natgillin/translations-raw huggingface dataset:
Interstitiel lungesygdom (ILD) eller ILD-lignende bivirkninger (f.eks. pneumonitis) blev rapporteret hos 3,9 % og var dødelig hos 0,4 % af de 1.142 patienter, som fik TAGRISSO i FLAURA- og AURA-studierne.
Interstitial Lung Disease (ILD) or ILD-like adverse reactions (e.g. pneumonitis) were reported in 3.9% and were fatal in 0.4% of the 1142 patients who received TAGRISSO in FLAURA and AURA studies.
På tidspunktet for interimanalysen af den samlede overlevelse (25 % modenhed), favoriserede HR på 0,63 TAGRISSO (95 % CI: 0,45, 0,88;
At the time of the interim analysis of overall survival (25% maturity), a HR of 0.63 favoured TAGRISSO (95% CI:
Gastrointestinale bivirkninger
Gastrointestinal effects
I en populationsbaseret farmakokinetisk analyse (n=1.367) blev der ikke identificeret klinisk signifikant sammenhæng mellem forventet steady state-eksponering (AUCss) og patientens alder (interval 25-91 år), køn (65 % kvinder), etnicitet (herunder hvide, asiatiske, japanske, kinesiske og ikke-asiatiske-ikke-hvide patienter), behandlingslinje og rygestatus (n=34 nuværende rygere, n=419 tidligere rygere).
In a population based pharmacokinetic analyses (n=1367), no clinically significant relationships were identified between predicted steady-state exposure (AUCss) and patient's age (range: 25 to 91 years), gender (65% female), ethnicity (including White, Asian, Japanese, Chinese and non-Asian-non-White patients), line of therapy and smoking status (n=34 current smokers, n=419 former smokers).
• Aliskiren - bruges mod forhøjet blodtryk
• Aliskiren-used for high blood pressure.
Kemoterapi (Pemetrexed/Cisplatin eller Pemetrexed/Carboplatin)
Chemotherapy (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin)
In vitro-studier har vist, at osimertinib er højpotent og har hæmmende aktivitet mod EGFR i en række klinisk relevante cellelinjer med ikke-småcellet lungecancer (NSCLC) med EGFR-sensibiliseringsmutation og T790M-mutation (tilsyneladende IC50'er fra 6 nM til 54 nM over for phospho-EGFR).
In vitro studies have demonstrated that osimertinib has high potency and inhibitory activity against EGFR across a range of all clinically relevant EGFR sensitising-mutant and T790M mutant non-small cell lung cancer (NSCLC) cell lines (apparent IC50s from 6 nM to 54 nM against phospho-EGFR).
De væsentligste fund, der blev observeret i toksicitetsstudier med gentagne doser hos rotter og hunde, omfattede atrofiske, inflammatoriske og/eller degenerative forandringer, der påvirker epitelet i cornea (ledsaget af nedsat gennemsigtighed og uklarhed af cornea hos hunde ved oftalmologisk undersøgelse), mave-tarm-kanalen (herunder også tungen), huden og de hanlige og hunlige kønsorganer med sekundære forandringer i milten.
The main findings observed in repeat dose toxicity studies in rats and dogs comprised atrophic, inflammatory and/or degenerative changes affecting the epithelia of the cornea (accompanied by corneal translucencies and opacities in dogs at ophthalmology examination), GI tract (including tongue), skin, and male and female reproductive tracts with secondary changes in spleen.
Behandlingen bør afbrydes hos patienter, som udvikler QTc-interval over 500 msek målt på mindst 2 forskellige EKG, indtil QTc-intervallet er under 481 msek eller tilbage til baseline-niveau, hvis QTc-intervallet er over eller lig med 481 msek; genstart TAGRISSObehandlingen med en reduceret dosis som beskrevet i Tabel 1.
Treatment should be withheld in patients who develop a QTc interval greater than 500 msec on at least 2 separate ECGs until the QTc interval is less than 481 msec or recovery to baseline if the QTc interval is greater than or equal to 481 msec, then resume TAGRISSO at a reduced dose as described in Table 1.
