Instructions Kanespor set ointment for external use tube with dispenser 10 g +15 strips +1 scraper
Composition
active ingredients: bifonazole and urea;
1 g of ointment contains 10 mg of bifonazole and 400 mg of urea;
excipients: white wax, white soft paraffin, lanolin.
Dosage form
Ointment for external use.
Main physicochemical properties: yellowish homogeneous ointment.
Pharmacotherapeutic group
Antifungal agents for use in dermatology. Bifonazole, combinations. ATX code D01A C60.
Pharmacological properties
Pharmacodynamics
The active ingredient of the drug Kanespor set - bifonazole - is an imidazole derivative with a broad spectrum of antifungal activity. The drug is active against dermatophytes, yeasts, molds and other fungi.
Bifonazole, unlike other azole derivatives and fungicidal agents, inhibits ergosterol biosynthesis not at one, but at two different levels. Inhibition of ergosterol synthesis leads to structural and functional disorders of the cytoplasmic membrane of pathogens.
The minimum inhibitory concentration for the specified types of fungi is 0.062-16 μg/ml of substrate or less. Bifonazole has a fungicidal effect on dermatophytes, in particular trichophyton pathogens. The full fungicidal effect is achieved at a concentration of approximately 5 μg/ml with an exposure of 6 hours. On yeast fungi, for example, of the genus Candida, at a concentration of 1-4 μg/ml bifonazole has a predominantly fungistatic effect, at a concentration of 20 μg/ml it is fungicidal.
Bifonazole is effective in conditions of resistance of pathogens to other antifungal drugs. Primary resistance in sensitive fungal species to bifonazole is very rare. During the studies, the development of secondary resistance in initially sensitive strains was not detected.
Urea softens keratinized tissues. Urea is a natural substance found in the human body. In the composition of the ointment, urea softens the keratin of the infected nail, which allows for a non-invasive and painless removal of the affected part of the nail. In vitro studies have shown that urea increases the depth of penetration of bifonazole into the affected nail. Thus, the combination of bifonazole and urea enhances the antifungal effect.
Pharmacokinetics
When treating nails with the drug Kanespor kit, the level of bifonazole in blood plasma was in all cases below the detection threshold (i.e. less than 1 ng/ml).
Indication
Treatment of fungal infections of fingernails and toenails with atraumatic nail removal and simultaneous antifungal action.
Contraindication
Allergy to bifonazole or other components of the drug.
Interaction with other medicinal products and other types of interactions
There is evidence of a possible interaction between topical bifonazole and warfarin, leading to an increase in the international normalized ratio (increased risk of bleeding). If bifonazole is used in patients treated with warfarin, appropriate monitoring should be performed.
Application features
Avoid contact with eyes. Do not swallow. Keep out of reach of children.
A sustained therapeutic effect depends primarily on removal of the affected area of the nail and continued treatment of the nail bed with Canespor, cream, or another dosage form of bifonazole.
Allergic reactions to the patch are possible, but are very rare. In case of allergic reactions, consult a doctor. You can use another waterproof bandage or surgical tape.
Patients with allergic reactions to other antifungal agents from the imidazole group (e.g. econazole, clotrimazole, miconazole) should use Canespor Kit with caution.
If symptoms persist, you should consult a doctor.
This medicine may cause local skin reactions (contact dermatitis) due to the lanolin content.
Fertility: Preliminary clinical studies have not shown that bifonazole can inhibit male or female fertility.
Preclinical studies of urea have not revealed any evidence of its damaging effects on sperm or female fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
This medicine has no or negligible influence on the ability to drive or use machines.
Use during pregnancy or breastfeeding
Pregnancy: Preclinical safety data and human pharmacokinetic data do not indicate any harmful effects of bifonazole on the mother or child when Canespor Kit is used during pregnancy.
During the first trimester, the use of bifonazole should be avoided.
Breastfeeding. It is not known whether bifonazole or urea are excreted in human milk. Pharmacodynamic and toxicological studies in animals have shown excretion of bifonazole and its metabolites in breast milk. Therefore, breast-feeding should be discontinued during treatment with bifonazole.
Method of administration and doses
The drug should be applied to the affected nail once a day in such an amount as to cover the entire surface with a thin layer. Treatment with the drug should be carried out thoroughly every day and continued until the softened fungal nail can be removed. This usually takes 7-14 days and depends on the spread of the infection and the thickness of the nail.
Cover the treated nail with a plaster for 24 hours. Replace the plaster once a day. After removing the plaster, wash the fingers with the affected nails in warm water for about 10 minutes, then remove the softened affected nail tissue with a scraper, then dry the nail. Then apply the Kanespor kit as indicated above.
There is no need to cover the skin around the nail. However, in some cases, irritation may occur. Therefore, the edge of the skin surrounding the nail should be smeared with zinc paste or another anti-inflammatory drug for topical use before fixing the patch. Kanespor Kit, an ointment for external use, affects only the nails affected by the fungus, healthy areas remain unaffected.
After nail removal, before continuing antifungal treatment, the doctor should ensure that onycholysis is completely complete and, if necessary, perform a final cleaning of the nail bed.
After removal of the nail resulting from antifungal therapy with the drug Kanespor set, the nail bed should be treated with Kanespor cream once a day for approximately 4 weeks.
How to use the drug:
Wash your foot or hand in warm water and then dry it thoroughly. Place the bottom of the tube in the slot of the stand and use the handle to position the tube in the center. Slowly turn the rotating tip of the dispenser to the right until the length of the ointment strip squeezed out corresponds to the length of the affected nail. Apply the dose of ointment to the nail. Do not press on it or rub it in. Place half of the patch under the toe or palm. The patch can be cut to fit the size of the nail. Fold the edges of the patch up and press them firmly. Then place the other half of the patch on the nail, folding the sticky ends down. Press firmly. The patch is now correctly positioned and acts as a protective covering on the damaged nail. This occlusive dressing should be kept on the nail for 24 hours. After 24 hours, remove the patch. Wash the foot or hand thoroughly again with warm water and dry thoroughly. Using a scraper, carefully remove the softened part of the affected nail.
Carefully perform the above operations every day. The procedure must be repeated until the nail bed is completely cleaned. This usually takes 7-14 days. If after 7-14 days all the affected parts of the nail are not removed and the nail bed does not become smooth, you should consult a doctor.
The drug Kanespor® Kit acts directly on the damaged nail, leaving the healthy areas untouched. After the nail is removed, antifungal treatment with Kanespor® cream should be carried out for approximately four weeks.
Children
Based on the available clinical data, there is no reason to expect toxic effects in children. However, children aged 1 to 3 years should only be given the drug under medical supervision.
Overdose
There have been no reports of overdose during treatment with the drug.
Adverse reactions
When treating fungal nail diseases, skin and subcutaneous tissue disorders may develop at the edges or on the nail bed in the form of contact dermatitis, maceration, skin detachment, nail peeling, nail discoloration, erythema, skin irritation, pain in the limb, itching, rashes. Pain and swelling of the skin at the site of application, eczema, urticaria, blisters, dryness, a feeling of heat on the skin are possible. These side effects disappear after discontinuation of treatment.
Expiration date
3 years.
After opening the tube, the shelf life is 3 months.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store out of the reach of children at a temperature not exceeding 30 ºС.
Packaging
10 g in a tube with a dispenser, 15 waterproof plaster strips, 1 nail scraper in a box.
Vacation category
Without a prescription.
Producer
Bayer AG.
Location of the manufacturer and its business address
Kaiser-Wilhelm-Allee 51368 Leverkusen, Germany.
