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SPC, UK: CANESTEN Cream (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Canesten Bifonazole Once Daily 1% w/w Cream. Canesten Bifonazole Once Daily Athletes Foot 1% w/w Cream.

Qualitative and quantitative composition

The cream contains 1% w/w bifonazole. Excipient with known effect: cetostearyl alcohol. For excipients see section 6.1.

Pharmaceutical form

A white cream.

Therapeutic indications

Treatment of athletes foot. The preparation is not for vaginal use.

Posology and method of administration

The cream should be thinly applied and rubbed into the affected areas once daily, preferably at night before retiring, for two to three weeks. The affected areas should be washed and dried thoroughly before ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Treatment of infants with nappy rash. Treatment of nail and scalp infections.

Special warnings and precautions for use

This product contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). If unsure of diagnosis, the patient should seek the advice of a doctor or pharmacist before using ...

Interaction with other medicinal products and other forms of interaction

Limited data suggest that an interaction between topical bifonazole and warfarin may be possible, leading to increases in INR. If bifonazole is used in a patient on warfarin therapy they should be appropriately ...

Fertility, pregnancy and lactation

Pregnancy There are no clinical data from the use of bifonazole in pregnant women. Studies in animals have shown reproductive toxicity at high oral doses (see section 5.3) however these effects should ...

Effects on ability to drive and use machines

Bifonazole cream has no or negligible influence on the ability to drive or use machines.

Undesirable effects

Immune system disorders: Very rarely, systemic hypersensitivity reactions may occur. The following adverse drug reactions are based on spontaneous reports, thus the frequency of individual events is not ...

Overdose

No risk of acute intoxication is seen as it is unlikely to occur following a single dermal application of an overdose (application over a large area under conditions favorable to absorption) or inadvertent ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antifungals for dermatological use – Bifonazole ATC Code: D01AC10 Bifonazole is an imidazole derivative with a broad antimycotic spectrum, which includes dermatophytes, yeasts, ...

Pharmacokinetic properties

Absorption Bifonazole penetrates well into infected skin layers. 6 hours after administration concentrations in the various skin layers reach from 1000 μg/cm³ in the top layer of the epidermis (stratum ...

Preclinical safety data

Toxicological studies showed good local tolerability of topical formulations. With bifonazole cream and solution slight skin irritant effects were observed which could be attributed to the excipients 2-octyldodecanol ...

List of excipients

Sorbitan stearate Polysorbate 60 Cetyl palmitate Cetostearyl alcohol 2-Octyldodecanol Benzyl alcohol Purified Water

Incompatibilities

None known.

Shelf life

Shelf life: 60 months.

Special precautions for storage

None.

Nature and contents of container

Aluminium tubes containing 15g, 20g, 25g or 30g of cream.

Special precautions for disposal and other handling

None.

Marketing authorization holder

Bayer plc, 400 South Oak Way, Reading, RG2 6AD

Marketing authorization number(s)

PL 00010/0508

Date of first authorization / renewal of the authorization

28/11/2007

Date of revision of the text

18/07/2018

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