FrancophonIA/ELRC3.0 huggingface dataset:
English: The clinical significance of the reductions in etravirine pharmacokinetic parameters and boceprevir Cmin in the setting of combination therapy with HIV antiretroviral medicines, which also affect the pharmacokinetics of etravirine and/or boceprevir, has not been directly assessed.
Danish: Under kombinationsbehandling med hiv-antiretrovirale lægemidler, som også indvirker på etravirins og/eller boceprevirs farmakokinetik, er det ikke blevet vurderet direkte, om reduktionerne i etravirins farmakokinetiske parametre og boceprevirs Cmin er klinisk signifikante.
English: Victrelis in combination with ribavirin and peginterferon alfa is contraindicated in women who are
Danish: Victrelis er i kombination med ribavirin og peginterferon alfa kontraindiceret hos gravide kvinder (se
English: Neutrophils (see section 4.4)
Danish: 4.4) Angioødem (se pkt.
English: Coadministration of quetiapine with Victrelis is contraindicated (see section 4.3).
Danish: Samtidig administration af quetiapin og Victrelis er kontraindiceret (se pkt.
English: It is not recommended to co-administer lopinavir/ritonavir and Victrelis.
Danish: Samtidig administration af lopinavir/ritonavir og Victrelis frarådes.
English: Decreased appetite* Dehydration*, hyperglycaemia*, hypertriglyceridaemia,
Danish: Dehydrering*, hyperglykæmi*, hypertriglyceridæmi, hyperurikæmi
English: Administer peginterferon alfa and ribavirin for 4 weeks, and then
Danish: Giv peginterferon alfa og ribavirin (PR) i 4 uger og
English: The distribution of subjects by genders was 69% men and 31% women.
Danish: Kønsfordelingen af forsøgspersoner var 69 % mænd og 31 % kvinder.
English: • Detailed information about the risk of haematological disorders (notably anaemia) associated with Victrelis, consisting of factual description of the haematological disorders in terms of frequency and time to onset and related clinical symptoms
Danish: • Detaljeret information om risikoen for hæmatologiske sygdomme (navnlig anæmi), der er forbundet med Victrelis.
English: Do not take Victrelis if any of the above apply to you.
Danish: Tag ikke Victrelis, hvis du kan sige ja til noget af ovenstående.
English: No dose adjustment of dabigatran is recommended.
Danish: Dosisjustering af dabigatran er ikke nødvendig.
English: The most common reason for dose reduction was anaemia, which occurred more frequently in subjects receiving the combination of Victrelis with peginterferon alfa-2b and ribavirin than in subjects receiving peginterferon alfa-2b and ribavirin alone.
Danish: Den mest almindelige årsag til dosisreduktion var anæmi, der forekom hyppigere hos forsøgspersoner, som fik kombinationen af Victrelis med peginterferon alfa-2b og ribavirin end hos forsøgspersoner, der fik peginterferon alfa-2b og ribavirin alene.
English: *, End of Treatment (EOT) and Relapse
Danish: *, afslutning af behandling (EOT) og tilbagefaldsrater
English: The data available (see section 5.3) warrant caution in patients at risk of QT prolongation (long
Danish: 5.3) berettiger til at udvise forsigtighed hos patienter med risiko for QTforlængelse (medfødt langt QT, hypokaliæmi).
English: Platelet counts were decreased for subjects in the Victrelis containing-arms (3%) compared to subjects receiving peginterferon alfa-2b and ribavirin alone (1%).
Danish: Trombocyttallene var nedsat for forsøgspersoner i de Victrelis-indeholdende arme (3 %) sammenlignet med forsøgspersoner, der kun fik peginterferon alfa-2b og ribavirin (1 %).
English: • Victrelis is always taken in combination with peginterferon alfa and ribavirin.
Danish: • Victrelis skal altid tages i kombination med peginterferon alfa og ribavirin.
English: • The Physician Educational Materials (PEM)
Danish: • Uddannelsesmateriale til lægen
English: Exposure of escitalopram was slightly decreased when co-administered with Victrelis.
Danish: Eksponeringen af escitalopram var let nedsat ved administration sammen med Victrelis.
English: In subjects who demonstrated interferon responsiveness by TW 4, treatment with the combination of Victrelis with peginterferon alfa-2b and ribavirin resulted in SVR rates of 79-81%, compared to 51% in subjects treated with standard of care.
Danish: Hos forsøgspersoner, som udviste interferonfølsomhed i behandlingsuge 4 resulterede behandling med kombinationen af Victrelis og peginterferon alfa-2b og ribavirin i en SVR-rate på 7981 % sammenlignet med 51 % hos forsøgspersoner, der fik standardbehandling.
English: Table 5 Sustained Virologic Response (SVR), End of Treatment (EOT), and Relapse in previously untreated patients (early and late responders)
Danish: Vedvarende virologisk respons (SVR), behandlingsafslutning (EOT) og tilbagefald hos ikke tidligere behandlede patienter (tidlige og sene respondenter)
English: If the patient has HCV-RNA results greater than or equal to 100 IU/mL at TW 12; then discontinue
Danish: Hvis patientens hcv-RNA-koncentration er større end eller lig med 100 IE/ml i behandlingsuge 12, afsluttes tre-stofbehandlingen.
English: ethinyl estradiol AUC ↓ 24% ethinyl estradiol Cmax ↔
Danish: ethinylestradiol AUC ↓ 26 % ethinylestradiol Cmaks.
English: Sustained Virologic Response (SVR) in patients receiving similar therapy up to treatment week 28
Danish: Vedvarende virologisk respons (SVR) hos patienter, der fik samme behandling indtil behandlingsuge
English: Very common (may affect more than 1 in 10 people) General: headache; chills, fever; feeling sick (nausea); flu-like symptoms; feeling dizzy, low energy; not being able to sleep; low appetite, weight loss; shortness of breath Mouth, nose or throat: cough; dry mouth; funny taste Skin and hair: dry skin, itching, rash; hair loss or thinning of hair Joints and muscles: unusual weakness; painful, swollen joints; muscle ache not caused by exercise
Danish: Meget almindelig (kan berøre flere end 1 ud af 10) Generelt: hovedpine; kuldegysninger, feber; kvalme; influenzalignende symptomer; svimmelhed, manglende energi; søvnproblemer; nedsat appetit, vægttab; åndenød Mund, næse eller svælg: hoste; mundtørhed; ubehagelig og mærkelig smag i munden Hud og hår: tør hud, kløe, udslæt; hårtab eller fældning Led og muskler: usædvanlig svækkelse; smertefulde, hævede led; ømme muskler, der ikke
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Danish: Brug af anden medicin sammen med Victrelis Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Exposure to atorvastatin was increased when administered with Victrelis.
Danish: Eksponeringen af atorvastatin øgedes ved administration sammen med Victrelis.
English: HIV Nucleoside Reverse Transcriptase Inhibitor (NRTI)
Danish: Hiv-nukleosid revers transkriptase-hæmmere (NRTI)
English: The addition of Victrelis to peginterferon alfa-2b and ribavirin significantly increased the SVR rates compared to peginterferon alfa-2b and ribavirin alone in the combined cohort (63% to 66% Victreliscontaining arms vs. 38% PR48 control) for randomized subjects who received at least one dose of any study medicine (Full-Analysis-Set population) and decreased the length of therapy to 28 weeks for early responders (see Table 4).
Danish: Tilføjelse af Victrelis til peginterferon alfa-2b og ribavirin øgede SVR signifikant sammenlignet med peginterferon alfa-2b og ribavirin alene i den samlede kohorte (63 % til 66 % i Victrelis-indeholdende arme vs. 38 % i PR48-kontrol) for randomiserede forsøgspersoner, der fik mindst én dosis studiemedicin (Full Analysis Set population) og reducerede behandlingstiden til 28 uger for tidlige respondenter (se tabel 4).
English: The addition of boceprevir to peginterferon alfa-2b and ribavirin resulted in higher incidences of neutropenia and Grade 3-4 neutropenia compared with peginterferon alfa-2b and ribavirin alone (see section 4.8).
Danish: Tilføjelsen af boceprevir til peginterferon alfa-2b og ribavirin resulterede i højere forekomster af neutropeni og grad 3-4 neutropeni sammenlignet med peginterferon alfa-2b og ribavirin alene (se
English: atorvastatin AUC ↑ 130% atorvastatin Cmax ↑ 166%
Danish: atorvastatin AUC ↑ 130 % atorvastatin Cmaks.
English: The addition of Victrelis to the peginterferon alfa-2b and ribavirin therapy significantly increased the SVR rates compared to peginterferon alfa-2b and ribavirin therapy alone (59% to 66% Victreliscontaining arms vs. 21% PR48 control) for randomized subjects who received at least one dose of any study medicine (Full-Analysis-Set population) and decreased the length of therapy to 36 weeks for many previous treatment failures (see Table 7).
Danish: Tilføjelse af Victrelis til peginterferon alfa-2b og ribavirin øgede SVR signifikant sammenlignet med peginterferon alfa-2b og ribavirin alene (59 % til 66 % i Victrelis-indeholdende arme vs. 21 % i PR48-kontrol) hos randomiserede forsøgspersoner, der fik mindst én dosis studiemedicin (Full Analysis Set population) og reducerede behandlingstiden til 36 uger for mange tidligere svigtede behandlinger (se tabel 7).
English: Refer to Summary of Product Characteristics for ribavirin and peginterferon alfa for additional information.
Danish: Se produktresumeet for ribavirin og peginterferon alfa for yderligere information.
English: (CYP3A inhibition - effect on
Danish: (CYP3A-hæmning - indvirkning
English: Tachycardia*, arrhythmia, cardiovascular disorder
Danish: Takykardi*, arytmi, kardiovaskulær sygdom
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Thyroid neoplasm (nodules)
Danish: cyster og polypper) Thyroidea neoplasi (noduli)
English: The distribution of subjects by genders was 37% men and 63% women.
Danish: Kønsfordelingen var 37 % mænd og 63 % kvinder.
English: Lopinavir/Ritonavir* (lopinavir 400 mg / ritonavir 100 mg two times daily + Victrelis 800 mg three times daily)
Danish: Darunavir/Ritonavir* (darunavir 600 mg / ritonavir 100 mg to gange dagligt + Victrelis 800 mg tre gange dagligt)
English: Hypokalaemia*¸ appetite disorder, diabetes mellitus, gout, hypercalcaemia
Danish: Hypokaliæmi*, manglende appetit, diabetes mellitus, podagra, hyperkalcæmi
English: The addition of Victrelis to peginterferon alfa-2b and ribavirin was associated to higher incidences of increase in uric acid, triglycerides and cholesterol total compared to peginterferon alfa-2b and
Danish: Tilføjelse af Victrelis til peginterferon alfa-2b og ribavirin var forbundet med højere forekomster af stigning i urat, triglycerider og kolesterol sammenlignet med peginterferon alfa-2b og ribavirin alene.
English: SVR rates with "missing=failure" approach were nearly identical to those in the table: 37% for Control, 62% for
Danish: SVRraterne (med "manglende=svigt"-metoden) var næsten identiske med værdierne i tabellen: 37 % for Kontrol; 62 % for Victrelis-RGT, 65 % for Victrelis-PR48.
English: o Subjects with undetectable HCV-RNA at TW 8 (early responders) and who also had undetectable HCV-RNA through TW 24 discontinued therapy and entered o Subjects with detectable HCV-RNA at TW 8 or any subsequent treatment week but subsequently undetectable at TW 24 (late responders) were changed in a blinded fashion to placebo at the TW 28 visit and continued therapy with peginterferon alfa-2b + ribavirin for an additional 20 weeks, for a total treatment
Danish: Behandlingen i denne behandlingsarm var begrænset til 24 ugers behandling med o Hos forsøgspersoner med ikke-detekterbart hcv-RNA i behandlingsuge 8 (tidlige respondenter), som også var negative til og med behandlingsuge 24, seponeredes behandlingen, og de indgik i opfølgningen ved kontrolbesøget i behandlingsuge o Forsøgspersoner med detekterbart hcv-RNA i behandlingsuge 8 eller anden efterfølgende behandlingsuge, men som efterfølgende var negative i behandlingsuge 24 (sene respondenter), blev under blinding skiftet til placebo ved kontrolbesøget i behandlingsuge 28 og fortsatte behandlingen med peginterferon alfa-2b + ribavirin i yderligere 20 uger til en samlet behandlingsvarighed på 48
English: Skin and hair: cold sores, tingling or numbness of the skin; reduced feeling or sense of touch; skin rash, patchy skin rash, red skin; red raised skin rash sometimes with pus-filled blisters; hot, tender and red skin, sometimes with fever and chills; increased sweating; skin disease with thick patches of red skin - often with silvery scales Joints and muscles: muscle spasm; feeling tired, muscle weakness, feeling cold; back pain,
Danish: Hud og hår: forkølelsessår, prikken eller sovende fornemmelse i huden; nedsættelse af berørings- eller følesans; hududslæt, plettet hududslæt, rød hud; rødt, hævet hududslæt, nogle gange med pusfyldte blærer; varm, øm og rød hud, nogle gange med feber og kuldegysninger; øget svedtendens; hudsygdom med store pletter af rød hud - ofte med sølvagtige skæl Led og muskler: muskelspasmer; træthedsfølelse, muskelsvækkelse, kuldefølelse; rygsmerter, nakkesmerter, smerter i arme eller ben
English: The race distribution of subjects was as follows: 84% white, 13% Black, 2% Asian, and 1% others.
Danish: Racefordelingen hos forsøgspersonerne var som følger: 84 % hvide, 13 % sorte, 2 % asiatere og 1 % andre.
English: 5.3 Preclinical safety data
Danish: Opsummering af sikkerhedsprofilen
English: Victrelis was associated with an additional decrease of approximately 1 g/dL in haemoglobin concentration (see section 4.4).
Danish: Victrelis blev forbundet med et øget fald i hæmoglobinkoncentration på 0,6 mmol/l (se pkt.
English: A secondary analysis of subjects who received at least one dose of Victrelis or placebo after the four week lead-in with peginterferon alfa-2b and ribavirin (Modified-Intent-to-Treat population) demonstrated SVR rates of 61% to 67% in the Victreliscontaining arms compared to 22% PR48 control.
Danish: En sekundær analyse af forsøgspersoner, som fik mindst én dosis Victrelis eller placebo efter fire ugers lead-in med peginterferon alfa-2b og ribavirin (Modified-Intent-to-Treat population), viste SVR-rater på 61 % til 67 % i Victrelis-indeholdende arme sammenlignet med 22 %
English: Among the 314 subjects, 230 were infected with genotype 1a HCV and 84 were infected with genotype 1b HCV. Seventy percent (70%) (162/230) of genotype 1a subjects no longer had any RAVs detected at the boceprevir-resistance associated loci by population sequencing.
Danish: Af de 314 forsøgspersoner var 230 inficeret med genotype 1a-hcv, og 84 var inficeret med genotype 1b-hcv.
English: Aggression*, homicidal ideation*, panic attack*, paranoia*, substance abuse*, suicidal ideation*, abnormal behaviour, anger, apathy, confusional state, mental status changes, restlessness Bipolar disorder*, completed suicide*, suicide attempt*, hallucination auditory, hallucination visual, psychiatric
Danish: Aggression*, mordtanker*, panikanfald*, paranoia*, stofmisbrug*, selvmordstanker*, unormal adfærd, vrede, apati, forvirringstilstand, ændring i mentaltilstand,
English: Table 8 Sustained Virologic Response (SVR), End of Treatment (EOT) and Relapse in patients who had failed previous therapy (early and late responders)
Danish: Vedvarende virologisk respons (SVR), behandlingsafslutning (EOT) og tilbagefald hos patienter, hvor tidligere behandling har svigtet (tidlige og sene respondenter)
English: A secondary analysis of subjects who received at least one dose of Victrelis or placebo after the four-week lead-in with peginterferon alfa-2b and ribavirin (ModifiedIntent-to-Treat population) demonstrated SVR rates in the combined cohort of 67% to 68% Victreliscontaining arms vs. 40% PR48 control.
Danish: En sekundær analyse af forsøgspersoner, som fik mindst én dosis Victrelis eller placebo efter fire ugers lead-in med peginterferon alfa-2b og ribavirin (Modified-Intent-to-Treat population), viste SVR-rater i den samlede kohorte på 67 % til 68 % i Victrelis-indeholdende arme vs. 40 % for PR48-kontrol.
English: Administer peginterferon alfa and ribavirin and finish through TW 48.
Danish: Giv peginterferon alfa og ribavirin uden Victrelis, og afslut i løbet af behandlingsuge 48.
English: The number of subjects with cirrhosis is limited (where 40 subjects were treated with Victrelis of the
Danish: Antallet af forsøgspersoner med cirrose er begrænset (hvor 40 ud af de 53 forsøgspersoner blev
English: **** Partial Responder: subject who failed to achieve SVR after at least 12 weeks of previous treatment with peginterferon alfa-2b and ribavirin, but demonstrated a ≥ 2 log10 reduction in HCVRNA by Week 12 and had detectable HCV-RNA at End of Treatment (EOT).
Danish: **** Delvis respons: forsøgsperson, som ikke opnåede SVR efter mindst 12 ugers tidligere behandling med peginterferon alfa-2b og ribavirin, men som viste et fald på ≥ 2 log10 i hcv-RNA i uge 12 og havde detekterbart hcv-RNA ved afslutningen af behandlingen (EOT).
English: No dose adjustment of Victrelis is required in patients with any degree of renal impairment (see
Danish: Nedsat nyrefunktion Det er ikke nødvendigt at justere dosis af Victrelis hos patienter med nedsat nyrefunktion (se pkt.
English: The median times for the most relevant boceprevir-resistant variants observed in genotype 1b patients (> 10%) to become undetectable were as follows: I/V170A, 0.46 years; T54A, 0.47 years; V55A, 0.83 years; A156S, 0.89 years; and T54S, 1.11 years.
Danish: Mediantiden, før alle RAVer blev ikke-detekterbare, var 1,04 år for genotype 1b. Mediantiderne, før de mest relevante boceprevir-resistente varianter set hos genotype 1b-patienter (>10 %) blev ikkedetekterbare, var følgende: I/V170A: 0,46 år; T54A: 0,47 år; V55A: 0,83 år; A156S: 0,89 år; og T54S: 1,11 år.
English: The race distribution of subjects was as follows: 82% White, 18% Non-White, 14% Black, 3% Asian, and 1% Multiracial.
Danish: Racefordelingen blandt forsøgspersonerne var: 82 % hvide, 18 % ikke-hvide, 14 % sorte, 3 % asiater, 1 % af blandet race.
English: The safety and efficacy of Victrelis alone or in combination with peginterferon alfa and ribavirin for the treatment of chronic hepatitis C genotype 1 infection has not been studied in patients who have failed previous therapy with Victrelis or other HCV protease inhibitors.
Danish: Victrelis' sikkerhed og virkning alene eller i kombination med peginterferon alfa og ribavirin til behandling af kronisk hepatitis C genotype 1 er ikke undersøgt hos patienter, som tidligere har oplevet svigt af behandling med Victrelis eller andre hcv-proteasehæmmere.
English: %, (n/N) 69 (72/105) 75 (77/103) EOT % (n/N) 79 (83/105) 86 (89/103)
Danish: EOT % (n/N) 43 (22/51) 86 (89/103) 43 (22/51)
English: Gastroenteritis*, pneumonia*, staphylococcal infection*, candidiasis, ear infection, fungal skin infection, nasopharyngitis, onychomycosis, pharyngitis, respiratory tract infection, rhinitis, skin infection, urinary tract
Danish: Gastroenteritis*, pneumoni*, stafylokokinfektion*, candidiasis, øreinfektion, svampeinfektion i huden, nasofaryngitis, onykomykosis, faryngitis, luftvejsinfektion, rhinitis, hudinfektion, urinvejsinfektion Epiglottitis*, otitis media, sepsis
English: Patients who have failed previous therapy: previous partial responders and relapsers to interferon and
Danish: Patienter, hvor tidligere behandling har svigtet: null-responders, patienter med tidligere delvis respons og patienter med tilbagefald på behandling med interferon og ribavirin
English: The race distribution of subjects was as follows: 82% White, 14% Black, 2% Asian, 1% multiracial, 1% American Indian or Alaskan Native.
Danish: Racefordelingen blandt forsøgspersonerne var således: 82 % hvide, 14 % sorte, 2 % asiater, 1 % multirace, 1 % indianere eller indfødte fra Alaska.
English: Victrelis inhibits the direct replication of the virus and contributes in this way to lowering the amount
Danish: Victrelis virker hæmmende på den direkte virusformering og medvirker således til at nedsætte mængden af hepatitis C-vira i din krop.
English: Continue with all three medicines (peginterferon alfa and ribavirin [PR] + Victrelis) and finish through Treatment Week 28 (TW 28).
Danish: Giv herefter Victrelis i tillæg til peginterferon alfa og ribavirin (PR), fortsæt med alle tre lægemidler indtil afslutningen af behandlingen i løbet af behandlingsuge 28.
English: Victrelis must not be administered in the absence of peginterferon alfa and ribavirin.
Danish: Victrelis må ikke anvendes uden peginterferon alfa og ribavirin.
English: The Summary of Product Characteristics of peginterferon alfa and ribavirin (PR) must be consulted prior to initiation of
Danish: Se produktresume for peginterferon alfa og ribavirin (PR) inden behandling med Victrelis påbegyndes.
English: • difficulty breathing or swallowing, wheezing, hives, itching, swelling of your face, eyes, lips,
Danish: • problemer med at trække vejret eller synke, hvæsende vejrtrækning, nældefeber, kløe, hævelse af ansigt, øjne, læber, tunge eller svælg - dette er tegn på en allergisk reaktion.
English: The safety and efficacy of Victrelis alone or in combination with peginterferon alfa and ribavirin for the treatment of chronic hepatitis C genotypes other than genotype 1 have not been established.
Danish: Victrelis' sikkerhed og virkning alene eller i kombination med peginterferon alfa og ribavirin til behandling af kronisk hepatitis C-genotyper ud over genotype 1 er ikke klarlagt.
English: General: shaking; fainting; difficulty breathing; feeling thirsty; trouble sleeping; throbbing headache; generally feeling unwell; feeling like you are spinning Eyes or ears: dry eyes; ringing in the ears; changes in your vision Mouth, nose or throat: mouth pain, tooth ache; pain when swallowing; nose bleed, stuffy nose; a change in how things smell; sore and raised patches in the mouth; feeling very thirsty with a dry mouth or dry skin; swelling of the thyroid gland, neck or voicebox; underactive thyroid gland; sores or swelling in the mouth, burning feeling on the tongue; feeling of tension or fullness in the nose, cheeks and behind the eyes - sometimes with a throbbing ache, fever or
Danish: Generelt: rysten; besvimelse; vejrtrækningsbesvær; tørstfølelse; søvnbesvær; dunkende hovedpine; generel utilpashed; følelse af, alt snurrer rundt Øjne eller ører: tørre øjne; ringen for ørene; ændring af dit syn Mund, næse eller svælg: smerter i munden, tandpine; synkesmerter; næseblod, tilstoppet næse; en ændring i hvordan tingene lugter; ømme og hævede pletter i munden; stor tørstfølelse og tør mund eller tør hud; hævet skjoldbruskkirtel, hals eller strubehoved; lav aktivitet af skjoldbruskkirtlen; sår eller hævelse i munden, brændende fornemmelse på tungen; følelse af spænding i næsen, kinderne eller bag øjnene - nogle gange med en dunkende smerte, feber eller
English: Table 11 Sustained Virologic Response (SVR) * and Relapse
Danish: Vedvarende virologisk respons (SVR)* og tilbagefaldsrater
English: Subjects were on an antiretroviral regimen with stable HIV disease (HIV-1 viral load < 50 copies/mL and CD4 count ≥ 200 cells/µL).
Danish: Forsøgspersonerne blev behandlet med PR i 4 uger efterfulgt af 44 uger med Victrelis eller placebo og PR. Forsøgspersonerne blev behandlet med et antiretroviralt regimen og havde stabil hiv-sygdom (hiv-1 viral load < 50 kopier/ml og CD4-tal ≥ 200 celler/µl).
English: Victrelis must be administered in combination with peginterferon alfa and ribavirin.
Danish: Victrelis skal tages i kombination med peginterferon alfa og ribavirin.
English: Dose adjustments of cyclosporine should be anticipated when administered with Victrelis and should be guided by close monitoring of cyclosporine blood concentrations, and frequent assessments of renal function and cyclosporine-related side effects.
Danish: Den skal foretages under tæt monitorering af ciclosporin blod-koncentrationen og hyppig vurdering af nyrefunktion og ciclosporin-relaterede bivirkninger.
English: The distribution of subjects by gender was 67% men and 33% women.
Danish: Kønsfordelingen af forsøgspersoner var 67 % mænd og 33 % kvinder.