BETESIL Plaster (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
BETESIL 2.250 mg medicated plaster.
2. Qualitative and quantitative composition
Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone). Excipients with known effect: methyl parahydroxybenzoate (2.250 mg), propyl ...
3. Pharmaceutical form
Medicated plaster. Colourless plaster.
4.1. Therapeutic indications
BETESIL is indicated in adults. Treatment of inflammatory skin disorders which do not respond to treatment with less potent corticosteroids, such as eczema, lichenification, lichen planus, granuloma annulare, ...
4.2. Posology and method of administration
Posology Apply the medicated plaster to the skin area to be treated once a day. Do not exceed the maximum daily dose of six medicated plasters and the maximum treatment period of 30 days. A new medicated ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Cutaneous tuberculosis and viral skin infections (including vaccinia pustules, herpes zoster and herpes simplex). ...
4.4. Special warnings and precautions for use
In general, use of topical corticosteroids on large areas of the body and for prolonged periods, as well as the use of occlusive dressing can cause a temporary suppression of the hypothalamus-pituitaryadrenal ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. At recommended doses, betamethasone valerate for topical use is not known to cause medically significant drug interactions. BETESIL did not show significant ...
4.6. Fertility, pregnancy and lactation
Pregnancy Topical administration of corticosteroids to pregnant laboratory animals may cause impairment of foetal maturation. The importance of this preclinical data has not been evaluated in humans: however, ...
4.7. Effects on ability to drive and use machines
BETESIL has no or negligible influence on the ability to drive and use machine.
4.8. Undesirable effects
The commonly reported adverse reactions are skin and subcutaneous tissue disorders, occurring in about 15% of patients treated. These undesirable effects are mainly due to the pharmacological effects of ...
4.9. Overdose
No case of overdose has been reported. Due to the product characteristics and the route of administration, the occurrence of symptoms and signs of corticosteroid overdose is unlikely. However, prolonged ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Corticosteroids, dermatological products: active corticosteroids (group III) <b>ATC code:</b> D07AC01 Betamethasone valerate for topical application is active in the treatment ...
5.2. Pharmacokinetic properties
Corticosteroids applied to the skin are mainly held back by the stratum corneum, and only a small part reaches the dermis where they can be absorbed. Several factors may however favour greater absorption: ...
5.3. Preclinical safety data
There are no significant data from preclinical trials, which may be relevant to physicians other than those already reported in other sections of the Summary of Product Characteristics.
6.1. List of excipients
<u>Plaster:</u> unwoven cloth (polypropylene/polyethylene and rayon fibres) laminated with an ethylenemethyl methacrylate copolymer film. <u>Adhesive layer:<u> sodium hyaluronate, 1,3-butylene glycol, ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years. After opening the sachet: 1 month.
6.4. Special precautions for storage
Do not store above 25°C. Store the medicated plaster in its original sachet in order to preserve its integrity. For storage conditions after first opening of the medicinal product, see section 6.3.
6.5. Nature and contents of container
Boxes: 4 medicated plasters / 8 medicated plasters / 16 medicated plasters Each medicated plaster is packed individually in a paper/polyethylene/aluminium/ethylenemethacrylic acid copolymer sachet. Each ...
6.6. Special precautions for disposal and other handling
Used medicated plasters must not be flushed down toilets. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia 2, 26900, Lodi
8. Marketing authorization number(s)
PL 21039/0009
9. Date of first authorization / renewal of the authorization
Date of first authorization: 12/03/2007 Date of latest renewal: 09/10/2011
10. Date of revision of the text
23 January 2019
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