Protargol baby®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PROTARGOL BABY® (PROTARGOL BABY®)

Composition:

Active substance: silver proteinate;

1 vial contains 0.1 g of silver proteinate;

Solvent — water for injections, 10 ml, or without solvent.

Pharmaceutical form. Powder for solution for intranasal use.

Main physico-chemical properties: powder — yellowish-brown or brown, light powder, hygroscopic, sensitive to light; solvent — clear, colorless liquid; reconstituted solution — brown liquid, opalescence may be observed.

Pharmacotherapeutic group. Agents used in nasal disorders. Other agents for the treatment of nasal disorders.

ATC Code R01AX.

Pharmacological properties.

Pharmacodynamics.

The medicinal product has astringent, antiseptic, and anti-inflammatory properties. Silver ions contained in the preparation exert bactericidal and bacteriostatic effects against most gram-positive and gram-negative bacteria, such as Streptococcus pneumoniae, Staphylococcus aureus, Moraxella catarrhalis, and others, as well as against fungal flora. The bactericidal action of Prothargol Baby® is based on the formation of a protective film due to silver-induced precipitation of bacterial proteins on the mucosa damaged by the infectious process. This, in turn, reduces mucosal sensitivity to infectious agents, decreases capillary lumen, thereby inhibiting inflammatory processes. In addition, Prothargol Baby**®** exerts a mild vasoconstrictive effect.

Pharmacokinetics.

When applied locally, Prothargol Baby**®** is poorly absorbed and therefore does not produce any systemic effects.

Clinical characteristics.

Indications.

Used in the complex treatment of infectious and inflammatory processes of the nasal cavity and paranasal sinuses, including the treatment of acute or chronic rhinitis, sinusitis, and adenoiditis. Treatment of recurrent nasopharyngitis.

Contraindications.

Hypersensitivity to the active substance.

Special precautions.

Avoid contact of the preparation with the eyes.

Before use, apply a small amount of the preparation to the skin in the area of the elbow bend to detect possible individual intolerance. If symptoms of individual intolerance occur (irritation, burning, itching of the skin), wash the application site thoroughly with large amounts of water. Discontinue use of the preparation and, if necessary, consult a physician.

Adhere to the recommended dosage and method of administration. Silver-containing preparations, if used excessively over a prolonged period, may cause argyria (pigmentation due to deposition of silver in tissues).

Interaction with other medicinal products and other forms of interaction.

Concomitant local use of preparations containing alkaloid salts and organic bases (e.g., adrenaline) is not recommended. Protargol Baby**®** is pharmaceutically incompatible with zinc sulfate. Silver proteinate may interact with preparations containing papain. Simultaneous use of the medicinal product Protargol Baby**®** and a preparation containing papain may reduce the enzymatic activity of the latter.

Special precautions.

Use during pregnancy or breastfeeding.

The medicinal product is intended for use in children from birth up to 3 years of age.

Ability to influence reaction rate while driving or operating machinery.

Not observed.

Method of Administration and Dosage

Administer intranasally as a 1 % solution, which must be shaken before use.

For use in children from birth to 3 years of age.

After cleaning the nasal cavity, instill 1–3 drops of the 1 % solution into each nostril 2–3 times daily for 5–10 days.

Method for preparing 1 % solution of Protargol Baby**®** included with solvent

Dissolve the contents of the vial in 10 ml of solvent (water for injections):

Preparation method of 1% Protargol Baby® solution without solvent, supplied with a measuring device (measuring tube or measuring cup)

Add freshly boiled and cooled to room temperature water to the vial with powder:

Children.

Protargol Baby**®** is recommended for children from birth up to 3 years of age.

For infants from birth to 3 months of age, the drug should be used only as directed by a physician.

Overdose.

There have been no reported cases of overdose with Protargol Baby**®**.

However, prolonged uncontrolled use of the drug in large quantities may lead to its accumulation in the spleen, skin, and mucous membranes, resulting in gray-green or slate-gray discoloration, particularly in exposed areas of the body (argyria). UV radiation intensifies pigmentation. Initial signs of argyria during treatment with silver-containing preparations typically appear 2–4 years after the start of continuous daily use: deposition of silver may occur in connective tissues, capillary walls of various organs, including kidneys and bone marrow. Symptoms of argyria may include pain in the right subcostal region, hepatomegaly, and reduced visual acuity in dim light.

Adverse reactions.

There is no data on the frequency of the listed effects.

Immune system side effects: hypersensitivity reactions, including allergic reactions such as urticaria, anaphylactic shock, Quincke's edema, atopic dermatitis.

General disorders and administration site reactions: mild irritation of the mucous membrane, burning sensation, itching.

Prolonged use may cause argyria (see section "Overdose").

Shelf life.

Powder for solution for intranasal use, 0.1 g — 3 years.

Solvent — water for injections, 10 ml — 2 years.

Storage conditions.

Store in the original packaging to protect from light at a temperature not exceeding 25 °C. Keep out of reach of children.

The prepared solution should be stored in a refrigerator for no more than 30 days (at a temperature of 2 to 8 °C).

Packaging.

0.1 g of powder in an orange-colored glass vial closed with a tamper-evident cap.

The kit contains: vial with powder, single-dose container with solvent (10 ml), dropper cap in a cardboard box.

The kit contains: vial with powder, measuring device (measuring tube or measuring cup), dropper cap in a cardboard box.

Availability category.

Over-the-counter.

Manufacturer.

LLC "Istok-Plus".

Manufacturer's address and location of business activity.

4 Makarenko Street, Zaporizhzhia, Ukraine, 69032.