Lotseril nail lacquer 5% 2.5ml vial kit

Description

Composition
Active substance:
amorolfine hydrochloride – 64.0 mg, which corresponds amorolfine base – 57.4 mg.
Excipients:
methyl methacrylate, ethyl acrylate and trimetilammonioetilmetakrilata chloride copolymer [1: 2: 0.2] – 143.0 mg, triacetin – 12.0 mg, butyl acetate – 57.0 mg, ethyl acetate – 172.0 mg, absolute ethanol – 552.0 mg.
Description:
clear, colorless or almost colorless liquid
Product form:
Nail Varnish 5%.
2.5 ml vial of dark glass with a plastic screw cap having a built-in applicator, and an insert of a polymeric material which prevents the drug from drying. Each vial together with instructions for use, 30 swabs wetted with isopropyl alcohol (in a hermetically sealed envelope made of laminated aluminum foil) and the saws 30 is placed in a cardboard box with a first opening control.
Contraindications
Hypersensitivity to amorolfine or any of the components.
Dosage
50 mg / ml
Indications
– the treatment of fungal nail infections caused by dermatophytes, yeasts and molds;
– fungal nail infections prevention.
Overdose
When applied topically the drug development of systemic symptoms overdose is not expected.
In case of accidental ingestion of the drug necessary to carry out the appropriate symptomatic therapy.
pharmachologic effect
Pharmacological group:
Antifungal agent.
Pharmacodynamics:
Antifungal agent for external use. It has fungistatic and fungicidal action due to damage of the cytoplasmic membrane by fungal sterol biosynthesis disorders. Ergosterol content is reduced, accumulated content atypical sterically nonplanar sterols.
It has a wide spectrum of action. Highly active against the most common and rare pathogens of fungal nail infections: Dermatophytes: Trichophyton spp, Microsporum spp, Epidermophyton spp… Yeasts: Candida spp, Cryptococcus spp, Malassezia spp… (. Pityrosporum spp) molds: Alternaria spp, Scopulariopsis spp, Hendersonula spp… Mushrooms from Dematiaceae family: Cladopsorium spp, Fonsecaea spp, Wangiella spp…
Dimorphic fungi: Coccidioides spp, Histoplasma spp, Sporothrix spp…
Pharmacokinetics:
When applied on the nails penetrate the nail plate and further into the nail bed (almost entirely within the first 24 hours). The effective concentration is maintained in the affected nail plate within 7-10 days after the first application. Systemic absorption is negligible: plasma concentration is below the detection limit of determination methods (less than 0.5 ng / ml).
Pregnancy and breast-feeding
Given the limited data on the use of amorolfine in pregnant and lactating women, the use of the drug during pregnancy and lactation is not recommended.
Conditions of supply of pharmacies
Without recipe
side effects
In applying the drug Lotseril® undesirable reactions are rare. Such damaging the nail as a color change, destruction of the nail plate, nail fragility, can be the result of fungal nail infections.
All adverse reactions noted during application of the drug Lotseril® presented below in accordance with accepted classification system for organs and occurrence frequency: very often (> 1/10), often (> 1/100 – 1/1000 – 1/10 000 –
Violations by the immune system
Frequency unknown * – hypersensitivity reactions-sequence (systemic allergic reaction) *
Violations of the skin and subcutaneous tissue
Rare (> 1/10 000 –
unknown frequency * – * erythema, pruritus * * contact dermatitis, urticaria *, blistering *
* These post-marketing observational
If any of these instructions side effects are compounded, or observed any other side effects not mentioned in the instructions, you should immediately inform your doctor.
special instructions
– saws used for the treatment of the affected nails should not be used for the treatment of healthy nails;
– persons working with organic solvents, should wear gloves to protect impermeable nail varnish coated;
– during treatment should avoid the overhead of artificial nails;
– a preparation containing ethanol, however too frequent or incorrect application it may cause irritation or dry skin around the nail;
– swab contains flammable.
lacquer contact should be avoided in the eyes, ears and mucous membranes. In case of contact with eyes, nail polish, rinse immediately with water. Patients with conditions that predispose to the development of fungal nail infections (violation of the peripheral circulation, diabetes, immune deficiencies), as well as patients with nail dystrophy or damaged nail plate, psoriasis and other chronic skin diseases should consult a doctor.
If the destruction or fungal lesions is subject to more than 2/3 of the nail plate, it is also necessary to see a doctor for the appointment of concomitant oral therapy.
In the event of systemic and local allergic reactions should immediately stop using Lotseril® varnish and seek medical advice. Using the nail polish remover, it is necessary to remove the drug from the nail. Do not apply the drug again.
Storage conditions
At a temperature of not higher than 30 degrees.
Keep out of the reach of children!
Dosing and Administration
Outwardly. Apply to the affected nails of fingers or toes 1-2 times a week as follows:
1. Prior to application of the drug to remove the affected nail portions capabilities (particularly from its surface) with the appended nail files.
2. The surface of the nail, clean and degrease the supplied alcohol swab.
Before each subsequent application of the drug to also conduct processing infected nail sawing and then delete the remaining lacquer layer alcohol swab.
3. Lower the applicator into the bottle of lacquer and then gently remove it without erasing the excess lacquer on the bottle neck.
4. Use applicator apply varnish uniformly applied to the entire surface of the affected nail.
The above procedure was repeated for each of the affected nail.
5. Allow the varnish to dry for 3 minutes.
6. Wipe applicator swab used for nail cleaning, while avoiding contact of the treated nails and the tampon. Tightly close the bottle immediately after the end of the procedure. Used tampon throw.
Application of decorative nail may not earlier than 10 minutes after application of nail polish Lotseril®.
Repeated application of lacquer Lotseril®, must be carefully removed from the remainder of the decorative nail varnish and then with the accompanying saws treat the affected areas of the nail and to remove the remaining layer of lacquer alcohol swab.
After the procedure, wash your hands thoroughly. If the varnish is applied to the nails on the hands, wait until it is completely dry first.
After drying the varnish is allowed regular washing of hands and feet with soap.
Treatment should be continued until regeneration of nail and complete cure of the affected portion.
The average duration of treatment is 6 months for fingernails and 9-12 months for toenails.
In view of the slow growth of the nail plate the first signs of improvement may become visible only after 2-3 months of use of the drug. If there is no sign of improvement after 3 months it is recommended to consult a doctor.
Use in children
Clinical data on the use of the drug in pediatric patients are not available, therefore, should not be given to his children.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist