PROFLUX

Organization name

GRUPPO FARMAIMPRESA SRL

SRN

IT-MF-000012625

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  Avoid contact with eyes. 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 productor a period exceeding 30 consecutive days. It is important to inform your doctor or pharmacist of any side effects not described in this package insert. Single-dose product to be used in a single administration. The incorrect observance of the warnings and of the methods of use, as well as the use of a partial dose of the product, could prejudice its effectiveness or be the cause of the aggravation of the existing pathological situation.

Primary placement in Italy; available across 1 country total.

Trade name

PROFLUX

UDI-DI code

D-FT.CE.107.FG.11.124K

Basic UDI-DI

B-FT.CE.107.FG.11.124K

Reference / catalog number

FT.CE.107.FG.11.12

Issuing entity

EUDAMED

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

PROFLUX is a medical device useful in the symptomatic treatment of all those states linked to gastro-oe-sophageal 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 gastrosophageal tract and supports the process of reconstruc tion 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. Magnesium Alginate, thanks to its film-forming properties, coats the mucous membranes protecting them from gastric juices, contributing to the reduction of the harmful effects of the same and to the burning sensation and irritation due to reflux episodes.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

D-FT.CE.107.FG.11.124K

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

European Medical Device Nomenclature — the EU product classification assigned to this device.

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