PROTEIN SILVER * 0.5% 10ML

PROTEIN SILVER * 0.5% 10ML

Therapeutic indications

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

Dosage and method of use

Adults and childrenAdminister 1-2 drops in each nostril or ear canal 2-3 times a day.

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 disordersDermatitis Rash Burns Skin irritation Skin discoloration Hypersensitivity reactions Argyria (see section 4.9)Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

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).Important information about some of the ingredients:The presence of bronopol can cause local skin reactions (e.g. contact dermatitis)

Pregnancy and breastfeeding

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

Expiry and retention

Keep the bottle tightly closed in the original package in order to protect the medicine from light.

Interactions with other drugs

The silver proteinated solution can interact with papain products. Papain is a proteolytic enzyme, belonging to the class of hydrolases, which is extracted from the immature fruit of the papaya (Carica papaya). The concomitant use of silver proteinate and papain could inhibit the enzymatic action of papain.

Overdose

High plasma silver concentrations and skin discoloration may occur in the event of 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.

Active principles

PROTEIN SILVER NOVA ARGENTIA 0.5% nasal and ear drops, solution100 g of solution contain:Active principle: proteinated silver g 0.50.PROTEIN SILVER NOVA ARGENTIA 1% nasal and ear drops, solution100 g of solution contain:Active principle: proteinated silver g 1.00.PROTEIN SILVER NOVA ARGENTIA 2% nasal and ear drops, solution100 g of solution contain:Active principle: Proteinated silver 2.00 g. For the full list of excipients see section 6.1.

Excipients

Excipients:dibasic sodium phosphate, monobasic potassium phosphate, bronopol, purified water.