FrancophonIA/ELRC3.0 huggingface dataset:
English: Rydapt is dosed on days 8-21 of induction and consolidation chemotherapy cycles, and then for patients in complete response every day as single agent maintenance therapy until relapse for up to 12 cycles of 28 days each (see section 4.1).
Danish: Rydapt doseres på dag 8-21 i induktions- og konsolideringskemoterapi serierne og for patienter med komplet respons herefter hver dag som monoterapi vedligeholdelsesbehandling indtil tilbagefald i op til 12 serier af 28 dages varighed (se pkt.
English: Carmine (E120) Hypromellose Propylene glycol
Danish: Carminer (E 120) Hypromellose Propylenglycol
English: Haemoglobin less than 8 g/dl attributed to Rydapt in patients without MCL, or life-threatening anaemia attributed to Rydapt in patients with baseline haemoglobin value of 8-10 g/dl
Danish: Hæmoglobinværdier på mindre end 8 g/dl som tilskrives Rydapt hos patienter uden mastcelleleukæmi, eller livstruende anæmi som tilskrives Rydapt hos patienter med hæmoglobinværdier ved baseline på 8-10 g/dl
English: Rydapt + chemo n=229
Danish: Rydapt + kemo n=229
English: The pharmacokinetics of midostaurin in paediatric patients were explored in a phase I dose escalation monotherapy study with 22 patients (12 aged 0-2 years and 10 aged 10-17 years) with AML or MLL-rearranged ALL using a population pharmacokinetic approach.
Danish: Farmakokinetikken af midostaurin hos pædiatriske patienter blev undersøgt i et fase I-monoterapistudie med dosisøgning, der omfattede 22 patienter (12 i alderen 0-2 år og 10 i alderen 10-17 år) med AML eller MLL-omlejret ALL, ved brug af en populationsfarmakokinetisk tilgang.
English: No midostaurin dose adjustment is required based on gender.
Danish: Det er ikke påkrævet at justere midostaurin-dosis på basis af køn.
English: Soft capsule
Danish: Bløde kapsler
English: Sexually active women of childbearing potential are advised to have a pregnancy test within 7 days prior to starting treatment with Rydapt and that they should use effective contraception (methods that result in less than 1% pregnancy rates) when using Rydapt and for at least 4 months after stopping treatment with Rydapt.
Danish: Seksuelt aktive kvinder i den fertile alder rådes til at få foretaget en graviditetstest, inden for 7 dage før behandling med Rydapt påbegyndes, og at de bør anvende sikker kontraception (metoder, der resulterer i graviditetsrater på mindre end 1 %), mens de bruger Rydapt og i mindst 4 måneder efter ophør af behandling med Rydapt.
English: Tmax was delayed for all entities, midostaurin median Tmax was 3 h, and for CGP52421 and CGP62221 Tmax was delayed to 6 and 7 hours respectively.
Danish: Tmax blev forsinket for alle enheder, midostaurin medianTmaxvar 3 t, og for CGP52421 og CGP62221 blev Tmax forsinket til henholdsvis 6 og 7 timer.
English: CGP52421 concentrations do not appear to decline as significantly as for midostaurin and CGP62221.
Danish: Koncentrationen af CGP52421 synes ikke at falde så signifikant som koncentrationerne af midostaurin og CGP62221.
English: The efficacy and safety of midostaurin in combination with standard chemotherapy versus placebo plus standard chemotherapy and as single agent maintenance therapy was investigated in 717 patients (18 to 60 years of age) in a randomised, double-blind, phase III study.
Danish: Effekten og sikkerheden af midostaurin i kombination med standardkemoterapi versus placebo plus standardkemoterapi og som enkeltstof-vedligeholdelsesbehandling blev undersøgt hos 717 patienter (i alderen 18-60 år) i et randomiseret, dobbeltblindet fase III-studie.
English: Midostaurin in combination with chemotherapeutic agents (cytarabine, doxorubicin, idarubicin and daunorubicin) resulted in synergistic growth inhibition in FLT3-ITD expressing AML cell lines.
Danish: Midostaurin i kombination med kemoterapeutika (cytarabin, doxorubicin, idarubicin og daunorubicin) resulterede i synergistisk væksthæmning i FLT3-ITD-udtrykkende AML-cellelinjer.
English: Tell your doctor, pharmacist or nurse straight away if you get any of these symptoms during treatment with Rydapt: - if you have fever, sore throat or mouth ulcers, because these may indicate that your white blood cell count is low.
Danish: Fortæl det straks til lægen, apotekspersonalet eller sundhedspersonalet, hvis du får nogen af disse symptomer under behandling med Rydapt: - hvis du har feber, ondt i halsen eller mundsår, da disse kan være tegn på, at du har for få hvide blodlegemer.
English: DFS (CR induction) (HR)
Danish: DFS (CR induktion) (HR)
English: Sensitivity analyses for both OS and EFS when censored at the time of SCT also supported the clinical benefit with midostaurin plus standard chemotherapy over placebo.
Danish: Når data blev censureret ved tidspunktet for SCT, understøttede følsomhedsanalyser for både OS og EFS også den kliniske fordel med midostaurin plus standardkemoterapi sammenlignet med placebo plus standardkemoterapi.
English: Following multiple oral doses, midostaurin displayed time-dependent pharmacokinetics with an initial increase in plasma concentrations during the first week (peak Cmin) followed by a decline with time to a steady-state after approximately 28 days (2.5-fold decrease).
Danish: Efter flere orale doser udviste midostaurin en tidsafhængig farmakokinetik med en initial stigning i plasmakoncentrationerne i løbet af den første uge (højeste Cmin) efterfulgt af et fald med tiden til et steady state efter ca. 28 dage (2,5 gange fald).
English: - if you have new or worsening symptoms such as fever, cough with or without mucous, chest pain, trouble breathing or shortness of breath, because these may be signs of infections or lung problems.
Danish: - hvis du har nye symptomer eller forværring af symptomer som fx feber, hoste med eller uden slim, smerter i brystkassen, vejrtrækningsbesvær eller åndenød, da disse kan være tegn på infektioner eller lungeproblemer.
English: On day 7, AUCCtrough (exposure under the curve of Ctrough from day 1 to day 7) was 5410 ng*h/ml in healthy subjects and was decreased by 35% and 20% in subjects with mild and moderate hepatic impairment, respectively.
Danish: På dag 7 var AUCCtrough (eksponering under kurven for Ctrough fra dag 1 til dag 7) 5410 ng*t/ml hos raske forsøgspersoner og var reduceret med 35 % og 20 % hos forsøgspersoner med henholdsvis let og moderat nedsat leverfunktion.
English: Women of childbearing potential should be informed that animal studies show midostaurin to be harmful to the developing foetus.
Danish: Kvinder i den fertile alder bør informeres om, at midostaurin i dyrestudier har vist sig at have en skadelig virkning på det udviklende foster.
English: Pregnant women should be informed of the potential risk to a foetus; females of reproductive potential should be advised to have a pregnancy test within 7 days prior to starting treatment with Rydapt and to use effective contraception during treatment with Rydapt and for at least 4 months after stopping treatment.
Danish: Gravide kvinder bør informeres om den mulige risiko for fosteret, og kvinder i den fertile alder bør rådes til at tage en graviditetstest inden for 7 dage før behandling med Rydapt initieres, samt til at anvende sikker kontraception under behandling med Rydapt og i mindst 4 måneder efter behandlingsophør.
English: There was a trend favouring midostaurin for CR rate by day 60 for the midostaurin arm (58.9% versus 53.5%; p = 0.073) that continued when considering all CRs during induction (65.0% versus 58.0%; p = 0.027).
Danish: Der var en trend til fordel for Rydapt for CR-rate ved dag 60 for midostaurin-armen (58,9 % versus 53,5 %; p = 0,073), som fortsatte, når alle CR'er under induktionen blev taget i betragtning (65,0 % versus 58,0 %; p = 0,027).
English: For EFS, considering complete remissions within 60 days of study treatment start, the HR was 0.602 (95% CI: 0.372, 0.974) for patients with SCT and 0.827 (95% CI: 0.689, 0.993) for patients without SCT, favouring midostaurin.
Danish: For EFS ved komplette remissioner inden for 60 dage efter behandlingsstart var HR 0,602 (95% CI: 0,372, 0,974) for patienter med SCT og 0,827 (95% CI: 0,689, 0,993) for patienter uden SCT, der favoriserer midostaurin.
English: Other possible side effects in patients with ASM, SM-AHN and MCL Other side effects include those listed below.
Danish: Andre bivirkninger hos patienter med ASM, SM-AHN og mastcelleleukæmi Andre bivirkninger omfatter dem, der er anført nedenfor.
English: At steady state of midostaurin (50 mg twice daily for 21 days), with the strong CYP3A4 inhibitor itraconazole at steady state in a subset of patients (N=7), midostaurin steady-state exposure (Cmin) was increased by 2.09-fold.
Danish: Ved steady state af midostaurin (50 mg to gange daglig i 21 dage) og med den potente CYP3A4hæmmer itraconazol ved steady state hos en undergruppe af patienter (N=7), var steady stateeksponeringen for midostaurin (Cmin) øget 2,09 gange.
English: Stop taking Rydapt and tell your doctor straight away if you notice any of the following as these could be signs of an allergic reaction: - difficulty breathing or swallowing - dizziness - swelling of the face, lips, tongue or throat - severe itching of the skin, with a red rash or raised bumps
Danish: Stop omgående med at tage Rydapt, og fortæl det straks til lægen, hvis du bemærker noget af følgende, da det kan være tegn på en allergisk reaktion: - vejrtrækningsbesvær eller synkebesvær - svimmelhed - hævelse af ansigt, læber, tunge eller svælg - voldsom hudkløe med rødt udslæt eller hævede knopper
English: Table 1 Rydapt dose interruption, reduction and discontinuation recommendations in patients with AML
Danish: Tabel 1 Anbefalinger til doseringssafbrydelse, reduktion og seponering af Rydapt hos patienter med AML
English: Table 7 Efficacy of midostaurin in ASM, SM-AHN and MCL: primary efficacy population
Danish: Tabel 7 Virkning af midostaurin ved ASM, SM-AHN og mastcelleleukæmi (MCL): primær effekt-population
English: - The other ingredients are: macrogolglycerol hydroxystearate, gelatin, macrogol, glycerol, ethanol anhydrous, maize oil mono-di-triglycerides, titanium dioxide (E171), all-rac-alpha-tocopherol, iron oxide yellow (E172), iron oxide red (E172), carmine (E120), hypromellose, propylene glycol, purified water.
Danish: - Øvrige indholdsstoffer: ricinusolie, polyoxyleret, hydrogeneret, gelatine, macrogol, glycerol, vandfri ethanol, majsolie-mono-di-triglycerider, titandioxid (E 171), all-rac-alfa-tocopherol, gul jernoxid, (E 172), rød jernoxid (E 172), carminer (E 120), hypromellose, propylenglycol, renset vand.
English: Midostaurin is not an inhibitor of CYP3A4 in vivo.
Danish: Midostaurin hæmmer ikke CYP3A4 in vivo.
English: Otherwise continue Rydapt 50 mg once daily.
Danish: Alternativt fortsæt med 50 mg Rydapt en gang daglig.
English: The pharmacokinetics of midostaurin have not been assessed in patients with baseline severe hepatic impairment (Child-Pugh Class C) (see section 4.4).
Danish: Midostaurins farmakokinetik er ikke blevet vurderet hos patienter med svært nedsat leverfunktion (Child-Pugh-klasse C) ved baseline (se pkt.
English: AML The recommended dose of Rydapt is 50 mg orally twice daily.
Danish: AML Den anbefalede dosis af Rydapt er 50 mg oralt to gange daglig.
English: A dedicated QT study in 192 healthy subjects with a dose of 75 mg twice daily did not reveal clinically significant prolongation of QT by midostaurin and CGP62221 but the study duration was not long enough to estimate the QTc prolongation effects of the long-acting metabolite CGP52421.
Danish: Et dedikeret QT-studie hos 192 raske forsøgspersoner med en dosis på 75 mg to gange daglig viste ingen klinisk signifikant forlængelse af QT forårsaget af midostaurin og CGP62221, men studiets varighed var ikke lang nok til at estimere indvirkningen af den langtidsvirkende metabolit CGP52421 på QTc-bredden.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Rydapt in one or more subsets of the paediatric population in the treatment of acute myeloid leukaemia (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Rydapt i en eller flere undergrupper af den pædiatriske population ved behandling af akut myeloid leukæmi (se pkt.
English: If you have any questions about how long to take Rydapt, talk to your doctor or pharmacist.
Danish: Hvis du har spørgsmål til, hvor længe du skal tage Rydapt, så tal med lægen eller apotekspersonalet.
English: 9/l) was generally reversible by withholding Rydapt until recovery and discontinuation in the ASM, SM-AHN and MCL studies.
Danish: 9/l) var generelt reversibel, hvis behandling med Rydapt blev afbrudt indtil bedring eller seponeret i studierne af ASM, SM-AHN og mastcelleleukæmi.
English: Midostaurin inhibits multiple receptor tyrosine kinases, including FLT3 and KIT kinase.
Danish: Midostaurin hæmmer flere receptortyrosinkinaser, herunder FLT3- og KIT-kinase.
English: Lipase increased*
Danish: Forhøjet lipaseniveau*
English: In AML and ASM, SM-AHN and MCL patients, population pharmacokinetic estimates for clearance of midostaurin at steady state were 5.9 l/h and 4.4 l/h, respectively.
Danish: Hos patienter med AML og patienter med ASM, SM-AHN og mastcelleleukæmi var de populationsfarmakokinetiske estimater af midostaurins clearance ved steady state henholdsvis 5,9 l/t og 4,4 l/t.
English: Clinical experience in patients with severe renal impairment is limited and no data are available in patients with end-stage renal disease (see sections 4.4 and 5.2).
Danish: Der er begrænset klinisk erfaring med patienter med svært nedsat nyrefunktion og der foreligger ingen data om patienter med nyresygdom i slutstadiet (se pkt.
English: The efficacy of midostaurin in patients with ASM, SM-AHN and MCL, collectively referred to as advanced systemic mastocytosis (SM), was evaluated in two open-label, single-arm, multicentre studies (142 patients in total).
Danish: Virkningen af midostaurin hos patienter med ASM, SM-AHN og mastcelleleukæmi, samlet betegnet som fremskreden systemisk mastocytose (SM), blev vurderet i to ublindede multicenterstudier med en enkelt arm (142 patienter i alt).
English: Rydapt contains the active substance midostaurin.
Danish: Rydapt indeholder det aktive stof midostaurin.
English: The overall rate of SCT was 59.4% (214/360) of patients in the midostaurin plus standard chemotherapy arm versus 55.2% (197/357) in the placebo plus standard chemotherapy arm. All patients were followed for survival.
Danish: Den samlede SCT-rate var 59,4 % (214/360) af patienterne i armen med midostaurin plus standardkemoterapi versus 55,2 % (197/357) i armen med placebo plus standardkemoterapi.
English: Two major metabolites have been identified in murine models and humans, i.e. CGP62221 and CGP52421.
Danish: To hovedmetabolitter er blevet identificeret hos murine modeller og mennesker, dvs. CGP62221 og CGP52421.
English: Midostaurin inhibits FLT3 receptor signalling and induces cell cycle arrest and apoptosis in leukaemic cells expressing FLT3 ITD or TKD mutant receptors or over-expressing FLT3 wild type receptors.
Danish: Midostaurin hæmmer FLT3-receptor-signalering og inducerer cellecyklusstop og apoptose i leukæmiske celler, der udtrykker receptorer med en FLT3-ITD- eller TKD-mutation eller overudtrykker FLT3-vildtypereceptorer.
English: - Patients with ASM, SM-AHN or MCL
Danish: - Patienter med ASM, SM-AHN eller mastcelleleukæmi
English: Each soft capsule contains approximately 83 mg ethanol anhydrous and 415 mg macrogolglycerol hydroxystearate.
Danish: Hver blød kapsel indeholder ca. 83 mg ethanol, vandfri og 415 mg ricinusolie, polyoxyleret, hydrogeneret.
English: Two of its metabolites demonstrated pharmacological activities (CGP52421 and CGP62221).
Danish: To af dets metabolitter udviste farmakologisk aktivitet (CGP52421 og CGP62221).
English: In the repeat-dose studies, target organs for toxicity were the gastrointestinal tract (emesis in dogs and monkeys, diarrhoea and mucosal alteration), testes (decreased spermatogenesis), bone marrow (hypocellularity) and lymphoid organs (depletion/atrophy).
Danish: I studierne med gentagne doser var målorganerne for toksicitet mave-tarm-kanalen (opkastning hos hunde og aber, diarré og slimhindeforandringer), testiklerne (nedsat sædudvikling), knoglemarven (hypocellularitet) og lymfeorganerne (udtømning/atrofi).
English: - This medicine does not require any special temperature storage conditions.
Danish: - Der er ingen særlige krav vedrørende opbevaringstemperaturer for dette lægemiddel.
English: No dose adjustment is required in patients with mild or moderate (Child-Pugh A or B) hepatic impairment (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat (Child-Pugh A eller B) leverfunktion (se pkt.
English: Neutropenia has occurred in patients receiving Rydapt as monotherapy and in combination with chemotherapy (see section 4.8).
Danish: Der er forekommet neutropeni hos patienter, som fik Rydapt som monoterapi og i kombination med kemoterapi (se pkt.
English: The usual daily dose is 100 mg (4 capsules) twice daily.
Danish: Den sædvanlige daglige dosis er 100 mg (4 kapsler) to gange daglig.
English: It is currently unknown whether midostaurin may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method of contraception (see section 4.6).
Danish: På nuværende tidspunkt vides det ikke, om midostaurin kan nedsætte effektiviteten af hormonelle kontraceptiva og derfor bør kvinder, der anvender hormonelle kontraceptiva, tilføje en svangerskabsforebyggende barrieremetode (se pkt.
English: Peak midostaurin concentration (Cmax) was reduced by 20% with a standard meal and by 27% with a high-fat meal versus on an empty stomach (see section 5.2).
Danish: Maksimumskoncentrationen (Cmax) af midostaurin blev reduceret med 20 % med et standardmåltid og med 27 % med et fedtholdigt måltid i forholde til administration på tom mave (se pkt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Rydapt in all subsets of the paediatric population in the treatment of malignant mastocytosis and mast cell leukaemia (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Rydapt i alle undergrupper af den pædiatriske population ved behandling af malign mastocytose og mastcelleleukæmi (se pkt.
English: You must use an effective method of contraception while taking Rydapt and for at least 4 months after you have stopped taking it.
Danish: Du skal bruge en sikker svangerskabsforebyggende metode, mens du tager Rydapt, og i mindst 4 måneder efter at du er stoppet med at tage det.
English: While the exact mechanism for the declining concentration of midostaurin is unclear, it is likely due to the auto-induction properties of midostaurin and its two active metabolite CGP52421 and CGP62221 on CYP3A4.
Danish: Selvom den nøjagtige mekanisme bag den faldende koncentration af midostaurin ikke kendes, kan det sandsynligvis skyldes autoinduktionsegenskaber for midostaurin og dets to aktive metabolitter CGP52421 og CGP62221 på CYP3A4.
English: Patients with newly diagnosed FLT3-mutated AML as determined by a clinical study assay were randomised (1:1) to receive midostaurin 50 mg twice daily (n=360) or placebo (n=357) sequentially in combination with standard daunorubicin (60 mg/m daily on days 1-3) / cytarabine (200 mg/m daily on days 1-7) induction and high-dose cytarabine (3 g/m every 12 hours on days 1, 3, 5) consolidation, followed by continuous midostaurin or placebo treatment according to initial assignment for up to 12 additional cycles (28 days/cycle).
Danish: Patienter med nydiagnosticeret FLT3-muteret AML bestemt med en klinisk studie-analyse blev randomiseret (1:1) til at tage 50 mg midostaurin to gange daglig (n=360) eller placebo (n=357) sekventielt i kombination med standard daunorubicin (60 mg/m daglig på dag 1-3)/cytarabin (200 mg/m daglig på dag 1-7)-induktion og højdosis-cytarabin (3 g/m hver 12. time på dag 1, 3, 5)-konsolidering efterfulgt af kontinuerlig behandling med midostaurin eller placebo i henhold til den indledende tildeling i op til yderligere 12 serier (28 dage/serie).
