Medrol 16 mg

Informazioni principali

  • Nome commerciale:
  • Medrol 16 mg Tabletten
  • Forma farmaceutica:
  • Tabletten
  • Composizione:
  • methylprednisolonum 16 mg, excipiens pro compresso.
  • 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:
  • Medrol 16 mg Tabletten
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Glucocorticoidi-Therapie

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 24785
  • Data dell'autorizzazione:
  • 09-02-1959
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Medrol®, compresse

Pfizer PFE Switzerland GmbH

Che cos'è Medrol e quando si usa?

Medrol va utilizzato su prescrizione medica.

Medrol contiene il principio attivo metilprednisolone, un ormone sintetico della corteccia surrenale

(corticosteroide). I corticosteroidi sono ormoni che vengono prodotti nel corpo dalle ghiandole

surrenali e che influenzano processi d'importanza vitale, quali il bilancio idrico e il metabolismo dei

sali minerali. Come tutti i corticosteroidi, Medrol esercita un'azione antinfiammatoria e antiallergica.

Medrol Compresse trova indicazione, dietro prescrizione e sotto continuo controllo medico, nel

trattamento di tutte le malattie che richiedono una terapia generale con corticosteroidi, quali:

Affezioni reumatiche come poliartrite cronica, artrosi, infiammazioni reumatiche del cuore, borsiti o

infiammazioni delle guaine tendinee, nonché gomito del tennista, come trattamento a breve termine

di un attacco acuto oppure - in determinati casi - quale terapia di mantenimento con dosi basse.

Gravi malattie infiammatorie della pelle, quali eczema generalizzato, psoriasi.

Forme gravi di affezioni allergiche, quali asma bronchiale, febbre da fieno, reazioni di ipersensibilità

ai medicamenti, eczemi da contatto.

Processi allergici e infiammatori gravi degli occhi.

Determinate malattie del sangue (p.es. determinate forme di anemia).

Determinate malattie dei reni (p.es. sindrome nefrotica, in combinazione con un cosiddetto

mineralcorticoide in caso di funzione ridotta della corteccia della ghiandola surrenale).

Determinate forme di cancro (determinate forme di leucemia e di tumore dei linfonodi).

Determinate malattie gastrointestinali come ad esempio nelle fasi critiche di degenerazione ulcerosa

della parete intestinale (colite ulcerosa o enterite regionale).

Attacchi acuti di sclerosi multipla

Disturbi ormonali in caso di malattie della corteccia surrenale o in determinate affezioni della tiroide.

Di che cosa occorre inoltre tener conto durante il trattamento?

In caso di trattamento prolungato si otterrà una migliore tolleranza se si seguono le seguenti

raccomandazioni:

·non prendere peso (pesarsi ogni giorno, adeguare l'apporto calorico);

·limitare l'uso di sale e zucchero;

·seguire un'alimentazione ricca di potassio (frutta e verdura, specialmente albicocche e banane);

·garantire un apporto sufficiente di calcio (latte e latticini);

·garantire un apporto sufficiente di proteine.

Informazione per i diabetici:

Se soffre di diabete, deve prestare attenzione al contenuto di zuccheri (saccarosio) delle compresse

da 4 mg, 16 mg e 32 mg.

1 compressa da 4 mg contiene 1.5 mg di carboidrati utilizzabili (saccarosio).

1 compressa da 16 mg contiene 2.8 mg di carboidrati utilizzabili (saccarosio).

1 compressa da 32 mg contiene 5.6 mg di carboidrati utilizzabili (saccarosio).

Quando non si può usare Medrol?

Medrol compresse è controindicato nei seguenti casi: ipersensibilità nei confronti del principio attivo

metilprednisolone o a una delle sostanze ausiliarie elencate nella composizione, infezioni

generalizzate da funghi, ulcere gastrointestinali, infezioni batteriche e virali, fragilità ossea

(osteoporosi), innalzamento della pressione intraoculare (glaucoma), ipertensione arteriosa

difficilmente regolabile, tubercolosi polmonare o ossea recente, gravi malattie muscolari, alterazioni

dei linfonodi in seguito a vaccinazione contro la tubercolosi. Vaccini vivi o vaccini vivi attenuati non

devono essere somministrati contemporaneamente a dosi elevate di Medrol poiché queste ultime

sopprimono il sistema immunitario.

Quando è richiesta prudenza nella somministrazione di Medrol?

Questo medicamento può compromettere la capacità di reazione, la capacità di guidare o di utilizzare

macchine o attrezzi.

Se si è affetti da una delle malattie seguenti, Medrol va preso soltanto dietro esplicita prescrizione

medica: diabete mellito, tubercolosi, ipertensione arteriosa, insufficienza del cuore o dei reni,

ispessimento dei tessuti (sclerodermia) degli organi interni, feocromocitoma (tumore del surrene),

infarto miocardico recente, grave malattia del fegato, funzione ridotta della tiroide, malattie con

disturbi ormonali, debolezza muscolare, turbe della psiche, infezioni causate da parassiti.

Informi assolutamente il medico se ha avuto una delle malattie seguenti: malattie contagiose (p.es.

tubercolosi), disturbi cardiocircolatori (ipertensione arteriosa, insufficienza cardiaca, infarto

miocardico), malattie gastrointestinali quali ulcere, pancreatite, colite ulcerosa, diverticolite, diarrea

cronica, gravi malattie del fegato o dei reni, malattie con disturbi ormonali, fragilità ossea

(osteoporosi), miastenia grave (debolezza muscolare), glaucoma, coaguli nelle gambe o nei polmoni

(trombosi, embolia), turbe della psiche.

Nelle donne in menopausa il medico sorveglierà il trattamento con Medrol in modo particolarmente

accurato per via dell'aumentata tendenza all'osteoporosi.

Le vaccinazioni non sono consigliate durante il trattamento con Medrol. Il medico sa cosa fare in

questi casi. E' bene che gli comunichi anche se negli ultimi tempi si è recato in paesi tropicali.

Se durante la cura con Medrol dovesse subentrare una malattia infettiva, avvisi immediatamente il

medico. Questo vale in particolar modo per i bambini se contraggono la varicella o il morbillo (negli

adulti è piuttosto raro), poiché in queste circostanze tali malattie potrebbero avere un decorso più

grave. Il medico curante sa che cosa fare in questo caso.

Poiché la somministrazione protratta di corticosteroidi può causare opacità del cristallino (cataratta),

aumento della pressione intraoculare (glaucoma) o altre malattie dell'occhio, può darsi che il medico

la faccia visitare periodicamente dall'oftalmologo.

Molti altri medicamenti possono interagire con Medrol in caso di somministrazione contemporanea.

Si tratta di determinati antibiotici e medicamenti contro le infezioni fungine, di determinati

medicamenti per impedire le convulsioni di origine cerebrale (in particolare di tipo epilettico), di

antipsicotici, di farmaci per il trattamento dell'HIV o di contraccettivi nonché di farmaci per curare

l'insufficienza cardiaca, il diabete, la nausea, il vomito o i disturbi della coagulazione. È richiesta

prudenza anche se si assumono contemporaneamente determinati farmaci per curare malattie

infiammatorie o reumatiche oppure diuretici o succo di pompelmo.

Informi il medico o il farmacista se, soffre di altre malattie, soffre di allergie o, assume o applica per

uso esterno altri medicamenti (anche se acquistati di propria iniziativa!).

Si può somministrare Medrol durante la gravidanza o l'allattamento?

Se è incinta o se desidera avere figli per precauzione dovrebbe, se possibile, fare a meno di prendere

medicamenti. I principi attivi come quelli contenuti in Medrol attraversano la placenta e passano

anche al latte materno e possono quindi nuocere allo sviluppo di suo figlio. Per questo durante la

gravidanza il preparato può essere preso unicamente dietro esplicita prescrizione medica.

Poiché i corticosteroidi passano nel latte materno, sussiste il rischio di effetti collaterali nel lattante.

Per questo motivo, se allatta, non deve assumere Medrol; se invece lo assume, deve smettere di

allattare.

In caso di gravidanza presunta o accertata prima di continuare a prendere Medrol deve informare

assolutamente il medico.

Come usare Medrol?

Il medico stabilisce la posologia per ogni paziente, a seconda del genere e della gravità della malattia.

Il medico deciderà anche se prima della cura con Medrol dovrà somministrare un altro medicamento

dello stesso tipo per via endovenosa, se nel corso della cura sarà necessario aumentare la posologia o

se la si potrà ridurre gradualmente, se occorrerà un trattamento supplementare o se dovrà sostituire

Medrol con un altro medicamento dello stesso tipo.

In conformità con il ciclo giornaliero della produzione di cortisone nel corpo, la dose giornaliera va

ingerita preferibilmente al mattino, prima delle ore otto. Le compresse non sono adatte ad essere

divise, quindi non cercare di frazionarle.

Nei bambini il medico stabilirà la posologia piuttosto in funzione della gravità della malattia che non

dell'età o del peso corporeo.

Poiché durante la cura prolungata con corticosteroidi la reazione del corpo a sollecitazioni

improvvise e forti ("stress", infezioni gravi, lesioni o interventi operatori) è disturbata, è possibile che

il medico aumenti, in via provvisoria, la posologia di Medrol prima, durante e dopo tali situazioni. La

reazione alle sollecitazioni può essere disturbata fino a un anno dopo la cessazione di Medrol, in caso

di terapia a lungo termine. Questo rende necessaria la somministrazione preventiva di corticosteroidi

in situazioni di stress. Il medico stabilisce il modo di procedere.

Per ridurre gli effetti collaterali descritti più avanti (vedere il paragrafo «Quali effetti collaterali può

avere il Medrol?») il medico ridurrà gradualmente la dose fino al livello più basso possibile, non

appena il suo stato di salute lo permette.

Per contrastare un eventuale eccessiva perdita di potassio e una ritenzione di acqua e di sali durante

una terapia prolungata con Medrol ad alte dosi, il medico potrebbe consigliare l'uso di sale dietetico.

Lei stesso può prevenire la perdita di potassio ingerendo Medrol con un bicchiere di succo d'arancia

(vedere «Di che cosa occorre inoltre tener conto durante il trattamento con Medrol?»).

Al termine di una cura prolungata con corticosteroidi possono manifestarsi reazioni di astinenza quali

febbre, malessere, dolori ai muscoli e alle articolazioni, ma anche disturbi gravi o addirittura

pericolosi, causati dalla deficienza funzionale della ghiandola surrenale.

Per questo un trattamento prolungato con Medrol non può assolutamente essere interrotto

bruscamente, ma soltanto gradualmente e sempre sotto il controllo del medico.

Al termine di una cura prolungata è necessario che lei continui a sottoporsi ai controlli del medico

anche dopo aver sospeso il Medrol, per poter riconoscere e curare tempestivamente i disturbi che

potrebbero ripresentarsi.

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

troppo debole o troppo forte ne parli al medico o al farmacista.

Quali effetti collaterali può avere Medrol?

Nel corso di una terapia con corticosteroidi si possono manifestare effetti collaterali dovuti al

dosaggio e alla durata del trattamento. I seguenti effetti collaterali possono insorgere durante

l'assunzione di Medrol:

Ritenzione di liquido nei tessuti, aumento di peso, disturbi della distribuzione del grasso corporeo

(quali faccia da luna piena, adiposità del tronco), accumulo del tessuto adiposo, ipertensione

arteriosa, debolezza muscolare, aumento della fragilità ossea (osteoporosi), disturbi gastrointestinali

(nausea, vomito, diarrea) con il rischio del riaprirsi di ulcere gastroenteriche, cicatrizzazione

rallentata delle ferite, alterazioni cutanee (strie rosse, ecchimosi puntiformi, ematomi, acne,

orticaria), alterazioni oculari (opacità del cristallino, cataratta) aumento della pressione intraoculare

