Veromistin®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VЕROMISTIN® (VEROMISTIN)

Composition:

Active substance: miramistin;

1 ml of solution contains miramistin 0.1 mg;

Excipient: water for injections.

Pharmaceutical form. Solution for external use.

Main physicochemical properties: colorless clear liquid which foams when shaken.

Pharmacotherapeutic group. Antiseptics and disinfectants. ATC code D08A J.

Pharmacological properties.

Pharmacodynamics.

Miramistin exerts a pronounced bactericidal effect against Gram-positive and Gram-negative, aerobic and anaerobic bacteria both as monocultures and microbial associations, including hospital strains resistant to antibiotics. The medicinal product is effective against Gram-positive bacteria (Staphylococcus spp., Streptococcus spp., Streptococcus pneumoniae, etc.) and Gram-negative bacteria (Pseudomonas aeruginosa, Escherichia coli, Klebsiella spp., etc.); it acts on pathogens of sexually transmitted infections (Chlamydia spp., Treponema spp., Trichomonas vaginalis, Neisseria gonorrhoeae), as well as on herpes viruses, human immunodeficiency virus, etc. It exhibits antifungal activity against ascomycetes of the genus Aspergillus and Pénicillium, yeast fungi (Rhodotorula rubra, Torulopsis gabrata, etc.) and yeast-like fungi (Candida albicans, Candida tropicalis, Candida krusei, etc.), dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton schoenleini, Trichophyton violaceum, Epidermophyton Kaufmann-Wolf, Epidermophyton floccosum, Microsporum gypseum, Microsporum canis, etc.), as well as against other pathogenic fungi, for example, Pityrosporum orbiculare (Malassezia furfur), both as monocultures and microbial associations, including fungal microflora resistant to chemotherapeutic agents. It effectively prevents wound and burn infections and activates regenerative processes. It stimulates protective responses at the site of application by enhancing phagocytic engulfment and digestion functions, thereby potentiating the activity of the mononuclear phagocyte system. It possesses pronounced hyperosmolar activity, thereby suppressing wound and perifocal inflammation and absorbing purulent exudate, promoting the formation of a dry scab. It does not damage granulation tissue or viable skin cells and does not inhibit marginal epithelialization. It has no sensitizing properties and does not cause local irritation.

Pharmacokinetics.

When applied topically, it is not absorbed through the skin and mucous membranes.

Clinical characteristics.

Indications.

Otorhinolaryngology: complex treatment of acute and chronic otitis, sinusitis, tonsillitis, pharyngitis, and laryngitis.

Stomatology: treatment and prevention of infectious-inflammatory diseases of the oral cavity: stomatitis, gingivitis, periodontitis. Hygienic care of removable dentures.

Surgery, traumatology: prevention of suppuration and treatment of purulent wounds. Treatment of purulent-inflammatory processes of the musculoskeletal system.

Obstetrics and gynecology: prevention and treatment of postpartum wound infections, perineal and vaginal injuries, postpartum infections, inflammatory diseases (vulvovaginitis).

Burn medicine (combustiology): treatment of superficial and deep partial-thickness burns of degree II and IIIA; preparation of burn wounds for skin grafting.

Dermatology: treatment and prevention of pyoderma and dermatomycoses, cutaneous and mucosal candidiasis, tinea pedis (athlete's foot).

Urology: complex treatment of acute and chronic urethritis and urethroprostatitis of both specific (chlamydia, trichomoniasis, gonorrhea) and nonspecific origin.

Contraindications.

Individual hypersensitivity to miramistin.

Interaction with other medicinal products and other forms of interaction.

When used concomitantly with antibiotics, an increase in their antibacterial and antifungal properties has been observed.

Special precautions for use.

To minimize the risk of infection spread, the medicinal product from a single vial should not be used for more than one person.

If there is no improvement after treatment, symptoms worsen, or new symptoms appear, a doctor should be consulted.

Use the medicine only according to the method of administration and in doses specified in the instructions.

Use during pregnancy or breastfeeding.

According to available data, Veromistin® has no systemic effect when administered at doses specified in the instructions; therefore, its use during pregnancy or breastfeeding is possible. However, the decision on the appropriateness of use should be made by a physician.

Ability to affect reaction speed when driving or operating machinery.

Veromistin® does not affect the ability to drive vehicles or engage in other potentially hazardous activities requiring increased attention and rapid psychomotor reactions.

Method of Administration and Dosage

The solution is ready for use. Apply locally.

Otorhinolaryngology

Use in adults and children aged 3 years and older.

In cases of sinusitis, during puncture, the maxillary sinus is irrigated with an adequate amount of Veromistin®.

