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SPC, UK: DAKTARIN Intensiv Cream (2017)

Αναφορές

Βιβλιογραφική αναφορά

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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). For tinea pedis, Daktarin Intensiv cream should be applied thinly to the affected ...

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

None.

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

Shelf life: 36 months.

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, Foundation Park, Roxborough Way, Maidenhead, Berkshire, SL6 3UG, 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

24 April 2017

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