Miramed^® Evalar (Solution) Instructions for Use

Marketing Authorization Holder

Evalar, CJSC (Russia)

Contact Information

Evalar, CJSC (Russia)

ATC Code

D08AJ (Quaternary ammonium compounds)

Active Substance

Benzyldimethyl-myristoylamino-propylammonium (Grouping name)

Dosage Form

Miramed® Evalar

Solution for topical and external use 0.01%: fl. 50 ml or 150 ml

Dosage Form, Packaging, and Composition

Solution for topical and external use colorless, transparent, foaming when shaken.

Excipients: purified water.

50 ml – polymeric bottles made of 70% low-density polyethylene: 30% high-density polyethylene (1) with a urological applicator made of low-density polyethylene and a cap made of high-density polyethylene – cardboard packs.
50 ml – polymeric bottles made of 70% low-density polyethylene: 30% high-density polyethylene (1) with a urological applicator made of low-density polyethylene and a cap made of high-density polyethylene, complete with a vaginal nozzle^× – cardboard packs.
150 ml – bottles made of high-density polyethylene (1) with a polypropylene cap – cardboard packs.
150 ml – bottles made of high-density polyethylene (1) with a polypropylene cap, complete with a spray nozzle^× – cardboard packs.
150 ml – bottles made of high-density polyethylene (1) with a polypropylene cap, complete with a spray nozzle^× and a measuring cup – cardboard packs.

^× in individual packaging.
Protective stickers may be additionally applied to the cardboard packs.

Clinical-Pharmacological Group

Antiseptic for external and topical use

Pharmacotherapeutic Group

Antiseptics and disinfectants; quaternary ammonium compounds

Pharmacological Action

The drug has a broad spectrum of antimicrobial action, including hospital strains resistant to antibiotics.

The drug has a pronounced bactericidal effect against gram-positive (Staphylococcus spp., Streptococcus spp., Streptococcus pneumoniae), gram-negative (Pseudomonas aeruginosa, Escherichia coli, Klebsiella spp.), aerobic and anaerobic bacteria, determined as monocultures and microbial associations, including hospital strains with polyresistance to antibiotics.

It has an antifungal effect on ascomycetes of the genus Aspergillus and the genus Penicillium, yeast (Rhodotorula rubra, Torulopsis glabrata) and yeast-like fungi (Candida albicans, Candida tropicalis, Candida krusei, Pityrosporum orbiculare (Malassezia furfur)), dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton schoenleini, Trichophyton violacent, Epidermophyton Kaufman-Wolf, Epidermophyton floccosum, Microsporum gypseum, Microsporum canis) in the form of monocultures and microbial associations, including fungal microflora with resistance to chemotherapeutic drugs.

It has an antiviral effect, active against complex viruses (herpes viruses, human immunodeficiency virus).

The drug acts on pathogens of sexually transmitted diseases (Chlamydia spp., Treponema spp., Trichomonas vaginalis, Neisseria gonorrhoeae).

Effectively prevents infection of wounds and burns. Activates regeneration processes. Stimulates protective reactions at the site of application, by activating the absorptive and digestive function of phagocytes, potentiates the activity of the monocyte-macrophage system. It has a pronounced hyperosmolar activity, as a result of which it relieves wound and perifocal inflammation, absorbs purulent exudate, promoting the formation of a dry scab. It does not damage granulations and viable skin cells, does not suppress marginal epithelialization.

It does not have a local irritant effect or allergenic properties.

Pharmacokinetics

When applied topically and externally, it is not able to be absorbed through the skin and mucous membranes.

Indications

For adults and children aged 3 to 18 years

Otorhinolaryngology:

• Complex treatment of tonsillitis, pharyngitis, laryngitis.

For adults and children aged 0 to 18

Otorhinolaryngology

• Complex treatment of acute and chronic external otitis, sinusitis.