(glaucoma), disturbi della vista («macchie grigie» nel campo visivo, distorsioni dell'immagine,

disturbi della percezione del colore), aumento della predisposizione a contrarre infezioni, trombosi,

embolia polmonare, alterazioni della psiche quali umore depresso o euforico, dipendenza psichica,

pensieri di suicidio, disturbi comportamentali, sensazione d'ansia, stati confusionali, insonnia,

irritabilità, disturbi mentali, alterazioni dell'umore e della personalità, disturbi psicotici comprendenti

mania, idee deliranti, allucinazioni e schizofrenia oppure il loro aggravarsi, disturbi della memoria,

vertigini, stanchezza, disturbi della secrezione di ormoni sessuali (che possono manifestarsi sotto

forma di impotenza nell'uomo e sotto forma di cessazione delle mestruazioni e aumento della crescita

dei peli (irsutismo) nella donna).

Nei bambini possono subentrare disturbi della crescita.

Nel corso di un trattamento con corticosteroidi si può manifestare un peggioramento del metabolismo

degli zuccheri. Le persone affette da diabete debbono essere controllate accuratamente e la loro cura

antidiabetica deve essere eventualmente adeguata.

Qualora si dovessero manifestare effetti collaterali, avvisare il medico.

Un trattamento con corticosteroidi nel periodo tra 8 settimane prima e 2 settimane dopo una

vaccinazione può ridurre o persino compromettere l'immunizzazione.

In genere dopo la sospensione del preparato scompaiono a poco a poco gli effetti collaterali, ad

eccezione della fragilità ossea (osteoporosi), del glaucoma, della cataratta e dei disturbi della crescita

nell'infanzia.

Informi il medico se nota sintomi degli effetti collaterali qui sopra elencati.

Il cambiamento d'umore, della motivazione e della facoltà di concentrazione che si avverte

soprattutto all'inizio del trattamento con Medrol può avere effetto sulla capacità di guidare

autoveicoli o di manovrare di macchinari.

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

Di che altro occorre tener conto?

Conservare a temperatura non superiore ai 25 °C nella confezione originale per proteggere le

compresse dalla luce e dall'umidità. Tenere fuori dalla portata dei bambini.

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

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

darle ulteriori informazioni.

Che cosa contiene Medrol?

Medrol compresse contiene:

Principio attivo: 4 mg, 16 mg, 32 mg e 100 mg di metilprednisolone.

Sostanze ausiliarie:

Compresse da 4 mg (bianche, con scanalatura decorativa): lattosio, amido di mais, stearato di calcio,

1.5 mg di saccarosio.

Compresse da 16 mg (bianche, con scanalatura decorativa): lattosio, amido di mais, paraffina liquida,

2.8 mg di saccarosio, stearato di calcio.

Compresse da 32 mg (bianche, con scanalatura decorativa): lattosio, amido di mais, paraffina liquida,

5.6 mg di saccarosio, stearato di calcio.

Compresse da 100 mg (azzurre, con scanalatura decorativa): cellulosa microcristallina, sodio amido

glicolato, metilcellulosa, stearato di magnesio, colorante E 132.

Numero dell’omologazione

24785 (Swissmedic).

Dov'è ottenibile Medrol compresse? Quali confezioni sono disponibili?

Medrol è ottenibile in farmacia dietro presentazione della prescrizione medica.

E' disponibile nelle confezioni seguenti:

Medrol 4 mg: confezioni da 30 compresse.

Medrol 16 mg: confezioni da 10 compresse.

Medrol 32 mg: confezioni da 10 compresse.

Medrol 100 mg: confezioni da 10 compresse.

Titolare dell’omologazione

Pfizer PFE Switzerland GmbH, Zürich.

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

competente in materia di medicamenti (Swissmedic).

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Vijf jaar NIX brengt normverandering roken en drinken op gang

Vijf jaar NIX brengt normverandering roken en drinken op gang

Op 1 januari is het precies vijf jaar geleden dat de leeftijdsgrens voor roken en drinken werd verhoogd naar 18 jaar. In deze periode is er veel veranderd, blijkt uit een recente peiling in opdracht van het ministerie van VWS. Zo vindt ongeveer driekwart van de ouders en tieners het ‘normaal’ dat je pas mag roken en drinken vanaf 18 jaar. 78,2% van de ouders vindt dit tegenover 75,4% van de jongeren. De afgelopen jaren is het gebruik van alcohol onder tieners teruggelopen. Sinds 2011 gaat het in de total...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-12-2018

Annual Report of the Scientific Network on BSE‐TSE 2018

Annual Report of the Scientific Network on BSE‐TSE 2018

Published on: Fri, 14 Dec 2018 The EFSA Scientific Network on bovine spongiform encephalopathies and other transmissible spongiform encephalopathies (BSE‐TSE) held its 13th meeting on 15‐16 October 2018 in Parma. The meeting served as an opportunity to exchange scientific information on BSE‐TSE related issues among EU Member States, countries from the European Free Trade Association (EFTA), EFSA, the European Commission and ad hocparticipants. In this occasion, ad hoc representation included the World A...

Europe - EFSA - European Food Safety Authority Publications

3-12-2018

January 16, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement

January 16, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement

January 16, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

22-11-2018


Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Europe - EMA - European Medicines Agency

20-11-2018

Pest categorisation of non‐EU Monochamus spp.

Pest categorisation of non‐EU Monochamus spp.

Published on: Mon, 19 Nov 2018 The Panel on Plant Health performed a pest categorisation of non‐EU Monochamus spp., a well‐defined insect genus in the family Cerambycidae (Insecta: Coleoptera). Species can be identified using taxonomic keys at national and regional level, and DNA barcoding. Two online world catalogues exist for the genus. The genus includes about one hundred species and many subspecies colonising conifers and non‐conifer trees in many areas in the world. The non‐EU species are listed in...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Published on: Fri, 16 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean MON 89788, for food and feed uses, excluding cultivation within the European Union....

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Peer review of the pesticide risk assessment of the active substance clodinafop (variant evaluated clodinafop‐propargyl)

Peer review of the pesticide risk assessment of the active substance clodinafop (variant evaluated clodinafop‐propargyl)

Published on: Fri, 16 Nov 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Greece and co‐rapporteur Member State Germany for the pesticide active substance clodinafop‐propargyl are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of clodinafop‐p...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

Published on: Fri, 16 Nov 2018 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 tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 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 guidance on the scientific requirements for health claims related to muscle function and physical performance, prepared by the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), supported by the Working Group on Claims. The draft guidance was endorsed by the Panel for public consultation ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from ...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Shirley’s Cookie Company In. Issues Allergy Alert on Undeclared Peanuts in "Chocolate Whoopie Pie"

Shirley’s Cookie Company In. Issues Allergy Alert on Undeclared Peanuts in "Chocolate Whoopie Pie"

Shirley’s Cookie Company Inc. of Claysburg, PA, is recalling its 16 ounce packages of "Chocolate Whoopie Pie" because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Stewart’s Shops Issues Allergy Alert on Undeclared Milk in Cranberry Apple Refresher

Stewart’s Shops Issues Allergy Alert on Undeclared Milk in Cranberry Apple Refresher

Saratoga Springs, NY - Stewart’s Shops Corp. is recalling units of Stewart’s Shops brand Cranberry Apple Refresher 16 fluid oz. because the product may contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product. Approximately 2,300 units of affected product were distributed in upstate New York and Southern Vermont.

FDA - U.S. Food and Drug Administration

18-10-2018

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

The recalled products may contain phthalate levels that exceed the allowable levels.

Health Canada

17-10-2018

New Nan Fong Hong Trading Inc. Issues Allergy Alert on Undeclared Sulfites in Source Day Natural Treasures Dried Liquorice Slice

New Nan Fong Hong Trading Inc. Issues Allergy Alert on Undeclared Sulfites in Source Day Natural Treasures Dried Liquorice Slice

New Nan Fong Hong Trading Inc. is recalling its 16 oz (454g) packages of Source Day Natural Treasures Dried Liquorice Slice because they contain undeclared sulfites. Consumers who are allergic to sulfite allergens run the risk of serious or life-threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

16-1-2019

Erleada (Janssen-Cilag International NV)

Erleada (Janssen-Cilag International NV)

Erleada (Active substance: apalutamide) - New authorisation - Commission Decision (2019)257 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4452

Europe -DG Health and Food Safety

14-1-2019

Consultation: Benzocaine: proposed advisory statements for medicines

Consultation: Benzocaine: proposed advisory statements for medicines

The TGA is seeking comments on proposed new required label statements for medicines containing benzocaine. Closing date: 16 October 2018

Therapeutic Goods Administration - Australia

24-12-2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement for 16 November 2018 published

Therapeutic Goods Administration - Australia

10-12-2018

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (Active substance: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate) - Transfer of orphan designation - Commission Decision (2018)8626 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/011/16/T/01

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)8630 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002507

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (Active substance: Recombinant adeno-associated viral vector serotype 9 carrying the gene for the human E6-AP ubiquitin protein ligase) - Transfer of orphan designation - Commission Decision (2018)8632 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002508

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1802 (FGK Representative Service GmbH)

EU/3/16/1802 (FGK Representative Service GmbH)

EU/3/16/1802 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)8627 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002422

Europe -DG Health and Food Safety

16-11-2018

Daptomycin Hospira (Hospira UK Limited)

Daptomycin Hospira (Hospira UK Limited)

Daptomycin Hospira (Active substance: daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7678 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004310/T/0008

Europe -DG Health and Food Safety

16-11-2018

Incruse Ellipta (Glaxo Group Ltd)

Incruse Ellipta (Glaxo Group Ltd)

Incruse Ellipta (Active substance: umeclidinium bromide) - Centralised - Yearly update - Commission Decision (2018)7676 of Fri, 16 Nov 2018

Europe -DG Health and Food Safety

16-11-2018

Benlysta (GlaxoSmithKline (Ireland) Limited)

Benlysta (GlaxoSmithKline (Ireland) Limited)

Benlysta (Active substance: belimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7679 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2015/T/60

Europe -DG Health and Food Safety

16-11-2018

Laventair Ellipta (GlaxoSmithKline (Ireland) Limited)

Laventair Ellipta (GlaxoSmithKline (Ireland) Limited)

Laventair Ellipta (Active substance: umeclidinium bromide / vilanterol trifenatate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7673 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3754/T/26

Europe -DG Health and Food Safety

16-11-2018

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Active substance: lurasidone) - Centralised - Renewal - Commission Decision (2018)7674 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2713/R/20

Europe -DG Health and Food Safety

16-11-2018

Emgality (Eli Lilly Nederland B.V.)

Emgality (Eli Lilly Nederland B.V.)

Emgality (Active substance: galcanezumab) - Centralised - Authorisation - Commission Decision (2018)7672 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4648/00

Europe -DG Health and Food Safety

16-11-2018

Ontruzant (Samsung Bioepis NL B.V.)

Ontruzant (Samsung Bioepis NL B.V.)

Ontruzant (Active substance: trastuzumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7553 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004323/T/0012

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Active substance: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains) - Transfer of orphan designation - Commission Decision (2018)7574 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/270/16/02

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Active substance: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate) - Transfer of orphan designation - Commission Decision (2018)6989 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/253/15/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1689 (Alan Boyd Consultants Ltd)

EU/3/16/1689 (Alan Boyd Consultants Ltd)

EU/3/16/1689 (Active substance: Teriparatide) - Transfer of orphan designation - Commission Decision (2018)6987 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/031/16/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1704 (Drug Development and Regulation S.L.)

EU/3/16/1704 (Drug Development and Regulation S.L.)

EU/3/16/1704 (Active substance: Sirolimus) - Transfer of orphan designation - Commission Decision (2018)6988 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/045/16/T/01

Europe -DG Health and Food Safety

16-10-2018

Dexxience (Portola Pharma UK Limited)

Dexxience (Portola Pharma UK Limited)

Dexxience (Active substance: betrixaban) - Refusal of authorisation - Commission Decision (2018)6226 of Tue, 16 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4309

Europe -DG Health and Food Safety

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

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