DAKTARIN INTENSIV Cream (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Daktarin Intensiv Cream.
Qualitative and quantitative composition
Ketoconazole 2% w/w. Excipients include: propylene glycol, stearyl alcohol, cetyl alcohol. For full list of excipients, see section 6.1.
Pharmaceutical form
Cream. White homogenous cream.
Therapeutic indications
For the treatment of the following mycotic infections of the skin: tinea pedis and tinea cruris.
Posology and method of administration
Ketoconazole cream is for use in adults. For the treatment of tinea pedis (athletes foot) and tinea cruris (dhobie itch). <u>Tinea cruris and tinea pedis:</u> It is recommended that Daktarin Intensiv Cream ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Special warnings and precautions for use
Daktarin Intensiv cream is not for ophthalmic use. To prevent a rebound effect after stopping a prolonged treatment with topical corticosteroids it is recommended to continue applying a mild topical corticosteroid ...
Interaction with other medicinal products and other forms of interaction
None known.
Pregnancy and lactation
There are no adequate and well-controlled studies in pregnant or lactating women. To date, no other relevant epidemiological data are available. Data on a limited number of exposed pregnancies indicate ...
Effects on ability to drive and use machines
This medicine has no influence on the ability to drive and use machines.
Undesirable effects
The safety of ketoconazole cream was evaluated in 1079 subjects who participated in 30 clinical trials. Ketoconazole cream was applied topically to the skin. Based on pooled safety data from these clinical ...
Overdose
Topical application. Excessive topical application may lead to erythema, oedema and a burning sensation, which will disappear upon discontinuation of the treatment. In the event of accidental ingestion, ...
Pharmacodynamic properties
ATC code: D01AC08 Ketoconazole has a potent antimycotic action against dermatophytes and yeasts. Ketoconazole cream acts rapidly on the pruritus, which is commonly seen in dermatophyte and yeast infections. ...
Pharmacokinetic properties
Plasma concentrations of ketoconazole were not detectable after topical administration of ketoconazole Cream in adults on the skin. In one study in infants with seborrhoeic dermatitis (n=19), where approximately ...
Preclinical safety data
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
List of excipients
Propylene glycol Stearyl alcohol Cetyl alcohol Sorbitan stearate Polysorbate 60 Isopropyl myristate Sodium sulphite anhydrous (E221) Polysorbate 80 Purified water
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Tube made of 99.7% aluminum, lined on inner side with heat polymerised epoxyphenol resin with a latex coldseal ring at the end of the tube. The cap is made of 60% polypropylene, 30% calcium carbonate and ...
Special precautions for disposal and other handling
No special requirements. Any unused medicinal products or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
McNeil Products Limited, 50–100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, United Kingdom
Marketing authorization number(s)
PL 15513/0181
Date of first authorization / renewal of the authorization
16/12/2009
Date of revision of the text
02 November 2020
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: