8878/14536A

Organization name

LABIALFARMA – LABORATÓRIO DE PRODUTOS FARMACÊUTICOS E NUTRACÊUTICOS, S.A.

SRN

PT-MF-000003551

Manufacturer status

Active

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

• CW999

  Contraindications and Precautions of Use: Do not use in children under 2 years of age. It should be used under adult supervision in children up to 12 years of age. This product should not be used in patients with hemophilia and mechanical obstruction ileus. Do not use in case of hypersensitivity to Dexpanthenol or any of the components. If you notice sensitivity to the product, you should stop using it and consult a doctor. This medical device contains benzalkonium chloride as preservative (0.1 mg/ml) which can cause tumefaction (swelling) of the nasal mucosa, especially if used for long periods of time. If you suspect that you are experiencing this reaction (persistent nasal congestion), you should stop using the product and consult with your doctor. The duration of administration should not exceed 5 days, after which, if symptoms persist, a doctor should be consulted. This product must not be used for a prolonged period of time. If symptoms persist or worsen, consult your doctor or pharmacist. If you are pregnant or breastfeeding, consult your doctor before using this medical device. The product should not be used after the date indicated on the packaging. After the first application, do not use the product for more than 6 months.

Primary placement in Portugal; available across 1 country total.

Trade name

not provided

UDI-DI code

05601653010597

Basic UDI-DI

B-05601653010597

Reference / catalog number

8878/14536A

Issuing entity

GS1

Risk category

Class III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Medical Device intended for export to a third country (Libya) Isotonic solution with 5% dexpanthenol which provides a decongestant cleaning action and a moisturizing effect on the nasal mucosa, improving its regeneration ability and physiological balance in discomfort situations.

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

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

• Q030103NASAL IRRIGATION SOLUTIONS