HYALGAN 20 mg/2 ml S inj en seringue préremplie pour voie intra-articulaire Ser/2ml

VIDAL
Medicines
Update of 09/11/2026

HYALGAN^®
sodium hyaluronate

Forms and presentations

Injectable solution for intra-articular use at 20 mg/2 ml:  Prefilled syringe of 2 ml, single-unit carton.

Composition

	per syringe
Sodium hyaluronate (Hyalectin)	20 mg

Excipients: sodium chloride, disodium phosphate dodecahydrate, monosodium phosphate dihydrate, water for injectable preparations.

Indications

Symptomatic treatment of painful knee osteoarthritis with effusion.

Dosage and administration

Dosage

The dosage is one intra-articular injection of 20 mg/2 ml per week, for a maximum of 5 weeks.

Method of administration:

Intra-articular route. Reserved for adults.

Injections must be performed under strictly aseptic conditions. It is important to aspirate before injecting, in order to ensure that the needle tip is not in a vessel.

Contraindications

• Hypersensitivity to the active substance or to closely related substances or to any of the excipients mentioned in the section Composition.
  
• Ongoing anticoagulant treatment (risk of haematoma, as with all injectable medicines).
  
• Children under 16 years of age.
  

Warnings and precautions

Inject under strictly aseptic conditions due to the risk of septic arthritis.

Interactions

No dangerous drug interaction has been observed to date.

Fertility, pregnancy and breastfeeding

Pregnancy:

In animals, Hyalgan has no effect on fertility or on general reproductive capacity. It is neither embryotoxic nor teratogenic and has no effect on peri- and post-natal development.

It is recommended not to administer Hyalgan during pregnancy, in the absence of experience of its use in humans.

Breastfeeding:

It is not recommended to administer this product to women during breastfeeding, in the absence of data.

Adverse effects

• Local effects related to the mode of administration: pain, inflammation, hydrarthrosis.
  
• Systemic effects reported: hyperthermia, pseudo-anaphylactic reactions.
  

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.

Pharmacodynamics

Pharmacotherapeutic class: Other drugs for musculoskeletal disorders. ATC code: M09AX01.

The active ingredient of Hyalgan is a purified specific fraction of hyaluronic acid, extracted from rooster combs. This natural polysaccharide is present in the synovial fluid and in the ground substance of cartilage tissue. It determines the viscosity of the synovial fluid and takes part in the metabolism of cartilage proteoglycan aggregates and improves certain experimental osteoarthritis.

The therapeutic effect is obtained through the combination of different pharmacological activities, in particular:

• Binding to specific hyaluronic acid receptors on joint cells.
  
• Action on the metabolism of various inflammatory mediators.
  
• Action on the endogenous production of hyaluronic acid by synoviocytes and fibroblasts.
  

These mechanisms, established in vivo and in vitro, are dose-dependent.

The effect of Hyalgan is delayed, by approximately 2 to 3 months.

Pharmacokinetics

Immediately after intra-articular injection of a dose of 20 mg/2 ml, the expected concentrations in the synovial fluid of treated patients (theoretical data for a synovial fluid volume between 0,13 and 4 ml) are between 3 and 9 mg/ml.

After intra-articular injection, approximately 80 % of hyaluronic acid fractions of molecular weights equivalent to those of Hyalgan bind to synovial tissues and in particular to synovial cells, cartilage and the pericellular matrix of chondrocytes.

Preclinical safety

Acute, medium-term and chronic (6 months) toxicity studies were carried out in several animal species (mice, rats and dogs) after intravenous or subcutaneous administration of doses up to 100 mg/kg acutely and 16 mg/kg chronically. No sign of specific toxicity related to the administration of Hyalgan was observed during these studies. The product showed no toxicity on reproductive functions and no mutagenic effect (in vitro and ex vivo tests).

Several studies carried out in different animal species showed that Hyalgan did not cause any sign of local or general toxicity after intra-articular injection of doses between 5 and 100 mg.

The product showed no sensitizing effect (negative antigenicity tests).

Storage conditions

Store in the outer packaging, protected from light and at a temperature not exceeding 25 °C.

Do not freeze.

HANDLING/DISPOSAL INSTRUCTIONS

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Prescription, supply and reimbursement

LIST I

Marketing authorisation (AMM)

3400933565718 (1992, SmPC rev 10.04.2024).

Not reimbursed by Social Security and not approved for Collectivités.

Laboratoires FIDIA
Immeuble Paroi Nord de La Grande Arche.
1, parvis de la Défense. 92800 Puteaux
E-mail: info@fidiapharma.fr
Tel: 01 53 24 53 88. Fax: 01 84 10 48 34