Emovate

Informazioni principali

  • Nome commerciale:
  • Emovate Salbe
  • Forma farmaceutica:
  • Salbe
  • Composizione:
  • clobetasoni-17 butyras 0.5 mg, excipiens annuncio unguentum pro 1 g.
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco biologico

Documenti

  • per i professionisti:
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.


    Richiedi il foglio illustrativo per i professionisti.

Localizzazione

  • Disponibile in:
  • Emovate Salbe
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Entzündliche, nicht infizierte Dermatosen

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 43143
  • Data dell'autorizzazione:
  • 25-08-1980
  • Ultimo aggiornamento:
  • 19-10-2018

Foglio illustrativo: composizione, posologia, indicazioni, interazioni, gravidanza, allattamento, effetti indesiderati, controindicazioni

Patienteninformation

Emovate®

GlaxoSmithKline AG

Che cos'è Emovate e quando si usa?

Emovate contiene come principio attivo un corticosteroide di media potenza per uso topico. Il

preparato si usa per il trattamento di eczemi di diversa origine, reazioni alle punture di insetti,

scottature solari ed altre affezioni cutanee di lieve entità a carattere infiammatorio o allergico. L'uso

di Emovate porta ad un rapido alleviamento dei sintomi concomitanti della malattia cutanea, in

particolare prurito, bruciore o arrossamento.

Emovate si può usare anche per malattie della pelle più ostinate, negli intervalli terapeutici o dopo un

trattamento con corticosteroidi molto potenti.

Emovate si deve usare solo dietro prescrizione del medico.

Quando non si può usare Emovate?

In presenza di rosacea (chiamata comunemente couperose), acne, prurito senza infiammazione,

reazioni infiammatorie attorno alla bocca e dermopatie da virus (p. es. infezioni erpetiche quali

herpes labiale, varicella, ecc.), da batteri o da funghi. Inoltre, Emovate non deve essere applicato su

ferite aperte o infiammazioni purulente quali p. es. foruncoli od ascessi.

Quando è richiesta prudenza nell’uso di Emovate?

Emovate è un medicamento molto efficace. Non oltrepassi la durata di trattamento prescritta dal

medico, che normalmente è di 2-3 settimane, poiché altrimenti possono insorgere danni alla pelle.

Se l'affezione cutanea non risponde al trattamento entro alcuni giorni o se addirittura peggiora,

consulti il suo medico. Inoltre, deve segnalare al medico l'insorgenza di prurito, arrossamento,

vescicole, forte assottigliamento della pelle o lesioni.

Informi il suo medico, se è allergico al clobetasone o a uno degli altri componenti del medicamento.

Questo medicamento non va utilizzato ogni giorno ininterrottamente per più di quattro settimane.

Va evitato l'uso del prodotto su superfici estese (più del 10% della superficie corporea) nonché su

aree cutanee ad assorbimento più intenso (ferite aperte, pelle lesa, pieghe della pelle, incavo di

articolazioni, spazio tra le dita delle mani o dei piedi, zone di transizione tra pelle e mucosa e zona

perioculare).

Utilizzi bendaggi occlusivi sopra questo medicamento solo dietro indicazione del medico. Se utilizza

Emovate sotto un bendaggio occlusivo, presti attenzione alla pulizia della pelle prima

dell'applicazione di un nuovo bendaggio, al fine di evitare infezioni.

In presenza di eczema nell'area di un'ulcera della gamba, l'impiego di un corticosteroide topico può

aumentare il rischio di reazione allergica o di infezione nell'area dell'ulcera.

Si rivolga al suo medico nel caso in cui sviluppi un'infezione.

Come per tutti i corticosteroidi, si sconsiglia l'applicazione prolungata sulla pelle particolarmente

sensibile del viso e nelle pieghe cutanee.

Emovate non deve entrare in contatto con gli occhi e non deve essere applicato su zone perioculari.

Il trattamento di un'area cutanea estesa o l'applicazione prolungata e ininterrotta, specie in pazienti

pediatrici (bambini e bambini piccoli), vanno eseguiti solo dietro esplicita prescrizione medica. Nel

trattamento dell'eritema da pannolino, i pannolini molto aderenti o i pannolini a mutandina

plastificata favoriscono l'assorbimento del principio attivo nel circolo sanguigno. Se possibile,

quindi, si dovrebbero usare pannolini di stoffa senza mutandina di plastica.

Emovate è destinato esclusivamente all'uso esterno. Come tutti gli altri medicamenti, va conservato

fuori dalla portata dei bambini. Se un bambino dovesse ingerire Emovate, sciacquargli la bocca con

molta acqua e contattare immediatamente il medico o il farmacista.

Il medico le ha prescritto Emovate per curare la sua attuale affezione cutanea. Lo usi solo per tale

scopo e non ne faccia uso in futuro per la cura di altre affezioni cutanee. Non dia Emovate ad altre

persone.

Informi il suo medico o il suo farmacista nel caso in cui

·soffra di altre malattie,

·soffra di allergie o

·assuma o applichi esternamente altri medicamenti (anche se acquistati di sua iniziativa!).

Si può impiegare Emovate durante la gravidanza o l'allattamento?

Sebbene finora non siano stati riscontrati effetti dannosi sul nascituro quando Emovate è stato usato

durante la gravidanza, esperimenti fatti su animali indicano un rischio di malformazioni.

Durante la gravidanza, o se si intende iniziare una gravidanza, deve impiegare Emovate

esclusivamente su indicazione del medico. Lo stesso vale durante l'allattamento. Se dovesse

utilizzare ugualmente Emovate durante l'allattamento, non lo applichi nella zona del seno, al fine di

evitare che il bambino lo ingerisca inavvertitamente.

Come usare Emovate?

Salvo diversa prescrizione medica, applicare Emovate con parsimonia 1-2 volte al giorno sulle zone

di pelle ammalate.

Si lavi le mani dopo l'applicazione, a meno che il trattamento non riguardi le mani.

Se impiega anche un prodotto per la cura della pelle (crema idratante), attenda l'assorbimento

completo di Emovate prima di applicare il prodotto di cura.

Se ha dimenticato un'applicazione di Emovate, la esegua non appena se ne ricorda e poi prosegua il

trattamento come di consueto. Non applichi una quantità maggiore di medicamento, se ha

dimenticato la precedente applicazione.

Non modifichi di propria iniziativa la posologia prescritta. Se ritiene che l'azione del medicamento

sia troppo debole o troppo forte, ne parli al suo medico o al suo farmacista.

Quali effetti collaterali può avere Emovate?

Con l'applicazione di Emovate possono manifestarsi i seguenti effetti collaterali: effetti indesiderati

locali quali irritazioni della pelle, bruciore, prurito e secchezza, come pure reazioni di ipersensibilità.

Qualora insorgessero sintomi di ipersensibilità, si deve interrompere subito il trattamento ed

informarne il medico.

Con l'uso di bendaggi occlusivi (soprattutto fogli di plastica) o dopo uso prolungato possono

manifestarsi i seguenti effetti collaterali: assottigliamento della pelle, formazione di strie, dilatazione

di piccoli vasi sanguigni cutanei superficiali, modifiche della pigmentazione, aumento di

peso/sovrappeso, faccia a forma di luna ed aumento della peluria corporea. Nei bambini,

specialmente nei lattanti e nei bambini piccoli, bisogna tener presente che il principio attivo viene

assorbito nel circolo sanguigno in misura maggiore, per cui, in caso di uso prolungato, possono

insorgere, tra l'altro, disturbi della crescita. Inoltre, i pannolini possono avere l'effetto di un

bendaggio occlusivo.

Se osserva effetti collaterali qui non descritti dovrebbe informare il suo medico o il suo farmacista.

Di che altro occorre tener conto?

Il medicamento non dev'essere utilizzato oltre la data indicata con «EXP» sul contenitore.

Emovate va conservato nella confezione originale, a temperatura ambiente (15-25 °C) e fuori dalla

portata dei bambini.

Il suo medico o il suo farmacista, che sono in possesso di un'informazione professionale dettagliata,

possono darle ulteriori informazioni.

Cosa contiene Emovate?

1 g di Emovate crema contiene 0,5 mg di clobetasone-17-butirrato quale principio attivo e il

conservante clorocresolo in una base lavabile.

1 g di Emovate unguento contiene 0,5 mg di clobetasone-17-butirrato quale principio attivo in una

base grassa non lavabile.

Numero dell’omologazione

43142, 43143 (Swissmedic).

Dov'è ottenibile Emovate? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica.

Emovate crema: 25 g e 30 g.

Emovate unguento: 25 g e 30 g.

Titolare dell'omologazione

GlaxoSmithKline AG, 3053 Münchenbuchsee.

Questo foglietto illustrativo è stato controllato l'ultima volta nel febbraio 2014 dall'autorità

competente in materia di medicamenti (Swissmedic).

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Europe -DG Health and Food Safety

15-8-2018

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)5555 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/17/T/01

Europe -DG Health and Food Safety

7-8-2018

EU/3/18/1996 (Worphmed Srl)

EU/3/18/1996 (Worphmed Srl)

EU/3/18/1996 (Active substance: Melatonin) - Transfer of orphan designation - Commission Decision (2018)5409 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/227/17/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/18/2013 (Roche Registration GmbH)

EU/3/18/2013 (Roche Registration GmbH)

EU/3/18/2013 (Active substance: Polatuzumab vedotin) - Transfer of orphan designation - Commission Decision (2018)5054 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/231/17/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Active substance: Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin) - Transfer of orphan designation - Commission Decision (2018)5049 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/066/17/T/01

Europe -DG Health and Food Safety

26-7-2018

Regulatory and procedural guideline:  EudraVigilance release notes v.1.17

Regulatory and procedural guideline: EudraVigilance release notes v.1.17

This document lists and briefly describes the following areas for the releases of EVWEB starting with the release on 22 November 2017.

Europe - EMA - European Medicines Agency

18-7-2018

Agenda:  Agenda - CVMP agenda of the 17-19 July 2018 meeting

Agenda: Agenda - CVMP agenda of the 17-19 July 2018 meeting

Committee for Medicinal Products for Veterinary Use - Draft agenda of July 2018 meeting

Europe - EMA - European Medicines Agency

17-7-2018

Attivazione nuova piattaforma "OsSC" e progetto “Fast Track” (17/07/2018)

Attivazione nuova piattaforma "OsSC" e progetto “Fast Track” (17/07/2018)

L’Agenzia Italiana del Farmaco comunica l’attivazione della nuova versione dell’Osservatorio sulle Sperimentazioni Cliniche (OsSC), che sarà operativa a partire dal 18 luglio 2018 alle ore 14:00. La nuova versione sarà accessibile al link https://servizionline.aifa.gov.it/, dove apparirà nella sezione “Servizi in Single Sign-On” una voce “Osservatorio sulla sperimentazione clinica - OsSC”, con le utenze già attive con la precedente versione.

Italia - AIFA - Agenzia Italiana del Farmaco

17-7-2018

Agenda:  Agenda - COMP agenda of the 17-19 July 2018 meeting

Agenda: Agenda - COMP agenda of the 17-19 July 2018 meeting

Draft agenda for the meeting on 17-19 July 2018

Europe - EMA - European Medicines Agency

17-7-2018

Rebif (Merck Serono Europe Limited)

Rebif (Merck Serono Europe Limited)

Rebif (Active substance: Interferon beta-1a) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4780 of Tue, 17 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/136/T/135

Europe -DG Health and Food Safety

17-7-2018

Naglazyme (BioMarin International Limited)

Naglazyme (BioMarin International Limited)

Naglazyme (Active substance: galsulfase) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4782 of Tue, 17 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/640/T/72

Europe -DG Health and Food Safety

17-7-2018

Firdapse (BioMarin Europe Ltd)

Firdapse (BioMarin Europe Ltd)

Firdapse (Active substance: amifampridine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4779 of Tue, 17 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1032/T/57

Europe -DG Health and Food Safety

17-7-2018

Karvea (Sanofi-Aventis groupe)

Karvea (Sanofi-Aventis groupe)

Karvea (Active substance: Irbesartan) - Centralised - Yearly update - Commission Decision (2018)4781 of Tue, 17 Jul 2018

Europe -DG Health and Food Safety

17-7-2018

Comunicazione EMA su medicinali contenenti il principio attivo valsartan (17/07/2018)

Comunicazione EMA su medicinali contenenti il principio attivo valsartan (17/07/2018)

E’ attualmente in corso la revisione da parte dell’ Agenzia Europea dei Medicinali (EMA) dei medicinali a base di valsartan in relazione a un'impurezza riscontrata nella sostanza attiva prodotta da Zhejiang Huahai Pharmaceuticals. L'impurezza - N-nitrosodimetilammina (NDMA) - è classificata come probabile cancerogeno per l'uomo, in base ai risultati di test di laboratorio, e potrebbe causare il cancro nell’uso a lungo termine. Nelle ultime due settimane, le autorità sanitarie nazionali hanno richiamato i...

Italia - AIFA - Agenzia Italiana del Farmaco

17-7-2018

Agenda:  Agenda - Follow up information session on the TransCelerate initiative, 17 July 2018

Agenda: Agenda - Follow up information session on the TransCelerate initiative, 17 July 2018

Follow up information session on the TransCelerate initiative

Europe - EMA - European Medicines Agency

12-7-2018

Tabelle farmaci di classe A e H al 17/04/2018

Tabelle farmaci di classe A e H al 17/04/2018

Al fine di consentire la prescrizione per principio attivo disposta dall’articolo 15, comma 11-bis, del decreto legge 6 luglio 2012 n.95, convertito con modificazioni dalla Legge 7 agosto 2012 n. 135, l’Agenzia Italiana del Farmaco rende disponibili per tutti gli Operatori sanitari, le tabelle contenenti l’elenco dei farmaci di fascia A, dispensati dal Servizio sanitario Nazionale, ordinati rispettivamente per principio attivo e per nome commerciale.

Italia - AIFA - Agenzia Italiana del Farmaco

9-7-2018

 Minutes of the PRAC meeting 14-17 May 2018

Minutes of the PRAC meeting 14-17 May 2018

Europe - EMA - European Medicines Agency

29-6-2018

EU/3/07/505 (Faron Pharmaceuticals Limited)

EU/3/07/505 (Faron Pharmaceuticals Limited)

EU/3/07/505 (Active substance: Interferon beta) - Amendment of orphan designation - Commission Decision (2018)4186 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/080/17

Europe -DG Health and Food Safety