Instruction

Introduction date December 13, 2007 Federal Service for Surveillance in Healthcare and Social
Development Order No.4785-Пр/07 dd.13/12/2007

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General information

Registration number

Р N001926/01

Trade name

Miramistin®

Chemical name

Benzyl-dimetyl-[3-(tetradecanoylamino)propyl]azanium chloride

Medicinal form

topical solution

Composition

Active substance: benzyl dimethyl[3-(myristoylamine)-propyl] ammonium chloride monohydrate (on an anhydrous substance basis) – 0.1
Excipient: purified water – ad 1 l

Description

colorless transparent liquid forming foam when shaken

Therapeutic category

antiseptic medicine

ATX code

[D08AJ]

Storage temperature

up to 25°С

Shelf life

3 years

Prescription status

Over the counter

Forms of issue

Solution for topical application 0.01%. Each bottle of 50 ml, 150 ml, 500 ml, together with instructions for use, are placed in a cardboard box.

For hospitals: 12 bottles of 500 ml each without a pack with an equal number of instructions for use are placed in a cardboard box for consumer packaging.

with a spray nozzle

150 ml

travel form

50 ml

with urological applicator

50 ml

with a gynecologic nozzle

50 ml

miramistin

500 ml

ointment miramistin®

30 г

Original medicinal product with antiseptic action

product overview

Indications, method of administration and doses

Otorhinolaryngology

Adults and children

In case of maxillary sinusitis, flush the maxillary antrum with a sufficient amount of Miramistin® during the puncture.
Acute and chronic external otitis: instill up to 5 drops of the medicine in the external auditory canal 4 times a day using a dropping pipette or, instead of instillation, place a gauze drain impregnated with the medicine in the external auditory canal 4 times a day. The period of treatment is 10 days.
Tonsillitis, pharyngitis, and laryngitis:
Children of 3-6: press the head of the spray nozzle once or use 3-5 ml of the medicine per one gargling 3-4 times a day;
Children of 7-14: press the head of the spray nozzle two times or use 5-7 ml of the medicine per one gargling 3-4 times a day;
Children over 14 and adults: Press the head of the spray nozzle 3-4 times or use 10-15 ml of the medicine per one gargling 3-4 times a day.
The period of treatment varies from 4 to 10 days depending on the start of remission.

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Combustiology (burns)

Adults and children

For the purpose of treatment and prevention of repeated introduction of infection in wounds, irrigate the surface of wounds with Miramistin solution®. Attach gauze tampons impregnated with Miramistin® solution on the wound surface. Tampons can be inserted in wounds and/or fistulous passages during surgical manipulations, as necessary. Active draining of wounds and/or cavities is possible. The daily flow of Miramistin® is up to 1 l per day.

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Gynecology

Adults

Prevention and treatment of puerperal trauma suppuration, perineal and vaginal wounds, obstetric infections: Use Miramistin® in the form of vaginal irrigation prior to the delivery (for 5-7 days), during the delivery after every examination. In the postpartum period, Miramistin® is used in the form of tampons wetted with 50 ml of the medicine applied for 2 hours for 5 days.
In case of operative delivery by means of C-section, treat the vagina immediately before the operation, apply the medicine on the uterine cavity and the uterine incision during the operation, and during the postoperative period insert tampons impregnated with Miramistin® in the vagina for 2 hours for 7 days.
Inflammatory diseases are treated in the form of a course of medication during 2 weeks by inserting tampons impregnated with Miramistin® in the vagina or by medical ionization.
Complex treatment of inflammatory conditions in gynecology (vulvovaginitis): Perform vaginal irrigation or insert tampons wetted with Miramistin® for 2 hours for 7-14 days (the duration of treatment and frequency of administration are to be defined by medical prescription).
For convenience, use the gynecologic nozzle for vaginal irrigations. Use the gynecologic nozzle to introduce the contents of the bottle in the vagina and perform irrigation.

Children

The application method, duration of treatment and frequency of administration are to be defined by medical prescription.

