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

22-6-2018

Draeger Medical Systems, Inc. Jaundice Meter JM-103 and Jaundice Meter JM-105 Recalled Due to Misinterpretation of Display Messages for Out of Range Values  https://go.usa.gov/xUqzz  #medicaldevice #fda

Draeger Medical Systems, Inc. Jaundice Meter JM-103 and Jaundice Meter JM-105 Recalled Due to Misinterpretation of Display Messages for Out of Range Values https://go.usa.gov/xUqzz  #medicaldevice #fda

Draeger Medical Systems, Inc. Jaundice Meter JM-103 and Jaundice Meter JM-105 Recalled Due to Misinterpretation of Display Messages for Out of Range Values https://go.usa.gov/xUqzz  #medicaldevice #fda

FDA - U.S. Food and Drug Administration

6-6-2018

Update: Increased application audit requirements for some medical devices applications

Update: Increased application audit requirements for some medical devices applications

TGA no longer considers it necessary to apply increased audit requirements to particular European notified bodies for medical devices.

Therapeutic Goods Administration - Australia

5-6-2018

#DYK The misuse of prescription drugs means taking a medication in a manner or dose other than prescribed; taking someone else’s prescription, even if for a legitimate medical complaint such as pain; or taking a medication to feel euphoria. #FDAInnovation

#DYK The misuse of prescription drugs means taking a medication in a manner or dose other than prescribed; taking someone else’s prescription, even if for a legitimate medical complaint such as pain; or taking a medication to feel euphoria. #FDAInnovation

#DYK The misuse of prescription drugs means taking a medication in a manner or dose other than prescribed; taking someone else’s prescription, even if for a legitimate medical complaint such as pain; or taking a medication to feel euphoria. #FDAInnovationChallenge pic.twitter.com/QI0mrJactV

FDA - U.S. Food and Drug Administration

1-6-2018

News and press releases:  New medicine for hereditary rare disease

News and press releases: New medicine for hereditary rare disease

Tegsedi addresses unmet medical need for treatment of hereditary transthyretin amyloidosis

Europe - EMA - European Medicines Agency

1-6-2018

TGA presentation: Health Consumers Workshop - Medical Devices, 1 March 2018

TGA presentation: Health Consumers Workshop - Medical Devices, 1 March 2018

Presentations for the medical devices health consumer workshop on consumer information for implantable medical devices.

Therapeutic Goods Administration - Australia

30-5-2018

#FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development & review of their device proposals to prevent and treat opioid use dis

#FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development & review of their device proposals to prevent and treat opioid use dis

#FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development & review of their device proposals to prevent and treat opioid use disorder. #FDA MedicalDevice

FDA - U.S. Food and Drug Administration

30-5-2018

As part of FDA’s ongoing effort to address the epidemic of #opioid addiction, the agency has announced an innovation challenge to spur development of medical devices, including digital health and diagnostic devices, to help combat opioid addiction. #FDAIn

As part of FDA’s ongoing effort to address the epidemic of #opioid addiction, the agency has announced an innovation challenge to spur development of medical devices, including digital health and diagnostic devices, to help combat opioid addiction. #FDAIn

As part of FDA’s ongoing effort to address the epidemic of #opioid addiction, the agency has announced an innovation challenge to spur development of medical devices, including digital health and diagnostic devices, to help combat opioid addiction. #FDAInnovationChallenge pic.twitter.com/W21hFOinRg

FDA - U.S. Food and Drug Administration

29-5-2018

Ensure that you have optimised your Class I medical device ARTG entries

Ensure that you have optimised your Class I medical device ARTG entries

Information sheet to assist sponsors to optimise their Class I ARTG

Therapeutic Goods Administration - Australia

28-5-2018

#OnThisDay- May 28, 1976- President Gerald D. Ford signs Medical Device Amendments of FDCA of 1938, establishing federal regulatory controls for medical devices #FDAHistory

#OnThisDay- May 28, 1976- President Gerald D. Ford signs Medical Device Amendments of FDCA of 1938, establishing federal regulatory controls for medical devices #FDAHistory

#OnThisDay- May 28, 1976- President Gerald D. Ford signs Medical Device Amendments of FDCA of 1938, establishing federal regulatory controls for medical devices #FDAHistory

FDA - U.S. Food and Drug Administration

25-5-2018

Medical devices and IVDs: Suspensions from the ARTG

Medical devices and IVDs: Suspensions from the ARTG

Revocation of suspension of Device Embolisation Device ARTG entries 281030 and 281033

Therapeutic Goods Administration - Australia

24-5-2018

#ThrowBackThursday- May 24, 1977- Bureau of Medical Devices and Diagnostic Products renamed Bureau of Medical Devices and new Office of Small Manufacturers Assistance created, as required by law. #OnThisDay #FDAHistory

#ThrowBackThursday- May 24, 1977- Bureau of Medical Devices and Diagnostic Products renamed Bureau of Medical Devices and new Office of Small Manufacturers Assistance created, as required by law. #OnThisDay #FDAHistory

#ThrowBackThursday- May 24, 1977- Bureau of Medical Devices and Diagnostic Products renamed Bureau of Medical Devices and new Office of Small Manufacturers Assistance created, as required by law. #OnThisDay #FDAHistory

FDA - U.S. Food and Drug Administration

24-5-2018

Submissions received: Proposed regulatory changes related to personalised and 3D printed medical devices

Submissions received: Proposed regulatory changes related to personalised and 3D printed medical devices

Submissions received on the Proposed regulatory changes related to personalised and 3D printed medical devices have been published

Therapeutic Goods Administration - Australia

4-5-2018

Medical devices and IVDs: Cancellations from the ARTG

Medical devices and IVDs: Cancellations from the ARTG

Cancellation of Profile Surgical Forceps, biopsy

Therapeutic Goods Administration - Australia

20-4-2018

The Poisons Standard and medical devices

The Poisons Standard and medical devices

New guidance explaining the labelling requirements of medical devices containing poisons

Therapeutic Goods Administration - Australia