FrancophonIA/ELRC3.0 huggingface dataset:
English: ↑ doravirine AUC 1.15 (1.07, 1.24) Cmax 1.11 (0.97, 1.27) C24 1.24 (1.13, 1.36)
Danish:  doravirin AUC 1,15 (1,07; 1,24) Cmax 1,11 (0,97; 1,27) C24 1,24 (1,13; 1,36)
English: • decreased levels of potassium in your blood
Danish: • nedsat indhold af kalium i blodet
English: No clinically relevant racial differences in the pharmacokinetics of doravirine have been identified based on a population pharmacokinetic analysis of doravirine in healthy and HIV-1-infected subjects.
Danish: På baggrund af en farmakokinetisk populationsanalyse af doravirin hos raske og hiv-1-inficerede forsøgspersoner er der ikke identificeret klinisk relevante racemæssige forskelle i doravirins farmakokinetik.
English: • lesinurad (a medicine to treat gout)
Danish: • lesinurad (et lægemiddel til behandling af urinsyregigt)
English: Rare chest pain, chills, pain, thirst
Danish: Sjælden brystsmerter, kuldegysninger, smerter, tørst
English:  doravirine AUC 1.56 (1.45, 1.68) Cmax 1.41 (1.25, 1.58) C24 1.61 (1.45, 1.79) (Inhibition of CYP3A)
Danish:  doravirin AUC 1,56 (1,45; 1,68) Cmax 1,41 (1,25; 1,58) C24 1,61 (1,45; 1,79) (CYP3A-hæmning)
English: • Tenofovir disoproxil - a nucleoside analogue reverse transcriptase inhibitor (NRTI)
Danish: • tenofovirdisoproxil - en nukleosidanalog revers transkriptasehæmmer (NRTI).
English:  doravirine AUC 0.50 (0.45, 0.55) Cmax 0.99 (0.85, 1.15) C24 0.32 (0.28, 0.35) (Induction of CYP3A)
Danish:  doravirin AUC 0,50 (0,45; 0,55) Cmax 0,99 (0,85; 1,15) C24 0,32 (0,28; 0,35) (CYP3A-induktion)
English: 0.03 mg ethinyl oestradiol/ 0.15 mg levonorgestrel SD, doravirine 100 mg QD
Danish: 0,03 mg ethinylestradiol/ 0,15 mg levonorgestrel enkeltdosis, doravirin 100 mg en gang dagligt
English: When Delstrigo is co-administered with rifabutin, a 100 mg dose of doravirine should be given daily, approximately 12 hours after doravirine/lamivudine/tenofovir disoproxil dose (see section 4.2).
Danish: Når Delstrigo administreres sammen med rifabutin, skal en 100 mg dosis doravirin gives dagligt ca. 12 timer efter administration af doravirin/lamivudin/tenofovirdisoproxil (se pkt.
English: Each film-coated tablet contains 100 mg of doravirine, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil.
Danish: Hver filmovertrukken tablet indeholder 100 mg doravirin, 300 mg lamivudin og 300 mg tenofovirdisoproxilfumarat svarende til 245 mg tenofovirdisoproxil.
English: Opioid Analgesics methadone (20-200 mg QD individualised dose, doravirine 100 mg QD)
Danish: Opioidanalgetika methadon (Individualiseret dosis på 20-200 mg en gang dagligt, doravirin 100 mg en gang dagligt)
English: Renal excretion of doravirine is minor.
Danish: Doravirin udskilles i mindre grad via nyrerne.
English: Expected:  doravirine (Inhibition of CYP3A due to ritonavir)
Danish: Forventet:  doravirin (CYP3A-hæmning grundet ritonavir)
English: Recommendation Concerning Co-administration with doravirine/lamivudine/tenofo vir disoproxil
Danish: Anbefalinger vedrørende administration sammen med doravirin/lamivudin/tenofovirdisoproxil ribavirin
English: Each film-coated tablet contains 100 mg of doravirine, 300 mg of lamivudine and 245 mg of tenofovir disoproxil.
Danish: Hver filmovertrukken tablet indeholder 100 mg doravirin, 300 mg lamivudin og 245 mg tenofovirdisoproxil.
English: If co-administration cannot be avoided, a 100 mg dose of doravirine should be taken daily, approximately 12 h after the dose of doravirine/lamivudine/tenofovir disoproxil.
Danish: Hvis samtidig administration ikke kan undgås, skal en 100 mg dosis doravirin tages dagligt ca. 12 timer efter dosis af doravirin/lamivudin/tenofovirdisoproxil.
English: How to take Delstrigo
Danish: Sådan skal du tage Delstrigo
English: • decreased levels of platelets in your blood (you may bleed more easily)
Danish: • nedsat indhold af blodplader i blodet (øget blødningstendens)
English:  R-methadone AUC 0.95 (0.90, 1.01) Cmax 0.98 (0.93, 1.03) C24 0.95 (0.88, 1.03)
Danish:  R-methadon AUC 0,95 (0,90; 1,01) Cmax 0,98 (0,93; 1,03) C24 0,95 (0,88; 1,03)
English:  ethinyl oestradiol AUC 0.98 (0.94, 1.03) Cmax 0.83 (0.80, 0.87)
Danish:  ethinylestradiol AUC 0,98 (0,94; 1,03) Cmax 0,83 (0,80; 0,87)
English: • trouble concentrating, memory problems, tingling of hands and feet, stiff muscles, poor quality of sleep
Danish: • koncentrationsbesvær, hukommelsesproblemer, prikken og snurren i hænder og fødder,
English: • increased levels in liver enzymes (AST)
Danish: • forhøjet indhold af leverenzymer (ASAT)
English: For potential medicine product interactions with tenofovir disoproxil or lamivudine, (see sections 4.4 and 5.2).
Danish: 4.4 og 5.2 for oplysninger om potentielle lægemiddelinteraktioner med tenofovirdisoproxil eller lamivudin.
English: • If you have any further questions, ask your doctor, pharmacist, or nurse.
Danish: Er du i tvivl, så spørg lægen, apotekspersonalet eller sygeplejersken.
English: Because tenofovir is primarily eliminated by the kidneys through a combination of glomerular filtration and active tubular secretion (see section 5.2), co-administration of doravirine/lamivudine/tenofovir disoproxil with medicinal products that reduce renal function or compete for active tubular secretion via OAT1, OAT3 or MRP4 may increase serum concentrations of tenofovir.
Danish: 5.2), kan samtidig administration af doravirin/lamivudin/tenofovirdisoproxil og lægemidler, der nedsætter nyrefunktionen eller konkurrerer om aktiv tubulær sekretion via OAT1, OAT3 eller MRP4, øge serumkoncentrationen af tenofovir.
English: indigestion, soft stools, stomach spasms, frequent bowel movements, inflammation of the pancreas (pancreatitis) (causing stomach pain, vomiting)
Danish: fordøjelsesproblemer, blød afføring, mavekramper, hyppig afføring, betændelse i bugspytkirtlen
English: Uncommon: may affect up to 1 in 100 people: • nightmares, depression, anxiety, irritability, confusion, suicidal thoughts
Danish: • mareridt, depression, angst, irritabilitet, forvirring, selvmordstanker
English: Doravirine
Danish: Doravirin
English:  doravirine
Danish:  doravirin
English: Antidiabetics metformin (1000 mg SD, doravirine 100 mg QD)
Danish: Antidiabetika metformin (1.000 mg enkeltdosis, doravirin 100 mg en gang dagligt)
English:  = increase, ↓ = decrease, ↔ = no change CI = Confidence Interval; SD = Single Dose; QD = Once Daily; BID = Twice Daily *AUC0- for single dose, AUC0-24 for once daily.
Danish: *AUC0- for enkeltdosis, AUC0-24 for en gang dagligt.
English: NRTI background therapy
Danish: NRTI-baggrundsbehandling
English: Single dose rifampicin (600 mg SD, doravirine 100 mg SD)
Danish: Enkeltdosis rifampicin (600 mg enkeltdosis, doravirin 100 mg enkeltdosis)
English: What Delstrigo is and what it is used for What you need to know before you take Delstrigo How to take Delstrigo
Danish: Det skal du vide, før du begynder at tage Delstrigo Sådan skal du tage Delstrigo Bivirkninger
English: lamivudine AUC 0.94 (0.88, 1.00) Cmax 0.92 (0.81, 1.05)
Danish:  lamivudin AUC 0,94 (0,88; 1,00) Cmax 0,92 (0,81; 1,05)
English: HIV Antiviral Agents tenofovir disoproxil (300 mg QD, doravirine 100 mg SD)
Danish: Hiv-antivirale midler tenofovirdisoproxil (300 mg en gang dagligt, doravirin 100 mg enkeltdosis)
English: Uncommon asthenia, malaise
Danish: Ikke almindelig asteni, utilpashed
English:  doravirine AUC 0.83 (0.76, 0.91) Cmax 0.88 (0.76, 1.01) C24 0.84 (0.77, 0.92)
Danish:  doravirin AUC 0,83 (0,76; 0,91) Cmax 0,88 (0,76; 1,01) C24 0,84 (0,77; 0,92)
English: rifabutin (300 mg QD, doravirine 100 mg SD)
Danish: rifabutin (300 mg en gang dagligt, doravirin 100 mg enkeltdosis)
English: Do not remove the desiccant.
Danish: Tørremidlet må ikke fjernes.
English:  doravirine AUC 0.95 (0.80, 1.12) Cmax 0.80 (0.64, 1.01) C24 0.94 (0.78, 1.12)
Danish:  doravirin AUC 0,95 (0,80; 1,12) Cmax 0,80 (0,64; 1,01) C24 0,94 (0,78; 1,12)
English:  doravirine AUC 1.01 (0.92, 1.11) Cmax 0.86 (0.74, 1.01) C24 1.03 (0.94, 1.12)
Danish:  doravirin AUC 1,01 (0,92; 1,11) Cmax 0,86 (0,74; 1,01) C24 1,03 (0,94; 1,12)
English:  S-methadone AUC 0.98 (0.90, 1.06) Cmax 0.97 (0.91, 1.04) C24 0.97 (0.86, 1.10)
Danish:  S-methadon AUC 0,98 (0,90; 1,06) Cmax 0,97 (0,91; 1,04) C24 0,97 (0,86; 1,10)
English: Rare dermatitis allergic, rosacea, angioedema* Musculoskeletal and connective tissue disorders Common muscle disorders*
Danish: Sjælden allergisk dermatitis, rosácea, angioødem*
English:  doravirine AUC 0.91 (0.78, 1.06) Cmax 1.40 (1.21, 1.63) C24 0.90 (0.80, 1.01)
Danish:  doravirin AUC 0,91 (0,78; 1,06) Cmax 1,40 (1,21; 1,63) C24 0,90 (0,80; 1,01)
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Danish: Tiden til udbrud er imidlertid mere variabel og kan være mange måneder efter initiering af behandling (se pkt.
English:  doravirine AUC 0.96 (0.87, 1.06) Cmax 0.97 (0.88, 1.07) C24 0.94 (0.83, 1.06)
Danish:  doravirin AUC 0,96 (0,87; 1,06) Cmax 0,97 (0,88; 1,07) C24 0,94 (0,83; 1,06)
English: (cells/mm
Danish: + T-celletal (celler/mm
English: Statins atorvastatin (20 mg SD, doravirine 100 mg QD)
Danish: Statiner atorvastatin (20 mg enkeltdosis, doravirin 100 mg en gang dagligt)
English: Expected: ↓ doravirine (Induction of CYP3A)
Danish: Forventet: ↓ doravirin (CYP3A-induktion)
English: pantoprazole (40 mg QD, doravirine 100 mg SD)
Danish: pantoprazol (40 mg en gang dagligt, doravirin 100 mg enkeltdosis)
English: Antigout and Uricosuric Agents lesinurad
Danish: Midler mod urinsyregigt og urikosuriske midler lesinurad
English: Do not take Delstrigo:
Danish: Delstrigo indeholder:
English: Expected:  doravirine (Induction of CYP3A)
Danish: Forventet:  doravirin (CYP3A-induktion)
English: If you stop taking Delstrigo
Danish: Hvis du har taget for meget Delstrigo
English: • kidney damage, kidney stones, kidney failure, damage to kidney tubule cells, kidney injury,
Danish: • nyreskade, nyresten, nyresvigt, beskadigede nyrerørsceller, nyreskader, afgivelse af store mængder urin og tørstfølelse
English: Because lamivudine is primarily eliminated by the kidneys through a combination of glomerular filtration and active tubular secretion (see section 5.2), co-administration of doravirine/lamivudine/tenofovir disoproxil with medicinal products that reduce renal function or compete for active tubular secretion may increase serum concentrations of lamivudine.
Danish: 5.2), kan samtidig administration af doravirin/lamivudin/tenofovirdisoproxil og lægemidler, der nedsætter nyrefunktionen eller konkurrerer om aktiv tubulær sekretion, øge serumkoncentrationen af lamivudin.
English: Tablet core
Danish: Tabel 3.
English: Your doctor will do blood tests to check your kidney function before and during treatment with Delstrigo.
Danish: Før og under behandlingen med Delstrigo vil lægen tage blodprøver for at undersøge din nyrefunktion.
English: Expected:  doravirine (inhibition of CYP3A)
Danish: Forventet:  doravirin (CYP3A-hæmning)
English: • decreased levels of haemoglobin
Danish: • nedsat indhold af hæmoglobin.
English: If you have been told by your doctor that you have an intolerance to lactose, talk to your doctor before taking this medicine.
Danish: Kontakt lægen, før du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter (lactose).
English: • hair loss, rash
Danish: • hårtab, udslæt
English: Swallow whole.
Danish: Sluges hel.
English: 7, pancreatitis*
Danish: 4, opkastning,
English: In addition, the European Commission requested the Agency to give its opinion, as to whether provisional measures were necessary to protect public health.
Danish: Desuden anmodede Europa-Kommissionen agenturet om en udtalelse om, hvorvidt det er nødvendigt at iværksætte midlertidige foranstaltninger af hensyn til folkesundheden.
English: It is to be noted that the data currently available to the PRAC is very limited and does not enable the PRAC to give definite conclusions.
Danish: Det skal bemærkes, at de data, som PRAC aktuelt råder over, er meget begrænsede og ikke gør det muligt for PRAC at fremsætte endelige konklusioner.
English: Furthermore, in depth assessment is needed to firmly establish factors that may have driven death rates and it is too early to conclude that the risk is most apparent in the first 6 months.
Danish: Det er desuden nødvendigt at gennemføre grundige vurderinger for at fastslå, hvilke faktorer der kan have udløst de dødelige udfald, og det er for tidligt at konkludere, om risikoen er størst i de første 6 måneder.
English: These recommendations should be reflected in the product information and communicated to healthcare professionals via a dedicated letter.
Danish: Disse anbefalinger bør medtages i produktinformationen og kommunikeres til sundhedspersoner i et særskilt brev.
English: These measures will be further reviewed as part of the ongoing Article 20.
Danish: Foranstaltningerne vil blive yderligere gennemgået som led i den igangværende artikel 20-procedure.
English: Regular clinical and laboratory screening for cytomegalovirus should also be performed.
Danish: Regelmæssig klinisk og laboratoriemæssig screening for cytomegalovirus bør også gennemføres.
English: • monitoring for respiratory signs and symptoms of throughout treatment and reporting of new respiratory symptoms;
Danish: • overvågning af åndedrætsbesvær og lignende symptomer i hele behandlingsforløbet og indberetning af nye åndedrætssymptomer
English: In addition, given the higher risk for infection, advice on dose reduction or treatment interruption in the event of severe neutropenia was also proposed.
Danish: Derudover tilrådes det i lyset af den højere risiko for infektion også at reducere dosis eller seponere behandling i tilfælde af svær neutropeni.
English: The current recommendation relates only to provisional measures recommended by the PRAC for idelalisib.
Danish: Den aktuelle anbefaling angår kun de midlertidige foranstaltninger, som PRAC har anbefalet vedrørende idelalisib.
English: • The PRAC considered the provisional measure under Article 20(3) of Regulation (EC) No 726/2004 in the framework of Article 20 of Regulation (EC) No 726/2004 procedure resulting from pharmacovigilance data for Zydelig (idelalisib).
Danish: • PRAC har taget højde for den midlertidige foranstaltning i henhold til artikel 20, stk. 3, i forordning (EF) nr. 726/2004 inden for rammerne af artikel 20 i forordning (EF) nr. 726/2004, for så vidt angår data fra bivirkningsovervågning af Zydelig (idelalisib).
English: Also, post-marketing reports of adverse events in EudraVigilance indicate that infections (including sepsis and pneumocystis) account for a large proportion of reported cases, including fatal cases.
Danish: Desuden indikerer indberetninger af bivirkninger til EudraVigilance efter markedsføringen, at infektioner (herunder sepsis og pneumocystis) udgør en stor del af de indberettede tilfælde, herunder tilfælde med dødeligt udfald.
English: • prophylaxis for Pneumocystis jirovecii pneumonia (PJP) to all patients throughout treatment;
Danish: • profylakse mod Pneumocystis jirovecii-lungebetændelse (PJP) til alle patienter i hele behandlingsforløbet
English: Further measures to minimise the risk of infection should also be carried forward to clinical practice, including those used in studies supporting the initial marketing authorisation application with favourable results.
Danish: Der bør også gennemføres yderligere foranstaltninger til at minimere risikoen for infektion i klinisk praksis, herunder foranstaltninger, der blev anvendt i de undersøgelser, der understøttede den oprindelige ansøgning om markedsføringstilladelse, og som havde positive resultater.
English: • monitoring of absolute neutrophil counts (ANC) in all patients at least every two weeks for the first six months of treatment with idelalisib, and at least weekly in patients while ANC is less than 1,000 per mm3.
Danish: • overvågning af det absolutte neutrofiltal (ANC) hos alle patienter som minimum hver anden uge i de første seks måneder af behandlingen med idelalisib og mindst én gang om ugen hos patienter med et ANC på under 1 000 pr. mm 3.
English: Annex IV Scientific conclusions
Danish: Bilag IV
English: • regular clinical and laboratory screening for cytomegalovirus (CMV) infection.
Danish: • regelmæssig klinisk og laboratoriemæssig screening for cytomegalovirus (CMV)-infektion.
English: Further, if continuing with therapy, new risk minimisation (see below) should be implemented.
Danish: Hvis dette besluttes, bør der gennemføres nye risikominimerende foranstaltninger (se nedenfor).
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for idelalisib.
Danish: PRAC anbefaler derfor, at betingelserne for markedsføringstilladelserne for idelalisib ændres.
English: The reason why patients in the earlier stages of disease might be at increased risk of death and serious infection with idelalisib is not clear, although it is likely that there is an interaction between benefit-risk balance in differing populations and their level of disease-related mortality.
Danish: Grunden til, at patienter i de tidlige sygdomsstadier kan have en øget risiko for død og alvorlig infektion med idelalisib, er ikke klarlagt, men sandsynligvis er der en forbindelse mellem benefit/risk-forholdet i forskellige populationer og deres niveau af sygdomsrelateret mortalitet.
English: As only very limited data is available, these measures are only temporary and are without prejudice to the ongoing review under Article 20.
Danish: Eftersom der kun er meget sparsomme oplysninger til rådighed, bør disse foranstaltninger kun indføres på midlertidig basis og med forbehold for den igangværende artikel 20-procedure.
English: The impact of the new safety findings in the currently authorised indications and extension of indication for use in CLL in combination with ofatumumab cannot be evaluated with certainty at present in view of the limited data available.
Danish: Betydningen af de nye sikkerhedsfund i de aktuelt godkendte indikationer og udvidelsen af indikationen til brug ved CLL i kombination med ofatumumab kan ikke vurderes endegyldigt på nuværende tidspunkt på grund af de begrænsede data, der er til rådighed.
English: Similarly, studies -0124 and -0125 are not consistent with the FL indication because idelalisib was combined with rituximab or rituximab and bendamustine, respectively, which are not authorised combinations.
Danish: Tilsvarende er undersøgelserne -0124 og -0125 heller ikke i overensstemmelse med FL-indikationen, idet idelalisib blev kombineret med henholdsvis rituximab eller rituximab og bendamustin, hvilket ikke er godkendte kombinationer.
English: These temporary measures may be revised in light of the data that will become available and will be assessed in the ongoing Article 20 procedure, as the precise factors for the differences in safety outcomes between the three new studies (0123, -0124 and -0125) and those observed in studies supporting the initial marketing authorisation and proposed extension of indication for use in CLL in combination with ofatumumab.
Danish: Disse midlertidige foranstaltninger kan ændres under hensyntagen til de data, der bliver tilgængelige, og som vil blive vurderet i den igangværende artikel 20-procedure som de præcise faktorer for forskellene i sikkerhedsresultater mellem de tre nye undersøgelser (-0123, -0124 og -125) og dem, der er observeret i de undersøgelser, der understøttede den oprindelige markedsføringstilladelse og ansøgningen om udvidelse af indikationen til brug ved CLL i kombination med ofatumumab.
English: A table to guide physicians was proposed for the posology section.
Danish: Introduktion af en vejledende tabel til læger i administrationsafsnittet er blevet foreslået.
English: Based on the inhibitory effects of idelalisib on the PI3K pathway, it is possible that the increased risk of serious infection observed in studies 0123, -0124 and -0125 could be relevant to the authorised indications.
Danish: I betragtning af idelalisibs hæmmende virkning på PI3K-metaboliseringsvejen er det muligt, at den øgede risiko for alvorlig infektion, der er set i undersøgelserne -0123, -0124 og -0125, kan være relevant for de godkendte indikationer.
English: However, in light of the emerging safety data, the European Commission (EC) considered that the findings from the clinical trials and all available safety data related to idelalisib should be reviewed in order to assess their potential impact on the benefit-risk balance of Zydelig in the approved indications and relevant ongoing variations.
Danish: I lyset af de fremkomne sikkerhedsdata vurderede Europa-Kommissionen imidlertid, at fundene fra de kliniske forsøg og alle tilgængelige sikkerhedsdata vedrørende idelalisib skulle gennemgås for at vurdere deres eventuelle betydning for benefit/risk-forholdet for Zydelig i de godkendte indikationer og igangværende variationsprocedurer.
English: On 11 March 2016 the EC therefore triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of Zydelig (idelalisib) and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Danish: På baggrund af disse lægemiddelovervågningsdata indledte Europa-Kommissionen derfor den 11. marts 2016 en procedure i henhold til forordning (EF) nr. 726/2004, artikel 20, og bad PRAC om at vurdere ovenstående problemstillings betydning for benefit/risk-forholdet for Zydelig (idelalisib) og fremsætte en anbefaling om, hvorvidt de pågældende markedsføringstilladelser bør opretholdes, ændres, suspenderes eller tilbagekaldes.
English: The PRAC also considered available safety data from clinical trials submitted in support of the initial marketing authorisation and extensions of indication and Eudravigilance data in relation to the overall risk of treatment with idelalisib.
Danish: PRAC har også gennemgået de tilgængelige sikkerhedsdata fra kliniske forsøg, der blev indsendt som understøttende dokumentation for den oprindelige markedsføringstilladelse og udvidelsen af indikationen, samt data fra EudraVigilance i forhold til den samlede risiko ved behandling med idelalisib.
English: Interim results of these studies have shown an increased risk of death and serious adverse events in the idelalisib treatment arms compared to placebo.
Danish: Foreløbige resultater af disse undersøgelser har vist en øget risiko for død og alvorlige, uønskede hændelser i de behandlingsgrupper, der fik idelalisib, sammenholdt med placebo.
English: • The PRAC noted that the use of idelalisib in studies -0123, -0124 and -0125 was in different conditions than those currently authorised, and at earlier stages of the diseases.
Danish: • PRAC bemærker, at brugen af idelalisib i forsøgene -0123, -0124 og -0125 skete under andre betingelser end dem, som aktuelt er godkendt, og på tidlige stadier af sygdommene.
English: Whilst the matter is being further reviewed, the PRAC recommended as a provisional measure an update of the posology and warnings to take due account that treatment should not be initiated in patients with systemic infections, patients should be monitored for respiratory symptoms and be administered Pneumocystis jirovecii pneumonia prophylaxis.
Danish: Mens sagen undersøges nærmere, anbefaler PRAC, at der som midlertidig sikkerhedsforanstaltning gennemføres en opdatering af administrationsoplysningerne og advarslerne for at gøre lægerne opmærksomme på, at behandling ikke bør påbegyndes hos patienter med systemiske infektioner, at patienterne bør overvåges for symptomer på åndedrætsbesvær, og at de bør gives profylakse mod Pneumocystis jirovecii-lungebetændelse.