FrancophonIA/ELRC3.0 huggingface dataset:
English: • Signs of inflammation of the intestines (colitis) may include diarrhoea (loose stools) or more bowel movements than usual, blood in your stools or dark, tarry, sticky stools, or severe stomach (abdomen) pain or tenderness.
Icelandic: Merki um bólgu í þörmum (ristilbólgu) geta verið niðurgangur (þunnar hægðir) eða tíðari hægðir en venjulega, blóð í hægðum eða dökkar, tjörulitar, slímkenndar hægðir eða svæsnir verkir í maga (kvið) eða eymsli.
English: Figure 4: Forest plot of progression-free survival based on BICR assessment in patients irrespective of PD-L1 expression
Icelandic: Forest plot mynd af lifun án versnunar samkvæmt blindaðri og óháðri matsnefnd hjá sjúklingum óháð PD-L1 tjáningu
English: bumpy rash or skin wheals, flushing, low blood pressure (dizziness, fatigue, nausea) fever,
Icelandic: upphleypt útbrot eða rauðkláðaþot á húð, roðaþot, lágan blóðþrýsting (sundl, þreyta,
English: The median time to onset of thyroid disorders was 2.8 months (range: 2 weeks to 13 months).
Icelandic: Miðgildi tímans þar til skjaldkirtilsraskanir hófust var 2,8 mánuðir (bil: 2 vikur til 13 mánuðir).
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).
Icelandic: Ef um er að ræða ónæmistengda lungnabólgu af stigi 2 skal hætta notkun avelúmabs þar til hún gengur til baka og hætta notkun alveg ef um er að ræða ónæmistengda lungnabólgu af stigi 3, stigi 4 eða endurtekna ónæmistengda lungnabólgu af stigi 2 (sjá kafla 4.2).
English: Infusion-related reactions, which might be severe, have been reported in patients receiving avelumab (see section 4.8).
Icelandic: Tilkynnt hefur verið um innrennslistengdar aukaverkanir, sem kunna að reynast alvarlegar, hjá sjúklingum sem fengu avelúmab (sjá kafla 4.8).
English: Of the 88 patients, 65 (74%) were male, the median age was 73 years (range 33 years to 88 years), 81 (92%) patients were Caucasian, and 49 (56%) patients and 39 (44%) patients with an Eastern Cooperative Oncology Group (ECOG) performance status 0 and 1, respectively.
Icelandic: Af sjúklingunum 88 voru 65 (74%) karlkyns, miðgildi aldurs var 73 ár (á bilinu 33 ár til 88 ár), 81 (92%) sjúklingur var hvítur og 49 (56%) sjúklingar og 39 (44%) sjúklingar voru með færnistöðu samkvæmt
English: • Feeling less hungry, weight loss
Icelandic: Minni matarlyst, þyngdartap
English: In patients treated with avelumab in combination with axitinib, Type 1 diabetes mellitus without an alternative aetiology occurred in 1.0% (5/489) of patients.
Icelandic: Hjá sjúklingum sem fengu meðferð með avelúmabi samhliða axitinibi kom sykursýki af gerð 1 án annars uppruna fram hjá 1,0% (5/489) sjúklinga.
English: If you stop receiving Bavencio
Icelandic: Ef hætt er að nota Bavencio
English: In patients treated with avelumab in combination with axitinib, immune-related nephritis occurred in 0.4% (2/489) of patients.
Icelandic: Hjá sjúklingum sem fengu meðferð með avelúmabi samhliða axitinibi kom ónæmistengd nýrnabólga fram hjá 0,4% (2/489) sjúklinga.
English: Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).
Icelandic: Bavencio er ætlað sem einlyfjameðferð til að meðhöndla fullorðna sjúklinga með bjálkakrabbamein með meinvörpum.
English: If ALT or AST ≥ 5 times ULN or > 3 times ULN with concurrent total bilirubin ≥ 2 times ULN or total bilirubin ≥ 3 times ULN, both Bavencio and axitinib should be permanently discontinued and corticosteroid therapy should be considered.
Icelandic: 2 sinnum ULN eða heildargallrauði er ≥ 3 sinnum ULN, skal stöðva meðferð með Bavencio og axitinibi til frambúðar og íhuga barksterameðferð.
English: Patients should be monitored for changes in liver function and symptoms of immune-related hepatitis and causes other than immune-related hepatitis should be ruled out.
Icelandic: Hafa skal eftirlit með sjúklingum með tilliti til breytinga á starfsemi lifrar og einkenna um ónæmistengda lifrarbólgu og útiloka skal aðrar orsakir en ónæmistengda lifrarbólgu.
English: Weight decreased
Icelandic: Mjög algengar Þyngdartap
English: Adverse reactions Infections and infestations
Icelandic: Útlimabjúgur, inflúensulíkur sjúkdómur
English: Lymphopenia, eosinophilia
Icelandic: Eitilfrumnafæð, eósínfíklager
English: The median time to onset of immune-related hepatitis was 2.3 months (range: 2.1 weeks to 14.5 months).
Icelandic: Miðgildi tímans þar til ónæmistengd lifrarbólga hófst var 2,3 mánuðir (bil: 2,1 vika til 14,5 mánuðir).
English: How to store Bavencio
Icelandic: Hvernig geyma á Bavencio
English: • Patient Alert Card
Icelandic: Öryggiskort sjúklings
English: If corticosteroids are used to treat an adverse reaction, a taper of at least 1 month duration should be initiated upon improvement.
Icelandic: Ef barksterar eru notaðir til þess að meðhöndla aukaverkun skal hefja stigminnkandi meðferð sem stendur í a.m.k.
English: • inflammation of your pancreas (pancreatitis);
Icelandic: • bólga í brisi (brisbólga);
English: Immune-related hepatitis occurred in patients treated with avelumab.
Icelandic: Ónæmistengd lifrarbólga kom fram hjá sjúklingum sem fengu meðferð með avelúmabi.
English: • Joint pain, back pain, belly pain, muscle pain
Icelandic: Liðverkir, bakverkir, vöðvaverkir
English: Immune-related nephritis and renal dysfunction Avelumab can cause immune-related nephritis (see section 4.8).
Icelandic: Ónæmistengd nýrnabólga og vanstarfsemi nýrna Avelúmab getur valdið ónæmistengdri nýrnabólgu (sjá kafla 4.8).
English: The European Medicines Agency will review new information on this medicinal product at least every year and this SmPC will be updated as necessary.
Icelandic: Evrópu metur nýjar upplýsingar um lyfið að minnsta kosti árlega og uppfærir samantekt á eiginleikum lyfsins eftir því sem þörf krefur.
English: Two fatal cases have been reported in patients receiving avelumab (see section 4.8).
Icelandic: Tilkynnt var um tvö banvæn tilfelli hjá sjúklingum sem fengu avelúmab (sjá kafla 4.8).
English: Patients should be monitored for signs and symptoms of adrenal insufficiency during and after treatment.
Icelandic: Hafa skal eftirlit með sjúklingum með tilliti til merkja og einkenna um nýrnahettubilun meðan á meðferð stendur og eftir að henni lýkur.
English: Patients should be monitored for signs and symptoms of immune-related pneumonitis and causes other than immune-related pneumonitis should be ruled out.
Icelandic: Hafa skal eftirlit með sjúklingum með tilliti til merkja og einkenna um ónæmistengda lungnabólgu og útiloka skal aðrar orsakir en ónæmistengda lungnabólgu.
English: Table 4: Response to avelumab 10 mg/kg every 2 weeks in patients with metastatic MCC in study EMR100070-003 (Part A)*
Icelandic: Svörun við avelúmabi 10 mg/kg á 2 vikna fresti hjá sjúklingum með bjálkakrabbamein með meinvörpum í rannsókn EMR100070-003 (hluta A)*
English: For any of the following:
Icelandic: Ef um eftirfarandi er að ræða:
English: Eight (88.9%) patients with immune-related adrenal insufficiency were treated with corticosteroids and 2 (25%) of the 8 patients received high-dose corticosteroids (≥ 40 mg prednisone or equivalent) for a median of 8 days (range: 5 days to 11 days).