English: Overall survival probability, %
Danish: OS-sandsynlighed, %
English: A dedicated hepatic impairment study assessed the systemic exposure of midostaurin after oral administration of 50 mg twice daily for 6 days in subjects with baseline mild or moderate hepatic impairment (Child-Pugh Class A or B, respectively) and control subjects with normal hepatic function.
Danish: I et dedikeret studie af nedsat leverfunktion blev der foretaget en vurdering af den systemiske eksponering for midostaurin efter oral administration af 50 mg to gange daglig i 6 dage hos forsøgspersoner med let eller moderat nedsat leverfunktion (henholdsvis Child-Pugh-klasse A eller B) ved baseline og kontrol-forsøgspersoner med normal leverfunktion.
English: At the median peak Cmin concentrations attained at a dose of 100 mg twice daily, neither midostaurin, CGP62221 nor CGP52421 showed a potential to cause clinically significant QTcF prolongation, since the upper bounds of predicted change at these concentration levels were less than 10 msecs (5.8, 2.4, and 4.0 msecs, respectively).
Danish: Ved medianen af de højeste Cmin-koncentrationer opnået ved en dosis på 100 mg to gange daglig viste hverken midostaurin, CGP62221 eller CGP52421 potentiale til at forårsage klinisk signifikant QTcF-forlængelse, da de øvre grænser for forventet ændring ved disse koncentrationsniveauer var mindre end 10 ms (henholdsvis 5,8, 2,4 og 4,0 ms).
English: The major plasma components included midostaurin and two major active metabolites, CGP62221 (via O-demethylation) and CGP52421 (via hydroxylation), accounting for 27.7±2.7% and 38.0±6.6%, respectively, of the total plasma exposure at 96 hours after a single 50 mg dose of midostaurin.
Danish: Hovedkomponenterne i plasma omfattede midostaurin og to aktive hovedmetabolitter, CGP62221 (via O-demethylering) og CGP52421 (via hydroxylering), der tegnede sig for henholdsvis 27,7 ± 2,7 % og 38,0±6,6 % af den samlede plasmaeksponering ved 96 timer efter en enkelt dosis på 50 mg midostaurin.
English: What Rydapt contains - The active substance is midostaurin.
Danish: Rydapt indeholder: - Aktivt stof: midostaurin.
English: Because of the potential for serious adverse reactions in breast-feeding infants from Rydapt, women should discontinue breast-feeding during treatment with Rydapt and for at least 4 months after stopping treatment (see section 4.6).
Danish: På grund af risikoen for alvorlige bivirkninger af Rydapt hos ammede spædbørn bør kvinder stoppe med at amme under behandling med Rydapt og i mindst 4 måneder efter behandlingsophør (se pkt.
English: The supportive study was a single-arm, multicentre, open-label phase II study of 26 patients with ASM, SM-AHN and MCL (CPKC412A2213).
Danish: Det understøttende studie var et ublindet fase II-multicenterstudie med en enkelt arm, der omfattede 26 patienter med ASM, SM-AHN og mastcelleleukæmi (CPKC412A2213).
English: If any of these side effects become severe, tell your doctor or pharmacist.
Danish: Hvis nogen af disse bivirkninger bliver alvorlige, skal du fortælle det til lægen eller apotekspersonalet.
English: 9/l attributed to Rydapt in patients with baseline ANC value of 0.5-1.5 x 10
Danish: 9/l som tilskrives Rydapt hos patienter med en baseline ANC-værdi på 0,5-1,5 x 10
English: Pale orange, oblong capsule with red imprint “PKC NVR”.
Danish: Lys orange, aflang kapsel påtrykt “PKC NVR” i rødt.
English: In the randomised AML study no difference in CHF was observed between the Rydapt + chemotherapy and placebo + chemotherapy arms.
Danish: Der blev ikke observeret nogen forskel i CHF mellem armene med Rydapt + kemoterapi og placebo + kemoterapi i det randomiserede AML-studie.
English: Adverse reactions observed were diarrhoea, abdominal pain and vomiting.
Danish: De observerede bivirkninger var diarré, mavesmerter og opkastning.