Isoconazole Nitrate 1% Cream 1gr

ICALIV

Isoconazole Nitrate 1%

Cream

 

 

COMPOSITION:

 

Each 100g contains:

Isoconazole Nitrate …… ..1.00 g

Excipients csp

 

For the full list of ingredients, see List of excipients.

 

CLINICAL DATA

 

THERAPEUTIC INDICATIONS

Superficial fungal infections of hairless skin, for example, the interdigital spaces of the

feet and hands, the groin and genital area.

 

DOSAGE AND METHOD OF ADMINISTRATION.

 

Dosage

Unless otherwise directed by the doctor, Icaliv is applied once a day to the affected areas of

the skin.

 

In general, a local treatment of fungal infections should be applied for a period of 2 to 3

weeks, also up to 4 weeks in case of persistent infections (especially in areas

interdigital). It is often recommended to apply a gauze soaked with Travogen cream between the

fingers or toes. Longer periods of treatment are possible, through a

formal prescription.

To avoid recurrences, treatment should be continued for at least 2 weeks after

clinical recovery.

 

Pediatric patients

No dose adjustment is necessary when Icaliv is administered to infants, children or adolescents.

 

FORM OF ADMINISTRATION

 

Cutaneous route

 

COUNTER-INDICATIONS

 

Hypersensitivity to the active substance or to any of the excipients included in the list of excipients.

 

WARNINGS AND SPECIAL PRECAUTIONS FOR USE.

 

When used on the face, care must be taken that Icaliv does not come into contact with the eyes.

 

If necessary, the doctor should inform the patient about hygiene measures and care of the

skin to be applied during treatment.

If Icaliv is applied to the genitals, mineral oil (excipient contained in the medicine)

can damage latex products used simultaneously as barrier methods, such as

condoms and diaphragms; The effectiveness of these products may be reduced.

SHEET PROJECT

Icaliv contains cetyl alcohol which can cause local skin reactions (for example, dermatitis

contact).

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION.

No interaction studies have been performed.

FERTILITY, PREGNANCY AND LACTATION.

Pregnancy

Experience with the use of isoconazole preparations during pregnancy does not indicate the risk of

teratogenic effects in humans.

Lactation

It is not known whether isoconazole nitrate is excreted in human milk. A risk cannot be excluded

for babies.

Lactating women should avoid the use of Icaliv on the nipples to avoid absorption by part

of the baby.

Fertility

Preclinical data do not indicate a risk to fertility.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES.

No effects have been observed on the ability of patients treated with Icaliv to drive and

use machines.

 

OVERDOSE

The results of acute toxicity studies do not indicate a risk of acute poisoning after

from a single application of an excessive dose to the skin (application to a large area under conditions

favorable for absorption) or after involuntary oral ingestion.