DAKTACORT Cream (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Daktacort 2% / 1% w/w cream.
2. Qualitative and quantitative composition
Miconazole nitrate 2% w/w and hydrocortisone 1% w/w. <u>Excipients with known effect:</u> Daktacort contains 2 mg/g benzoic acid (E210). 5 g: This medicine contains 10 mg benzoic acid in each tube of 5 ...
3. Pharmaceutical form
White, homogeneous cream.
4.1. Therapeutic indications
For the topical treatment of inflamed dermatoses where infection by susceptible organisms and inflammation co-exist, eg intertrigo and infected eczema. Moist or dry eczema or dermatitis including atopic ...
4.2. Posology and method of administration
For topical administration. Apply the cream two or three times a day to the affected area, rubbing in gently until the cream has been absorbed by the skin. The properties of Daktacort indicate it particularly ...
4.3. Contraindications
True hypersensitivity to miconazole/miconazole nitrate, other imidazole derivatives, hydrocortisone or to any of the excipients listed in section 6.1. Tubercular or viral infections of the skin or those ...
4.4. Special warnings and precautions for use
When Daktacort is used by patients taking oral anticoagulants, the anticoagulant effect should be carefully monitored. Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been ...
4.5. 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 (see Section 5.2 Pharmacokinetic properties), clinically relevant ...
4.6. Pregnancy and lactation
Pregnancy Clinical data on the use of Daktacort Cream in pregnancy are limited. In animals, corticosteroids are known to cross the placenta and consequently can affect the foetus (see Section 5.3). Administration ...
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
The safety of Daktacort Cream was evaluated in 480 patients who participated in 13 clinical trials (six double-blind and seven open-label trials) of Daktacort Cream. These studies examined patients from ...
4.9. Overdose
Prolonged and excessive use can result in skin irritation, which usually disappears after discontinuation of therapy. Topically applied corticosteroids can be absorbed in sufficient amounts to produce ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Imidazole and triazole derivatives, combinations <b>ATC code:</b> D01AC20 Miconazole nitrate is active against dermatophytes and pathogenic yeasts, and many Gram-positive ...
5.2. Pharmacokinetic properties
Absorption Miconazole remains in the skin after topical application for up to 4 days. Systemic absorption of miconazole is limited, with a bioavailability of less than 1% following topical application ...
5.3. Preclinical safety data
Preclinical data on the drug product (miconazole nitrate + hydrocortisone) revealed no special hazard for humans based on conventional studies of ocular irritation, dermal sensitization, single dose oral ...
6.1. List of excipients
PEG-6, PEG-32 and glycol stearate Oleoyl macroglycerides Liquid paraffin Benzoic acid (E210) Disodium edetate Butylated hydroxyanisole (E320) Purified water
6.2. Incompatibilities
Contact should be avoided between latex products such as contraceptive diaphragms or condoms and Daktacort since the constituents of Daktacort may damage the latex.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Store in a refrigerator (2-8°C).
6.5. Nature and contents of container
Aluminium tube with polypropylene cap. Each tube contains 5 g, 10 g, 15 g, 30 g or 75 g cream.
6.6. Special precautions for disposal and other handling
None.
7. Marketing authorization holder
Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4 EG, UK
8. Marketing authorization number(s)
PL 00242/0042
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 04/02/77 Renewal of authorisation: 24/02/2009
10. Date of revision of the text
04 October 2021
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