FrancophonIA/ELRC3.0 huggingface dataset:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 50 mg
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM RIFGÖTUÐ ÞYNNA fyrir 50 mg
English: GIOTRIF (40 mg/day) N=160
Icelandic: GIOTRIF (40 mg/sólarhring) N=392
English: If you get any side effects, talk to your doctor or pharmacist.
Icelandic: Ef þú færð útbrot skaltu segja lækninum frá því.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/010
Icelandic: MARKAÐSLEYFISNÚMER EU/1/13/879/010
English: Randomization was stratified by race (Eastern Asian vs non Eastern Asian).
Icelandic: Slembiröðun var lagskipt eftir kynþætti (austurasískum annars vegar og öðrum hins vegar).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 20 mg)
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI ASKJA (PAKKNING FYRIR ÞYNNUR fyrir 20 mg)
English: Subjects with moderate renal impairment (n=8; eGFR 30-59 mL/min/1.73m², according to the Modification of Diet in Renal Disease [MDRD] formula) had an exposure of 101% (Cmax) and 122% (AUC0-tz) in comparison to their healthy controls.
Icelandic: [Modification of Diet in Renal Disease]) voru með 101% (Cmax) og 122% (AUC0-tz) útsetningu samanborið við heilbrigða einstaklinga.
English: Weight decreased
Icelandic: Staðfesta skal stöðu
English: Each film-coated tablet contains 20 mg of afatinib (as dimaleate).
Icelandic: Hver filmuhúðuð tafla inniheldur 20 mg af afatinibi (sem dimaleat).
English: In humans, excretion of afatinib is primarily via the faeces.
Icelandic: Hjá mönnum er útskilnaður afatinibs aðallega með hægðum.
English: Includes Stomatitis, Aphthous stomatitis, Mucosal inflammation, Mouth ulceration, Mucosal erosion Includes group of rash preferred terms
Icelandic: Felur í sér munnbólgu, munnangur, slímhúðarbólgu, sár í munni og fleiður á munnslímhúð Felur í sér ýmiss konar útbrot
English: Reporting the frequency of patients with all causality AEs Includes Paronychia, Nail infection, Nail bed infection Includes Stomatitis, Aphthous stomatitis, Mucosal inflammation, Mouth ulceration, Oral mucosa erosion, Mucosal erosion, Mucosal ulceration Includes group of rash preferred terms Includes Acne, Acne pustular, Dermatitis acneiform
Icelandic: Tíðni sjúklinga með aukaverkanir af hvaða orsök sem er Felur í sér naglgerðisbólgu, sýkingu í nöglum og sýkingu í naglabeði Felur í sér munnbólgu, munnangur, slímhúðarbólgu og sár í munni, fleiður á munnslímhúð, fleiður á slímhúð og sár á slímhúð Felur í sér ýmiss konar útbrot Felur í sér þrymlabólur og graftarþrymlabólur, húðbólgu sem líkist þrymlabólum
English: Exposure to afatinib moderately increased with lowering of the creatinine clearance (CrCL, calculated according to Cockcroft Gault), i.e. for a patient with a CrCL of 60 mL/min or 30 mL/min exposure (AUCτ,ss) to afatinib increased by 13% and 42%, respectively, and decreased by 6% and 20% for a patient with CrCL of 90 mL/min or 120 mL/min, respectively, compared to a patient with the CrCL of 79 mL/min (median CrCL of patients in the overall patient population analysed).
Icelandic: Útsetning fyrir afatinibi jókst miðlungsmikið þegar kreatínínúthreinsun var minni (reiknuð kreatínínúthreinsun samkvæmt Cockcroft Gault), þ.e. hjá sjúklingum með kreatínínúthreinsun 60 ml/mín. eða 30 ml/mín. jókst útsetning
English: Hazard Ratio/ Odds Ratio (95%CI)
Icelandic: Áhættuhlutfall/ líkindahlutfall (95%CI)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 30 mg
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM RIFGÖTUÐ ÞYNNA fyrir 30 mg
English: Odds Ratio (OR) (95%CI) p-value
Icelandic: Líkindahlutfall (OR) (95%CI) p-gildi
English: NAME OF THE MEDICINAL PRODUCT GIOTRIF 20 mg tablets afatinib
Icelandic: HEITI LYFS GIOTRIF 20 mg töflur afatinib
English: GIOTRIF 50 mg film-coated tablets EU/1/13/879/010
Icelandic: GIOTRIF 50 mg filmuhúðaðar töflur EU/1/13/879/010
English: GIOTRIF 30 mg film-coated tablets
Icelandic: GIOTRIF 30 mg filmuhúðaðar töflur
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED BLISTER for 40 mg
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM RIFGÖTUÐ ÞYNNA fyrir 40 mg
English: GIOTRIF 20 mg film-coated tablets afatinib
Icelandic: GIOTRIF 20 mg filmuhúðaðar töflur afatinib
English: Includes Hypokalaemia, Blood potassium decreased Includes Rhinorrhoea, Nasal inflammation
Icelandic: Felur í sér kalíumskort og lækkað kalíum í blóði Felur í sér nefrennsli, nefbólgu
English: GIOTRIF 40 mg film-coated tablets
Icelandic: GIOTRIF 40 mg filmuhúðaðar töflur
English: Patients who become dehydrated may require administration of intravenous electrolytes and fluids.
Icelandic: Sjúklingum sem útsettir eru fyrir sólarljósi er ráðlagt að nota hlífðarfatnað og sólarvörn.
English: NAME OF THE MEDICINAL PRODUCT GIOTRIF 30 mg tablets afatinib
Icelandic: HEITI LYFS GIOTRIF 30 mg töflur afatinib
English: Other secondary endpoints included ORR, DCR, change in tumour size and HRQOL.
Icelandic: Aðrir aukaendapunktar voru m.a. svörunartíðni, beislun sjúkdóms, breyting á stærð æxlis og heilbrigðistengd lífsgæði (HRQOL).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 20 mg afatinib (as dimaleate).
Icelandic: VIRK(T) EFNI Hver filmuhúðuð tafla inniheldur 20 mg afatinib (sem dimaleat).
English: NAME OF THE MEDICINAL PRODUCT GIOTRIF 50 mg tablets afatinib
Icelandic: HEITI LYFS GIOTRIF 50 mg töflur afatinib
English: Severe hepatic impairment
Icelandic: Lifun án versnunar sjúkdóms
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 September 2013
Icelandic: DAGSETNING FYRSTU ÚTGÁFU MARKAÐSLEYFIS / ENDURNÝJUNAR MARKAÐSLEYFIS
English: Grade > 3
Icelandic: Tafla 3:
English: GIOTRIF 50 mg film-coated tablets
Icelandic: GIOTRIF 50 mg filmuhúðaðar töflur
English: Missed dose
Icelandic: Skammtur sem gleymist
English: Dose adjustment for adverse reactions
Icelandic: Upplýsingar um skammtaaðlögun vegna aukaverkana
English: What you need to know before you take GIOTRIF 3.
Icelandic: Upplýsingar um GIOTRIF og við hverju það er notað Áður en byrjað er að nota GIOTRIF Hvernig nota á GIOTRIF
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 30 mg)
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI ASKJA (PAKKNING FYRIR ÞYNNUR fyrir 30 mg)
English: What GIOTRIF looks like and contents of the pack GIOTRIF 30 mg film-coated tablets are dark blue and round shaped.
Icelandic: GIOTRIF 30 mg filmuhúðaðar töflur eru dökkbláar og kringlóttar.
English: Each film-coated tablet contains 40 mg of afatinib (as dimaleate).
Icelandic: Hver filmuhúðuð tafla inniheldur 40 mg af afatinibi (sem dimaleat).
English: Includes Acne, Acne pustular, Dermatitis acneiform
Icelandic: Felur í sér kláða, útbreiddan kláða
English: NAME OF THE MEDICINAL PRODUCT GIOTRIF 40 mg tablets afatinib
Icelandic: HEITI LYFS GIOTRIF 40 mg töflur afatinib
English: Any Grade
Icelandic: Hvaða stig sem var
English: Dosage The recommended dose is 40 mg each day.
Icelandic: Skammtur Ráðlagður skammtur er 40 mg á sólarhring.
English: Animal studies with afatinib did not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Icelandic: Dýrarannsóknir benda hvorki til beinna né óbeinna skaðlegra áhrifa á æxlun (sjá kafla 5.3).
English: The efficacy results are summarized in Table 9.
Icelandic: Niðurstöður um verkun eru teknar saman í töflu
English: GIOTRIF 30 mg film-coated tablets EU/1/13/879/004
Icelandic: GIOTRIF 30 mg filmuhúðaðar töflur EU/1/13/879/004
English: GIOTRIF 30 mg film-coated tablets afatinib
Icelandic: GIOTRIF 30 mg filmuhúðaðar töflur afatinib
English: They are debossed with the code “T20” on one side and the Boehringer Ingelheim company logo on the other.
