BIOPORT TRICOMBO

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.
• 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 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.
• CW999

  KOMBIHYLAN 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 KOMBIHYLAN 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.
• CW009

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

Marché principal en Finlande ; disponible dans 1 pays au total.

Dénomination commerciale

BIOPORT TRICOMBO

Code d'UDI-DI

05944728011632

Basic UDI-DI

B-05944728011632

Numéro de référence/catalogue

KOMBIHYLAN

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

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

Aucune dimension clinique enregistrée pour ce dispositif.

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES