natgillin/translations-raw huggingface dataset:
• betændelse i leveren: Symptomerne kan omfatte kvalme eller opkastning, at føle sig mindre sulten, smerter i højre side af maven, gulfarvning af huden eller det hvide i øjnene, døsighed, mørk urin eller blødning eller at have lettere ved at få blå mærker end normalt
• inflammation of the liver: symptoms may include nausea or vomiting, feeling less hungry, pain on the right side of your stomach, yellowing of skin or whites of eyes, drowsiness, dark urine or bleeding or bruising more easily than normal;
Patienterne bør monitoreres for kliniske tegn og symptomer på hypofysitis eller hypopituitarisme.
Patients should be monitored for clinical signs and symptoms of hypophysitis or hypopituitarism.
Immunmedieret pneumonitis/interstitiel lungesygdom
Immune-mediated pneumonitis/interstitial lung disease
Immunmedieret hepatitis bør behandles som anbefalet i pkt.
Immune-mediated hepatitis should be managed as recommended in section 4.2.
p omfatter autoimmun nefritis, tubulointerstitiel nefritis, nefritis, glomerulonefritis og membranøs glomerulonefritis.
p includes autoimmune nephritis, tubulointerstitial nephritis, nephritis, glomerulonephritis and glomerulonephritis membranous.
Infusionsrelaterede reaktioner skal behandles som anbefalet i pkt.
Infusion related reactions should be managed as recommended in section 4.2
• betændelsestilstand i lungerne (pneumonitis)
• inflammation of the lungs (pneumonitis)
Alle 7 patienter fik systemisk kortikosteroid; 2 af de 7 patienter fik højdosis-kortikosteroidbehandling (mindst 40 mg prednison eller tilsvarende per dag).
All 7 patients received systemic corticosteroids; 2 of the 7 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Kassér hætteglasset, hvis opløsningen er uklar, misfarvet eller synlige partikler observeres.
Discard the vial if the solution is cloudy, discoloured or visible particles are observed.
Øvrige indholdsstoffer: histidin, histidinhydrochloridmonohydrat, trehalosedihydrat, polysorbat 80, vand til injektionsvæsker.
The other ingredients are: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 80, water for injections.
I placebogruppen fik 11 ud af 16 patienter systemiske kortikosteroider, inklusive 9 patienter, der fik højdosis-kortikosteroidbehandling (mindst 40 mg prednison eller tilsvarende per dag).
In the placebo group, 11 of the 16 patients received systemic corticosteroids, including 9 patients who received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Resolution forekom hos 18 patienter.
Resolution occurred in 18 patients.
• smertefuld vandladning
• painful urination
frekvensen er baseret på hændelser, der ikke blev observeret i PACIFIC studiet, men observeret i AstraZeneca kliniske studier (n=1889).
h frequency is based on events not observed in the PACIFIC Study but observed in AstraZeneca clinical trials (n=4067).
Resolution forekom hos 23 patienter.
Resolution occurred in 23 patients.
Mediantiden til debut var 85 dage (interval: 9-378 dage).
The median time to onset was 85 days (range: 9-378 days).
I PACIFIC-studiet (n = 475 i IMFINZI-armen og n = 234 i placeboarmen) forekom immunmedieret pneumonitis hos 51 (10,7 %) patienter i gruppen, der fik IMFINZI, og hos 16 (6,8 %) patienter i placebogruppen, inklusive Grad 3 hos 8 (1,7 %) patienter, der fik IMFINZI, versus 6 (2,6 %) patienter, der fik placebo, og Grad 5 (letal) hos 4 (0,8 %) patienter, der fik IMFINZI versus 3 (1,3 %) patienter, der fik placebo.
In the PACIFIC Study, (n = 475 in the IMFINZI arm, and n = 234 in the placebo arm) immune-mediated pneumonitis occurred in 51 (10.7%) patients in the IMFINZI-treated group and 16 (6.8%) patients in the placebo group, including Grade 3 in 8 (1.7%) patients on IMFINZI vs. 6 (2.6%) patients on placebo and Grade 5 (fatal) in 4 (0.8%) patients on IMFINZI vs. 3 (1.3%) patients on placebo.
Mediantiden til debut var 141 dage (interval: 70-265 dage).
The median time to onset was 141 days (range: 70-265 days).
Resolution forekom hos 13 patienter.
Resolution occurred in 13 patients.
Initiér 1-2 mg/kg/dag prednison eller tilsvarende, efterfulgt af nedtrapning og hormonsubstitutionsbehandling som klinisk indiceret
Initiate 1 to 2 mg/kg/day prednisone or equivalent followed by a taper and hormone replacement as clinically indicated
Hypothyreoidisme og hyperthyreoidisme
Hypothyroidism and hyperthyroidism
Resolution forekom hos én patient.
Resolution occurred in 1 patient.
Resolution forekom hos 2 patienter.
Resolution occurred in 2 patients.
Ved symptomatisk adrenal insufficiens bør patienter behandles som anbefalet i pkt.
For symptomatic adrenal insufficiency, patients should be managed as recommended in section 4.2.
Lever og galdeveje Forhøjet aspartataminotransferase eller forhøjet alaninaminotransferase
Hepatobiliary disorders Aspartate aminotransferase increased or Alanine aminotransferase increased
• hævelse af benene (perifere ødemer)
• swelling of the legs (oedema peripheral)
I gruppen, der fik IMFINZI, fik 44 ud af 51 patienter systemiske kortikosteroider, inklusive 28 patienter, der fik højdosis-kortikosteroidbehandling (mindst 40 mg prednison eller tilsvarende per dag) og 2 patienter fik også infliximab.
In the IMFINZI-treated group, 44 of the 51 patients received systemic corticosteroids, including 28 patients who received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day), and 2 patients also received infliximab.
Ved symptomatisk hypofysitis eller hypopituitarisme bør patienterne behandles som anbefalet i pkt.
For symptomatic hypophysitis or hypopituitarism, patients should be managed as recommended in section 4.2.
Brug af anden medicin sammen med IMFINZI
Other medicines and IMFINZI
Alvorlige infusionsrelaterede reaktioner er blevet rapporteret hos patienter, der fik IMFINZI (se pkt.
Severe infusion related reactions have been reported in patients receiving IMFINZI (see section 4.8).
IMFINZI blev seponeret hos 26 patienter.
IMFINZI was discontinued in 26 patients.
Hjælpestoffer: histidin, histidinhydrochloridmonohydrat, trehalosedihydrat, polysorbat 80, vand til injektionsvæsker.
Excipients: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 80, water for injections.
Mediantiden til debut var 70 dage (interval: 15-312 dage).
The median time to onset was 70 days (range: 15-312 days).
Patienterne bør monitoreres for unormale leverprøver før og periodisk under behandling med IMFINZI, og som indiceret på baggrund af klinisk vurdering.
Patients should be monitored for abnormal liver tests prior to and periodically during treatment with IMFINZI, and as indicated based on clinical evaluation.
• infusionsrelaterede reaktioner: Symptomerne kan omfatte kuldefornemmelse eller rysten, kløe eller udslæt, rødme, åndenød eller hvæsende vejrtrækning, svimmelhed eller feber.
• Infusion-related reactions: symptoms may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing dizziness, or fever.
IMFINZI er en klar til opaliserende, farveløs til svagt gul opløsning.
IMFINZI is clear to opalescent, colourless to slightly yellow solution.
2,4 ml koncentrat i et Type 1-hætteglas med en elastomerprop og en grå afrivelig aluminiumsforsegling indeholdende 120 mg durvalumab.
2.4 mL of concentrate in a Type 1 glass vial with an elastomeric stopper and a gray flip-off aluminium seal containing 120 mg durvalumab.
45 ud af 79 patienter fik højdosis-kortikosteroidbehandling (mindst 40 mg prednison eller tilsvarende per dag) og 2 patienter fik også infliximab.
Forty-five of the 79 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day), and 2 patients also received infliximab.
• nyrebetændelse: Symptomerne kan indebære et fald i mængden af urin
• inflammation of the kidneys: symptoms may include decrease in the amount of urine you pass;
Immunmedieret pneumonitis
Immune-mediated pneumonitis
• betændelse i hjertemusklen: Symptomerne kan omfatte brystsmerter, åndenød eller uregelmæssig hjerterytme
• inflammation of the heart muscle: symptoms may include chest pain, shortness of breath or irregular heartbeat;
Spørg lægen, hvis der er noget, du er i tvivl om.
Talk to your doctor if you are not sure.
Grad 2 med ALAT eller ASAT >3-5 x ULN og/eller total bilirubin >1,5-3 x ULN Tilbagehold dosis
Grade 2 with ALT or AST > 3-5 x ULN and/or total bilirubin > 1.5-3 x ULN
Patienter bør monitoreres for unormale thyroideafunktionsprøver før og periodisk under behandling og som indiceret på baggrund af klinisk vurdering.
Patients should be monitored for abnormal thyroid function tests prior to and periodically during treatment and as indicated based on clinical evaluation.
Immunmedieret udslæt eller dermatitis
Immune-mediated rash or dermatitis
Ryst ikke hætteglasset.
Do not shake the vial.
Mediantiden til debut var 41 dage (interval: 14-195 dage).
The median time to onset was 41 days (range: 14-195 days).
IMFINZI blev seponeret hos 8 patienter.
IMFINZI was discontinued in 8 patients.
Immunmedieret myokarditis
Immune-mediated myocarditis
Sådan vil du få IMFINZI
How you are given IMFINZI
Immunmedieret type 1-diabetes mellitus forekom hos patienter, der fik IMFINZI (se pkt.
Immune-mediated type 1 diabetes mellitus occurred in patients receiving IMFINZI (see section 4.8).
• tarmbetændelse: Symptomerne kan omfatte diarré eller flere afføringer end normalt, eller afføring, der er sort, tjæreagtig eller klæbrig med blod eller slim, svære mavesmerter eller ømhed i maven
• inflammation of the intestines: symptoms may include diarrhoea or more bowel movements than usual, or stools that are black, tarry or sticky with blood or mucus, severe stomach pain or tenderness;
• betændelse i lungerne: Symptomerne kan omfatte ny eller forværret hoste, kortåndethed eller brystsmerter
• inflammation of the lungs: symptoms may include new or worsening cough, shortness of breath or chest pain;
Patienterne bør monitoreres for tegn og symptomer på colitis eller diarré og behandles som anbefalet i pkt.
Patients should be monitored for signs and symptoms of colitis or diarrhoea and managed as recommended in section 4.2.
Figur 3: Kaplan-Meier-kurve over OS for PD-L1 TC ≥ 1 %
Kaplan-Meier curve of OS for PD-L1 TC ≥ 1%
IMFINZI blev ikke seponeret hos nogen patienter på grund af hyperthyreoidisme.
IMFINZI was not discontinued in any patient due to hyperthyroidism.
Patienter skal monitoreres for tegn og symptomer og behandles som anbefalet for andre immunmedierede bivirkninger i pkt.
Patients should be monitored for signs and symptoms and managed as recommended for other immune-mediated adverse reactions, in section 4.2.
IMFINZI blev ikke seponeret hos nogen patienter på grund af hypothyreoidisme.
IMFINZI was not discontinued in any patient due to hypothyroidism.
I den samlede sikkerhedsdatabase for IMFINZI-monoterapi forekom immunmedieret hyperthyreoidisme hos 34 (1,8 %) patienter; der forekom ingen tilfælde af Grad 3 eller 4.
In the combined safety database with IMFINZI monotherapy, immune-mediated hyperthyroidism occurred in 34 (1.8%) patients, there were no Grade 3 or 4 cases.
• infektioner i tandkød og mundvæv
• tooth and mouth soft tissue infections
Mediantiden til debut var 53 dage (interval: 1-341 dage).
The median time to onset was 53 days (range: 1-341 days).
IMFINZI leveres i enkeltdosis hætteglas og indeholder ingen konserveringsmidler.
IMFINZI is supplied as a single-dose vial and does not contain any preservatives, aseptic technique must be observed.
• betændelse i huden: Symptomerne kan omfatte udslæt, kløe, blærer på huden eller sår i munden eller på andre slimhinder
• inflammation of the skin: symptoms may include rash, itching, skin blistering or ulcers in the mouth or on other moist surfaces;
Hver ml koncentrat til infusionsvæske, opløsning indeholder 50 mg durvalumab.
Each mL of concentrate for solution for infusion contains 50 mg of durvalumab.
Hvis noget af ovenstående gælder for dig (eller du er i tvivl), skal du tale med din læge, før du får IMFINZI.
If any of the above apply to you (or you are not sure), talk to your doctor before you are given IMFINZI.
Grad 3 med serumkreatinin >3 x baseline eller >3-6 x ULN;
Grade 3 with serum creatinine > 3 x baseline or > 3-6 x ULN; Grade 4 with serum creatinine > 6 x ULN
j omfatter abdominalsmerter, nedre abdominalsmerter, øvre abdominalsmerter og lændesmerter.
includes abdominal pain, abdominal pain lower, abdominal pain upper and flank pain.
IMFINZI koncentrat til infusionsvæske, opløsning er en steril, klar til opaliserende, farveløs til svagt gul opløsning uden konserveringsmidler, der er fri for synlige partikler.
What IMFINZI looks like and contents of the pack IMFINZI concentrate for solution for infusion is a sterile, preservative-free, clear to opalescent, colourless to slightly yellow solution, free from visible particles.
Klar til opaliserende, farveløs til svagt gul opløsning, fri for synlige partikler.
Clear to opalescent, colourless to slightly yellow solution, free from visible particles.
Koncentratet er en klar til opaliserende, farveløs til svagt gul opløsning, der er fri for synlige partikler.
The concentrate is a clear to opalescent, colourless to slightly yellow solution, free from visible particles.
Mediantiden til debut var 74 dage (interval: 1-365 dage).
The median time to onset was 74 days (range: 1-365 days).
Hypofysitis/hypopituitarisme
Hypophysitis/Hypopituitarism
Hypofysitis/ Hypopituitarisme
Hypophysitis/hypopituitarism
Strålingspneumonitis observeres hyppigt hos patienter, der modtager strålebehandling af lungerne, og den kliniske præsentation af pneumonitis og strålingspneumonitis er meget ens. I PACIFIC-studiet forekom pneumonitis eller strålingspneumonitis hos patienter, der havde afsluttet behandling med mindst 2 behandlingscykler samtidig kemostråling inden for 1 til 42 dage før forsøgets begyndelse, hos 161 (33,9 %) patienter i den gruppe, der fik IMFINZI, og 58 (24,8 %) i placebogruppen, inklusive Grad 3 (3,4 % versus 3,0 %) og Grad 5 (1,1 % versus 1,7 %) (se pkt.
In the PACIFIC Study, in patients who had completed treatment with at least 2 cycles of concurrent chemoradiation within 1 to 42 days prior to initiation of the trial, pneumonitis or radiation pneumonitis occurred in 161 (33.9%) patients in the IMFINZI-treated group and 58 (24.8%) in the placebo group, including Grade 3 (3.4% vs 3.0%) and Grade 5 (1.1% vs 1.7%) (see section 4.8).
IMFINZI indeholder: Aktivt stof: durvalumab
What IMFINZI contains The active substance is durvalumab.
Immunmedieret hypothyreoidisme
Immune-mediated hypothyroidism
Immunmedieret hypofysitis eller hypopituitarisme forekom hos patienter, der fik IMFINZI (se pkt.
Immune-mediated hypophysitis or hypopituitarism occurred in patients receiving IMFINZI (see section 4.8).
1 ml koncentrat indeholder 50 mg durvalumab.
One ml of concentrate contains 50 mg of durvalumab.
IMFINZI 50 mg/ml sterilt koncentrat durvalumab i.v.
IMFINZI 50 mg/ml sterile concentrate durvalumab
Immunmedierede endokrinopatier
Immune-mediated endocrinopathies
IMFINZI blev seponeret hos alle tre patienter.
IMFINZI was discontinued in all 3 patients.
Kassér eventuelt ubrugt lægemiddel, som er tilbage i hætteglasset.
Discard any unused portion left in the vial.
2 (0,1 %) patienter fik højdosis-kortikosteroidbehandling (mindst 40 mg prednison eller tilsvarende per dag).
Two (0.1%) patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
I den kombinerede sikkerhedsdatabase med IMFINZI-monoterapi (n = 1889 multiple tumortyper) forekom der immunmedieret pneumonitis hos 79 (4,2 %) patienter, herunder Grad 3 hos 12 (0,6 %) patienter.
In the combined safety database with IMFINZI monotherapy, (n = 1889 multiple tumour types), immune-mediated pneumonitis occurred in 79 (4.2%) patients, including Grade 3 in 12 (0.6%) patients, Grade 4 in 1 (< 0.1%) patient, and Grade 5 in 5 (0.3%) patients.
Immunmedieret pneumonitis eller interstitiel lungesygdom, defineret som behandlingskrævende med systemiske kortikosteroider og uden klar alternativ ætiologi, forekom hos patienter, der fik IMFINZI.
Immune-mediated pneumonitis or interstitial lung disease, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMFINZI.
Immunmedieret adrenal insufficiens forekom hos patienter, der fik IMFINZI (se pkt.
Immune-mediated adrenal insufficiency occurred in patients receiving IMFINZI (see section 4.8).
Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, monoklonale antistoffer, ATC-kode: L01XC28
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies.
Patienterne bør monitores for unormale nyrefunktionsprøver før og periodisk under behandling med IMFINZI og behandles som anbefalet i pkt.
Patients should be monitored for abnormal renal function tests prior to and periodically during treatment with IMFINZI and managed as recommended in section 4.2.
Andre immunmedierede bivirkninger
Other immune-mediated adverse reactions
IMFINZI blev seponeret hos 2 patienter.
IMFINZI was discontinued in 2 patients.
Immunmedieret hyperthyreoidisme
Immune-mediated hyperthyroidism
I den samlede sikkerhedsdatabase for IMFINZI-monoterapi forekom infusionsrelaterede reaktioner hos 35 (1,9 %) patienter, inklusive Grad 3 hos 5 (0,3 %) patienter.
In the combined safety database with IMFINZI monotherapy, infusion related reactions occurred in 35 (1.9%) patients, including Grade 3 in 5 (0.3%) patients.
IMFINZI blev seponeret hos 4 patienter.
IMFINZI was discontinued in 4 patients.
• muskelbetændelse
• inflammation of the muscle
• øget funktion af skjoldbruskkirtlen, der kan forårsage hurtig hjerterytme eller vægttab
• overactive thyroid gland that can cause fast heart rate or weight loss
I den samlede sikkerhedsdatabase for IMFINZI-monoterapi forekom immunmedieret hepatitis hos 19 (1,0 %) patienter, inklusive Grad 3 hos 11 (0,6 %) patienter og Grad 5 (letal) hos 1 (<0,1 %) patient.
In the combined safety database with IMFINZI monotherapy, immune-mediated hepatitis occurred in 19 (1.0%) patients, including Grade 3 in 11 (0.6%) patients and Grade 5 (fatal) in 1 (< 0.1%) patient.
Et hætteglas med 2,4 ml koncentrat indeholder 120 mg durvalumab.
One vial of 2.4 ml of concentrate contains 120 mg of durvalumab.
I den samlede sikkerhedsdatabase for IMFINZI-monoterapi forekom immunmedieret colitis eller diarré hos 31 (1,6 %) patienter, inklusive Grad 3 hos 6 (0,3 %) patienter og Grad 4 hos 1 (<0,1 %) patient.
In the combined safety database with IMFINZI monotherapy, immune-mediated colitis or diarrhoea occurred in 31 (1.6%) patients, including Grade 3 in 6 (0.3%) patients and Grade 4 in 1 (<0.1%) patient.
Permanent seponering a
Permanently discontinue a
IMFINZI 50 mg/ml koncentrat til infusionsvæske, opløsning durvalumab
IMFINZI 50 mg/ml concentrate for solution for infusion durvalumab
Det skal du vide, før du begynder at få IMFINZI Sådan vil du få IMFINZI Bivirkninger
What IMFINZI is and what it is used for What you need to know before you are given IMFINZI How you are given IMFINZI Possible side effects
Patienterne bør monitoreres for tegn og symptomer på udslæt eller dermatit og behandles som anbefalet i pkt.
Patients should be monitored for signs and symptoms of rash or dermatitis and managed as recommended in section 4.2.
Et hætteglas med 10 ml koncentrat indeholder 500 mg durvalumab.
One vial of 10 mL of concentrate contains 500 mg of durvalumab.
Patientrapporterede resultater
Patient reported outcomes
Reproduktionstoksicitet.
Reproductive toxicology
I den samlede sikkerhedsdatabase for IMFINZI-monoterapi forekom immunmedieret udslæt eller dermatitis hos 30 (1,6 %) patienter, inklusive Grad 3 hos 7 (0,4 %) patienter).
In the combined safety database with IMFINZI monotherapy, immune-mediated rash or dermatitis occurred in 30 (1.6%) patients, including Grade 3 in 7 (0.4%) patients.
I den samlede sikkerhedsdatabase for IMFINZI-monoterapi forekom immunmedieret type 1-diabetes mellitus hos 1 (< 0,1 %) patient (Grad 3).
In the combined safety database with IMFINZI monotherapy, immune-mediated type 1 diabetes mellitus occurred in 1 (< 0.1%) patient (Grade 3).
I den samlede sikkerhedsdatabase for IMFINZI-monoterapi forekom immunmedieret hypothyreoidisme hos 137 (7,3 %) patienter, inklusive Grad 3 hos 1 (< 0,1 %) patient.
In the combined safety database with IMFINZI monotherapy, immune-mediated hypothyroidism occurred in 137 (7.3%) patients, including Grade 3 in 1 (< 0.1%) patient.
I den samlede sikkerhedsdatabase for IMFINZI-monoterapi forekom immunmedieret adrenal insufficiens hos 7 (0,4 %) patienter inklusive Grad 3 hos 1 (< 0,1 %) patient.
In the combined safety database with IMFINZI monotherapy, immune-mediated adrenal insufficiency occurred in 7 (0.4%) patients, including Grade 3 in 1 (< 0.1%) patient.
I den samlede sikkerhedsdatabase for IMFINZI-monoterapi forekom immunmedieret hypopituitarisme hos 1 (< 0,1 %) patient (Grad 3).
In the combined safety database with IMFINZI monotherapy, immune-mediated hypopituitarism occurred in 1 (< 0.1%) patient (Grade 3).
IMFINZI 50 mg/ml koncentrat til infusionsvæske, opløsning
IMFINZI 50 mg/mL concentrate for solution for infusion
16 ud af de 31 patienter fik højdosis-kortikosteroidbehandling (mindst 40 mg prednison eller tilsvarende per dag).
Sixteen of the 31 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
11 af de 30 patienter fik højdosis-kortikosteroidbehandling (mindst 40 mg prednison eller tilsvarende per dag).
Eleven of the 30 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
I den samlede sikkerhedsdatabase for IMFINZI-monoterapi forekom immunmedieret nefritis hos 3 (0,2 %) patienter, inklusive Grad 3 hos 1 (< 0,1 %) patient.
In the combined safety database with IMFINZI monotherapy, immune-mediated nephritis occurred in 3 (0.2%) patients, including Grade 3 in 1 (< 0.1%) patient.
13 ud af 19 patienter fik højdosis-kortikosteroidbehandling (mindst 40 mg prednison eller tilsvarende per dag).
Thirteen of the 19 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
HR (95 % CI) 2-sidet p-værdi OS ved 24 måneder (%) (95 % CI) p-værdi PFS Antal hændelser (%) Median PFS (måneder) (95% CI) HR (95% CI) p-værdi p < 0,0001
HR (95% CI) 2-sided p-value OS at 24 months (%)
Overvej initial dosis på 1-4 mg/kg/dag prednison eller tilsvarende, efterfulgt af nedtrapning
Consider initial dose of 1 mg/kg/day to 4 mg/kg/day prednisone or equivalent followed by taper
PFS ved 18 måneder (%) (95% CI)
PFS at 12 months (%) (95% CI) PFS at 18 months (%) (95% CI) PFS2 Median PFS2
Immunmedieret colitis eller diarré, defineret som behandlingskrævende med systemiske kortikosteroider og uden klar alternativ ætiologi, forekom hos patienter, der fik IMFINZI (se pkt.
Immune-mediated colitis or diarrhoea, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMFINZI (see section 4.8).
Median PFS2 b (måneder)
b (months)
• nedsat funktion af skjoldbruskkirtlen, der kan forårsage træthed eller vægtøgning
• underactive thyroid gland that can cause tiredness or weight gain
Fremstilling af opløsning
Preparation of solution
Immunmedieret hepatitis, defineret som behandlingskrævende med systemiske kortikosteroider og uden klar alternativ ætiologi, forekom hos patienter, der fik IMFINZI (se pkt.
Immune-mediated hepatitis, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMFINZI (see section 4.8).
Initiér 2-4 mg/kg/dag prednison eller tilsvarende, efterfulgt af nedtrapning
Initiate 2 to 4 mg/kg/day prednisone or equivalent followed by a taper
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Immunmedieret nefritis, defineret som behandlingskrævende med systemiske kortikosteroider og uden klar alternativ ætiologi, forekom hos patienter, der fik IMFINZI (se pkt.
Immune-mediated nephritis, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMFINZI (see section 4.8).