Bisolnatural 3 in 1 100 ml SE, FI

Trade name

Bisolnatural 3 in 1 100 ml SE, FI

08056300621850

805630062FTPR77A3

Reference / catalog number

FTPR77

GS1

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Bisolnatural 3 in 1 is a medical device composed of substances, not sterile, intended for short term invasive contact with respect to body orifices (oral cavity), designed for the treatment of dry and productive cough and sore throat in children (2+), adolescents and adults.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES

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

• • If you do not notice appreciable results after a short period of treatment (7 days), contact your doctor. • Do not take it if you are allergic, intolerant or hypersensitive to any component. • Do not administer the product to children under two years of age. • Close the bottle accurately after use. • Do not use the product after the expiry date printed on the package. • The expiry date refers to the product in its intact package, and properly stored. • Do not use in case the package is not intact. • Keep out of the reach of children. • Do not use for purposes other than that for which the product is intended. • Wash the measuring cup accurately after use. • No side effects associated by used the device have been observed. If you notice the appearance of side effects, inform your doctor. • Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the Competent Authority. In case of any undesired event always seek medical advice. • Do not exceed the recommended daily dose. • The period of validity after the first opening of the syrup is 24 weeks. • Since no data on use during pregnancy and lactation are available, its use is generally not recommended as a precaution due to lack of experimental data. Even if no side effects are known, it is recommended not to use the product during pregnancy or breastfeeding. In any case, consult your doctor before taking it. (only for version B without aroma) • In the event of concomitant pharmacological treatment, although no interactions with drugs are known, it is advisable to consult a doctor before use.

  OTHER