Model:7502009746932
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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.