Mikospor kit for the treatment of nails ointment 10g + adhesive plaster 15 pcs scraper +

$29.98

Mikospor kit for the treatment of nails ointment 10g + adhesive plaster 15 pcs scraper +

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SKU: 01510731476 Categories: , , Tag:

Description

Composition
Active substance:
100 g of ointment contain: 1 g of bifonazole, urea 40 g.
Excipients:
White beeswax 5 g White vaseline 34 g Lanolin 20 g.
Description:
Homogeneous ointment white with a yellowish tinge.
Product form:
Ointment for external use.
10 g of the ointment in an aluminum tube with a plastic screw cap tube 1 together with instructions for medical application is placed in individual cardboard box; pack with the ointment with a water resistant patch package, scraper and instructions for application of ointment were placed in a common cardboard box.
Contraindications
Hypersensitivity to bifonazole or any component of the formulation.
Pregnancy (I term)
During breastfeeding.
Carefully.
Pregnancy (II and III trimesters) (cm. “Apply during pregnancy and breast-feeding”).
Children’s age (see. The section “Method of administration and dose”).
Used with caution in patients who have an increased sensitivity to other anti-fungal drugs from the group of imidazole (econazole, clotrimazole, miconazole).
Indications
Onychomycosis (non-surgical removal of affected nail fungus fingers and toes while antimycotic action).
Interaction with other drugs
There are limited data on possible interactions bifonazole for external use, and warfarin, resulting in an increase in the international normalized ratio and possible bleeding and bruising. In the case of bifonazole in patients who are on warfarin therapy should be carefully monitored for these patients.
Overdose
No risk of acute toxicity, as overdose (applying to extensive areas of skin under conditions conducive to absorption) after a single application of the drug to the skin or swallowed unlikely.
pharmachologic effect
Pharmacological group:
Combined antifungal drug.
Pharmacodynamics:
Bifonazole, the first active substance ointments Mikospor® Composition, is an imidazole derivative and has a broad spectrum of antimycotic action. Bifonazole possess fungicidal activity against dermatophytes (particularly against Trichophyton spp.). Full fungicidal effect is achieved by bifonazole concentration of 5 ug / ml and the duration of exposure of at least 6 hours. Bifonazole has fungistatic activity against yeasts and molds as well as Malassezia furfur. In lesions yeast, e.g., Candida species, at a concentration of 1-4 ug / ml of indicated predominantly fungistatic effect bifonazole; necessary for the fungicidal effect bifonazole concentration of 20 ug / ml. Bifonazole also active against Corynebacterium minutissimum (MIC 0.5 to 2 mg / ml) Gram-positive cocci, with the exception of enterococci (MIC 4 to 16 ug / ml).
Resistant strains of fungi are very rare. Studies have not confirmed the development of secondary resistance in primarily sensitive strains.
Bifonazole inhibit ergosterol biosynthesis at two different levels, which distinguishes it from other antifungals and other azole derivatives. This dual action results in structural and functional damage of the cytoplasmic membrane of fungi.
Urea, the second active agent ointment Mikospor® set, performs the function of keratoplasty: softens the keratin of the infected nail and increases the depth of penetration of bifonazole.
The combination of bifonazole and urea enhances the antimycotic effect of the drug.
Pharmacokinetics:
After contact with the ointment to the affected skin absorption is 2 – 4% of the dose. When applying the ointment Mikospor® kit for the treatment of nails bifonazole plasma concentration is always below the detection limit (i.e.
Bifonazole crosses the placental barrier in rats.
Pregnancy and breast-feeding
Pregnancy.
These pre-clinical and pharmacokinetic studies show that bifonazole and urea does not have any adverse effects on the mother and fetus. Clinical studies in pregnant women have not been conducted.
As a precautionary measure to avoid the application of bifonazole and urea in the first trimester of pregnancy.
In II and III trimester of pregnancy, the use of the drug is possible if the potential benefit to the mother outweighs the potential risk to the fetus.
During breastfeeding.
It is unknown whether bifonazole and urea penetrate into breast milk in women.
Data obtained in experimental animals show that bifonazole and its metabolites are excreted in breast milk.
If necessary, use Mikospor® set during lactation should stop breastfeeding.
Fertility.
The safety data obtained from preclinical studies give reason to assume that the use of bifonazole does not appear to have any negative impact on male and female fertility. The use of urea has no damaging effect on sperm, however, about the possible impact of the data on female fertility are not available.
Conditions of supply of pharmacies
Without recipe.
side effects
Disorders of the skin and subcutaneous tissue disorders: contact dermatitis, maceration, desquamation, nail infections (local response from the nail and nail bed – such as redness, irritation, nail bed, the splitting of the nail plate), impaired nail pigmentation, erythema, skin irritation, itch , rash (including allergic), pain at the site of pain in the limbs.
Side effects are reversible and disappear after discontinuation of the drug.
If any of these instructions side effects are compounded, or if you notice any other side effects not mentioned in the instructions, tell your doctor.
special instructions
Used with caution in patients who have an increased sensitivity to other anti-fungal drugs from the group of imidazole (econazole, clotrimazole, miconazole).
With increasing / symptoms persist after cessation of treatment, you should consult a doctor.
Avoid getting product in eyes.
Do not take internally.
Effects on ability to drive and use machines.
The drug Mikospor® set has no negative impact on the performance of potentially hazardous activities that require high concentration and psychomotor speed reactions (driving, work with moving machinery).
Storage conditions
Store at a temperature not higher than 30 C.
Keep out of the reach of children!.
Dosing and Administration
Outwardly.
Adults and children ointment is applied to the infected nail once a day in an amount sufficient to cover the whole nail with a thin surface layer.
The treated nail glued adhesive patch and left for 24 hours, after which the dressing change.
After removal of the treated surface of the patch is immersed in warm water for about 10 minutes and then carefully removed by scraping the softened part of the infected nail.
Thus treated nails carefully obsushivayut again applied ointment and sealed with tape. Should not be covered with ointment skin adjacent to the nail.
In the case of signs of irritation, the skin around the nail before applying the patch may be treated with a zinc-containing paste.
Change dressings every day.
Treatment is continued until, until the fungus infected softened nail plate no longer be removed with a scraper and nail bed is smooth. This usually requires 7-14 days, depending on the degree of infection of nail and thickness.
Carry out the final nail bed antifungal therapy using Mikospor® cream preparation for external use 1 time a day for 4 weeks.
A more pronounced dystrophic nail plates with their removal using urea more efficiently.
Separate studies in children have been conducted. Based on a review of clinical data did not reveal evidence of adverse side effects when using the drug in children.
However, in children the drug Mikospor® kit should be used only under medical supervision.
If within 7 days of improvement is not observed or has deteriorated, you should consult a doctor.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

Bayer Pharmaceuticals

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