Kaplan-Meier-kurver over progressionsfri overlevelse vurderet af investigator i FLAURA
Kaplan-Meier Curves of Progression-Free Survival as assessed by investigator in FLAURA
Aktive substanser, der kan nedsætte plasmakoncentrationen af osimertinib I et klinisk farmakokinetisk studie med patienter blev steady state-AUC af osimertinib reduceret med 78 % ved samtidig administration af rifampicin (600 mg dagligt i 21 dage).
Active substances that may decrease osimertinib plasma concentrations In a clinical pharmacokinetic study in patients, the steady-state AUC of osimertinib was reduced by 78% when co-administered with rifampicin (600 mg daily for 21 days).
• Dabigatran - bruges forebyggende mod blodpropper
• Dabigatran - used to prevent blood clots.
TAGRISSOs sikkerhed og virkning er ikke klarlagt hos patienter med nyresygdom i slutstadiet [kreatininclearance (CLcr) < 15 ml/min., beregnet efter Cockcrofts og Gaults formel], og hos patienter i dialyse.
The safety and efficacy of this medicinal product has not been established in patients with end-stage renal disease [creatinine clearance (CLcr) <15 mL/min, calculated by the Cockcroft and Gault equation], or on dialysis.
På baggrund af en populationsfarmakokinetisk analyse var der ingen sammenhæng mellem markører for leverfunktion (ALAT, ASAT, bilirubin) og osimertinibeksponering.
Based on population PK analysis, there was no relationship between markers of hepatic function (ALT, AST, bilirubin) and osimertinib exposure.
Patienter med lav legemsvægt (<50 kg), som fik TAGRISSO 80 mg, rapporterede højere frekvens af grad ≥3 bivirkninger (52 % versus 35 %) og QTc-forlængelse (14 % versus 4 %) end patienter med højere legemsvægt (≥50 kg).
Patients receiving TAGRISSO 80 mg with low body weight (<50 kg) reported higher frequencies of Grade ≥3 adverse events (52% versus 35%) and QTc prolongation (14% versus 4%) than patients with higher body weight (≥50 kg).
EGFR TKI-komparator (gefitinib eller erlotinib) (N=277)
EGFR TKI comparator (gefitinib or erlotinib) (N=277)
Svær, livstruende eller dødelig interstitiel lungesygdom (ILD) eller ILD-lignende bivirkninger (fx pneumonitis) er observeret hos patienter behandlet med TAGRISSO i kliniske studier.
Severe, life-threatening or fatal Interstitial Lung Disease (ILD) or ILD-like adverse reactions (e.g. pneumonitis) have been observed in patients treated with TAGRISSO in clinical studies.
Derfor er det sandsynligt, at CYP3A4-hæmmere ikke påvirker eksponeringen af osimertinib.
Therefore, CYP3A4 inhibitors are not likely to affect the exposure of osimertinib.
Baseret på in vitro-studier hæmmer osimertinib kompetitivt CYP 3A4/5, men ikke CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6 og 2E1 ved klinisk relevante koncentrationer.
Based on in vitro studies, osimertinib is a competitive inhibitor of CYP 3A4/5 but not CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6 and 2E1 at clinically relevant concentrations.
Sammenlignet med yngre forsøgspersoner (<65) rapporterede flere af forsøgspersonerne ≥ 65 år bivirkninger, der medførte dosisjustering af studiemedicinen (doseringsafbrydelse eller nedsat dosis) (13,4 % versus 7,6 %).
Compared with younger subjects (<65), more subjects ≥65 years old had reported adverse reactions that led to study drug dose modifications (interruptions or reductions) (13.4% versus 7.6%).
TAGRISSOs virkning og sikkerhed til behandling af patienter med lokalt avanceret eller metastatisk T790M-NSCLC, hvis sygdom var progredieret under eller efter EGFR-TKI-behandling, blev demonstreret i et randomiseret, åbent, aktivt kontrolleret fase 3-studie (AURA3).
The efficacy and safety of TAGRISSO for the treatment of patients with locally advanced or metastatic T790M NSCLC whose disease has progressed on or after EGFR TKI therapy, was demonstrated in a randomised, open-label, active-controlled Phase 3 study (AURA3).
Kaplan-Meier-kurver for progressionsfri overlevelse vurderet af investigator i AURA3
Kaplan-Meier curves of Progression-Free Survival as assessed by investigator in AURA3
Antal patienter, der fik første efterfølgende behandling eller afgik ved døden (%)
Number of patients who had first subsequent treatment or died (%)
Baseret på in vitro-studier er osimertinib substrat for P-gp og BCRP, men det er ikke sandsynligt, at det resulterer i klinisk relevante lægemiddelinteraktioner med aktive substanser og osimertinib i kliniske doser.
Based on in vitro studies, osimertinib is a substrate of P-gp and BCRP, but is unlikely to result in clinically relevant drug interactions with active substances by osimertinib at the clinical doses.
Information om andre indholdsstoffer i denne medicin Denne medicin indeholder mindre end 1 mmol (23 mg) natrium per 40 mg eller 80 mg tablet, dvs. den er i det væsentlige natriumfri.
Information on other ingredients in this medicine This medicine contains less than 1 mmol sodium (23 mg) per 40 mg or 80 mg tablet, that is to say essentially “sodium-free”.
En valideret test skal udføres under anvendelse af enten tumor-DNA fra en vævsprøve eller cirkulerende tumor-DNA (ctDNA) fra en plasmaprøve.
A validated test should be performed using either tumour DNA derived from a tissue sample or circulating tumour DNA (ctDNA) obtained from a plasma sample.
Indtil 9. måned var der ingen klinisk meningsfulde forskelle i patientrapporterede symptomer mellem TAGRISSO og EGFR TKI-komparatorgrupperne (vurderet som en forskel på ≥10 point).
Up to month 9 there were no clinically meaningful differences in patient-reported symptoms between TAGRISSO and EGFR TKI comparator groups (as assessed by a difference of ≥ 10 points).
Kemoterapi (Pemetrexed/Cisplatin eller Pemetrexed/Carboplatin) (N=140)
Chemotherapy (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin) (N=140)
Indtil flere data bliver tilgængelige, frarådes anvendelse til patienter med svært nedsat leverfunktion (se pkt.
Until additional data become available, use in patients with severe hepatic impairment is not recommended (see section 5.2).
Baseline-karakteristika for den samlede studiepopulation (AURAex og AURA2) var følgende: gennemsnitsalder 63 år, 13 % af patienterne var ≥75 år gamle, kvinder (68 %), hvide (36 %), asiater (60 %).
Baseline characteristics of the overall study population (AURAex and AURA2) were as follows: median age 63 years, 13% of patients were ≥75 years old, female (68%), White (36%), Asian (60%).
In vitro-studier har vist, at osimertinib ikke er substrat for OATP1B1 og OATP1B3.
In vitro studies have shown that osimertinib is not a substrate of OATP1B1 and OATP1B3.
En HR< 1 favoriserer TAGRISSO, en oddsratio på >1 favoriserer TAGRISSO Baseret på en interimanalyse med 25 % modenhed krævedes en P-værdi <0,0015 for at opnå statistisk signifikans ORR-resultater fra Blinded Independent Central Review (BICR) var i overstenstemmelse med det, der blev rapporteret via investigatorvurdering; ORR ved BICR-vurdering var 78 % (95 % CI: 73, 83) for TAGRISSO og 70 % (95 % CI: 65, 76) for EGFR TKI-komparator.
A HR< 1 favours TAGRISSO, an Odds ratio of >1 favours TAGRISSO Based on an interim analysis with 25% maturity a P-value < 0.0015 was required to achieve statistical significance ORR results by Blinded Independent Central Review (BICR) were consistent with those reported via investigator assessment; ORR by BICR assessment was 78% (95% CI:73, 83) on TAGRISSO and 70% (95% CI:65, 76) on EGFR TKI
AURA3 viste en statistisk signifikant forbedring i PFS for patienter, der fik TAGRISSO, sammenlignet med patienter, som fik kemoterapi, uanset deres status for CNS-metastaser ved studiets start.