Dentistry

• Treatment and prevention of infectious and inflammatory diseases of the oral cavity: stomatitis, gingivitis, periodontitis;
• Hygienic treatment of removable dentures.

Surgery, Traumatology

• Prevention of suppuration and treatment of purulent wounds;
• Treatment of purulent-inflammatory processes of the musculoskeletal system.

Obstetrics-Gynecology

• Prevention and treatment of suppuration of postpartum injuries, wounds of the perineum and vagina, postpartum infections, inflammatory diseases (vulvovaginitis).

Combustiology

• Treatment of superficial and deep burns of II and III degree, preparation of burn wounds for dermatoplasty.

Dermatology

• Treatment and prevention of pyoderma and dermatomycoses, foot mycoses, candidiasis of the skin and mucous membranes.

Venereology

• Individual prevention of sexually transmitted diseases (syphilis, gonorrhea, chlamydia, trichomoniasis, genital herpes, genital candidiasis).

Urology

• Complex treatment of acute and chronic urethritis and urethroprostatitis of specific (chlamydia, trichomoniasis, gonorrhea) and nonspecific etiology.

ICD codes

Dosage Regimen

Topically, externally. The drug is ready for use.

Adults

Otorhinolaryngology

For sinusitis during puncture, the maxillary sinus is washed with a sufficient amount of the drug.

For acute and chronic external otitis up to 5 drops of the drug are instilled into the external auditory canal using a pipette 4 times/day or, instead of instillation, a gauze turunda moistened with the drug is carefully inserted into the external auditory canal 4 times/day. The course of treatment is 10 days.

Tonsillitis, pharyngitis, laryngitis

Administer by 3-4 presses on the head of the spray nozzle or 10-15 ml per one rinse, 3-4 times/day.

The duration of therapy is from 4 to 10 days depending on the time of remission onset.

Dentistry

For stomatitis, gingivitis, periodontitis, rinsing the oral cavity with 10-15 ml of the drug, 3-4 times/day, is recommended. If rinsing is not possible, local application of gauze or cotton swabs moistened with the drug solution is allowed.

Surgery, Traumatology, Combustiology

For the treatment and prevention of secondary wound infection, the wound surface is irrigated with the drug solution.

Gauze swabs moistened with the drug solution are fixed on the wound surface.

If necessary, tamponade of the wound and/or fistula tracts may be performed during surgical procedures.

Active drainage of wounds and/or cavities may be performed. The daily consumption of the drug is up to 1 liter of the drug.

Obstetrics, Gynecology

Prevention and treatment of suppuration of postpartum injuries, wounds of the perineum and vagina, postpartum infections the drug is used in the form of vaginal irrigations before childbirth (5-7 days), during childbirth (after each vaginal examination). In the postpartum period, it is administered using tampons moistened with 50 ml of the drug, with further exposure of the tampon for 2 hours for 5 days.

During delivery of women by caesarean section, the vagina is treated immediately before the operation, during the operation – the uterine cavity and the incision on it, and in the postoperative period, tampons moistened with the drug are inserted into the vagina with an exposure of 2 hours for 7 days.

Treatment of inflammatory diseases is carried out in a course for 2 weeks by intravaginal administration of tampons with the drug, as well as by the method of drug electrophoresis.

Complex treatment of inflammatory diseases in gynecology (vulvovaginitis) in the form of vaginal irrigations or insertion of a tampon moistened with the drug, with an exposure of 2 hours, for 7-14 days (the duration of treatment and frequency of administration are determined as prescribed by the doctor).

For the convenience of vaginal irrigation, the use of a vaginal nozzle is recommended. Insert the contents of the bottle using the vaginal nozzle into the vagina and perform irrigation.

Dermatology

Treatment and prevention of pyoderma and dermatomycoses, candidiasis of the skin and mucous membranes, foot mycoses the drug is applied to the affected area of the skin by wiping with sterile gauze swabs, abundantly moistened with the drug. The drug is used 3 times/day on the affected areas of the skin.

Venereology

Prevention of sexually transmitted diseases use of the drug is effective within 2 hours after sexual intercourse.

Insert the contents of the bottle using the urological applicator into the urethra for 2-3 minutes.

Men: 2-3 ml of the drug.

Women: 1-2 ml of the drug is injected into the urethra and 5-10 ml – into the vagina (for convenience, the use of a vaginal nozzle is recommended).

Treat the skin of the inner surfaces of the thighs, pubis, and genitals.

After the procedure, it is recommended not to urinate for 2 hours.

Urology

In the complex treatment of urethritis and urethroprostatitis, spraying into the urethra of 2-3 ml of the drug 1-2 times/day is performed, the course is 10 days.

Children

Children from 0 to 18 years

When used in otorhinolaryngology (for sinusitis, for acute and chronic external otitis), dentistry, surgery, traumatology, combustiology, dermatology, the dosage regimen corresponds to the dosage regimen in adults.

When used in obstetrics and gynecology, urology, the method of application, duration of treatment and frequency of administration are determined as prescribed by the doctor.

Children from 3 to 18 years

Otorhinolaryngology

Tonsillitis, pharyngitis, laryngitis

Children 3-6 years the drug is administered by a single press on the head of the spray nozzle or 3-5 ml per one rinse, 3-4 times/day.

Children 7-14 years the drug is administered by double pressing on the head of the spray nozzle or 5-7 ml per one rinse, 3-4 times/day.

Children over 14 years and adults the drug is administered by 3-4 presses on the head of the spray nozzle or 10-15 ml per one rinse, 3-4 times/day.

The duration of therapy is from 4 to 10 days depending on the time of remission onset.

It is not recommended to use Miramed^® Evalar in the form of a spray for irrigation of the throat and tonsils for children under 3 years of age due to the risk of reactive laryngospasm (see section “Contraindications”).

Instructions for using the package with a spray nozzle

1) Remove the cap from the bottle.

2) Remove the supplied spray nozzle from the individual packaging.

3) Attach the spray nozzle to the bottle.

4) Activate the spray nozzle by pressing repeatedly.

Instructions for using the package with a vaginal nozzle

1) Remove the cap from the bottle.

2) Remove the supplied vaginal nozzle from the individual packaging.

3) Attach the vaginal nozzle to the bottle, without removing the urological applicator.

Instructions for using the package with a measuring cup

To use the drug as a rinse, the amount of the drug required for one rinse should be measured using the measuring cup included in the kit.

Adverse Reactions

Possible adverse reactions are distributed by system-organ classes with an indication of the frequency of their occurrence according to WHO recommendations: very common (≥1/10), common (≥1/100, but <1/10), uncommon (≥1/1000, but <1/100), rare (≥1/10000, but <1/1000), very rare (<1/10000), frequency unknown (cannot be estimated from the available data).

From the immune system: very rarely – allergic reactions.

General disorders and administration site conditions: very rarely – mild burning sensation, which resolves on its own after 15-20 seconds and does not require discontinuation of the drug.

Contraindications

• Hypersensitivity to benzyldimethyl-myristoylamino-propylammonium or to any of the excipients included in the drug;
• It is not recommended to use the drug in the form of a spray for irrigation of the throat and tonsils for children under 3 years of age due to the risk of reactive laryngospasm.

Use in Pregnancy and Lactation

Use of the drug during pregnancy and breastfeeding is possible if the intended benefit to the mother outweighs the potential risk to the fetus and child.

Pediatric Use

It is not recommended to use the drug in the form of a spray for irrigation of the throat and tonsils for children under 3 years of age due to the risk of reactive laryngospasm.

Special Precautions

Using one bottle of the drug by more than one person may lead to the spread of infection.

Effect on ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and work with mechanisms.

Overdose

No cases of drug overdose with topical or external use have been reported.

Drug Interactions

With simultaneous use with antibiotics, an enhancement of their antibacterial and antifungal properties has been noted.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed without a 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.