Amoderm neo-varnish d / nail 50 mg / ml fl. 2.5 ml

Manufacturers location and address of the place of business

Dublin Road, Lochray, Co. Galway, Ireland.

Nail polish must be applied to the affected area of the nail 1 time per week

Amoderm neo description

Drug: AMODERM NEO

Release form: nail polish

Group: Antifungal drugs for topical use

Subgroup: other topical antifungals

Composition: Amorolfine - 50 mg / m (Amorolfine)

Storage

active substance: amorolfine;

1 ml contains: amorolfine hydrochloride equivalent to amorolfine 50 mg;

Excipients: ammonium methacrylate copolymer (type A), triacetin, n-butyl acetate, ethyl acetate, ethanol anhydrous.

Dosage form Therapeutic nail polish.

Basic physical and chemical properties: clear solution from colorless to light yellow color.

Pharmacotherapeutic group

Antifungal drugs for dermatological use. Other antifungal drugs for topical use. ATX code D01A E16.

Pharmacological properties

Pharmacodynamics.

Antifungal drug for topical use. It has a fungistatic and fungicidal effect due to the change of the cell membrane by disrupting the biosynthesis of sterols. Amorolfine inhibits two different enzymes involved in the biosynthesis of ergosterol-delta14-reductase and delta7-delta8-isomerase.

Amorolfine has a broad spectrum of action. Highly active against both the most common and rare pathogens of fungal nail lesions:

- dermatophytes: Trichophyton spp., Microsporum spp., Epidermophyton spp .;

- yeast fungi: Candida spp., Cryptococcus spp., Malassezia spp. (Pityrosporum spp.);

- fungi: Alternaria spp., Scopulariopsis spp., Hendersonula spp., Aspergillus spp., Fusarium spp., Mucorales spp .;

- fungi of the genus Dematiaceae: Cladopsorium spp., Fonsecaea spp., Wangiella spp .;

- dimorphic fungi: Coccidioides spp., Histoplasma spp., Sporothrix spp.

Bacteria, with the exception of Actinomyces, are not sensitive to amorolfine. Propionibacterium acnes shows only weak sensitivity.

Pharmacokinetics.

During the first 24 hours after application of the solution, amorolfine penetrates into the nail plate and then into the nail bed. The effective concentration of amorolfine is maintained in the damaged nail plate for 7-10 days after the first application. Systemic absorption is negligible: the concentration of amorolfine in blood plasma is below the sensitivity limit of the methods of determination (less than 0.5 ng / ml).

Clinical characteristics

Indication

Fungal lesions caused by dermatomycetes, yeasts and molds, without affecting the nail base.

Treatment of uncomplicated distal and lateral onychomycosis caused by dermatomycete, yeast and mold, limited to two nails.

Prevention of fungal nail lesions.

Contraindication

Hypersensitivity to amorolfine or to any of the excipients.

Special security measures

Avoid getting the varnish in the eyes, ears and mucous membranes.

The use of decorative nail polish and false nails during treatment with the drug should also be avoided.

Interaction with other medicinal products and other forms of interaction

There are no special studies on concomitant treatment with other drugs for external use.

Features of application

Patients with peripheral circulatory disorders, diabetes mellitus and immunosuppression, nail dystrophy and damaged nail plate should consult a physician before use.

Use during pregnancy or breastfeeding.

The safety of Amoderm Neo during pregnancy has not been established, therefore it is not recommended to use the drug during this period.

No side effects have been found in breastfed infants. Because the concentration of amorolfine in breast milk is insignificant, amorolfine can be used during breastfeeding.

Before using the drug, consult a doctor.

Ability to influence the speed of reaction when driving a car or other machinery.

Does not affect.

Method of application and dosage

Nail polish should be applied to the affected area of ​​the nail once a week. The patient should apply the varnish as follows:

1. Before the first application of Amoderm Neo, it is very important that the affected areas of the nail (including the nail surface) are sanded as thoroughly as possible with a nail file.

