natgillin/translations-raw huggingface dataset:
• Lav sygdomsaktivitet og remission (SDAI) 
• Low disease activity and remission (SDAI)
På baggrunds-cDMARDs5 
On background cDMARDs5
Sjældne tilfælde af lymfoproliferative tilstande er blevet rapporteret. 
Rare cases of lymphoproliferative disorders have been reported.
Der er utilstrækkelige data fra anvendelse af baricitinib til gravide kvinder. 
There are no adequate data from the use of baricitinib in pregnant women.
Hyppigheden af alvorlige infektioner med Olumiant (1,1 %) svarede til placebo (1,2 %). 
The rate of serious infections with Olumiant (1.1 %) was similar to placebo (1.2 %).
Behandling med Olumiant må ikke genoptages, før infektionen er gået over. 
Olumiant treatment should not be resumed until the infection resolves.
• Tag ikke Olumiant, hvis du er gravid eller har mistanke om, at du kan være gravid: 
• Do not take Olumiant if you are pregnant or suspect you may be pregnant.
De fleste infektioner var lette til moderate i sværhedsgrad. 
Most infections were mild to moderate in severity.
Herpes zoster blev rapporteret hyppigere hos patienter ≥ 65 år, som tidligere har været i behandling med både biologiske og konventionelle DMARDs. 
Herpes zoster was reported more commonly in patients ≥ 65 years of age who had previously been treated with both biologic and conventional DMARDs.
Enkeltdoser på op til 40 mg og flere doser på op til 20 mg daglig i 10 dage er blevet administreret i kliniske studier uden dosisbegrænsende toksicitet. 
Single doses up to 40 mg and multiple doses of up to 20 mg daily for 10 days have been administered in clinical trials without dose-limiting toxicity.
• cellulose, mikrokrystallinsk 
• cellulose, microcrystalline
Der blev observeret stabile responsrater, og ACR20-/50-/70-responserne blev opretholdt i mindst 2 år, herunder i det længerevarende forlængelsesstudie. 
Continued, durable response rates were observed, with ACR20/50/70 responses maintained for at least 2 years including the long-term extension study.
I alt 3.464 patienter blev behandlet med Olumiant i kliniske studier vedrørende reumatoid artritis, og det repræsenterede 4.214 patientårs eksponering. 
A total of 3,464 patients were treated with Olumiant in clinical studies in rheumatoid arthritis representing 4214 patient-years of exposure.
Det gennemsnitlige fordelingsvolumen efter intravenøs infusion var 76 l, hvilket indikerer fordeling af baricitinib ind i væv. 
Mean volume of distribution following intravenous infusion administration was 76 L, indicating distribution of baricitinib into tissues.
• At det kan være nødvendigt, at patienten får kontrolleret kolesteroltallet under behandlingen. 
• That the patient may need to have their cholesterol level checked during treatment
Bivirkningerne var sammenlignelige med de bivirkninger, der blev set ved lavere doser, og der blev ikke identificeret nogen specifikke toksiske virkninger. 
Adverse events were comparable to those seen at lower doses and no specific toxicities were identified.
Der blev observeret højere remissionsrater sammenlignet med placebo så tidligt som i uge 4. 
Greater rates of remission compared to placebo were observed as early as week 4.
Behandling med Olumiant 4 mg resulterede i en statistisk signifikant hæmning af progression af strukturel ledskade (tabel 5). 
Treatment with Olumiant 4 mg resulted in a statistically significant inhibition of progression of structural joint damage (Table 5).
Hovedformålet med programmet er at gøre de ordinerende læger opmærksomme på de risici, der er forbundet med anvendelse af præparatet, og at fremhæve bestemte risikominimeringsforanstaltninger, der skal opfyldes før og under behandlingen med Olumiant. 
The main objectives of the programme are to make the prescribers aware of the risks associated with the product's use, and to highlight specific risk minimisation measures to be performed before and during the treatment with Olumiant.
QR-kode skal indsættes + www.olumiant.eu 
QR code to be included+ www.olumiant.eu
• Olumiant øger den potentielle risiko for infektioner. 
• That Olumiant increases the potential risk of infections.
Olumiant er kontraindiceret under graviditet (se pkt. 
Olumiant is contraindicated during pregnancy (see section 4.3).
De kliniske data er ikke tilstrækkelige til at vurdere den potentielle incidens af maligniteter efter eksponering for baricitinib. 
The clinical data are insufficient to assess the potential incidence of malignancies following exposure to baricitinib.
Infektioner rapporteret i forbindelse med behandling med Olumiant omfattede også herpes zoster. 
Infections reported with Olumiant treatment included Herpes zoster.
RA-BUILD cDMARD-IR patienter 
RA-BUILD cDMARD-IR patients
• At patienten til enhver tid skal have patientkortet med sig, og at patienten skal vise det til andre sundhedspersoner, der er involveret i hans/hendes behandling. 
• That the Patient Alert Card should be carried by the patient at any time and to share it with other healthcare professionals involved in their treatment.
Baricitinib er en selektiv og reversibel hæmmer af Janus-kinase (JAK) 1 og JAK2. 
Baricitinib is a selective and reversible inhibitor of Janus kinase (JAK)1 and JAK2.
Fra 1. juli 2019 var der efter markedsføring rapporteret om 114 VTE' i 102 tilfælde. 
As of 01 July 2019, 114 VTEs have been reported in 102 cases from post-marketing reports.
Opportunistiske infektioner relateret til demodicose (skab) blev observeret hos hunde ved eksponeringer på ca. 7 gange eksponeringen hos mennesker. 
Opportunistic infections related to demodicosis (mange) were observed in dogs at exposures approximately 7 times the human exposure.
Immunmodulerende lægemidler kan øge risikoen for maligniteter, herunder lymfom. 
Immunomodulatory medicinal products may increase the risk of malignancies including lymphoma.
Desuden bekræfter observationer i september 2018 af tilbagevendende DVT og efterfølgende PE hos patienter, som fortsatte behandling med baricitinib efter første DVT, også at der er en mulig sammenhæng mellem brug af baricitinib og forekomsten af VTE. 
Moreover, recurrent DVT and subsequent PE observed September 2018 in patient who continued treatment with baricitinib after the first DVT also confirm possible relationship between use of baricitinib and occurrence of VTE.
Dyrestudier indikerer, at baricitinib kan have en skadelig virkning på knogleudviklingen in utero ved højere doser. 
Animal studies indicate that baricitinib may have an adverse effect on bone development in utero at higher dosages.
Ud af de 316 bivirkninger, der indgik i review fra post-marketing rapporter, var udslæt (n=95) den hyppigst rapporterede bivirkning. 
From the 316 events included for review from post-marketing reports, rash (n=95) was the most frequently reported event.
Størstedelen af de patienter, der mistede deres status med lav sygdomsaktivitet eller remission efter dosisreduktion, kunne genvinde sygdomskontrol, efter at dosis igen var sat op til 4 mg. 
The majority of patients who lost their low disease activity or remission status after dose reduction could regain disease control after the dose was returned to 4 mg.
Patienter, der fik seponeret behandlingen eller fik nødbehandling, blev herefter anset for at være ikke-responderende. 
Patients who discontinued or received rescue therapy were considered as non-responders thereafter.
En risiko hos nyfødte/spædbørn kan ikke udelukkes, og Olumiant bør ikke anvendes under amning. 
A risk to newborns/infants cannot be excluded and Olumiant should not be used during breast-feeding.
For Olumiant var de hyppigste alvorlige infektioner herpes zoster og cellulitis. 
For Olumiant, the most common serious infections were herpes zoster, and cellulitis.
• et smertefuldt hududslæt med blærer. 
• A painful skin rash with blisters.
Du og lægen skal sammen afgøre, om du skal amme eller tage Olumiant. 
You and your doctor should decide if you will breast-feed or use Olumiant.
