TRAVOGEN CREAM DERM 20G 1%

TRAVOGEN 1% CREMA

active ingredients

1 g of Travogen cream contains: 10 mg of nitrate isoconazole (equivalent to 1% (p/p) of nitrate isoconazole). Excipients with known effects: cetostearilic alcohol 5% (p/p). For the full list of excipients, see paragraph 6.1

Excellent

Polysorbed 60, stearate sorbitan, cetostearilic alcohol, liquid paraffin, white vaseline, purified water.

Therapeutic indications

Surface mycosis (dermatitis, candidiasis, pityriasis versicolor) erythrax.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Population: Unless otherwise prescribed, the condition of Travogen is 1 application per day on the affected skin area. A local treatment of mycetic infections must generally have the duration of 2-3 weeks and sometimes even of 4 in cases of refractory infections. On specific medical prescription treatments are also possible longer duration. To avoid recurrence, treatment should be continued for at least two weeks after clinical healing. Pediatric population: Dosing adjustments are not necessary when Travogen is administered to infants, children and adolescents. Although the clinical experience in the pediatric population is much more limited, the medicine can be used in subjects of this age according to medical indication. Method of administration: Skin use.

Conservation

Store at a temperature not exceeding 25°C.

Warnings

To ensure the good success of the treatment it is necessary to carefully observe some hygienic precautions among which to carefully dry the interdigital spaces in case of mycosis located at the feet. Often it is appropriate, in case of interdigital lesions, to insert between the fingers an impregnated gauze tablet of Travogen cream. In case of application to the face, avoid placing the product in contact with the eyes. The doctor must inform the patient about hygiene and skin care measures to be taken during treatment. Wash your hands thoroughly after using the medicine. If Travogen is applied in the genital region, excipients liquid paraffin and white vaseline can reduce the resistance of latex products as condoms and diaphragms so as to compromise its effectiveness. The use, especially if prolonged, of products for topical use can give rise to awareness-raising phenomena. In this case it is necessary to stop the treatment and establish adequate therapy. It is not recommended to use the medicinal product in infants (0-2 years) if not in cases of actual need and under strict medical control, as the data in subjects of this age is very limited. It should be borne in mind that it is not known what isoconazole effect could have on the liver metabolism by the CYP450 system, if it was ingested following the sucking of the treated part. This medicine contains cetosterial alcohol therefore can cause local skin reactions (e.g. contact dermatitis).

Interactions

Crusade sensitivity reactions between isoconazole, miconazole, econazole and tioconazole are possible.

Effects

In clinical studies, adverse reactions observed with Travogen most frequently included: burning and irritation at the application site level. The frequency of adverse reactions observed in clinical studies and shown in the table below are defined according to the MedDRA frequency convention: common (from ≥1/100 to Organic systemic classification Municipalities Not common Rare Frequency not known General conditions and conditions at the site of administration Application site: - irritation; - burning Application site: - dryness; - itching Application site: - swelling - cracking Application site: - erythema, bladders Pathologies of skin and subcutaneous tissue   Eczema exudativo Disidrosis Contact Dermatitis   Skin allergic reactions Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

The results of acute toxicity studies showed no risk of acute intoxication as a result of a single epidermal application of an excessive dose (application on a wide area under conditions favourable to absorption). In case of accidental intake of an excessive dose of Travogen use appropriate support therapy.

Pregnancy: Experience with the use of preparations containing isoconazole nitrate during pregnancy does not indicate teratogenic risks to man. It is recommended to use in pregnancy, after consulting the doctor. Nursing: It is not known whether nitrate isoconazole is excreted in human breast milk. It is not possible to exclude exposure risks for the infant. Breastfeeding women should not apply the medicine on the nipples to avoid the accidental ingestion of Travogen by the child. The administration of Travogen during breastfeeding should only be taken into account if the expected benefit for the mother exceeds the risk for the child. Fertility: Preclinical data have not shown any risks to fertility.

Source: Farmadati