2. Then the nail surface should be cleaned and degreased with an alcohol solution.

Before re-applying Amoderm Neo, the affected area of ​​the nail should be sanded again, after which the nail should be cleaned with an alcohol solution.

Warning: Files that have been used for affected nails should not be used for healthy nails.

3. One of the included spatulas should apply varnish to the entire surface of the affected nail.

4. After application, allow the varnish to dry for 3-5 minutes.

5. When applying the product on each affected area of ​​the nail, it is necessary to lower the spatula into the bottle with varnish. When removing the spatula, do not wipe it against the neck of the vial.

6. Keep the vial tightly closed.

Warning: when working with organic solutions (solvents, white spirit, etc.) it is necessary to use waterproof gloves to keep the nail polish.

Treatment should be continued without interruption until the nail is restored and the affected areas heal. The frequency and duration of treatment depend mainly on the intensity and location of the infection. The treatment usually lasts 6 months (for toenails) and 9 to 12 months (for toenails). Repeat treatment is recommended at intervals of approximately 3 months.

In case of dermophytia of the foot, it is necessary to treat with an appropriate antifungal cream.

Children.

Efficacy and safety of the drug in children have not been established, therefore it is not prescribed to this age group of patients.

Overdose

No cases of overdose were observed, as the drug is applied topically.

In case of accidental oral administration, gastric lavage should be performed.

Adverse reactions

There may be isolated cases of adverse reactions. Nail lesions (such as discoloration of nails, brittle nails) may occur. Such reactions may also be associated with onychomycosis.

From the skin: rarely (≥1 / 10,000, <1/1000) - nail lesions, discoloration of nails; very rare (<1 / 10,000) - burning sensation of the skin.

Shelf life3 years.

Storage conditions

Store at a temperature not exceeding 30 ºC out of reach of children.

Keep the vial tightly closed.

Packaging

2.5 ml in a bottle together with spatulas for applying varnish in a cardboard box.

Vacation categoryNo prescription.

Producer

Chanel Medical.

Location of the manufacturer and his address of the place of its activity

Dublin Road, Lochray, Co. Galway, Ireland.

The applicant

PJSC "Kyivmedpreparat".

Location of the applicant

01032, Ukraine, Kyiv, street Saksaganskogo, 139.

INSTRUCTION

on the medical use of the drug

AMODERM NEO

Composition

active substance: amorolfine;

1 ml contains: amorolfine hydrochloride equivalent to amorolfine 50 mg;

excipients: ammonium methacrylate copolymer (type A), triacetin, n-butyl acetate, ethyl acetate, ethanol anhydrous.

Dosage form The nail polish is medical.

Main physical and chemical properties: clear solution from colorless to light yellow color.

Pharmacotherapeutic group

Antifungal drugs for dermatological use. Other topical antifungal drugs. ATX code D01A E16.

Pharmacological properties

Pharmacodynamics.

Antifungal drug for topical use. Shows fungistatic and fungicidal action due to changes in the cell membrane by disrupting the biosynthesis of sterols. Amorolfine inhibits two different enzymes involved in the biosynthesis of ergosterol-delta14-reductase and delta7-delta8-isomerase.

Amorolfine has a broad spectrum of action. Highly active both concerning the most widespread, and rare activators of fungal defeats of nails:

- dermatophytes: Trichophyton spp., Microsporum spp., Epidermophyton spp .;

- yeast fungi: Candida spp., Cryptococcus spp., Malassezia spp. (Pityrosporum spp.);

- molds: Alternaria spp., Scopulariopsis spp., Hendersonula spp., Aspergillus spp., Fusarium spp., Mucorales spp .;

- fungi of the genus Dematiaceae: Cladopsorium spp., Fonsecaea spp., Wangiella spp .;

- dimorphic fungi: Coccidioides spp., Histoplasma spp., Sporothrix spp.

Bacteria, with the exception of Actinomyces, are not sensitive to amorolfine. Propionibacterium acnes shows only low sensitivity.

