Batrafen Nail Lacquer

/ Sanofi

Dosage: Batrafen Nail Laquer is applied in a thin layer every other day in the first month, at least twice weekly in the second month and once a week from the third month onwards.
Method of administration: As much as possible of the destroyed nail material should be removed before the start of treatment with Batrafen Nail Laquer, for example with scissors or with the enclosed disposable nail files.
Unless directed otherwise, Batrafen Nail Laquer is applied in a thin layer to the diseased nail every other day in the first month. In this way, the nail is saturated with the active substance.
In the second month of treatment, application can be reduced to at least twice weekly and to once a week from the third month of treatment onwards.
Throughout the application period the entire layer of lacquer is removed once a week with alcohol swabs. During this process too, as much as possible of the affected nail material should be removed with disposable nail files.
If in the meantime the layer of lacquer becomes damaged, it is sufficient to paint over the chipped areas again with Batrafen Nail Laquer.
Do not use nail polish or other nail cosmetic products on the treated nails.
Duration of administration: The duration of use depends on the severity of the infection, but should not exceed a treatment period of 6 months.
In this period, the pathogens of the nail fungal infection are generally killed off. The doctor will decide whether it is necessary to continue treatment.
Pediatric Patients: Based on the safety profile in adults, Batrafen Nail Laquer is considered safe for use in children twelve years and older. No clinical trials have been conducted in the pediatric population.

For the treatment of fungal infections of the nails.

Batrafen Nail Laquer should not be used in patients with known hypersensitivity to the active substance ciclopirox or any of the excipients.
Because of a lack of clinical experience, the use of Batrafen Nail Laquer in children under 12 years old and during pregnancy and lactation is not indicated.

So far there is no relevant clinical experience with patients with insulin dependent diabetes or who have diabetic neuropathy. The risk of removal of the unattached, infected nail, by the health care professional and trimming by the patient should be carefully considered before prescribing to patients with a history of insulin dependent diabetes mellitus or diabetic neuropathy.
Caution is advised in patients who:
– Are immunocompromised (e.g., received an organ transplant, were HIV positive etc.) or had a history of immunosupression.
– Require medication to control epilepsy.
– Use or require topical corticosteroids on a repeated monthly basis.
– Use steroid inhalers on a regular basis.
Since ciclopirox has not been studied in those populations.
Do not light a cigarette or come into contact with fire until the preparation has completely dried.

Where Batrafen Nail Laquer has come into contact with skin adjacent to the nail, reddening and desquamation have been observed in very rare cases. Rare cases of allergic contact dermatitis have occurred.

Not known.

The use of Batrafen Nail Laquer in children under 12 years old and during pregnancy and lactation is not indicated because of a lack of clinical experience.

Shelf life: The preparation should not be used after the expiry date.
Once the bottle has been opened, Batrafen Nail Laquer has a shelf life of 6 months provided it is stored correctly.