FrancophonIA/ELRC3.0 huggingface dataset:
English: Avelumab should be withheld for Grade 2 hepatotoxicity until resolution and permanently discontinued for Grade 3 or Grade 4 hepatotoxicity.
Danish: Avelumab bør tilbageholdes ved grad 2 hepatotoksicitet, indtil reaktionen går væk, og det skal seponeres permanent for grad 3 eller grad 4 hepatotoksicitet.
English: The median time to onset of thyroid disorders was 2.8 months (range: 3.6 weeks to 19.3 months).
Danish: Mediantiden til tyreoideasygdomme opstod var 2,8 måneder (interval: 3,6 uger til 19,3 måneder).
English: The median time to onset of immune-related hepatitis was 3.2 months (range: 1 week to 15 months).
Danish: Mediantiden til immunrelateret hepatitis opstod var 3,2 måneder (interval: 1 uge til 15 måneder).
English: Hypothyroidism*
Danish: Hypotyroidisme*
English: The median time to onset of immune-related pneumonitis was 2.5 months (range: 3 days to 11 months).
Danish: Mediantiden til immunrelateret pneumonitis opstod, var 2,5 måneder (interval: 3 dage til 11 måneder).
English: Table 4: Response to avelumab 10 mg/kg every 2 weeks in patients with metastatic MCC in study EMR100070-003 (Part A)*
Danish: Tabel 4: Respons på avelumab 10 mg/kg hver 2. uge hos patienter med metastatisk MCC i studie EMR100070-003 (del A)*
English: The median time to onset of immune-related colitis was 5.1 months (range: 2.3 weeks to 14 months).
Danish: Mediantiden til immunrelateret colitis opstod var 5,1 måneder (interval: 2,3 uger til 14 måneder).
English: Bavencio 20 mg/mL concentrate for solution for infusion avelumab
Danish: Bavencio 20 mg/ml koncentrat til infusionsvæske, opløsning avelumab
English: All 13 patients with immune-related colitis were treated with corticosteroids and 12 (92.3%) of the 13 patients received high-dose corticosteroids for a median of 2.3 weeks (range: 5 days to 4.6 months).
Danish: Alle 13 patienter med immunrelateret colitis blev behandlet med kortikosteroider og 12 (92,3 %) ud af 13 patienter fik højdosis kortikosteroider i en median periode på 2,3 uger (interval: 5 dage til 4,6 måneder).
English: Premedication
Danish: Præmedicin
English: Diarrhoea, nausea, constipation, vomiting, abdominal pain
Danish: Meget almindelig Diarré, kvalme, forstoppelse, opkastning, abdominalsmerter Almindelig
English: Table 5: Objective response rates by PD-L1 expression and MCV tumour status in patients with metastatic MCC in study EMR100070-003 (Part A)
Danish: Tabel 5: Objektive responsrater efter PD-L1-ekspression og MCV-tumorstatus hos patienter med metastatisk MCC i studie EMR100070-003 (del A)
English: Corticosteroids should be administered (1 to 2 mg/kg/day prednisone intravenously or oral equivalent) for Grade ≥ 3 adrenal insufficiency followed by a taper until a dose of less than or equal to 10 mg/day has been reached.
Danish: Der skal administreres kortikosteroider (1-2 mg/kg/dag prednison, givet intravenøst eller som tilsvarende oral mængde) ved grad ≥ 3 binyreinsufficiens, efterfulgt af nedtrapning til dosisniveau på ≤ 10 mg/dag er nået.
English: Avelumab should be withheld for Grade 2 immune-related pneumonitis until resolution, and permanently discontinued for Grade 3, Grade 4 or recurrent Grade 2 immune-related pneumonitis (see section 4.2).
Danish: Avelumab bør tilbageholdes ved grad 2 immunrelateret pneumonitis, indtil reaktionen går væk, og skal seponeres permanent for grad 3, grad 4 eller tilbagevendende grad 2 immunrelateret pneumonitis (se pkt.
English: Administer the solution for infusion using a sterile, non-pyrogenic, low-protein binding 0.2 micrometre in-line or add-on filter as described in section 4.2.
Danish: Administrer infusionsvæsken, opløsningen, med et sterilt, ikke-pyrogent, lavproteinbindende 0,2 mikrometer in-line- eller add-on-filter, som beskrevet i pkt.
English: (HCV);
Danish: (AIDS),
English: The median duration was 1.6 weeks (range: 1 day to more than 9 months).
Danish: Medianvarigheden var 1,6 uger (interval: 1 dag til over 9 måneder).
English: Bavencio 20 mg/mL concentrate for solution for infusion
Danish: Bavencio 20 mg/ml koncentrat til infusionsvæske, opløsning
English: Immune-related pneumonitis did not lead to discontinuation of avelumab in any patient.
Danish: Immunrelateret pneumonitis førte ikke til seponering af avelumab hos nogen patienter.
English: The median time to onset of immune-related colitis was 2.1 months (range: 2 days to 11 months).
Danish: Mediantiden til immunrelateret colitis opstod var 2,1 måneder (interval: 2 dage til 11 måneder).
English: Liver function test increased
Danish: Forhøjede leverfunktionsprøver
English: • Red, itchy, scaly patches on the skin, acne-like rash
Danish: • Røde, kløende, skællende pletter på huden, aknelignende udslæt
English: • Increased muscle enzyme in the blood
Danish: • Forhøjet niveau af muskelenzymer i blodet
English: Immune-related nephritis did not lead to discontinuation of avelumab in any patient.
Danish: Immunrelateret nefritis førte ikke til seponering af avelumab hos nogen patienter.
English: Immune-related nephritis and renal dysfunction In patients treated with avelumab as monotherapy, immune-related nephritis occurred in 0.1% (1/1,738) of patients receiving avelumab leading to permanent discontinuation of avelumab.
Danish: Hos patienter behandlet med avelumab som monoterapi opstod immunrelateret nefritis hos 0,1 % (1/1.738) af patienterne, der fik avelumab, hvilket førte til permanent seponering af avelumab.
English: How you will receive Bavencio
Danish: Sådan vil du få Bavencio
English: How to use Bavencio
Danish: Sådan skal du bruge Bavencio
English: Nausea, diarrhoea, constipation, vomiting, abdominal pain
Danish: Meget almindelig Kvalme, diarré, forstoppelse, opkastning, abdominalsmerter Almindelig
English: In patients treated with avelumab as monotherapy, 1.5% (26/1,738) of patients developed immune-related colitis.
Danish: Hos patienter behandlet med avelumab som monoterapi udviklede 1,5 % (26/1.738) af patienterne immunrelateret colitis.
English: Immune-related pancreatitis has been reported in patients receiving avelumab.
Danish: Der er blevet rapporteret immunrelateret pankreatitis hos patienter, der fik avelumab.
English: The median time to onset of immune-related adrenal insufficiency was 2.5 months (range: 1 day to 8 months).
Danish: Mediantiden til immunrelateret binyreinsufficiens opstod var 2,5 måneder (interval: 1 dag til 8 måneder).
English: In patients treated with avelumab in combination with axitinib, 2.7% (13/489) of patients developed immune-related colitis.
Danish: Hos patienter behandlet med avelumab i kombination med axitinib udviklede 2,7 % (13/489) af patienterne immunrelateret colitis.
English: • Nausea, loose stools, constipation, vomiting
Danish: • Kvalme, løse afføringer, forstoppelse, opkastning
English: The median time to onset of thyroid disorders was 2.8 months (range: 2 weeks to 13 months).
Danish: Mediantiden til tyreoideasygdomme opstod var 2,8 måneder (interval: 2 uger til 13 måneder).
English: Two fatal cases have been reported in patients receiving avelumab (see section 4.8).
Danish: To tilfælde med dødelig udgang er blevet rapporteret hos patienter, der fik avelumab (se pkt.
English: The median duration was 6 weeks (range: 1 day to more than 14 months).
Danish: Medianvarigheden var 6 uger (interval: 1 dag til over 14 måneder).
English: Avelumab was discontinued in 0.4% (2/489) of patients due to immune-related colitis.
Danish: Avelumab blev seponeret hos 0,4% (2/489) af patienterne, på grund af immunrelateret colitis.
English: Immune-related adrenal insufficiency did not lead to discontinuation of avelumab in any patient.
Danish: Immunerelateret binyreinsufficiens førte ikke til seponering af avelumab hos nogen patienter.
