natgillin/translations-raw huggingface dataset:
Data fra et studie med 24 raske forsøgspersoner indikerede, at co-administration af en enkelt dosis dacomitinib på 45 mg med PPI'en rabeprazol 40 mg en gang dagligt i 7 dage reducerede dacomitinibs Cmax, AUC0-96t (areal under koncentrations-tidskurven fra tiden 0 til 96 timer) og AUCinf (AUC fra tiden 0 til uendeligt) (n=14) med henholdsvis ca. 51%, 39% og 29% sammenlignet med en enkeltdosis dacomitinib på 45 mg administreret alene.
Data from a study in 24 healthy subjects indicated that co-administration of a single 45 mg dacomitinib dose with the PPI rabeprazole 40 mg once daily for 7 days decreased dacomitinib Cmax, AUC0-96h (area under the concentration-time curve from time 0 to 96 hours), and AUCinf (AUC from time 0 to infinity) (n=14) by approximately 51%, 39%, and 29%, respectively, when compared to a single 45 mg dose of dacomitinib administered alone.
2-sidet p-værdi
2-sided p-value b
• Øjenbetændelse
• Eyes inflammation
De hyppigste (>20%) bivirkninger hos patienter, der fik dacomitinib, var diarré (88,6%), udslæt (79,2%), stomatitis (71,8%), neglesygdom (65,5%), hudtørhed (33,3%), nedsat appetit (31,8%), konjunktivitis (24,7%), vægttab (24,3%), alopeci (23,1%), pruritus (22,4%), forhøjede transaminaser (22,0%) og kvalme (20,4%).
The most common (> 20%) adverse reactions in patients receiving dacomitinib were diarrhoea (88.6%), rash (79.2%), stomatitis (71.8%), nail disorder (65.5%), dry skin (33.3%), decreased appetite (31.8%), conjunctivitis (24.7%), weight decreased (24.3%), alopecia (23.1%), pruritus (22.4%), transaminases increased (22.0%), and nausea (20.4%).
Data er baseret på ialt 255 patienter (på tværs af de kliniske studier), der fik Vizimpro 45 mg én gang dagligt som startdosis ved førstelinjebehandling af NSCLC med EGFR-aktiverende mutationer.
Data based on pool of 255 patients who received Vizimpro 45 mg once daily as starting dose for first-line treatment of NSCLC with EGFR-activating mutations across clinical studies.
Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. tablet, dvs. det er i det væsentlige natriumfrit.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.
Hvis du har glemt at tage Vizimpro
If you forget to take Vizimpro
Behandling hos denne population frarådes (se pkt.
Treatment in this population is not recommended (see section 5.2).
Tredive procent havde en ECOG-performancestatus på 0, og 70% havde en ECOG-performancestatus på 1; 59% havde en deletion i exon 19, og 41% havde en L858R-mutation i exon 21.
Thirty percent had baseline Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 and 70% had ECOG PS 1; 59% had an exon 19 deletion, and 41% had a L858R mutation in exon 21.
• Unormale blodtests af leverenzymer
• Abnormal liver enzyme blood tests
• Smagsforstyrrelser
• Alteration in taste
Hvis du holder op med at tage Vizimpro
If you stop taking Vizimpro
Det er vigtigt, at udslættet behandles tidligt.
It is important to treat the rash early.
Start behandling med anti-diarré lægemidler (fx loperamid) første gang diarré optræder.
Initiate treatment with anti-diarrhoeal medicinal products (e.g., loperamide) at first onset of diarrhoea.
Dacomitinib er et potentielt persistent, bioakkumulerende og toksisk stof (se pkt.
Dacomitinib has the potential to be a very persistent, bioaccumulative and toxic substance (see section 5.3).
Co-administration af en enkel oral dosis dacomitinib på 45 mg forøgede den gennemsnitlige eksponering (AUClast og Cmax) for dextromethorphan, et CYP2D6-probesubstrat, med henholdsvis 855% og 874%, sammenlignet med administration af dextromethorphan alene.
Co-administration of single 45 mg oral dose of dacomitinib increased the mean exposure (AUClast and Cmax) of dextromethorphan, a probe CYP2D6 substrate, 855% and 874%, respectively, compared with administration of dextromethorphan alone.
• Procainamid, som anvendes til at behandle uregelmæssig hjerterytme
• Procainamide, used to treat heart arrhythmias
Det kan være nødvendigt at afbryde og/eller nedsætte patienternes dosis af dacomitinib.
Patients may require dosing interruption and/or dose reduction of therapy with dacomitinib.
Alvorlige bivirkninger blev rapporteret hos 6,7% af de patienter, der blev behandlet med dacomitinib.
Serious adverse reactions were reported in 6.7% of patients treated with dacomitinib.
Der er ingen specifik antidot mod dacomitinib.
There is no known antidote for dacomitinib.
Bivirkninger, der er rapporteret fra kliniske studier med dacomitinib (N=255)
Adverse reactions reported in dacomitinib clinical studies (N=255) System organ class
Hvis du har taget for mange Vizimpro tabletter, skal du straks kontakte en læge eller tage på hospitalet.
If you take more Vizimpro than you should If you have taken too much Vizimpro, see a doctor or go to a hospital immediately.
Bivirkninger i form af ILS/pneumonitis blev rapporteret hos 2,7% af patienterne, der fik Vizimpro, og grad ≥ 3 bivirkninger i form af ILS/pneumonitis blev rapporteret hos 0,8%, inklusive et tilfælde med dødeligt udfald (0,4%) (se pkt.
ILD/pneumonitis adverse reactions were reported in 2.7% of patients receiving Vizimpro, and Grade ≥ 3 ILD/pneumonitis adverse reactions were reported in 0.8%, including a fatal event (0.4%) (see section 4.4).
In vitro har dacomitinib lavt potentiale for hæmning uridin-difosfat glucuronosyltransferase (UGT)1A4, UGT1A6, UGT1A9, UGT2B7 og UGT2B15.
In vitro, dacomitinib has a low potential to inhibit uridine-diphosphate glucuronosyltransferase (UGT)1A4, UGT1A6, UGT1A9, UGT2B7, and UGT2B15.
I forsøg, der undersøgte dacomitinibs toksicitet ved gentagne doser, blev der observeret påvirkning af reproduktionsorganerne hos hunrotter, der fik ca. 0,3 gange det ubundne AUC ved den anbefalede humane dosis (i 6 måneder), og disse var begrænset til reversibel atrofi i epitelet i cervix og vagina.
In repeat-dose toxicity studies with dacomitinib, effects on reproductive organs were observed in female rats given approximately 0.3 times the unbound AUC at the recommended human dose (for 6 months) and were limited to reversible epithelial atrophy in the cervix and vagina.
Bivirkninger, der medførte dosisreduktioner, blev rapporteret hos 52,2% af patienterne, der blev behandlet med dacomitinib.
Adverse reactions leading to dose reductions were reported in 52.2% of patients treated with dacomitinib.
Baseret på puljede patientdatasæt, havde histamin-2 (H2)-receptorantagonister ingen tilsyneladende virkning på dacomitinibs laveste steady state koncentration (geometrisk middelratio på 86% (90% konfidensinterval: 73-101).
Based on pooled data in patients, there was no apparent effect of histamine-2 (H2) receptor antagonists on steady-state trough concentration of dacomitinib (geometric mean ratio of 86% (90% CI: 73; 101).
Derudover blev der udelukkende hos rotter observeret hepatocellulær nekrose med forhøjet transaminase og hepatocellulær vakuolation.
In addition, hepatocellular necrosis with transaminase increases and hepatocellular vacuolation were observed in rats only.
Efter administration af en enkelt dosis dacomitinib tabletter på 45 mg er den gennemsnitlige orale biotilgængelighed af dacomitinib 80% (interval: 65% til 100%) sammenlignet med intravenøs administration, hvor Cmax opnås 5 - 6 timer efter oral dosering.
Following the administration of a single 45 mg dose of dacomitinib tablets, the mean oral bioavailability of dacomitinib is 80% (range: 65% to 100%) compared to intravenous administration, with Cmax occurring 5 to 6 hours after oral dosing.
Derfor kan der ikke gives nogen dosisanbefalinger for disse patientpopulationer (se pkt.
Thus no dosing recommendations can be made for either patient population (see section 5.2).
Det er ikke nødvendigt at justere startdosis, når Vizimpro gives til patienter med let eller moderat nedsat nyrefunktion (kreatininclearance [CrCl] ≥30 ml/min).
No starting dose adjustments are required when administering Vizimpro to patients with mild or moderate renal impairment (creatinine clearance [CrCl] ≥ 30 mL/min).
Bivirkningerne er angivet efter systemorganklasse.
Adverse reactions are listed according to system organ class (SOC).
Baseret på farmakokinetiske populationsanalyser havde let (60 ml/min ≤CrCl <90 ml/min; N=590) og moderat (30 ml/min ≤ CrCl <60 ml/min; N=218) nedsat nyrefunktion ingen indvirkning på dacomitinibs farmakokinetik sammenlignet med forsøgspersoner med normal (CrCl ≥ 90 ml/min; N=567) nyrefunktion.
Based on population pharmacokinetic analyses, mild (60 mL/min ≤ CrCl < 90 mL/min; N=590) and moderate (30 mL/min ≤ CrCl < 60 mL/min; N=218) renal impairment, did not alter dacomitinib pharmacokinetics, relative to subjects with normal (CrCl ≥ 90 mL/min; N=567) renal function.
Det er ikke nødvendigt at justere startdosis, når Vizimpro gives til patienter med let (Child-Pugh klasse A) eller moderat (Child-Pugh klasse B) nedsat leverfunktion.
No starting dose adjustments are required when administering Vizimpro to patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.
Forhøjede transaminaser omfatter følgende foretrukne termer: Forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjede transaminaser.
j Transaminases increased includes the following PTs: Alanine aminotransferase increased, Aspartate aminotransferase increased, Transaminases increased.
Eksfoliative hudsygdomme af grad 3 blev rapporteret hos 0,8% af patienterne (se pkt.
Grade 3 exfoliative skin conditions were reported in 0.8% of patients (see section 4.4).
De endelige resultater for samlet overlevelse (OS) (data cut-off 17- Feb-2017) da 48,7% af hændelserne havde fundet sted viste en hazard-ratio (HR) på 0,760 (95% CI: 0,582- 0,993) og en forbedring på 7,3 måneder i median OS (median OS: 34,1 måneder (95% CI: 29,5-37,7) og 26,8 måneder (95% CI: 23,7-32,1) i henholdsvis dacomitinib-armen og gefitinib-armen).
OS results from the final analysis (data cut-off date of 17-Feb-2017) when 48.7% of events had occurred showed a HR of 0.760 (95% CI: 0.582, 0.993) and a gain of 7.3 months in median OS (median OS: 34.1 months [95% CI: 29.5, 37.7] and 26.8 months [95% CI: 23.7, 32.1] in the dacomitinib and gefitinib arm, respectively).
In vitro har dacomitinib lavt potentiale for at inducere CYP1A2, CYP2B6 eller CYP3A4 ved klinisk relevante koncentrationer.
In vitro, dacomitinib has a low potential to induce CYP1A2, CYP2B6, or CYP3A4 at clinically relevant concentrations.
Patientalder, race (asiatere og ikke-asiatere), køn og kropsvægt har ingen klinisk relevant indflydelse på forventet eksponering for dacomitinib ved steady state, baseret på farmakokinetiske populationsanalyser.
Based on population pharmacokinetic analyses, patient age, race (Asian and non-Asian), gender, and body weight do not have a clinically relevant effect on predicted steady-state exposure of dacomitinib.
Hudeksfoliation (også omtalt som eksfoliative hudlidelser) omfatter følgende foretrukne termer: eksfoliativt udslæt, hudeksfoliation.
i Skin exfoliation (also referred to as Exfoliative skin conditions) includes the following PTs: Exfoliative rash, Skin exfoliation.
ILS/pneumonitis, som kan være letal, er rapporteret hos patienter, der får Vizimpro (se pkt.
ILD/pneumonitis, which could be fatal, has been reported in patients receiving Vizimpro (see section 4.8).
Dacomitinib var ikke mutagent i en bakteriel tilbagemutationstest (Ames test), og det var ikke klastogent eller aneugent i en mikronukleustest in vivo i knoglemarv fra han- og hunrotter.
Dacomitinib was not mutagenic in a bacterial reverse mutation (Ames) assay, and not clastogenic or aneugenic in the in vivo bone marrow micronucleus assay in male and female rats.
Der er kun begrænsede data tilgængelige for patienter med svært nedsat nyrefunktion (CrCl <30 ml/min).
Limited data are available in patients with severe renal impairment (CrCl < 30 mL/min).
Det kan være: gulfarvning af huden eller af det hvide i øjnene (gulsot), mørk eller brun (tefarvet) urin, lys afføring.
• if you have any symptoms of a liver problem which may include: yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea coloured) urine, light-coloured bowel movements (stools).
Dacomitinib er ikke blevet undersøgt hos patienter med svært (Child-Pugh klasse C) nedsat leverfunktion.
Dacomitinib has not been studied in patients with severe (Child-Pugh class C) hepatic impairment.
De hyppigst (≥1%) rapporterede alvorlige bivirkninger hos patienter, der fik dacomitinib, var diarré (2,0%), interstitiel lungesygdom (1,2%), udslæt (1,2%) og nedsat appetit (1,2%).
The most frequently (≥ 1%) reported serious adverse reactions in patients receiving dacomitinib were diarrhoea (2.0%), interstitial lung disease (1.2%), rash (1.2%), and decreased appetite (1.2%).
Undgå samtidig administration af lægemidler, som hovedsageligt metaboliseres via CYP2D6 medmindre disse produkter er nødvendige (se pkt.
Concomitant use of medicinal products predominantly metabolised by CYP2D6 should be avoided unless such products are considered necessary (see section 4.5).
Dacomitinibs farmakokinetik er ikke blevet undersøgt hos forsøgspersoner med svært nedsat leverfunktion (ChildPugh klasse C).
Dacomitinib pharmacokinetics has not been studied in subjects with severe hepatic impairment (Child-Pugh class C).
Det kan være nødvendigt at afbryde og/eller nedsætte dosis til patienterne i forbindelse med dacomitinib-behandlingen (se afsnit 4.2).
Patients may require dosing interruption and/or dose reduction of therapy with dacomitinib (see section 4.2).
Toksicitet ved gentagne doser
Repeated-dose toxicity
Resultater fra ARCHER 1050 hos patienter med tidligere ubehandlet NSCLC med EGFR-aktiverende mutationer - ITT-population
Efficacy results from ARCHER 1050 in patients with previously untreated NSCLC with EGFR-activating mutations - ITT population Dacomitinib N=227
Det skal du vide, før du begynder at tage Vizimpro
What you need to know before you take Vizimpro
• Dacomitinib skal seponeres midlertidigt under diagnostisk udredning af ILS/pneumonitis.
• Withhold dacomitinib during ILD/Pneumonitis diagnostic evaluation.
Interstitiel lungesygdom omfatter følgende foretrukne termer: Interstitiel lungesygdom, pneumonitis.
c Interstitial lung disease includes the following PTs: Interstitial lung disease, Pneumonitis.
Effekt af dacomitinib og O-desmethyl-dacomitinib på CYP-enzymer In vitro har dacomitinib og dets metabolit O-desmethyl-dacomitinib lavt potentiale for hæmning af CYP1A2-, CYP2B6-, CYP2C8-, CYP2C9-, CYP2C19- eller CYP3A4/5-aktiviet i koncentrationer, der er klinisk relevante.
Effect of dacomitinib and O-desmethyl dacomitinib on CYP enzymes In vitro, dacomitinib and its metabolite O-desmethyl dacomitinib have a low potential to inhibit the activities of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP3A4/5 at clinically relevant concentrations.
Det bør ikke anvendes til patienter med hereditære galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Samtidig brug af lægemidler, der hovedsageligt metaboliseres af CYP2D6 bør undgås (se pkt.
Concomitant use of medicinal products predominantly metabolised by CYP2D6 should be avoided (see section 4.4).
Anvendelse af protonpumpehæmmere (PPI'er) sammen med dacomitinib skal undgås (se pkt.
Concomitant use of proton pump inhibitors (PPIs) with dacomitinib should be avoided (see section 4.5).
Interstitiel lungesygdom (ILS)/pneumonitis
Interstitial lung disease (ILD)/Pneumonitis
Vizimpro findes i blisterpakninger med 30 filmovertrukne tabletter (tabletter).
It is available in blister packs of 30 film-coated tablets (tablets).
Sådan skal du tage Vizimpro 4.
