FrancophonIA/ELRC3.0 huggingface dataset:
English: Each vial contains 17.5 mg of dinutuximab in 5 mL.
Danish: Hvert hætteglas indeholder 17,5 mg dinutuximab i 5 ml.
English: Very common side effects (may affect more than 1 in 10 people): - cough - itching - loss of appetite - diarrhoea, being sick - low blood pressure that may make you feel dizzy or faint or high blood pressure - abnormal blood tests such as low platelets, low red or white blood cells, low level of albumin (this can cause swelling and make you feel weak and tired), abnormal liver function, low level of potassium,
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer): - hoste - kløe - nedsat appetit - diarré, opkastning - lavt blodtryk, som gør dig svimmel eller mat, eller højt blodtryk - unormale blodprøveresultater såsom lavt antal blodplader, lavt antal røde eller hvide blodlegemer, lavt albuminniveau (dette kan forårsage hævelse og gøre dig svag og træt), unormal leverfunktion, lavt niveau af kalium, natrium, kalcium, fosfater eller et højt glukoseniveau.
English: These are very common (affecting more than 1 in 10 people).
Danish: Det er meget almindeligt (forekommer hos flere end 1 ud af 10 personer).
English: Table 1: Courses 1, 3, and 5 dosing schedule for Unituxin, GM-CSF and isotretinoin Day
Danish: Tabel 1: Doseringsskema for behandlingsforløb 1, 3 og 5 for Unituxin, GM-CSF og isotretinoin Dag
English: Urticaria, pruritus
Danish: Nyrer og urinveje
English: Signs of an allergic reaction may include skin rash, hives, swelling in the face or throat, dizziness, a rapid heart beat or palpitations, being short of breath and difficulty breathing, fever, feeling sick, aches and pains in your joints.
Danish: Tegn på en allergisk reaktion kan omfatte hududslæt, nældefeber, hævelse i ansigtet eller på halsen, svimmelhed, hurtig eller uregelmæssig hjerterytme, stakåndethed, vejrtrækningsbesvær, feber, kvalme samt ømhed og smerter i leddene.
English: Unituxin 3.5 mg/mL concentrate for solution for infusion dinutuximab
Danish: Unituxin 3,5 mg/ml koncentrat til infusionsvæske, opløsning dinutuximab
English: • Start GM-CSF or IL-2 at 50 % of the dose when administered with dinutuximab.
Danish: • Start GM-CSF eller IL-2 med 50 % af dosis ved administration sammen med dinutuximab.
English: Respiratory, thoracic and mediastinal disorders
Danish: Luftveje, thorax og mediastinum lungeødem
English: • Resume GM-CSF or IL-2 the following day at 50 % of the dose until the last dose of dinutuximab for that course.
Danish: • Genoptag GM-CSF eller IL-2 den følgende dag med 50 % af dosis indtil det pågældende behandlingsforløbs sidste dosis dinutuximab.
English: Capillary leak syndrome is more likely when dinutuximab is co-administered with IL-2.
Danish: Sandsynligheden for kapillærlækagesyndrom er større, når dinutuximab administreres samtidig med IL-2.
English: Each mL of concentrate contains 3.5 mg of dinutuximab.
Danish: Hver ml koncentrat indeholder 3,5 mg dinutuximab.
English: • Delay course initiation until platelet count is at least 20,000/μL.
Danish: • Udsæt initiering af behandlingsforløbet, indtil trombocyttallet er mindst 20.000/μl.
English: 1 Includes preferred terms abdominal pain, abdominal pain upper, arthralgia, back pain, bladder pain, bone pain, chest pain, facial pain, gingival pain, musculoskeletal chest pain, myalgia, neck pain, neuralgia, oropharyngeal pain, pain, pain in extremity, and proctalgia.
Danish: 1 Omfatter betegnelserne mavesmerte, øvre mavesnerte, artralgi, rygsmerte, blæresmerte, knoglesmerte, brystsmerte, ansigtssmerte, gingival smerte, muskel- og knoglesmerter i brystet, myalgi, nakkesmerte, neuralgi, orofaryngeal smerte, smerte, smerte i ekstremiteter, proktalgi.
English: How Unituxin works
Danish: Hvordan virker Unituxin?
English: Refer to section 4.2 for advice on tapering off or discontinuation of this medicinal product.
Danish: Råd om nedtrapning eller seponering af dette lægemiddel findes i pkt.
English: • If capillary leak syndrome occurred during GM-CSF course, administer dinutuximab alone for subsequent GM-CSF courses.
Danish: • Hvis der forekom kapillærlækagesyndrom under behandlingsforløbet med GM-CSF, administreres dinutuximab i efterfølgende behandlingsforløb med GM-CSF.
English: Analgesics including intravenous opioids should be administered prior to each dose of Unituxin and continued until two hours following completion of Unituxin infusion.
Danish: Der bør administreres analgetika, herunder intravenøse opioider, før hver dosis Unituxin.
English: Unequal pupils
Danish: Uens pupiller
English: Unituxin 3.5 mg/mL concentrate for solution for infusion.
Danish: Unituxin 3,5 mg/ml koncentrat til infusionsvæske, opløsning.
English: Peripheral oedema, chills, fatigue, irritability Injection site reaction
Danish: Perifert ødem, kulderystelser, træthed, irritabilitet
English: • If symptoms resolve that day, resume the next day with premedication in the intensive care setting.
Danish: • Hvis symptomerne ophører samme dag, genoptages næste dag med
English: Atypical Haemolytic Uraemic Syndrome
Danish: Atypisk hæmolytisk uræmisk syndrom
English: Intravenous immunoglobulin
Danish: Intravenøs immunglobulin
English: • Reduce rate of infusion to 0.875 mg/m2/h.
Danish: • Nedsæt infusionshastigheden til 0,875 mg/m2/t.
English: Table 5: Adverse reactions that have occurred during studies in high risk neuroblastoma patients receiving dinutuximab in combination with GM-CSF, IL-2, and isotretinoin.
Danish: Tabel 5: Bivirkninger, der er forekommet i studier hos patienter med højrisiko-neuroblastom, der fik dinutuximab i kombination med GM-CSF, IL-2 og isotretinoin.
English: • If signs and symptoms resolve rapidly with the above measures, dinutuximab infusion may be resumed at a rate of 0.875 mg/m2/h.
Danish: • Hvis tegnene og symptomerne ophører hurtigt med ovenstående foranstaltninger, kan infusion af dinutuximab genoptages med en
English: • If IL-2 is not tolerated at 50 % of the dose, substitute with GM-CSF for the remainder of the IL-2 courses.
Danish: • Hvis IL-2 ikke tolereres med 50 % af dosis, erstattes det med GM-CSF i resten af behandlingsforløbene med IL-2.
English: Anaphylaxis Grade 3 or 4
Danish: Anafylaksi Grad 3 eller 4
English: • Resume GM-CSF or IL-2 the following day at 50 % of the dose if BP
Danish: • Genoptag GM-CSF eller IL-2 den følgende dag med 50 % af dosis, hvis
English: Table 5 summarizes adverse drug reactions reported when dinutuximab was administered in combination with GM-CSF, IL-2, and isotretinoin.
Danish: Tabel 5 opsummerer de lægemiddelbivirkninger, der er blevet indberettet, når dinutuximab blev administreret i kombination med GM-CSF, IL-2 og isotretinoin.
English: • If IL-2 is not tolerated at 50 % of the dose, administer dinutuximab alone for the remainder of the course.
Danish: • Hvis IL-2 ikke tolereres med 50 % af dosis, administreres dinutuximab alene i resten af behandlingsforløbet.
English: How Unituxin will be given
Danish: Sådan vil du få Unituxin
English: Serum sickness
Danish: Serumsygdom
English: • If GM-CSF is not tolerated at 50 % of the dose, administer dinutuximab alone for the remainder of the GM-CSF courses.
Danish: • Hvis GM-CSF ikke tolereres med 50 % af dosis, administreres dinutuximab alene i resten af behandlingsforløbene med GM-CSF.
English: • If GM-CSF is not tolerated at 50 % of the dose, administer dinutuximab alone for the remainder of the course.
Danish: • Hvis GM-CSF ikke tolereres med 50 % af dosis, administreres dinutuximab alene i resten af behandlingsforløbet.
English: Table 4: Dose modification guidance for the management of treatment-emergent adverse reactions during administration of dinutuximab in combination with GM-CSF, IL-2 and isotretinoin.
Danish: Tabel 4: Dosisjusteringsvejledning til håndtering af bivirkninger, som opstår under behandlingen, under administration af dinutuximab i kombination med GM-CSF, IL-2 og isotretinoin.
English: Recurrence
Danish: Recidiv
English: THE MEDICINAL PRODUCT
Danish: FARMACEUTISKE OPLYSNINGER
English: • If capillary leak syndrome occurred during IL-2 course, substitute GM-CSF for remainder of IL-2 courses.
Danish: • Hvis der forekom kapillærlækagesyndrom under behandlingsforløbet med IL-2, erstattes det med GM-CSF i resten af behandlingsforløbene med IL-2.
English: • Resume dinutuximab infusion at 0.875 mg/m2/h.
Danish: • Genoptag infusionen af dinutuximab ved 0,875 mg/m2/t.
English: • If BP remains stable for at least 2 hours after resuming GM-CSF or IL-2,
Danish: • Hvis BP forbliver stabilt i mindst 2 timer efter genoptagelse af GM-CSF eller IL-2, øges infusionen af dinutuximab til 1,75 mg/m2/t.
English: Subsequent courses
Danish: Efterfølgende behandlingsforløb
English: Specifically, in the presence of human effector cells including peripheral blood mononuclear cells (PBMC) and granulocytes from normal human donors, dinutuximab was found to mediate the lysis of several neuroblastoma cell lines in a dose-dependent manner.
Danish: Dinutuximab har nærmere bestemt vist sig at mediere lysis af flere neuroblastomcellelinjer på en dosisafhængig måde i tilstedeværelse af humane effektorceller, herunder perifere mononukleare blodlegemer (PBMC) og granulocytter fra normale humane donorer.
English: • If symptoms recur, discontinue dinutuximab, GM-CSF, and IL-2 for remaining courses.
Danish: • Hvis symptomerne recidiverer, seponeres dinutuximab, GM-CSF og IL-2 i resten af behandlingsforløbene.
English: Leukopaenia
Danish: Leukopeni
English: • Proceed with subsequent planned dinutuximab and GM-CSF or IL-2 courses.
Danish: • Fortsæt med efterfølgende planlagte behandlingsforløb med dinutuximab og GM-CSF eller IL-2.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic safety update reports
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: hypertension
Danish: Hyponatriæmi
English: Capillary leak syndrome, hypotension,
Danish: Mave-tarm-kanalen Diarré, opkastning,
English: Refer to section 4.4 for actions to be taken for specific adverse reactions.
Danish: 4.4 and 4.8), som ikke responderer tilstrækkeligt på understøttende foranstaltninger.
English: For shelf life after dilution, see section 6.3.
Danish: Holdbarhed efter fortynding, se pkt.
English: • Discontinue dinutuximab and GM-CSF or IL-2 for that day.
Danish: • Seponér dinutuximab og GM-CSF eller IL-2 for den pågældende dag.
English: • Immediately discontinue dinutuximab and intravenous GM-CSF or IL-2.
Danish: • Seponér omgående dinutuximab og intravenøs GM-CSF eller IL-2.
English: - higher risk of getting infections especially from the devices used to give you the medicine, blood or gut infections - skin problems where the injection was given, a red rash with small bumps - abnormal blood tests such as low levels of magnesium, glucose, high level of acids or creatinine.
Danish: - hovedpine - træthed, irritabilitet - forstoppelse, blod i afføring - skader på nerver rundt omkring i kroppen, som kan påvirke motorikken (”bevægelserne”) - sløret syn, lysfølsomhed, pupiller, der er permanent udvidede (‘dilaterede') - manglende evne til at lade vandet, blod eller protein i urinen - højere risiko for at få infektioner, især fra det udstyr, der anvendes til at give dig medicinen, infektioner i blodet eller i tarme - hudproblemer ved injektionsstedet, rødt udslæt med små knopper - unormale blodprøveresultater såsom et lavt niveau af magnesium, glukose, et højt niveau af syrer eller kreatinin
English: Onset of symptoms
Danish: Efter symptomophør
English: Tachycardia (sinusal, atrial, ventricular)
Danish: Takykardi (sinusal,
English: Constipation, lower gastrointestinal haemorrhage
Danish: Obstipation, blødning i nedre mave-tarmkanal
English: • Start GM-CSF or IL-2 at 50 % of the dose, increase to full dose if
Danish: • Start GM-CSF eller IL-2 med 50 % af dosis.
English: See section 2 for further information about sodium.
Danish: For yderligere information om natrium, se pkt.
English: • Discontinue dinutuximab and intravenous GM-CSF or IL-2.
Danish: • Seponér dinutuximab og intravenøs GM-CSF eller IL-2.
English: Posology
Danish: Nyredysfunktion
English: • Permanently discontinue dinutuximab and GM-CSF or IL-2.
Danish: • Seponer dinutuximab og GM-CSF eller IL-2 permanent.
English: • Discontinue dinutuximab, GM-CSF, and IL-2 for remaining courses.
Danish: • Seponér dinutuximab, GM-CSF og IL-2 i resten af behandlingsforløbene.
English: If any of the above apply to you (or you are not sure), talk to your doctor or nurse before being given Unituxin.
Danish: Kontakt lægen eller sundhedspersonalet, før du får Unituxin, hvis et eller flere af ovenstående forhold gælder for dig (eller du er i tvivl).
English: • Discontinue dinutuximab and GM-CSF or IL-2.
Danish: • Seponér dinutuximab og GM-CSF eller IL-2.
English: • Discontinue dinutuximab and GM-CSF or IL-2 for that course.
Danish: • Seponér dinutuximab og GM-CSF eller IL-2 for det pågældende behandlingsforløb.
English: • Maintain tolerated dinutuximab infusion rate for all subsequent courses
Danish: • Oprethold infusion af dinutuximab ved den tolererede hastighed for alle efterfølgende behandlingsforløb med GM-CSF eller IL-2.
English: 6.6 Special precautions for disposal and other handling The exact volume of Unituxin concentrate for solution for infusion required for the patient dose (see section 4.2) must be injected into a 100 mL bag of sodium chloride 9 mg/mL (0.9 %) solution for injection.
Danish: 4.2), skal injiceres i en 100 ml pose med en 9 mg/ml (0,9 %) natriumkloridopløsning til injektioner.
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Urticaria, pruritus
English: • If symptoms recur, discontinue dinutuximab, GM-CSF, and IL-2 for
Danish: • Hvis symptomerne recidiverer, seponeres dinutuximab, GM-CSF og IL2 i resten af behandlingsforløbene.
English: Unituxin 3.5 mg/mL sterile concentrate dinutuximab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Unituxin 3,5 mg/ml sterilt koncentrat dinutuximab
English: Your name:
Danish: Dit navn:
English: Doctor's phone number:
Danish: Lægens telefonnummer:
English: At present it is not known whether this is clinically relevant.
Danish: På nuværende tidspunkt vides det ikke, om dette er klinisk relevant.
English: Population (Number)
Danish: Population (Antal)
English: 28108 Madrid SPAIN
Danish: 28108 Madrid Spanien
English: VTE reporting rate is increasing.
Danish: VTE rapporteringsraten er stigende.
English: You can take the tablets either with or without food.
Danish: Du kan tage tabletterne sammen med eller uden mad.
English: Patients over 18 years of age were eligible to participate.
Danish: Patienter over 18 år var egnede til at deltage.
English: You should swallow your tablet with a drink of water.
Danish: Du skal synke din tablet og drikke et glas vand.
English: - Do not take a double dose to make up for a forgotten tablet.
Danish: - Du må ikke tage en dobbeltdosis som erstatning for en glemt tablet.
English: • Physical function (HAQ-DI)
Danish: • Fysisk funktion (HAQ-DI)
English: Olumiant is to be taken once daily with or without food and may be taken at any time of the day.
Danish: Olumiant skal tages én gang daglig sammen med eller uden mad og kan tages på et hvilket som helst tidspunkt af dagen.
English: Nausea was most frequent during the first 2 weeks of treatment.
Danish: Kvalme var hyppigst under de første 2 ugers behandling.
English: In July 2019 VTE reporting rate was 0,13% compared to 0,09% in February 2019.
Danish: I juli 2019 var VTE rapporteringsraten 0,13% sammenlignet med 0,09% i februar 2019.
English: Most cases were transient and did not require treatment discontinuation.
Danish: De fleste tilfælde var forbigående og krævede ikke behandlingsafbrydelse.
English: Doctor's name (who prescribed Olumiant):
Danish: Navn på lægen (der ordinerede Olumiant):
English: C-reactive protein
Danish: C-reaktivt protein
English: The tablets contain a recessed area on each side.
Danish: Tabletterne har et forsænket område på hver side.
English: No metabolites were quantifiable in plasma.
Danish: Ingen metabolitter var kvantificerbare i plasma.
English: You may get some of the side effects described in section 4.
Danish: Du kan få nogle af de bivirkninger, der er beskrevet i afsnit 4.
English: If the medicine is working well, your doctor may decide the dose can be reduced.
Danish: Hvis lægemidlet virker godt, kan lægen beslutte, at dosen kan nedsættes.
English: Taking into account information provided by MAH, at least part of non-specific events were indeed systemic however due the limited information it is not possible to categorise them properly.
Danish: Under hensyntagen til den information som blev givet af MAH, var i det mindste en del af de non-specifikke bivirkninger systemiske, men på grund af begrænset information er det ikke muligt at kategorisere dem korrekt.
English: Long-term safety evaluations are ongoing.
Danish: Der foretages løbende evalueringer af den langsigtede sikkerhed.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisteren og kartonen efter ‘EXP'.
English: The majority of these patients (n = 94) were co-treated with methotrexate.
Danish: Størstedelen af disse patienter (n = 94) blev samtidig behandlet med methotrexat.
English: Wed. Thu.
Danish: On. To.
English: - if you are pregnant or think you may be pregnant.
Danish: - hvis du er gravid eller tror, at du er gravid.
English: All patients who completed these studies were eligible to enrol in a long term extension study for up to 4 years continued treatment.
Danish: Alle patienter, der gennemførte disse studier, var egnede til at blive inkluderet i et længerevarende forlængelsesstudie med op til 4 års fortsat behandling.
English: • Tell your doctor immediately if you become (or wish to become) pregnant.
Danish: • Fortæl straks lægen, hvis du bliver (eller ønsker at blive) gravid.
English: From the 316 events retrieved as of 13 May 2019, 78 were categorised as systemic/oedema and 38 were categorised as non-specific.
Danish: Ud af de 316 bivirkninger indhentet 13. maj 2019, var 78 kategoriserede som systemiske/ødem og 38 var kategoriserede som non-specifikke.
English: • The guide for healthcare professionals to support counselling of the patient
Danish: • Vejledning til sundhedspersonale til at understøtte rådgivning af patienten
English: Note: Proportions of responders at each time point based on those initially randomised to treatment (N).
Danish: Note: Andelen af responderende på hvert tidspunkt var baseret på det antal personer, der til at starte med var randomiseret til behandling (N).
English: If you take more Olumiant than you should, contact your doctor.
Danish: Hvis du har taget mere Olumiant, end du skulle, skal du kontakte lægen.
English: The safety and efficacy of Olumiant in children and adolescents aged 0 to 18 years have not yet been established.
Danish: Olumiants sikkerhed og virkning hos børn og unge i alderen 0-18 år er endnu ikke klarlagt.
English: Swelling face (n=23) and urticaria (n=20) were also frequently reported.
Danish: Hævelse i ansigt (n=23) og urticaria (n=20) blev også ofte rapporteret.
English: Therefore, no dose adjustment is needed based on these patient factors.
Danish: Derfor er dosisjustering på basis af disse patientfaktorer ikke nødvendig.
English: The guide for healthcare professionals shall contain the following key elements:
Danish: Vejledningen til sundhedspersonale skal indeholde følgende hovedelementer:
English: c Includes changes detected during laboratory monitoring (see text below).
Danish: c Inkluderer ændringer fundet under monitorering via laboratorieanalyser (se beskrivelse nedenfor).
English: There was no change in the LDL/HDL ratio.
Danish: Der var ingen ændring i LDL/HDLforholdet.
English: Clinical Trial Summary Study name (Duration)
Danish: Oversigt over kliniske studier Studiets navn (Varighed)
English: Moreover positive dechallenge (e.g. one case categorised as systemic) and positive dechallenge and rechallenge (e.g. one case categorised as non-specific) also support the view that baricitinib may cause systemic events.
Danish: Desuden understøtter positiv dechallenge (f.eks. et tilfælde kategoriseret som systemisk) samt positiv dechallenge og rechallenge (f.eks. et tilfælde kategoriseret som non-specifikt) også, at baricitinib kan forårsage systemiske bivirkninger.
English: Treatment may be initiated once values have improved above these limits (see section 4.4).
Danish: Behandling kan indledes, når værdierne er kommet op over disse grænser (se pkt.
English: Age ≥ 65 years or ≥ 75 years has no effect on baricitinib exposure (Cmax and AUC).
Danish: Alder ≥ 65 år eller ≥ 75 år har ingen indvirkning på eksponeringen for baricitinib (Cmax og AUC).
English: Your doctor may give you a lower dose of 2 mg once a day, particularly if you are over 75 years old or if you have an increased risk of infections.
Danish: Lægen kan give dig en lavere dosis på 2 mg én gang om dagen, især hvis du er over 75 år, eller hvis du har en øget risiko for infektioner.
English: The overall incidence rate of serious infections in the clinical trial programme was 3.2 per 100 patient-years.
Danish: Den samlede incidensrate af alvorlige infektioner i det kliniske udviklingsprogram var 3,2 pr. 100 patientår.
English: Olumiant is not for use in children and adolescents under 18 years old because there is no information on use in this age group.
Danish: Olumiant må ikke anvendes til børn og unge under 18 år, da der ikke er information om anvendelse hos denne aldersgruppe.
English: • lecithin (soya) (E322)
Danish: • lecithin (soja) (E 322)
English: The presence of at least 6 tender and 6 swollen joints was required at baseline.
Danish: Tilstedeværelse af mindst 6 ømme og 6 hævede led ved baseline var påkrævet.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first Authorisation: 13 February 2017
Danish: Dato for første markedsføringstilladelse: 13. februar 2017
English: On background cDMARDs5 if on stable cDMARD at study entry
Danish: På baggrunds-cDMARDs5, hvis på stabil cDMARD ved indtrædelse i studie
English: Table 4: Response, Remission and Physical Function Study
Danish: Respons, remission og fysisk funktion Studie
English: The rate of serious infections remained stable during long term exposure.
Danish: Hyppigheden af alvorlige infektioner forblev stabil under længerevarende eksponering.
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: The majority of patients maintained low disease activity or remission based on CDAI score:
Danish: Størstedelen af patienterne opretholdt lav sygdomsaktivitet eller remission baseret på CDAI-scoren:
English: Prior to launch of Olumiant in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Inden lancering af Olumiant i de enkelte medlemslande skal indehaveren af markedsføringstilladelsen (MAH) aftale indholdet og formen af uddannelsesmaterialet, herunder kommunikationsmedier, distributionsmetode samt alle andre aspekter af programmet, med den nationale myndighed.
English: It is unknown whether baricitinib/metabolites are excreted in human milk.
Danish: Det vides ikke, om baricitinib/metabolitter udskilles i human mælk.
English: Baricitinib is approximately 50 % bound to plasma proteins.
Danish: Baricitinib er ca. 50 % bundet til plasmaproteiner.
English: Before treatment initiation and thereafter according to routine patient management
Danish: Før indledning af behandling og derefter i henhold til rutinemæssig håndtering af patienter.