Argento Proteinato New Fadem 0,5% Gocce Nasali e Auricolari Bambini 10 ml

Therapeutic indications

Decongestant and antiseptic of the nasal mucosa and antiseptic of the ear canal.

Dosage

Adults and children Administer 1-2 drops into each nostril or into the ear canal 2-3 times a day.

Overdose

High plasma silver concentrations and skin discoloration may occur in the event of an overdose. Additionally, systemic symptoms such as hepatotoxicity, cardiomyopathy, amnesia, and slurred speech can occur. Prolonged daily ingestion of silver protein can cause irreversible neurotoxicity, with myoclonic status epilepticus, leading to coma and, finally, death. An accumulation of silver in the skin, mucous membranes, membranes and eyes, due to ingestion or absorption of even small quantities, can lead to the appearance of argyria. Argyria is characterized by a gray to dark blue color of the skin, due to the binding of silver with different proteins and the consequent production of pigments.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Side effects

The following are the side effects of silver proteinated, organized according to the MedDRA system organ classification. Insufficient data are available to establish the frequency of the individual effects listed. Skin and subcutaneous tissue disorders Dermatitis Rash Burns Skin irritation Skin discoloration Hypersensitivity reactions Argyria (see section 4.9) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important, as allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

Pregnancy There are no adequate data from the use of silver protein in pregnant women. Protein silver should not be used during pregnancy unless absolutely necessary. Lactation There are no adequate data regarding the use of silver proteinated in lactation. Proteinated silver should not be used during breastfeeding unless absolutely necessary.

Special warnings

Avoid concomitant use with papain products (see section 4.5). Follow the recommended doses and methods of use. Proteinated silver, if accidentally ingested or if used for a long time in excessive doses, can cause toxic phenomena (see section 4.9).

Expiry and Retention

Store at a temperature not exceeding 30 ° C. Keep the bottle tightly closed in the original package in order to protect the medicine from light.

Active principles

Protein Silver New.Fa.Dem. Children 0.5% Nasal and Ear Drops, Solution 100 g of solution contain: Active ingredient : silver proteinate 0.5 g Silver Protein New.Fa.Dem. Adults 1% Nasal and Ear Drops, Solution 100 g of solution contain: Active ingredient : silver proteinate 1 g Silver Protein New.Fa.Dem. Adults 2% Nasal and Ear Drops, Solution 100 g of solution contain: Active ingredient : silver proteinate 2 g For the full list of excipients see section 6.1

Excipients

purified water