1% 10ML

PROTECTION SYSTEM NEW.FA.DEM. NASAL AND AURICULAR GOODS, DEVELOPMENT

active ingredients

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

Excellent

purified water

Therapeutic indications

Decongestant and antiseptic of the nasal and antiseptic mucosa of the auricular duct.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients.

Population

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

Conservation

Store at a temperature not exceeding 30 °C. Store the bottle well closed in the original packaging to protect the medicine from light.

Warnings

Avoid concomitant use with papain-based products (see paragraph 4.5). Follow the recommended doses and methods of use. Proteind silver, if accidentally ingested or used for a long period at excessive doses, can determine toxic phenomena (see paragraph 4.9).

Interactions

The protein silver solution can interact with papain-based products. The papain is a proteolytic enzyme, belonging to the class of hydrolase, which is extracted from the immature fruit of the papaya (Carica papaya). Concurrent use of protein silver and papain could inhibit papain enzyme action.

Effects

Below are the undesirable effects of protein silver, organized according to the systemic classification MedDRA. No sufficient data is available to determine the frequency of the individual effects listed. Pathologies of skin and subcutaneous tissue Dermatitis Rash Bruciori Skin irritation Skin coloration Reactions of hypersensitivity Argiria (see paragraph 4.9) Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

In case of overdose, high concentrations of silver can occur in the plasma and decoloration of the skin. In addition, systemic symptoms such as hepatotoxicity, cardiomyopathy, amnesia and confused language may occur. Prolonged daily ingestion of protein silver can determine irreversible neurotoxicity, with myoclonic epileptic state, until it determines coma and finally death. An accumulation of silver in the skin, mucosa, membranes and eyes, due to ingestion or absorption of small quantities, can determine the appearance of clay. The clay is characterized by a colouring of the skin from grey to dark blue, due to the bond of silver with different proteins and the resulting production of pigments.

Pregnancy There are no adequate data regarding the use of protein silver in pregnant women. Silver protein should not be used during pregnancy, if not in case of absolute necessity. Food There is no adequate data regarding the use of protein-feeding silver. Silver protein should not be used during breastfeeding, if not in case of absolute necessity.

Source: Farmadati