Pharmacokinetics.

During the first 24 hours after application of the solution, amorolfine penetrates into the nail plate and then into the nail bed. The effective concentration of amorolfine is maintained in the damaged nail plate for 7-10 days after the first application. Systemic absorption is negligible: the plasma concentration of amorolfine is below the sensitivity limit of the detection methods (less than 0.5 ng / ml).

Clinical characteristics

Indications

Fungal lesions caused by dermatomycetes, yeasts and molds, without affecting the nail base.

Treatment of uncomplicated distal and lateral onychomycosis caused by dermatomycete, yeast and mold, limited to two nails.

Prevention of fungal nail lesions.

Contraindications

Hypersensitivity to amorolfine or to any of the excipients.

Special security measures

Avoid getting nail polish on the eyes, ears and mucous membranes.

The use of decorative nail polish and false nails during treatment with the drug should also be avoided.

Interaction with other drugs and other types of interactions

There are no special studies on concomitant treatment with other drugs for external use.

Features of application

Patients with diseases of the peripheral circulatory system, diabetes mellitus and immunosuppression, with nail dystrophy and damaged nail plate should consult a doctor before use.

Use during pregnancy or breastfeeding.

The safety of Amoderm Neo during pregnancy has not been established, therefore it is not recommended to use the drug during this period.

No side effects have been found in breastfed babies.

Because the concentration of amorolfine in breast milk is insignificant, amorolfine can be used during breastfeeding.

Before using the drug, consult a doctor.

Ability to influence the speed of reaction when driving a car or other mechanisms.

Does not affect.

Method of application and dose

Nail polish should be applied to the affected area of ​​the nail once a week. The patient should apply the varnish as follows:

1. Before the first application of Amoderm Neo, it is very important that the affected areas of the nail (in particular the nail surface) are sanded as thoroughly as possible with a nail file.

2. Then the surface of the nail should be cleaned and degreased with an alcohol solution.

Before re-applying Amoderm Neo, the affected area of ​​the nail should be sanded again, after which the nail should be cleaned with an alcohol solution.

Warning: Files that have been used for affected nails should not be used for healthy nails.

3. One of the spatulas that are included, you need to apply varnish on the entire surface of the affected nail.

4. After application, the varnish must be allowed to dry for 3-5 minutes.

5. When applying the product on each affected area of ​​the nail, it is necessary to lower the spatula into the bottle with varnish. When removing the spatula, do not wipe it against the neck of the vial.

6. Keep the vial tightly closed.

Warning: when working with organic solutions (solvents, white spirit, etc.) it is necessary to use waterproof gloves to keep the nail polish.

Treatment should be continued without interruption until the nail is restored and the affected areas heal. The frequency and duration of treatment depend mainly on the intensity and location of the infection. The treatment usually lasts 6 months (for toenails) and 9 to 12 months (for toenails). Repeat treatment is recommended at intervals of about 3 months.

In case of dermophytia of the foot, it is necessary to be treated with an appropriate antifungal cream.

Where are you.

Efficacy and safety of the drug in children have not been established, and therefore it is not prescribed to this age group of patients.

Overdose

No cases of overdose were observed, as the drug is used topically.

In case of accidental ingestion, gastric lavage should be performed.

Adverse reactions

There may be some cases of adverse reactions. Nail lesions may occur (such as discoloration of nails, brittle nails). Such reactions may also be associated with onychomycosis.

From the skin: rarely (≥1 / 10000, <1/1000) - nail lesions, discoloration of nails; very rare (<1 / 10,000) - skin burning sensation.

Shelf life3 years.

Storage conditions

Store at a temperature not exceeding 30 ° C out of reach of children.

Keep the vial tightly closed.

Packaging

2.5 ml in a bottle together with spatulas for applying varnish in a cardboard box.

Vacation category No prescription.

Manufacturer

Chanel Medical.

Location of the manufacturer and his address of the place of activity

Dublin Road, Lochray, Co. Galway, Ireland.