TRAVOCORT Cream Ref.[8251] Active ingredients: Diflucortolone Isoconazole

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: Bayer Limited, The Atrium, Blackthorn Road, Dublin 18, Ireland

Therapeutic indications

Initial or interim treatment of those superficial fungal infections of the skin which are accompanied by highly inflammatory or eczematous skin conditions, e.g. in the region of the hands, the interdigital spaces of the feet and in the inguinal and genital regions.

Posology and method of administration

Cutaneous use.

Travocort should be applied twice daily to the diseased areas of skin.

Treatment with Travocort must be terminated after regression of the inflammatory or eczematous skin conditions or at the latest after 2 weeks and therapy continued or followed up with a glucocorticoid-free anti-fungal preparation. This applies in particular for use in the inguinal and genital regions.

Paediatric population

Dose adjustments are not required when Travocort is administered to children aged 2 years or older and adolescents.

Only limited data on the safety of Travocort in children aged below 2 years are available, for more details see section 5.1.

Overdose

Results from acute toxicity studies do not indicate that any risk of acute intoxication is to be expected following a single dermal application of an overdose (application over a large area under conditions favourable to absorption) or inadvertent oral ingestion.

Shelf life

3 years.

Special precautions for storage

Do not store above 30ยบC.

Nature and contents of container

Tube with 15 g made of pure aluminium, interior wall coated with epoxy resin, and with a polyester-based external coating, fold seal ring is made of polyamide based heat sealable material. The screw cap is made of high density polyethylene.

Special precautions for disposal and other handling

No special requirements.

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