Icelandic: Þær eru ígreyptar með kóðanum „T20“ á annarri hliðinni og kennimerki fyrirtækisins Boehringer Ingelheim á hinni hliðinni.
English: Second-line GIOTRIF significantly improved PFS and OS of patients with squamous NSCLC compared to erlotinib.
Icelandic: GIOTRIF sem önnur meðferð bætti marktækt lifun án versnunar sjúkdóms og heildarlifun hjá sjúklingum með lungnakrabbamein, sem ekki er af smáfrumugerð, af flöguþekjutegund, samanborið við erlotinib.
English: Each film-coated tablet contains 30 mg of afatinib (as dimaleate).
Icelandic: Hver filmuhúðuð tafla inniheldur 30 mg af afatinibi (sem dimaleat).
English: Each film-coated tablet contains 50 mg of afatinib (as dimaleate).
Icelandic: Hver filmuhúðuð tafla inniheldur 50 mg af afatinibi (sem dimaleat).
English: Contact your doctor or pharmacist immediately.
Icelandic: Látið lækninn eða lyfjafræðing vita um allar aukaverkanir.
English: What is in this leaflet
Icelandic: Erting í augum eða bólga
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 50 mg)
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI ASKJA (PAKKNING FYRIR ÞYNNUR fyrir 50 mg)
English: % of patients improved
Icelandic: % sjúklinga þar sem dró úr einkennum
English: GIOTRIF 40 mg film-coated tablets EU/1/13/879/007
Icelandic: GIOTRIF 40 mg filmuhúðaðar töflur EU/1/13/879/007
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg afatinib (as dimaleate).
Icelandic: VIRK(T) EFNI Hver filmuhúðuð tafla inniheldur 30 mg afatinib (sem dimaleat).
English: GIOTRIF 40 mg film-coated tablets afatinib
Icelandic: GIOTRIF 40 mg filmuhúðaðar töflur afatinib
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 40 mg afatinib (as dimaleate).
Icelandic: VIRK(T) EFNI Hver filmuhúðuð tafla inniheldur 40 mg afatinib (sem dimaleat).
English: GIOTRIF 20 mg film-coated tablets EU/1/13/879/001
Icelandic: GIOTRIF 20 mg filmuhúðaðar töflur EU/1/13/879/001
English: In general, rash manifests as a mild or moderate erythematous and acneiform rash, which may occur or worsen in areas exposed to sun. For patients who are exposed to sun, protective clothing, and use of sun screen is advisable.
Icelandic: Yfirleitt koma útbrotin fram sem væg eða miðlungsmikil roðaþot og útbrot sem líkjast þrymlabólum, sem geta komið fram eða aukist í sól.
English: They are debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other.
Icelandic: Þær eru ígreyptar með kóðanum „T50“ á annarri hliðinni og kennimerki fyrirtækisins Boehringer Ingelheim á hinni hliðinni.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (FOLDING BOX FOR BLISTER for 40 mg)
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI ASKJA (PAKKNING FYRIR ÞYNNUR fyrir 40 mg)
English: Keratitis
Icelandic: Töflukjarni
English: Dark blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T30” on one side and the Boehringer Ingelheim company logo on the other.
Icelandic: Dökkblá, kringlótt, tvíkúpt filmuhúðuð tafla með sniðbrún, ígreypt með kóðanum „T30“ á annarri hliðinni og kennimerki Boehringer Ingelheim á hinni hliðinni.
English: GIOTRIF 50 mg film-coated tablets afatinib
Icelandic: GIOTRIF 50 mg filmuhúðaðar töflur afatinib
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/004
Icelandic: MARKAÐSLEYFISNÚMER EU/1/13/879/004
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 50 mg afatinib (as dimaleate).
Icelandic: VIRK(T) EFNI Hver filmuhúðuð tafla inniheldur 50 mg afatinib (sem dimaleat).
English: They are debossed with the code “T30” on one side and the Boehringer Ingelheim company logo on the other.
Icelandic: Þær eru ígreyptar með kóðanum „T30“ á annarri hliðinni og kennimerki fyrirtækisins Boehringer Ingelheim á hinni hliðinni.
English: The dispersion can also be administered through a gastric tube.
Icelandic: Dreifuna má einnig gefa um magasondu.
English: Enzyme-catalyzed metabolic reactions play a negligible role for afatinib in vivo.
Icelandic: In vivo skipta ensímhvötuð umbrot óverulegu máli varðandi afatinib.
English: Light blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T40” on one side and the Boehringer Ingelheim company logo on the other.
Icelandic: Ljósblá, kringlótt, tvíkúpt filmuhúðuð tafla með sniðbrún, ígreypt með kóðanum „T40“ á annarri hliðinni og kennimerki Boehringer Ingelheim á hinni hliðinni.
English: Rash may occur or worsen in areas exposed to sun. Sun protection with protective clothing and sunscreen is recommended.
Icelandic: Útbrot geta komið fram eða versnað á svæðum sem verða fyrir sólargeislum.
English: Dark blue, oval, biconvex film-coated tablet debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other.
Icelandic: Dökkblá, sporöskjulaga, tvíkúpt filmuhúðuð tafla, ígreypt með kóðanum „T50“ á annarri hliðinni og kennimerki Boehringer Ingelheim á hinni hliðinni.
English: What GIOTRIF contains - The active substance is afatinib.
Icelandic: - Virka innihaldsefnið er afatinib.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/001
Icelandic: MARKAÐSLEYFISNÚMER EU/1/13/879/001
English: Other patient characteristics/intrinsic factors found with a significant impact on afatinib exposure were: ECOG performance score, lactate dehydrogenase levels, alkaline phosphatase levels and total protein.
Icelandic: ECOG, gildi laktatdehýdrógenasa, gildi alkalísks fosfatasa og heildarpróteins.
English: Afatinib is eliminated with an effective half-life of approximately 37 hours.
Icelandic: Virkur helmingunartími brotthvarfs afatinibs er u.þ.b. 37 klst.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/879/007
Icelandic: MARKAÐSLEYFISNÚMER EU/1/13/879/007
English: Hepatic impairment
Icelandic: Ógleði Uppköst
English: They are debossed with the code “T40” on one side and the Boehringer Ingelheim company logo on the other.
Icelandic: Þær eru ígreyptar með kóðanum „T40“ á annarri hliðinni og kennimerki fyrirtækisins Boehringer Ingelheim á hinni hliðinni.
English: Covalent adducts to proteins were the major circulating metabolites of afatinib.
Icelandic: Áttatíu og átta prósent af skammtinum sem fannst var móðurlyfið afatinib.
English: Epistaxis
Icelandic: Naglasýking
English: Additionally, in various organs pharmacodynamically mediated atrophy of epithelia was observed in both species.
Icelandic: Hjá báðum tegundunum kom auk þess fram rýrnun húðþekju í ýmsum líffærum vegna lyfhrifa.
English: Hazard Ratio/ Odds Ratio (95%CI) p-value
Icelandic: Áhættuhlutfall/ Líkindahlutfall (95%CI) p-gildi
English: Paronychia
Icelandic: Brisbólga
English: Recommended dosing
Icelandic: Tilkynning aukaverkana
English: • Sulfasalazine, used to treat inflammation/infection.
Icelandic: Sulfasalazin, lyf við bólgu/sýkingu.
English: LIST OF EXCIPIENTS Contains lactose.
Icelandic: HJÁLPAREFNI Inniheldur laktósa.
English: Duration of response Months (median)
Icelandic: Lengd svörunar í mánuðum (miðgildi)
English: Therefore, food should not be consumed for at least 3 hours before and at least 1 hour after taking GIOTRIF (see sections 4.2 and 4.5).
Icelandic: Þess vegna má ekki neyta fæðu í að minnsta kosti 3 klst. fyrir og 1 klst.
English: 7 x 1 tablet (unit dose)s
Icelandic: ESB markaðsleyfisnúmer
English: 30th January 2020
Icelandic: 30 janúar 2020
English: Your doctor will decide how many treatments you need.
Icelandic: Læknirinn mun ákveða hversu margar meðferðir þú þarft að fá.
English: Do not try to treat yourself with other medicines.
Icelandic: Ekki reyna að meðhöndla sjálfa/n þig með öðrum lyfjum.
English: (HCV);
Icelandic: C (HCV);
English: Succursale de Corsier-sur-Vevey Chemin du Fenil - Zone Industrielle B 1804 Corsier-sur-Vevey Switzerland
Icelandic: Succursale de Corsier-sur-Vevey Chemin du Fenil - Zone Industrielle B 1804 Corsier-sur-Vevey Sviss
English: 18.5 (17.8, NE)
Icelandic: 18,5 (17,8, EM)
English: (18, not estimable)
Icelandic: (18, ekki metanlegt)
English: * Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.03)
Icelandic: * Eiturverkun var flokkuð samkvæmt National Cancer Institute Common Terminology Criteria for Adverse Events útgáfu 4.0 (NCI-CTCAE v4.03)
English: Bavencio is used in adults to treat:
Icelandic: Bavencio er notað handa fullorðnum til þess að meðhöndla:
English: If you suffer from any of these you should seek urgent medical attention:
Icelandic: Ef þú finnur fyrir einhverjum þeirra skaltu leita læknishjálpar tafarlaust:
English: Bavencio has not been studied in children and adolescents below 18 years of age.
Icelandic: Bavencio hefur ekki verið rannsakað hjá börnum og unglingum yngri en 18 ára.
English: Do not drive or use machines after you have received Bavencio if you are not feeling well enough.
Icelandic: Ekki má aka eða nota vélar eftir að þú færð Bavencio ef líðan er ekki nægilega góð.
English: Do not freeze or shake the diluted solution.
Icelandic: Ekki má frysta eða hrista þynntu lausnina.
English: Do not stop treatment with Bavencio unless you have discussed this with your doctor.
Icelandic: Ekki hætta meðferð með Bavencio nema þú hafir rætt það við lækninn.
English: * 1-sided p-value based on stratified log-rank.
Icelandic: * 1-hliða p-gildi byggt á lagskiptu log-rank prófi.
English: If you have any questions about axitinib, ask your doctor.
Icelandic: Ef spurningar vakna varðandi axitinib skaltu spyrja lækninn.
English: Confirmed best overall response (BOR)
Icelandic: Staðfest besta heildarsvörun (BOR)
English: (10.2, not estimable)
Icelandic: (10,2, ekki metanlegt)
English: You will have blood tests during your treatment and your doctor will monitor your weight before and during treatment.
Icelandic: Þú munt fara í blóðrannsóknir meðan á meðferðinni stendur og læknirinn mun hafa eftirlit með þyngd þinni áður en meðferðin hefst og meðan á henni stendur.
English: Some side effects may happen weeks or months after your last dose.
Icelandic: Hugsanlegt er að sumar aukaverkanir komi fram nokkrum vikum eða mánuðum eftir síðasta skammtinn.
English: You will receive Bavencio in a hospital or clinic, under the supervision of an experienced doctor.
Icelandic: Þú munt fá Bavencio á sjúkrahúsi eða læknastofu, undir umsjón læknis sem hefur reynslu af notkun þess.
English: Time to response (TTR)
Icelandic: Tími fram að svörun (TTR)
English: The efficacy endpoints were based on 29 patients with 13 weeks of follow-up.
Icelandic: Verkunarendapunktarnir voru byggðir á 29 sjúklingum sem höfðu fengið 13 vikna eftirfylgni.
English: Randomization was stratified according to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 vs. 1) and region (United States vs. Canada/Western Europe vs. the rest of the world).
Icelandic: Slembiröðun var lagskipt samkvæmt ECOG færnistuðli (Eastern Cooperative Oncology Group Performance Status) (0 eða 1) og svæði (Bandaríkin eða Kanada/Vestur-Evrópa eða aðrir heimshlutar).
English: • Requirement for 10 mg per day or greater prednisone or equivalent for more than 12 weeks
Icelandic: Þörf á 10 mg á dag eða meira af prednisóni eða sambærilegu lengur en 12 vikur
English: Events (%)
Icelandic: Tilvik (%)
English: Blood tests and weight checks:
Icelandic: Blóðrannsóknir og vigtun:
English: If you miss an appointment, ask your doctor when to schedule your next dose.
Icelandic: Ef þú missir af einu skipti skaltu spyrja lækninn hvenær þú fáir næsta skammt.
English: This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Icelandic: Þetta lyf hefur fengið markaðsleyfi með skilyrtu samþykki og í samræmi við grein 14a(4) í reglugerð (EB) nr. 726/2004 skal markaðsleyfishafi ljúka eftirfarandi innan tilgreindra tímamarka:
English: Duration of response (DOR)a
Icelandic: Lengd svörunar (DOR)a
English: The volume of distribution at steady state was 4.72 L.
Icelandic: Dreifingarrúmmálið við jafnvægi var 4,72 l.
English: It is important that you also read the package leaflet for the medicine containing axitinib.
