Prevymis 240 mg/12 ml

Informazioni principali

  • Nome commerciale:
  • Prevymis 240 mg/12 ml Konzentrat zur Herstellung einer Infusionslösung
  • Forma farmaceutica:
  • Konzentrat zur Herstellung einer Infusionslösung
  • Composizione:
  • letermovirum 240 mg, idrossipropil betadexum, natrii chloridum, aqua ad iniectabilia q s. annuncio solutionem pro da 12 ml.
  • 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:
  • Prevymis 240 mg/12 ml Konzentrat zur Herstellung einer Infusionslösung
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Virostatikum

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 66653
  • Data dell'autorizzazione:
  • 05-04-2018
  • Ultimo aggiornamento:
  • 19-10-2018

Foglio illustrativo

Patienteninformation

Prevymis

MSD Merck Sharp & Dohme AG

Che cos’è Prevymis e quando si usa?

Prevymis è un medicamento antivirale che contiene il principio attivo letermovir e che le è stato

prescritto personalmente. Prevymis è un medicamento per gli adulti che hanno ricevuto da poco

tempo un trapianto di midollo osseo. Questo medicamento contribuisce a prevenire la malattia da

CMV («citomegalovirus»).

Quando non si può usare Prevymis?

Se è allergico al letermovir o a un altro componente di questo medicamento (vedere «Cosa contiene

Prevymis?»).

Se assume uno dei seguenti medicamenti:

·Pimozide (contro la sindrome di Tourette)

·Alcaloidi della segale cornuta quali ad esempio l'ergotamina e la diidroergotamina (contro la cefalea

emicranica)

Se assume Prevymis con ciclosporina:

Se assume Prevymis con ciclosporina, non prenda:

·Pitavastatina né simvastatina

Se uno dei punti precedenti corrisponde al suo caso, non assuma Prevymis. In caso di incertezze, si

rivolga al suo medico, al suo farmacista o al suo infermiere prima di assumere Prevymis.

Quando è richiesta prudenza nell’assunzione di Prevymis?

Se prende uno dei seguenti medicamenti, si rivolga al suo medico, al suo farmacista o al suo

infermiere prima di assumere Prevymis:

·Alfentanil (contro i dolori forti)

·Fentanil (contro i dolori forti)

·Chinidina (contro le aritmie cardiache)

Se uno dei punti precedenti corrisponde al suo caso (o se non è sicuro), consulti il suo medico, il suo

farmacista o il suo infermiere, prima di assumere Prevymis.

Bambini e adolescenti

Non è noto se Prevymis sia sicuro ed efficace nelle persone sotto i 18 anni di età, perché Prevymis in

questa fascia di età non è stato ancora esaminato.

Altri medicamenti e Prevymis

Riferisca al suo medico o al suo farmacista, se assume attualmente anche altri medicamenti, se ne ha

assunti fino a poco tempo fa o se ha intenzione di assumerne in un prossimo futuro. Di questi

medicamenti fanno parte quelli soggetti e non soggetti a prescrizione medica, le vitamine e gli

integratori alimentari di origine vegetale. Prevymis può influenzare, infatti, il meccanismo d'azione

di altri medicamenti e, viceversa, il meccanismo d'azione di Prevymis può essere influenzato

dall'assunzione di altri medicamenti. Il suo medico o il suo farmacista le dirà se l'assunzione di

Prevymis assieme ad altri medicamenti è sicura.

Informi il suo medico soprattutto se assume uno dei seguenti medicamenti:

·Alfentanil (contro i dolori forti)

·Fentanil (contro i dolori forti)

·Chinidina (contro le aritmie cardiache)

·Amiodarone (utilizzato per correggere le aritmie cardiache)

·Midazolam (utilizzato come tranquillante)

·Ciclosporina, tacrolimus, sirolimus (per prevenire il rigetto di trapianto)

·Voriconazolo (contro le infezioni da funghi)

·Statine, quali ad esempio atorvastatina pitavastatina, simvastatina, lovastatina, pravastatina,

rosuvastatina (contro i valori elevati di colesterolo)

·Omeprazolo, pantoprazolo (in caso di ulcera gastrica e altri problemi dello stomaco)

·Glibenclamide, repaglinide, rosiglitazone (contro i valori elevati della glicemia)

·Fenitoina (contro le convulsioni)

·Warfarin (come anticoagulante e contro i coaguli di sangue)

Chieda al suo medico o al suo farmacista una lista dei medicamenti che potrebbero avere delle

interazioni con Prevymis.

