DUBINE Cream (2018)
Βιβλιογραφική αναφορά
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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 ...
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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