010-IBMAXZ

Organization name

Natur Produkt Zdrovit Sp. z o.o.

SRN

PL-MF-000010540

Manufacturer status

Active

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

• CW010

  Contraindications: • ibesan MAX sachets must not be used if, in addition to diarrhea, the following occur: − fever above 38.5 °C − blood in the stool In such cases, consult a doctor immediately. • Patients who suffer from, or have previously suffered from, severe constipation should not use ibesan MAX sachets. • Do not use in case of hypersensitivity to any of the ingredients. Do not use during pregnancy and breastfeeding. Do not use in children under 2 years of age. WARNINGS, RECOMMENDED PRECAUTIONS, AND OTHER SPECIAL INSTRUCTIONS: Always consult a doctor: − in case of persistent and unexplained abdominal complaints, and in case of bloating and a feeling of fullness on an empty stomach, − if severe bloating does not subside after 7 days, − if the consistency of the stool changes, bloating is very painful, or other symptoms occur in addition to bloating. During the use of ibesan MAX, a sufficient amount of fluids (approx. 2 litres per day) should be consumed; otherwise, there is a risk of excessive thickening of the intestinal contents and fecal impaction in the rectum.

Primary placement in Poland; available across 1 country total.

Trade name

not provided

UDI-DI code

05906204023935

Basic UDI-DI

5904730876MD_NPZ_0217W

Reference / catalog number

010-IBMAXZ

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

Suspension in sachets intended for use as supportive treatment in patients with irritable bowel syndrome.The diosmectite and simethicone contained in the ibesan MAX medical device may help in: • irritable bowel syndrome, when the following symptoms occur: − irregular bowel movements with a tendency to diarrhea, − excessive gas, − abdominal pain, − feeling of fullness, − bloating, • non-infectious diarrhea, especially if accompanied by a painful feeling of pressure and tension in the epigastrium.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 12 sachets

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

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

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

Certificate health across this manufacturer's portfolio.