FrancophonIA/ELRC3.0 huggingface dataset:
Dutch: Behandeling met Galafold dient te worden ingesteld en gecontroleerd door specialisten met ervaring in de diagnosestelling en behandeling van de ziekte van Fabry.
Icelandic: Læknar með sérfræðiþekkingu og reynslu í greiningu og meðferð Fabry-sjúkdóms eiga að hefja meðferð með Galafold og hafa umsjón með henni.
Dutch: c.T148C of c.C150G of c.C150A F50L
Icelandic: c.T148C eða c.C150G eða c.C150A
Dutch: c.G612T of c.G612C
Icelandic: c.G612T eða c.G612C
Dutch: c.T258G of c.T258A
Icelandic: c.T258G eða c.T258A
Dutch: c.G471C of c.G471T
Icelandic: c.G471C eða c.G471T
Dutch: c.T241C of c.T241A
Icelandic: c.T241C eða c.T241A
Dutch: c.228G>C of c.228G>A of c.228G>T
Icelandic: c.228G>C eða c.228G>A eða c.228G>T
Dutch: c.540G>C of c.540G>T
Icelandic: c.540G>C eða c.540G>T
Dutch: c.552T>A of c.552T>G
Icelandic: c.552T>A eða c.552T>G
Dutch: Galafold is niet bedoeld voor gelijktijdig gebruik met enzymvervangende therapie.
Icelandic: Galafold er ekki ætlað til samhliða notkunar með ensímuppbótarmeðferð.
Dutch: c.G131A of c.G132A
Icelandic: c.G131A eða c.G132A
Dutch: c.G540C of c.G540T
Icelandic: c.G540C eða c.G540T
Dutch: c.519C>A of c.519C>G
Icelandic: c.519C>A eða c.519C>G
Dutch: c.G132T of c.G132C
Icelandic: c.G132T eða c.G132C
Dutch: c.187T>A of c.188G>C
Icelandic: c.187T>A eða c.188G>C
Dutch: Galafold is niet onderzocht bij patiënten met de ziekte van Fabry die een GFR hebben van minder dan 30 ml/min/1,73 m2.
Icelandic: Galafold hefur ekki verið rannsakað hjá sjúklingum með Fabry-sjúkdóm sem eru með gauklasíunarhraða sem er minni en 30 ml/mín./1,73 m2.
Dutch: c.131G>A of c.132G>A
Icelandic: c.131G>A eða c.132G>A
Dutch: c.279C>G of c.279C>A
Icelandic: c.279C>G eða c.279C>A
Dutch: c.T960G of c.T960A
Icelandic: c.T960G eða c.T960A
Dutch: c.A588T of c.A588C
Icelandic: c.A588T eða c.A588C
Dutch: c.233C>G of c.233C>A
Icelandic: c.233C>G eða c.233C>A
Dutch: c.G567C of c.G567T
Icelandic: c.G567C eða c.G567T
Dutch: c.G243T of c.G243C
Icelandic: c.G243T eða c.G243C
Dutch: c.337T>C of c.339T>A of c.339T>G
Icelandic: c.337T>C eða c.339T>A eða c.339T>G
Dutch: c.285G>T of c.285G>C
Icelandic: c.285G>T eða c.285G>C
Dutch: c.C525G of c.C525A
Icelandic: c.C525G eða c.C525A
Dutch: c.153G>A of c.153G>T of c.153G>C
Icelandic: c.153G>A eða c.153G>T eða c.153G>C
Dutch: Amicus Therapeutics Europe Limited Tel.: 0808 034 288 / 877 309 5040 e-mail: MedInfo@amicusrx.com
Icelandic: Amicus Therapeutics Europe Limited Tel.: 0808 034 288 / 877 309 5040 e-mail:
Dutch: c.207C>A of c.207C>G
Icelandic: c.207C>A eða c.207C>G
Dutch: Na gemiddeld 3,4 jaar behandeling was de gemiddelde, op jaarbasis berekende verandering van de eGFRCKD-EPI -0,74 ml/min/1,73 m (95%-BI: -1,89; 0,40; n=41).
Icelandic: Meðalgildi hlutfallslegrar breytingar á ársgrundvelli fyrir eGFRCKD-EPI var -0,74 ml/mín./1,73 m CI: -1,89, 0,40; n=41) eftir að meðaltali 3,4 ára meðferð.
Dutch: A377_P380dup c.1139delC
Icelandic: A377_P380dup
Dutch: NIET BEKEND (del Exon1_2?)
Icelandic: ÓÞEKKT (del Exon1_2?)
Dutch: Er is maar heel weinig ervaring met het gebruik van dit geneesmiddel bij zwangere vrouwen.
Icelandic: Mjög takmarkaðar upplýsingar liggja fyrir um notkun lyfsins á meðgöngu.
Dutch: Farmacotherapeutische categorie: Diverse spijsverteringskanaal- en metabolismeproducten ATC-code: A16AX14
Icelandic: {Ýmis efni fyrir meltingarveg og efnaskiptalyf}, ATC-flokkur:
Dutch: c.G144T of c.G144C
Icelandic: c.G144T eða c.G144C
Dutch: c.561G>T of c.561G>A of c.561G>C
Icelandic: c.561G>T eða c.561G>A eða c.561G>C
Dutch: c.A840T of c.A840C
Icelandic: c.A840T eða c.A840C
Dutch: c.816C>A of c.816C>G
Icelandic: c.816C>A eða c.816C>G
Dutch: c.242G>A of c.243G>A
Icelandic: c.242G>A eða c.243G>A
Dutch: c.525C>G of c.525C>A
Icelandic: c.525C>G eða c.525C>A
Dutch: De ziekte van Fabry is een progressieve X-gebonden lysosomale stapelingsziekte die bij mannen en vrouwen kan voorkomen.
Icelandic: Fabry-sjúkdómur er ágeng truflun á geymslu lýsósómal ensíma sem tengist X-litningi og leggst bæði á karla og konur.
Dutch: Het leeftijdseffect werd geëvalueerd in een populatiefarmacokinetische analyse van de plasmaklaring van migalastat bij de ERT-naïeve onderzoekspopulatie.
Icelandic: Áhrif aldurs voru metin með þýðisgreiningu á lyfjahvörfum á úthreinsun migalastats úr plasma í rannsókninni hjá sjúklingum sem ekki hafa fengið ERT-meðferð.
Dutch: Besloten moet worden of de borstvoeding of de behandeling met Galafold moet worden gestaakt, waarbij het voordeel van borstvoeding voor het kind en het voordeel van de behandeling voor de vrouw in overweging moeten worden genomen.
Icelandic: Vega þarf og meta kosti brjóstagjafar fyrir barnið og ávinning meðferðar fyrir konuna og ákveða á grundvelli matsins hvort hætta eigi brjóstagjöf eða hætta meðferð með Galafold.
Dutch: c.982G>A of c.982G>C
Icelandic: c.982G>A eða c.982G>C
Dutch: c.G140A of G141A
Icelandic: G140A eða G141A
Dutch: NIET BEKEND (del Exon5_7?)
Icelandic: ÓÞEKKT (del Exon5_7?)
Dutch: c.T369G of c.T369A
Icelandic: c.T369G eða c.T369A
Dutch: c.G831T of c.G831C
Icelandic: c.G831T eða c.G831C
Dutch: c.141G>C of c.141G>T
Icelandic: c.141G>C eða c.141G>T
Dutch: c.C453G of c.C453A
Icelandic: c.C453G eða c.C453A
Dutch: c.243G>T of c.243G>C
Icelandic: c.243G>T eða c.243G>C
Dutch: c.612G>T of c.612G>C
Icelandic: c.612G>T eða c.612G>C
Dutch: c.G609C of c.G609T
Icelandic: c.G609C eða c.G609T
Dutch: c.258T>G of c.258T>A
Icelandic: c.258T>G eða c.258T>A
Dutch: c.103G>C of c.103G>A
Icelandic: c.103G>C eða c.103G>A
Dutch: c.T514A of c.G515C
Icelandic: c.T514A eða c.G515C
Dutch: Na de follow-up in de OLE was de gemiddelde verandering van de LVMi ten opzichte van de uitgangswaarde bij patiënten met linkerventrikelhypertrofie bij de start van het onderzoek in maand 36 -30,0 (95%-BI: -57,9; -2,2; n=4) en in maand 48 -33,1 (95%-BI: -60,9; -5,4; n=4).
Icelandic: Við eftirfylgni í opnu framhaldsrannsókninni var meðalbreyting frá grunngildi á LVMi hjá sjúklingum með stækkun vinstri slegils við grunngildi í 36. mánuði -30,0 (95%) CI: -57.9, -2.2; n=4) og í 48. mánuði -33,1 (CI:-60.9,5.4).
Dutch: c.859T>C of c.859T>A
Icelandic: c.859T>C eða c.859T>A
Dutch: Op basis van in-vivo-gegevens is migalastat een substraat voor UGT; dit is een onbelangrijke eliminatieroute.
Icelandic: Samkvæmt in vivo upplýsingum er migalastat hvarfefni fyrir UGT og er minniháttar brotthvarfsleið.
Dutch: Slik de capsules in hun geheel door.
Icelandic: Gleypið hylkin í heilu lagi.
Dutch: Tabel 2: Tabel behandelbare mutaties met Galafold (migalastat)
Icelandic: Tafla yfir móttækileika fyrir Galafold (migalastat)
Dutch: c.T610C of c.T610A
Icelandic: c.T610C eða c.T610A
Dutch: Verminderde -Gal A-activiteit gaat dan ook gepaard met progressieve ophoping van substraat in daarvoor gevoelige organen en weefsels, wat tot de morbiditeit en mortaliteit leidt die met de ziekte van Fabry is geassocieerd.
Icelandic: -Gal A tengist því ágengri uppsöfnun hvarfefna í viðkvæmum líffærum og vefjum sem veldur því sjúkdómsástandi og dánartíðni sem tengist Fabry-sjúkdómi.
Dutch: c.881T>G of c.881T>A
Icelandic: c.881T>G eða c.881T>A
Dutch: c.305C>G of c.305C>A
Icelandic: c.305C>G eða c.305C>A
Dutch: c.T465A of c.T465G
Icelandic: c.T465A eða c.T465G
Dutch: De verandering van de LVMi (g/m2) vanaf de start van het onderzoek tot maand 18 bij patiënten met linkerventrikelhypertrofie (vrouwen met een uitgangs-LVMi > 95 g/m en mannen met een uitgangs-LVMi > 115 g/m2) was -8,4 (95%-BI: -15,7;
Icelandic: Breytingin á LVMi (g/m2) frá grunngildi að 18. mánuði hjá sjúklingum með þykknun vinstri slegils (konum með LVMi > 95 g/m við grunngildi og körlum með LVMi > 115 g/m2) við grunngildi var -8,4 (95% CI: -15,7, 2,6; n=13) fyrir migalastat og 4,5 (95% CI: -10,7, 18,4; n=5) fyrir ERT.
Dutch: • Als u allergisch bent voor migalastat of een van de stoffen in dit geneesmiddel.
Icelandic: ef um er að ræða ofnæmi fyrir migalastati eða einhverju öðru innihaldsefni lyfsins (talin upp í kafla 6)
Dutch: c.3G>A of c.3G>T of c.3G>C c.G3A of c.G3T of c.G3C
Icelandic: M1R c.3G>A eða c.3G>T eða c.3G>C c.G3A eða c.G3T eða c.G3C M1I c.19G>T
Dutch: c.453C>G of c.453C>A
Icelandic: c.453C>G eða c.453C>A
Dutch: c.G216A of c.G216T of c.G216C M72I
Icelandic: c.G216A eða c.G216T eða c.G216C
Dutch: c.G860A of c.G861A
Icelandic: c.G860A eða c.G861A
Dutch: c.166T>A of c.167G>C
Icelandic: c.166T>A eða c.167G>C
Dutch: c.108G>C of c.108G>T
Icelandic: c.108G>C eða c.108G>T
Dutch: c.C966A of c.C966G
Icelandic: c.C966A eða c.C966G
Dutch: c.610T>C of c.610T>A
Icelandic: c.610T>C eða c.610T>A
Dutch: c.132G>T of c.132G>C
Icelandic: c.132G>T eða c.132G>C
Dutch: c.609G>C of c.609G>T
Icelandic: c.609G>C eða c.609G>T
Dutch: Er werden geen klinisch relevante verschillen gezien tijdens de initiële placebogecontroleerde periode van 6 maanden.
Icelandic: Enginn klínískt marktækur munur kom fram á fyrsta 6 mánaða samanburðartímabilinu með lyfleysu.
Dutch: Galafold wordt niet aanbevolen voor gebruik tijdens de zwangerschap.
Icelandic: Galafold er ekki ætlað til notkunar á meðgöngu.
Dutch: c.T408A of c.T408G
Icelandic: c.T408A eða c.T408G
Dutch: c.G242A of c.G243A
Icelandic: c.G242A eða c.G243A
Dutch: Neem dan contact op met uw arts, apotheker of verpleegkundige voordat u dit geneesmiddel gebruikt.
Icelandic: Leitið til læknisins, lyfjafræðings eða hjúkrunarfræðingsins ef þörf er á frekari upplýsingum um notkun lyfsins.
Dutch: Eenmaal in de lysosomen wordt de -Gal A-activiteit door dissociatie van migalastat hersteld; dit leidt tot het katabolisme van GL-3 en verwante substraten.
Icelandic: Í lýsósómunum endurheimitir klofnun migalastats virkni -Gal A sem veldur sundrun á GL-3 og tengdum hvarfefnum.
Dutch: c.C456A of c.C456G
Icelandic: c.C456A eða c.C456G
Dutch: Als u of uw partner zwanger wil worden, neem dan contact op met uw arts, apotheker of verpleegkundige voor advies.
Icelandic: Ef þungun er fyrirhuguð skal leita ráða hjá lækninum, lyfjafræðingi eða hjúkrunarfræðingnum.
Dutch: c.960T>G of c.960T>A
Icelandic: c.960T>G eða c.960T>A
Dutch: c.G71A of c.G72A
Icelandic: c.G71A eða c.G72A
Dutch: c.T280A of c.G281C
Icelandic: c.T280A eða c.G281C
Dutch: c.144G>T of c.144G>C
Icelandic: c.144G>T eða c.144G>C
Dutch: c.G830A of c.G831A
Icelandic: c.G830A eða c.G831A
Dutch: c.870G>A of c.870G>C of c.870G>T
Icelandic: c.870G>A eða c.870G>C eða c.870G>T
Dutch: c.830G>A of c.831G>A
Icelandic: c.830G>A eða c.831G>A
Dutch: c.T154A of c.G155C
Icelandic: c.T154A eða c.G155C
Dutch: c.C897G of c.C897A
Icelandic: c.C897G eða c.C897A
Dutch: • Gewichtstoename
Icelandic: Þyngdaraukning
Dutch: PARTIJ:
Icelandic: Tel:
Dutch: NIET BEKEND (del Exon3?)
Icelandic: ÓÞEKKT (del Exon3?)
Dutch: Amicus Therapeutics Europe Limited Tfn: 020 795 493 e-post: MedInfo@amicusrx.com
Icelandic: Amicus Therapeutics Europe Limited Tfn: 020 795 493 e-post:
Dutch: c.897C>G of c.897C>A
Icelandic: c.897C>G eða c.897C>A
Dutch: c.T648A of c.T648G
Icelandic: c.T648A eða c.T648G
Dutch: Constipatie Droge mond Defecatie-aandrang Dyspepsie
Icelandic: Kviðverkur Hægðatregða Munnþurrkur Bráðar hægðir Meltingartruflanir
Dutch: c.734G>A of c.735G>A
Icelandic: c.734G>A eða c.735G>A
Dutch: c.T676C of c.T676A
Icelandic: c.T676C eða c.T676A
Dutch: c.G485A of c.G486A
Icelandic: c.G485A eða c.G486A
Dutch: c.G141C of c.G141T
Icelandic: c.G141C eða c.G141T
Dutch: c.707G>A of c.708G>A
Icelandic: c.707G>A eða c.708G>A
Dutch: NIET BEKEND (del Exon3_7?)
Icelandic: ÓÞEKKT (del Exon3_7?)
Dutch: c.154T>A of c.155G>C
Icelandic: c.154T>A eða c.155G>C
Dutch: Amicus Therapeutics, UK Limited Tel: +44 175 3888 567 / 08 0823 46864 e-mail: MedInfo@amicusrx.com
Icelandic: +44 175 3888 567 / 08 0823 46864 e-mail:
Dutch: c.966C>A of c.966C>G
Icelandic: c.966C>A eða c.966C>G
Dutch: c.860G>A of c.861G>A
Icelandic: c.860G>A eða c.861G>A
Dutch: c.465T>A of c.465T>G
Icelandic: c.465T>A eða c.465T>G
Dutch: c.485G>A of c.486G>A
Icelandic: c.485G>A eða c.486G>A
Dutch: c.708G>C of c.708G>T
Icelandic: c.708G>C eða c.708G>T
Dutch: c.70T>C of c.70T>A
Icelandic: c.70T>C eða c.70T>A
Dutch: c.861G>C of c.861G>T
Icelandic: c.861G>C eða c.861G>T
Dutch: c.T834G of c.T834A
Icelandic: c.T834G eða c.T834A
Dutch: c.T667A of c.G668C
Icelandic: c.T667A eða c.G668C
Dutch: c.102T>G of c.102T>A
Icelandic: c.102T>G eða c.102T>A
Dutch: Na een enkelvoudige orale dosis van 150 mg migalastathydrochloride-oplossing bedroeg de tijd tot de piekconcentratie in het plasma ongeveer 3 uur.
Icelandic: Eftir stakan 150 mg skammt af migalastat hýdróklóríð lausn til inntöku náðist hámarksplasmaþéttni eftir u.þ.b. 3 klst.
Dutch: c.394G>A of c.394G>C
Icelandic: c.394G>A eða c.394G>C
Dutch: Amicus Therapeutics BV Tel: + 31 20 235 8510 / 0800 022 8399 e-mail: MedInfo@amicusrx.com
Icelandic: + 31 20 235 8510 / 0800 022 8399 e-mail:
Dutch: c.A868C of c.A868T
Icelandic: c.A868C eða c.A868T
Dutch: c.408T>A of c.408T>G
Icelandic: c.408T>A eða c.408T>G
Dutch: c.439G>A of c.439G>C
Icelandic: c.439G>A eða c.439G>C
Dutch: c.G439A of c.G439C
Icelandic: c.G439A eða c.G439C
Dutch: c.456C>A of c.456C>G
Icelandic: c.456C>A eða c.456C>G
Dutch: c.588A>T of c.588A>C
Icelandic: c.588A>T eða c.588A>C
Dutch: c.676T>C of c.676T>A
Icelandic: c.676T>C eða c.676T>A
Dutch: c.720G>C of c.720G>T
Icelandic: c.720G>C eða c.720G>T
Dutch: c.288G>A of c.288G>T of c.288G>C
Icelandic: c.288G>A eða c.288G>T eða c.288G>C
Dutch: c.G486C of c.G486T
Icelandic: c.G486C eða c.G486T
Dutch: c.G837C of c.G837T
Icelandic: c.G837C eða c.G837T
Dutch: c.834T>G of c.834T>A
Icelandic: c.834T>G eða c.834T>A
Dutch: c.T894G of c.T894A
Icelandic: c.T894G eða c.T894A
Dutch: c.G720C of c.G720T
Icelandic: c.G720C eða c.G720T
Dutch: c.T70C of c.T70A
Icelandic: c.T70C eða c.T70A
Dutch: Alle patiënten kregen de aanbevolen dosering van 123 mg Galafold om de andere dag.
Icelandic: 123 mg af Galafold annan hvern dag.
Dutch: c.G394A of c.G394C
Icelandic: c.G394A eða c.G394C
Dutch: c.T817C of c.T819A of c.T819G F273L
Icelandic: c.T817C eða c.T819A eða c.T819G
Dutch: c.G861C of c.G861T
Icelandic: c.G861C eða c.G861T
Dutch: c.T337C of c.T339A of c.T339G F113L
Icelandic: c.T337C eða c.T339A eða c.T339G
Dutch: c.514T>A of c.515G>C
Icelandic: c.514T>A eða c.515G>C
Dutch: c.486G>C of c.486G>T
Icelandic: c.486G>C eða c.486G>T
Dutch: c.888G>A of c.888G>T of c.888G>C
Icelandic: c.888G>A eða c.888G>T eða c.888G>C
Dutch: c.837G>C of c.837G>T
Icelandic: c.837G>C eða c.837G>T
Dutch: c.G785A of c.G786A
Icelandic: c.G785A eða c.G786A
Dutch: c.71G>A of c.72G>A
Icelandic: c.71G>A eða c.72G>A
Dutch: c.978G>C of c.978G>T
Icelandic: c.978G>C eða c.978G>T
Dutch: c.A712C of c.T714A of c.T714G S238R
Icelandic: c.A712C eða c.T714A eða c.T714G
Dutch: Toedieningsweg Verpakking Inhoud Verpakkings -grootte
Icelandic: Íkomuleið Umbúðir Innihald Pakkningastærð
Dutch: Zie rubriek 4.7.
Icelandic: Sjá kafla 4.7.
Dutch: Datum van eerste vergunningverlening: 09/01/2018
Icelandic: Dagsetning fyrstu útgáfu markaðsleyfis: 09/01/2018
Dutch: Een klinische respons op de behandeling wordt meestal binnen 7 dagen gezien.
Icelandic: Klínísk svörun við meðferð kemur yfirleitt fram innan 7 daga.
Dutch: De veiligheid van het diergeneesmiddel is niet vastgesteld bij honden die jonger zijn dan 9 maanden en bij honden die minder wegen dan 3,6 kg.
Icelandic: Ekki hefur verið sýnt fram á öryggi dýralyfsins hjá hundum yngri en 9 mánaða og hundum sem vega minna en 3,6 kg.
Dutch: EU/2/17/221/001 (fles van 20 mg, 7 tabletten, 20 ml) EU/2/17/221/002 (fles van 20 mg, 30 tabletten, 20 ml) EU/2/17/221/003 (fles van 60 mg, 7 tabletten, 20 ml) EU/2/17/221/004 (fles van 60 mg, 30 tabletten, 35 ml) EU/2/17/221/005 (fles van 100 mg, 7 tabletten, 35 ml) EU/2/17/221/006 (fles van 100 mg, 30 tabletten, 60 ml)
Icelandic: EU/2/17/221/001 (20 mg, 7 töflur, 20 ml glas) EU/2/17/221/002 (20 mg, 30 töflur, 20 ml glas) EU/2/17/221/003 (60 mg, 7 töflur, 20 ml glas) EU/2/17/221/004 (60 mg, 30 töflur, 35 ml glas) EU/2/17/221/005 (100 mg, 7 töflur, 35 ml glas) EU/2/17/221/006 (100 mg, 30 töflur, 60 ml glas)
Dutch: 100 mg Zie rubriek 6.1 voor de volledige lijst van hulpstoffen.
Icelandic: 100 mg Sjá lista yfir öll hjálparefni í kafla 6.1.
Dutch: Niet bewaren boven 30 °C.
Icelandic: Geymið við lægri hita en 30°C.
Dutch: EU/2/17/221/006 (fles van 100 mg, 30 tabletten, 60 ml)
Icelandic: EU/02/17/221/006 (100 mg, 30 töflur, 60 ml glas)
Dutch: De eliminatiehalfwaardetijd van grapiprant bedraagt ongeveer 4,6 tot 5,67 uur.
Icelandic: Helmingunartími brotthvarfs grapiprants er u.þ.b. 4,6 til 5,67 klst.
Dutch: NUMMER(S) VAN DE VERGUNNING(EN) VOOR HET IN DE HANDEL BRENGEN EU/2/17/221/001-006
Icelandic: MARKAÐSLEYFISNÚMER EU/2/17/221/001-006
Dutch: Het volgende aantal tabletten moet eenmaal daags worden gegeven:
Icelandic: Gefa skal eftirfarandi fjölda af töflum einu sinni á dag:
Dutch: De farmacologische activiteit van de metabolieten is niet bekend.
Icelandic: Lyfjafræðileg virkni umbrotsefnanna er ekki þekkt.
Dutch: 26 Rue de la Chapelle 68330 Huningue Frankrijk
Icelandic: Elanco France S.A.S. 26 Rue de la Chapelle 68330 Huningue Frakkland
Dutch: Dosisbereik (mg/kg lichaamsgewicht)
Icelandic: Skammtabil (mg/kg líkamsþunga)
Dutch: Grapiprant accumuleert niet in de hond na herhaalde toediening.
Icelandic: Grapiprant safnast ekki upp hjá hundum eftir endurtekna lyfjagjöf.
Dutch: De algemene succespercentages in de twee klinische veldonderzoeken, gebaseerd op CBPI (Canine Brief Pain Inventory, zoals ingevuld door de eigenaar), 28 dagen na aanvang van de behandeling, waren 51,3% (120/235) voor Galliprant en 35,5% (82/231) voor de placebogroep.
Icelandic: Í klínísku vettvangsrannsóknunum tveimur var heildar árangurstíðni byggð á CBPI stuðlinum (Canine Brief Pain Inventory, samkvæmt útfyllingu eiganda) að 28 dögum liðnum frá upphafi meðferðar 51,3% (120/235) hvað varðar Galliprant og 35,5% (82/231) hvað varðar hópinn sem fékk lyfleysu.
Dutch: In vitro eiwitbinding van grapiprant wijst erop dat grapiprant hoofdzakelijk bindt aan serumalbumine bij de hond.
Icelandic: In vitro próteinbinding grapiprants gefur til kynna að grapiprant sé að mestu bundið albúmíni í sermi hunda.
Dutch: Eén witte HDPE-fles met een kindveilige dop met daarin 7 of 30 tabletten (tabletten van 20 mg, 60 mg of 100 mg).
Icelandic: Eitt hvítt HDPE glas með barnaöryggisloki sem inniheldur 7 eða 30 töflur (20 mg, 60 mg eða 100 mg töflur).
Dutch: Grapiprant wordt gemakkelijk en snel uit het maag-darmkanaal van honden opgenomen.
Icelandic: Grapiprant frásogast auðveldlega og hratt úr meltingarvegi hjá hundum.
Dutch: Grapiprant is een methylbenzeensulfonamide.
Icelandic: Grapiprant er metýlbenzensúlfónamíð.
Dutch: BIJZONDERE BEWAARVOORSCHRIFTEN Niet bewaren boven 30 °C.
Icelandic: SÉRSTÖK GEYMSLUSKILYRÐI Geymið við lægri hita en 30°C.
Dutch: Gedetailleerde informatie over dit diergeneesmiddel is beschikbaar op de website van het Europees Geneesmiddelenagentschap http://www.ema.europa.eu/.
Icelandic: Ítarlegar upplýsingar um dýralyfið eru birtar á vef Lyfjastofnunar Evrópu (http://www.ema.europa.eu/)
Dutch: Indien er tekenen van overgevoeligheid voor sulfonamiden optreden, moet de behandeling worden gestaakt.
Icelandic: Ef merki um ofnæmi fyrir súlfónamíði koma fram skal hætta meðferðinni.
Dutch: Het gemiddelde percentage ongebonden grapiprant was 4,35% en 5,01% bij een grapiprantconcentratie van 200 ng/ml en 1000 ng/ml.
Icelandic: Meðaltals prósentuhlutfall óbundins grapiprants var 4,35% og 5,01% við þéttni grapiprants sem nam 200 ng/ml og 1000 ng/ml.
Dutch: Ongeveer 70-80% van de toegediende dosis wordt binnen 48-72 uur uitgescheiden, waarbij het merendeel van de dosis onveranderd wordt uitgescheiden.
Icelandic: U.þ.b. 70-80% af gefnum skammti skiljast út innan 48-72 klst. og mestur hluti þess skammts sem skilst út er óbreyttur.
Dutch: Het diergeneesmiddel is beschikbaar in de volgende verpakkingsgrootten:
Icelandic: Dýralyfið fæst í eftirfarandi pakkningastærðum:
Dutch: Eén fles per kartonnen doos.
Icelandic: Eitt glas í hverri pappaöskju.
Dutch: Eerdere behandeling met andere ontstekingsremmende stoffen kan leiden tot bijkomende of ernstigere bijwerkingen en daardoor moet een behandelingsvrije periode met dergelijke geneesmiddelen in acht worden genomen voordat de behandeling met dit diergeneesmiddel start.
Icelandic: Fyrri meðferð með öðrum bólgueyðandi efnum getur valdið fleiri eða alvarlegri aukaverkunum og því þarf að líða tímabil án meðferðar með slíkum dýralyfjum áður en meðferð er hafin með þessu dýralyfi.
Dutch: Dien dit diergeneesmiddel eenmaal daags toe op een nuchtere maag (bijv. 's ochtends) en ten minste één uur vóór de volgende maaltijd in een doeldosis van 2 mg per kg lichaamsgewicht .
Icelandic: Gefa skal dýralyfið á fastandi maga (t.d. að morgni) og a.m.k. einni klst. fyrir næstu máltíð einu sinni á dag í markskammtinum 2 mg á kg líkamsþyngdar.
Dutch: Verpakkingsgrootten van 7 en 30 tabletten per fles.
Icelandic: Pakkningastærðir með 7 og 30 töflum í hverju glasi.
Dutch: Twee gehydroxyleerde metabolieten en één N-geoxideerde metaboliet worden ook aangetroffen in gal, feces en/of urine.
Icelandic: Tvö hýdroxýltengd umbrotsefni og eitt N-oxað umbrotsefni koma einnig fram í galli, hægðum og/eða þvagi.