AURA3 demonstrated a statistically significant improvement in PFS for patients receiving TAGRISSO compared to those receiving chemotherapy irrespective of CNS metastases status at study entry.
I et fertilitetsstudie med hunrotter havde administration af osimertinib i en dosis på 20 mg/kg pr. dag (svarende omtrent til den anbefalede daglige kliniske dosis på 80 mg) ingen indvirkning på brunstcyklussen eller på antallet af hunrotter, som blev drægtige, men det medførte tidlig embryodød.
In a female fertility study in rats, administration of osimertinib at 20 mg/kg/day (approximately equal to the recommended daily clinical dose of 80 mg) had no effects on oestrus cycling or the number of females becoming pregnant, but caused early embryonic deaths.
Se også punkt 2.
See also Section 2.
• Perikon (Hypericum perforatum) - et naturlægemiddel, der bruges mod depression.
• St. John's Wort (Hypericum perforatum) - an herbal medicine used for depression.
PFS for en præspecificeret undergruppeanalyse, baseret på status for CNS-metastaser ved studiets start, blev udført i AURA3 og er vist i figur 4.
A pre-specified PFS subgroup analysis based on CNS metastases status at study entry was performed in AURA3 and is shown in Figure 4.
I et klinisk forsøg har patienter med forskellige typer af fremskredne solide tumorer og med let nedsat leverfunktion (Child Pugh A, gennemsnitlig score = 5,3, n = 7) eller moderat nedsat leverfunktion (Child Pugh B, gennemsnitlig score = 8,2, n = 5) sås ingen stigning i eksponering sammenlignet med patienter med normal leverfunktion (n = 10) efter en enkelt 80 mg dosis TAGRISSO.
In a clinical trial, patients with different types of advanced solid tumours and with mild hepatic impairment (Child Pugh A, mean score = 5.3, n=7) or moderate hepatic impairment (Child Pugh B, mean score = 8.2, n=5) had no increase in exposure compared to patients with normal hepatic function (n=10) after a single 80 mg dose of TAGRISSO.
In vivo oral administration af osimertinib medførte tumorskrumpning i både EGFRm- og T790M-NSCLC i xenograft-lungecancermodeller og lungecancermodeller med transgene mus.
In vivo oral administration of osimertinib lead to tumour shrinkage in both EGFRm and T790M NSCLC xenograft and transgenic mouse lung tumour models.
In vitro-studier indikerer, at osimertinib hovedsageligt metaboliseres af CYP3A4 og CYP3A5.
In vitro studies indicate that osimertinib is metabolised predominantly by CYP3A4, and CYP3A5.
TAGRISSO viste en klinisk betydningsfuld og statistisk signifikant forbedring i PFS sammenlignet med EGFR TKI-komparator (henholdsvis median 18,9 måneder og 10,2 måneder, HR=0,46, 95 % CI: 0,37, 0,57; P<0,0001).
TAGRISSO demonstrated a clinically meaningful and statistically significant improvement in PFS compared to EGFR TKI comparator (median 18.9 months and 10.2 months, respectively, HR=0.46, 95% CI: 0.37, 0.57; P<0.0001).
Frem til 9. måned var der ingen klinisk meningsfulde forskelle mellem TAGRISSO og EGFR TKIkomparatorgrupperne i funktionsevne eller HRQL.
Up to month 9, there were no clinically meaningful differences between the TAGRISSO and EGFR TKI comparator groups in functioning or HRQL.
Typen af rapporterede bivirkninger var ens uanset alder. Ældre patienter rapporterede flere bivirkninger af grad 3 eller højere i sammenligning med yngre patienter (13,4 % versus 9,3 %).
Older patients reported more Grade 3 or higher adverse reactions compared to younger patients (13.4% versus 9.3%).
Ved baseline blev der ikke observeret forskelle i patientrapporterede symptomer, funktion eller HRQL mellem TAGRISSO og EGFR TKI-komparatorarme (gefitinib eller erlotinib).
