DAKTARIN Oral gel (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
DAKTARIN Oral Gel.
Qualitative and quantitative composition
Each gram of Daktarin Oral Gel contains 20 mg of miconazole. Excipients with known effect: Alcohol 7.59 mg/g. For the full list of excipients, see 6.1.
Pharmaceutical form
Oral gel. White gel with orange taste.
Therapeutic indications
Oral treatment of candidosis of the oropharynx. Miconazole gel is for use in adults, children and infants 4 months and older. Consideration should be given to official guidance on the appropriate use of ...
Posology and method of administration
For oral administration. 1 measuring spoon (provided) is equivalent to 124 mg miconazole per 5 mL gel. Oropharyngeal candidosis Infants 4-24 months: 1.25 mL (¼ measuring spoon) of gel, applied four times ...
Contraindications
Known hypersensitivity to miconazole, other imidazole derivatives or to any of the excipients listed in section 6.1. In infants less than 4 months of age or in those whose swallowing reflex is not yet ...
Special warnings and precautions for use
Miconazole is systemically absorbed and is known to inhibit CYP2C9 and CYP3A4 (see Section 5.2 Pharmacokinetic Properties) which can lead to prolonged effects of warfarin. Bleeding events, some with fatal ...
Interaction with other medicinal products and other forms of interaction
When using any concomitant medication the corresponding label should be consulted for information on the route of metabolism. Miconazole can inhibit the metabolism of drugs metabolised by the CYP3A4 and ...
Pregnancy and lactation
In animals, miconazole has shown no teratogenic effects but is foetotoxic at high oral doses. The significance of this to man is unknown. However, as with other imidazoles, Daktarin Oral Gel should be ...
Effects on ability to drive and use machines
Daktarin should not affect alertness or driving ability.
Undesirable effects
The safety of Daktarin Oral Gel was evaluated in 111 patients with oral candidiasis or oral mycoses who participated in 5 clinical trials. Of these 111 patients, 88 were adults with oral candidiasis or ...
Overdose
Symptoms In the event of accidental overdose, vomiting and diarrhoea may occur. Treatment Treatment is symptomatic and supportive. A specific antidote is not available.
Pharmacodynamic properties
ATC Code: A01AB09 and A07AC01 Miconazole possesses an antifungal activity against the common dermatophytes and yeasts as well as an antibacterial activity against certain gram-positive bacilli and cocci. ...
Pharmacokinetic properties
Absorption Miconazole is systemically absorbed after administration as the oral gel. Administration of a 60 mg dose of miconazole as the oral gel results in peak plasma concentrations of 31 to 49 ng/mL, ...
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
Purified water Pregelatinised potato starch Alcohol Polysorbate 20 Sodium saccharin Cocoa flavour Orange flavour Glycerol
Incompatibilities
None known.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not Store above 30°C.
Nature and contents of container
Aluminium tubes containing 5g*, 15g*, 30g* 40g* or 80g gel. A 5 ml plastic spoon, marked with a 2.5 ml graduation is provided. * not marketed
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
Marketing authorization number(s)
PL 00242/0048
Date of first authorization / renewal of the authorization
Date of First Authorisation: 19 July 1977 Date of Renewal of Authorisation: 22 May 2008
Date of revision of the text
26 February 2019
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