Icelandic: Mikilvægt er að lesa einnig fylgiseðilinn fyrir lyfið sem inniheldur axitinib.
English: Seek urgent medical attention if you experience inflammation in any part of your body or if you have any of the following signs or symptoms, or if they get worse.
Icelandic: Leitaðu tafarlaust til læknis ef þú finnur fyrir bólgu í einhverjum hluta líkamans eða ef vart verður við einhver eftirfarandi merkja eða einkenna eða ef þau versna.
English: • you have an autoimmune disease (a condition where the body attacks its own cells);
Icelandic: þú ert með sjálfsnæmissjúkdóm (sjúkdóm þar sem líkaminn ræðst gegn eigin frumum);
English: Avelumab plus axitinib
Icelandic: Avelúmab + Axitinib:
English: The solution pH is in the range of 5.0 - 5.6 and the osmolality is between 270 and 330 mOsm/kg.
Icelandic: Lausnin hefur pH gildi á bilinu 5,0-5,6 og osmólalstyrk á milli 270 og 330 mOsm/kg.
English: If you experience any of these symptoms when taking Bavencio do not try to treat them on your own with other medicines.
Icelandic: Ef vart verður við einhver af þessum einkennum við töku Bavencio skaltu ekki reyna að meðhöndla þau sjálf/ur með öðrum lyfjum.
English: The active substance is avelumab.
Icelandic: Virka innihaldsefnið er avelúmab.
English: Check with your doctor or nurse before you receive Bavencio if:
Icelandic: Ráðfærðu þig við lækninn eða hjúkrunarfræðing áður en þú færð Bavencio ef:
English: Some side effects may not have symptoms and may only be discovered through blood tests.
Icelandic: Sumum aukaverkunum fylgja engin einkenni og þær finnast hugsanlega aðeins með blóðrannsóknum.
English: • The card should also prompt to enter contact details of the physician and include a warning message for healthcare professionals treating the patient at any time, including in conditions of emergency, that the patient is using Bavencio.
Icelandic: Kortið skal einnig hvetja til skráningar á samskiptaupplýsingum um lækninn og inniheldur viðvörunarskilaboð fyrir heilbrigðisstarfsmenn sem meðhöndla sjúklinginn á hverjum tíma, m.a. í neyðartilvikum, um að sjúklingurinn noti Bavencio.
English: Bavencio can cause harm to your unborn baby.
Icelandic: Bavencio getur valdið ófæddu barni skaða.
English: • Redness in the skin
Icelandic: Roði í húð
English: Patients were randomised (1:1) to one of the following treatment arms:
Icelandic: Sjúklingum var slembiraðað (1:1) í einn af eftirfarandi meðferðarhópum:
English: • you have had an organ transplant.
Icelandic: • þú hefur fengið líffæraígræðslu.
English: Patients excluded from clinical studies
Icelandic: Sjúklingar sem voru útilokaðir frá klínískum rannsóknum
English: • or stop your treatment with Bavencio altogether.
Icelandic: eða hætta alveg meðferðinni með Bavencio.
English: Avelumab ORR (95% CI)
Icelandic: Avelúmab ORR (95% CI)
English: Efficacy results are presented in Table 7 and Figure 3 based on a data cut-off date of 28 January 2019.
Icelandic: Niðurstöður varðandi verkun eru sýndar í töflu 7 og á mynd 3 sem byggðar eru á lokadagsetningunni 28. janúar 2019.
English: The majority (n=160, 71.4%) of the patients with progressive disease continued treatment with both medicinal products after progression.
Icelandic: Meirihluti (n=160; 71,4%) sjúklinga með framsækinn sjúkdóm hélt áfram meðferð með báðum lyfjunum eftir versnun.
English: • you receive medicines to suppress your immune system;
Icelandic: • þú færð lyf sem bæla ónæmiskerfið;
English: The safety and efficacy of Bavencio in children and adolescents below 18 years of age have not been established.
Icelandic: Börn Ekki hefur verið sýnt fram á öryggi og verkun Bavencio hjá börnum og unglingum yngri en 18 ára.
English: A risk to the breast-fed child cannot be excluded.
Icelandic: Ekki er hægt að útiloka hættu fyrir börn sem eru á brjósti.
English: Administration of Bavencio should continue according to the recommended schedule until disease progression or unacceptable toxicity.
Icelandic: Halda skal gjöf Bavencio áfram samkvæmt ráðlagðri áætlun þar til sjúkdómur versnar eða vart verður við óviðunandi eiturverkanir.