FrancophonIA/ELRC3.0 huggingface dataset:
English: Read the information ‘Other possible side effects of Trizivir' in Section 4 of this leaflet.
Danish: Læs om det i ”Andre mulige bivirkninger ved Trizivir” under punkt 4 i denne indlægsseddel.
English: Lamivudine-TP, carbovir-TP (the active triphosphate form of abacavir) and zidovudine-TP are substrates for and competitive inhibitors of HIV reverse transcriptase (RT).
Danish: Lamivudin-TF, carbovir-TF (den aktive triphosphatform af abacavir) og zidovudin-TF er substrater for og kompetitive hæmmere af hiv revers-transkriptase (RT).
English: Trizivir tablets are available in opaque white PCTFE/PVC-Al blister packs or child-resistant foil PVC/PCTFE/PVC-Al/Paper blister packs containing 60 tablets, or child resistant HDPE bottles containing 60 tablets.
Danish: Trizivir tabletter findes i uigennemsigtige, hvide PCTFE/PVC-Al-blisterpakninger eller børnesikrede folie PVC/PCTFE/PVC-Al/papir-blisterpakninger med 60 tabletter, eller børnesikrede HDPEbeholdere med 60 tabletter.
English: Trizivir is used to treat HIV (human immunodeficiency virus) infection in adults.
Danish: Trizivir bruges til at behandle hiv (humant immundefektvirus)-infektion hos voksne.
English: None M184V alone Any one NRTI mutation Any two NRTIassociated mutations 22
Danish: Ingen M184V alene En NRTI-mutation 82 To NRTI-forbundne mutationer Tre NRTI-forbundne mutationer Fire eller flere NRTIforbundne mutationer
English: Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products (e.g. systemic pentamidine, dapsone, pyrimethamine, co-trimoxazole, amphotericin, flucytosine, ganciclovir, interferon, vincristine, vinblastine and doxorubicin) may also increase the risk of adverse reactions to zidovudine (see section 4.8).
Danish: Samtidig behandling, specielt akut behandling, med potentielt nefrotoksiske eller myelosuppressive lægemidler (f.eks. systemisk pentamidin, dapson, pyrimethamin, sulfa/trim, amphotericin B, flucytosin, ganciclovir, interferon, vincristin, vinblastin og doxorubicin) kan også øge risikoen for bivirkninger af zidovudin (se pkt.4.8).
English: • In order to avoid restarting abacavir patients who have experienced a suspected HSR should be instructed to dispose of their remaining Trizivir tablets
Danish: For at undgå genoptagelse af abacavir-behandling bør patienter, der har oplevet en formodet overfølsomhedsreaktion, instrueres i at bortskaffe deres resterende Trizivir-tabletter.
English: The recommended dose of Trizivir in adults (18 years and over) is one tablet twice daily.
Danish: Den anbefalede dosis Trizivir til voksne (fra 18 år) er 1 tablet 2 gange daglig.
English: • lactic acidosis (excess lactic acid in the blood ; see the next section, ‘Other possible side effects of
Danish: • for meget mælkesyre i blodet (laktacidose), (se afsnittet ”Andre mulige bivirkninger ved Trizivir”)
English: No pharmacokinetic data are available in patients over 65 years of age.
Danish: Ældre Der er ingen tilgængelige farmakokinetiske data for patienter over 65 år.
English: Lamivudine is predominately cleared by renal excretion of unchanged lamivudine.
Danish: Lamivudin udskilles hovedsageligt ved renal ekskretion af uomdannet lamivudin.
English: The usual dose of Trizivir for adults is one tablet twice a day.
Danish: Hvor meget Trizivir skal du tage Den sædvanlige dosis af Trizivir til voksne er 1 tablet 2 gange daglig.
English: IMPORTANT - ALERT CARD TRIZIVIR (abacavir sulfate / lamivudine / zidovudine) Tablets Carry this card with you at all times
Danish: VIGTIGT - OPLYSNINGSKORT TRIZIVIR (abacavirsulfat / lamivudin / zidovudin) tabletter Hav altid dette kort med dig
English: Lactic acidosis is more likely to develop in people who have liver disease, or in obese (very overweight) people, especially women.
Danish: Laktacidose udvikles oftere hos personer, der har en leversygdom, eller er fede (meget overvægtige), især kvinder.
English: The safety and efficacy of Trizivir has not been established in patients with significant underlying liver disorders.
Danish: Sikkerheden og effekten af Trizivir er ikke klarlagt hos patienter med underliggende leversygdomme.
English: Patients should be regularly assessed for signs of lipoatrophy during therapy with zidovudine and zidovudine-containing products (Combivir and Trizivir).
Danish: Patienter skal undersøges regelmæssigt for tegn på lipoatrofi under behandling med zidovudin og lægemidler, som indeholder zidovudin (Combivir og Trizivir).
English: Data show that abacavir, lamivudine and zidovudine penetrate the central nervous system (CNS) and reach the cerebrospinal fluid (CSF).
Danish: Data viser, at abacavir, lamivudin og zidovudin penetrerer centralnervesystemet (CNS) og når ud i cerebrospinalvæsken (CSF).
English: The study Data Safety Monitoring Board stopped the ZDV/3TC/ABC arm at this time based on the higher proportion of patients with virologic failure.
Danish: Data- og sikkerhedsmonitoreringskomitéen for studiet stoppede behandlingsarmen med ZDV/3TC/ABC baseret på den højere andel af patienter med virologiske svigt.
English: Clinical studies have shown that there are no clinically significant interactions between abacavir, lamivudine and zidovudine.
Danish: Kliniske studier har vist, at der ikke er klinisk signifikante interaktioner mellem abacavir, lamivudin og zidovudin.
English: These findings included decreased foetal body weight, foetal oedema, and an increase in skeletal variations/malformations, early intra-uterine deaths and still births.
Danish: Disse fund omfattede nedsat fostervægt, føtale ødemer og en øgning i skeletale variationer/misdannelser, tidlig intrauterin død og dødfødsler.
English: When do these reactions happen?
Danish: Hvornår optræder symptomerne?
English: The antiviral activity of abacavir in cell culture was not antagonized when combined with the nucleoside reverse transcriptase inhibitors (NRTIs) didanosine, emtricitabine, stavudine or tenofovir, the non-nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine, or the protease inhibitor (PI) amprenavir.
Danish: Abacavirs antivirale aktivitet i cellekulturer blev ikke antagoniseret ved kombination med nukleosid revers transkriptasehæmmere (NRTI'er) didanosin, emtricitabin, stavudin eller tenofovir, non-nukleosid revers transkriptasehæmmeren (NNRTI) nevirapin eller proteasehæmmeren (PI) amprenavir.
English: Treatment with zidovudine should be discontinued in the setting of symptomatic hyperlactatemia and metabolic/lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Danish: Behandling med zidovudin bør stoppes i tilfælde af symptomatisk hyperlaktatæmi og metabolisk acidose/laktacidose, fremadskridende hepatomegali eller hurtigt stigende aminotransferaseniveauer.
English: • difficulty in sleeping (insomnia)
Danish: • søvnløshed (insomni)
English: • interferon, to treat viral infections
Danish: • interferon, til behandling af virusinfektioner
English: Lactic acidosis is caused by a build-up of lactic acid in the body.
Danish: Laktacidose skyldes ophobning af mælkesyre i kroppen.
English: No definitive recommendation on dose reduction is possible in patients with mild hepatic impairment due to substantial variability of abacavir exposure in this patient population.
Danish: En definitiv anbefaling for dosisreduktion til patienter med let nedsat leverfunktion kan derfor ikke gives på grund af en betydelig variation i eksponeringen af abacavir i denne patientpopulation.
English: It is important to take Trizivir regularly, because if you take it at irregular intervals it may not continue to work against the HIV infection, and you may be more likely to have a hypersensitivity reaction.
Danish: Det er vigtigt at tage Trizivir regelmæssigt, da uregelmæssig indtagelse kan betyde, at medicinen ikke virker mod hiv-infektionen og det kan øge risikoen for overfølsomhedsreaktioner.
English: Abacavir-resistant isolates of HIV-1 have been selected in vitro and are associated with specific genotypic changes in the RT codon region (codons M184V, K65R, L74V and Y115F).
Danish: Der er påvist abacavir-resistente isolater af hiv-1 in vitro, som er forbundet med specifikke genotypeforandringer i RT-codonregionen (codoner M184V, K65R, L74V og Y115F).
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse reactions.
Danish: Patienter med kronisk hepatitis B eller C behandlet med antiretroviral kombinationsbehandling har større risiko for alvorlige og potentielt fatale leverbivirkninger.
English: Renal clearance of zidovudine is estimated to be 0.34 l/h/kg, indicating glomerular filtration and active tubular secretion by the kidneys.
Danish: Den renale clearance af zidovudin er beregnet til 0,34 l/time/kg, hvilket tyder på glomerulær filtration og aktiv tubulær sekretion i nyrerne.
English: Intravenous studies with abacavir, lamivudine and zidovudine showed that the mean apparent volume of distribution is 0.8, 1.3 and 1.6 l/kg respectively.
Danish: I studier med intravenøst administreret abacavir, lamivudin og zidovudin var det gennemsnitlige tilsyneladende fordelingsvolumen henholdsvis 0,8, 1,3 og 1,6 l/kg.
English: Trizivir contains three active ingredients that are used to treat HIV infection: abacavir, lamivudine and zidovudine.
Danish: Trizivir indeholder tre aktive stoffer, der bruges til behandling af hiv-infektion: abacavir, lamivudin og zidovudin.
English: In this study, addition of ABC to ZDV/3TC/EFV did not significantly improve efficacy.
Danish: Tilføjelsen af ABC til ZDV/3TC/EFV forbedrede ikke signifikant effekten i dette studie.
English: Therefore, patients should remain under close clinical observation by physicians experienced in the treatment of these associated HIV diseases.
Danish: Patienter bør derfor fortsat følges tæt af læger med erfaring i behandling af disse sygdomme, som ledsager hiv.
English: Number of Subjects Number of Virological Failures Number of On-Therapy Genotypes K65R L74V Y115F M184V/I TAMs1 1.
Danish: Antal forsøgspersoner Antal virologiske svigt Antal genotyper i behandling K65R L74V Y115F M184V/I TAM'er1
English: • if their immune systems are very weak
Danish: • hvis dit immunforsvar er stærkt nedsat
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACHOF CHILDREN
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: Virologic failure (HIV RNA >200 copies/ml)
Danish: Virologisk svigt (hivRNA > 200 kopier/ml)
English: Single dose lamivudine oral solution 300 mg
Danish: Enkelt dosis lamivudin oral opløsning 300 mg
English: Who gets these reactions?
Danish: Hvem får en overfølsomhedsreaktion?
English: Although a similar antiviral effect was observed between the abacavir and indinavir containing regimens in terms of proportion of patients with undetectable viral load (≤ 400 copies/ml; intention to treat analysis (ITT), 47 % versus 49 %; as treated analysis (AT), 86 % versus 94 % for abacavir and indinavir combinations respectively), results favoured the indinavir combination, particularly in the subset of patients with high viral load (> 100,000 copies/ml at baseline; ITT, 46 % versus 55 %; AT, 84 % versus 93 % for abacavir and indinavir respectively).
Danish: Skønt en lignende antiviral effekt fandtes mellem regimerne med abacavir og indinavir, hvad angår andelen af patienter med udetekterbar virusbyrde (≤ 400 kopier/ml; ”intention to treat”-analyse (ITT) på 47 % versus 49 %; analyse af behandlede (AB) på 86 % versus 94 % for kombinationerne med henholdsvis abacavir og indinavir), var resultaterne til fordel for kombinationen med indinavir, særligt hos undergruppen af patienter med høj virusbyrde (udgangsværdi > 100.000 kopier/ml; ITT på 46 % versus 55 %; AB på 84 % versus 93 % for henholdsvis abacavir og indinavir).
English: Abacavir, lamivudine and zidovudine triphosphates show significantly less affinity for host cell DNA polymerases.
Danish: Abacavir-, lamivudin- og zidovudin-triphosphat har signifikant mindre affinitet til værtscelle DNA-polymeraser.
English: HLA-B*5701 status must always be documented and explained to the patient prior to initiating therapy.
Danish: HLA-B*5701-status skal altid dokumenteres og forklares til patienten før behandlingen initieres.
English: Nervous system disorders Common: headache
Danish: Nervesystemet Almindelig: Hovedpine.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Your doctor may advise you to stop taking Trizivir.
Danish: Lægen kan råde dig til at stoppe behandlingen med Trizivir.
English: Very rare side effects
Danish: Sjældne bivirkninger
English: Zidovudine AUC ↑80% (UGT inhibition) ANTIHISTAMINES (HISTAMINE H2 RECEPTOR ANTAGONISTS) Ranitidine/Abacavir
Danish: Zidovudin: AUC  80 % (Hæmning af UGT) ANTIHISTAMINER (HISTAMIN H2-RECEPTORANTAGONISTER) Ranitidin / abacavir
English: If you are breast-feeding, or thinking about breast-feeding:
Danish: Hvis du ammer eller planlægger at amme:
English: There are no data available on the safety of abacavir and lamivudine when administered to babies less than three months old.
Danish: Der foreligger ingen data om sikkerheden af lamivudin hos spædbørn under 3 måneder.
English: The pharmacokinetics of abacavir have been studied in patients with mild hepatic impairment (Child-Pugh score 5-6) receiving a single 600 mg dose; the median (range) AUC value was 24.1 (10.4 to 54.8) ug.h/ml.
Danish: Abacavirs farmakokinetik er blevet undersøgt hos patienter med let nedsat leverfunktion (Child-Pugh score 5-6), der fik en enkelt dosis på 600 mg; den mediane (interval) AUC var 24,1 (10,4 - 54,8) mikrog·time/ml.
English: In addition, the selection of L74V and K65R was reduced when co-administered with ZDV (K65R: without ZDV: 13/127, 10 %; with ZDV: 1/86, 1 %; L74V: without ZDV: 51/127, 40 %; with ZDV: 2/86, 2 %).
Danish: Når behandlingen blev suppleret med ZDV blev forekomsten af L74V og K65R reduceret (K65R: uden ZDV: 13/127, 10 %; med ZDV: 1/86, 1 %; 1,74V; uden ZDV: 51/127, 40 %; med ZDV: 2/86, 2 %).
English: The metabolites and unchanged abacavir account for about 83 % of the administered abacavir dose in the urine the remainder is eliminated in the faeces.
Danish: Metabolitterne og uomdannet abacavir i urinen udgør ca. 83 % af den administrerede dosis abacavir, resten elimineres i fæces.
English: A small amount of the ingredients in Trizivir can also pass into your breast milk.
Danish: Indholdsstofferne i Trizivir kan også udskilles i små mængder i mælken.
English: If ABC hypersensitivity cannot be ruled out, ABC should be permanently discontinued, regardless of the results of HLA-B*5701 screening.
Danish: Hvis ABC-overfølsomhed ikke kan udelukkes, skal ABC seponeres permanent, uanset resultatet af HLA-B*5701-screening.
English: The carcinogenic potential of a combination of abacavir, lamivudine and zidovudine has not been tested.
Danish: Den potentielle karcinogenicitet af en kombination af abacavir, lamivudin og zidovudin er ikke undersøgt.
English: Due to the active substance zidovudine, Trizivir is contraindicated in patients with abnormally low neutrophil counts (< 0.75 x 109/l), or abnormally low haemoglobin levels (< 7.5 g/dl or 4.65 mmol/l) (see section 4.4).
Danish: På grund af det aktive indholdsstof zidovudin er Trizivir kontraindiceret hos patienter med unormalt lavt neutrofiltal (< 0,75 x 109/l) eller unormalt lavt hæmoglobinniveau (< 7,5 g/dl eller 4,65 mmol/l) (se pkt.
English: In patients with mild hepatic impairment (Child-Pugh score 5-6) close monitoring is required, including monitoring of abacavir plasma levels if feasible (see sections 4.4 and 5.2).
Danish: Hos patienter med let nedsat leverfunktion (Child-Pugh score 5-6) er omhyggelig monitorering påkrævet, herunder monitorereing af plasmakoncentrationen af abacavir, hvis det er muligt (se pkt.
English: In long-term oral carcinogenicity studies in rats and mice, lamivudine did not show any carcinogenic potential.
Danish: I langtidskarcinogenicitetsstudier hos rotter og mus efter oral dosering viste lamivudin intet karcinogent potentiale.
English: The demonstration of the benefit of Trizivir is mainly based on results of studies performed in treatment naive patients or moderately antiretroviral experienced patients with non-advanced disease.
Danish: Påvisning af fordelen ved Trizivir er hovedsageligt baseret på resultater af studier hos tidligere ubehandlede patienter eller patienter, som tidligere har modtaget moderat antiretroviral behandling, og hvor sygdommen ikke er fremskreden.
English: • liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis)
Danish: • sygdom i leveren såsom gulsot, forstørret lever, fedtlever eller leverbetændelse (hepatitis)
English: Based on data obtained for abacavir, Trizivir is not recommended in patients with moderate or severe hepatic impairment.
Danish: Baseret på data fra abacavir, anbefales Trizivir ikke til patienter med moderat til svært nedsat leverfunktion.
English: A fertility study in the rat has shown that abacavir had no effect on male or female fertility.
Danish: Et fertilitetsstudie udført i rotter har vist, at abacavir ikke havde effekt på hanlig eller hunlig fertilitet.
English: There is no evidence from clinical studies that abacavir is hepatotoxic.
Danish: Kliniske studier viser ingen tegn på, at abacavir skulle være hepatotoksisk.
English: You are more likely to develop such a reaction if you have a gene called HLA-B*5701 (but you can get a reaction even if you do not have this gene).
Danish: Du har større risiko for at udvikle en overfølsomhedsreaktion, hvis du har det gen, der hedder HLAB*5701 (men selv hvis du ikke har den gentype, kan du udvikle overfølsomhed).
English: Major symptoms associated with ABC HSR are fever (~80%), rash (~70%), gastrointestinal symptoms (>50%) such as nausea, abdominal pain, vomiting, and diarrhoea, generalise malaise, fatigue, and headache (~50%) and other symptoms (~30%) such as respiratory, mucosal, and musculoskeletal symptoms.
Danish: Vigtigste symptomer forbundet med ABC-overfølsomhedsreaktion er feber (~80 %), udslæt (~70 %), gastrointestinale symptomer (>50 %) som f.eks. kvalme, abdominalsmerter, opkastning og diarré, generel utilpashed, træthed og hovedpine (~50 %) og andre symptomer (~30 %) som f.eks. respiratoriske, slimhinde-, og muskuloskeletale symptomer.
English: Cimetidine eliminated only in part by renal organic cation transport system.
Danish: Cimetidin elimineres kun delvist via det renale organisk kation transportsystem.
English: Since Trizivir contains abacavir some patients taking Trizivir may develop a hypersensitivity reaction (serious allergic reaction) which can be life-threatening if treatment with Trizivir is continued.
Danish: Da Trizivir indeholder abacavir, kan nogle patienter, som tager Trizivir, måske få en overfølsomhedsreaktion (alvorlig allergisk reaktion), som kan være livstruende, hvis behandling med Trizivir fortsættes.
English: Signs of lactic acidosis include:
Danish: Tegnene på laktacidose omfatter:
English: Tablet Core: microcrystalline cellulose, sodium starch glycollate (type A), magnesium stearate.
Danish: Tabletkerne: Mikrokrystallinsk cellulose, natriumstivelsesglycolat (type A), magnesiumstearat.
English: A large amount of data on pregnant women taking lamivudine or zidovudine indicate no malformative toxicity (more than 3000 outcomes from first trimester exposure each, of which over 2000 outcomes involved exposure to both lamivudine and zidovudine).
Danish: En stor datamængde fra gravide, der har fået lamivudin eller zidovudin indikerede ingen tegn på malformationer (mere end 3.000 graviditeter, hvor der er forekommet eksponering i første trimester for hvert indholdsstof, hvoraf mere end 2.000 graviditeter involverede eksponering over for både lamivudin og zidovudin).
