REFLUSOD

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

  In case of concomitant therapy with other drugs and / or medical devices, consult your doctor before using the product. Do not use the product after the expiration date; the expiry date refers to the intact and properly stored product. For pregnant and lactating women, the use of the product should be limited to cases of real need and under the direct supervision of the doctor. Do not use in case of individual hypersensitivity to the components present. Do not use the product in association with quaternary ammonium compounds. Do not use the product for a period exceeding 30 consecutive days. It is important to inform your doctor or pharmacist of any side eects not described in this package insert. Incorrect compliance with warnings and instructions for use, as well as direct use by more than one person of the dosing syringe, could compromise the eectiveness of the product or cause the aggravation of existing problems or cause problems to occur before not present. Consume the product within 3 months of opening.

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

Dénomination commerciale

REFLUSOD

Code d'UDI-DI

D-FT.CE.107.FH.2.2105A

Basic UDI-DI

B-FT.CE.107.FH.2.2105A

Numéro de référence/catalogue

FT.CE.107.FH.2.210

Entité d'attribution

EUDAMED

Catégorie de risque

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

REFLUSOD is a medical device useful in the symptomatic treatment of all those states linked to gastro-oesophageal reflux (NERD, functional pyrosis, hypersensitive esophagus to acid and non-acid reflux). Its viscous formulation, capable of adhering and covering the esophageal mucosa, forms a protective barrier. Hyaluronic acid, a component naturally present in the extracellular matrices of our body, hydrates and protects the mucous membranes of the gastro-oesophageal tract and supports the process of reconstruction of the damaged epithelium. The Simethicone, thanks to its chemical-physical properties, reduces the surface tension of the gases present in the gastric liquid, favoring their elimination. This process moderates the pressure that the gases exert on the gastric fluid responsible for reflux. Sodium alginate creates a viscous barrier capable of preventing the contents of the stomach from rising towards the esophagus.

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

D-FT.CE.107.FH.2.2105A

La génération de DataMatrix prend en charge les IUD émis par GS1. La prise en charge HIBCC / ICCBBA arrive bientôt.

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

• G0401ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS