MEDODERMONE Cream (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Medodermone 0.05% w/w cream.
2. Qualitative and quantitative composition
Each 1 g of cream contains 0.5mg clobetasol propionate. <u>Excipients with known effect:</u> cetostearyl alcohol, methyl-p-hydroxybenzoate and propyl-p-hydroxybenzoate. For the full list of excipients, ...
3. Pharmaceutical form
Cream. White, soft, homogeneous, smooth, odourless cream.
4.1. Therapeutic indications
Clobetasol is a very potent topical corticosteroid indicated for adults, elderly and children over 1 year for the short term treatment only of more resistant inflammatory and pruritic manifestations of ...
4.2. Posology and method of administration
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 corticosteroid ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The following conditions should not be treated with clobetasol: Untreated cutaneous infections Rosacea Acne vulgaris ...
4.4. Special warnings and precautions for use
Clobetasol should be used with caution in patients with a history of local hypersensitivity to other corticosteroids or to any of the excipients in the preparation. Local hypersensitivity reactions (see ...
4.5. Interaction with other medicinal products and other forms of interaction
Co-administered drugs that can inhibit CYP3A4 (eg ritonavir and itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to which this ...
4.6. 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). ...
4.7. 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 ...
4.8. 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), ...
4.9. Overdose
Post-marketing dataSymptoms 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 ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Corticosteroids, very potent (group IV), corticosteroids, plain <b>ATC code:</b> D07AD01 Mechanism of action Topical corticosteroids act as anti-inflammatory agents via ...
5.2. 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 ...
5.3. 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 ...
6.1. List of excipients
Liquid paraffin Cetostearyl alcohol White soft paraffin Cetomacrogol 1000 Methyl-p-hydroxybenzoate (E218) Propyl-p-hydroxybenzoate (E216) Purified water
6.2. Incompatibilities
None known.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Store below 25°C in the original package, in order to protect from moisture.
6.5. Nature and contents of container
PVC screwed-cap pilferproof aluminium tubes of 15 g and 25 g. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
19980
9. Date of first authorization / renewal of the authorization
Date of first authorization: 20/12/2005 Date of latest renewal: 24/05/2017
10. Date of revision of the text
12/2020
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