FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be monitored for abnormal liver tests prior to and periodically during treatment as indicated based on clinical evaluation and managed with cemiplimab treatment modifications and corticosteroids (see section 4.2).
Danish: Patienterne bør monitoreres for unormale leverprøver før og regelmæssigt under behandlingen, hvis indiceret på baggrund af klinisk evaluering, og bør behandles med justeringer i cemiplimab-behandlingen og kortikosteroid (se pkt.
English: The infusion should be stopped and cemiplimab should be permanently discontinued for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions (see section 4.2).
Danish: Ved alvorlige (grad 3) eller livstruende (grad 4) infusionsrelaterede reaktioner bør infusionen stoppes og cemiplimab seponeres permanent (se pkt.
English: Among the 7 patients with immune-related diarrhoea or colitis, the median time to onset was 3.8 months (range: 15 days to 6.0 months) and the median duration of immune-related diarrhoea or colitis was 30 days (range: 4 days to 8.6 months).
Danish: Blandt de 7 patienter med immunrelateret diarré eller colitis var mediantid til indtræden 3,8 måneder (interval: 15 dage til 6,0 måneder), og median varighed af immunrelateret diarré eller colitis var 30 dage (interval: 4 dage til
English: No dose adjustment is recommended for patients with mild hepatic impairment.
Danish: Der er ikke behov for dosisjustering til patienter med let nedsat leverfunktion.
English: Among the 3 patients with adrenal insufficiency, the median time to onset was 11.5 months (range: 10.4 months to 12.3 months).
Danish: Blandt de 3 patienter med binyrebarkinsufficiens var mediantid til indtræden 11,5 måneder (interval: 10,4 måneder til 12,3 måneder).
English: Immune-related pneumonitis occurred in 22 (3.7%) of 591 patients receiving cemiplimab, including 2 (0.3%) patients with Grade 5, 2 (0.3%) patients with Grade 4, and 6 (1.0%) patients with Grade 3 pneumonitis.
Danish: Immunrelateret pneumonitis forekom hos 22 (3,7 %) af de 591 patienter, der fik cemiplimab, inklusive 2 (0,3 %) patienter med grad 5, 2 (0,3 %) patienter med grad 4 og 6 (1,0 %) patienter med grad 3 pneumonitis.
English: • cough, inflammation of the lungs
Danish: • hoste, lungebetændelse
English: Immune-related diarrhoea or colitis occurred in 7 (1.2%) of 591 patients receiving cemiplimab including 2 (0.3%) with Grade 3 immune-related diarrhoea or colitis.
Danish: Immunrelateret diarré eller colitis forekom hos 7 (1,2 %) af de 591 patienter, der fik cemiplimab inklusive 2 (0,3 %) med grad 3 immunrelateret diarré eller colitis.
English: Type 1 diabetes mellitus without an alternative aetiology occurred in 4 (0.7%) of 591 patients including 3 (0.5%) patients with Grade 4 and 1 (0.2%) patient with Grade 3 type 1 diabetes mellitus.
Danish: Type 1-diabetes mellitus uden anden ætiologi forekom hos 4 (0,7 %) ud af 591 patienter inklusive 3 (0,5 %) patienter med grad 4 og 1 (0,2 %) patient med grad 3 type 1-diabetes mellitus.
English: • LIBTAYO is for single use only.
Danish: • LIBTAYO er kun til engangsbrug.
English: Patients with suspected pneumonitis should be evaluated with radiographic imaging as indicated based on clinical evaluation and managed with cemiplimab treatment modifications and corticosteroids.
Danish: Mistanke om pneumonitis hos patienterne bør evalueres med røntgenbillede, hvis indiceret på basis af den kliniske evaluering og behandles med justeringer i cemiplimab-behandlingen og kortikosteroid (se pkt.
English: • inflammation of the mouth
Danish: • betændelse i munden
English: Among the 3 patients with immune-related nephritis, the median time to onset was 1.8 months (range: 29 days to 4.1 months) and the median duration of nephritis was 18 days (range: 9 days to 29 days).
Danish: Blandt de 3 patienter med immunrelateret nefritis var mediantid til indtræden 1,8 måneder (interval: 29 dage til 4,1 måneder), og median varighed af nefritis var 18 dage (interval: 9 dage til 29 dage).
English: k. Fatigue is a composite term that includes fatigue and asthenia.
Danish: k. Træthed er en sammensat term, der omfatter træthed og asteni.
English: Gastrointestinal disorders Diarrhoea e
Danish: Mave-tarm-kanalen Diarré e
English: Initiate symptomatic management immediately, including initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper
Danish: Initiér straks symptomatisk behandling, inklusive initial dosis prednison på 12 mg/kg/dag eller tilsvarende efterfulgt af nedtrapning
English: • Liver problems (hepatitis)
Danish: • Leverproblemer (leverbetændelse)
English: Eye disorders Keratitis
Danish: Øjne Keratitis
English: • Kidney problems (nephritis and kidney failure)
Danish: • Nyreproblemer (nyrebetændelse og nyresvigt)
English: Immune-related hypophysitis has been observed in patients receiving cemiplimab (see section 4.8).
Danish: Immunrelateret hypofysitis er observeret hos patienter, der har fået cemiplimab (se pkt.
English: LIBTAYO is for single use only.
Danish: LIBTAYO er kun til engangsbrug.
English: Preparation
Danish: Fremstiller
English: One ml contains 50 mg of cemiplimab.
Danish: 1 ml indeholder 50 mg cemiplimab.
English: Immune-related hepatitis occurred in 11 (1.9%) of 591 patients receiving cemiplimab including 1 (0.2%) patient with Grade 5, 1 (0.2%) patient with Grade 4, and 9 (1.5%) patients with Grade 3 immune-related hepatitis.
Danish: Immunrelateret hepatitis forekom hos 11 (1,9 %) af de 591 patienter, der fik cemiplimab, inklusive 1 (0,2 %) patient med grad 5, 1 (0,2 %) patient med grad 4 og 9 (1,5 %) patienter med grad 3 immunrelateret hepatitis.
English: • One ml of concentrate contains 50 mg of cemiplimab.
Danish: • En ml koncentrat indeholder 50 mg cemiplimab.
English: Grade 2 to 4
Danish: Grad 2-4
English: Nine patients (1.5%) with immune-related skin adverse reactions received high-dose corticosteroids for a median of 16 days (range: 7 days to 2.6 months).
Danish: Ni patienter (1,5 %) med immunrelaterede hudreaktioner fik højdosis-kortikosteroid i gennemsnitligt 16 dage (interval: 7 dage til 2,6 måneder).
English: severe nausea or vomiting, pain on right side of your stomach (abdomen), feeling sleepy, dark urine (the colour of tea), bleeding or bruising more easily than normal and feeling less hungry than usual.
Danish: • Leverproblemer (leverbetændelse) som f.eks. gulfarvning af huden og det hvide i øjnene, kraftig kvalme eller opkastning, smerter i den højre side af maven, søvnighed, mørkfarvet urin (te-farvet), nemmere ved at bløde eller få blå mærker end normalt og nedsat sultfølelse.
English: The following side effects have been reported in clinical trials of patients with CSCC: Very common (may affect more than 1 in 10 people):
Danish: Følgende bivirkninger er rapporteret i kliniske studier med patienter med CSCC:
English: Patients should be monitored for signs and symptoms of infusion-related reactions and managed with cemiplimab treatment modifications and corticosteroids.
Danish: Patienterne bør monitoreres for tegn og symptomer på infusionsrelaterede reaktioner og behandles med justeringer i cemiplimab-behandlingen og kortikosteroid.
English: • Each vial contains 350 mg cemiplimab in 7 ml of concentrate.
Danish: • Et hætteglas indeholder 350 mg cemiplimab i 7 ml koncentrat.
English: Severe and fatal immune-related adverse reactions have been observed with cemiplimab (see section 4.8).
Danish: Der er observeret svære og letale immunrelaterede bivirkninger med cemiplimab (se pkt.
English: Immune-related hepatitis led to permanent discontinuation of cemiplimab in 5 (0.8%) of 591 patients.
Danish: Immunrelateret hepatitis medførte permanent seponering af cemiplimab hos 5 (0,8 %) af 591 patienter.
English: Hypothyroidism occurred in 42 (7.1%) of 591 patients receiving cemiplimab including 1 (0.2%) patient with Grade 3 hypothyroidism.
Danish: Hypothyreoidisme forekom hos 42 (7,1 %) af de 591 patienter, der fik cemiplimab, inklusive 1 (0,2 %) patient med grad 3 hypothyreoidisme.
English: Immune-related pneumonitis led to permanent discontinuation of cemiplimab in 11 (1.9%) of 591 patients.
Danish: Immunrelateret pneumonitis medførte permanent seponering af cemiplimab hos 11 (1,9 %) ud af de 591 patienter.
English: Musculoskeletal and connective tissue disorders: Myalgia, Arthritis d, Sjogren's syndrome
Danish: Immunsystemet: immun trombocytopenisk purpura Vaskulære sygdomme: vasculitis Knogler, led, muskler og bindevæv: myalgi, artritis d, Sjögrens syndrom
English: Central nervous system inflammation Uncommon Neuropathy peripheral c
Danish: Perifer neuropati c
English: Resume LIBTAYO when diabetes mellitus returns to Grade 0 to 1 or is otherwise clinically stable
Danish: Genoptag LIBTAYO, når diabetes mellitus igen er grad 0-1 eller i øvrigt er klinisk stabil
English: Infusion-related reactions occurred in 54 (9.1%) of 591 patients treated with cemiplimab including 1 (0.2%) patient with Grade 3 infusion-related reaction.
Danish: Infusionsrelaterede reaktioner forekom hos 54 (9,1 %) af de 591 patienter, der fik cemiplimab, inklusive 1 (0,2 %) patient med grad 3 infusionsrelateret reaktion.
English: Immune-related diarrhoea or colitis led to permanent discontinuation of cemiplimab in 1 (0.2%) of 591 patients.
Danish: Immunrelateret diarré eller colitis medførte permanent seponering af cemiplimab hos 1 (0,2 %) af 591 patienter.
English: Type 1 diabetes mellitus led to permanent discontinuation of cemiplimab in 1 (0.2%) of 591 patients.
Danish: Type 1diabetes mellitus medførte permanent seponering af cemiplimab hos 1 (0,2 %) af 591 patienter.
English: • type 1 diabetes that may include feeling more hungry or thirsty than usual, needing to urinate more often, weight loss, and feeling tired
Danish: • type 1-diabetes som kan omfatte øget sultfølelse eller øget tørst, hyppigere vandladning,
English: Encephalitis
Danish: Encefalitis
English: Resume LIBTAYO if hepatitis improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent or returns to baseline AST or ALT after completion of corticosteroid taper
Danish: Genoptag LIBTAYO, hvis hepatitis bedres og forbliver grad 0-1 efter nedtrapning af kortikosteroid til ≤10 mg/dag prednison eller tilsvarende eller vender tilbage til baseline ASAT- eller ALAT-niveau efter nedtrapning af kortikosteroid
English: How to store LIBTAYO
Danish: Sådan får du LIBTAYO
English: • Kidney problems (nephritis and kidney failure) such as passing water less often than usual, passing blood, swollen ankles and feeling less hungry than normal.
Danish: • Nyreproblemer (nyrebetændelse og nyresvigt) som f.eks. nedsat vandladningsfrekvens, blod i urinen, hævede ankler og nedsat sultfølelse.
English: LIBTAYO 350 mg concentrate for solution for infusion.
Danish: LIBTAYO 350 mg koncentrat til infusionsvæske, opløsning.
English: What you need to know before you are given LIBTAYO
Danish: Det skal du vide, før du begynder at få LIBTAYO Sådan får du LIBTAYO
English: Resume LIBTAYO when hyperthyroidism returns to Grade 0 to 1 or is otherwise clinically stable
Danish: Genoptag LIBTAYO, når hyperthyreoidisme igen er grad 0-1 eller i øvrigt er klinisk stabil
English: Hyperthyroidism occurred in 11 (1.9%) of 591 patients receiving cemiplimab including 1 (0.2%) patient with Grade 3 hyperthyroidism.
Danish: Hyperthyreoidisme forekom hos 11 (1,9 %) af de 591 patienter, der fik cemiplimab, inklusiv 1 (0,2 %) patient med grad 3 hyperthyreoidisme.
English: Immune-related skin adverse reactions occurred in 12 (2.0%) of 591 patients receiving cemiplimab including 6 (1.0%) patients with Grade 3 immune-related skin adverse reactions.
Danish: Immunrelaterede hudreaktioner forekom hos 12 (2,0 %) af de 591 patienter, der fik cemiplimab inklusive 6 (1,0 %) patienter med grad 3 immunrelaterede hudreaktioner.
English: Sanofi S.p.A. Tel: 800.536 389
Danish: Tel: 800.536 389
English: Patients should be monitored for signs and symptoms of diarrhoea or colitis and managed with cemiplimab treatment modifications, anti-diarrhoeal agents, and corticosteroids (see section 4.2).
Danish: Patienterne bør monitoreres for tegn og symptomer på diarré eller colitis og behandles med justeringer i cemiplimab-behandlingen, lægemidler mod diarré og kortikosteroid (se pkt.
English: • eye pain, irritation, itchiness or redness; uncomfortable sensitivity to light • inflammation of the nerves causing tingling, numbness, weakness or burning pain of the arms or legs
Danish: • nervebetændelse med snurrende, prikkende fornemmelse, følelsesløshed eller brændende smerte i arme eller ben
English: Immune-related adverse reactions (see section 4.4) Immune-related pneumonitis
Danish: Immunrelaterede bivirkninger (se pkt.
English: Tel: +39 02 39394275
Danish: Sanofi S.p.A Tel: +39 02 39394275
English: Patients should be managed with cemiplimab treatment modifications and corticosteroids (see section 4.2).
Danish: Patienterne bør behandles med justeringer i cemiplimab-behandlingen og kortikosteroid (se pkt.
English: Immune-related nephritis occurred in 3 (0.5%) of 591 patients receiving cemiplimab including 2 (0.3%) patients with Grade 3 immune-related nephritis.
Danish: Immunrelateret nefritis forekom hos 3 (0,5 %) af de 591 patienter, der fik cemiplimab, inklusive 2 (0,3 %) patienter med grad 3 immunrelateret nefritis.
English: Severitya
Danish: Sværhedsgrada
English: Immune-related diarrhoea or colitis, defined as requiring use of corticosteroids with no clear alternate aetiology, has been observed in patients receiving cemiplimab (see section 4.8).
Danish: Immunrelateret diarré eller colitis, defineret som behandlingskrævende med kortikosteroid og uden klar alternativ ætiologi, er observeret hos patienter, der har fået cemiplimab (se pkt.
English: Immune-related endocrinopathies, defined as treatment-emergent endocrinopathies with no clear alternate aetiology, have been observed in patients receiving cemiplimab (see section 4.8).
Danish: Immunrelaterede endokrinopatier, defineret som behandlingsrelaterede endokrinopatier uden anden klar ætiologi, er observeret hos patienter, der har fået cemiplimab (se pkt.
English: Do not store any unused portion of the infusion solution for re-use.
Danish: Eventuelt resterende infusionsvæske må ikke gemmes til senere brug.
English: Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
Danish: Grad 2 der varer længere end 1 uge, Grad 3 eller mistanke om StevensJohnsons syndrom (SJS) eller toksisk epidermal nekrolyse (TEN)
English: • Infusion-related reactions
Danish: • infusionsrelaterede reaktioner
English: • infusion-related reactions
Danish: • Infusionsrelaterede reaktioner
English: Alanine aminotransferase increased Common Aspartate aminotransferase increased Common Blood alkaline phosphatase increased Common Blood creatinine increased
Danish: Forhøjet alkalisk fosfatase i blodet
English: Adrenal insufficiency has been observed in patients receiving cemiplimab (see section 4.8).
Danish: Binyrebarkinsufficiens er observeret hos patienter, der har fået cemiplimab (se pkt.
English: Resume LIBTAYO when hypothyroidism returns to Grade 0 to 1 or is otherwise clinically stable
Danish: Genoptag LIBTAYO, når hypothyreoidisme igen er grad 01 eller i øvrigt er klinisk stabil
English: Immune-related nephritis led to permanent discontinuation of cemiplimab in 1 (0.2%) of 591 patients.
Danish: Immunrelateret nefritis medførte permanent seponering af cemiplimab hos 1 (0,2 %) af 591 patienter.
English: One ml of concentrate contains 50 mg of cemiplimab.
Danish: Hver ml koncentrat indeholder 50 mg cemiplimab.
English: Patients should be monitored for signs and symptoms of hypophysitis and managed with cemiplimab treatment modifications and corticosteroids (see section 4.2).
Danish: Patienterne bør monitoreres for tegn og symptomer på hypofysitis og behandles med justeringer i cemiplimab-behandlingen og kortikosteroid (se pkt.
English: • inflammation of the liver
Danish: • betændelse i hjertesækken
English: No patient discontinued cemiplimab due to hypothyroidism.
Danish: Hypothyreoidisme førte ikke til seponering af cemiplimab hos nogen af patienterne.
English: Tel: +40 (0) 21 317 31 36
Danish: Sanofi Romania SRL Tel: +40 (0) 21 317 31 36
English: No patient discontinued cemiplimab due to hyperthyroidism.
Danish: Hyperthyreoidisme førte ikke til seponering af cemiplimab hos nogen af patienterne.
English: Resume LIBTAYO if hypophysitis improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent or is otherwise clinically stable
Danish: Genoptag LIBTAYO, hvis hypofysitis bedres og forbliver grad 0-1 efter nedtrapning af kortikosteroid til ≤10 mg/dag prednison eller tilsvarende eller i øvrigt er klinisk stabil
English: Resume LIBTAYO if colitis or diarrhoea improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent
Danish: Genoptag LIBTAYO, hvis colitis eller diarré bedres og forbliver grad 0-1 efter nedtrapning af kortikosteroid til ≤10 mg/dag prednison eller tilsvarende
English: Immune-related skin adverse reactions led to permanent discontinuation of cemiplimab in 2 (0.3%) of 591 patients.
Danish: Immunrelaterede hudreaktioner medførte permanent seponering af cemiplimab hos 2 (0,3 %) af 591 patienter.
English: • joint pain, swelling, polyarthritis and joint effusion
Danish: Knogler, led, muskler og bindevæv Artralgi
English: Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper
Danish: Initial dosis prednison på 12 mg/kg/dag eller tilsvarende efterfulgt af nedtrapning
English: Initial dose of 2 to 4 mg/kg/day prednisone or equivalent followed by a taper
Danish: Initial dosis prednison på 24 mg/kg/dag eller tilsvarende efterfulgt af nedtrapning
English: If you have any questions about your treatment, ask your doctor.
Danish: Spørg lægen, hvis der er noget, du er i tvivl om.
English: Immune-related hepatitis, defined as requiring use of corticosteroids with no clear alternate aetiology, including fatal cases, has been observed in patients receiving cemiplimab (see section 4.8).
Danish: Immunrelateret hepatitis, defineret som behandlingskrævende med kortikosteroid og uden klar alternativ ætiologi, inklusive letale tilfælde, er observeret hos patienter, der har fået cemiplimab (se pkt.
English: Resume LIBTAYO if adrenal insufficiency improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent or is otherwise clinically stable
Danish: Genoptag LIBTAYO, hvis binyrebarkinsufficiens bedres og forbliver grad 0-1 efter nedtrapning af kortikosteroid til ≤10 mg/dag prednison eller tilsvarende eller i øvrigt er klinisk stabil
English: Immune-related pneumonitis, defined as requiring use of corticosteroids with no clear alternate aetiology, including fatal cases, has been observed in patients receiving cemiplimab (see section 4.8).
Danish: Immunrelateret pneumonitis, defineret som behandlingskrævende med kortikosteroid og uden klar alternativ ætiologi, inklusive letale tilfælde, er observeret hos patienter, der har fået cemiplimab (se pkt.
English: Adrenal insufficiency occurred in 3 (0.5%) of 591 patients receiving cemiplimab including 1 (0.2%) patient with Grade 3 adrenal insufficiency.
Danish: Binyrebarkinsufficiens forekom hos 3 (0,5 %) af de 591 patienter, der fik cemiplimab, inklusive 1 (0,2 %) patient med grad 3 binyrebarkinsufficiens.
