Rabeprazol "Medical Valley"

Primær information

  • Handelsnavn:
  • Rabeprazol "Medical Valley" 20 mg enterotabletter
  • Dosering:
  • 20 mg
  • Lægemiddelform:
  • enterotabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

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Lokation

  • Fås i:
  • Rabeprazol "Medical Valley" 20 mg enterotabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 43120
  • Sidste ændring:
  • 01-02-2018

Produktresumé

26. april 2018

PRODUKTRESUMÉ

for

Rabeprazol "Medical Valley", enterotabletter

0.

D.SP.NR.

25948

1.

LÆGEMIDLETS NAVN

Rabeprazol "Medical Valley"

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

10 mg

Hver enterotablet indeholder 10 mg rabeprazolnatrium, svarende til 9,42 mg rabeprazol.

20 mg

Hver enterotablet indeholder 20 mg rabeprazolnatrium, svarende til 18,85 mg rabeprazol.

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Enterotabletter

10 mg: Lyserøde, filmovertrukne, bikonvekse tabletter.

20 mg: Gule, filmovertrukne, bikonvekse tabletter.

4.

KLINISKE OPLYSNINGER

4.1

Terapeutiske indikationer

Rabeprazol "Medical Valley" er indiceret til:

Aktivt ulcer duodeni

Aktivt godartet ulcer ventriculi

Symptomatisk erosiv eller ulcerøs gastroøsofageal reflux-sygdom (GORD).

Gastroøsofageal reflux-sygdom, langtidsstyring (GORD vedligeholdelse)

Symptomatisk behandling af moderat til meget svær gastroøsofageal reflux-sygdom

(symptomatisk GORD)

Zollinger-Ellison syndrom

43120_spc.doc

Side 1 af 12

Eradikation af Helicobacter pylori hos patienter med peptisk ulcus i kombination med

hensigtsmæssig antibiotikabehandling. Se pkt. 4.2.

4.2

Dosering og indgivelsesmåde

Dosering

Voksne/ældre

Aktivt ulcer duodeni og aktivt, godartet ulcer ventriculi

Den anbefalede orale dosis for både aktivt ulcer duodeni og aktivt godartet ulcer ventriculi

er 20 mg, der skal tages en gang daglig om morgenen.

De fleste patienter med aktivt ulcer duodeni helbredes inden for fire uger. Nogle patienter

kan dog kræve yderligere fire ugers behandling for at opnå helbredelse. De fleste patienter

med godartet aktivt ulcus ventriculi helbredes inden for seks uger. Dog kan nogle patienter

igen kræve yderligere seks ugers behandling for at opnå helbredelse.

Erosiv eller ulcerøs gastroøsofageal reflux-sygdom (GORD)

Den anbefalede orale dosis for denne tilstand er 20 mg, der skal tages en gang daglig i fire

til otte uger.

Gastroøsofageal reflux-sygdom, langtidsstyring (GORD vedligeholdelsesterapi)

Til langtidsstyring kan der bruges en vedligeholdelsesdosis på 20 mg eller 10 mg en gang

daglig, afhængigt af patientens respons.

Symptomatisk behandling af moderat til meget svær gastroøsofageal reflux-sygdom

(symptomatisk GORD)

10 mg en gang daglig til patienter uden øsofagitis. Hvis der ikke er opnået symptomkontrol

i løbet af 4 uger, skal patienten undersøges yderligere. Når symptomerne er forsvundet, kan

der opnås efterfølgende symptomkontrol ved at bruge et efter-behov regime, hvor der tages

10 mg en gang daglig, når det er påkrævet.

Zollinger-Ellison syndrom

Den anbefalede startdosis til voksne er 60 mg en gang daglig. Dosen kan titreres opad til

120 mg/dag baseret på individuelle patientbehov. Der kan gives daglige enkeltdoser på op

til 100 mg/dag. 120 mg-dosen kan kræve opdelte doser, 60 mg to gange daglig. Behandling

bør fortsætte, så længe det er klinisk indiceret.

Eradikation af Helicobacter pylori

Patienter med H. pylori infektion bør behandles med eradikationsbehandling. Der

anbefales følgende kombination doseret i 7 dage:

Rabeprazolnatrium 20 mg to gange dagligt + clarithromycin 500 mg to gange dagligt og

amoxycillin 1 g to gange dagligt.

Nyre- og leverinsufficiens

Dosisjustering er ikke nødvendig for patienter med nedsat nyre- eller leverfunktion.

Se pkt. 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen af

rabeprazolnatrium i behandlingen af patienter med stærkt nedsat leverfunktion.

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Side 2 af 12

Pædiatrisk population

Rabeprazolnatrium anbefales ikke til brug hos børn, da der ikke er nogen erfaringer med

brugen af den til denne gruppe.

Administration

Til oral anvendelse.

For indikationer, der kræver behandling en gang daglig, skal Rabeprazol "Medical Valley"

enterotabletter tages om morgenen før morgenmaden. Selvom det hverken er påvist, at

tidspunktet på dagen eller fødeindtagelse har nogen virkning på rabeprazolnatriums

aktivitet, vil dette regime lette overholdelse af behandlingen.

Patienterne bør advares om, at Rabeprazol "Medical Valley" enterotabletter ikke må tygges

eller knuses, men skal sluges hele.

4.3

Kontraindikationer

Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført

i pkt. 6.1.

Rabeprazol "Medical Valley" er kontraindiceret ved graviditet og under amning.

4.4

Særlige advarsler og forsigtighedsregler vedrørende brugen

Symptomatisk respons på terapi med rabeprazolnatrium udelukker ikke tilstedeværelsen af

gastrisk eller øsofageal malignitet, og derfor skal muligheden for malignitet udelukkes før

påbegyndelse af behandling med Rabeprazol "Medical Valley".

Patienter i langtidsbehandling (især dem, der behandles i mere end et år) bør holdes under

regelmæssig overvågning.

En risiko for krydsoverfølsomhedsreaktioner med andre protonpumpehæmmere eller

substituerede benzimidazoler kan ikke udelukkes.

Patienterne bør advares om, at Rabeprazol "Medical Valley" enterotabletter ikke må tygges

eller knuses, men skal synkes hele.

Der har været rapporter efter markedsføringen om bloddyskrasier (trombocytopeni og

neutropeni). I flertallet af de tilfælde, hvor en alternativ ætiologi ikke kan identificeres, var

hændelserne ukomplicerede og forsvandt ved seponering af rabeprazol.

Leverenzymabnormiteter er set i kliniske undersøgelser og har også været rapporteret efter

markedsføringstilladelse. I flertallet af de tilfælde, hvor en alternativ ætiologi ikke kan

identificeres, var hændelserne ukomplicerede og forsvandt efter seponering af rabeprazol.

Der sås ingen evidens for signifikante lægemiddelrelaterede sikkerhedsproblemer i en

undersøgelse af patienter med mildt til moderat nedsat leverfunktion versus normale

kontrolpersoner med samme alder og køn. Da der ikke findes nogen kliniske data om

brugen af rabeprazolnatrium i behandlingen af patienter med svær leverdysfunktion, rådes

den ordinerende læge dog til at udvise forsigtighed, når behandling med Rabeprazol

"Medical Valley" første gang initieres hos sådanne patienter.

Samtidig administration af atazanavir med rabeprazolnatrium anbefales ikke (se pkt. 4.5).

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Side 3 af 12

Behandling med protonpumpehæmmere, herunder rabeprazol, kan øge risikoen for

gastrointestinale infektioner som Salmonella, Campylobacter og Clostridium difficile (se

pkt. 5.1).

Protonpumpehæmmere kan øge risikoen for hofte-, håndleds- og rygfrakturer beskedent,

hovedsageligt hos ældre eller ved tilstedeværelse af andre kendte risikofaktorer især hvis

det bruges i høje doser og over lange behandlingsperioder (> 1år). Observationsstudier

antyder, at protonpumpehæmmere kan øge den overordnede risiko for fraktur med 10-40

%. Noget af denne øgning kan skyldes andre risikofaktorer.

Patienter med risiko for osteoporose bør modtage behandling i henhold ti1 gældende

kliniske guidelines og de bør have et tilstrækkeligt indtag af vitamin D og calcium.

Interferens med laboratorieprøver

Forhøjet chromogranin A (CgA) kan interferere med undersøgelser for neuroendokrine

tumorer. For at undgå denne interferens bør rabeprazol seponeres mindst 5 dage inden

måling af CgA (se pkt. 5.1). Hvis indholdet af CgA og gastrin ikke er returneret til

referenceområdet ved den første måling, bør målingen gentages 14 dage efter seponering

af protonpumpehæmmeren.

Hypomagnesiæmi

Alvorlig hypomagnesiæmi har været rapporteret hos patienter behandlet med

protonpumpehæmmere (PPI’er), såsom rabeprazol, i mindst tre måneder og i de fleste

tilfælde i et år. Alvorlige manifestationer af hypomagnesiæmi som træthed, tetani,

delirium, kramper, svimmelhed og ventrikulær arytmi kan forekomme, men kan begynde

stille og kan blive overset. Tilstanden forbedres hos de fleste patienter efter magnesium

erstatning og seponering af PPI.

Det bør overvejes at måle serummagnesium før opstart af PPI behandling og regelmæssigt

under behandlingen hos patienter, der forventes at være i langvarig behandling eller tager

PPI'er samtidigt med digoxin eller andre lægemidler, der kan forårsage hypomagnesiæmi

(f.eks. diuretika).

Samtidig brug af rabeprazol og methotrexat

Litteraturen tyder på, at samtidig brug af PPI'er og methotrexat (primært i høje doser, se

produktinformationen til methotrexat) kan forhøje og forlænge serumniveauerne af

methotrexat og/eller dets metabolit og muligvis føre til methotrexattoksiciteter. Ved

administration af høje doser methotrexat kan midlertidig seponering af PPI'en overvejes

hos nogle patienter.

Påvirkning af absorption af B

-vitamin

Rabeprazolnatrium kan som alle syreblokerende lægemidler nedsætte absorptionen af B

vitamin (cyanocobalamin) på grund af hypo- eller achlorhydri. Dette bør overvejes hos

patienter med mangel på eller risikofaktorer for nedsat absorption af B

vitamin ved

langvarig behandling, eller hvis der observeres kliniske symptomer.

Subakut kutan lupus erythematosus (SCLE)

Protonpumpehæmmere er forbundet med meget sjældne tilfælde af SCLE. Hvis sådanne

hudreaktioner optræder, navnlig på hudområder udsat for sol, og er ledsaget af artralgi, bør

patienten straks søge læge, og lægen bør overveje at seponere Rabeprazol "Medical

Valley". SCLE efter tidligere behandling med en protonpumpehæmmer kan øge risikoen

for SCLE med andre protonpumpehæmmere.

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Side 4 af 12

Pædiatrisk population

Rabeprazolnatrium enterotabletter anbefales ikke til børn, da der ikke er nogen erfaringer

med anvendelse til denne patientgruppe.

4.5

Interaktion med andre lægemidler og andre former for interaktion

Rabeprazolnatrium producerer en dybtgående og langvarig hæmning af mavesyresekretion.

Der kan forekomme en interaktion med forbindelser, hvis absorption er pH-afhængig.

Samtidig administration af rabeprazolnatrium og ketoconazol eller itraconazol kan føre til

en signifikant sænkning af fungicid-plasmaniveauer. Det kan derfor være nødvendigt at

overvåge individuelle patienter for at fastslå, om en dosisjustering er nødvendig, når

ketoconazol eller itraconazol tages samtidig med Rabeprazol "Medical Valley".

I kliniske forsøg blev der brugt antacider samtidig med administrationen af

rabeprazolnatrium, og i en specifik undersøgelse af lægemiddel-lægemiddel interaktion

blev der ikke observeret nogen interaktion med flydende antacider.

Samtidig administration af atazanavir 300 mg/ritonavir 100 mg og omeprazol (40 mg en

gang daglig) eller atazanavir 400 mg med lansoprazol (60 mg en gang daglig) til raske,

frivillige forsøgspersoner medførte en væsentlig reduktion af atazanavireksponering.

Absorptionen af atazanavir er pH-afhængig. Selvom det ikke er blevet undersøgt, forventes

lignende resultater med andre protonpumpehæmmere. Derfor bør protonpumpehæmmere,

herunder rabeprazol, ikke administreres samtidig med atazanavir (se pkt. 4.4).

Methotrexat

Patient cases, publicerede farmakokinetiske populationsstudier og retrospektive analyser

tyder på, at samtidig administration af PPI'er og methotrexat (primært i høje doser, se

produktinformationen til methotrexat) kan forhøje og forlænge serumniveauerne af

methotrexat og/eller dets metabolit hydroxymethotrexat. Der er dog ikke udført nogen

formelle lægemiddelinteraktionsstudier med methotrexat og PPI'er.

4.6

Graviditet og amning

Graviditet

Der foreligger ingen data om rabeprazols sikkerhed ved human graviditet.

Reproduktionsstudier gennemført med rotter og kaniner har ikke afsløret nogen evidens for

nedsat fertilitet eller skade på fosteret på grund af rabeprazolnatrium, selvom der

forekommer lav føtoplacentær overførsel hos rotter. Rabeprazol "Medical Valley" er

kontraindiceret under graviditet (se pkt. 4.3).

Amning

Det vides ikke, om rabeprazolnatrium udskilles i human modermælk. Der er ikke

gennemført nogen undersøgelser med ammende kvinder. Rabeprazolnatrium udskilles

imidlertid i rotters mammæsekretioner. Rabeprazol "Medical Valley" bør derfor ikke

bruges under amning (se pkt. 4.3).

4.7

Virkninger på evnen til at føre motorkøretøj eller betjene maskiner

Ikke mærkning.

På grundlag af de farmakodynamiske egenskaber og bivirkningsprofilen er det

usandsynligt, at rabeprazolnatrium vil forårsage en forringelse af evnen til at føre

motorkøretøj eller nedsætte evnen til at betjene maskiner. Hvis årvågenheden imidlertid er

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Side 5 af 12

nedsat på grund af døsighed, anbefales det at undgå at føre motorkøretøj og betjene

komplekse maskiner.

4.8

Bivirkninger

Resumé af sikkerhedsprofil

De hyppigst rapporterede uønskede lægemiddelreaktioner under kontrollerede kliniske

forsøg med rabeprazol var hovedpine, diarre, abdominale smerter, asteni, flatulens, udslæt

og mundtørhed. Flertallet af de uønskede hændelser, der oplevedes under kliniske forsøg,

var milde eller moderate i sværhedsgrad og af forbigående natur.

Skematisk oversigt over bivirkninger

Følgende bivirkninger har været rapporteret fra kliniske forsøg og erfaringer efter

markedsføringen.

Hyppigheden er defineret som: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10),

ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1000), meget sjælden

(<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).

Systemorgan-

klasse

Almindelig

Ikke

almindelig

Sjælden

Meget

sjælden

Ikke kendt

Infektioner og

parasitære

sygdomme

Infektion

Blod og

lymfesystem

Neutropeni,

Leukopeni,

Trombo-

cytopeni,

Leukocytose

Immun-

systemet

Hyper-

sensitivitet

Metabolisme

og ernæring

Anoreksi

Hyponatriæmi,

Hypomagnesiæ

mi (se pkt. 4.4)

Psykiske

forstyrrelser

Søvnløshed

Nervøsitet

Depression

Konfusion

Nerve-

systemet

Hovedpine,

Svimmelhed

Somnolens

Øjne

Syns-

forstyrrelser

Vaskulære

sygdomme

Perifert ødem

Luftveje,

thorax og

mediastinum

Hoste,

Faryngitis,

Rhinitis

Bronkitis,

Sinusitis

Mave-tarm-

kanalen

Diarré,

Opkastning,

Kvalme,

Abdominal-

Dyspepsi,

Mundtørhed,

Opstød

Gastritis,

Stomatitis,

Smags-

forstyrrelser

Mikroskopisk

kolitis

43120_spc.doc

Side 6 af 12

Systemorgan-

klasse

Almindelig

Ikke

almindelig

Sjælden

Meget

sjælden

Ikke kendt

smerter,

Forstoppelse,

Flatulens,

Benigne

gastriske

polypper

Lever og

galdeveje

Hepatitis,

Gulsot,

Hepatisk

Encefalopati

Hud og

subkutane væv

Udslæt,

Erytem

Pruritus,

Svedtendens,

Bulløse

reaktioner

Erythema

multiforme,

Toksisk

epidermal

nekrolyse

(TEN),

Stevens-

Johnson's-

syndrom (SJS)

Subakut kutan

lupus

erythematosus

(se pkt. 4.4)

Knogler, led,

muskler og

bindevæv

Ikke-

specifikke

smerter,

Rygsmerter

Myalgi,

Kramper i

benene,

Artralgi,

Hofte-,

håndleds- eller

rygfrakturer

(se pkt. 4.4)

Nyrer og

urinveje

Urinvejs-

infektion

Interstitiel

nefritis

Det

reproduktive

system og

mammae

Gynækomasti

Almene

symptomer og

reaktioner på

administra-

tionsstedet

Asteni,

Influenza-

lignende

sygdom

Brystsmerter,

Kulderystelse

Pyreksi

Undersøgelser

Forhøjede

leverenzymer

Vægtøgning

Omfatter opsvulmen af ansigt, hypotension og dyspnø.

Erythem, bulløse reaktioner og overfølsomhedsreaktioner forsvinder sædvanligvis efter

seponering af terapi.

Der er modtaget sjældne rapporter om hepatisk encefalopati hos patienter med underliggende

cirrhose. Ved behandling af patienter med svær hepatisk dysfunktion rådes den ordinerende læge til

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Side 7 af 12

at udvise forsigtighed, når behandling med Rabeprazol "Medical Valley" første gang initieres hos

sådanne patienter (se pkt. 4.4).

Indberetning af formodede bivirkninger

Når lægemidlet er godkendt, er indberetning af formodede bivirkninger vigtig. Det

muliggør løbende overvågning af benefit/risk-forholdet for lægemidlet. Læger og

sundhedspersonale anmodes om at indberette alle formodede bivirkninger via:

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

4.9

Overdosering

Den hidtidige erfaring med tilsigtet eller utilsigtet overdosering er begrænset. Den

fastslåede eksponering har ikke oversteget 60 mg to gange daglig eller 160 mg en gang

daglig. Virkningerne er generelt minimale, repræsentative for den kendte bivirkningsprofil

og reversible uden yderligere lægelig intervention. Der kendes ingen specifik modgift.

Rabeprazolnatrium er i udstrakt grad proteinbundet og er derfor ikke let at dialysere. Som i

ethvert tilfælde af overdosering bør behandling være symptomatisk, og der skal anvendes

generelle støttende forholdsregler.

4.10

Udlevering

5.

FARMAKOLOGISKE EGENSKABER

5.0

Terapeutisk klassifikation

ATC kode: A 02 BC 04. Fordøjelseskanalen og metabolisme, lægemidler til mavesår og

gastroøsofageal reflux-sygdom (GORD), protonpumpehæmmere.

5.1

Farmakodynamiske egenskaber

Farmakodynamisk virkning

Rabeprazolnatrium tilhører klassen af antisekretoriske forbindelser, de substituerede

benzimidazoler, som ikke hæmmer anticholinerge eller H

-histamin-antagonistegenskaber,

men supprimerer mavesyresekretion ved specifik hæmning af H

-ATPase enzym (syre-

eller protonpumpen). Effekten er dosisrelateret og fører til hæmning af både basal og

stimuleret syresekretion uanset stimulus. Dyreforsøg indikerer, at rabeprazolnatrium efter

administration hurtigt forsvinder fra både plasma og maveslimhinden. Som en svag base

absorberes rabeprazol hurtigt efter alle doser og koncentreres i parietalcellernes sure miljø.

Rabeprazol konverteres til den aktive sulfenamidform gennem protonering og reagerer

efterfølgende med de tilgængelige cysteiner på protonpumpen.

Antisekretorisk aktivitet

Efter oral administration af en 20-mg dosis rabeprazolnatrium starter den antisekretoriske

effekt inden for en time, og den maksimale effekt optræder inden for to til fire timer.

Hæmning af basal og fødestimuleret syresekretion 23 timer efter den første dosis

rabeprazolnatrium er henholdsvis 69 % og 82 %, og hæmning varer op til 48 timer.

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Rabeprazolnatriums hæmmende virkning på syresekretion øges en smule med gentagen

dosering en gang daglig, idet steady-state hæmning opnås efter tre dage. Når lægemidlet

seponeres, normaliseres den sekretoriske aktivitet over 2 til 3 dage.

Nedsat gastrisk surhedsgrad, uanset årsag, herunder protonpumpehæmmere som

rabeprazol, øger antallet af bakterier, som normalt er til stede i mave-tarm-kanalen.

Behandling med protonpumpehæmmere kan muligvis øge risikoen for gastrointestinale

infektioner som Salmonella, Campylobacter og Clostridium difficile (se pkt. 4.4).

Virkninger på serum-gastrin

I kliniske forsøg blev patienter behandlet en gang daglig med 10 mg eller 20 mg

rabeprazolnatrium i op til 43 måneder. Serum gastrin niveauerne øgedes under de første 2

til 8 uger, hvilket afspejler de hæmmende virkninger på syresekretion, og forblev stabile,

mens behandlingen fortsattes. Gastrinværdierne vendte tilbage til præbehandlingsniveauer,

som regel 1 til 2 uger efter seponering af terapi.

Humane gastriske biopsiprøver fra antrum og fundus fra over 500 patienter, der modtog

rabeprazol- eller komparatorbehandling i op til 8 uger, har ikke sporet ændringer i ECL-

cellehistologi, graden af gastritis, forekomst af atrofisk gastritis, intestinal metaplasi eller

distribution af H. pylori infektion. Hos over 250 patienter, der blev fulgt gennem 36

måneders kontinuerlig terapi, blev der ikke observeret nogen signifikant ændring i fund,

der var til stede ved baseline.

Andre virkninger

Der er hidtil ikke fundet systemiske virkninger af rabeprazolnatrium i CNS, kardio-

vaskulære og åndedrætssystemer. Rabeprazolnatrium givet i orale doser på 20 mg i 2 uger

havde ingen effekt på thyroidea-funktion, kulhydratmetabolisme eller cirkulerende

niveauer af parathyroideahormon, kortisol, østrogen, testosteron, prolaktin, kolecystokinin,

sekretin, glukagon, follikel-stimulerende hormon (FSH), luteiniserende hormon (LH),

renin, aldosteron eller somatotropin.

Forsøg med raske, frivillige forsøgspersoner har vist, at rabeprazolnatrium ikke har klinisk

signifikante interaktioner med amoxicillin. Rabeprazol påvirker ikke plasmakoncentra-

tioner af amoxicillin eller clarithromycin negativt, når de administreres samtidigt med

henblik på udryddelse af H. pylori infektion i øvre del af mave-tarm-kanalen.

Under behandling med sekretionshæmmende lægemidler stiger indholdet af gastrin i serum

som reaktion på den nedsatte syresekretion. Også indholdet af CgA stiger på grund af den

nedsatte gastriske aciditet. Det forhøjede indhold af CgA kan interferere med

undersøgelser for neuroendokrine tumorer.

Den foreliggende publicerede dokumentation antyder, at protonpumpehæmmere bør

seponeres mellem 5 dage og 2 uger før måling af CgA. Dette er for at eventuelle falskt

forhøjede værdier af CgA i forbindelse med behandling med protonpumpehæmmere kan

vende tilbage til referenceområdet.

5.2

Farmakokinetiske egenskaber

Absorption

Rabeprazol "Medical Valley" enterotabletter er en syreresistent (gastroresistent) tablet-

formulering af rabeprazolnatrium. Denne præsentation er nødvendig, fordi rabeprazol er

syrelabil. Absorption af rabeprazol begynder derfor efter, at tabletten forlader maven.

43120_spc.doc

Side 9 af 12

Absorption er hurtig med peak plasma niveauer af rabeprazol, der optræder ca. 3,5 timer

efter en 20 mg dosis. Peak plasma-koncentrationer (C

) af rabeprazol og AUC er lineære

inden for et doseringsområde på 10 mg til 40 mg. Absolut biotilgængelighed af en oral 20

mg dosis (sammenlignet med intravenøs administration) er omkring 52 %, i vidt omfang på

grund af præ-systemisk metabolisme. Desuden synes biotilgængeligheden ikke at øges

med gentagen administration. Hos raske forsøgspersoner er halveringstiden i plasma ca. 1

time (fra 0,7 til 1,5 timer), og den totale clearance estimeres til at være 283 ± 98 ml/min.

Der var ingen klinisk relevant interaktion med føde. Hverken føde eller tidspunkt på dagen

for administration af behandlingen påvirker absorptionen af rabeprazolnatrium.

Fordeling

Rabeprazol bindes ca. 97 % til humane plasmaproteiner.

Biotransformation

Som det er tilfældet med andre medlemmer af protonpumpehæmmerne, metaboliseres

rabeprazolnatrium via det cytokrome P450 (CYP450) hepatisk-metaboliske system. In

vitro forsøg med humane levermikrosomer indikerede, at rabeprazolnatrium metaboliseres

af isoenzymer af CYP450 (CYP2C19 og CYP3A4). I disse forsøg hverken inducerer eller

hæmmer rabeprazol ved forventede humane plasmakoncentrationer CYP3A4; og selvom

in vitro studier ikke nødvendigvis altid er prædiktive for in vivo status, indikerer disse

fund, at der ikke forventes nogen interaktion mellem rabeprazol og cyclosporin. Hos

mennesker er sulfid (M1) og carboxylsyre (M6) de vigtigste plasma-metabolitter, mens

sulfon (M2), desmethylsulfid (M4) og sulfanylurinsyrekonjugat (M5) er mindre væsentlige

metabolitter, der observeres ved lavere niveauer. Kun desmethyl-metabolitten (M3) har en

mindre antisekretorisk aktivitet, men er ikke til stede i plasma.

Elimination

Efter en enkelt 20 mg

C mærket oral dosis rabeprazolnatrium fandtes ingen uomdannet

medicin i urinen. Ca. 90 % af dosis blev udskilt via urinen, hovedsagelig som de to

metabolitter: Et mercaptansyrekonjugat (M5) og en carboxylsyre (M6) plus to ukendte

metabolitter. Den resterende dosis blev genfundet i fæces

Køn

Når der justeres for kropsmasse og højde, er der ingen signifikante kønsforskelle i de

farmakokinetiske parametre efter en enkelt 20 mg dosis rabeprazol.

Nyreinsufficiens

Hos patienter med kronisk nyresvigt i slutstadiet, som kræver hæmodialyse (kreatinin-

clearance

5ml/min/1,73 m

), var rabeprazols metabolisme og udskillelse meget lig den,

som ses hos raske forsøgspersoner. AUC og C

hos disse patienter var ca. 35 % lavere

end de tilsvarende parametre hos raske forsøgspersoner. Den gennemsnitlige halveringstid

for rabeprazol var 0,82 timer hos raske forsøgspersoner, 0,95 timer hos patienter i

hæmodialyse og 3,6 timer post dialyse. Stoffets clearance hos patienter med hæmodialyse-

krævende nyresygdom var omtrent det dobbelte af de raske, forsøgspersoners.

Leverinsufficiens

Efter en enkelt 20 mg dosis rabeprazol givet til patienter med kronisk mild til moderat

nedsat leverfunktion fordobledes AUC, og der var 2-3 gange stigning i rabeprazols

halveringstid sammenlignet med raske forsøgspersoner. Efter en 20 mg dosis daglig i 7

dage forøgedes AUC imidlertid til kun 1,5 gange og C

til kun 1,2 gange. Rabeprazols

halveringstid hos patienter med nedsat leverfunktion var 12,3 timer sammenlignet med 2,1

43120_spc.doc

Side 10 af 12

timer hos raske forsøgspersoner. Den farmakodynamiske respons (gastrisk pH kontrol) i de

to grupper var klinisk sammenlignelig.

Ældre

Udskillelsen af rabeprazol var noget nedsat hos ældre. Efter 7 dages daglig dosering med

20 mg rabeprazolnatrium blev AUC omtrent fordoblet, C

forøgedes med 60 %, og

halveringstiden forøgedes med ca. 30 % sammenlignet med unge raske forsøgspersoner.

Der var imidlertid ingen tegn på akkumulering af rabeprazol.

CYP2C19 polymorfisme

Efter en 20 mg daglig dosis rabeprazol i 7 dage havde CYP2C19-langsomme

metabolisatorer AUC og t½, som var cirka 1,9 og 1,6 gange de tilsvarende parametre hos

ekstensive metabolisatorer, hvorimod C

kun var forøget med 40 %.

5.3

Prækliniske sikkerhedsdata

Ikke-kliniske virkninger blev kun observeret ved eksponeringer, som overskred den

maksimale humane eksponering, hvilket gør bekymring for den humane sikkerhed

ubetydelig i forhold til dyredata.

Studier vedrørende mutagenitet gav tvetydige resultater. Forsøg med lymfome

musecellerækker var positive, men in vivo kernelegeme og in vivo og in vitro DNA

regenerations-tests var negative. Carcinogenitetsstudier afslørede ingen særlige farer for

mennesker.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Tabletkerne

Mannitol

Tungt magnesiumoxid

Hydroxypropylcellulose

Magnesiumstearat

Mellemlag

Ethylcellulose

Tungt magnesiumoxid

Tabletovertræk

Hypromellosephthalat

Phthalat

Dibutylsebacat

Talcum

Titaniumdioxid (E171)

Gul jernoxid (E172) (20 mg)

Rød jernoxid (E172) (10 mg)

6.2

Uforligeligheder

Ikke relevant.

43120_spc.doc

Side 11 af 12

6.3

Opbevaringstid

2 år.

6.4

Særlige opbevaringsforhold

Må ikke opbevares ved temperaturer over 25 °C.

Opbevares i den originale yderpakning.

6.5

Emballagetyper og pakningsstørrelser

Aluminium/aluminiumblister, i papæske.

Pakningsstørrelser: 1, 5, 7, 14, 15, 25, 28, 30, 50, 56, 75, 98 og 120 stk.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

6.6

Regler for destruktion og anden håndtering

Ingen særlige forholdsregler.

Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale

retningslinjer.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Medical Valley Invest AB

Brädgårdsvägen 28

236 32 Höllviken

Sverige

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

10 mg: 43119

20 mg: 43120

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

16. november 2009

10.

DATO FOR ÆNDRING AF TEKSTEN

26. april 2018

43120_spc.doc

Side 12 af 12

  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.

    Anmode informationsbrochure for offentligheden.



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FDA - U.S. Food and Drug Administration

14-9-2018

Federal Register Notice: #FDA Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee. Nominations are due by November 5, 2018. For more information, click here:  https://go.usa.g

Federal Register Notice: #FDA Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee. Nominations are due by November 5, 2018. For more information, click here: https://go.usa.g

Federal Register Notice: #FDA Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee. Nominations are due by November 5, 2018. For more information, click here: https://go.usa.gov/xPgW5  #MedicalDevice

FDA - U.S. Food and Drug Administration

14-9-2018

Federal Register Notice: Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee. Nominations are due by October 9, 2018. For more information, click here:  https://go.usa.gov/xPgWa  #MedicalDevice

Federal Register Notice: Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee. Nominations are due by October 9, 2018. For more information, click here: https://go.usa.gov/xPgWa  #MedicalDevice

Federal Register Notice: Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee. Nominations are due by October 9, 2018. For more information, click here: https://go.usa.gov/xPgWa  #MedicalDevice

FDA - U.S. Food and Drug Administration

14-9-2018

#FDA approves device for treatment of acute coronary artery perforations. Read more about the approval here:  https://go.usa.gov/xPgTA  #MedicalDevice

#FDA approves device for treatment of acute coronary artery perforations. Read more about the approval here: https://go.usa.gov/xPgTA  #MedicalDevice

#FDA approves device for treatment of acute coronary artery perforations. Read more about the approval here: https://go.usa.gov/xPgTA  #MedicalDevice

FDA - U.S. Food and Drug Administration

14-9-2018

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here:  http://go.usa.gov/xPgTB  #MedicalDevice

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here: http://go.usa.gov/xPgTB  #MedicalDevice

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here: http://go.usa.gov/xPgTB  #MedicalDevice

FDA - U.S. Food and Drug Administration

14-9-2018

#FDA awards five grants to advance the development of pediatric medical devices. Click the link to read more about the grants and the FDA's work to advance the development of pediatric #MedicalDevices:  http://go.usa.gov/xPg2A 

#FDA awards five grants to advance the development of pediatric medical devices. Click the link to read more about the grants and the FDA's work to advance the development of pediatric #MedicalDevices: http://go.usa.gov/xPg2A 

#FDA awards five grants to advance the development of pediatric medical devices. Click the link to read more about the grants and the FDA's work to advance the development of pediatric #MedicalDevices: http://go.usa.gov/xPg2A 

FDA - U.S. Food and Drug Administration

14-9-2018

#FDA's Dr. Binita Ashar provides a statement on continuing the agency’s commitment to studying breast implant safety. To read the statement, click the link:  https://go.usa.gov/xPg4C  #MedicalDevices

#FDA's Dr. Binita Ashar provides a statement on continuing the agency’s commitment to studying breast implant safety. To read the statement, click the link: https://go.usa.gov/xPg4C  #MedicalDevices

#FDA's Dr. Binita Ashar provides a statement on continuing the agency’s commitment to studying breast implant safety. To read the statement, click the link: https://go.usa.gov/xPg4C  #MedicalDevices

FDA - U.S. Food and Drug Administration

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

6-9-2018

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program:  https://go.usa.gov/xPxVa 

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program: https://go.usa.gov/xPxVa 

