FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose is DARZALEX 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule in Table 4.
Danish: Den anbefalede dosis er 16 mg DARZALEX pr. kg legemsvægt administreret som intravenøs infusion i henhold til doseringsskemaet i tabel 2.
English: Post-marketing adverse reaction
Danish: Bivirkning efter markedsføring
English: For information on the VMP dose and dosing schedule when administered with DARZALEX, see section 5.1.
Danish: For oplysninger om dosis og doseringsskema for VMP ved administration sammen med DARZALEX henvises til pkt.
English: Each 20 mL vial contains 400 mg of daratumumab (20 mg daratumumab per mL).
Danish: Hvert hætteglas med 20 ml indeholder 400 mg daratumumab (20 mg daratumumab pr. ml).
English: First dose of the every-3-week dosing schedule is given at Week 7 First dose of the every-4-week dosing schedule is given at Week 55
Danish: Første dosis i doseringsskemaet for hver 3. uge gives i uge 7 Første dosis i doseringsskemaet for hver 4. uge gives i uge 55
English: NK cells are known to express high levels of CD38 and are susceptible to daratumumab mediated cell lysis.
Danish: NK- (naturlige dræberceller)-celletal og T-celletal NK-celler vides at udtrykke høje niveauer af CD38 og er følsomme for daratumumab-medieret cellelyse.
English: DRd=daratumumab-lenalidomide-dexamethasone; Rd=lenalidomide-dexamethasone; MRD=minimal residual disease; CI=confidence interval; NE=not estimable.
Danish: DRd = daratumumab-lenalidomid-dexamethason; Rd = lenalidomid-dexamethason; MRD = minimal restsygdom; CI = konfidensinterval; NE = kan ikke estimeres.
English: DARZALEX dosing schedule in combination with bortezomib, melphalan and prednisone ([VMP]; 6-week cycle dosing regimen)
Danish: Tabel 2: Skema for dosering af DARZALEX i kombination med bortezomib, melphalan og prednison ([VMP]; doseringsregime med 6-ugers serier)
English: On DARZALEX infusion days, the dexamethasone dose was given as a pre-infusion medication.
Danish: På dage med infusion af DARZALEX blev dexamethasondosen givet som præinfusionsmedicinering.
English: On the days of DARZALEX infusion, 20 mg of the dexamethasone dose was administered as a pre-infusion medication.
Danish: På dagene med infusion af DARZALEX blev 20 mg af dexamethason-dosen administreret før infusionen.
English: Study MMY3007, an open-label, randomised, active-controlled Phase III study, compared treatment with DARZALEX 16 mg/kg in combination with bortezomib, melphalan and prednisone (D-VMP), to treatment with VMP in patients with newly diagnosed multiple myeloma.
Danish: Studie MMY3007, et åbent, randomiseret, aktivt kontrolleret fase III-studie, sammenlignede behandling med 16 mg/kg DARZALEX i kombination med bortezomib, melphalan og prednison (D-VMP) med behandling med VMP hos patienter med nydiagnosticeret myelomatose.
English: Upper respiratory tract infection
Danish: Infektion i øvre luftveje Urinvejsinfektion
English: Manufacturer Janssen Biologics B.V. Einsteinweg 101
Danish: Fremstiller Janssen Biologics B.V.
English: First dose of the every-3-week dosing schedule is given at Week 10 First dose of the every-4-week dosing schedule is given at Week 25
Danish: Første dosis i doseringsskemaet for hver 3. uge gives i uge 10 Første dosis i doseringsskemaet for hver 4. uge gives i uge 25
English: Each vial of 20 mL concentrate contains 400 mg of daratumumab (20 mg/mL).
Danish: Hvert hætteglas med 20 ml koncentrat indeholder 400 mg daratumumab (20 mg/ml).
English: Thrombocytopenia
Danish: Trombocytopeni Anæmi
English: For IRRs of any grade/severity, immediately interrupt the DARZALEX infusion and manage symptoms.
Danish: Hvis en IRR forekommer, skal infusion af DARZALEX straks afbrydes og symptomerne behandles, uanset graden/sværhedsgraden af IRR'en.
English: Additional efficacy results from Study MMY3004 are presented in Table 12 below.
Danish: Yderligere effektresultater fra studie MMY3004 præsenteres i tabel 12 nedenfor.
English: Haemolysis
Danish: Rygsmerter
English: Pre-infusion medications should be administered to reduce the risk of infusion-related reactions (IRRs) prior to treatment with DARZALEX.
Danish: Håndtering af infusionsrelaterede reaktioner Der skal administreres lægemidler før infusion af DARZALEX for at reducere risikoen for IRR'er.
English: First dose of the every-2-week dosing schedule is given at Week 9 First dose of the every-4-week dosing schedule is given at Week 25
Danish: Første dosis i doseringsskemaet for hver 2. uge gives i uge 9 Første dosis i doseringsskemaet for hver 4. uge gives i uge 25
English: • lung infection (pneumonia)
Danish: • lungebetændelse
English: Based on the population PK analysis of daratumumab monotherapy (Analysis 1), daratumumab steady state is achieved approximately 5 months into the every 4-week dosing period (by the 21
Danish: Baseret på den farmakokinetiske populationsanalyse af daratumumab som monoterapi (analyse 1) nås steady state for daratumumab cirka 5 måneder inde i perioden med en dosis hver 4. uge (ved infusion nr. 21), og middelforholdet (SD) mellem Cmax ved steady state og Cmax efter første dosis var 1,6 (0,5).
English: Study MMY3008, an open-label, randomized, active-controlled Phase III study, compared treatment with DARZALEX 16 mg/kg in combination with lenalidomide and low-dose dexamethasone (DRd) to treatment with lenalidomide and low-dose dexamethasone (Rd) in patients with newly diagnosed multiple myeloma.
Danish: Studie MMY3008, et åbent, randomiseret, aktivt kontrolleret fase III-studie, sammenlignede behandling med 16 mg/kg DARZALEX i kombination med lenalidomid og lavdosis dexamethason (DRd) med behandling med lenalidomid og lavdosis dexamethason (Rd) hos patienter med nydiagnosticeret myelomatose.
English: • chest discomfort
Danish: • svaghedsfornemmelse
English: D-VMP=daratumumab-bortezomib-melphalan-prednisone; VMP=bortezomib-melphalan-prednisone; MRD=minimal residual disease; CI=confidence interval
Danish: D-VMP = daratumumab-bortezomib-melphalan-prednison; VMP = bortezomib-melphalan-prednison; MRD = minimal restsygdom; CI = konfidensinterval Baseret på Intent-to-treat-population.
English: Maximum rate
Danish: Maksimal hastighed
English: Study MMY3004, an open-label, randomised, active-controlled Phase III trial, compared treatment with DARZALEX 16 mg/kg in combination with bortezomib and dexamethasone (DVd), to treatment with bortezomib and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma who had received at least one prior therapy.
Danish: Studie MMY3004, et åbent, randomiseret, aktivt kontrolleret fase III-forsøg, sammenlignede behandling med 16 mg/kg DARZALEX i kombination med bortezomib og dexamethason (DVd) med behandling med bortezomib og dexamethason (Vd) hos patienter med recidiverende eller refraktær myelomatose, som havde fået mindst én tidligere behandling.
English: Study MMY3004 demonstrated an improvement in PFS in the DVd arm as compared to the Vd arm; the median PFS had not been reached in the DVd arm and was 7.2 months in the Vd arm (HR [95% CI]: 0.39 [0.28, 0.53]; p-value<0.0001), representing a 61% reduction in the risk of disease progression or death for patients treated with DVd versus Vd.
Danish: Median PFS blev ikke nået i DVd-armen og var 7,2 måneder i Vd-armen (HR [95 % CI]: 0,39 [0,28; 0,53]; p < 0,0001), hvilket repræsenterer en 61 % reduktion af risikoen for sygdomsprogression eller død hos patienter behandlet med DVd versus Vd (se figur 4).
English: Additional efficacy results from Study MMY3003 are presented in Table 11 below.
Danish: Yderligere effektresultater fra studie MMY3003 præsenteres i tabel 11 nedenfor.
English: How to store DARZALEX
Danish: Sådan får du DARZALEX
English: The baseline demographic and disease characteristics were similar between the DARZALEX and the control arm.
Danish: Demografiske data og sygdomskarakteristika ved baseline var ens i de 2 arme.
English: Discard any unused portion left in the vial.
Danish: Ikke anvendt lægemiddel i hætteglasset skal bortskaffes.
English: Odds ratio with 95% CI P-value
Danish: Oddsratio med 95 % CI P-værdi
English: Figure 1: Kaplan-Meier Curve of PFS in Study MMY3008
Danish: Figur 1: Kaplan-Meier-kurve for PFS i studie MMY3008
English: Additional efficacy results from Study MMY3007 are presented in Table 8 below.
Danish: Yderligere effektresultater fra studie MMY3007 præsenteres i tabel 8 nedenfor.
English: Study MMY3003, an open-label, randomised, active-controlled Phase III trial, compared treatment with DARZALEX 16 mg/kg in combination with lenalidomide and low-dose dexamethasone (DRd) to treatment with lenalidomide and low-dose dexamethasone (Rd) in patients with relapsed or refractory multiple myeloma who had received at least one prior therapy.
Danish: Studie MMY3003, et åbent, randomiseret, aktivt kontrolleret fase III-forsøg, sammenlignede behandling med 16 mg/kg DARZALEX i kombination med lenalidomid og lavdosis-dexamethason (DRd) med behandling med lenalidomid og lavdosis-dexamethason (Rd) hos patienter med recidiverende eller refraktær myelomatose, som havde fået mindst én tidligere behandling.
English: Additional efficacy results from Study MMY3008 are presented in Table 7 below.
Danish: Yderligere effektresultater fra studie MMY3008 præsenteres i tabel 7 nedenfor.
English: Immune system disorders Anaphylactic reaction b Rare Metabolism and nutrition Decreased appetite Very Common 12
Danish: Metabolisme og ernæring Nedsat appetit
English: Kaplan-Meier Curve of Primary Analysis of PFS in Study MMY3007
Danish: Figur 2: Kaplan-Meier-kurver for primær analyse af PFS i studie MMY3007
English: Figure 4: Kaplan-Meier Curve of PFS in Study MMY3004
Danish: Figur 4: Kaplan-Meier-kurver for PFS i studie MMY3004
English: Study MMY3003 demonstrated an improvement in PFS in the DRd arm as compared to the Rd arm; the median PFS had not been reached in the DRd arm and was 18.4 months in the Rd arm (HR=0.37; 95% CI: 0.27, 0.52; p<0.0001), representing 63% reduction in the risk of disease progression or death in patients treated with DRd (see Figure 3).
Danish: Median PFS blev ikke nået i DRd-armen og var 18,4 måneder i Rd-armen (HR = 0,37; 95 % CI: 0,27; 0,52; p < 0,0001), hvilket repræsenterer en 63 % reduktion af risikoen for sygdomsprogression eller død hos patienter behandlet med DRd (se figur 3).
English: Figure 3: Kaplan-Meier Curve of PFS in Study MMY3003
Danish: Figur 3: Kaplan-Meier-kurver for PFS i studie MMY3003
English: Each 5 mL vial contains 100 mg of daratumumab (20 mg daratumumab per mL).
Danish: Hvert hætteglas med 5 ml indeholder 100 mg daratumumab (20 mg daratumumab pr. ml).
English: Each vial of 5 mL concentrate contains 100 mg of daratumumab.
Danish: Hvert hætteglas med 5 ml koncentrat indeholder 100 mg daratumumab.
English: The primary analysis of PFS in Study MMY3007 showed an improvement in the D-VMP arm as compared to the VMP arm; the median PFS had not been reached in the D-VMP arm and was 18.1 months in the VMP arm (HR=0.5; 95% CI: 0.38, 0.65; p<0.0001), representing 50% reduction in the risk of disease progression or death in patients treated with D-VMP.
Danish: Median PFS blev ikke nået i D-VMP-armen og var 18,1 måneder i VMP-armen (HR = 0,5; 95 % CI: 0,38, 0,65; p < 0,0001), hvilket repræsenterer en 50 % reduktion af risikoen for sygdomsprogression eller død hos patienter behandlet med D-VMP.
English: Each vial of 5 mL concentrate contains 100 mg of daratumumab (20 mg/mL).
Danish: Hvert hætteglas med 5 ml koncentrat indeholder 100 mg daratumumab (20 mg/ml).
English: Each vial of 20 mL concentrate contains 400 mg of daratumumab.
Danish: Hvert hætteglas med 20 ml koncentrat indeholder 400 mg daratumumab.
English: Overall response (sCR+CR+VGPR+PR) n(%) p-value
Danish: Samlet respons (sCR+CR+VGPR+PR) n(%) p-værdi
English: Study MMY3008 showed an improvement in Progression Free Survival (PFS) in the DRd arm as compared to the Rd arm; the median PFS had not been reached in the DRd arm and was 31.9 months in the Rd arm (hazard ratio [HR]=0.56; 95% CI: 0.43, 0.73; p<0.0001), representing 44% reduction in the risk of disease progression or death in patients treated with DRd.
Danish: Den mediane PFS blev ikke nået i DRd-armen og var 31,9 måneder i Rd-armen (hazard ratio [HR] = 0,56; 95 % CI: 0,43; 0,73; p < 0,0001), hvilket repræsenterede en 44 % reduktion i risikoen for sygdomsprogression eller død hos patienter, som fik behandling med DRd.
English: Overall response rate 1 (ORR: sCR+CR+VGPR+PR) [n (%)]
Danish: 1 (ORR: sCR+CR+VGPR+PR) [n (%)]
English: Lymphopenia
Danish: Kulderystelser
English: D-VTd=daratumumab-bortezomib-thalidomide-dexamethasone; VTd=bortezomib-thalidomide-dexamethasone; MRD=minimal residual disease; CI=confidence interval Based on intent-to-treat population p-value from Cochran Mantel-Haenszel Chi-Squared test.
Danish: D-VTd = daratumumab-bortezomib-thalidomid-dexamethason; VTd = bortezomib-thalidomid-dexamethason; MRD = minimal restsygdom; CI = konfidensinterval Baseret på intent-to-treat-population.
English: • wheezing.
Danish: • kløe
English: CR or better (sCR + CR) p-value
Danish: Delvist respons (PR) CR eller bedre (sCR + CR) p-værdi
English: Dosing schedule in combination with bortezomib (3-week cycle regimen):
Danish: Skema for dosering i kombination med bortezomib, melphalan og prednison (regime med 6-ugers serier):
English: Table 12: Additional efficacy results from Study MMY3004 Response evaluable patient number
Danish: Tabel 12: Yderligere effektresultater fra studie MMY3004
English: p-value is from a likelihood-ratio chi-squared test.
Danish: p-værdien er fra en chi
English: Weeks 1, 2, 4 and 5 for the first 6-week cycle (Cycle 1; 8 doses), followed by once weekly administrations at Weeks 1, 2, 4 and 5 for eight more 6-week cycles (Cycles 2-9; 4 doses per cycle).
Danish: Bortezomib blev administreret via subkutan (s.c.) injektion med en dosis på 1,3 mg/m2 legemsoverfladeareal to gange om ugen i uge 1, 2, 4 og 5 i den første 6-ugers serie (serie 1; 8 doser), efterfulgt af administration en gang om ugen i uge 1, 2, 4 og 5 i yderligere otte 6-ugers serier (serie 2-9; 4 doser pr. serie).
English: MRD negativity rate (95% CI)
Danish: Forekomst af negativ MRD (95 % CI) Oddsratio med 95 % CI P-værdi
English: DRd=daratumumab-lenalidomide-dexamethasone; Rd=lenalidomide-dexamethasone; MRD=minimal residual disease; CI=confidence interval
Danish: DRd = daratumumab-lenalidomid-dexamethason; Rd = lenalidomid-dexamethason; MRD = minimal restsygdom; CI = konfidensinterval Baseret på Intent-to-treat-population.
English: Table 11: Additional efficacy results from Study MMY3003 Response evaluable patient number
Danish: Tabel 11: Yderligere effektresultater fra studie MMY3003
English: Cardiac disorders
Danish: Hypokalcæmi Dehydrering
English: Dose modifications
Danish: Dosisjustering
English: Schedule
Danish: Skema
English: What you need to know before you take [product] Warning and precautions
Danish: Det skal du vide, før du begynder at tage [produkt] Advarsler og forsigtighedsregler Kontakt lægen, før du tager [produkt]:
English: Adopted at the 3-6 September 2018 PRAC
Danish: Vedtaget på PRAC's møde den 3.-6. september 2018
English: Most cases occurred within 2 months of alemtuzumab dosing.
Danish: De fleste tilfælde skete inden for to måneder efter administration af alemtuzumab.
