2006

Organization name

FARMA-DERMA S.r.l.

SRN

IT-MF-000020737

Manufacturer status

Active

9 warnings recorded — scroll inside the panel to see all entries.

• CW007

  Do not use after the expiry date or if the pack is open or damaged.
• CW010

  Directions for use and warnings: read the instructions for use included in the inside package insert.
• CW135

  Keep out of the reach of children.
• CW999

  CONTRAINDICATIONS Do not use in case of individual hypersensitivity to one of the components of the product.
• CW275

  In caso di gravidanza o allattamento, non essendo stati effettuati studi clinici specifici, consultare il medico prima dell’utilizzo del dispositivo./In case of pregnancy and breastfeeding it is advisable to consult your doctor.
• CW999

  INTERACTIONS WITH OTHER PRODUCTS Interactions with other products are not known, therefore it is advisable to consult the doctor before using PROKTIS-M PLUS rectal ointment in association with other medical devices or drugs for rectal use.
• CW999

  UNDESIRED EFFECTS Use of all products for topical use, especially if prolonged, may cause sensitisation. In that case, or if other undesired effects occur, stop treatment and consult your doctor or pharmacist.
• CW999

  Avoid contact with eyes. Do not swallow.
• CW999

  A personal use of the medical device is recommended. If necessary PROKTIS-M PLUS rectal ointment can be used for prolonged periods, in any case after 30 days of continuous use suspend treatment for one week.

Primary placement in Italy; available across 1 country total.

Trade name

not provided

UDI-DI code

08032595871361

Basic UDI-DI

803259587TF06EM

Reference / catalog number

2006

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Indications: adjuvant treatment of reparative processes of the ano-rectal canal following proctological surgery; internal and external haemorrhoids; proctitis; cryptitis; anal rhagades; fissures; perianal fistulae.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• hyaluronic acid sodic salt — 0.1 MU999
• white vaseline and vaseline oil — 953 MU999
• Adulti e bambini/Adults and children

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

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

• G05TOPICAL ANORECTAL ADMINISTERED GASTRO-INTESTINAL SYSTEM DEVICES