For acute and chronic external otitis, instill 5 drops of the medicinal product into the external auditory canal using a dropper, 4 times daily. As an alternative to instillation, a gauze or cotton swab moistened with miramistin may be inserted into the external auditory canal 4 times daily. Treatment course – 10 days.

For the treatment of tonsillitis, laryngitis, and pharyngitis:

Children aged 3–6 years: rinse the throat with Veromistin® solution 3–4 times daily. The amount of medicinal product per rinse – 3–5 mL.

Children aged 7–14 years: rinse the throat with Veromistin® solution 3–4 times daily. The amount of medicinal product per rinse – 5–7 mL.

Adults and children aged 14 years and older: the amount of medicinal product per rinse – 10–15 mL, 3–4 times daily.

The duration of therapy ranges from 4 to 10 days, depending on the clinical response and time to remission.

Dentistry

Use in adults and children.

For stomatitis, gingivitis, and periodontitis, rinse the oral cavity with 10–15 mL of the medicinal product 3–4 times daily. If rinsing is not possible, gauze or cotton swabs moistened with Veromistin® solution may be used.

For hygienic cleaning of removable dentures, leave them overnight in a miramistin solution. Before use, thoroughly rinse the dentures with running water.

Surgery, Traumatology, and Burn Care

Use in adults and children.

For prophylaxis and treatment of secondary infection of wounds and burns, irrigate the wound or burn surface with Veromistin®. Apply gauze swabs moistened with Veromistin® solution to the wound surface. If necessary, wounds or fistulous tracts may be packed with the solution during surgical procedures.

Active wound and cavity drainage may be performed with a daily volume of up to 1 L of the medicinal product.

Obstetrics and Gynecology

Use in adults.

For the treatment and prevention of postpartum infections and suppuration in postpartum wounds of the perineum and vagina, Veromistin® should be used as vaginal irrigation before delivery (5–7 days), after each vaginal examination during labor, and in the postpartum period as intravaginal tampons moistened with 50 mL of the medicinal product, with an exposure time of 2 hours for 5 days.

In cesarean section deliveries, the vagina should be treated immediately before surgery, the uterine cavity and uterine incision during surgery, and intravaginal tampons moistened with the medicinal product should be applied postoperatively with an exposure time of 2 hours for 7 days.

Treatment of inflammatory diseases of female genital organs should be conducted over a 2-week course using intravaginal tampons soaked in the medicinal product, treatment of the skin of external genital organs, and iontophoresis.

In complex treatment of inflammatory conditions (vulvovaginitis) in gynecology, Veromistin® should be used as vaginal irrigation or intravaginal tampons moistened with the medicinal product, with an exposure time of 2 hours for 7–14 days (frequency and duration of treatment are determined individually by the physician).

Use in children.

The method of administration, duration of treatment, and frequency of application are determined by the physician.

Dermatology

Use in adults and children.

Treatment and prevention of pyoderma, dermatomycoses, cutaneous and mucosal candidiasis, tinea pedis, and intertriginous fungal infections should be performed by applying the Veromistin® product to the affected skin area using sterile gauze swabs thoroughly moistened with the solution, 3 times daily.

Urology

Use in adults.

Complex treatment of urethritis and urethroprostatitis should be performed by instilling 2–3 mL of Veromistin® solution into the urethra 1–2 times daily. Treatment course – 10 days.

Use in children.

The method of administration, duration of treatment, and frequency of application are determined by the physician.

Children.

The medicinal product should be used in children according to the specified indications.

The method of administration, duration of treatment, and frequency are individually determined by the physician.

Overdose

No cases of overdose with the medicinal product have been reported during topical or external use.

Adverse reactions.

All adverse reactions are listed by system organ class and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), frequency not known (cannot be estimated from the available data).

Skin and subcutaneous tissue disorders: very rare – sensation of mild burning, which resolves spontaneously within 15–20 seconds and does not require discontinuation of the medicinal product.

Immune system disorders: very rare – hypersensitivity reactions, including local skin irritation symptoms: pruritus, hyperemia, burning sensation, dry skin.

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows ongoing monitoring of the benefit-risk balance of the product. Healthcare professionals, pharmacists, patients, and their legal representatives are encouraged to report all suspected adverse reactions and/or lack of therapeutic efficacy through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Do not freeze. Keep out of reach and sight of children.

Packaging. 100 ml, 200 ml, or 400 ml in bottles.

100 ml, 200 ml, or 400 ml in bottles with protective cap.

Prescription status. Prescription only.

Manufacturer. JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and place of business.

13 Borispilska Street, Kyiv, 02093, Ukraine.