FrancophonIA/ELRC3.0 huggingface dataset:
English: All study participants took previous laxatives at some time for the treatment of OIC prior to entering the trials V9231 or V9232.
Danish: Alle studiedeltagerne havde tidligere taget afføringsmidler i en periode for at behandle OIC, før de indgik i studie V9231 eller V9232.
English: A total of 547 patients in Study V9231, 551 patients in Study V9232 and 1246 patients in Study V9235 were randomised in a 1:1 ratio to receive 200 micrograms of naldemedine or placebo once daily for 12 weeks for Studies V9231 and V9232, for 52 weeks for Study V9235.
Danish: I alt 547 patienter i studie V9231, 551 patienter i studie V9232 og 1246 patienter i studie V9235 blev randomiseret i forholdet 1:1 til at få 200 mikrogram naldemedin eller placebo én gang dagligt i 12 uger i studie V9231 og V9232 og i 52 uger i studie V9235.
English: Talk to your doctor if you are already breast-feeding.
Danish: Kontakt lægen, hvis du allerede ammer.
English: Stop taking Rizmoic and contact your doctor if you develop opioid withdrawal symptoms.
Danish: Hold op med at tage Rizmoic, og kontakt lægen, hvis du udvikler opioide abstinenssymptomer.
English: Uncommon Unknown
Danish: Ikke almindelig Ikke kendt
English: Naldemedine is primarily metabolised by CYP3A with some contribution from UGT1A3 and is a substrate of P-glycoprotein (P-gp) (see section 5.2).
Danish: Naldemedin metaboliseres primært af CYP3A med et vist bidrag fra UGT1A3, og det er et substrat for P-glykoprotein (P-gp) (se pkt.
English: [Carbonyl-14C]-naldemedine-derived radioactivity was excreted into milk in lactating rats.
Danish: [Carbonyl-14C]-naldemedinderiveret radioaktivitet blev udskilt i mælken hos diegivende rotter.
English: • diverticulitis (an illness where your gut is inflamed);
Danish: • divertikulitis (en sygdom med tarmbetændelse),
English: The use of naldemedine during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood brain barrier.
Danish: Brugen af naldemedin under graviditet kan udløse opioidabstinenser hos fosteret på grund af, at blodhjernebarrieren hos fosteret ikke er fuldt udviklet.
English: The patients who participated in Studies V9231, V9232 and V9235 were taking a wide range of opioids.
Danish: Patienterne, der deltog i studie V9231, V9232 og V9235, tog flere forskellige opioider.
English: Naldemedine also undergoes cleavage in the gastrointestinal tract to form benzamidine and naldemedine carboxylic acid.
Danish: Naldemedin gennemgår også spaltning i mave-tarm-kanalen, så der dannes benzamidin og naldemedin-carboxylsyre.
English: Opioid withdrawal syndrome aMedDRA Preferred Terms: abdominal pain, abdominal pain upper, abdominal pain lower and abdominal discomfort
Danish: Opioidabstinenssyndrom aMedDRA foretrukne termer: abdominalsmerter, øvre abdominalsmerter, nedre abdominalsmerter og abdominalt ubehag
English: There were 4 secondary endpoints in Studies V9231 and V9232 (see Table 3).
Danish: Der var 4 sekundære endepunkter i studie V9231 og V9232 (se tabel 3).
English: Rizmoic must be discontinued if treatment with the opioid pain medicinal product is discontinued.
Danish: Rizmoic skal seponeres, hvis behandlingen med smertelindrende opioide lægemidler seponeres.
English: The number of patients in the LIR and non-LIR subgroups were 629 (naldemedine: 317 and placebo: 312) and 451 (naldemedine: 223 and placebo: 228) for pooled Studies V9231 and V9232.
Danish: Antallet af patienter i LIR- og ikke-LIR-undergrupperne var 629 (naldemedin: 317 og placebo: 312) og 451 (naldemedin: 223 og placebo: 228) for studie V9231 og V9232 sammenlagt.
English: The efficacy and safety of naldemedine has been established in patients with chronic non-cancer pain and OIC and in patients with cancer and OIC.
Danish: Naldemedins virkning og sikkerhed er blevet fastlagt hos patienter med non-maligne kroniske smerter og OIC og hos patienter med cancer og OIC.
English: These were mild or moderate in severity and resolved.
Danish: Disse var af let eller moderat sværhedsgrad og gik væk.
English: Naldemedine is primarily metabolized by CYP3A to nor-naldemedine, with a minor contribution from UGT1A3 to form naldemedine 3-G.
Danish: Naldemedin metaboliseres primært af CYP3A til nor-naldemedin med et mindre bidrag fra UGT1A3 til dannelse af naldemedin 3-G.
English: Yellow iron oxide (E172)
Danish: Gul jernoxid (E172)
English: The discontinuation rate due to gastrointestinal treatment emergent adverse events with naldemedine 200 micrograms compared to placebo was 3.2% and 1% respectively in patients with chronic non-cancer pain and OIC and 4.5% and 0% respectively for patients with cancer and OIC.
Danish: Seponeringshyppigheden på grund af gastrointestinale behandlingsrelaterede bivirkninger med naldemedin 200 mikrogram sammenlignet med placebo, var hhv. 3,2 % og 1 % hos patienter med non-maligne kroniske smerter og OIC og hhv. 4,5 % og 0 % for patienter med cancer og OIC.
English: Concomitant use with strong CYP3A inhibitors should be avoided.
Danish: Anvendelse sammen med potente CYP3A-hæmmere bør undgås.
English: Abdominal pain, diarrhoea, nausea and vomiting were the most commonly reported adverse reactions in clinical studies with patients with chronic non-cancer pain and OIC and with patients with cancer and OIC.
Danish: Abdominalsmerter, diarré, kvalme og opkastning var de mest almindeligt rapporterede bivirkninger i kliniske studier med patienter med non-maligne kroniske smerter og OIC og med patienter med cancer og OIC.
English: Placental transfer of [carbonyl-14C]-naldemedine-derived radioactivity was observed in pregnant rats.
Danish: Der blev observeret overførsel af [carbonyl-14C]-naldemedinderiveret radioaktivitet over placenta hos drægtige rotter.
English: Possible opioid withdrawal, defined as at least three adverse reactions potentially related to opioid withdrawal that occurred on the same day and that were not exclusively related to the gastrointestinal system, occurred in 0.8% (9/1,163) of patients with chronic non-cancer pain and OIC taking naldemedine compared to 0.2% (2/1,165) of patients taking placebo regardless of maintenance opioid treatment, and 0.6% (1/155) of patients with cancer and OIC taking naldemedine 200 micrograms compared to 0% (0/152) of patients taking placebo.
Danish: Muligt opioidabstinenssyndrom, defineret som mindst tre bivirkninger potentielt relateret til opioidseponering, der forekom på den samme dag, og som ikke udelukkende var relateret til mavetarm-kanalen, forekom hos 0,8 % (9/1.163) af patienterne med non-maligne kroniske smerter og OIC, der tog naldemedin, sammenlignet med 0,2 % (2/1.165) af patienterne, der tog placebo, uanset vedligeholdelsesbehandling med opioider, og hos 0,6 % (1/155) af patienterne med cancer og OIC, der tog naldemedin 200 mikrogram, sammenlignet med 0 % (0/152) af patienterne, der tog placebo.
English: The recommended dose of naldemedine is 200 micrograms (one tablet) daily.
Danish: Den anbefalede dosis af naldemedin er 200 mikrogram (én tablet) dagligt.
English: In the non-LIR subgroup, consistent with the results in the LIR subgroup, a greater proportion of responders was observed with naldemedine (54.3%) compared with placebo (38.9%) and the difference between groups (15.6%) was statistically significant (p=0.0009).
Danish: I ikke-LIR-undergruppen blev der i overensstemmelse med resultaterne i LIR-undergruppen observeret en større andel respondere med naldemedin (54,3 %) sammenlignet med placebo (38,9 %), og forskellen mellem grupperne (15,6 %) var statistisk signifikant (p=0,0009).
English: Adverse reactions presented by System Organ Class and frequency in patients with cancer and opioid-induced constipation
Danish: Bivirkninger opstillet efter systemorganklasse og hyppighed hos patienter med cancer og opioid-induceret forstoppelse
English: Pack sizes of 7, 10, 28, 30, 84 or 100 film-coated tablets.
Danish: Pakningsstørrelser på 7, 10, 28, 30, 84 eller 100 filmovertrukne tabletter.
English: In Studies V9231 and V9232, OIC was confirmed through a 2-week run-in period and was defined as no more than 4 spontaneous bowel movements (SBMs) total over 14 consecutive days and <3 SBMs in a given week with at least 25% of the SBMs associated with one or more of the following conditions: (1) straining, (2) hard or lumpy stools; (3) having a sensation of incomplete evacuation; and (4) having a sensation of anorectal obstruction/blockage.
Danish: I studie V9231 og V9232 blev OIC bekræftet i løbet af en 2-ugers indkøringsperiode, og det blev defineret som ikke over 4 spontane afføringer (spontaneous bowel movements, SBMer) i alt i løbet af 14 på hinanden følgende dage og <3 SBMer i løbet af en uge, hvor mindst 25 % af SBMerne var forbundet med en eller flere af følgende ting: (1) kræver anstrengelse, (2) hård eller knoldet afføring, (3) en følelse af ufuldstændig tarmtømning og (4) en følelse af anorektal obstruktion/blokering.
English: Decreases in the viability index on Day 4 after birth were noted at 30 and 1000 mg/kg/day and low body weights and delayed pinna unfolding were noted at 1000 mg/kg/day in pups.
Danish: Reduktioner i levedygtighedsindekset på dag 4 efter fødslen blev bemærket ved 30 og 1.000 mg/kg/dag, og lav kropsvægt og forsinket udfoldning af det ydre øre blev bemærket hos afkommet ved 1.000 mg/kg/dag.
English: Overall, whilst the limitations in the evidence base solely for Naldemedine are acknowledged it is considered that supporting information is also provided by other agents in the class which are mechanistically indistinguishable from Naldemedine and which have similar effects on the GI tract.
Danish: Selvom det erkendes, at der er begrænsninger i evidensgrundlaget specifikt for naldemedin, vurderes det overordnet, at der også er tilvejebragt tilgængelige understøttende oplysninger for andre stoffer i klassen, som mekanistisk ikke kan skelnes fra naldemedin, og som har en virkning på mave-tarm-kanalen, der svarer til naldemedins.
English: Common (may affect up to 1 in 10 people):
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer):
English: Symptoms included, but were not limited to hyperhidrosis, chills, lacrimation increased, hot flush/flushing, pyrexia, sneezing, feeling cold, abdominal pain, diarrhoea, nausea, vomiting, arthralgia, myalgia, and tachycardia (see section 4.4).
Danish: Symptomerne inkluderede, men var ikke begrænsede til, hyperhidrose, kulderystelser, øget tåreflåd, hedetur/rødme, pyreksi, nysen, kuldefornemmelse, abdominalsmerter, diarré, kvalme, opkastning, artralgi, myalgi og takykardi (se pkt.
English: Naldemedine has no or negligible influence on the ability to drive and use machines.
Danish: Naldemedin påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: If you are being treated with an opioid medicine for chronic non-cancer pain.
Danish: Hvis du bliver behandlet med et opioidt lægemiddel for kroniske smerter, der ikke stammer fra kræft.
English: Cases of possible opioid withdrawal syndrome have been reported in the naldemedine clinical programme (see section 4.8).
Danish: Der er rapporteret tilfælde af muligt opioidabstinenssyndrom i det kliniske program med naldemedin (se pkt.
English: One serious case of abdominal pain and one serious case of nausea were reported in patients with chronic non-cancer pain and OIC.
Danish: Ét alvorligt tilfælde med abdominalsmerter og et alvorligt tilfælde med kvalme blev rapporteret hos patienter med non-maligne kroniske smerter og OIC.
English: The mean baseline opioid morphine equivalent daily dosage was 132.42 mg, 120.93 mg, and 122.06 mg per day for Studies V9231, V9232 and V9235 respectively.
Danish: Den gennemsnitlige morfinækvivalente daglige opioiddosis ved baseline var 132,42 mg, 120,93 mg og 122,06 mg dagligt for hhv. studie V9231, V9232 og V9235.
English: Concomitant use of naldemedine with moderate inducers (e.g. efavirenz) has not been established, and patients should be monitored (see section 4.4).
Danish: Anvendelse af naldemedin sammen med moderate induktorer (f.eks. efavirenz) er ikke klarlagt, og patienterne bør overvåges (se pkt.
English: The most commonly reported adverse reactions in patients with chronic non-cancer pain and OIC were abdominal pain (7.8%), diarrhoea (5.9%), nausea (3.6%), and vomiting (1.1%).
Danish: De mest almindeligt rapporterede bivirkninger hos patienter med kroniske non-maligne smerter og OIC var abdominalsmerter (7,8 %), diarré (5,9 %), kvalme (3,6 %) og opkastning (1,1 %).
English: In the pre- and postnatal development study in rats, one dam died at parturition at 1000 mg/kg/day, and poor nursing, suppression of body weight gain and decrease in food consumption were noted at 30 and 1000 mg/kg/day.
Danish: I det præ- og postnatale udviklingsstudie hos rotter døde ét moderdyr under fødslen ved 1.000 mg/kg/dag, og der blev bemærket dårlig diegivning, undertrykt kropsvægttilvækst og nedsat fødeindtagelse ved 30 og 1.000 mg/kg/dag.
English: Caution with regards to the use of naldemedine should be exercised in patients with any conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g. peptic ulcer disease, Ogilvie's syndrome, malignancy of the GI tract, Crohn's disease).
Danish: Der bør udvises forsigtighed ved brugen af naldemedin hos patienter med tilstande, der kan føre til en nedsat integritet af mave-tarm-væggen (f.eks. mavesår, Ogilvies syndrom, malignitet i mave-tarm-kanalen, Crohns sygdom).
English: There is no risk of interaction with concomitant use of mild CYP3A inhibitors.
Danish: Der er ingen interaktionsrisiko ved anvendelse sammen med svage CYP3A-hæmmere.
English: Clinical studies in patients with chronic non-cancer pain and OIC The safety and efficacy of naldemedine was evaluated in two identical, 12-week randomised, doubleblind placebo-controlled trials (Studies V9231 and V9232) in which naldemedine was used without laxatives and in a third long-term 52-week randomised, double-blind placebo-controlled trial (Study V9235) in which naldemedine was used with or without stable laxatives in patients with chronic noncancer pain and OIC.
Danish: Kliniske studier med patienter med non-maligne kroniske smerter og OIC Naldemedins sikkerhed og virkning blev evalueret i to identiske 12-ugers randomiserede, dobbeltblindede, placebokontrollerede studier (studie V9231 og V9232), hvor naldemedin blev anvendt uden afføringsmidler, og i et tredje 52-ugers randomiseret, dobbeltblindet, placebokontrolleret langtidsstudie (studie V9235), hvor naldemedin blev anvendt med eller uden stabile afføringsmidler hos patienter med non-maligne kroniske smerter og OIC.
English: Cases of gastrointestinal perforation have been reported in post-marketing setting, including fatal cases, when naldemedine was used in patients who were at an increased risk of gastrointestinal perforation.
Danish: Der er blevet rapporteret tilfælde af mave-tarm-perforation efter markedsføring, herunder dødelige tilfælde, hvor naldemedin blev anvendt til patienter, som havde en øget risiko for mave-tarmperforation.
English: The mean baseline SBMs was 1.31, 1.17, and 1.60, for Studies V9231, V9232 and V9235 respectively.
Danish: De gennemsnitlige SBMer ved baseline var 1,31, 1,17 og 1,60 for hhv. studie V9231, V9232 og V9235.
English: Gastrointestinal disorders
Danish: Gastrointestinale bivirkninger
English: Concomitant use of strong CYP3A inhibitors such as grapefruit juice, itraconazole, ketoconazole, ritonavir, indinavir, saquinavir, telithromycin and clarithromycin should be avoided.
Danish: Anvendelse sammen med potente CYP3A-hæmmere, såsom grapefrugtjuice, itraconazol, ketoconazol, ritonavir, indinavir, saquinavir, telithromycin og clarithromycin, bør undgås.
English: There was no adverse effect on pre- and postnatal development at 1 mg/kg/day (12 times the exposure [AUC0-24hr] in humans at an oral dose of 200 micrograms).
Danish: Der var ingen bivirkninger på præ-og postnatal udvikling ved 1 mg/kg/dag (12 gange eksponeringen [AUC0-24t] hos mennesker ved en oral dosis på 200 mikrogram).
English: Naldemedine is a derivative of naltrexone to which a side chain has been added that increases the molecular weight and the polar surface area, thereby reducing its ability to cross the blood-brain barrier (BBB); the CNS penetration of naldemedine is expected to be negligible at the recommended dose.
Danish: Naldemedin er et derivat af naltrexon, hvor en sidekæde er blevet tilføjet, hvilket øger molekylvægten og det polære overfladeareal og derved reducerer dets evne til at krydse blod-hjerne-barrieren (bloodbrain barrier, BBB).
English: Concomitant use of P-gp inhibitors such as cyclosporine may increase plasma concentrations of naldemedine.
Danish: Anvendelse sammen med P-gp-hæmmere, såsom ciclosporin, kan øge plasmakoncentrationen af naldemedin.
English: Cases of gastrointestinal perforation have been reported in the post-marketing setting, including fatal cases, when naldemedine was used in patients who were at an increased risk of gastrointestinal (GI) perforation, (e.g. diverticular disease and underlying malignancies of the gastrointestinal tract or peritoneal metastases).
Danish: Der er blevet rapporteret tilfælde af mave-tarm-perforation efter markedsføring, herunder dødelige tilfælde, hvor naldemedin blev anvendt til patienter, som havde en øget risiko for mave-tarmperforation (f.eks. divertikulær sygdom og underliggende maligniteter i mave-tarm-kanalen eller peritoneale metastaser).
English: In the event of an overdose, patients should be closely monitored for potential signs and symptoms of opioid withdrawal syndrome (see section 4.4) and provided with appropriate supportive care.
Danish: I tilfælde af en overdosering skal patienterne overvåges nøje for evt. tegn og symptomer på opioidabstinenssyndrom (se pkt.
English: The effect of hepatic impairment on the pharmacokinetics of a single 200 microgram dose of naldemedine was studied in subjects with hepatic impairment classified as mild (Child-Pugh class A) or moderate (Child-Pugh class B) and compared with healthy subjects with normal hepatic function.
Danish: Virkningen af nedsat leverfunktion på farmakokinetikken for en enkelt 200 mikrogram dosis af naldemedin blev undersøgt hos forsøgspersoner med nedsat leverfunktion klassificeret som let (ChildPugh klasse A) eller moderat (Child-Pugh klasse B) og sammenlignet med raske forsøgspersoner med normal leverfunktion.
English: If you stop taking Rizmoic
Danish: Hvis du holder op med at tage Rizmoic
English: Concomitant use of moderate CYP3A inhibitors such as fluconazole, may increase the plasma concentration of naldemedine.
Danish: Anvendelse sammen med moderate CYP3A-hæmmere, såsom fluconazol, kan øge plasmakoncentrationen af naldemedin.
English: Effects of other medicinal products on naldemedine
Danish: Andre lægemidlers virkning på naldemedin
English: If you forget to take Rizmoic
Danish: Hvis du har glemt at tage Rizmoic
English: Interaction with strong and moderate CYP3A inducers Rifampicin, a strong CYP3A inducer, significantly decreased exposure to naldemedine by 83% .
Danish: Interaktion med potente og moderate CYP3A-induktorer Rifampicin, en potent CYP3A-induktor, reducerede eksponeringen for naldemedin signifikant med
English: Interactions with CYP3A inhibitors
Danish: Interaktioner med CYP3A-hæmmere
English: Talk to your doctor if you stop taking Rizmoic.
Danish: Kontakt lægen, hvis du holder op med at tage Rizmoic.
English: • cancer of the bowel or peritoneum.
Danish: • kræft i tarmen eller bughinden.
English: Rizmoic may be used with or without laxative(s).
Danish: Rizmoic kan bruges med eller uden afføringsmiddel/-midler.
English: In the rat fertility and early embryonic development study, prolongation of the dioestrous phase was observed at 10 mg/kg/day and above, but was not observed at 1 mg/kg/day (12 times the exposure [AUC0-24hr] in humans at an oral dose of 200 micrograms).
Danish: I studiet af fertilitet og tidlig embryonisk udvikling hos rotter blev der observeret en forlængelse af diøstrusfasen ved 10 mg/kg/dag og derover, men dette blev ikke observeret ved 1 mg/kg/dag (12 gange eksponeringen [AUC0-24t] hos mennesker ved en oral dosis på 200 mikrogram).
English: In Study V9232, they were back pain (53.6%); pain (10.2%) and arthralgia (7.8%).
Danish: I studie V9232 var de rygsmerter (53,6 %), smerter (10,2 %) og artralgi (7,8 %).
English: Adverse reactions presented by System Organ Class and frequency in patients with chronic non-cancer pain and opioid-induced constipation
Danish: Bivirkninger opstillet efter systemorganklasse og hyppighed hos patienter med non-maligne kroniske smerter og opioid-induceret forstoppelse
English: Concomitant use with strong CYP3A inducers is not recommended (see section 4.5).
Danish: Anvendelse sammen med potente CYP3A-induktorer anbefales ikke (se pkt.
English: The majority of these gastrointestinal adverse reactions were of mild to moderate severity and resolved without discontinuation of naldemedine treatment.
Danish: Hovedparten af disse gastrointestinale bivirkninger var af let eller moderat sværhedsgrad og gik væk, uden at behandlingen med naldemedin blev seponeret.
English: Concomitant use of strong CYP3A inducers such as St. John's wort (Hypericum perforatum), rifampicin, carbamazepine, phenobarbital and phenytoin is not recommended.
Danish: Samtidig anvendelse med potente CYP3A-induktorer, såsom prikbladet perikon (Hypericum perforatum), rifampin, carbamazepin, phenobarbital og phenytoin anbefales ikke.
English: No adverse effects were observed in male or female fertility and reproductive performance at up to 1000 mg/kg/day (in excess of 16,000 times the exposure [AUC0-24hr] in humans at an oral dose of 200 micrograms).
Danish: Der blev ikke observeret nogen bivirkninger på fertilitet og reproduktionsevne hos hanner og hunner ved op til 1.000 mg/kg/dag (mere end 16.000 gange eksponeringen [AUC0-24t] hos mennesker ved en oral dosis på 200 mikrogram).
English: Shionogi Srl Tel: +39 06 94 805 118 contattaci@shionogi.eu
Danish: Tel: +39 06 94 805 118 contattaci@shionogi.eu
English: In Study V9235, patients on a stable laxative regimen at screening (52.4%) were allowed to continue using that same regimen without change throughout the study duration.
Danish: Alle studiedeltagerne havde tidligere taget afføringsmidler for at behandle OIC. I studie V9235 kunne patienter, der fik et stabilt behandlingsprogram med afføringsmidler ved screening (52,4 %), fortsætte med det samme behandlingsprogram uden ændringer i løbet af studiets varighed.
English: Concomitant use of naldemedine with moderate CYP3A inducers (e.g. efavirenz) has not been established and should be used with caution (see section 4.5).
Danish: Anvendelse af naldemedin sammen med moderate CYP3A-induktorer (f.eks. efavirenz) er ikke klarlagt, og det bør anvendes med forsigtighed (se pkt.
English: Other medicines and Rizmoic
Danish: Brug af anden medicin sammen med Rizmoic
English: Naldemedine was found to have no clinically relevant adverse effects on fertility or reproductive performance in male and female rats (see section 5.3).
Danish: Det er vist, at naldemedin ikke har nogen klinisk relevante bivirkninger på fertiliteten eller reproduktionsevnen hos han- og hunrotter (se pkt.
English: The safety and efficacy of naldemedine was also evaluated in 2 randomised, double-blind and placebocontrolled studies (V9222 and V9236) in patients with cancer and OIC.
Danish: Kliniske studier med patienter med cancer og OIC Naldemedins sikkerhed og virkning blev evalueret i 2 randomiserede, dobbeltblindede og placebokontrollerede studier (V9222 og V9236) med patienter med cancer og OIC.
English: If naldemedine is used with strong P-gp inhibitors, monitor for adverse reactions.
Danish: Hvis naldemedin anvendes sammen med potente P-gp-hæmmere, skal der overvåges for bivirkninger.
English: Rizmoic 200 micrograms film-coated tablets
Danish: Rizmoic 200 mikrogram filmovertrukne tabletter
English: Hypersensitivitya
Danish: Overfølsomheda
English: The majority of these gastrointestinal adverse reactions were of mild to moderate severity and resolved with treatment.
Danish: Hovedparten af disse gastrointestinale bivirkninger var af let eller moderat sværhedsgrad og gik væk med behandling.