Source: Health Products Regulatory Authority (IE) Revision Year: 2018 Publisher: Ferrer Internacional, S.A., Gran VĂa Carlos III, 94, 08028, Barcelona, Spain
Dubine is indicated for the short term treatment of non-bullous impetigo in adults, adolescents, children, and infants aged 6 months and older) (see sections 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial medicinal products.
A thin layer of cream should be applied to the affected area twice daily for five days. The treated area may be covered by a sterile bandage or gauze dressing, if desired.
Patients not showing a clinical response within three days should be re-evaluated and alternative therapy should be considered.
No dosage adjustment is necessary.
No dosage adjustment is necessary. See section 5.2.
No dosage adjustment is necessary. See section 5.2.
The safety and efficacy of ozenoxacin 10 mg/g cream in children under 6 months of age have not been established.
Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made.
Ozenoxacin is for cutaneous use only.
Any sign or symptom of overdose, either topically or by accidental ingestion, should be treated symptomatically. No specific antidote is known.
Unopened tube: 3 years.
In-use stability after first opening: 45 days.
This medicinal product does not require any special storage conditions.
Aluminium tube with a white screw cap. The tube has an epoxy-phenolic internal lacquer and a sealant lacquer at the tube end.
Dubine is available in tubes containing 10 g of cream.
Once opened, the tube can be re-used for a second treatment, provided that 45 days of in-use shelf-life are not exceeded.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
This medicinal product may pose a risk to the environment (see section 5.3).
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