Pharmacological properties

Pharmacodynamics. active active ingredient of medicaments канеспор® and канеспор® set — bifonazol — derivative an imidazole with a wide range of anti-mycotic activity. medicaments are active concerning dermatophytes, barmy, mold and other mushrooms (malassezia furfur, corynebacterium minutissimum). bifonazol, unlike other azoles and fungicide medicines, ergosterol biosynthesis not on one, and at two various levels oppresses. oppression of synthesis of ergosterol leads to structural and functional disturbances of a cytoplasmic membrane of activators.

MIK for the specified types of fungi is made by 0.062-16 mkg/ml of substrate or less. Bifonazol has fungicide activity against dermatophytes, including causative agents of a trichophytia.

Bifonazol has the significant fungicide effect on dermatophytes at concentration of 5 mkg/ml and duration of action of 6 h. On barmy mushrooms, for example, sort Candida mushrooms, in concentration of 1-4 mkg/ml bifonazol works mainly fungistaticly, in concentration of 20 mkg/ml — it is fungicidal. Besides, active ingredient shows fungistasis in concentration which are 2-10 times lower than MIK value. Already at 3 mkg/ml of substrate the proliferating mycelium of Trichophyton mentagrophytes is quickly inhibited.

At gram-positive cocci, except for enterococci, MIK of a bifonazol makes 4–16 mkg/ml. At MIK korinebakteriya — 0.5-2 mkg/ml.

in the conditions of resistance of activators to other antifungal drugs. Very seldom primary resistance to a bifonazol at sensitive types of fungi can be shown. In researches the development of secondary resistance in initially sensitive strains is not revealed so far.

, being a part of the medicament Kanespor ^® set, softens the keratosic fabrics. Urea is natural substance which is in a human body. As a part of ointment urea softens a keratin of the infected nail that allows to remove without serious consequences in the noninvasive way the struck part of a nail. The researches in vitro showed that urea increases penetration depth of a bifonazol in the affected nail. Thus, the combination of a bifonazol and urea strengthens anti-mycotic action.

Pharmacokinetics. Bifonazol well gets into affected areas of skin. In 6 h after use the concentration of a bifonazol in various layers of skin reaches from 1000 mkg/cm ³ in an upper layer of epidermis to 5 mkg/cm ³ in papillary. All concentration defined thus are in limits of the confirmed anti-mycotic activity.

for the medicament Kanespor ^® cream of at least 48-72 h

Considerable duration of finding of the medicament Kanespor ^® cream on skin in concentration with antifungal action and accounting of fungicide type of action are a basis for single use in local therapy.

during researches on absorption after topical administration on the uninjured skin of the person of concentration always are in blood serum below line of definition (1 ng/ml), only at the inflamed skin the insignificant absorption is confirmed. It is not necessary to expect system effect of such small concentration of active ingredient (as a rule, less than 5 ng/ml). At treatment of nails the medicament Kanespor ^® Set, level of a bifonazol in blood plasma in all cases was below an identification threshold (less than 1 ng/ml).

Indication

Kanespor® cream. treatment:

• fungus diseases of skin, caused by activators, sensitive to a bifonazol (dermatophytes; barmy, mold mushrooms and other fungal infections; Malassezia furfur and Corynebacterium minutissimum);
• superficial candidiases and mycoses of skin (including mycoses of feet and interdigital intervals, mycoses of brushes, mycoses of smooth skin and folds of skin of a body);
multi-colored depriving of
• ;
• an erythrasma;
• processing of a nail bed when carrying out a course of treatment of fungus diseases of nails (onychomycoses) after removal of a nail plate.

Kanespor ^® set. Treatment in fungal infections of nails of fingers of hands and legs with atraumatic removal of nails and simultaneous anti-mycotic action.

Use

Kanespor® cream. to apply 1 time a day, it is desirable in the evening before going to bed. to apply with a thin layer on an affected area of skin and to rub. for ensuring long-term effect the medicament treatment канеспор® cream needs to be carried out during the specified treatment terms, even after disappearance of symptoms. usual courses of treatment: mycoses of feet and interdigital intervals — 3 weeks; mycoses of brushes, smooth skin and folds of skin of a body — 2–3 weeks; multi-colored deprive, an erythrasma — 2 weeks; superficial candidiasis of skin — 2–4 weeks of a small amount of cream is usually enough for treatment of the site of skin of the size of a palm.

Kanespor ^® cream is applied after performing treatment of a nail the medicament Kanespor ^® set. A nail bed Children process the medicament Kanespor ^® cream of 1 times a day during 4 weeks

. Proceeding from the available clinical given there are no grounds to assume toxic manifestations at children. However children under 3 years (including newborn) need to use medicament only under observation of the doctor.

Kanespor ^® set. To apply medicament on the affected nail of 1 times a day in such quantity to cover all surface with a thin layer. Drug treatment should be carried out carefully every day and to continue until the softened nail affected with a fungus can be removed. It usually lasts 7–14 days and depends on spread of an infection and thickness of a nail.

with a plaster on 24 h. To replace a plaster 1 time a day. After removal of a plaster to wash fingers with the affected nails in warm water about 10 min., then to remove the softened struck substance of a nail with a scraper then to dry a nail. Further ® set to apply the medicament Kanespor ^{as it is stated above.}

need to close skin around a nail. But in certain cases the irritation can appear. Therefore the edge of the skin surrounding a nail needs to be smeared with zinc paste or other anti-inflammatory medicament for topical administration before fixing a plaster. Kanespor ^® set, ointment for external use, influences only the nails affected with a fungus, healthy sites remain invariable.

After onychectomy that he onikholizis is fully completed, and if it is necessary, to carry out final cleaning of a nail bed.