English: • Muscle pain
Danish: • Muskelsmerter
English: All 21 patients with immune-related pneumonitis were treated with corticosteroids and 17 (81%) of the 21 patients were treated with high-dose corticosteroids for a median of 8 days (range: 1 day to
Danish: Alle 21 patienter med immunrelateret pneumonitis blev behandlet med kortikosteroider, og 17 (81 %) af de 21 patienter blev behandlet med højdosis kortikosteroider i en mediantid på 8 dage (interval: 1 dag til 2,3 måneder).
English: All 26 patients with immune-related colitis were treated with corticosteroids and 15 (58%) of the 26 patients received high-dose corticosteroids for a median of 19 days (range: 1 day to 2.3 months).
Danish: Alle 26 patienter med immunrelateret colitis blev behandlet med kortikosteroider og 15 (58 %) af de 26 patienter fik højdosis kortikosteroider i en mediantid på 19 dage (interval: 1 dag til 2,3 måneder).
English: • Loose stools, nausea, constipation, vomiting
Danish: • Løs afføring, kvalme, forstoppelse, opkastning
English: Avelumab should be withheld for Grade 3 or Grade 4 symptomatic adrenal insufficiency (see section 4.2).
Danish: Avelumab bør afbrydes ved grad 3 eller grad 4 symptomatisk binyreinsufficiens (se pkt.
English: All 16 patients with immune-related hepatitis treated with corticosteroids and 15 (94%) of the 16 patients received high-dose corticosteroids for a median of 14 days (range: 1 day to 2.5 months).
Danish: Alle 16 patienter med immunrelateret hepatitis blev behandlet med kortikosteroider og 15 (94 %) af de 16 patienter fik højdosis kortikosteroider i en mediantid på 14 dage (interval: 1 dag til 2,5 måneder).
English: • Information that avelumab can cause serious side effects during or after treatment, that need to be treated right away and warning message on the importance of being aware of signs and symptoms while receiving avelumab treatment
Danish: • Oplysninger om, at avelumab kan forårsage alvorlige bivirkninger under og efter behandlingen,
English: Rash, pruritus
Danish: Nyrer og urinveje
English: Of these patients, there were 7 (0.4%) patients with Grade 3 immune-related colitis.
Danish: Ud af disse patienter var der 7 (0,4 %) patienter med grad 3 immunrelateret colitis.
English: Avelumab should be withheld for Grade 2 or Grade 3 immune-related colitis until resolution, and permanently discontinued for Grade 4 or recurrent Grade 3 immune-related colitis (see section 4.2).
Danish: Avelumab bør tilbageholdes ved grad 2 eller grad 3 immunrelateret colitis, indtil reaktionen går væk, og skal seponeres permanent for grad 4 eller tilbagevendende grad 3 immunrelateret colitis (se pkt.
English: Avelumab was discontinued in 0.3% (6/1,738) of patients due to immune-related pneumonitis.
Danish: Avelumab blev seponeret hos 0,3 % (6/1.738) af patienterne, på grund af immunrelateret pneumonitis.
English: Rash pruritic, rash maculo-papular, pruritus generalized, dermatitis acneiform, erythema, rash macular, rash papular, rash erythematous, dermatitis, eczema, rash generalized
Danish: Kløende udslæt, makulopapuløst udslæt, generaliseret pruritus, dermatitis acneiform, erytem, makuløst udslæt, papulært udslæt, erytematøst udslæt, dermatitis, eksem, generaliseret udslæt
English: • problems with your hormone producing glands (the thyroid, adrenal and pituitary glands) that may affect how these glands work;
Danish: • problemer med dine hormonproducerende kirtler (skjoldbruskkirtlen, binyrerne og hypofysen),
English: Avelumab should be withheld for Grade 3 or Grade 4 thyroid disorders (see section 4.2).
Danish: Avelumab bør afbrydes ved grad 3 eller grad 4 tyreoideasygdomme (se pkt.
English: Other immune-related adverse reactions
Danish: Andre immunrelaterede bivirkninger
English: • Joint pain, back pain, belly pain, muscle pain
Danish: • Ledsmerter, rygsmerter, mavesmerter, muskelsmerter
English: Avelumab should be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for Grade 4 immune-related adverse reaction (see section 4.2).
Danish: Avelumab skal seponeres permanent ved alle grad 3 immunrelaterede bivirkninger, der vender tilbage, og ved grad 4 immunrelaterede bivirkninger (se pkt.
English: Avelumab was discontinued in 0.5% (9/1,738) of patients due to immune-related hepatitis.
Danish: Avelumab blev seponeret hos 0,5 % (9/1.738) af patienterne, på grund af immunrelateret hepatitis.
English: In patients treated with avelumab as monotherapy, 1.2% (21/1,738) of patients developed immune-related pneumonitis.
Danish: Hos patienter behandlet med avelumab som monoterapi udviklede 1,2 % (21/1.738) af patienterne immunrelateret pneumonitis.
English: One fatal case has been reported in patients receiving avelumab (see section 4.8).
Danish: Et tilfælde med dødelig udgang er blevet rapporteret hos patienter, der fik avelumab (se pkt.
English: Alanine aminotransferase (ALT) increased*, aspartate aminotransferase (AST) increased*, blood creatine phosphokinase increased*, transaminases increased*
Danish: Forhøjet gamma-glutamyltransferase, forhøjet basisk phosphatase i blodet, forhøjet amylase, forhøjet lipase, forhøjet kreatinin i blodet Ikke almindelig Forhøjet alaninaminotransferase (ALAT)*, forhøjet aspartataminotransferase (ASAT)*, forhøjet kreatinphosphokinase i blodet*, forhøjede transaminer*
English: • Hoarseness, cough, shortness of breath
Danish: • Hæshed, hoste, stakåndethed
English: In patients treated with avelumab in combination with axitinib, 6.3% (31/489) of patients developed immune-related hepatitis.
Danish: Hos patienter behandlet med avelumab i kombination med axitinib udviklede 6,3 % (31/489) af patienterne immunrelateret hepatitis.
English: Acute kidney injury
Danish: Akut nyreskade
English: Suspected myocarditis
Danish: Formodet myokarditis
English: • Headache, dizziness
Danish: • Hovedpine, svimmelhed
English: In patients treated with avelumab in combination with axitinib, 0.6% (3/489) of patients developed immune-related pneumonitis.
Danish: Hos patienter behandlet med avelumab i kombination med axitinib udviklede 0,6 % (3/489) af patienterne immunrelateret pneumonitis.
English: The median time to onset of immune-related hepatitis was 2.3 months (range: 2.1 weeks to 14.5 months).
Danish: Mediantiden til immunrelateret pneumonitis opstod var 2,3 måneder (interval: 2,1 uger til 14,5 måneder).
English: Avelumab should be withheld for Grade 2 immune-related hepatitis until resolution and permanently discontinued for Grade 3 or Grade 4 immune-related hepatitis (see section 4.2).
Danish: Avelumab bør afbrydes ved grad 2 immunrelateret hepatitis, indtil reaktionen går væk, og skal seponeres permanent for grad 3 eller grad 4 immunrelateret hepatitis (se pkt.
English: Your doctor may
Danish: Kontakt derimod din læge som kan
English: In patients treated with avelumab as monotherapy, 0.9% (16/1,738) of patients developed immune-related hepatitis.
Danish: Hos patienter behandlet med avelumab som monoterapi udviklede 0,9 % (16/1.738) af patienterne immunrelateret hepatitis.
English: Adrenal insufficiency
Danish: Binyreinsufficiens
English: In patients treated with avelumab in combination with axitinib, 1.8% (9/489) of patients developed immune-related adrenal insufficiency.
Danish: Hos patienter behandlet med avelumab i kombination med axitinib udviklede 1,8 % (9/489) af patienterne immunrelateret binyreinsufficiens.
English: Of these patients, there was 1 (0.1%) patient with Grade 3 immune-related adrenal insufficiency.
Danish: Ud af disse patienter var der 1 (0,1 %) patient med grad 3 immunrelateret binyreinsufficiens.
English: Avelumab was discontinued in 0.2% (1/489) of patients due to immune-related thyroid disorders.
Danish: Avelumab blev seponeret hos 0,2% (1/489) af patienterne, på grund af immunrelaterede tyreoideasygdomme.
English: Hepatic impairment
Danish: Pustuløst udslæt
English: Corticosteroids (initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a corticosteroid taper) should be administered for Grade ≥ 2 nephritis.
Danish: Der bør administreres kortikosteroider (indledende dosis på 1-2 mg/kg/dag prednison eller tilsvarende, efterfulgt af en nedtrapning af kortikosteroider) til nefritis grad ≥ 2.
English: Hypertension, hypotension
Danish: Hypertension, hypotension Ikke almindelig Rødme
English: Headache, dizziness
Danish: • Hoste, stakåndethed
English: Infusion-related reactions Grade 1 infusion-related reaction
Danish: Grad 1 infusionsrelateret reaktion
English: Of the 116 patients, 81 (70%) were male, the median age was 74 years (range: 41 to 93 years), 75 (65%) were Caucasian, and 72 (62%) and 44 (38%) had an ECOG performance status of 0 and 1, respectively.
Danish: Medianalderen var 74 år (interval 41 til 93 år), 75 (65 %) var kaukasere og 72 (62 %) og 44 (38 %) havde en ECOG performancestatus på hhv. 0 og 1.
English: In patients treated with avelumab as monotherapy, 0.5% (8/1,738) of patients developed immune-related adrenal insufficiency.
Danish: Hos patienter behandlet med avelumab som monoterapi udviklede 0,5 % (8/1.738) af patienterne immunrelateret binyreinsufficiens.
English: Avelumab was discontinued in 0.5% (9/1,738) of patients due to immune-related colitis.
Danish: Avelumab blev seponeret hos 0,5 % (9/1.738) af patienterne, på grund af immunrelateret colitis.
English: bumpy rash or skin wheals, flushing, low blood pressure (dizziness, fatigue, nausea) fever,
Danish: kulderystelser eller rysten, ujævnt udslæt eller hudvabler, rødmen, lavt blodtryk
English: • Increased pancreatic enzymes in the blood
Danish: • Forhøjet niveau af enzymer fra bugspytkirtlen i blodet
English: Withhold
Danish: Afbryd
English: Treatment modifications when Bavencio is used in combination with axitinib If ALT or AST ≥ 3 times ULN but < 5 times ULN or total bilirubin ≥ 1.5 times ULN but < 3 times ULN, both Bavencio and axitinib should be withheld until these adverse reactions recover to Grades 0-1.
Danish: men < 3 gange ULN, skal både Bavencio og axitinib afbrydes, indtil disse bivirkninger bedres til grad 0-1.
English: Dysphonia, cough, dyspnoea
Danish: Meget almindelig Dysfoni, hoste, dyspnø Almindelig
English: Avelumab was discontinued in 0.1% (2/1,738) of patients due to immune-related adrenal insufficiency.
Danish: Avelumab blev seponeret hos 0,1 % (2/1.738) af patienterne, på grund af immunrelateret binyreinsufficiens.
English: Corticosteroids should be administered for immune-related myocarditis (initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a corticosteroid taper).
Danish: Der bør administreres kortikosteroider for immunrelateret myokarditis (indledende dosis på 1-2 mg/kg/dag prednison eller tilsvarende, efterfulgt af en nedtrapning af kortikosteroid).
English: Thrombocytopenia, eosinophilia§
Danish: Lymfopeni Ikke almindelig Trombocytopeni, eosinofili§
English: • Increased glucose in the blood
Danish: • Forhøjet sukkerniveau i blodet
English: Fatigue, chills, asthenia, pyrexia
Danish: Meget almindelig Træthed, kulderystelser, asteni, pyreksi Almindelig
English: Avelumab was discontinued in 0.1% (2/1,738) of patients due to immune-related thyroid disorders.
Danish: Avelumab blev seponeret hos 0,1 % (2/1.738) af patienterne, på grund af immunrelaterede tyreoideasygdomme.
English: Of these patients, there were 2 (0.4%) patients with Grade 3 immune-related nephritis.
Danish: Ud af disse patienter var der 2 (0,4 %) patienter med grad 3 immunrelateret nefritis.
English: What Bavencio is and what it is used for What you need to know before you use Bavencio How to use Bavencio
Danish: Det skal du vide, før du begynder at bruge Bavencio 3.
English: Corticosteroids should be administered for immune-related pancreatitis (initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a corticosteroid taper).
Danish: Der bør administreres kortikosteroider for immunrelateret pankreatitits (indledende dosis på 1-2 mg/kg/dag prednison eller tilsvarende, efterfulgt af en nedtrapning af kortikosteroid).
English: • Increased liver enzymes in the blood
Danish: • Øgede leverenzymer i blodet
English: Intravenous use after dilution Read the package leaflet before use.
Danish: Intravenøs anvendelse efter fortynding.
English: Corticosteroids should be administered for Grade ≥ 2 events (initial dose of 1 to 2 mg/kg/day prednisone or equivalent, followed by a corticosteroid taper).
Danish: Der bør administreres kortikosteroider ved grad ≥ 2 hændelser (indledende dosis på 1-2 mg/kg/dag prednison eller tilsvarende, efterfulgt af en nedtrapning af kortikosteroid).
English: Of these patients, there were 2 (0.4%) patients with Grade 3 immune-related adrenal insufficiency.
Danish: Ud af disse patienter var der 2 (0,4 %) patienter med grad 3 immunrelateret binyreinsufficiens.
English: Of these patients, there were 3 (0.2%) patients with Grade 3 immune-related thyroid disorders.
Danish: Ud af disse patienter var der 3 (0,2 %) patienter med grad 3 immunrelaterede tyreoideasygdomme.
English: Arthralgia, back pain, myalgia
Danish: Meget almindelig Artralgi, rygsmerter, myalgi
English: Anaemia
Danish: Amning
English: Infusion related reaction
Danish: Meget almindelig Infusionsrelateret reaktion
English: Of these patients, there were 2 (0.4%) patients with Grade 3 immune-related thyroid disorders.
Danish: Ud af disse patienter var der 2 (0,4 %) patienter med grad 3 immunrelaterede tyreoideasygdomme.
English: Lymphopenia
Danish: Mundtørhed
English: Concentrate for solution for infusion.
Danish: Koncentrat til infusionsvæske, opløsning.
English: Myalgia
Danish: Dosering
English: Cough, dyspnoea
Danish: Meget almindelig Hoste, dyspnø Almindelig
English: Posology
Danish: Ringe
English: Hepatobiliary disorders
Danish: • Tarmobstruktion
English: Uveitis*
Danish: Sværhedsgrad*
English: Diabetes mellitus*, Type 1 diabetes mellitus*
Danish: Meget almindelig Nedsat appetit Ikke almindelig Diabetes mellitus*, type 1 diabetes mellitus*
English: • If you get any side effects, talk to your doctor.
Danish: • Kontakt lægen, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt i denne indlægsseddel.
English: Invented name Strength
Danish: Særnavn Styrke
English: EU number
Danish: EU- nummer
English: Pharmaceutical Form Route of administration Packaging
Danish: Lægemiddelform
English: Some people will die from this illness.
Danish: Nogle mennesker dør af denne sygdom.
English: Therefore, the potential risk for humans is unknown.
Danish: Derfor er den potentielle risiko for mennesker ukendt.
English: However the reasons for this difference are unknown and could be related to other factors.
Danish: Grunden til denne forskel er dog ukendt og kan være relateret til andre faktorer.
English: In the majority of cases, no reactions have been observed.
Danish: I størstedelen af tilfældene blev der ikke observeret nogen reaktioner.
English: In addition, an updated RMP should be submitted
Danish: Derudover skal der indsendes en opdateret RMP
English: Risk Management Plan
Danish: Risk managementplan
English: Bleeding risk should be taken into account when considering the risk benefit for individual patients.
Danish: Blødningsrisikoen bør tages i betragtning, når man vurderer risk-benefit for individuelle patienter.
English: If you are pregnant your doctor will only give you Xigris if necessary.
Danish: Hvis De er gravid, vil Deres læge kun give Dem Xigris, hvis det er nødvendigt.
English: • Any other condition in which the physician considers significant bleeding is likely
Danish: • Enhver anden tilstand, hvor lægen mener, at en signifikant blødning er sandsynlig
English: PROWESS Follow-up Study
Danish: PROWESS opfølgningsundersøgelse
English: • Active internal bleeding
Danish: • Aktiv indre blødning
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Danish: • Når der fremkommer nye oplysninger, der kan have indflydelse på den gældende sikkerhedsspecifikation, pharmacovigilanceplan eller risikominimerende aktiviteter
English: Please remember that you cannot take Xigris by yourself because both your illness and the use of this medicine need constant medical care.
Danish: Vær venligst opmærksom på, at De ikke kan tage Xigris selv, idet både Deres sygdom og brugen af dette lægemiddel kræver konstant overvågning af en læge.
English: This causes an illness called severe sepsis which can make you very ill.
Danish: Dette medfører en sygdom, der hedder svær sepsis, og som kan gøre Dem meget syg.
English: This medicine has been authorised under “Exceptional Circumstances”.
Danish: Dette lægemiddel er godkendt under ”særlige omstændigheder”.