CLARELUX Cutaneous foam (2018)
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
<u>Active substance:</u> Each gram of cutaneous foam contains 500 micrograms of clobetasol propionate. 500 micrograms of clobetasol propionate are equivalent to 440 micrograms of clobetasol. <u>Excipients ...
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
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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