English: shaking or fever, itching or rash, flushing or swollen face, being short of breath or wheezing, feeling dizzy or feel like passing out and back or neck pain.
Danish: • Infusionsrelaterede reaktioner (kan i nogle tilfælde være alvorlige eller livstruende) som f.eks. kulderystelser, skælven eller feber, kløe eller udslæt, rødme eller hævelse af ansigtet, åndenød eller hvæsende vejrtrækning, svimmelhed eller følelse af at skulle besvime og ryg- og nakkesmerter.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med LIBTAYO Fortæl lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Danish: BATCHNUMMER<, DONATIONS- OG PRODUKTKODER>
English: Immune-related nephritis, defined as requiring use of corticosteroids with no clear alternate aetiology, has been observed in patients receiving cemiplimab (see section 4.8).
Danish: Immunrelateret nefritis, defineret som behandlingskrævende med kortikosteroid og uden klar alternativ ætiologi, er observeret hos patienter, der har fået cemiplimab (se pkt.
English: Resume LIBTAYO if skin reaction or other immune-related adverse reaction improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent
Danish: Genoptag LIBTAYO, hvis hudreaktion eller anden immunrelateret bivirkning bedres og forbliver grad 0-1 efter nedtrapning af kortikosteroid til ≤10 mg/dag prednison eller tilsvarende
English: Patients should be monitored for signs and symptoms of immune-related adverse reactions and managed with cemiplimab treatment modifications and corticosteroids (see section 4.2).
Danish: Patienterne skal monitores for tegn og symptomer på immunrelaterede bivirkninger og behandles med justeringer i cemiplimab-behandlingen og kortikosteroid (se pkt.
English: Resume LIBTAYO if other immune-related adverse reaction improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent
Danish: Genoptag LIBTAYO, hvis anden immunrelateret bivirkning bedres og forbliver grad 0-1 efter nedtrapning af kortikosteroid til ≤10 mg/dag prednison eller tilsvarende
English: Resume LIBTAYO if pneumonitis improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent
Danish: Genoptag LIBTAYO, hvis pneumonitis bedres og forbliver grad 0-1 efter nedtrapning af kortikosteroid til ≤10 mg/dag prednison eller tilsvarende
English: Resume LIBTAYO if nephritis improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent
Danish: Genoptag LIBTAYO, hvis nefritis bedres og forbliver grad 0-1 efter nedtrapning af kortikosteroid til ≤10 mg/dag prednison eller tilsvarende
English: Mix the diluted solution by gentle inversion.
Danish: Bland den fortyndede opløsning ved forsigtigt at vende infusionsposen på hovedet.
English: Immune-related adverse reactions
Danish: Immunrelaterede hudreaktioner
English: No patient discontinued cemiplimab due to adrenal insufficiency.
Danish: Binyrebarkinsufficiens medførte ikke seponering af cemiplimab hos nogen af patienterne.
English: Resume LIBTAYO if skin reaction improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent
Danish: Genoptag LIBTAYO, hvis hudreaktion bedres og forbliver grad 0-1 efter nedtrapning af kortikosteroid til ≤10 mg/dag prednison eller tilsvarende
English: Patients should be monitored for signs and symptoms of adrenal insufficiency during and after treatment and managed with cemiplimab treatment modifications and corticosteroids (see section 4.2).
Danish: Patienterne bør monitoreres for tegn og symptomer på binyrebarkinsufficiens og behandles med justeringer i cemiplimab-behandlingen og kortikosteroid (se pkt.
English: Each vial contains 350 mg of cemiplimab in 7 ml.
Danish: Et hætteglas med 7 ml opløsning indeholder 350 mg cemiplimab.
English: LIBTAYO.
Danish: Klargøring
English: Nephritis
Danish: Nefritis
English: Strength Pharmaceutical form
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage
English: 200 mg Concentrate for solution for infusion
Danish: 200 mg Koncentrat til infusionsvæske, opløsning
English: 1.33 ml (150 mg/ml)
Danish: Hætteglas (glas) 1,33 ml (150 mg/ml)
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Administration Emballage Indhold (koncentration)
English: List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), ADMINISTRATIONSVEJ(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: United Kingdom Teva United Kingdom Limted
Danish: Storbritanien Teva United Kingdom Limted