Miramidez®

INSTRUCTION
for medical use of medicinal product

MIRAMIDEZ®

Composition:

active substance: benzyl dimethyl [3-(myristoylamino)propyl] ammonium chloride monohydrate;

1 ml of solution contains 1 mg of benzyl dimethyl [3-(myristoylamino)propyl] ammonium chloride monohydrate (calculated as anhydrous substance);

excipients: ethanol 70 %.

Pharmaceutical form. Ear drops, alcoholic solution.

Main physicochemical properties: colorless transparent liquid with the smell of alcohol.

Pharmacotherapeutic group.

Preparations used in otology. Antimicrobial agents. ATC code S02A A.

Pharmacological properties.

Pharmacodynamics.

Benzyl dimethyl [3-(myristoylamino)propyl] ammonium chloride monohydrate – antimicrobial agent (antiseptic).

The mechanism of action of Miramidex® is based on direct hydrophobic interaction of the molecule with lipids in microbial cell membranes, leading to their fragmentation and destruction.

Unlike other antiseptics, Miramidex® has high selectivity of action against microorganisms, as it practically does not affect human cell membranes. This effect is due to the different structure of human cell membranes (significantly longer lipid radicals, which greatly limit the possibility of hydrophobic interaction between the active substance and cells).

Miramidex® is active against many microorganisms, including bacteria, pathogenic fungi, viruses, protozoa, both as monocultures and microbial associations, as well as hospital strains with polyresistance to antibiotics. It exerts a detrimental effect on sexually transmitted disease agents: gonococci, Treponema pallidum, Trichomonas, Chlamydia, and also on herpes and human immunodeficiency viruses. It has antifungal activity against dermatophytes, yeasts and yeast-like fungi, and other pathogenic fungi, including those resistant to chemotherapeutic agents. Under the influence of Miramidex®, microbial resistance to antibiotics decreases.

Miramidex® exhibits anti-inflammatory effects, enhances local defense reactions, regenerative processes, and activates immune defense mechanisms.

Pharmacokinetics. Miramidex® exerts a local effect. Data on the possibility of the drug penetrating into systemic circulation are lacking.

Clinical characteristics.

Indications.

Bacterial and fungal, acute and chronic, external or middle non-perforated otitis.

Contraindications.

Individual hypersensitivity to the medicinal product.

Interaction with other medicinal products and other forms of interaction.

When used simultaneously, Miramidex® may enhance the efficacy of antibiotics.

During treatment of otitis, Miramidex® may be used after instillation of vasoconstrictive and local anesthetic agents, but not earlier than 5–10 minutes after their administration.

Special precautions.

Use during pregnancy or breastfeeding.

No strictly controlled safety studies have been conducted during pregnancy or breastfeeding; therefore, the decision on using the medicinal product should be made by a physician, taking into account the benefit/ risk ratio.

Ability to influence reaction rate when driving or operating machinery.

Does not affect.

Method and dosage of administration.

For use in adults.

In external otitis, insert a tampon moistened with the preparation into the auditory canal of the affected ear for 10–15 minutes, 2–3 times daily.

In middle otitis, instill the preparation into the auditory canal of the affected ear, 3–5 drops 3–4 times daily in adults.

Treatment duration – up to 2 weeks.

Children.

There are insufficient data on the use of the drug in pediatric patients.

Overdose.

Not observed.

Adverse reactions.

In individual cases, transient burning sensation may occur, which resolves spontaneously within 15–20 seconds and does not require discontinuation of the drug. Hypersensitivity reactions are possible during use of the drug.

Shelf life.

3 years.

Storage conditions.

Does not require special storage conditions. Store away from heating devices and open flame. Keep out of reach of children.

Packaging.

5 ml of the preparation in a polymer vial with a dropper, 1 vial per pack.

Prescription status.

Over-the-counter.

Manufacturer.

1. LLC "VALARTIN PHARMA" (batch release).
2. LLC "Ternofarm" (manufacturing, packaging, quality control).

Location of manufacturer and address of its business activities.

1. 60, Hrushevskoho St., village Chayky, Kyiv-Sviatoshyn district, Kyiv region, 08135, Ukraine.
2. 4, Fabrychna St., Ternopil, Ternopil region, 46010, Ukraine.