After onychectomy that set is result of anti-mycotic therapy by the medicament Kanespor ^® , a nail bed needs to be processed the medicament Kanespor ^® cream of 1 times in day approximately during 4 weeks

a medicament use Order

1. To wash up a leg or a hand in warm water and after that carefully to wipe.

2. To apply an ointment dose on a nail. Not to press it and not to rub.

3. To place a half of a plaster under a toe or palms. The plaster can be cut off according to the nail size.

4. To wrap edges of a plaster up and it is good to press them.

5. After that to put other half of a plaster on a nail, wrapping the sticky ends down. It is good to press.

6. The plaster located correctly serves as a protective cover on the injured nail. It is necessary to hold this occlusive bandage on a nail during 24 h

7. In 24 h to remove a plaster. Again carefully to wash up a leg or a hand warm water and it is good to dry.

8. By means of a scraper carefully to remove the softened part of the affected nail.

Daily carefully to carry out the above operations. The procedure needs to be repeated before full clarification of a nail bed. On it 7–14 days usually are required.

If in 7–14 days does not remove all affected areas of a nail and the nail bed will not become smooth, it is necessary to see a doctor.

directly the injured nail, healthy sites remain not changed. After the nail is removed, it is necessary to carry out antifungal treatment using Kanespor cream ^® during about 4 weeks

Children. Considering the available clinical data, there are no bases to assume toxic manifestations at children. However children aged from 1 up to 3 years need to use medicament only under observation of the doctor.

Contraindication

Known hypersensitivity to active ingredient or to any other excipient. for the preprat канеспор® cream also contraindicated: hypersensitivity to antifungal medicines of group of an imidazole. treatment of children with an intertrigo. medicament not for vaginal use. treatment of an infection of a hairy part of head skin. not to use medicament before removal of the struck part of a nail plate for treatment of fungus diseases of nails.

Side effects

Kanespor® cream

General disturbances and changes in the place of use. Can cause local skin reactions (for example contact dermatitis), pain and a cutaneous dropsy in the place of use.

from the immune system. System reactions of hypersensitivity are seldom or never possible.

from skin and hypodermic cellulose. Development of contact dermatitis, allergic dermatitis, an erythema, eczema, a skin itching, rash, a small tortoiseshell, blisters, peeling, dryness, irritation, maceration and feeling of heat on skin.

after medicament withdrawal.

Cetostearyl alcohol can cause emergence of irritations of skin in the place of use (for example contact dermatitis). At hypersensitivity to cetostearyl alcohol there can be allergic reactions on skin.

Kanespor ^® set. At treatment of fungus diseases of nails the development of skin and hypodermic fabric disturbances at the edges or on a nail bed in the form of contact dermatitis, maceration, peeling of skin, an oblushchivaniye of a nail, decolouration of a nail, an erythema, irritation of skin, extremity pain, an itching, rashes is possible. Pain and a cutaneous dropsy in the place of use, eczema, urticaria, blisters, dryness, feeling of heat on skin are possible. These side effects pass after the treatment termination.

to Avoid

hits in eyes. not to swallow. to store in the places inaccessible for children.

Sick with allergic reactions to other antifungal medicines from group of an imidazole (for example econazol, Clotrimazolum, Miconazolum) should be applied Kanespor ^® with care.

If symptoms remain, it is necessary to see a doctor.

Antifungal treatment of skin of the nail roller using the medicament Kanespor ^® cream can be carried out by

within therapy of mycosis of nails only after preliminary keratolytic removal of the infected site of a nail.

Lasting therapeutic effect of the medicament Kanespor ^® set depends mainly on removal of an affected area of a nail and continuation of treatment of a nail bed the medicament Kanespor ^® , cream, or other dosage form of a bifonazol.

Allergic reactions to a plaster are possible

, but are observed very seldom. In case of allergic reactions consult with the doctor. It is possible to use other waterproof bandage or a surgical fingerstall.

Kanespor ^® set can cause the local reactions on skin (contact dermatitis) caused by lanolin content.

Use during pregnancy or feeding by a breast. Pregnancy. Data of preclinical trials and data of pharmacokinetics in a human body do not confirm an adverse effect of a bifonazol on mother and the child if Kanespor ^® is applied during pregnancy. But clinical data are absent. In the I trimester of pregnancy it is desirable to avoid use of a bifonazol.

feeding Period breast. It is unknown whether gets bifonazol into breast milk of the person. Researches of a pharmacodynamics and toxicological data at animals demonstrate excretion of a bifonazol and its metabolites in breast milk. Therefore throughout treatment bifonazoly it is necessary to stop feeding by a breast. During feeding bifonazol it is not necessary to apply with a breast on area of a thorax.

Fertility. Preliminary clinical trials did not reveal that bifonazol can suppress male or female fertility. As a result of clinical trials of urea, data on its damaging influence on spermatozoa or female fertility are not revealed.

Ability to influence speed of response at control of vehicles or other mechanisms. This medicine does not influence or extremely slightly affects ability to run vehicles or other mechanisms.

Interaction

data confirming possible interaction between bifonazoly, applied locally, and warfarin that leads to increase in the international normalized relation (risk of developing of bleeding) Exist. if bifonazol it is applied at patients who are treated by warfarin, then it is necessary to carry out the corresponding monitoring.

Overdose

Messages about overdose cases at medicament treatment канеспор® did not arrive.

After single skin use of risk of acute intoxication. The overdose is possible at use on extensive sites of skin or at careless oral administration.

Storage conditions

Kanespor® cream: for this medicine of special storage conditions it is not required.

Kanespor ^® set: to store at a temperature not above 30 °C.