TRAVOCORT Cream (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Travocort 0.1 + 1% w/w Cream.
Qualitative and quantitative composition
Contains 0.1% w/w diflucortolone valerate (1mg/g) and 1% w/w isoconazole nitrate (10mg/g). Excipient with known effect: cetostearyl alcohol. For the full list of excipients, see section 6.1.
Pharmaceutical form
Cream. A white to yellowish opaque cream.
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 ...
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 ...
Contraindications
Tuberculous or syphilitic processes in the area to be treated; virus diseases (e.g. varicella, herpes zoster), rosacea, perioral dermatitis and postvaccination skin reactions in the area to be treated. ...
Special warnings and precautions for use
Specific additional therapy is required for bacterial infections of the skin. Travocort should not be allowed to come into contact with the eyes when being applied to the face. Visual disturbance may be ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of isoconazole nitrate/diflucortolon valerate in pregnant women Studies in animals (mice, rats and rabbits) have shown reproductive toxicity for diflucortolone ...
Effects on ability to drive and use machines
No effects on ability to drive and use machines have been observed in patients treated with Travocort.
Undesirable effects
In clinical studies, most frequently observed adverse reactions included application site irritation and application site burning. Frequencies of adverse reactions observed in clinical studies and given ...
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 ...
Pharmacodynamic properties
Pharmacotherapeutic group: Imidazole and triazole derivatives, combinations ATC Code: D01AC20 Isoconazole nitrate is for use in the treatment of superficial fungal diseases of the skin. It displays a very ...
Pharmacokinetic properties
Isoconazole nitrate Isoconazole penetrates rapidly into human skin from Travocort cream and maximum drug concentrations in the horny layer and in the living skin are present 1 hour after application. High ...
Preclinical safety data
In systemic tolerance studies following repeated dermal and subcutaneous administration, the effect of diflucortolone valerate was that of a typical glucocorticoid. Following repeated dermal application ...
List of excipients
Paraffin, white soft Paraffin, liquid Cetostearyl alcohol Polysorbate 60 Sorbitan stearate Disodium edetate dihydrate Water, purified
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 30ºC.
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 ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Bayer Limited, The Atrium, Blackthorn Road, Dublin 18, Ireland
Marketing authorization number(s)
PA1410/073/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 27 March 1981 Date of last renewal: 27 March 2006
Date of revision of the text
April 2019
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