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DUBINE Cream (2018)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα

Name of the medicinal product

Dubine 10 mg/g cream.

Qualitative and quantitative composition

Each gram of cream contains 10 mg of ozenoxacin. Excipient(s) with known effect: Each gram of cream contains 1mg of benzoic acid (E-210), 150 mg of propylene glycol and 40 mg of stearyl alcohol. For the ...

Pharmaceutical form

Cream. Pale yellow, homogeneous cream.

Therapeutic indications

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 ...

Posology and method of administration

Adults, adolescents, children, and infants aged 6 months and older 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 ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Treatment of bullous impetigo with ozenoxacin is not recommended (see section 5.1). Safety and efficacy have not been established in the following: Bullous impetigo Impetigo lesions exceeding 100 cm² in ...

Interaction with other medicinal products and other forms of interaction

The effect of concurrent application of ozenoxacin and other topical medicinal products to the same area of skin has not been studied, and it is not recommended. In human liver microsomes, ozenoxacin showed ...

Fertility, pregnancy and lactation

Pregnancy There are no data from the use of ozenoxacin in pregnant women. Studies in animals have shown reproductive toxicity after oral exposure (see section 5.3). No effects during pregnancy are anticipated, ...

Effects on ability to drive and use machines

Dubine has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile In clinical studies in which 559 patients with superficial skin infections applied ozenoxacin cream, the most commonly reported adverse reaction was application site irritation, ...

Overdose

Any sign or symptom of overdose, either topically or by accidental ingestion, should be treated symptomatically. No specific antidote is known.

Pharmacodynamic properties

Pharmacotherapeutic group: Antibiotics and chemotherapeutics for dermatological use, Antibiotics for topical use ATC code: D06AX14 Mechanism of action Ozenoxacin is a non-fluorinated quinolone with a dual ...

Pharmacokinetic properties

Absorption No detectable systemic exposure levels were observed in adult healthy volunteers and in adult patients with impetigo following repeated topical application of ozenoxacin 10 mg/g cream for up ...

Preclinical safety data

Repeated dose studies Topically administered, ozenoxacin was well tolerated. Plasma levels of ozenoxacin after single dermal administration were below LOQ while only low systemic exposure was detected ...

List of excipients

Macrogol stearate Ethylene glycol monopalmitostearate Oleoyl macrogol glycerides Octyldodecanol Stearyl alcohol Propylene glycol Benzoic acid (E210) Purified water

Incompatibilities

Not applicable.

Shelf life

Shelf life Unopened tube: 3 years. In-use stability after first opening: 45 days.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

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.

Special precautions for disposal and other handling

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 ...

Marketing authorization holder

Ferrer Internacional, S.A., Gran Vía Carlos III, 94, 08028, Barcelona, Spain

Marketing authorization number(s)

PA1744/003/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 16<sup>th</sup> June 2017

Date of revision of the text

July 2018

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