DERMOVATE Scalp application (2021)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
Εκδότης | GlaxoSmithKline UK |
---|---|
Διεύθυνση | Stockley Park West, Uxbridge, Middlesex, UB11 1BT |
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Περιεχόμενα
Name of the medicinal product
Dermovate Scalp Application.
Qualitative and quantitative composition
Each 1 g contains 0.5 mg of clobetasol propionate (0.05% w/w).
Pharmaceutical form
Scalp application.
Therapeutic indications
Clobetasol propionate is a very potent topical corticosteroid which is indicated for use in short courses for conditions which do not respond satisfactorily to less active steroids. It is indicated for ...
Posology and method of administration
<b>Clobetasol propionate belongs to the most potent class of topical corticosteroids (Group IV) and prolonged use may result in serious undesirable effects (see section 4.4). If treatment with a local ...
Contraindications
Infections of the scalp. Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Dermatoses in children under one year of age, including dermatitis.
Special warnings and precautions for use
Cases of osteonecrosis serious infections (including necrotizing fasciitis) and systemic immunosuppression (sometimes resulting in reversible Kaposis sarcoma lesions) have been reported with long-term ...
Interaction with other medicinal products and other forms of interaction
Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir and itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to which ...
Fertility, pregnancy and lactation
Pregnancy There are limited data from the use of clobetasol in pregnant women. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development (see section 5.3). ...
Effects on ability to drive and use machines
There have been no studies to investigate the effect of clobetasol on driving performance or the ability to operate machinery. A detrimental effect on such activities would not be anticipated from the ...
Undesirable effects
Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), ...
Overdose
Symptoms Topically applied clobetasol may be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Corticosteroids, very potent (group IV) <b>ATC code:</b> D07AD Mechanism of action Topical corticosteroids act as anti-inflammatory agents via multiple mechanisms to inhibit ...
Pharmacokinetic properties
Absorption Topical corticosteroids can be systemically absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle ...
Preclinical safety data
Carcinogenesis / Mutagenesis Carcinogenesis Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate. Genotoxicity Clobetasol propionate was not ...
List of excipients
Carbomer Isopropyl Alcohol Sodium Hydroxide Purified Water
Incompatibilities
None known.
Shelf life
Unopened: 24 months. Opened: 3 months.
Special precautions for storage
Do not store above 30°C. Keep container tightly closed when not in use. Contents are flammable. Keep away from fire, flame or heat. Do not leave Dermovate Scalp Application in direct sunlight.
Nature and contents of container
White High Density Polyethylene (HDPE) container with a white low density polyethylene (LDPE) nozzle and a white HDPE screw cap. Pack size: 25ml, 30ml, 100ml. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Patients should be advised to wash their hands after applying Dermovate Scalp Application. For detailed instructions for use refer to the Patient Information Leaflet in every pack. Do not use near a naked ...
Marketing authorization holder
Glaxo Wellcome UK Ltd trading as Glaxo Laboratories and/or GlaxoSmithKline UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS
Marketing authorization number(s)
PL 10949/0046
Date of first authorization / renewal of the authorization
Date of first authorisation: 01 April 1993 Date of last renewal: 24 February 2010
Date of revision of the text
22 March 2021
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