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Urology

Adult

As part of complex treatment of urethritis and urethroprostatitis, inject 2-3 ml of Miramistin® in the urethra 1-2 times a day for 10 days. Children
The application method, duration of treatment and frequency of administration are to be defined by medical prescription.
If the treatment produces no positive effect or the symptoms become more intense, or new symptoms appear, consult the doctor. Use the medicine only according to the administration method and in the doses specified in the Instruction.

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Dermatology

Adults and children

Treatment and prevention of pyodermia and dermatomycosis, cutaneous and mucous candidosis, foot mycosis: apply Miramistin® to the affected skin area by cleaning it with sterile gauze sponges amply wetted with the medicine. Miramistin® is used 3 times a day on the affected skin areas.

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Surgery

Adults and children

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Attachments Use

Remove the cap and the special urological applicator from the 50 ml bottle

Take out the enclosed spray nozzle from the protective packaging

Attach the spray nozzle to the bottle

Activate the spray nozzle by repeated pressing

Remove the cap from the bottle.

Take out the enclosed gynecologic nozzle from the protective packaging.

Attach the gynecologic nozzle to the bottle without removing the urologic applicator.

Extra

Pharmacological properties

Miramistin has a wide antimicrobial effect, including hospital strains resistant to antibiotics.The medicine has a significant antimicrobial effect against gram-positive (Staphylococcus spp., Streptococcus spp., Streptococcus pneumoniae) and gram-negative (Pseudomonas aeruginosa, Escherichia coli, Klebsiella spp.), aerobic and anaerobic bacteria in the form of one-species cultures and microbial associations, including polyresistant hospital strains.It has an antifungal effect on ascomycetes of Aspergillus and Penicillium genera, yeasts (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 one-species cultures and microbial associations, including fungous microflora resistant to chemotherapeutic compounds.It produces an antiviral action and is active against complex viruses (herpes, human immunodeficiency viruses).Miramistin® is active against sexually transmitted pathogens (Chlamydia spp., Treponema spp., Trichomonas vaginalis, Neisseria gonorrhoeae).It effectively prevents the ingress of infection to wounds and burns and activates regenerative processes. It stimulates defensive reactions in the place of administration and intensifies the activity of monocyte-macrophagal system by activating the absorption and digestion functions of phagocytes. Miramistin is characterized by a significant hyperosmolar activity, which is why it stops the wound and perifocal inflammation and absorbs purulent effluent contributing to the formation of a dry scab. It does not damage granulation tissues and vital skin cells and does not suppress marginal epithelialization.It has no local irritant effect or allergizing properties.

Contraindications

Hypersensitivity to the active substance. Using the medicine in the form of spray to irrigate the throat and tonsils for children under the age of 3 is not recommended due to the risk of reactive laryngospasm.

Side effects

Slight burning that disappears on its own in 15-20 seconds and does not require the medicine withdrawal. Allergic reactions.

Drug-to-drug interaction

When used together with antibiotics, the medicine enhances their antibacterial and antifungal properties.

INFAMED LLC

Manufactured by

12, Kommunalnaya St., Bagrationovsk, Bagrationovsky District, Kaliningrad Region, Russia, 238420 Tel.: (4012) 31-03-66

Organization authorized to accept customer complaints:

INFAMED LLC Office 9, 2nd floor, bldg. 473, territory of VZ GIAP JSC industrial zone, Vidnoe, Leninsky District, Moscow Region, Russia, 142700 Tel.: 8 (800) 700-48-12; e-mail: infamed@infamed.ru; website: www.miramistin.ru

Instruction

General information

Forms of issue

Indications, method of administration and doses

Adults and children

Adults and children

Adults

Children

Adult

Adults and children

Adults and children

Attachments Use

Extra

Privacy Policy

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Instruction

General information

Forms of issue

Indications, method of administration and doses

Adults and children

Adults and children

Adults

Children

Adult

Adults and children

Adults and children

Attachments Use

Extra

Privacy Policy

Переход на внешний ресурс