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CLARELUX Cutaneous foam (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

CLARELUX 500 micrograms/g cutaneous foam in pressurised container.

Qualitative and quantitative composition

Active substance: Each gram of cutaneous foam contains 500 micrograms of clobetasol propionate. 500 micrograms of clobetasol propionate are equivalent to 440 micrograms of clobetasol. Excipients with known ...

Pharmaceutical form

Cutaneous foam in pressurised container. White foam that breaks down upon contact with skin.

Therapeutic indications

CLARELUX 500 micrograms/g, cutaneous foam in pressurised container is indicated for a short-course treatment of steroid responsive dermatoses of the scalp such as psoriasis, which do not respond satisfactorily ...

Posology and method of administration

Posology Use in adults CLARELUX 500 micrograms/g, cutaneous foam in pressurised container is a highly potent topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts ...

Contraindications

CLARELUX is contraindicated in patients with: hypersensitivity to clobetasol propionate, to other corticosteroids, or to any of the excipients listed in section 6.1; ulcerated lesions, burns; rosacea; ...

Special warnings and precautions for use

Special warnings Hypersensitivity CLARELUX should be used with caution in patients with a history of local hypersensitivity to corticosteroids or to any of the excipients in the preparation. Local hypersensitivity ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

Fertility, pregnancy and lactation

Pregnancy Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development (see section 5.3). There are no adequate and well-controlled studies of clobetasol propionate ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Undesirable effects

Summary of the safety profile As with other topical corticosteroids, prolonged use of large amounts, or treatment of extensive areas can result in adrenocortical suppression. This is likely to be transient ...

Overdose

No overdoses have been reported. Topically applied CLARELUX in pressurised container can be absorbed in sufficient amounts to produce systemic effects. If features of hypercorticoidism appear topical steroids ...

Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids, very potent (group IV) ATC code: D07AD01 Mechanism of action Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and ...

Pharmacokinetic properties

Absorption and distribution The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the carrier, the integrity of the epidermal barrier, the ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity and genotoxicity. No topical studies were performed to assess the safety, pharmacology and the carcinogenic ...

List of excipients

Ethanol anhydrous Purified water Propylene glycol Cetyl alcohol Stearyl alcohol Polysorbate 60 Citric acid anhydrous Potassium citrate Propellant: propane/n-butane/isobutane

Incompatibilities

Not applicable.

Shelf life

Shelf life: 36 months.

Special precautions for storage

Do not store above 25°C. Do not refrigerate. Store upright. The canister contains a pressurised, flammable liquid. Do not use near a naked flame. Do not expose to temperatures higher than 50°C or to direct ...

Nature and contents of container

Pressurised aluminium container closed with an inverted valve, containing 50g or 100g of foam. The inside of the can is lined with a double coated, clear epoxy-phenolic lacquer. Each filled canister is ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Pierre Fabre Dermatologie, 45 Place Abel-Gance, 92100 Boulogne Cedex, France

Marketing authorization number(s)

PL 20693/0004

Date of first authorization / renewal of the authorization

Date of first authorisation: 23/03/2005 Date of last renewal: 29/03/2012

Date of revision of the text

10/07/2018

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