How to store Vizimpro 6.
Pfizer Europe MA EEIG (som logo for indehaveren af markedsføringstilladelsen)
NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG (as MA holder logo)
Konjunktivitis omfatter følgende foretrukne termer: Blefaritis, konjunktivitis, tørre øjne, ikke-infektiøs konjunktivitis.
Conjunctivitis includes the following PTs: Blepharitis, Conjunctivitis, Dry eye, Noninfective conjunctivitis.
• Dacomitinib skal seponeres midlertidigt ved diarré af grad 2, hvis der ikke ses en forbedring til grad ≤ 1 indenfor 24 timer, mens der anvendes behandling med anti-diarré lægemidler (fx loperamid), og der er sørget for tilstrækkelig oral væskeindtagelse.
• For Grade 2 diarrhoea, if not improved to Grade ≤ 1 within 24 hours while using anti-diarrhoeal medicinal products (e.g., loperamide) and adequate oral fluid intake, withhold dacomitinib.
Den mediane varighed af enhver grad og grad ≥3 af forhøjede transaminaser var henholdsvis 11 uger og 1 uge.
The median duration of any grade and Grade ≥ 3 transaminases increased was 11 weeks and 1 week, respectively.
Objektiv responsrate (ifølge IRC) Objektiv responsrate i % (95% CI) 2-sidet p-værdi
Objective Response Rate (per IRC) Objective Response Rate % (95% CI)
Start eller fortsæt behandling og/eller giv yderligere behandling (fx bredspektret oral eller intravenøs antibiotika og topikale steroider).
Initiate or continue treatment and/or provide additional treatment (e.g., broad spectrum oral or intravenous antibiotics and topical steroids).
• Langtidsvirkende lægemidler, der nedsætter produktionen af mavesyre såsom syrepumpehæmmere (til mavesår, fordøjelsesbesvær og halsbrand).
• Long-acting medicines for reducing stomach acid, such as proton pump inhibitors (for ulcers, indigestion and heartburn).
Vejledning for dosisjustering og behandling i forbindelse med specifikke bivirkninger er vist i tabel 2 (se pkt.
Dose modification and management guidelines for specific adverse reactions are provided in Table 2 (see sections 4.4 and
Som alternativ kan du tage et korttidsvirkende lægemiddel, fx syreneutraliserende medicin eller et lægemiddel, der nedsætter produktionen af mavesyre, en såkaldt ”H2-blokker”.
As an alternative, you can take a short-acting medicine, such as an antacid, or an H2 blocker medicine.
Derudover havde let nedsat leverfunktion ingen effekt på dacomitinibs farmakokinetik, hvilket var baseret på en farmakokinetisk populationsanalyse med data fra 1381 patienter, som inkluderede 158 patienter med let nedsat leverfunktion, hvilket var defineret ifølge kriterierne fra National Cancer Institute (NCI) (total bilirubin ≤ den øvre grænse for normalområdet (ULN) og aspartataminotransferase (ASAT) > ULN eller total bilirubin >1,0 til 1,5 × ULN og en hvilken som helst ASAT; N=158).
In addition, based on a population pharmacokinetic analysis using data from 1381 patients, that included 158 patients with mild hepatic impairment defined by National Cancer Institute (NCI) criteria [total bilirubin ≤ Upper Limit of Normal (ULN) and Aspartate Aminotransferase (AST) > ULN, or total bilirubin > 1.0 to 1.5 × ULN and any AST; N=158], mild hepatic impairment had no effect on the pharmacokinetics of dacomitinib.
Bivirkninger, der medførte permanent seponering, blev rapporteret hos 6,7% af patienterne, der blev behandlet med dacomitinib.
Adverse reactions leading to permanent discontinuation were reported in 6.7% of patients treated with dacomitinib.
Virkning og sikkerhed af Vizimpro blev undersøgt i et fase 3studie (ARCHER 1050), der blev udført hos patienter med lokalt fremskreden NSCLC, der ikke kunne behandles med helbredende/radikal kirurgi eller strålebehandling, eller metastatisk NSCLC med aktiverende EGFR-mutationer, med henblik på at demonstrere superioriteten af dacomitinib versus gefitinib.