Hæmning af IL-6-induceret fosforylering af STAT3 
Inhibition of IL-6 induced STAT3 phosphorylation
Patienter med hepatitis B-overflade-antistof og hepatitis B-kerne-antistof, men uden hepatitis B-overflade-antigen kunne også deltage; sådanne patienter bør monitoreres for ekspression af hepatitis B-virus (HBV)-DNA. 
Patients with hepatitis B surface antibody and hepatitis B core antibody, without hepatitis B surface antigen, were also allowed to participate; such patients should be monitored for expression of hepatitis B virus (HBV) DNA.
Der blev ikke observeret nogen føtale virkninger ved eksponeringer på 2 gange eksponeringen hos mennesker baseret på AUC. 
No adverse foetal effects were observed at exposures 2 times the human exposure based on AUC.
Forkortelser: QD = én gang daglig, Q2W = én gang hver anden uge, s.c. = subkutant, ACR = American College of Rheumatology, SDAI = Simplified Disease Activity Index, HAQ-DI = Health Assessment Questionnaire-Disability Index, mTSS = modified Total Sharp Score. 
Abbreviations: QD = Once daily; Q2W = Once every 2 weeks; SC = Subcutaneously; ACR = American College of Rheumatology; SDAI = Simplified Disease Activity Index; HAQ-DI = Health Assessment Questionnaire-Disability Index; mTSS = modified Total Sharp Score
I alle studier rapporterede de patienter, der blev behandlet med Olumiant, forbedringer i patientrapporteret livskvalitet målt ved Short Form (36) Health Survey (SF-36) Physical Component Score og træthed målt ved Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale. 
In all studies, Olumiant-treated patients reported improvements in patient-reported quality of life, as measured by the Short Form (36) Health Survey (SF-36) Physical Component Score and fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F).
Derfor kan estimater for den glomerulære filtrationshastighed baseret på serum-kreatinin være lettere reducerede uden en reel forringelse af nyrefunktionen eller forekomst af negative renale virkninger. 
Consequently, estimates of the glomerular filtration rate based on serum creatinine may be slightly reduced, without actual loss of renal function or the occurrence of renal adverse events.
Før behandling med Olumiant påbegyndes, anbefales det, at patienterne bringes a jour med al immunisering i overensstemmelse med gældende retningslinjer for immunisering. 
Prior to initiating Olumiant, it is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines.
Fortæl straks lægen, hvis du får symptomer på en infektion, f.eks.: 
Inform your doctor immediately if you get symptoms of infection, such as:
Dette kan være et tegn på herpes zosterinfektion. 
This could be a sign of a herpes zoster infection.
Baricitinib kan være en klinisk relevant hæmmer af OCT1, men der er på nuværende tidspunkt ingen kendte selektive OCT1-substrater, for hvilke klinisk signifikante interaktioner kan forudsiges. 
Baricitinib may be a clinically relevant inhibitor of OCT1, however there are currently no known selective OCT1 substrates for which clinically significant interactions might be predicted.
Efter oral administration af baricitinib blev der observeret en dosisproportional stigning i den systemiske eksponering i det terapeutiske dosisinterval. 
Following oral administration of baricitinib, a dose-proportional increase in systemic exposure was observed in the therapeutic dose range.
Hos hunrotter var der et nedsat antal corpora lutea og implantationssteder, et øget præ-implantationstab og/eller negative virkninger på embryoernes intrauterine overlevelse. 
In female rats there were decreased numbers of corpora lutea and implantation sites, increased pre-implantation loss, and/or adverse effects on intrauterine survival of the embryos.
• hoste, der ikke vil gå over, nattesved og vægttab. 
• A cough that won't go away, night sweats, and weight loss.
Patienter med dokumenteret aktiv hepatitis B- eller C-infektion blev ekskluderet fra kliniske studier. 
Patients with evidence of active hepatitis B or C infection were excluded from clinical trials.
Baricitinibs potentiale til at påvirke farmakokinetikken af andre lægemidler 
Potential for baricitinib to affect the pharmacokinetics of other medicinal products
Disse virkninger kan medføre, at det bliver lettere at udføre normale dagligdags aktiviteter og kan derved forbedre den helbredsrelaterede livskvalitet hos patienter med leddegigt. 
These effects can help you to do normal daily activities and so improve the health-related quality of life for patients with rheumatoid arthritis.
Baricitinib modulerer disse signalveje ved delvist at hæmme den enzymatiske aktivitet af JAK1 og JAK2 og dermed reducere fosforyleringen og aktiveringen af STATs. 
Baricitinib modulates these signalling pathways by partially inhibiting JAK1 and JAK2 enzymatic activity, thereby reducing the phosphorylation and activation of STATs.
I et klinisk farmakologisk studie blev ca. 75 % af den administrerede dosis udskilt i urinen, mens ca. 20 % af dosis blev udskilt i fæces. 
In a clinical pharmacology study, approximately 75 % of the administered dose was eliminated in the urine, while about 20 % of the dose was eliminated in the faeces.
• Brug sikker prævention, mens du tager Olumiant (og i mindst 1 uge efter, hvis du har stoppet behandlingen). 
• Use effective contraception while taking Olumiant (and for 1 week after, if you stop treatment).
Ved at nedsætte aktiviteten af dette enzym hjælper Olumiant med at mindske smerter, stivhed og hævelse i og omkring leddene samt træthed og hjælper med at bremse skader på knogler og brusk i leddene. 
By reducing the activity of this enzyme, Olumiant helps to reduce pain, stiffness and swelling in your joints, tiredness, and helps to slow damage to the bone and cartilage in the joints.
Monitoreringsvejledning 
Monitoring Guidance
Kombination med biologiske DMARDs eller andre Janus-kinase (JAK)-hæmmere anbefales ikke, da en risiko for additiv immunsuppression ikke kan udelukkes. 
Combination with biologic DMARDs or other Janus kinase (JAK) inhibitors is not recommended, as a risk of additive immunosuppression cannot be excluded.
Olumiant virker ved at nedsætte aktiviteten af et enzym i kroppen, der kaldes ‘Janus-kinase', som er forbundet med inflammation. 
Olumiant works by reducing the activity of an enzyme in the body called ‘Janus kinase', which is involved in inflammation.
Absolut neutrofiltal (ANC) 
Absolute Neutrophil Count (ANC)
Patienter, der udvikler bivirkninger, skal have relevant behandling. 
Patients who develop adverse reactions should receive appropriate treatment.
Du skal fortælle det til lægen, hvis du bliver gravid, da Olumiant ikke må anvendes under graviditet. 
You must tell your doctor if you become pregnant as Olumiant should not be used during pregnancy.
Behandlingen bør afbrydes midlertidigt, hvis der er mistanke om lægemiddelinduceret leverskade. 
Treatment should be temporarily interrupted if drug-induced liver injury is suspected
• titandioxid (E 171) 
• titanium dioxide (E171)
• At Olumiant ikke må anvendes under graviditet, og at kvinder skal fortælle deres læge, hvis de bliver (eller planlægger at blive) gravide. 
• That Olumiant should not be taken while pregnant and that women should inform their doctor should they become (or wish to become) pregnant
BEACON (24 uger) 
BEACON (24 weeks)
Fald i parametre for røde blodceller blev observeret hos mus, rotter og hunde ved eksponeringer på ca. 6-36 gange eksponeringen hos mennesker. 
Decreases in red blood cell parameters were observed in mice, rats and dogs at exposures approximately 6 to 36 times the human exposure.
Den anbefalede dosis er 2 mg én gang daglig hos patienter med kreatininclearance 30-60 ml/min. 
The recommended dose is 2 mg once daily in patients with creatinine clearance between 30 and 60 mL/min.
b Sammensat term (eczema herpeticum, herpes simplex, oftalmisk herpes simplex, oral herpes). 
b Combined term (eczema herpeticum, herpes simplex, ophthalmic herpes simplex, oral herpes).
Du må ikke stoppe med at tage Olumiant, medmindre lægen fortæller dig, at du skal stoppe med at tage det. 
If you stop taking Olumiant Do not stop taking Olumiant unless your doctor tells you to stop taking it.
I den intracellulære signalvej fosforylerer og aktiverer JAKs signaltransduktorer og aktivatorer af transskription (STATs), hvilket aktiverer genekspression inde i cellen. 
Within the intracellular signalling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs), which activate gene expression within the cell.
Risiciene og fordelene ved Olumiant-behandling skal nøje overvejes forud for indledning af behandling hos patienter med aktive, kroniske eller tilbagevendende infektioner (se pkt. 
The risks and benefits of treatment with Olumiant should be carefully considered prior to initiating therapy in patients with active, chronic or recurrent infections (see section 4.2).
Da der ikke var nogen indvirkning på spermatogenesen (vurderet ved histopatologi) eller sæd/sperma-endepunkter hos hanrotter, var den nedsatte samlede parringsevne sandsynligvis et resultat af virkningerne på hunrotter. 
Since there were no effects on spermatogenesis (as assessed by histopathology) or semen/sperm endpoints in male rats, the decreased overall mating performance was likely the result of these female effects.
Immunsupprimerende lægemidler 
Immunosuppressive medicinal products
Hvis der opstår en alvorlig allergisk eller anafylaktisk reaktion, skal behandling med baricitinib straks seponeres. 
If any serious allergic or anaphylactic reaction occurs, baricitinib should be discontinued immediately.
Janus-kinaser (JAKs) er enzymer, der transducerer intracellulære signaler fra celleoverfladereceptorer for en række cytokiner og vækstfaktorer, som er involveret i hæmatopoiese, inflammation og immunfunktion. 
Janus kinases (JAKs) are enzymes that transduce intracellular signals from cell surface receptors for a number of cytokines and growth factors involved in haematopoiesis, inflammation and immune function.
• feber, sår, usædvanlig træthed eller tandproblemer. 
• Fever, wounds, feeling more tired than usual, or dental problems.
43,1 % (95 % CI: 34,0 %, 52,8 %) af patienterne opnåede tilfredsstillende IgG-immunresponser på tetanusvaccination. 
In 43.1 % (95 % CI: 34.0 %, 52.8 %) of the patients, a satisfactory IgG immune response to tetanus vaccination was achieved.
Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for baricitinib er CHMP nået frem til følgende videnskabelige konklusioner: 
Taking into account the PRAC Assessment Report on the PSUR(s) for baricitinib, the scientific conclusions of CHMP are as follows:
Patienter, der var hepatitis C-antistof-positive, men negative for hepatitis C-virus-RNA, kunne deltage. 
Patients, who were positive for hepatitis C antibody but negative for hepatitis C virus RNA, were allowed to participate.
Prodrugget leflunomid omdannes hurtigt til teriflunomid, der er en svag OAT3hæmmer, og som derfor kan lede til øget baricitinib-eksponering. 
The prodrug leflunomide rapidly converts to teriflunomide which is a weak OAT3 inhibitor and therefore may lead to an increase in baricitinib exposure.
Radiologiske forandringer 
Radiographic Changes
• Formål og anvendelse af Patientkortet. 
• The purpose and use of the Patient Alert Card
JAK/STAT-signalvejen er vist at være involveret i celleadhæsion og cellepolaritet, hvilket kan påvirke den tidlige embryonale udvikling. 
The JAK/STAT pathway has been shown to be involved in cell adhesion and cell polarity which can affect early embryonic development.
Hvis HBV-DNA påvises, bør en specialist i leversygdomme konsulteres for at afgøre, om det er nødvendigt at afbryde behandlingen. 
If HBV DNA is detected, a liver specialist should be consulted to determine if treatment interruption is warranted.
I kontrollerede studier blev der over de første 16 uger observeret følgende forekomster for Olumiant vs. placebo: 
In controlled studies, for up to 16 weeks, the following rates were observed for Olumiant vs. placebo:
• Behandlingen med Olumiant skal afbrydes i tilfælde af herpes zoster eller ved enhver anden infektion, der ikke responderer på standardbehandling, indtil symptomerne forsvinder. 
• That Olumiant use should be stopped in case of herpes zoster or any other infection that doesn't respond to standard treatment until the event resolves.
Baricitinib blev påvist i mælken hos diegivende rotter. 
Baricitinib was detected in the milk of lactating rats.
Efter oral administration absorberes baricitinib hurtigt med en median-tmax på ca. 1 time (interval 0,5-3,0 time) og en absolut biotilgængelighed på ca. 79 % (CV = 3,94 %). 
Following oral administration, baricitinib is rapidly absorbed with a median tmax of approximately 1 hour (range 0.5 - 3.0 h) and an absolute bioavailability of approximately 79 % (CV = 3.94 %).
Behandling med baricitinib var forbundet med dosisafhængige stigninger i lipidparametre, herunder totalkolesterol, triglycerider, LDL-kolesterol og HDL-kolesterol. 
Baricitinib treatment was associated with dose-dependent increases in lipid parameters including total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol.
Der blev set forbedring så tidligt som i uge 1, og i studierne RA-BEGIN og RA-BEAM blev denne opretholdt frem til uge 52. 
Improvements were seen as early as Week 1 and, in studies RA-BEGIN and RA-BEAM, this was maintained for up to 52 weeks.
Hævelse i ansigtet Urticaria 
Swelling of the face, Urticaria
I et studie af præ- og postnatal udvikling blev der observeret nedsat vægt hos afkommet og nedsat postnatal overlevelse ved eksponeringer på henholdsvis 4 og 21 gange eksponeringen hos mennesker. 
In a pre- and postnatal development study, decreased pup weights and decreased postnatal survival were observed at exposures 4 and 21 times, respectively, the human exposure.
Du må ikke tage Olumiant, mens du ammer, da det ikke vides, om det går over i mælken. 
You should not use Olumiant while breast-feeding as it is not known if this medicine passes into milk.
RA-BEACON TNF-IR patienter 
RA-BEACON TNF-IR patients
Olumiant skal anvendes med forsigtighed til patienter med kendte risici for DVT/PE, såsom alder, overvægt, anamnese med DVT/PE eller patienter som gennemgår operation og immobilisering. 
Olumiant should be used with caution in patients with risk factors for DVT/PE, such as older age, obesity, a medical history of DVT/PE, or patients undergoing surgery and immobilisation.
Kombination med biologiske DMARDs eller andre JAK-hæmmere er ikke blevet undersøgt. 
Combination with biologic DMARDs or other JAK inhibitors has not been studied.
Olumiant 2 mg filmovertrukne tabletter EU/1/16/1170/001 
Olumiant 2 mg film-coated tablets EU/1/16/1170/001
En dosis på 2 mg én gang daglig er passende til f.eks. patienter ≥ 75 år og kan være passende til patienter med kroniske eller tilbagevendende infektioner i anamnesen. 
A dose of 2 mg once daily is appropriate for patients such as those aged ≥ 75 years and may be appropriate for patients with a history of chronic or recurrent infections.
Olumiant påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner. 
Olumiant has no or negligible influence on the ability to drive and use machines.
Hvis graviditet planlægges, skal behandling med Olumiant ophøre. 
If a planned pregnancy is considered, Olumiant treatment should be stopped.
Virkningen og sikkerheden af Olumiant én gang daglig blev vurderet i 4 randomiserede, dobbeltblinde fase 3-multicenterstudier hos patienter med moderat til svær aktiv reumatoid artritis diagnosticeret i henhold til ACR/EULAR 2010-kriterierne (se tabel 3). 
The efficacy and safety of Olumiant once daily was assessed in 4 Phase III randomised, double-blind, multicentre studies in patients with moderate to severe active rheumatoid arthritis diagnosed according to the ACR/EULAR 2010 criteria (see Table 3).
I tilfælde af overdosering anbefales det, at patienten monitoreres for symptomer på bivirkninger. 
In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions.