CITALOPRAM LABORATORI ALTER

Informazioni principali

  • Nome commerciale:
  • CITALOPRAM LAB.ALT OS GTT 15ML
  • Forma farmaceutica:
  • GOCCE OS/LIQUIDO OS
  • Composizione:
  • "40 MG/ML GOCCE ORALI, SOLUZIONE " FLACONE 15 ML
  • Classe:
  • A
  • Tipo di ricetta:
  • Ricetta ripetibile, validità 6 mesi, ripetibile 10 volte
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco allopatico

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:
  • CITALOPRAM LAB.ALT OS GTT 15ML
    Italia
  • Lingua:
  • italiano

Altre informazioni

Status

  • Fonte:
  • AIFA - Agenzia Italiana del Farmaco
  • Numero dell'autorizzazione:
  • 036836017
  • Ultimo aggiornamento:
  • 09-08-2016

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

CATEGORIAFARMACOTERAPEUTICA

Inibitoreselettivodellaricaptazionedellaserotonina.

INDICAZIONI

Sindromidepressiveendogeneeprevenzionedellericaduteedelle

ricorrenze.

Disturbid'ansiaconcrisidipanico,conosenzaagorafobia.

CONTROINDICAZIONI/EFFETTISECONDARI

Ipersensibilita'alprincipioattivooadunoqualsiasidegli

eccipienti.

Eta'inferioreai18anni.

Citalopramnondeveesseresomministratoapazientiin

trattamentoconMAO-inibitoriecomunquenonprimadi14giorni

dopolalorosospensione.

Generalmentecontroindicatoingravidanzaedurante

l'allattamento.

POSOLOGIA

Sintomidasospernsioneosservatiinseguitoadinterruzionedel

trattamento.

Sideveevitareun'interruzionebruscadeltrattamento.

QuandosiinterrompeiltrattamentoconCITALOPRAMLABORATORI

ALTERladosedeveessereridottagradualmenteinunperiododi

almeno1-2settimaneperirdurreilrischiodireazionida

sospensione(vederesezione4.4“Avvertenzespecialieopportune

precauzionid'impiego”esezione4.8“Effettiindesiderati”).

Sesidovesseromanifestare,aseguitodellariduzionedelladose

oalmomentodellainterruzionedeltrattamento,sintominon

tollerabili,sipuo'prendereinconsiderazioneilripristino

delladoseprescrittainprecedenza.

Successivamenteilmedicopuo'continuarearidurreladose,ma

inmodopiu'graduale.

Sindromidepressiveendogene.

Adulti:CITALOPRAMLABORATORIALTER40mg/mlgocceorali,

soluzionevienesomministratoinun'unicadosegiornaliera.

Ladoseinizialee'di16mg(8gocce)algiorno,lasera.

Sullabasedellarispostaclinicaindividuale,questapuo'essere

aumentatafinoa32mg/die(16gocce).

Solosenecessario,ladosepotra'essereulteriormenteaumentata

finoa48mg/die(24gocce)dosemassima.

L'effettoantidepressivosimanifestaingenereentro2-4

settimanedall'iniziodellaterapia;e'opportunocheilpaziente

vengaseguitodalmedicofinoaremissionedellostato

depressivo.

Poiche'iltrattamentoconantidepressivoe'sintomatico,deve

esserecontinuatoperunappropriatoperiododitempo,ingenere

4-6mesinellemalattiemaniaco-depressive.

Inpazienticondepressioneunipolarericorrentepuo'essere

necessariocontinuarelaterapiadimantenimentoperlungo

terminealfinediprevenirenuoviepisodidepressivi.

Disturbid'ansiaconcrisidipanico,conosenzaagorafobia.

Adulti:Ladoseinizialee'di8mg(4gocce)algiorno.

Dopounasettimanaladosepuo'essereaumentataa16mg(8

gocce)algiorno.

Ildosaggiogiornalieroottimalee'di16mg(8gocce)–24mg(12

gocce).

Incasodirispostainsufficienteladosepuo'essereaumentata

finoadunmassimodi48mg(24gocce)algiorno.

finoadunmassimodi48mg(24gocce)algiorno.

Neidisturbiconcrisidipanicoiltrattamentoe'alungo

termine.

Ilmantenimentodellarispostaclinicae'statodimostrato

duranteiltrattamentoprolungato(1anno).

Incasodiinsonniaodiforteirrequietezzasiraccomandaun

trattamentoaddizionaleconsedativiinfaseacuta.

Quandosidecidediinterrompereiltrattamentoledosidevono

essereridotteinmodogradualeperminimizzarel'entita'dei

sintomidiastinenza.

Anziani:Aipazientisoprai65annidieta'deveessere

somministratameta'delladoseraccomandataacausadiun

rallentatometabolismo.

Soggettidieta'inferioreai18anni.

CITALOPRAMLABORATORIALTERnondeveessereutilizzatoperil

trattamentodisoggettialdisottodei18annidieta'.

Insufficienzaepatica:Neipazienticoninsufficienzaepaticae'

consigliabileunadosegiornalieranonsuperiorea20-30mg.

Insufficienzarenale:inquestipazientie'consigliabile

attenersialdosaggiominimoconsigliato.

Modalita'disomministrazione:legoccepossonoesseremiscelate

conacqua,succod'aranciaosuccodimela.1goccia=2mldi

citalopram.

AVVERTENZE

LasomministrazionecontemporaneadicitaloprameMAO-inibitori

puo'causaregravireazioniavverseavolteletalielacomparsa

dicrisiipertensive.

Pertantocitalopramnondeveesseresomministratoapazientiin

trattamentoconMAO-inibitoriecomunquenonprimadialmeno14

giornidopolalorosospensione.

UntrattamentoabasediMAO-inibitoripuo'essereiniziato7

giornidopolasospensionedelcitalopram.

Qualorailpazienteentrasseinunafasemaniacale,il

trattamentodeveesseresospesoesideveistituireun

trattamentoappropriatoconneurolettici.

Ilrischiodisuicidioneipazientidepressipersistefino

aquandononsiottieneunasignificativaremissione,poiche'il

bloccoinibitoriopuo'veniremenoprimachesistabiliscauna

efficaceazioneantidepressiva.

E'importantemonitorareassiduamenteilpazienteduranteil

periodoiniziale.

Alcunipazienticondisturbid'ansiaconcrisidipanicopossono

riferireun'accentuazionedeisintomid'ansiaall'iniziodella

terapiaconantidepressivi.

Taleaumentoparadossodeisintomid'ansiae'piu'marcatodurante

iprimigiorniditerapiaescompareconilproseguiredel

trattamento(ingenereentroduesettimane).

Quandosiinterrompebruscamenteiltrattamentoconinibitori

dellaricaptazionedellaserotoninapossonocomparireinsonnia,

vertigini,sudorazione,palpitazioni,nausea,ansia,

irritabilita',parestesieecefalea,pertanto,quandosidecidedi

interrompereiltrattamentoledosidevonoesserediminuitein

modogradualeperridurrealminimol'entita'ditalisintomi.

Porreattenzioneanoninterpretaretalisintomiattribuendoliad

unpeggioramentodellamalattiapsichiatricatrattata.

Glieffettiindesideratipossonoesserepiu'frequenti

durantel'usocontemporaneodiinibitoridellaricaptazionedella

serotonina(SSRIs),nefadozone,trazodone,triptanie

preparazioniabasediHypericumperforatum.

CITALOPRAMLABORATORIALTERnondeveessereutilizzatoperil

trattamentodisoggettialdisottodei18annidieta'.

Perdipiu',nonsonodisponibiliidatisullasicurezzaalungo

termineperibambiniegliadolescentiperquantoconcernela

crescita,lamaturazioneelosviluppocognitivoe

comportamentale.

comportamentale.

Pazienticoninsufficienzaepaticadevonoiniziareiltrattamento

conunadosebassaedessereattentamentemonitorati.

Neipazienticonfunzionalita'renalefortementeridottae'

consigliabileattenersialdosaggiominimoconsigliato.

Deveessereusatoconcautelainpazienticonunastoriadi

convulsioni.

Ilfarmacodeveesseresospesoqualorasiosserviunincremento

dellafrequenzadegliattacchiconvulsivi.

Neipazienticondiabete,unaterapiaabasediSSRIpuo'

alterareilcontrolloglicemico;questopotrebbeessereuna

conseguenzadelmiglioramentodelladepressione.

E'possibilechesianecessarioaggiustareildosaggio

dell'insulinae/odiantidiabeticiorali.

Ilprodottocontiene9,6vol%dietanolo.

Unadosepuo'contenerefino0,11gdietanolo(dosemassima).

Dannosoperqueipazientichesoffronodiaffezioniepatiche,

alcolismo,epilessia,lesioniomalattiecerebralioperledonne

ingravidanzaebambini.

Ladepressionee'associataadaumentatorischiodipensieri

suicidari,autolesionismoesuicidio.

Talerischiopersistefinoachesiverifichiunaremissione

significativa.

Poiche'possonononverificarsimiglioramentiduranteleprime

settimaneditrattamentooinquelleimmediatamentesuccessive,i

pazientidevonoessereattentamentecontrollatifinoadavvenuto

miglioramento.

E'esperienzaclinicaingeneralecheilrischiodisuicidiopuo'

aumentarenelleprimefasidelmiglioramento.

AltrepatologiepsichiatricheperlequaliCITALOPRAMe'

prescrittopossonoancheessereassociateadunaumentato

rischiodicomportamentosuicidario.

Inoltre,questepatologiepossonoessereassociatealdisturbo

depressivomaggiore.

Quandositrattanopazienticondisturbidepressivimaggiorisi

devono,pertanto,osservarelestesseprecauzioniseguitedurante

iltrattamentodipazienticonaltrepatologiepsichiatriche.

Pazienticonanamnesipositivapercomportamentoopensieri

suicidari,ochemanifestanoungradosignificativodiideazione

suicidariaprimadell'iniziodeltrattamento,sonoarischio

maggiorediideazionesuicidariaoditentatividisuicidio,e

devonoessereattentamentecontrollatiduranteiltrattamento.

Unametanalisihamostratounaumentodelrischiodi

comportamentosuicidarionellafasciadieta'inferiorea25anni

deipazientitrattaticonantidepressivirispettoalplacebo.

Ipazienti(ochisiprendecuradiloro)dovrebberoessere

avvertitidellanecessita'dimonitorareediriportare

immediatamentealpropriomedicocurantequalsiasi

peggioramentodelquadroclinico,l'insorgenzadicomportamentoo

pensierisuicidariodicambiamenticomportamentali.

L'usodiCITALOPRAMLABORATORIALTERe'statoassociatoallo

sviluppodiacatisia,caratterizzatadaunasensazioneinternadi

irrequietezzaediagitazionepsicomotoriaqualel'impossibilita'

disedereostareimmobile,generalmenteassociateadun

malesseresoggettivo.

Cio'e'piu'probabilecheaccadaentroleprimesettimanedi

trattamento.

Inpazientichesviluppinoquestisintomi,l'aumentodeldosaggio

puo'esseredannoso.

Sintomidasospensioneosservatiinseguitoadinterruzionedel

trattamento.

Isintomidasospensioneosservatiquandoiltrattamentoe'

interrottosonocomuni,inparticolareincasodibrusca

interruzione.

Ilrischiodicomparsadeisintomidasospensionepuo'dipendere

dadiversifattori,compresiladuratadellaterapia,ildosaggio

eiltassodiriduzionedelladose.

Sonostatiriportativertigini,disturbidelsensorio(comprese

parestesiaesensazionediscossaelettrica),disturbidelsonno

(compresiinsonniaesognivividi),agitazioneoansia,nausea

e/ovomito,tremore,confusione,sudorazione,cefalea,diarrea,

palpitazioni,instabilita'emotiva,irritabilita'edisturbi

visivi.

Generalmente,l'intensita'ditalisintomie'dalievea

moderata,tuttaviainalcunipazientipuo'esseregrave.

Ingenerecompaionoentroiprimigiornidisospensionedel

trattamento,mavisonostaticasimoltorarineiqualisono

comparsiinpazienticheavevanoinavvertitamentesaltatouna

dose.

Generalmentetalisintomisonoauto-limitanti,edisolitosi

risolvonoentroduesettimane,sebbeneinalcuniindividui

possonodurarepiu'alungo(2-3mesiopiu').

Siconsiglia,pertanto,diridurregradualmenteladosedi

CITALOPRAMquandosisospendeiltrattamento,nelcorsodiun

periododidiversesettimaneomesi,inbaseallenecessita'del

paziente.

INTERAZIONI

Labiotrasformazionedicitalopramindemetilcitaloprame'

mediatodagliisoenzimidelsistemacitocromoP450,CYP2C19

(circail60%),CYP3A4(circail30%)eCYP2D6(circail10%).

L'inibizionedegliisoenzimiCYP2C9,CYP2E1eCYP3A4dapartedi

citalopramedemetilcitaloprame'trascurabileediduecomposti

sonosoloinibitoridebolidegliisoenzimiCYP1A2,CYP2C19e

CYP2D6rispettoadaltriSSRI,concuie'statadimostratauna

inibizionesignificativa.

Pertanto,e'improbabilechecitalopraminibiscailmetabolismodi

farmacimediatodaP450adositerapeutiche.

LasomministrazionecontemporaneadiMAO-inibitori,ivicompresii

MAO-inibitorireversibili(RIMA),qualilamoclobemide,puo'

causaregravireazioniavverseavolteletali,qualicrisi

ipertensiveounasindromeserotoninergica.

Nonsonostateriportateinterazionilegateallaassunzione

contemporaneadialcool.

Lacimetidinadeterminaunmodestoaumentodeilivellimedidi

citalopramallostatostazionario.

Siconsigliapertantodiprocedereconcautelaquando

vengonosomministratiidosaggiterapeuticipiu'elevatidi

citalopraminassociazioneadosaggielevatidicimetidina

(potenteinibitorediCYP2D6,3A4).

Visonostatesegnalazionidiunpotenziamentodeglieffetti

quandogliSSRIvengonosomministratiassiemeallitioodal

triptofano;pertanto,e'necessarioprocedereconcautelaquando

questifarmacivengonousaticontemporaneamente.

Ifarmaciappartenentiallaclassedegliantidepressiviinibitori

dellaricaptazionedellaserotoninapossonoaccrescereilrischio

disanguinamentoquandosonosomministratiinconcomitanzacon

anticoagulantioconfarmacicheinfluenzanol'aggregazione

piastrinica(FANS,acidoacetilsalicilico,ticlopidina,ecc.).

Unostudiosullainterazionefarmacodinamicaefarmacocinetica

tracitalopramemetoprololo(unsubstratodiCYP2D6)ha

evidenziatounraddoppiamentodelleconcentrazionidi

metoprololo,manessunaumentosignificativodeglieffettidi

metoprololosullapressionearteriosaesullafrequenzacardiaca

involontarisani.

Lasomministrazioneconcomitantedialtrifarmaci

serotoninergici,qualiiltramadoloedilsumatriptan,puo'

potenziareglieffetti5HTassociati.

Sonostatieffettuatistudisull'interazionefarmacocineticacon

lalevomepromazina(uninibitoredell'isoenzimaCYP2D6e

prototipodellefenotiazine)econl'imipramina(uninibitore

parzialediCYP2D6,unprototipodegliantidepressivi

parzialediCYP2D6,unprototipodegliantidepressivi

triciclici).

Nonsonostaterilevateinterazionidinaturafarmacocinetica

aventiimportanzaclinica.

EFFETTIINDESIDERATI

Lereazionisecondarieosservatesonoingenerale,dilieve

entita'editipotransitorio.

Essesimanifestanosoprattuttonellaprimaosecondasettimana

diterapia,perpoisparireconilmiglioramentodellostato

depressivo.

Glieffettiindesideratifrequenti(>1%-<10%)sono:disturbi

delmetabolismoenutrizione:riduzionedell'appetito;disturbi

psichiatrici:riduzionedellalibidoedanormalita'

dell'orgasmo(donne);disturbidelsistemanervoso:agitazione,

insonnia,sonnolenza,capogiro;disturbidell'apparato

respiratorio:sbadigli;disturbigastrointestinali:nausea,

secchezzadellefauci,diarrea,stipsi;affezionidellacutee

deltessutosottocutaneo:aumentodellasudorazione;disturbia

caricodell'apparatoriproduttivo:disturbidellaeiaculazione,

impotenza;compromissionedellecondizionigenerali:

affaticamento.

Effettiindesideratirari:ideazione/comportamentosuicidarlo;

irrequietezzapsicomotoria/acatisia;reazionedasospensione.

Effettiindesideratimoltorari(<1/10.000)sono:disturbi

dell'apparatoendocrino:secrezioneinappropriatadiADH(specie

nelledonneanziane);disturbidelmetabolismoenutrizione:

iponatremia;disturbidell'apparatonervoso:convulsioni,

disturbiextrapiramidali;affezionidellacuteedeltessuto

sottocutaneo:ecchimosi,porpora;compromissionedellecondizioni

generali:reazionidaipersensibilita',sindromeserotoninergica,

sintomidaastinenza(capogiro,nauseaeparestesie).

Raramente,inseguitoallasomministrazionediantidepressivi

inibitoridellaricaptazionedellaserotoninasipossono

verificaremanifestazioniemorragichequaliecchimosi,emorragie

ginecologiche,manifestazioniemorragicheacaricodeltratto

gastrointestinale,dellemucoseoanchedialtridistrettidell'

organismo.

Quandosiinterrompebruscamenteiltrattamentopossonocomparire

sintomidiastinenza.

Talisintomisono,ingenere,lieviedicompletarisoluzionee

comprendono,adesempio:insonnia,vertigini,sudorazione,

palpitazioni,nausea,ansia,irritabilita',parestesieecefalea.

Quandosidecidediinterrompereiltrattamentoledosidevono

essereridotteinmodogradualeperminimizzarel'entita'ditali

sintomi.

Altrieffettiindesideratichesonostatiosservaticonfarmaci

SSRIsono:apparatocardiovascolare:ipotensioneposturale,

disturbidell'occhio:anormalita'dellavista;disturbi

gastrointestinali:vomito;disturbiepatobiliari:alterazioni

degliesamidifunzionalita'epatica;disturbimuscolo-

scheletrici:artralgia,mialgia;disturbipsichiatrici:

allucinazioni,mania,confusione,ansia,depersonalizzazione,

attacchidipanico,nervosismo;disturbidell'apparatourinario:

ritenzioneurinaria;disturbidell'apparatoriproduttivo:

galattorrea;affezionidellacuteedeitessutisottocutanei:

prurito.

E'statasegnalataiponatriemia,probabilmentedovutaaduna

secrezioneinappropriatadiormoneantidiuretico,comereazione

avversararaall'usodiSSRI.Sembracheledonneanziane

costituiscanoungruppoparticolarmentearischio.

E'statararamentesegnalatauna"sindromeserotoninica"nei

pazientiintrattamentoconSSRI.Lacomparsadiunaseriedi

sintomi,tracuiagitazione,confusione,tremore,mioclonieed

ipertermia,possonocostituireiprodromidellasindrome.

Sintomidasospensioneosservatiinseguitoadinterruzionedel

trattamentoL'interruzionedeltrattamentocon(soprattuttose

trattamentoL'interruzionedeltrattamentocon(soprattuttose

brusca)portaingenereasintomidasospensione.

Sonostatiriportativertigini,disturbidelsensorio(comprese

parestesiaesensazionediscossaelettrica),disturbidelsonno

(compresiinsonniaesognivividi),agitazioneoansia,nauseae/o

vomito,tremore,confusione,sudorazione,cefalea,diarrea,

palpitazioni,instabilita'emozionale,irritabilita'edisturbi

visivi.

Generalmentetalieventisonodalieviamoderatiedauto-

limitanti,tuttaviainalcunipazientipossonoesseregravie/o

prolungati.

Siconsigliapertantoche,senone'piu'richiestoil

trattamentoconCITALOPRAM,visiaunagradualeinterruzione,

condottatramiteundecrementogradualedelladose.

GRAVIDANZAEALLATTAMENTO

L'innocuita'dicitalopramingravidanzanone'statastabilita.

Sebbeneglistudieffettuatisuglianimalidaesperimentonon

abbianoevidenziatosegnidipotenzialeteratogenicita',ne'

effettisullariproduzioneosullecondizioniperinatali,poiche'

ilcitalopramconisuoimetabolitipassalabarrieraplacentare

epoiche'unapiccolissimaquantita'vieneriscontratanellatte

materno,senesconsiglial'usodurantelagravidanzae

l'allattamento.

20-12-2018

Pest categorisation of Cronartium spp. (non‐EU)

Pest categorisation of Cronartium spp. (non‐EU)

Published on: Wed, 19 Dec 2018 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium spp. (non‐EU), a well‐defined and distinguishable group of fungal pathogens of the family Cronartiaceae. There are at least 40 species described within the Cronartium genus, of which two are considered native to the EU (C. gentianeum and C. pini) and one has been introduced in the 19th century (C. ribicola) and is now widespread in the EU – these t...

Europe - EFSA - European Food Safety Authority EFSA Journal

30-11-2018

Understanding ASF spread and emergency control concepts in wild boar populations using individual‐based modelling and spatio‐temporal surveillance data

Understanding ASF spread and emergency control concepts in wild boar populations using individual‐based modelling and spatio‐temporal surveillance data

Published on: Thu, 29 Nov 2018 African swine fever (ASF) infection is circulating in Eurasia since a decade within wild boar populations without a demonstrated vector host. Further the infection was recurrently translocated by spatio‐temporal dynamics that is incompatible with wild boar movement characteristics. Management actions are required in areas affected by ASF. Control measures address areas with recent focal introduction and areas with ASF circulating several seasons or endemic occurrence. In v...

Europe - EFSA - European Food Safety Authority Publications

29-11-2018

Glyphosate: ANSES launches a comparative assessment with the available alternatives

Glyphosate: ANSES launches a comparative assessment with the available alternatives

Following the five-year re-approval of this active substance at European level in December 2017, ANSES is reassessing marketing authorisations for products containing glyphosate. For products for which an application for authorisation or re-authorisation has been submitted, the Agency will carry out a comparative assessment with the available alternatives. For each glyphosate-based product, all uses for which there is an alternative that meets the substitution criteria will therefore be prohibited.

France - Agence Nationale du Médicament Vétérinaire

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

16-11-2018

FDA Proposes Study with Intent of Eliminating Use of Dogs in Certain Types of Research

FDA Proposes Study with Intent of Eliminating Use of Dogs in Certain Types of Research

In keeping with the goals of reducing, replacing, and/or refining the use of animals in research, the U.S. Food and Drug Administration today released for public comment proposed research to validate an alternative approach for bioequivalence studies for certain animal drugs.

FDA - U.S. Food and Drug Administration

13-11-2018

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

FDA - U.S. Food and Drug Administration

8-11-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program

The FDA is committed to the expanded access program which provides a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases and life-threatening conditions outside of clinical trials when no comparable or satisfactory approved alternative therapy options are available.

FDA - U.S. Food and Drug Administration

1-11-2018

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

Roche Diagnostics issued voluntary recall of certain test strips used with CoaguChek meter devices; patients affected by the recall should seek alternative methods for testing.

FDA - U.S. Food and Drug Administration

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The goal of this research is to better address the problems related to the widespread presence of pesticides in the environment. Despite the unquestionable utility of the pesticides against various pests in the agricultural field, most pesticides and the corresponding pesticide residues are toxic to the environment and hazardous to human health. The recent literature on organophosphate compounds emphasises a clear correlation between their use and the occurr...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

BioLyte Laboratories Issues Voluntary Nationwide Recall Due to the Voluntary Nationwide Recall initiated by King Bio Inc. (a Raw Material Supplier) for NeoRelief for Muscle Cramping and Restlessness Topical Gel Due to Possible Microbial Contamination

BioLyte Laboratories Issues Voluntary Nationwide Recall Due to the Voluntary Nationwide Recall initiated by King Bio Inc. (a Raw Material Supplier) for NeoRelief for Muscle Cramping and Restlessness Topical Gel Due to Possible Microbial Contamination

BioLyte Laboratories is voluntarily recalling lot numbers 1138, 1139, 1146, and 1160 of NeoRelief for Muscle Cramping and Restlessness Topical Gel to the retail and consumer level. King Bio Inc., a manufacturer of some of the active ingredients in this product, has been found to have some water contamination issues that potentially could have affected this product. King Bio has issued a recall of these active ingredients in BioLyte’s lot specific product. To date, there have been no reports of illness or...

FDA - U.S. Food and Drug Administration

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

24-7-2018

FDA Advises Vets of Percorten™-V Shortage and Alternative Drug Option for Treatment of Canine Addison’s Disease

FDA Advises Vets of Percorten™-V Shortage and Alternative Drug Option for Treatment of Canine Addison’s Disease

FDA is aware of a shortage of Percorten™-V (desoxycorticosterone pivalate injectable suspension), which is approved for use as replacement therapy for mineralocorticoid deficit in dogs with primary adrenocortical insufficiency, more commonly known as Addison’s Disease.

FDA - U.S. Food and Drug Administration

30-5-2018

Risks and benefits of plant protection products containing neonicotinoids compared with their alternatives

Risks and benefits of plant protection products containing neonicotinoids compared with their alternatives

In 2016, as part of the implementation of the Act "for the restoration of biodiversity, nature and landscapes” and as requested by the Ministries of Agriculture, Health and Ecology, ANSES initiated an assessment weighing up the risks and benefits of plant protection products containing neonicotinoids, compared with their chemical and non-chemical alternatives. Today, ANSES is publishing its final opinion. For most uses of plant protection products containing neonicotinoids, sufficiently effective and ope...

