CARTInorm XL TRIO

Nom de l'organisation

Rompharm Company SRL

SRN

RO-MF-000002517

Statut du fabricant

Actif

11 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW010

  EUDAMED n'a pas publié de description pour ce code.
• CW009

  EUDAMED n'a pas publié de description pour ce code.
• CW001

  EUDAMED n'a pas publié de description pour ce code.
• CW007

  EUDAMED n'a pas publié de description pour ce code.
• CW032

  EUDAMED n'a pas publié de description pour ce code.
• CW999

  Contraindications: is contraindicated in patients with: •known allergy (hypersensitivity) to sodium hyaluronate, chondroitin sulfate, N-acetylglucosamine or to any components of CARTInorm XL TRIO • 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 CARTInorm XL TRIO may contain trace amounts of gram-positive bacterial proteins and is contraindicated for patients with a history of such allergies. CARTInorm XL TRIO should not be used in patients with known allergy to derived bovine material. CARTInorm XL TRIO should not be used in patients with known allergy to material derived from shrimps, crabs or seafoods.
• CW999

  CARTInorm XL TRIO should be administered in the synovial knee joint space only by medical professionals trained in intra-articular administration technique.
• CW999

  Due to limited information, caution is advised regarding the CARTInorm XL TRIO administration in patients taking anticoagulants or antiplatelet agents.
• CW999

  Exacerbation of asthma symptoms after initiation of glucosamine supplements have been described (symptoms resolved after withdrawal of glucosamine), therefore, asthmatic patients should be aware of potential worsening of symptoms.
• CW999

  The product is administered only if the solution is clear.
• CW999

  After opening, the contents of the syringe should be used immediately.

Marché principal en Hongrie ; disponible dans 2 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

05944728007079

Basic UDI-DI

B-05944728007079

Numéro de référence/catalogue

CARTInorm XL TRIO

Entité d'attribution

GS1

Catégorie de risque

Classe III

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

CARTInorm XL TRIO 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. CARTInorm XL TRIO 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. CARTInorm XL TRIO 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

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES