Active substance: silver proteinate.

100 g of solution contains 1 g of silver proteinate.
Excipients: disodium phosphate, potassium dihydrogen phosphate, imidourea, purified water.

Nasal/ear drops, solution 1%.

Basic physical and chemical properties
Brown-colored solution with a slight opalescence.

Preparations for nasal use. Decongestants and other topical preparations for nasal use. Other nasal preparations.
ATC code: R01AX10.

Pharmacodynamic properties:

Antibacterial agent. Silver proteinate, as well as silver ions or salts, inhibits the growth of gram-positive and gram-negative bacteria (bacteriostatic effect). Additionally, silver ions cause precipitation of bacterial proteins (bactericidal effect).

Pharmacokinetic properties:

When applied topically, silver proteinate is less absorbed.

Decongestant and antiseptic for the nasal mucosa and antiseptic for the auditory canal.

Hypersensitivity to any of the components of the medicine.

Protargol may react with preparations containing papain.
Papain is a proteolytic enzyme from the hydrolase class derived from unripe papaya fruit (Carica papaya).
Concomitant use of silver proteinate and papain may reduce the enzymatic activity of papain.

Concomitant topical use with preparations containing alkaloid salts and organic bases (such as adrenaline) is not recommended.
This medicinal product is pharmaceutically incompatible with zinc sulfate.

Avoid simultaneous use with papaya-based preparations (see section “Interaction with other medicinal products and other forms of interaction”).
Follow the recommended dosage and method of administration.
Excessive or prolonged use of silver proteinate may result in toxic effects.

Use during pregnancy or breast-feeding
This medicinal product should not be used during pregnancy or breast-feeding due to lack of sufficient data on its safety during these periods.

Effects on ability to drive and use machines
No influence reported.

Apply 1 to2 drops into each nostril or ear canal 2 to 3 times a day.
The treatment course is 5 to 10 days.
The duration of treatment is determined individually by a doctor.

Children
The 0.5% dosage form is recommended for children from birth to 3 years of age.
For children from birth to 3 months, the product should be used only under medical supervision.
The 1% and 2% solutions are not intended for use in children.

Reported cases:

No overdose cases have been reported.

Symptoms:

In case of overdose related to the accumulation of high concentrations of silver ions in the blood plasma, symptoms may include skin discoloration and slurred speech.
Prolonged uncontrolled daily use of silver protein may cause irreversible neurotoxicity with myoclonic epileptic status, leading to coma and ultimately death.

Accumulation of silver in the skin, mucous membranes, spleen, membranes, and eyes — due to ingestion or absorption, even in small amounts — may result in argyria, a condition characterized by skin discoloration ranging from gray to dark blue. This is due to the interaction of silver with various proteins and the resulting pigment formation.
UV exposure may intensify pigmentation.

Early signs of argyria may appear 2–4 years after beginning daily use of silver preparations. Silver may deposit in connective tissue, capillary walls of various organs, including the kidneys and bone marrow.
Patients with argyria may experience pain in the right hypochondrium, liver enlargement, and decreased twilight vision.
Other systemic symptoms may include hepatotoxicity, cardiomyopathy, and amnesia, resulting from neurotoxic effects.

Adverse reactions

Frequency not specified.

Immune system disorders:

Hypersensitivity reactions including urticaria, atopic dermatitis, anaphylactic shock, angioedema.

Skin and subcutaneous tissue disorders:

Dermatitis, rash, burning sensation, skin irritation, skin discoloration, hypersensitivity reactions, allergic reactions.

General disorders and administration site conditions:

Mild irritation of the nasal mucosa, burning, itching.
Prolonged use may lead to argyria (see section “Overdose”).

Reporting of suspected adverse reactions

Reporting adverse reactions after marketing authorization is important. It enables continued monitoring of the benefit-risk balance of the medicinal product.
Healthcare professionals, pharmacists, patients or their legal representatives should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at:https://aisf.dec.gov.u

2 years.

Store in the original package at a temperature not exceeding 25°C.
Keep out of reach of children.
Shelf life after first opening: 15 days.

10 ml in a glass bottle with a dropper cap;
1 bottle per cardboard box.

Over-the-counter (OTC).