France - Agence Nationale du Médicament Vétérinaire

24-5-2018

Reference Delegation Day: an annual meeting of the reference laboratories

Reference Delegation Day: an annual meeting of the reference laboratories

Every year, ANSES brings together all the French holders of the national reference laboratory and European Union reference laboratory mandates, with support from the Joint Laboratory Service of the fraud control and customs services. This delegation day aims to improve cooperation and sharing of experience, and symbolises the importance of reference work to ANSES's missions.

France - Agence Nationale du Médicament Vétérinaire

24-5-2018

Three questions for Gilles Salvat, ANSES Managing Director General for Research and Reference

Three questions for Gilles Salvat, ANSES Managing Director General for Research and Reference

As Reference Delegation Day is held at ANSES, bringing together representatives of national and European reference laboratories, Gilles Salvat, Managing Director General for Research and Reference, gives us an overview of this essential part of ANSES's work. What do you mean by reference? Reference is an essential component of the system for safeguarding health. The work of the reference laboratories is vital to improving knowledge and identification of the major hazards we face in food safety, animal...

France - Agence Nationale du Médicament Vétérinaire

23-5-2018

The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs

The FDA is Seeking Input on the Evaluation of Approaches to Demonstrate Effectiveness of Heartworm Preventatives for Dogs

FDA’s CVM is evaluating the design of studies intended to support the standard of effectiveness for new animal drugs to prevent heartworm disease in dogs. The FDA is requesting public input on evaluating these products to assist in the potential development of alternative study designs.

FDA - U.S. Food and Drug Administration

23-5-2018

Do Teething Babies Need Medicine on Their Gums? No

Do Teething Babies Need Medicine on Their Gums? No

Teething is a normal part of childhood that doesn’t need a 'cure' with prescription or over-the-counter (OTC) medications. FDA warns parents that benzocaine products are not safe for treating teething in children. There are safer, non-toxic alternatives.

FDA - U.S. Food and Drug Administration

27-4-2018

ANSES assesses the efficacy and safety of alternatives to antibiotics in animal husbandry and considers the need for a specific status for these products

ANSES assesses the efficacy and safety of alternatives to antibiotics in animal husbandry and considers the need for a specific status for these products

Today, the Agency is publishing an inventory of alternatives to antibiotics aimed at reducing their use in animal husbandry and based on an original method for evaluating the diverse scientific publications in the field. In its report, ANSES identifies numerous products and substances including compounds, plants, plant extracts and micro-organisms, which are used as alternatives to antibiotics. However, it emphasises the diversity of the data available to assess their safety and efficacy, and their abili...

France - Agence Nationale du Médicament Vétérinaire

3-1-2012

Danish Pharmacovigilance Update, 15 December 2011

Danish Pharmacovigilance Update, 15 December 2011

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Atomoxetine (Strattera®) and the risk of increased blood pressure and heart rate, increased suspicion of risk of congenital malformations with the antiepileptic topiramate (Topimax® and others), and new recommendations for the antidepressant escitalopram.

Danish Medicines Agency

1-12-2011

Danish Pharmacovigilance Update, 17 November 2011

Danish Pharmacovigilance Update, 17 November 2011

In this issue of Danish Pharmacovigilance Update, you can read about domperidone (Motilium® etc.) and potential risk of cardiac disorders, about the European Medicines Agency's recommendation on a lower dose of the antidepressant citalopram as well as about more interesting aspects of pharmacovigilance.

Danish Medicines Agency

7-10-2011

Changed reimbursement for medicines for depression and anxiety as of 5 March 2012

Changed reimbursement for medicines for depression and anxiety as of 5 March 2012

With effect from 5 March 2012, the reimbursement is changed for certain medicinal products for treatment of depression and anxiety (antidepressants and anxiolytics). Based on the Reimbursement Committee's recommendation, the Danish Medicines Agency has decided that in future the general rule is that treatment with inexpensive medicines (e.g. sertraline and citalopram) must be attempted before reimbursement can be granted for more expensive medicines (e.g. escitalopram, duloxetine, pregabalin and agomelat...

Danish Medicines Agency

11-1-2019

Syvazul BTV (LABORATORIOS SYVA, S.A.U.)

Syvazul BTV (LABORATORIOS SYVA, S.A.U.)

