8878/14536A

Nom de l'organisation

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

SRN

PT-MF-000003551

Statut du fabricant

Actif

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• 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.

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

Dénomination commerciale

non renseigné

Code d'UDI-DI

05601653010597

Basic UDI-DI

B-05601653010597

Numéro de référence/catalogue

8878/14536A

Entité d'attribution

GS1

Catégorie de risque

Classe III

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

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.

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

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

• Q030103NASAL IRRIGATION SOLUTIONS