Il suo medico dovrà eventualmente modificare i medicamenti o il loro dosaggio.

Si informi in maniera approfondita sui medicamenti che assume. Compili una lista dei suoi

medicamenti e la mostri al suo medico o al suo farmacista quando riceve un nuovo medicamento.

Prevymis contiene lattosio

Prevymis contiene lattosio monoidrato. Se soffre di intolleranza al lattosio o se le è stata

diagnosticata un'intolleranza a determinati tipi di zuccheri, chieda consiglio al suo medico prima di

assumere questo medicamento.

Capacità di condurre un veicolo e di utilizzare macchine

Prevymis probabilmente non influisce sulla capacità di condurre un veicolo e di utilizzare macchine.

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 assumere/usare Prevymis durante la gravidanza o l'allattamento?

Gravidanza

Se è in gravidanza o se sospetta o desidera una gravidanza, lo riferisca al suo medico prima di

assumere questo medicamento, perché non è noto se Prevymis possa danneggiare il bambino durante

la gravidanza.

Allattamento

Se è in allattamento o se desidera allattare al seno, informi il suo medico prima di assumere questo

medicamento, perché non è noto se Prevymis passi nel latte materno e venga assunto dal bambino.

Come usare Prevymis?

La dose raccomandata è di 1 compressa una volta al giorno.

·Assuma Prevymis ogni giorno alla stessa ora.

·Assuma il medicamento con o senza i pasti.

·Deglutisca la compressa intera, senza frantumarla, schiacciarla o masticarla.

·Assuma Prevymis esattamente secondo le istruzioni del suo medico.

·Conservi il medicamento nella confezione originale, fino al momento dell'assunzione.

·Si accerti che le compresse di Prevymis non si esauriscano.

Come comportarsi se si assumono troppe compresse di Prevymis?

Se ha assunto un numero eccessivo di compresse PREVYMIS, lo riferisca immediatamente al suo

medico.

Come comportarsi se si dimentica di assumere una compressa di Prevymis?

È molto importante ricordarsi di assumere le dosi di Prevymis.

·Se ha dimenticato di prendere una dose, la assuma non appena se ne accorge. Se però è quasi ora di

prendere la dose successiva, salti la dose dimenticata e assuma la dose successiva come al solito.

·Non prenda mai due dosi di Prevymis per compensare una dose dimenticata.

·Se non è sicuro su cosa fare, si rivolga al suo medico o al suo farmacista.

Non interrompa l'assunzione di Prevymis

Non modifichi di propria iniziativa l'assunzione di Prevymis, senza averne prima parlato con il suo

medico.

In caso di altre domande sull'uso di questo medicamento, si rivolga al suo medico o al suo

farmacista.

Si attenga sempre strettamente alla posologia prescritta dal suo medico. 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 Prevymis?

Come tutti i medicamenti, anche questo medicamento può avere effetti collaterali, sebbene non tutte

le persone li manifestino.

Chieda consiglio al suo medico, se compaiono uno o più dei seguenti effetti collaterali.

Molto comuni: possono interessare più di 1 persona su 10

·Nausea

·Diarrea

·Vomito

·Gonfiore di mani o piedi

·Tosse

·Mal di testa

·Stanchezza/esaurimento

·Dolori addominali.

Occasionali: possono comparire in meno di 1 persona trattata su 100

·Reazioni allergiche (ipersensibilità). I segni possono essere: respiro ansimante, fame d'aria, eruzione

cutanea od orticaria, prurito, gonfiore.

Se osserva effetti collaterali non descritti in questo foglietto illustrativo, dovrebbe informare il suo

medico o il suo farmacista.

Di che altro occorre tener conto?

