.
Hialurom Hondro may contain traces of proteins from gram-positive bacteria and is contraindicated for patients with known allergies of this type.
Hialurom Hondro should not be used in patients with known hypersensitivity to bovine materials.
POSSIBLE SIDE EFFECTS:
After intra-articular injection of Hialurom Hondro, swelling and temporary pain may occur. These reactions generally subside within 72 hours.
Reported product-related side effects
The most frequently reported side effects after marketing related to the use of Hialurom Hondro were
Joint pain, joint stiffness, joint effusion, joint swelling, joint warming, and gait disturbance.
Cases of fever and malaise have also been reported. These side effects improved within a few days after treatment, such as applying ice to the injection site, treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), or antipyretics.
DOSAGE AND METHOD OF ADMINISTRATION:
Not for intravenous injection.
This product is for intra-articular use only. It must not be injected extra-articularly.
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 reaction with the hyaluronic acid.
If present, remove joint effusions before injecting Hialurom Hondro. Joint puncture (arthrocentesis) before injection is recommended. Remove the prefilled syringe from the packaging. Break the visible seal before administration and remove the cap from the prefilled syringe. Attach the hypodermic needle of an appropriate gauge and length and ensure it is properly secured by gently twisting. Common needle sizes for knee injections range between 18 and 21 G (1.2–0.8 mm).
The final choice of needle for each intra-articular treatment is made by the physician.
Injection of subcutaneous lidocaine or another anesthetic before the injection with Hialurom Hondro may be advisable.
As with any invasive joint procedure, it is recommended that the patient avoid any strenuous activity and prolonged (e.g., over one hour) physical exertion, such as tennis or jogging, for 48 hours after the injection.
PRECAUTIONS FOR USE:
Although sodium hyaluronate and chondroitin sodium sulfate are highly purified biological polymers, the physician must be aware of the risks of allergies inherently associated with the use of biological materials.
General precautions for intra-articular injections must be observed.
Hialurom Hondro may only be injected by medical professionals trained in intra-articular administration techniques.
If the 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 injection, and the doctor must decide whether treatment with Hialurom Hondro should be started in such cases.
Patients who experience abnormal subsequent complications after administration of Hialurom Hondro must immediately consult a doctor.
The safety and effectiveness of Hialurom Hondro have not been established in children and adolescents, as well as in pregnant and breastfeeding women.
Since there is no clinical evidence for the use of sodium hyaluronate and chondroitin sodium sulfate in patients with concomitant inflammatory arthropathy (such as rheumatoid arthritis, gouty arthritis), recent orthopedic surgery, or trauma to the index finger joint, treatment with Hialurom Hondro is not recommended for these patients.
There have been some case reports of increased INR (International Normalized Ratio) in patients who simultaneously received warfarin and dietary supplements containing glucosamine and chondroitin. Due to limited information, caution is advised when treating patients with Hialurom Hondro who are also taking anticoagulants or platelet aggregation inhibitors.
WARNINGS:
Check the expiration date and the condition of the packaging before use.
Do not use Hialurom Hondro after the expiration date printed on the packaging.
Do not use the syringe if the seal is opened or damaged.
Use the product only if the solution is clear.
After opening, the contents of the syringe must be used immediately.
The product Hialurom Hondro is intended for single use only! Do not reuse. Each prefilled syringe of Hialurom Hondro is intended for a single application in one patient only.
Used needles and syringes must be disposed of after injection and must not be kept for other injections. Reusing already used needles and syringes can lead to the transmission of infectious agents (including HIV and hepatitis).
Do not re-sterilize as this may damage or alter the product.
FEATURES AND MODE OF ACTION:
Hialurom Hondro is a product for viscosupplementation, which is a safe, effective, and well-established treatment for osteoarthritis, where a solution based on hyaluronic acid is injected into the affected synovial joint.
Hialurom Hondro acts as a temporary supplement and replacement for synovial fluid.
Hialurom Hondro relieves joint pain, improves joint mobility, and protects cartilage.
Hyaluronic acid is a main component of synovial fluid and cartilage and is responsible for lubrication and cushioning of the joints thanks to its viscoelastic and rheological properties. It reduces friction between joint surfaces and protects soft tissue from injury by acting as a shock absorber.
The amount and quality of hyaluronic acid in synovial fluid is reduced in patients with osteoarthritis because its synthesis by joint and cartilage cells is impaired. Therefore, the protection of joint surfaces is greatly reduced, cartilage becomes vulnerable due to friction and pressure, and is subject to structural degradation.
Chondroitin sulfate, a sulfated glycosaminoglycan, is an important structural component of the extracellular cartilage matrix. Due to specific interactions, chondroitin sulfate optimizes the flow properties of hyaluronic acid.
Furthermore, in vitro studies have shown that chondroitin sulfate inhibits enzymes mainly involved in the destruction of the cartilage matrix: metalloproteinases and aggrecanases. Chondroitin sulfate also inhibits the secretion of pro-inflammatory factors.
These data support the observed clinical
Activity of chondroitin sulfate as a symptomatic, slow-acting substance in osteoarthritis with pain relief and reinforcement function.
A single injection of Hialurom Hondro restores joint protection through good lubrication and shock absorption and leads to a significant improvement in symptoms.
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 global consensus on the effectiveness of viscosupplementation with hyaluronic acid for other joint osteoarthritis has not yet been reached.
COMPOSITION:
Each Hialurom Hondro prefilled syringe contains 3 ml of sterile, viscoelastic solution of sodium hyaluronate (60 mg) and chondroitin sodium sulfate (90 mg).
Hialurom Hondro is available in a secondary packaging containing: one blister with a single-use prefilled syringe and instructions for use.
Hialurom Hondro is a medical device. It may only be used under the supervision of a doctor.
SHELF LIFE AND 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
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