ETRIVEX Shampoo (2021)
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Περιεχόμενα
1. Name of the medicinal product
Etrivex 500 micrograms/g Shampoo.
2. Qualitative and quantitative composition
One gram of shampoo contains 500 micrograms of clobetasol propionate. <u>Excipient of known effect:</u> One gram of shampoo contains 100 milligrams of Ethanol. For a full list of excipients, see section ...
3. Pharmaceutical form
Shampoo. Viscous, translucent, colourless to pale yellow liquid shampoo with alcoholic odour.
4.1. Therapeutic indications
Topical treatment of moderate scalp psoriasis in adults.
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. Etrivex 500 micrograms/g shampoo must not be applied on skin areas affected by bacterial, viral (varicella, herpes ...
4.4. Special warnings and precautions for use
Hypersensitivity to corticosteroids can be observed. Therefore, Clobetasol propionate, is not recommended in patients who are hypersensitive to other corticosteroids. Cases of osteonecrosis serious infections ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of topical clobetasol propionate in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans ...
4.7. Effects on ability to drive and use machines
Etrivex 500 micrograms/g shampoo has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile During clinical development of Etrivex 500 micrograms/g shampoo, in a total of 558 patients receiving Etrivex 500 micrograms/g shampoo, the most commonly reported adverse ...
4.9. Overdose
Acute overdose is very unlikely to occur, however, in the case of chronic overdose or misuse, the features of hypercortisolism may appear and in this situation, treatment should be discontinued gradually. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Corticosteroids, Very Potent (Group IV) <b>ATC code:</b> D07AD01 Mechanism of action Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, ...
5.2. Pharmacokinetic properties
<em>In vitro</em> liberation –penetration studies on human skin showed that only a small percentage (0.1%) of the applied dose of Etrivex Shampoo can be found in the epidermis (including the stratum corneum) ...
5.3. Preclinical safety data
Non clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single, repeated dose toxicity and genotoxicity. The carcinogenicity of clobetasol has not been ...
6.1. List of excipients
Ethanol Coco alkyl dimethyl betaine Sodium laurethsulfate Polyquaternium-10 Sodium citrate Citric acid monohydrate Purified water
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years. Shelf life after first opening: 6 months.
6.4. Special precautions for storage
Store in the original container in order to protect from light.
6.5. Nature and contents of container
The product is packaged in high density polyethylene (HDPE) bottles of 60 ml or 125 ml fitted with polypropylene snap closures. The HDPE bottle of 30 ml is fitted with polypropylene screw closure. Bottles ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS, UK
8. Marketing authorization number(s)
PL 10590/0052
9. Date of first authorization / renewal of the authorization
28/11/2011
10. Date of revision of the text
7 May 2021
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