Description
Release form
Nail polish, 5%. 2.5 and 5 ml in a dark glass bottle with a plastic cap with a lining made of a polymer material that protects the drug from drying out, and a ring to control the first opening.
1 fl. together with 30 alcohol wipes in hermetically sealed aluminum foil envelopes, 60 nail files and 10 applicators are placed in a cardboard box.
Pharmacological action
Antifungal drug for external use. It has a fungistatic and fungicidal effect due to damage to the cytoplasmic membrane of the fungus by disrupting the sterol biosynthesis. Ergosterol is reduced the content of atypical steric non-planar sterols accumulates.
Has a wide spectrum of action. Highly active against both the most common and rare causative agents of fungal infections of the nails: dermatophytes Trichophyton spp., Microsporum spp., Epidermophyton floccosum yeast Candida spp. mold fungi Alternaria spp., Scopulariopsis spp., Hendersonula spp. fungi from the family Dematiaceae Cladosporium spp. insensitive species of Aspergillus, Fusarium, Micorales.
Pharmacokinetics
When applied to the nails, it penetrates the nail plate and then into the nail bed, almost completely during the first 24 hours. The effective concentration remains in the affected nail plate for 7 10 days after the first application. Systemic absorption is negligible: plasma concentration is below the sensitivity limit of determination methods (less than 0.5 ng / ml).
Indications
Treatment of fungal infections of the nails caused by dermatophytes, yeasts and molds
prevention of fungal infections of the nails.
Contraindications
Hypersensitivity to amorolfine and other components of the drug
age up to 18 years.
Special instructions
A file used to treat affected nails should not be used to treat healthy nails.
During treatment, the use of decorative nail polish and false artificial nails should be avoided.
Avoid contact with eyes, ears and mucous membranes.
The product contains ethanol, therefore, too frequent and improper application can lead to irritation or dry skin around the nail.
Napkin contains a flammable substance.
Persons working with organic solvents (including paint thinners, gasoline, kerosene) should wear airtight gloves to protect their varnished nails.
To prevent the varnish from drying out, close the lid tightly after use. To prevent the cap from sticking, avoid getting varnish on the thread.
If you missed the application of varnish, you should not apply its excessive amount in several layers, it is enough to continue treatment according to the instructions for use.
Do not pour out the remaining product at the place where the water or household waste is drained.
Patients with conditions predisposing to the development of fungal infections of the nails (impaired peripheral circulation, diabetes mellitus, immunodeficiency), as well as patients with nail dystrophy, it is recommended that you consult a doctor before using the drug.
In the event that more than 2/3 of the nail plate is subject to destruction or fungal infection, it is also necessary to consult a doctor for prescribing concomitant oral therapy.
Impact on the ability to drive vehicles and mechanisms. Not studied.
Composition of
Composition of 1 ml of varnish:
active ingredient:
amorolfine – 50 mg (in the form of amorolfine hydrochloride – 55.74 mg)
auxiliary components:
ethanol,
ethyl acetate,
triacrylomethyl methacrylate methylacrylate triudryl methyl acetate ethyl acrylate (2: 0, 2: 1)],
triacetin,
n-butyl acetate.
Dosage and Administration
Topically. Apply to affected nails of fingers or toes 1-2 times a week.
1. Before applying Onyhelp ® varnish, remove as many affected nails as possible with scissors and carefully treat the affected areas of the nail on its surface with the supplied nail file.
2. Then clean and degrease the surface of the nail with the alcohol wipe included in the kit.
3. Dip the applicator in the varnish. The applicator should be removed from the bottle without touching its neck, and excess varnish should not be washed off the neck of the bottle.
4. Apply the varnish to the surface of the affected nail using the applicator.
5. Close the varnish bottle tightly immediately after use to prevent it from drying out.
6. After use, wipe the applicator with an alcohol wipe. Discard the used tissue.
7. Let the varnish dry for about 3-5 minutes.
The above procedure should be performed for each affected nail. Before each subsequent application of Onihelp ®, it is necessary to remove the previous layer of varnish with an alcohol cloth, treat the nails with a file, and then clean and degrease the surface using an alcohol cloth.
Treatment should be carried out continuously until the complete healing of the affected area and regeneration of the nail plate.
If the patient forgot to apply the varnish on the planned day, it must be applied as soon as possible.
The duration of treatment is usually 6 months for fingernails and 9 to 12 months for toenails.
If improvement does not occur within 3 months, it is recommended to consult a doctor.
Side effects of
When using Onihelp®, adverse reactions are rare. Such damage to the nails as discoloration, destruction of the nail plates, brittle nails can be the result of fungal damage to the nails.
All adverse reactions noted with the use of Onihelp® are presented below in accordance with the accepted classification according to organ systems and frequency of occurrence: very often (? 10%) often (? 1% and < 10%) infrequently (? 0.1% and <1%) rarely (? 0.01% and <0.1%) very rarely (<0.01%), the frequency is unknown (cannot be estimated from the available data) . From the skin and subcutaneous tissues: rarely – damage to nails, discoloration, onychoclasia (fragility of the nail plate), onychorexis (fragility of the nail plate) is very rare – burning sensation of the skin frequency is unknown – erythema, pruritus, contact dermatitis, urticaria, blistering . If any of these side effects are exacerbated or any other side effects are noted, you should inform your doctor. Drug Interactions Not studied. Overdose The drug is intended for external use, therefore, if the drug accidentally enters the inside, rinse the stomach and conduct symptomatic treatment. Day Enikeev substance amorolfine Terms and conditions without prescription