English: At week 48 the proportion of subjects with HIV RNA <50 copies/ml were 63 %, 80 % and 86 % for the ZDV/3TC/ABC, ZDV/3TC/EFV and ZDV/3TC/ABC/EFV arms, respectively.
Danish: Ved uge 48 var andelen af patienter med hiv-RNA < 50 kopier/ml 63 %, 80 % og 86 % for henholdsvis ZDV/3TC/ABC, ZDV/3TC/EFV og ZDV/3TC/ABC/EFV.
English: The mean systemic clearance of lamivudine is approximately 0.32 l/h/kg, with predominantly renal clearance (> 70 %) via the organic cationic transport system.
Danish: Den gennemsnitlige systemiske clearance af lamivudin er omkring 0,32 l/time/kg, overvejende ved renal clearance (> 70 %) via organisk kation-transportsystemet.
English: • fluconazole or flucytosine, to treat fungal infections such as candida
Danish: • fluconazol eller flucytosin, til behandling af svampeinfektioner som f.eks. candida
English: During your treatment, your doctor will monitor you for signs of lactic acidosis.
Danish: Undervejs i behandlingen holder lægen øje med tegn på laktacidose.
English: If lamivudine is being used concomitantly for the treatment of HIV and HBV, additional information relating to the use of lamivudine in the treatment of hepatitis B infection is available in the Zeffix SmPC.
Danish: Hvis lamivudin anvendes samtidigt til behandling af såvel hiv som HBV, kan der findes yderligere information i produktresumeet for Zeffix vedrørende behandling af hepatitis B med lamivudin.
English: Depending on the overall condition of the patient, blood tests may be performed less often, for example every one to three months.
Danish: Blodprøver kan derfor tages sjældnere, afhængigt af patientens almene tilstand, f.eks. med 1-3 måneders mellemrum.
English: • HLA-B*5701 status must always be documented prior to initiating therapy.
Danish: HLA-B*5701-status skal altid være dokumenteret før initiering af behandling
English: Limited data in patients with cirrhosis suggest that accumulation of zidovudine may occur in patients with hepatic impairment because of decreased glucuronidation.
Danish: Begrænsede data fra patienter med cirrose tyder på, at der kan forekomme akkumulering af zidovudin hos patienter med nedsat leverfunktion på grund af nedsat glucuronidering.
English: Adverse reactions have been reported with abacavir, lamivudine and zidovudine used separately or in combination for therapy of HIV disease.
Danish: Der er rapporteret bivirkninger for abacavir, lamivudin og zidovudin anvendt hver for sig eller i kombination til behandling af hiv-sygdom.
English: • if you are allergic (hypersensitive) to abacavir (or any other medicine containing abacavirKivexa, Triumeq or Ziagen), lamivudine or zidovudine, or any of the other ingredients of this medicine (listed in Section 6) Carefully read all the information about hypersensitivity reactions in Section 4.
Danish: • hvis du er allergisk (overfølsom) over for abacavir (eller ethvert andet lægemiddel med abacavirKivexa, Triumeq eller Ziagen), lamivudin eller zidovudin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Tabulated list of adverse reactions reported with the individual substances
Danish: Tabel over bivirkninger rapporteret for de enkelte stoffer
English: Some medicines can make it more likely that you will have side effects, or make side effects worse These include:
Danish: Nogle lægemidler kan øge risikoen for, at du får bivirkninger, eller de kan forværre bivirkningerne.
English: To date there are insufficient data on the efficacy and safety of Trizivir given concomitantly with NNRTIs or PIs.
Danish: Der er indtil nu utilstrækkelige data om effekten og sikkerheden ved Trizivir givet sammen med NNRTI'er eller PI'er.
English: Abacavir, lamivudine and zidovudine are rapidly and well absorbed from the gastro-intestinal tract following oral administration.
Danish: Abacavir, lamivudin og zidovudin absorberes hurtigt og godt fra mave-tarmkanalen efter oral administration.
English: In this patient population, hypersensitivity reactions are particularly difficult to identify.
Danish: Det kan være særligt vanskeligt at identificere overfølsomhedsreaktioner i denne patientpopulation.