Instructions Protargol Baby powder for solution for intranasal use bottle 0.1 g No. 1
Composition
active ingredient: silver proteinate;
1 bottle contains 0.1 g of silver proteinate;
solvent - water for injection, 10 ml.
Dosage form
Powder for solution for intranasal use.
Main physicochemical properties: powder - yellow-brown or brown light powder, hygroscopic, sensitive to light; solvent - clear colorless liquid; reconstituted solution - brown liquid, opalescence is allowed.
Pharmacotherapeutic group
Means used for diseases of the nasal cavity. Other means for the treatment of diseases of the nasal cavity.
ATX code R01 AX.
Pharmacological properties
Pharmacodynamics
The drug has astringent, antiseptic and anti-inflammatory properties. Silver ions, which are part of the drug, have a bactericidal and bacteriostatic effect on most gram-positive and gram-negative bacteria, such as Streptococcus pneumoniae, Staphylococcus aureus, Moraxella catarrhalis and others, as well as on fungal flora. The bactericidal effect of the drug Protargol Baby is based on the formation of a protective film due to the deposition of silver on bacterial proteins on the mucous membrane damaged by the infectious process, which, in turn, helps to reduce the sensitivity of the mucous membranes to infectious agents, reduces the lumen of the capillaries, thereby inhibiting inflammatory processes. In addition, Protargol Baby has a mild vasoconstrictor effect.
Pharmacokinetics
When applied topically, Protargol Baby is poorly absorbed, therefore it does not have a general systemic effect.
Indication
It is used in the complex treatment of infectious and inflammatory processes of the nasal cavity and paranasal sinuses, including for the treatment of acute or chronic rhinitis, sinusitis, adenoiditis. Treatment of recurrent nasopharyngitis.
Contraindication
Increased individual sensitivity to the active substance.
Special safety measures.
Do not allow the drug to get into the eyes.
Before use, apply a small amount of the drug to the skin in the elbow bend to detect possible individual intolerance. If symptoms of individual intolerance occur (irritation, burning, itching of the skin), rinse the application site with plenty of water. Discontinue use of the drug and consult a doctor if necessary.
Follow the recommended doses and method of administration. Silver preparations, if used excessively over a long period of time, can cause argyria (pigmentation caused by silver deposition in tissues).
Interaction with other medicinal products and other types of interactions
Simultaneous topical use of products containing alkaloid salts and organic bases (adrenaline) is not recommended. Protargol Baby is pharmaceutically incompatible with zinc sulfate. Silver proteinate may interact with drugs containing papain. Simultaneous use of Protargol Baby and a drug containing papain may reduce the enzymatic action of the latter.
Ability to influence reaction speed when driving vehicles or other mechanisms
Not detected.
Use during pregnancy or breastfeeding
The drug is intended for use in children aged from birth to 3 years.
Method of administration and doses
It is used intranasally as a 1% solution, which must be shaken before use.
Apply to children from birth to 3 years.
After cleaning the nasal cavity, instill 1-3 drops of a 1% solution into each nasal passage 2-3 times a day for 5-10 days.
Method of preparing 1% Protargol Baby solution
Dissolve the contents of the vial in 10 ml of solvent (water for injections):
Unscrew the cap on the powder vial. Open the single-dose container with the solvent (water for injections) by turning the top of the container counterclockwise. Pour the solvent completely into the powder vial. Screw the cap on the vial and shake until the drug is completely dissolved (8-10 minutes). Replace the cap with the dropper cap provided. The solution is ready for use. Before use, the dropper should be rinsed with warm water and checked for damage. A damaged dropper should not be used.
Children
Protargol Baby is recommended for children from birth to 3 years of age.
For children from birth to 3 months, the drug is used only as prescribed by a doctor.
Overdose
However, with prolonged uncontrolled use of the drug in large quantities, the latter may accumulate in the spleen, skin, mucous membranes, which gives them a gray-green or aspid color, especially on exposed areas of the body (argyria). UV rays increase pigmentation. The first signs of argyria in treatment with silver preparations appear 2-4 years after the start of constant daily use of the drug: silver may be deposited in the connective tissue, capillary walls of various organs, including the kidneys, bone marrow. Argyria is accompanied by complaints of pain in the right hypochondrium, liver enlargement, and decreased visual acuity at dusk.
Adverse reactions
There are no data on the frequency of the listed effects.
On the part of the immune system: hypersensitivity reactions, including allergic reactions in the form of urticaria, anaphylactic shock, angioedema, atopic dermatitis.
General disorders and administration site reactions: feeling of mild irritation of the mucous membrane, burning, itching.
Prolonged use may cause argyria (see section "Overdose").
Expiration date
2 years.
Storage conditions
Store in the original packaging to protect from light at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Store the prepared solution in the refrigerator for no more than 30 days (at a temperature of 2 to 8 °C).
Packaging
0.1 g of powder in an orange glass vial, closed with a tamper-evident cap. A vial with powder and a dropper cap are packed in a cardboard box.
Vacation category
Without a prescription.
Producer
"Istok-Plus" LLC.
Location of the manufacturer and its business address
Ukraine, 69032, Zaporizhia, Makarenka St., 4.
