Leovisc 2% (1 prefilled syringe)

Nom de l'organisation

GRUPPO FARMAIMPRESA SRL

SRN

IT-MF-000012625

Statut du fabricant

Actif

Santé des certificats sur le portefeuille de ce fabricant.

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW999

  Leovisc is suitable only for intra-articular injections and must only be dispensed by a doctor who has received specific training on the intra-articular injection technique. Before use, check the integrity of the syringe and the expiration date. Do not use needles other than those listed. The product should not be injected in the presence of a infected or severely inflamed joint. The infiltration must be avoided in the case of infections in place or inflammatory conditions of the skin in proximity of the injection. As no clinical experience is available for the use of Hyaluronan in children, treatment with Leovisc is not recommended in these cases. After the intra-articular injection it is advisable to recommend to the patient to avoid physical activities demanding stress for the articulation and resume normal activities after a few days. Leovisc is a disposable product, the quality and sterility are guaranteed only if the syringe is sealed. Any residue must be discarded and not reused even after new sterilisation. Do not use the product if the package is already opened or damaged. The assembled syringe must be discarded immediately after use, regardless of whether or not the solution has been completely administered. After use, dispose according to applicable national practice. Do not reuse: reuse of the product may result in serious infections. In case of a serious accident occurring in relation to the medical device report the incident to the Manufacturer and the Competent Authority. Pregnancy and Lactation: There are not adequate data on the use of the product in pregnant women and during lactation, so it should not be used unless a real need and after evaluation by the doctor. Do not use in case of patients with severe liver disease.

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

Dénomination commerciale

Leovisc 2% (1 prefilled syringe)

Code d'UDI-DI

08055748843756

Basic UDI-DI

805574884FTMDR74YE

Numéro de référence/catalogue

FT.MDR.74

Entité d'attribution

GS1

Catégorie de risque

Classe III

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Leovisc is a sterile, biodegradable, isotonic, injectable gel, for intra-articular use. Leovisc consists of medium chain (1.0-1.5 x 10^6 Dalton) hyaluronic acid, obtained from Streptococcus equi bacteria, formulated to a concentration of 20 mg/ml in a physiologic buffer.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• 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.

• A02010799PREFILLED SYRINGES - OTHER