Prevymis non dev'essere utilizzato oltre la data indicata con «EXP» sull'etichetta e sul contenitore in

cartone. La data di scadenza si riferisce all'ultimo giorno del mese indicato.

Come conservare Prevymis?

Conservare a temperatura non superiore a 30 °C.

Tenere nella confezione blister originale fino al momento dell'uso.

Conservare fuori dalla portata e dalla vista dei bambini.

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

darle ulteriori informazioni.

Cosa contiene Prevymis?

1 compressa rivestita con film contiene:

Principio attivo: letermovir.

Sostanze ausiliarie: cellulosa microcristallina, croscarmellosa sodica, povidone 25, diossido di silicio

colloidale, magnesio stearato e le seguenti sostanze ausiliarie nella pellicola di rivestimento: lattosio

monoidrato, ipromellosa 2910, diossido di titanio, triacetina, ossido di ferro giallo, ossido di ferro

rosso (solo compresse da 480 mg), cera di carnauba come lucidante.

Numero dell’omologazione

66652, 66653 (Swissmedic).

Dov’è ottenibile Prevymis? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica non rinnovabile.

Prevymis confezioni da 240 mg con 1× 28 compresse rivestite con film. (A)

Prevymis confezioni da 480 mg con 1× 28 compresse rivestite con film. (A)

Titolare dell’omologazione

MSD MERCK SHARP & DOHME AG, Lucerna.

Questo foglietto illustrativo è stato controllato l'ultima volta nel gennaio 2018 dall'autorità

competente in materia di medicamenti (Swissmedic).

CCDS-MK8228-MF-032017/ MK8228-CHE-2018-017039

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Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 13 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

8-8-2018

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.

FDA - U.S. Food and Drug Administration

12-10-2018

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6772 of Fri, 12 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/785T/79

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

26-9-2018

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application:   http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/Zsmq00NCdd

FDA - U.S. Food and Drug Administration

24-9-2018

INCRELEX (Ipsen Pharma)

INCRELEX (Ipsen Pharma)

INCRELEX (Active substance: Mecasermin) - Centralised - Yearly update - Commission Decision (2018)6240 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

19-9-2018

Reminder: #FDA site visit proposal solicitation period for the 2018  Experiential Learning Program is currently OPEN through Wednesday,  9/26/18 @ 12 pm EST. Click the link to find more about the  program & to submit your application  https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/FN1mNN65dD

FDA - U.S. Food and Drug Administration

19-9-2018

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Active substance: Memantine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5972 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2660/T/12

Europe -DG Health and Food Safety

14-9-2018

Agenda:  Agenda - CAT agenda of the 12-14 September 2018 meeting

Agenda: Agenda - CAT agenda of the 12-14 September 2018 meeting

Europe - EMA - European Medicines Agency

12-9-2018

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application  https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #FDA #MedicalDevice pic.twitter.com/Kyo5z44Os4

FDA - U.S. Food and Drug Administration

12-9-2018

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Active substance: Brentuximab vedotin) - Centralised - Annual renewal - Commission Decision (2018)5973 of Wed, 12 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2455/R/58

Europe -DG Health and Food Safety

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency

5-9-2018

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application:  https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.usa.gov/xPcpn  #MedicalDevice

FDA - U.S. Food and Drug Administration

7-8-2018

Inlyta (Pfizer Europe MA EEIG)

Inlyta (Pfizer Europe MA EEIG)

Inlyta (Active substance: Axitinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5429 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2406/T/24

Europe -DG Health and Food Safety

7-8-2018

ACMD meeting statement, Meeting 40, 12 April 2018

ACMD meeting statement, Meeting 40, 12 April 2018

Advisory Committee on Medical Devices meeting statement

Therapeutic Goods Administration - Australia

27-7-2018

EU/3/12/1097 (Celgene Europe B.V.)

EU/3/12/1097 (Celgene Europe B.V.)

EU/3/12/1097 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5043 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/158/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1091 (bluebird bio (Germany) GmbH)

EU/3/12/1091 (bluebird bio (Germany) GmbH)

EU/3/12/1091 (Active substance: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene) - Transfer of orphan designation - Commission Decision (2018)5032 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/146/12/T/01

Europe -DG Health and Food Safety