Promovia 60

Dénomination commerciale

Promovia 60

08051040330208

B-08051040330208

Numéro de référence/catalogue

INN38

GS1

Classe III

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

PROMOVIA is a synovial fluid substitute which, thanks to its viscoelastic and lubricant properties, promotes the restoration of rheological conditions of the joints, altered in degenerative or post-traumatic conditions.The product, improving the characteristics of the synovial fluid, exerts a protective action of the joints and helps the improvement of joint function and the reduction of pain symptoms. PROMOVIA acts only at the joint where it is injected, without exerting any systemic action.

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

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

• Consulter la notice d’utilisation
• Ne pas réutiliser
• Ne pas restériliser
• Ne pas utiliser si l’emballage est endommagé
• Ne pas utiliser après la date indiquée
• Is suitable only for intra-articular injections and must only be dispensed by a doctor who has received specific training on the intra-articular injections technique. The device must not be used in pregnant or breastfeeding women, as has not been tested in such cases. The device must be not be used in patients with ascertained individual hypersensitivity to any of the ingredients of the product. As no clinical experience is available for the use of Hyaluronan in children, treatment with Promovia 60 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. After the intra-articular injection it is advisable to recommend to the patient to avoid driving for at least 48 hours. Is a disposable product, the quality and sterility are guaranteed only if the syringe is sealed. Before use, check the integrity of the syringe and the expiration date. 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 infection in place or inflammatory conditions of the skin in proximity of the injection. 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. For additional information consult instruction for use.