Aurisan^® (Drops) Instructions for Use

Marketing Authorization Holder

Experimental Plant SRLS, LLC (Ukraine)

Manufactured By

Experimental Plant SRLS, LLC (Ukraine)

Or

Pharmex Group, LLC (Ukraine)

ATC Code

S02AA (Antimicrobial drugs)

Active Substance

Decametoxin (Grouping name)

Dosage Form

Aurisan®

Ear drops 0.5 mg/1 ml: bottle 5 ml with dropper cap

Dosage Form, Packaging, and Composition

Ear drops colorless, transparent, with an alcohol odor.

5 ml – bottles (1) with dropper cap – cardboard packs.

Clinical-Pharmacological Group

Topical antiseptic for use in ENT practice

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

The drug Aurisan^® has an antiseptic effect and has a broad spectrum of antimicrobial action against gram-positive and gram-negative microorganisms (genus Streptococcus, genus Staphylococcus, family Enterobacteriaceae, Corynebacterium diphtheriae), yeast-like fungi of the genus Candida, dermatomycetes (genus Trichophyton, genus Epidermophyton), protozoa and viruses. The drug acts on microorganisms in a bactericidal, sporicidal, fungicidal manner. Aurisan^® increases the sensitivity of bacteria to antibiotics and potentiates the effect of traditional antimicrobial agents in complex treatment.

Pharmacokinetics

Not studied.

Indications

• For the treatment of bacterial and fungal acute and chronic external and middle otitis.

ICD codes

Dosage Regimen

Use Aurisan^® topically for the treatment of otitis.

Warm the solution to body temperature prior to administration.

Insert a sterile cotton or gauze wick into the patient’s external auditory canal.

Instill 2-3 drops of the solution directly onto the wick.

Apply the drops 3-4 times daily at regular intervals.

Continue this treatment regimen for a standard course of 7 days.

For severe or persistent infections, combine this local treatment with systemic antibiotic therapy.

Ensure the bottle is tightly closed with the dropper cap after each use.

Do not use if the tympanic membrane is perforated.

Discontinue use and consult a physician if severe local irritation or allergic reactions occur.

Adverse Reactions

Local allergic reactions are possible: hyperemia, itching, and peeling of the skin of the external auditory canal, which disappear without treatment after discontinuation of the drug.

A transient burning sensation when using the drug is possible, as well as a local irritation reaction of the ear with increased individual sensitivity to decamethylenedimethylmethoxycarbonylmethylammonium dichloride (decametoxin).

Contraindications

• Violation of the integrity of the tympanic membrane;
• Children under 12 years of age;
• Individual intolerance.

Use in Pregnancy and Lactation

Use during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.

Pediatric Use

Contraindicated in children under 12 years of age.

Special Precautions

Aurisan^® is used exclusively for ear diseases. For severe and persistent infections, local treatment should be supplemented with systemic use of antibiotics.

Effect on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and mechanisms, as well as to perform other work that requires increased concentration and speed of reactions.

Overdose

Cases of overdose have not been described to date.

Drug Interactions

Currently, there is no information on the interaction of the drug Aurisan^® with other medicines.

Storage Conditions

List B. Store in a place protected from light and out of reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.