Vizimpro in first-line treatment of NSCLC patients with EGFR-activating mutations (ARCHER 1050) The efficacy and safety of Vizimpro was studied in a Phase 3 trial (ARCHER 1050) conducted in patients with locally advanced, not amenable to curative surgery or radiotherapy, or metastatic NSCLC harbouring activating mutations of EGFR, to demonstrate the superiority of dacomitinib versus gefitinib.
Der er rapporteret om forhøjede transaminaser (forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjede transaminaser) under behandling med Vizimpro (se pkt.
Transaminases increased (alanine aminotransferase increased, aspartate aminotransferase increased, transaminases increased) have been reported during treatment with Vizimpro (see section 4.8).
In vitro har dacomitinib lavt potentiale for hæmning af aktiviteten af lægemiddeltransportører, P-gp (systemisk), organiske anion-transportører (OAT)1 og OAT3, OCT2, det organiske aniontransporterende polypeptid (OATP)1B1 og OATP1B3, men dacomitinib hæmmer muligvis aktiviteten af P-gp (i mave-tarmkanalen), BCRP (systemisk og i mave-tarmkanalen) og OCT1 ved klinisk relevante koncentrationer.
In vitro, dacomitinib has a low potential to inhibit the activities of drug transporters P-gp (systemically), organic anion transporters (OAT)1 and OAT3, OCT2, organic anion transporting polypeptide (OATP)1B1, and OATP1B3, but may inhibit the activity of P-gp (in the GI tract), BCRP (systemically and GI tract), and OCT1 at clinically relevant concentrations.
I et studie, der undersøgte nedsat leverfunktion, var eksponeringen for dacomitinib (AUCinf og Cmax) uændret ved let nedsat leverfunktion (Child-Pugh A; N=8) efter en enkelt oral dosis Vizimpro 30 mg, og den faldt med henholdsvis 15% og 20% ved moderat nedsat leverfunktion (Child-Pugh B; N=9), når der blev sammenlignet med forsøgspersoner med normal leverfunktion (N=8).
In a dedicated hepatic impairment trial, following a single-oral dose of 30 mg Vizimpro, dacomitinib exposure (AUCinf and Cmax) was unchanged in mild hepatic impairment (Child-Pugh A; N=8) and decreased by 15% and 20%, respectively in moderate hepatic impairment (Child-Pugh B; N=9) when compared to subjects with normal hepatic function (N=8).
Der foreligger ingen data for patienter, der har behov for hæmodialyse.
No data are available in patients requiring haemodialysis.
Hypokaliæmi omfatter følgende foretrukne termer: Nedsat kaliumindhold i blodet, hypokaliæmi.
a Hypokalaemia includes the following preferred terms (PTs): Blood potassium decreased, Hypokalaemia.
De hyppigst rapporterede (>5%) årsager til dosisreduktioner som følge af bivirkninger hos patienter, der fik dacomitinib, var udslæt (32,2%), neglesygdom (16,5%) og diarré
The most frequently reported (> 5%) reasons for dose reductions due to any adverse reactions in patients receiving dacomitinib were rash (32.2%), nail disorder (16.5%), and diarrhoea
I et multicenter, multinationalt, randomiseret, åbent fase 3-studie, blev i alt 452 patienter randomiseret 1:1 til at modtage dacomitinib eller gefitinib.
A total of 452 patients were randomised 1:1 to dacomitinib or gefitinib in a multicentre, multinational, randomised, open-label Phase 3 study.
Der blev rapporteret forhøjede transaminaser (forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjede transaminaser) hos 22,0% af patienterne, der fik Vizimpro, og disse var grad 1 til 3.
Transaminases increased (alanine aminotransferase increased, aspartate aminotransferase increased, transaminases increased) were reported in 22.0% of patients receiving Vizimpro and were Grades 1 to 3, with the majority Grade 1 (18.4%) (see section 4.4).
Forhøjede transaminaser
Transaminases increased
De mest almindelige (>0,5%) årsager til permanent seponering i forbindelse med bivirkninger hos patienter, der fik dacomitinib, var udslæt (2,4%), interstitiel lungesygdom (2,0%) og diarré (0,8%).
The most common (> 0.5%) reasons for permanent discontinuations associated with adverse reactions in patients receiving dacomitinib were: rash (2.4%), interstitial lung disease (2.0%), and diarrhoea (0.8%).