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program: https://go.usa.gov/xPxVa  #MedicalDevice pic.twitter.com/dOcFpbed9K

FDA - U.S. Food and Drug Administration

5-9-2018

Patients may not have access to an #FDA approved or cleared device in the absence of adequate coverage. That’s why we’re expanding our work with private payors to help narrow the time it takes for payors to make a coverage determination on new medical dev

Patients may not have access to an #FDA approved or cleared device in the absence of adequate coverage. That’s why we’re expanding our work with private payors to help narrow the time it takes for payors to make a coverage determination on new medical dev

Patients may not have access to an #FDA approved or cleared device in the absence of adequate coverage. That’s why we’re expanding our work with private payors to help narrow the time it takes for payors to make a coverage determination on new medical devices

FDA - U.S. Food and Drug Administration

5-9-2018

In today’s FDA Voice Blog, I highlight our work to help address a potential road block to timely patient access to medical devices – payor coverage decisions. We want to be a partner in helping facilitate efficient access to beneficial innovations  https:

In today’s FDA Voice Blog, I highlight our work to help address a potential road block to timely patient access to medical devices – payor coverage decisions. We want to be a partner in helping facilitate efficient access to beneficial innovations https:

In today’s FDA Voice Blog, I highlight our work to help address a potential road block to timely patient access to medical devices – payor coverage decisions. We want to be a partner in helping facilitate efficient access to beneficial innovations https://go.usa.gov/xPcyB 

FDA - U.S. Food and Drug Administration

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

5-9-2018

#FDA announces draft guidance: Consideration of Uncertainty in Making Benefit-Risk Determinations in #MedicalDevice Premarket Approvals. The document is now open for comment for 90 days. Click the link to review the draft guidance and provide comments:  h

#FDA announces draft guidance: Consideration of Uncertainty in Making Benefit-Risk Determinations in #MedicalDevice Premarket Approvals. The document is now open for comment for 90 days. Click the link to review the draft guidance and provide comments: h

#FDA announces draft guidance: Consideration of Uncertainty in Making Benefit-Risk Determinations in #MedicalDevice Premarket Approvals. The document is now open for comment for 90 days. Click the link to review the draft guidance and provide comments: https://go.usa.gov/xPcpT  pic.twitter.com/hAuLWaIYiK

FDA - U.S. Food and Drug Administration

5-9-2018

Click the link for more information about the workshop and how to register:  https://go.usa.gov/xPcVM  #MedicalDevice

Click the link for more information about the workshop and how to register: https://go.usa.gov/xPcVM  #MedicalDevice

Click the link for more information about the workshop and how to register: https://go.usa.gov/xPcVM  #MedicalDevice

FDA - U.S. Food and Drug Administration

5-9-2018

FDA's Center for Devices and Radiological Health, along with the University of Maryland Center of Excellence in Regulatory Science and Innovation will be hosting a workshop on #PatientEngagement in Real-World Evidence Lessons and Best Practices for medica

FDA's Center for Devices and Radiological Health, along with the University of Maryland Center of Excellence in Regulatory Science and Innovation will be hosting a workshop on #PatientEngagement in Real-World Evidence Lessons and Best Practices for medica

FDA's Center for Devices and Radiological Health, along with the University of Maryland Center of Excellence in Regulatory Science and Innovation will be hosting a workshop on #PatientEngagement in Real-World Evidence Lessons and Best Practices for medical devices on Sept. 9th

FDA - U.S. Food and Drug Administration

4-9-2018

Certificates of free sale and export certificates for medical devices

Certificates of free sale and export certificates for medical devices

The TGA has introduced a new process for certificates of free sale and export certificates.

Therapeutic Goods Administration - Australia

22-8-2018

Routine eye exams and visiting your eye doctor will help ensure and maintain healthy eyes for everyone. #OnePairTakeCare #FDA #MedicalDevicepic.twitter.com/SQYFz30oFy

Routine eye exams and visiting your eye doctor will help ensure and maintain healthy eyes for everyone. #OnePairTakeCare #FDA #MedicalDevicepic.twitter.com/SQYFz30oFy

Routine eye exams and visiting your eye doctor will help ensure and maintain healthy eyes for everyone. #OnePairTakeCare #FDA #MedicalDevice pic.twitter.com/SQYFz30oFy

FDA - U.S. Food and Drug Administration

20-8-2018

Comparable overseas regulators for medical device applications

Comparable overseas regulators for medical device applications

Use of market authorisation evidence from comparable overseas regulators for medical devices

Therapeutic Goods Administration - Australia

20-8-2018

Application requirements for medical devices - preliminary assessment

Application requirements for medical devices - preliminary assessment

Applications for the inclusion of medical devices (including IVDs) in the ARTG must meet certain requirements in order to pass preliminary assessment

Therapeutic Goods Administration - Australia

17-8-2018

#FDA issues letter to healthcare providers on the final post-approval study results & risks associated with #SynCardia TAH-t: C2 Driver System.  https://go.usa.gov/xUeYd  #MedicalDevices

#FDA issues letter to healthcare providers on the final post-approval study results & risks associated with #SynCardia TAH-t: C2 Driver System. https://go.usa.gov/xUeYd  #MedicalDevices

#FDA issues letter to healthcare providers on the final post-approval study results & risks associated with #SynCardia TAH-t: C2 Driver System. https://go.usa.gov/xUeYd  #MedicalDevices

FDA - U.S. Food and Drug Administration

17-8-2018

#FDA issues FR notice on proposed list of #MedicalDevice accessories suitable for class I. Comments open for 60 days. View the list here:  https://go.usa.gov/xUe37  #FDARA

#FDA issues FR notice on proposed list of #MedicalDevice accessories suitable for class I. Comments open for 60 days. View the list here: https://go.usa.gov/xUe37  #FDARA

#FDA issues FR notice on proposed list of #MedicalDevice accessories suitable for class I. Comments open for 60 days. View the list here: https://go.usa.gov/xUe37  #FDARA

FDA - U.S. Food and Drug Administration

15-8-2018

Electronic Instructions for Use - eIFU

Electronic Instructions for Use - eIFU

New guidance on electronic instructions for use for medical devices

Therapeutic Goods Administration - Australia

14-8-2018

We are excited by all the feedback we received over the last two days during the Pediatric Medical Device Development meeting. All presentation materials will be available on the Pediatric Medical Device webpage at  https://go.usa.gov/xUF39   #Devices4Kid

We are excited by all the feedback we received over the last two days during the Pediatric Medical Device Development meeting. All presentation materials will be available on the Pediatric Medical Device webpage at https://go.usa.gov/xUF39  #Devices4Kid

We are excited by all the feedback we received over the last two days during the Pediatric Medical Device Development meeting. All presentation materials will be available on the Pediatric Medical Device webpage at https://go.usa.gov/xUF39  #Devices4Kids #MedicalDevice pic.twitter.com/XGwlpgopGn

FDA - U.S. Food and Drug Administration

14-8-2018

Today is Day 2 of the Pediatric Medical Device Public Meeting. Today we will be discussing the importance of International Regulation Harmonization.  https://go.usa.gov/xU6rg  #Devices4Kids #MedicalDevicepic.twitter.com/bMYgjX8CTX

Today is Day 2 of the Pediatric Medical Device Public Meeting. Today we will be discussing the importance of International Regulation Harmonization. https://go.usa.gov/xU6rg  #Devices4Kids #MedicalDevicepic.twitter.com/bMYgjX8CTX

Today is Day 2 of the Pediatric Medical Device Public Meeting. Today we will be discussing the importance of International Regulation Harmonization. https://go.usa.gov/xU6rg  #Devices4Kids #MedicalDevice pic.twitter.com/bMYgjX8CTX

FDA - U.S. Food and Drug Administration

14-8-2018

We thank the participants that joined in person and remotely during Day 1 of the Pediatric Medical Device Development public meeting.  We look forward to continuing discussions around increasing medical device options for children today.  #Devices4Kids #M

We thank the participants that joined in person and remotely during Day 1 of the Pediatric Medical Device Development public meeting. We look forward to continuing discussions around increasing medical device options for children today. #Devices4Kids #M

We thank the participants that joined in person and remotely during Day 1 of the Pediatric Medical Device Development public meeting. We look forward to continuing discussions around increasing medical device options for children today. #Devices4Kids #MedicalDevice pic.twitter.com/7cXPFfvfif

FDA - U.S. Food and Drug Administration

14-8-2018

FDA Commissioner, @SGottliebFDA , speaking during day 1 of the Pediatric Medical Device Development Public Meeting  #devices4kids #FDA #MedicalDevicepic.twitter.com/0I1Poe9Yqn

FDA Commissioner, @SGottliebFDA , speaking during day 1 of the Pediatric Medical Device Development Public Meeting #devices4kids #FDA #MedicalDevicepic.twitter.com/0I1Poe9Yqn

FDA Commissioner, @SGottliebFDA , speaking during day 1 of the Pediatric Medical Device Development Public Meeting #devices4kids #FDA #MedicalDevice pic.twitter.com/0I1Poe9Yqn

FDA - U.S. Food and Drug Administration

13-8-2018

More highlights from today's Pediatric Medical Device Development Public Meeting: Dr. Michelle Tarver of CDRH highlighting that collaboration is imperative in helping to promote pediatric device development. #devices4kids #MedicalDevicepic.twitter.com/mzl

More highlights from today's Pediatric Medical Device Development Public Meeting: Dr. Michelle Tarver of CDRH highlighting that collaboration is imperative in helping to promote pediatric device development. #devices4kids #MedicalDevicepic.twitter.com/mzl

More highlights from today's Pediatric Medical Device Development Public Meeting: Dr. Michelle Tarver of CDRH highlighting that collaboration is imperative in helping to promote pediatric device development. #devices4kids #MedicalDevice pic.twitter.com/mzlmU6Nq9U

FDA - U.S. Food and Drug Administration

13-8-2018

Highlights from today's Pediatric Medical Device Development Public Meeting: Bakul Patel discussed #digitalhealth and how technology enables development and access to safe medical devices #devices4kids #FDAPreCertpic.twitter.com/X4wQbX0Tjc

Highlights from today's Pediatric Medical Device Development Public Meeting: Bakul Patel discussed #digitalhealth and how technology enables development and access to safe medical devices #devices4kids #FDAPreCertpic.twitter.com/X4wQbX0Tjc

Highlights from today's Pediatric Medical Device Development Public Meeting: Bakul Patel discussed #digitalhealth and how technology enables development and access to safe medical devices #devices4kids #FDAPreCert pic.twitter.com/X4wQbX0Tjc

FDA - U.S. Food and Drug Administration

13-8-2018

Today is Day 1 of the Pediatric Medical Device Development Public Meeting. Today we will discuss the programs, policies, and procedures at the #FDA intended to streamline evidence generation.  https://go.usa.gov/xU6rg 
#devices4kids #Pediatricspic.twitter

Today is Day 1 of the Pediatric Medical Device Development Public Meeting. Today we will discuss the programs, policies, and procedures at the #FDA intended to streamline evidence generation. https://go.usa.gov/xU6rg  #devices4kids #Pediatricspic.twitter

Today is Day 1 of the Pediatric Medical Device Development Public Meeting. Today we will discuss the programs, policies, and procedures at the #FDA intended to streamline evidence generation. https://go.usa.gov/xU6rg  #devices4kids #Pediatrics pic.twitter.com/3tXTgwPJPo

FDA - U.S. Food and Drug Administration