Description

Dosage form

Transparent solution from colorless to pale yellow.

Release form

5 ml each in a dark glass bottle, with a plastic cap with a polymer overlay that protects the preparation from drying out, and a ring to control the first opening.

One bottle along with instructions for use, 30 alcohol wipes in hermetically sealed aluminum foil envelopes, 60 files and 10 applicators are placed in a cardboard box.

Structure

1 ml of the preparation contains: active substance: amorolfine hydrochloride 55.74 mg (corresponds to 50 mg of amorolfine base).

Excipients: ethanol - 482.53 mg, ethyl acetate - 144.59 mg, eudragit RL 100 (methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate copolymer [2: 0.2: 1]) - 127.60 mg, n-butyl acetate - 50, 08 mg, triacetin - 10.45 mg.

pharmachologic effect

Antifungal drug for external use.

It has a fungistatic and fungicidal effect caused by damage to the cytoplasmic membrane of the fungus by disrupting the biosynthesis of sterols.

The content of ergosterol decreases, the content of atypical steric non-planar sterols accumulates.

Possesses a wide spectrum of action.

It is highly active against both the most common and rare pathogens of fungal nail infections:

Dermatophytes: Trichophyton spp., Microsporum spp., Epidermophyton floccosum

Yeast fungi: Candida spp .

Molds: Alternaria spp., Scopulariopsis spp., Hendersonula spp .

Fungi from the Dematiaceae family: Cladosporium spp .

Insensitive species: Aspergillus, Fusarium, Micorales.

Pharmacokinetics

When applied to the nails, it penetrates into the nail plate and further into the nail bed, almost completely within the first 24 hours.

Effective concentration remains in the affected nail plate for 7-10 days after the first application.

Systemic absorption is insignificant: plasma concentration is below the detection limit of detection methods (less than 0.5 ng / ml).

Side effects

The following classification is used to indicate the frequency of side effects: very often (? 10%), often (? 1% and < 10%), infrequently (? 0.1% and < 1%), rarely (? 0.01% and < 0.1%), very rare (? 0.01%), the frequency is unknown (cannot be estimated from the available data).

Rarely - damage to nails, discoloration of nails, increased fragility and cracks of the nail plate, which may be the result of a fungal infection of the nail, are possible.

Very rarely - a slight short-term burning sensation in the nail area after application of the drug, contact dermatitis.

Frequency unknown - erythema, pruritus, urticaria, fliktena (superficial pustule in the form of a bladder).

If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.

Selling features

Available without a prescription

Special conditions

-The file used to treat affected nails should not be used on healthy nails!

-During treatment, use of decorative nail polish and false artificial nails should be avoided.

-Do not allow the varnish to come into contact with the eyes, ears and mucous membranes.

-The napkin contains a flammable substance.

-Persons working with organic solvents (eg paint thinners, gasoline, kerosene, etc.) should wear sealed gloves to protect nails covered with varnish.

-To prevent the varnish from drying out, close the lid tightly after use.

To prevent the cover from sticking, avoid getting varnish on the threads.

-If you missed applying the varnish, you should not apply an excessive amount of it in several layers, it is enough to continue the treatment according to the instructions for use.

-Do not pour out the remaining drug in the place where water or household waste is drained.

-Patients with conditions predisposing

Name ENG

ONIHELP

Clinical and pharmacological group

Antifungal drug for external use

ATX code

Amorolfine

Dosage

5% x 5ml

Structure

1 ml of the preparation contains: active substance: amorolfine hydrochloride 55.74 mg (corresponds to 50 mg of amorolfine base).

Excipients: ethanol - 482.53 mg, ethyl acetate - 144.59 mg, eudragit RL 100 (methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate copolymer [2: 0.2: 1]) - 127.60 mg, n-butyl acetate - 50, 08 mg, triacetin - 10.45 mg.

Indications

Treatment of fungal nail infections caused by dermatophytes, yeasts and molds

-Prevention of fungal nail infections.

INN / Active ingredient

amorolfine

Storage conditions and periods

At a temperature not exceeding 30 degrees, in a sealed package, in an upright position, away from heat sources.

Expiration date: 3 years

Contraindications

Hypersensitivity to amorolfine and other components of the drug.

Age under 18.

Specifications

Category

Antifungal

Scope of the drug

Dermatology

Release form

Nail polish

Manufacturer country

Ireland

Package quantity, pcs

one

Way of introduction

On nails

Vacation conditions

Without recipe

Brand name

BELUPO, Medicines and cosmetics HR

Components

applicator (10), file (60), alcohol napkin (30)

The amount of the dosage form in the primary package

5 ml

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Antifungal agent

Anatomical and therapeutic characteristics

D01AE16 Amorolfine

Dosage form

Nail polish

Dosage (volume) of the substance in the preparation

50 mg

Expiration date in days

1095

Package weight, g

45

Mode of application

:

Outwardly. Apply to the affected nails of the fingers or toes 1-2 times a week as follows: 1. Before using Onyhelp® varnish, remove as much of the affected nail as possible with scissors, and carefully treat the affected areas of the nail on it using the supplied nail file surface. 2.Then, the surface of the nail is cleaned and degreased with the included alcohol napkin. 3. Dip the applicator into the varnish. The applicator should be removed from the bottle without touching its neck, and excess varnish should not be wiped off the neck of the bottle. 4. Apply the varnish to the surface of the affected nail using the applicator. 5. Close the bottle with varnish tightly immediately after use to avoid drying out. 6.After use, wipe the applicator with an alcohol wipe.Throw away the used napkin. 7. Let the varnish dry for about 3-5 minutes.

Information on technical characteristics, delivery set, country of manufacture

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