PREFIJECT-M

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.
• CW032

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

  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 PREFIJECT-M • 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 PREFIJECT-M may contain trace amounts of gram-positive bacterial proteins and is contraindicated for patients with a history of such allergies. PREFIJECT-M should not be used in patients with known allergy to derived bovine material. PREFIJECT-M should not be used in patients with known allergy to material derived from shrimps, crabs or seafoods.
• CW999

  PREFIJECT-M 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 PREFIJECT-M 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 EL ; disponible dans 1 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

05944728007086

Basic UDI-DI

B-05944728007086

Numéro de référence/catalogue

PREFIJECT-M

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

PREFIJECT-M 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. PREFIJECT-M 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. PREFIJECT-M 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