DAKTARIN Cream (2016)
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 2% Cream.
Qualitative and quantitative composition
Miconazole nitrate 2% w/w.
Excipients:
Benzoic acid, Butylated hydroxyanisole.
For a full list of excipients, see Section 6.1.
Pharmaceutical form
Cream.
White homogeneous cream.
Therapeutic indications
For the treatment of mycotic infections of the skin and nails and superinfections due to Gram-positive bacteria.
Posology and method of administration
Route of administration:
Cutaneous use.
Recommended dosage
For all ages
Fungal infections of the skin
Apply some cream to the lesions two times daily. Rub the cream into the skin with your finger ...
Contraindications
Hypersensitivity to the active substances(s), other imidazole derivatives or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Daktarin Cream must not come into contact with the mucosa of the eyes.
Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Daktarin Cre...
Interaction with other medicinal products and other forms of interaction
Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patie...
Pregnancy and lactation
Pregnancy
In animals miconazole nitrate has shown no teratogenic effects but is foetotoxic at high oral doses. Only small amounts of miconazole nitrate are absorbed following topical administration...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Adverse drug reactions reported among 834 patients who received miconazole nitrate 2% cream (n=426) and/or placebo cream base (n=408) in 21 double-blind clinical trials are presented in Table 1 bel...
Overdose
Symptoms
Cutaneous use:
Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.
Treatment
Daktarin cream is intended for cutaneous use, not for oral...
Pharmacodynamic properties
Pharmacotherapeutic classification:
Antifungals for dermatological/topical use; imidazole derivative
ATC code:
D01AC02
Miconazole nitrate is an imidazole antifungal agent and may act by interfer...
Pharmacokinetic properties
Absorption
There is little absorption through skin or mucous membranes when miconazole nitrate is applied topically.
Distribution
Absorbed miconazole is bound to plasma proteins (88.2%) and red blo...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of local irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.
List of excipients
PEG-6, PEG-32 and glycol stearate
Oleoyl macroglycerides
Liquid paraffin
Benzoic acid (E210)
Butylated hydroxyanisole (E320)
Purified water
Incompatibilities
Not applicable.
Shelf life
Shelf life: 24 months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Aluminium tube inner lined with heat polymerised epoxy-phenol resin with a white polypropylene cap containing 15g, 30g or 70g of cream, or aluminium tube inner lined with heat polymerised epoxy-phe...
Special precautions for disposal and other handling
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire, SL6 3UG, United Kingdom
Marketing authorization number(s)
PL 15513/0307
Date of first authorization / renewal of the authorization
01/04/2009
Date of revision of the text
08 August 2016
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