Icelandic: (25%) af sjúklingunum 8 fengu meðferð með stórum skömmtum af barksterum (≥ 40 mg af prednisóni eða sambærilegu) í 8 daga að miðgildi (bil: 5 dagar til 11 dagar).
English: Grade 4 colitis or diarrhoea or recurrent Grade 3 colitis
Icelandic: Ristilbólga eða niðurgangur af stigi 4 eða endurtekin ristilbólga af stigi 3
English: Table 6: Subsequent interim analysis of response to avelumab 10 mg/kg every 2 weeks in patients with metastatic MCC in study EMR100070-003 (Part B)*
Icelandic: Síðari milligreining á svörun við avelúmabi 10 mg/kg á 2 vikna fresti hjá sjúklingum með bjálkakrabbamein með meinvörpum í rannsókn EMR100070-003 (hluta B)*
English: Withhold
Icelandic: Samantekt
English: The median time to onset of immune-related colitis was 5.1 months (range: 2.3 weeks to 14 months).
Icelandic: Miðgildi tímans þar til ónæmistengd ristilbólga hófst var 5,1 mánuður (bil: 2,3 vikur til 14 mánuðir).
English: One fatal case has been reported in patients receiving avelumab (see section 4.8).
Icelandic: Tilkynnt var um eitt banvænt tilfelli hjá sjúklingum sem fengu avelúmab (sjá kafla 4.8).
English: • Patient Information brochure
Icelandic: Upplýsingar fyrir sjúkling
English: • Grade 2 or Grade 3 clinical signs or symptoms of an immune-related adverse reaction not described above.
Icelandic: Klínísk merki eða einkenni um ónæmistengda aukaverkun sem ekki er lýst hér að ofan, af stigi 2 eða 3.
English: • Signs of type 1 diabetes may include feeling more hungry or thirsty than usual, needing to urinate more often, weight loss, and feeling tired.
Icelandic: Merki um sykursýki af gerð 1 geta m.a. verið meiri svengd eða þorsti en venjulega, tíðari þörf til að kasta þvagi, þyngdartap og þreytutilfinning.
English: Avelumab was discontinued in 0.3% (6/1,738) of patients due to immune-related pneumonitis.
Icelandic: Notkun avelúmabs var hætt hjá 0,3% (6/1.738) sjúklinga vegna ónæmistengdrar lungnabólgu.
English: If refrigerated, allow the diluted solution in the intravenous bags to come to room temperature prior to use.
Icelandic: Ef þynnta lausnin í pokum til notkunar í bláæð er geymd í kæli skal láta hana ná stofuhita fyrir notkun.
English: Dose reduction according to the axitinib product information should be considered if rechallenging with axitinib.
Icelandic: Íhuga skal skammtaminnkun samkvæmt lyfjaupplýsingunum um axitinib við endurgjöf með axitinibi.
English: 1 vial
Icelandic: Mynd 1:
English: • Increased liver enzymes in the blood
Icelandic: Hækkuð lifrarensím í blóði
English: For Grade 3 or Grade 4 infusion-related reactions, the infusion should be stopped and avelumab should be permanently discontinued (see section 4.2).
Icelandic: Ef um er að ræða innrennslistengdar aukaverkanir af stigi 3 eða 4 skal stöðva innrennslið og hætta notkun avelúmabs fyrir fullt og allt (sjá kafla 4.2).
English: • Guillain-Barré Syndrome (an immune system disorder that causes nerve inflammation and can result in pain, numbness, muscle weakness and difficulty walking)
Icelandic: Guillaine-Barré heilkenni (röskun í ónæmiskerfi sem veldur taugabólgu og getur valdið verk,
English: The median time to onset of immune-related adrenal insufficiency was 2.5 months (range: 1 day to 8 months).
Icelandic: Miðgildi tímans þar til ónæmistengd nýrnahettubilun hófst var 2,5 mánuðir (bil: 1 dagur til 8 mánuðir).
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)
Icelandic: Hlutlæg svörun eftir PD-L1 tjáningu og MCV æxlisstöðu hjá sjúklingum með bjálkakrabbamein með meinvörpum í rannsókn EMR100070-003 (hluta A)
English: In patients treated with avelumab in combination with axitinib, 0.6% (3/489) of patients developed immune-related pneumonitis.
Icelandic: Hjá sjúklingum sem fengu meðferð með avelúmabi samhliða axitinibi fengu 0,6% (3/489) sjúklinga ónæmistengda lungnabólgu.
English: Human IgG1 immunoglobulins are known to cross the placental barrier.
Icelandic: Þekkt er að IgG1 ónæmisglóbúlín manna berast yfir fylgju.
English: Premedication
Icelandic: Háþrýstingur
English: may include extreme tiredness, rapid heartbeat, increased sweating, changes in mood or behaviour, such as irritability or forgetfulness, feeling cold, very low blood pressure (fainting, dizziness, fatigue, nausea), weight change or headache.
Icelandic: • Merki um bólgu í kirtlum sem framleiða hormón (sem getur haft áhrif á það hvernig kirtlarnir virka) geta m.a. verið óvenju mikil þreyta, hraður hjartsláttur, aukin svitamyndun, breytingar á skapi eða hegðun svo sem pirringur eða gleymska, kuldatilfinning, mjög lágur blóðþrýstingur (yfirlið, sundl, þreyta, ógleði), breytingar á þyngd eða höfuðverkur.
English: Vascular disorders
Icelandic: Skjaldkirtilsraskanir
English: Autoimmune hepatitis*, acute hepatic failure*, hepatic failure*, hepatitis*
Icelandic: Sjálfsnæmislifrarbólga*, bráð lifrarbilun*, lifrarbilun*, lifrarbólga*
English: Tumour response assessments were performed every 6 weeks, as assessed by an Independent Endpoint Review Committee (IERC) using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Icelandic: Mat var framkvæmt á æxlissvörun á 6 vikna fresti í samræmi við mat sjálfstæðrar endurskoðunarnefndar varðandi endapunkta (IERC) þar sem notast var við viðmiðun fyrir svörunarmat vegna fastra æxla (RECIST), útg.
English: • Recommendation to consult the package leaflet
Icelandic: Tilmæli um að lesa fylgiseðilinn
English: INSTRUCTIONS ON USE
Icelandic: Leiðbeiningar um meðhöndlun
English: Rash*, pruritus*, rash maculo-papular*, dry skin
Icelandic: Útbrot*, kláði*, dröfnu-örðuútbrot*, þurr húð
English: Your doctor may
Icelandic: Karl Kona
English: The prespecified interim analysis for Part B included 39 patients who received at least one dose of avelumab and 29 patients with a minimum 13 weeks of follow-up at the time of the data cut-off (cut-off date 24 March 2017).
Icelandic: Forskilgreinda milligreiningin fyrir hluta B tók til 39 sjúklinga sem fengu a.m.k. einn skammt af avelúmabi og 29 sjúklinga sem höfðu fengið a.m.k.
English: The median time to onset of immune-related hepatitis was 3.2 months (range: 1 week to 15 months).
Icelandic: Miðgildi tímans þar til ónæmistengd lifrarbólga hófst var 3,2 mánuðir (bil: 1 vika til 15 mánuðir).
English: • Signs of infusion-related reactions such as shortness of breath or wheezing, chills or shaking,
Icelandic: • Merki um innrennslistengdar aukaverkanir á borð við mæði eða más, kuldahroll eða skjálfta,
English: Rash pustular
Icelandic: Ónæmistengd brisbólga
English: Dry mouth, colitis
Icelandic: Húðútbrot, kláði
English: The following side effects have been reported in clinical trials with avelumab alone:
Icelandic: Tilkynnt hefur verið um eftirfarandi aukaverkanir í klínískum rannsóknum á avelúmabi einu og sér:
English: Headache, dizziness
Icelandic: Útbrot, kláði
English: The median time to onset of immune-related colitis was 2.1 months (range: 2 days to 11 months).
Icelandic: Miðgildi tímans þar til ónæmistengd ristilbólga hófst var 2,1 mánuðir (bil: 2 dagar til 11 mánuðir).
English: Based on the severity of the adverse reaction, avelumab should be withheld and corticosteroids to be administered.
Icelandic: Byggt á vægi aukaverkana skal hætta notkun avelúmabs og gefa barkstera.
English: Infusion related reaction
Icelandic: Innrennslistengd viðbrögð
English: Bavencio 20 mg/mL concentrate for solution for infusion avelumab
Icelandic: Bavencio 20 mg/ml innrennslisþykkni, lausn avelúmab
English: Rash pruritic*, erythema*, rash generalised*, psoriasis*, rash erythematous*, rash macular*, rash papular*, dermatitis exfoliative*, erythema multiforme*, pemphigoid*, pruritus generalised*, eczema, dermatitis
Icelandic: Útbrot ásamt kláða*, roði*, almenn útbrot*, sóri*, útbrot ásamt roða*, dröfnuútbrot*, örðuútbrot*, skinnflagningsbólga*, regnbogaroði*, húðupphlaup*, almennur kláði*, exem, húðbólga
English: In patients treated with avelumab in combination with axitinib, 6.3% (31/489) of patients developed immune-related hepatitis.
Icelandic: Hjá sjúklingum sem fengu meðferð með avelúmabi samhliða axitinibi fengu 6,3% (31/489) sjúklinga ónæmistengda lifrarbólgu.
English: In patients treated with avelumab as monotherapy, 1.5% (26/1,738) of patients developed immune-related colitis.
Icelandic: Hjá sjúklingum sem fengu meðferð með avelúmabi sem einlyfjameðferð fengu 1,5% (26/1.738) sjúklinga ónæmistengda ristilbólgu.
English: In ADA positive patients, there may be an increased risk for infusion-related reactions (about 40% and 25% in ADA ever-positive and ADA never-positive patients, respectively).
Icelandic: 40% hjá sjúklingum sem alltaf voru jákvæðir fyrir meðferðartengdum mótefnum gegn lyfinu og 25% hjá sjúklingum sem aldrei voru jákvæðir fyrir meðferðartengdum mótefnum gegn lyfinu).
English: The key secondary endpoints were PFS based on BICR assessment per RECIST v1.1 and OS irrespective of PD-L1 expression.
Icelandic: Helstu viðbótarmælibreytur voru lifun án versnunar metin af blindaðri og óháðri matsnefnd samkvæmt RECIST v1.1 og heildarlifun óháð PD-L1 tjáningu.
English: Two fatal cases have been reported in patients receiving avelumab in combination with axitinib (see section 4.8).
Icelandic: Tilkynnt var um tvö banvæn tilfelli hjá sjúklingum sem fengu avelúmab samhliða axitinibi (sjá kafla 4.8).
English: Pneumonitis
Icelandic: Vöðvaverkir
English: Avelumab was discontinued in 0.4% (2/489) of patients due to immune-related colitis.
Icelandic: Notkun avelúmabs var hætt hjá 0,4% (2/489) sjúklinga vegna ónæmistengdrar ristilbólgu.
English: When avelumab 10 mg/kg was administered in combination with axitinib 5 mg, the respective exposures of avelumab and axitinib were unchanged compared to the single agents.
Icelandic: 10 mg/kg var gefið samhliða axitinibi 5 mg var útsetning fyrir avelúmabi og axitinibi, hvoru um sig, eins og þegar lyfin voru gefin ein sér.
English: Patients should be monitored for hyperglycaemia or other signs and symptoms of diabetes.
Icelandic: Hafa skal eftirlit með sjúklingum með tilliti til blóðsykurshækkunar eða annarra merkja og einkenna um sykursýki.
English: Treatment modification
Icelandic: Breyting á meðferð
English: Autoimmune thyroiditis, hypophysitis
Icelandic: Sjálfsnæmisskjaldkirtilsbólga, heiladingulsbólga
English: In patients treated with avelumab in combination with axitinib, 1.8% (9/489) of patients developed immune-related adrenal insufficiency.
Icelandic: Hjá sjúklingum sem fengu meðferð með avelúmabi samhliða axitinibi fengu 1,8% (9/489) sjúklinga ónæmistengda nýrnahettubilun.
English: Of these patients, there were 7 (0.4%) patients with Grade 3 immune-related colitis.
Icelandic: Af þessum sjúklingum fengu 7 (0,4%) sjúklingar ónæmistengda ristilbólgu af stigi 3.
English: For Part B, the major efficacy outcome measure was durable response, defined as objective response (complete response (CR) or partial response (PR)) with a duration of at least 6 months; secondary outcome measures included BOR, DOR, PFS, and OS.
Icelandic: Í hluta B var helsta mælingin á verkunarniðurstöðum viðvarandi svörun, sem var skilgreind sem hlutlæg svörun (full svörun (CR) eða hlutasvörun (PR)) sem varði a.m.k.
English: Hepatic impairment
Icelandic: Ónæmistengd hjartavöðvabólga
English: • you have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS);
Icelandic: þú ert með sýkingu af völdum HIV veiru eða alnæmi;
English: Avelumab was discontinued in 0.2% (1/489) of patients due to Type 1 diabetes mellitus.
Icelandic: Notkun avelúmabs var hætt hjá 0,2% (1/489) sjúklinga vegna sykursýki af gerð 1.
English: Grade 3 or Grade 4 infusion-related reaction
Icelandic: Innkirtlakvillar af stigi 3 eða 4
English: The objective response rate (ORR) was 62.1% (95% CI: 42.3, 79.3) with 4 (14%) of patients reported to have a complete response and 14 (48%) to have a partial response.
Icelandic: 42,3; 79,3) og tilkynnt var um að 4 (14%) sjúklingar hefðu náð fullri svörun og 14 (48%) hefðu náð hlutasvörun.
English: No interaction studies have been conducted with avelumab.
Icelandic: Ekki hafa verið gerðar neinar rannsóknir á milliverkunum með avelúmabi.
English: Adrenal insufficiency resolved in 1 patient with corticoid treatment at the time of data cut-off.
Icelandic: Nýrnahettubilun gekk til baka hjá 1 sjúklingi sem fékk barksterameðferð, í lok rannsóknartímans.
English: Uveitis*
Icelandic: Æðahjúpsbólga*
English: Of these patients, there were 2 (0.4%) patients with Grade 3 immune-related adrenal insufficiency.
Icelandic: Af þessum sjúklingum voru 2 (0,4%) sjúklingar með ónæmistengda nýrnabólgu af stigi
English: In patients treated with avelumab as monotherapy, 0.9% (16/1,738) of patients developed immune-related hepatitis.
Icelandic: Hjá sjúklingum sem fengu meðferð með avelúmabi sem einlyfjameðferð fengu 0,9% (16/1.738) sjúklinga ónæmistengda lifrarbólgu.
English: Immune-related pancreatitis
Icelandic: Ónæmistengd lifrarbólga
English: Musculoskeletal and connective tissue disorders
Icelandic: Aukaverkanir Stoðkerfi og bandvefur
English: Avelumab was discontinued in 0.2% (1/489) of patients due to immune-related thyroid disorders.
Icelandic: Notkun avelúmabs var hætt hjá 0,2% (1/489) sjúklinga vegna ónæmistengdra skjaldkirtilsraskana.
English: Avelumab should be withheld for Grade 3 or Grade 4 thyroid disorders (see section 4.2).
Icelandic: Ef um er að ræða skjaldkirtilsraskanir af stigi 3 eða 4 skal hætta notkun avelúmabs (sjá kafla 4.2).
English: Breast-feeding women should be advised not to breast-feed during treatment and for at least 1 month after the last dose due to the potential for serious adverse reactions in breast-fed infants.
Icelandic: 1 mánuð eftir síðasta skammtinn þar sem möguleiki er á alvarlegum aukaverkunum hjá börnum sem eru á brjósti.
English: Analysis of progression-free survival (PFS) was based on 39 patients who received at least one dose of avelumab, with median PFS of 9.1 months (95% CI: 1.9, not estimable) and estimated 3-month PFS rate by Kaplan-Meier of 67% (95% CI: 48, 80).
Icelandic: Greining á lifun án versnunar sjúkdóms (PFS) var byggð á 39 sjúklingum sem fengu a.m.k. einn skammt af avelúmabi, þar sem miðgildi lifunar án versnunar sjúkdóms var 9,1 mánuður (95% CI:
English: Patients should be monitored for signs and symptoms of immune-related pancreatitis.
Icelandic: Hafa skal eftirlit með sjúklingum með tilliti til merkja og einkenna um ónæmistengda brisbólgu.
English: Twenty-eight (90.3%) of the 31 patients received high dose corticosteroids for a median of 2.4 weeks (range: 1 day to 10.2 months).
Icelandic: 31 voru meðhöndlaðir með stórum skömmtum af barksterum í 2,4 vikur að miðgildi (bil: 1 dagur til 10,2 mánuðir).
English: Pancreatitis
Icelandic: Undirhópur
English: Dry mouth
Icelandic: Munnþurrkur
English: • Feeling tired or weak
Icelandic: Þreytu- eða slappleikatilfinning
English: Treatment with avelumab should be resumed when metabolic control is achieved on insulin replacement therapy.
Icelandic: Hefja skal meðferð með avelúmabi á ný þegar stjórn hefur verð náð á efnaskiptum við uppbótarmeðferð með insúlíni.
English: Treatment-related adverse reaction
Icelandic: Meðferðartengd aukaverkun
English: Patients should be monitored for signs and symptoms of immune-related colitis and causes other than immune-related colitis should be ruled out.
Icelandic: Hafa skal eftirlit með sjúklingum með tilliti til merkja og einkenna um ónæmistengda ristilbólgu og útiloka skal aðrar orsakir en ónæmistengda ristilbólgu.
English: Avelumab has also shown to induce natural killer (NK) cell-mediated direct tumour cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC).
Icelandic: örvar beint rof æxlisfrumna sem miðlað er af náttúrulegum drápsfrumum (NK) samanborið við mótefnaháðar frumumiðlaðar eiturverkanir á frumur (ADCC).
English: For renal cell cancer, Bavencio is to be used in combination with axitinib.
Icelandic: Hvað varðar nýrnafrumukrabbamein á að nota Bavencio samhliða axitinibi.
English: In patients treated with avelumab as monotherapy, 0.5% (8/1,738) of patients developed immune-related adrenal insufficiency.
Icelandic: Hjá sjúklingum sem fengu meðferð með avelúmabi sem einlyfjameðferð fengu 0,5% (8/1.738) sjúklinga ónæmistengda nýrnahettubilun.
English: Mannitol
Icelandic: Bavencio
English: Preparation and administration An aseptic technique for the preparation of the solution for infusion should be used.
Icelandic: Undirbúningur og lyfjagjöf Undirbúa skal innrennslislausnina með smitgát.
English: Avelumab was discontinued in 0.5% (9/1,738) of patients due to immune-related colitis.
Icelandic: Notkun avelúmabs var hætt hjá 0,5% (9/1.738) sjúklinga vegna ónæmistengdrar lifrarbólgu.
English: Of the 39 patients, 30 (77%) were male, the median age was 75 years (range: 47 to 88 years), 33 (85%) were Caucasian, and 31 (79%) and 8 (21%) had an ECOG performance status of 0 and 1 respectively.
Icelandic: 47 ár til 88 ár), 33 (85%) sjúklingar voru hvítir og 31 (79%) sjúklingur og 8 (21%) sjúklingar voru með færnistöðu samkvæmt