English: - if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Danish: - hvis du har haft hudkræft, eller hvis du udvikler en uventet hudlæsion under behandlingen.
English: Coughing, wheezing and shortness of breath which may be accompanied by a high temperature
Danish: Hoste, hvæsende vejrtrækning og åndenød, som kan være ledsaget af en høj temperatur
English: In clinical trials, a single dose of infliximab 5 mg/kg was added unless contraindicated.
Danish: I kliniske forsøg blev der tilføjet en enkeltdosis infliximab 5 mg/kg, medmindre det var kontraindiceret.
English: Rare side effects (may affect up to 1 in 1000 people)
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 patienter)
English: XEstimated frequency based on placebo-controlled clinical trials and
Danish: XEstimeret hyppighed baseret på placebokontrollerede kliniske studier og
English: Tell your doctor right away if you have symptoms of infection such as fever or swollen glands.
Danish: Fortæl det straks til lægen, hvis du har symptomer på infektion som f.eks. feber eller hævede kirtler.
English: Special warnings and precautions Immune-related gastrointestinal reactions:
Danish: Særlige advarsler og forholdsregler Immunrelaterede gastrointestinale reaktioner:
English: Patients must be monitored for gastrointestinal signs and symptoms that may be indicative of immunerelated colitis or gastrointestinal perforation.
Danish: Patienten skal monitoreres for gastrointestinale tegn og symptomer, der kan indikere immunrelateret colitis eller gastrointestinal perforation.
English: Uncommon (may affect up to 1 in 100 people) Infections: […], cytomegalovirus infection
Danish: Ikke almindelig (forekommer hos op til 1 ud af 100 patienter) Infektioner: […], cytomegalovirusinfektion
English: The experience from clinical trials on the management of corticosteroid-refractory diarrhoea or colitis is limited.
Danish: Erfaringen fra kliniske forsøg vedrørende behandling af kortikosteroid-refraktær diarré eller colitis er begrænset.
English: Possible side effects Uncommon side effects These may affect up to 1 in 100 people: - reduction in blood platelets
Danish: Ikke almindelige bivirkninger Disse kan forekomme hos op til 1 ud af 100 patienter: - nedsat antal blodplader
English: - if you have experienced a previous episode of aortic dissection (a tear in the aorta wall).
Danish: - hvis du tidligere har haft et tilfælde af aortadissektion (en rift i aortavæggen).
English: Fluoroquinolones for systemic and inhaled use2 - Aortic aneurysm and dissection (EPITT no 18651)
Danish: Fluorquinoloner til systemisk brug og inhalation2aortaaneurisme og -dissektion (EPITT nr. 18651)
English: Infliximab must not be used if gastrointestinal perforation or sepsis is suspected (see the Summary of Product Characteristics for infliximab).
Danish: Infliximab må ikke anvendes ved mistanke om gastrointestinal perforation eller sepsis (se produktresuméet for infliximab).
English: 2 Ciprofloxacin; flumequine; levofloxacin; lomefloxacin; moxifloxacin; norfloxacin; ofloxacin; pefloxacin; prulifloxacin; rufloxacin.
Danish: 2 Ciprofloxacin, flumequin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin, rufloxacin.
English: YEstimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebo-controlled clinical trials.
Danish: YEstimeret hyppighed baseret på rapporterede bivirkninger under overvågning efter markedsføring; ikke observeret i placebokontrollerede kliniske studier.
English: Dimethyl fumarate (Tecfidera) - Immune thrombocytopenic purpura and thrombocytopenia (EPITT no
Danish: Dimetylfumarat (Tecfidera) - immunbetinget trombocytopenisk purpura og trombocytopeni (EPITT nr.
English: Talk to your doctor <or> <pharmacist> <or> <nurse> before <taking> <using> X
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager X
English: What you need to know before you are administered LEMTRADA Warnings and precautions
Danish: Det skal du vide, før du får LEMTRADA Advarsler og forsigtighedsregler Infektioner
English: In clinical trials, immune-related colitis was associated with evidence of mucosal inflammation, with or without ulcerations, and lymphocytic and neutrophilic infiltration.
Danish: I kliniske forsøg var immunrelateret colitis associeret med tegn på slimhindeinflammation, med eller uden ulceration, samt infiltration af lymfocytter og neutrofile granulocytter.
English: - if you have been diagnosed with an enlargement or "bulge" of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).
Danish: - hvis du er diagnosticeret med en udposning på en stor blodåre (aortaaneurisme eller perifer aneurisme i en stor blodåre).
English: Clinical presentation may include diarrhoea, increased frequency of bowel movements, abdominal pain, or haematochezia, with or without fever.
Danish: Den kliniske tilstand kan omfatte diarré, hyppigere afføring, mavesmerter eller hæmatokeksi, med eller uden feber.
English: Hydrochlorothiazide - Skin cancer (EPITT no 19138)
Danish: Hydrochlorthiazid - hudkræft (EPITT-nr. 19138)
English: Summary of Product Characteristics 4.8.
Danish: Produktresumé 4.8.
English: Duloxetine - Interstitial lung disease (EPITT no 19175)
Danish: Duloxetin - interstitiel lungesygdom (EPITT nr. 19175)
English: Diarrhoea or colitis occurring after initiation of ipilimumab must be promptly evaluated to exclude infectious or other alternate etiologies.
Danish: Diarré eller colitis, der opstår efter behandlingsstart med ipilimumab, skal undersøges med det samme for at udelukke infektiøse eller alternative ætiologier.
English: - if you have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular EhlersDanlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure, or known atherosclerosis).
Danish: - hvis der i din familie tidligere har været et tilfælde af aortaaneurisme eller aortadissektion eller andre risikofaktorer eller prædisponerende sygdomme (f.eks. bindevævssygdom som Marfans syndrom eller vaskulær Ehlers-Danlos syndrom eller karsygdomme som f.eks. Takayasu arteritis (blodårebetændelse), kæmpecelle arteritis, Behcets sygdom, for højt blodtryk eller kendt aterosklerose (åreforkalkning)).
English: Ipilimumab - Cytomegalovirus gastrointestinal infection (EPITT no 19207)
Danish: Ipilimumab - gastrointestinal cytomegalovirus-infektion (EPITT-nr. 19207)
English: However, aAddition of an alternative immunosuppressive agent to the corticosteroid regimen may should be considered in corticosteroid-refractory immune-related colitis if other causes are excluded (including Cytomegalovirus (CMV) infection/reactivation evaluated with viral PCR on biopsy, and other viral, bacterial and parasitic etiology) be considered.
Danish: Det børdog overvejes at tilføje et andet immunosuppressivt stof til kortikosteroidbehandlingen kanved kortikosteroid-refraktær immunrelateret colitis, hvis andre årsager er udelukket (herunder cytomegalovirus (CMV)-infektion/reaktivering, som vurderet ved viral PCR på biopsi, og andre virale, bakterielle og parasitære ætiologier)overvejes.
English: Frequency ‘rare': Eosinophilic pneumoniaY
Danish: Hyppighed "sjælden": Eosinofil pneumoniY
English: Infections and infestations: cytomegalovirus infection - frequency uncommon
Danish: Infektioner og parasitære sygdomme: cytomegalovirusinfektion - hyppighed "Ikke almindelig"
English: Post-marketing cases of cytomegalovirus (CMV) infection/reactivation have been reported in patients with corticosteroid-refractory immune-related colitis.
Danish: Efter markedsføring er der rapporteret om tilfælde af cytomegalovirus (CMV)infektion/reaktivering hos patienter med kortikosteroid-refraktær immunrelateret colitis.
English: Special warnings and precautions for use Infections
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Infektioner
English: Frequency ‘rare': Interstitial lung diseaseX
Danish: Hyppighed "sjælden": Interstitiel lungesygdomX
English: Stool infections work-up should be performed upon presentation of diarrhoea or colitis to exclude infectious or other alternate etiologies.
Danish: Afføringen bør undersøges for infektioner ved forekomst af diarré eller colitis for at udelukke infektiøse eller alternative ætiologier.
English: Undesirable effects Tabulated list of adverse reactions Respiratory, thoracic and mediastinal disorders
Danish: Bivirkninger Oversigt over bivirkninger Luftveje, thorax og mediastinum
English: Cytomegalovirus (CMV) infections including cases of CMV reactivation have been reported in LEMTRADA-treated patients.
Danish: Der er indberettet tilfælde af cytomegalovirus (CMV)-infektioner, herunder tilfælde af CMVreaktivering, hos patienter behandlet med LEMTRADA.