Dutch: Speciale voorzorgsmaatregelen voor elke doeldiersoort:
Icelandic: Sérstök varnaðarorð fyrir hverja dýrategund:
Dutch: Het is niet bekend of honden met een voorgeschiedenis van overgevoeligheid voor sulfonamiden overgevoeligheid vertonen voor grapiprant.
Icelandic: Ekki er þekkt hvort hundar með sögu um ofnæmi fyrir súlfónamíðum sýni ofnæmisviðbrögð gagnvart grapipranti.
Dutch: Fles (20 en 35 ml)
Icelandic: INNRI UMBÚÐUM Glas (20 og 35 ml)
Dutch: VERPAKKINGSGROOTTE 7 tabletten
Icelandic: PAKKNINGASTÆRÐ 7 töflur
Dutch: Aangezien de veldstudies maximaal 28 dagen duurden, moet een langdurigere behandeling zorgvuldig worden overwogen en dient de dierenarts regelmatig te monitoren.
Icelandic: Þar sem vettvangsrannsóknir voru takmarkaðar við 28 daga þarf að íhuga lengri meðferð vandlega og dýralæknirinn þarf að veita reglulegt eftirlit.
Dutch: GEGEVENS DIE OP DE PRIMAIRE VERPAKKING MOETEN WORDEN VERMELD Fles (60 ml)
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á INNRI UMBÚÐUM Glas (60 ml)
Dutch: De duur van de behandeling hangt af van de respons die op de behandeling wordt waargenomen.
Icelandic: Lengd meðferðar fer eftir þeirri meðferðarsvörun sem fram kemur.
Dutch: DE DATUM WAAROP DE BIJSLUITER VOOR HET LAATST IS HERZIEN Gedetailleerde informatie over dit diergeneesmiddel is beschikbaar op de website van het Europees Geneesmiddelenagentschap http://www.ema.europa.eu/.
Icelandic: 14. DAGSETNING SÍÐUSTU SAMÞYKKTAR FYLGISEÐILSINS Ítarlegar upplýsingar um dýralyfið eru birtar á vef Lyfjastofnunar Evrópu (http://www.ema.europa.eu/).
Dutch: Door inductie afgesloten, witte, ronde polyethyleen(PE) flessen met hoge dichtheid (HDPE) (20, 35 en 60 ml) met een kindveilige dop met schroefdraad en wikkeling van kunstzijde.
Icelandic: Hitainnsigluð, hvít, kringlótt glös úr háþéttnipólýetýleni (HDPE) (20, 35, og 60 ml) með áskrúfuðu barnaöryggisloki og rúllu úr ræoni.
Dutch: De frequentie van bijwerkingen wordt als volgt gedefinieerd: - Zeer vaak (meer dan 1 op de 10 behandelde dieren vertonen bijwerkingen tijdens de duur van één behandeling) - Vaak (meer dan 1 maar minder dan 10 van de 100 behandelde dieren) - Soms (meer dan 1 maar minder dan 10 van de 1.000 behandelde dieren) - Zelden (meer dan 1 maar minder dan 10 van de 10.000 behandelde dieren) - Zeer zelden (minder dan 1 van de 10.000 behandelde dieren, inclusief geïsoleerde rapporten)
Icelandic: - Mjög algengar (aukaverkanir koma fyrir hjá fleiri en 1 af hverjum 10 dýrum sem fá meðferð) - Algengar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 100 dýrum sem fá meðferð) - Sjaldgæfar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 1.000 dýrum sem fá meðferð) - Mjög sjaldgæfar (koma fyrir hjá fleiri en 1 en færri en 10 af hverjum 10.000 dýrum sem fá meðferð)
Dutch: Na een enkele orale dosis van 2 mg grapiprant/kg, werden in nuchtere staat Cmax- en AUC-waarden bereikt van 1,21 µg/ml en 2,71 µg.h/ml.
Icelandic: Eftir inntöku á stökum skammti sem nemur 2 mg af grapipranti/kg, náðust Cmax og AUC gildi sem námu 1,21 µg/ml og 2,71 µg.klst./ml á fastandi maga.
Dutch: In klinische onderzoeken zijn de volgende lichte en in het algemeen tijdelijke bijwerkingen waargenomen: braken, zachte ontlasting, diarree en gebrek aan eetlust.
Icelandic: Í klínískum rannsóknum varð vart við eftirfarandi aukaverkanir, sem voru vægar og yfirleitt skammvinnar: uppköst, linar hægðir, niðurgangur og lystarleysi.