HYALEXO CROSS Intra-articular solution 3 % 1 Prefilled syringe/3ml

VIDAL
Parapharmacy
Update of 08/09/2025

^CE HYALEXO CROSS

PRESENTATION AND COMPOSITION 

Hyalexo Cross is presented as a viscous, transparent, viscoelastic and colorless gel. It contains a gel based on cross-linked hyaluronic acid, with a volume of 3 ml, in a sterile and apyrogenic syringe. As the product has viscoelastic properties and a high binding capacity to water molecules, it acts as a lubricant, normalizes the viscosity of the synovial fluid and is used in the form of a sterile gel that supports the intra-articular connective tissue. The product contains cross-linked hyaluronic acid obtained by bacterial fermentation, at a concentration of 30 mg/ml, and dissolved in a physiologically buffered saline solution. The entire gel corresponds to cross-linked hyaluronic acid obtained by fermentation with a phosphate buffer.
 
Each box contains 1 prefilled syringe containing 3 ml of cross-linked hyaluronic acid gel.
The product is sterilized by steam. The contents of the syringe are sterile.
 
EAN code: 8684771349968.

PROPERTIES and USE 

Hyalexo Cross is indicated in painful joint disorders caused by degenerative or post-traumatic diseases or joint lesions. Thanks to the viscoelastic properties of the gel, the product helps joints maintain their optimal rheological and physiological state. It helps improve joint function and reduce painful symptoms. It is indicated for the treatment of pain in patients suffering from osteoarthritis of the knee. The effects of the product are related to lubrication and mechanical improvement.

Directions for use 

The product must be administered exclusively by a qualified healthcare professional as part of treatment by intra-articular injection. Use a needle of appropriate diameter and length depending on the location of the joint to be treated. It is recommended to use a single-use needle.

1. A strict aseptic technique must be observed during the intra-articular injection.
   
2. Gently remove the protective cap from the syringe (Fig. 1).
   
3. Screw the needle firmly into the luer-lock tip (Fig. 2). Secure the needle firmly while holding the tip firmly to ensure a perfect seal and prevent leaks during administration. Remove the needle guard (Fig. 3). Do not overtighten and do not apply excessive force when inserting the needle or removing the needle guard, otherwise the syringe tip could break.
   
4. Before injection, the injection site must be disinfected with an appropriate disinfectant.
   
5. The product is then injected into the joint.
   

Contraindications 

• Do not use this product in patients with hypersensitivity to hyaluronic acid preparations.
  
• Do not administer to persons with known hypersensitivity (allergy) to gram-positive bacterial proteins.
  
• Do not inject into the knee joint in patients with infections or skin diseases at the injection site or the joint.
  
• Do not administer if the intended injection site is the site of pain, infection or signs of an acute or chronic disease.
  
• Do not inject in patients with known systemic bleeding disorders.
  

Precautions for use 

• During administration, a strict aseptic injection technique must be used.
  
• The product must be injected exclusively into the affected knee joint, by a qualified physician or healthcare professional experienced in intra-articular injection procedures, and in premises suitable for such injections.
  
• Do not inject into blood vessels, outside the joint, or into synovial tissues or the joint capsule.
  
• If injection pressure increases, this may indicate incorrect extra-articular positioning of the needle or injection of an excessive amount of gel into the joint.
  
• The patient must be carefully examined before administration to detect signs of acute inflammation and the physician must assess whether treatment should be initiated in this case.
  
• Remove the joint effusion, if any, before the injection.
  
• In case of effusion accompanied by intense pain, the fluid must first be removed from the affected joint.
  
• Transient local reactions may occur after an intra-articular injection, such as redness, swelling, for example. Local application of ice for 5 to 10 minutes may reduce these effects.
  
• The safety and efficacy of the concomitant use of Hyalexo Cross with other intra-articular injectable products have not been established.
  
• Do not use if the packaging is open or damaged.
  
• Do not use after the expiration date indicated on the packaging.
  
• For single use only, do not reuse.
  
• The product must not be resterilized as the performance of the device could be compromised.
  
• The product has not been tested in pregnant women or children under 18 years.
  
• Its safety and efficacy have not been established in breastfeeding women.
  

Warnings:

• Avoid using disinfectants containing quaternary ammonium salts for skin preparation at the same time as the product.
  
• When quaternary ammonium salts - such as benzalkonium chloride - are mixed with hyaluronic acid solutions, they may form a precipitate.
  
• Do not inject intravascularly as this could lead to systemic adverse events.
  

Intended use:

Hyalexo Cross should be used only by qualified physicians (orthopedics-traumatology, rheumatology, physical and rehabilitation medicine, sports medicine specialists or equivalents) trained in the intra-articular injection technique.

Adverse effects

Adverse effects reported in the literature after intra-articular injection:

• After intra-articular injections, patients may experience temporary pain and/or swelling and/or joint effusion. In some cases of infiltrations, phenomena of acute inflammation of the treated joint by intra-articular injection have been reported, characterized by joint pain, swelling, effusion and sometimes with warmth and/or stiffness, redness, arthralgia.
  
• Reported adverse effects include hypersensitivity reactions such as anaphylactoid reactions, anaphylactic shock and Quincke's edema.
  
• Sometimes, mild to moderate cases of temporary swelling and discomfort have been observed following intra-articular injection of cross-linked hyaluronic acid preparations.
  

Any serious incident occurring in relation to the medical device must be reported to the manufacturer and to the competent authority of the Member State in which the user and/or patient is established. Competent authority in France: Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) - Website: https://signalement.social-sante.gouv.fr.

STORAGE CONDITIONS 

Store the product in its original packaging, at a temperature between 2 °C and 25 °C, protected from light. Do not freeze.
Shelf life The expiration date is indicated on the packaging.

ADMINISTRATIVE INFORMATION 

Available only on medical prescription.
Class III medical device. CE marking 2292.
Date of revision of the leaflet: 24/04/2024.
Manufactured by: Semikal Teknoloji Sanayi ve Ticaret Anonim Sirketi, AOSB 3. Kisim Mah. 25. Cad. No:14/111 Dösemealti, Antalya, Turkey.
Distributed by: Laboratoires Expanscience.

Laboratoires Expanscience SAS
1, place des Saisons. 92048 Paris-La-Défense cdx
Phone: 01 43 34 60 00. Fax: 01 43 34 61 00
https://www.expanscience.com