Syvazul BTV (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 3)) - New authorisation - Commission Decision (2019)135 of Fri, 11 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/V/C/4611

Europe -DG Health and Food Safety

19-12-2018

These devices offer new ways to treat or diagnose a disease, have significant advantages over existing treatment alternatives, or provide another public health benefit. Find out more about breakthrough devices:  https://go.usa.gov/xExHZ 

These devices offer new ways to treat or diagnose a disease, have significant advantages over existing treatment alternatives, or provide another public health benefit. Find out more about breakthrough devices: https://go.usa.gov/xExHZ 

These devices offer new ways to treat or diagnose a disease, have significant advantages over existing treatment alternatives, or provide another public health benefit. Find out more about breakthrough devices: https://go.usa.gov/xExHZ 

FDA - U.S. Food and Drug Administration

10-12-2018

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Active substance: Mercaptopurine (oral suspension)) - Transfer of orphan designation - Commission Decision (2018)8629 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002301

Europe -DG Health and Food Safety

7-8-2018

LETIFEND (Laboratorios LETI, S.L.unipersonal)

LETIFEND (Laboratorios LETI, S.L.unipersonal)

LETIFEND (Active substance: Recombinant Protein Q from L. infantum MON-1) - Centralised - Yearly update - Commission Decision (2018)5415 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Numient (Impax Laboratories Ireland Limited)

Numient (Impax Laboratories Ireland Limited)

Numient (Active substance: levodopa / carbidopa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5418 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2611/T/5

Europe -DG Health and Food Safety

30-7-2018

UBAC (Laboratorios Hipra, S.A.)

UBAC (Laboratorios Hipra, S.A.)

UBAC (Active substance: Streptococcus uberis vaccine (inactivated)) - Centralised - Authorisation - Commission Decision (2018)5152 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4595

Europe -DG Health and Food Safety

27-7-2018

Scientific guideline:  Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Scientific guideline: Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Established veterinary antibiotics are not always used at the authorised dose, and the dose may need to be reviewed in order to maintain their effectiveness whilst limiting the risks of antimicrobial resistance. Before a new dose is introduced, the company would typically have to conduct new studies to ensure it does not negatively affect the safety of the target animal, the consumer of animal produce, or the environment. This may reduce product availability, which could have a negative impact on antimic...

Europe - EMA - European Medicines Agency

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

11-7-2018

ERYSENG (Laboratorios Hipra, S.A.)

ERYSENG (Laboratorios Hipra, S.A.)

ERYSENG (Active substance: Inactivated Erysipelothrix rhusiopathiae, strain R32E11) - Centralised - Yearly update - Commission Decision (2018)4523 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Pylobactell (Torbet Laboratories Limited)

Pylobactell (Torbet Laboratories Limited)

Pylobactell (Active substance: 13C-urea) - Centralised - Yearly update - Commission Decision (2018)4517 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Active substance: Live gE- tk- double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL) - Centralised - Yearly update - Commission Decision (2018)4520 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

4-7-2018

ERYSENG PARVO (Laboratorios Hipra, S.A.)

ERYSENG PARVO (Laboratorios Hipra, S.A.)

ERYSENG PARVO (Active substance: Inactivated porcine parvovirus, strain NADL-2 / Inactivated Erysipelothrix rhusiopathiae, strain R32E11) - Centralised - Yearly update - Commission Decision (2018) 4354 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

29-6-2018

Evalon (Laboratorios Hipra, S.A.)

Evalon (Laboratorios Hipra, S.A.)

Evalon (Active substance: Coccidiosis vaccine live for chickens) - Centralised - Yearly update - Commission Decision (2018)4165 of Fri, 29 Jun 2018

Europe -DG Health and Food Safety

20-6-2018

 Statement non compliance GMP. Officina Farmaceutica:  Dhanuka Laboratories LTD - INDIA (20/06/2018)

Statement non compliance GMP. Officina Farmaceutica: Dhanuka Laboratories LTD - INDIA (20/06/2018)

richiesta alle aziende farmaceutiche detentrici dell’autorizzazione all’immissione in commercio per il mercato italiano di medicinali ad uso umano e/o alle aziende produttrici di medicinali destinati al mercato comunitario o all'esportazione in paesi terzi contenenti sostanze attive e/o intermedi di produzione fabbricati nell'officina farmaceutica Dhanuka Laboratories LTD, India.

Italia - AIFA - Agenzia Italiana del Farmaco

20-6-2018

Rhiniseng (Laboratorios Hipra, S.A.)

Rhiniseng (Laboratorios Hipra, S.A.)

Rhiniseng (Active substance: inactivated vaccine against atrophic rhinitis in pigs) - Centralised - Yearly update - Commission Decision (2018)3952 of Wed, 20 Jun 2018

Europe -DG Health and Food Safety