KOMBIHYLAN

Dénomination commerciale

KOMBIHYLAN

05944728010116

B-05944728010116

Numéro de référence/catalogue

KOMBIHYLAN

GS1

Classe III

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

KOMBIHYLAN is a bio-matrix in the form of a sterile, viscoelastic solution consisting of two highly purified cross-linked biopolymers, sodium hyaluronate and chondroitin sodium sulfate, and N-acetylglucosamine (NAG), a naturally amino sugar. KOMBIHYLAN contains sodium hyaluronate derived from bacterial fermentation of a Streptococcus strain, chondroitin sodium sulfate sourced from bovine cartilage, and NAG sourced from chitin, a naturally long-chain polymer of N-acetylglucosamine. KOMBIHYLAN is a sterile viscoelastic solution processed by aseptic technique and supplied in a disposable glass syringe delivering 2.25 mL of solution.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 2.25 MU03

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

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• Consulter la notice d’utilisation
• Ne pas restériliser
• Ne pas utiliser si l’emballage est endommagé
• Ne pas utiliser après la date indiquée
• Contraindications: is contraindicated in patients with: • known allergy (hypersensitivity) to sodium hyaluronate, chondroitin sulfate, N-acetylglucosamine or to any components of KOMBIHYLAN • pre-existing infections or skin diseases in the area of the intended injection site • known infection of the index joint • known systemic bleeding disorders, bleeding or tendency to bleeding KOMBIHYLAN may contain trace amounts of gram-positive bacterial proteins and is contraindicated for patients with a history of such allergies. KOMBIHYLAN should not be used in patients with known allergy to derived bovine material. KOMBIHYLAN should not be used in patients with known allergy to material derived from shrimps, crabs or seafoods.

  AUTRE

• KOMBIHYLAN should be administered in the synovial knee joint space only by medical professionals trained in intra-articular administration technique.