At baseline, no differences in patient reported symptoms, function or HRQL were observed between TAGRISSO and EGFR TKI comparator (gefitinib or erlotinib) arms.
I delmængden af patienter uden CNS-læsioner ved baseline var der et lavere antal nye CNS-læsioner i TAGRISSO-armen sammenlignet med EGFR TKIkomparatorarmen (henholdsvis 7/226 [3,1 %] versus 15/214 [7,0 %]).
In the subset of patients without CNS lesions at baseline, there were a lower number of new CNS lesions in the TAGRISSO arm compared to the EGFR TKI comparator arm (7/226 [3.1%] vs. 15/214 [7.0%], respectively).
CNS-progressionsfri overlevelse
CNS Progression-free survival
PFS-fordelen ved TAGRISSO sammenlignet med EGFR TKI-komparator var konsistent på tværs af alle foruddefinerede undergrupper, der blev analyseret, herunder etnicitet, alder, køn, rygehistorik, CNS-metastasestatus ved indtrædelse i studiet og EGFR-mutationstype (Exon 19-deletion eller L858R).
The PFS benefit of TAGRISSO compared to EGFR TKI comparator was consistent across all predefined subgroups analysed, including ethnicity, age, gender, smoking history, CNS metastases status at study entry and EGFR mutation type (Exon 19 deletion or L858R).
• Phenytoin, carbamazepin og phenobarbital - bruges mod krampeanfald.
• Phenytoin, carbamazepine or phenobarbital -used for seizures or fits.
I kliniske studier forekom der fald i venstre ventrikels ejektionsfraktion (LVEF) ≥ 10 %, og et fald til under 50 % optrådte hos 3,9 % (35/908) af de patienter, der blev behandlet med TAGRISSO, og hvor der forelå baseline-LVEF og mindst én opfølgende vurdering.
Across clinical trials, Left Ventricular Ejection Fraction (LVEF) decreases greater than or equal to 10% and a drop to less than 50% occurred in 3.9% (35/908) of patients treated with TAGRISSO who had baseline and at least one follow-up LVEF assessment.
Denne medicin indeholder <1 mmol natrium (23 mg) per 40 mg eller 80 mg tablet, dvs. den er i det væsentlige "natriumfri".
This medicine contains < 1 mmol sodium (23 mg) per 40 mg or 80 mg tablet, that is to say essentially “sodium-free”.
Permanent seponering af TAGRISSO
Permanently discontinue TAGRISSO
I et klinisk pregnane-X-receptor (PXR)-interaktionsstudie viste co-administration af TAGRISSO med fexofenadin (P-gp substrat) en øgning i fexofenadins AUC og Cmax med henholdsvis 56 % (90 % CI 35, 79) og 76 % (90 % CI 49, 108) efter en enkelt dosis og 27 % (90 % CI 11, 46) og 25 % (90 % CI 6, 48) ved steady state.
In a clinical Pregnane X Receptor (PXR) interaction study, co-administration of TAGRISSO with fexofenadine (P-gp substrate) increased the AUC and Cmax of fexofenadine by 56% (90% CI 35, 79) and 76% (90% CI 49, 108) after a single dose and 27% (90% CI 11, 46) and 25% (90% CI 6, 48) at steady state, respectively.
Uanset CNS-læsionsstatus ved studieinklusion viste patienter i TAGRISSO-armen en effektivitetsgevinst overfor de i EGFR TKI-komparatorarmen, og der var færre patienter med nye CNS-læsioner i TAGRISSO-armen sammenlignet med EGFR TKI-komparatorarmen (TAGRISSO 11/279 [3,9 %] sammenlignet med EGFR TKI-komparator, 34/277 [12,3 %]).
Irrespective of CNS lesion status at study entry, patients in the TAGRISSO arm demonstrated an efficacy benefit over those in the EGFR TKI comparator arm and there were fewer patients with new CNS lesions in the TAGRISSO arm compared to the EGFR TKI comparator arm (TAGRISSO, 11/279 [3.9%] compared to EGFR TKI comparator, 34/277 [12.3%]).
Antal patienter, der fik anden efterfølgende behandling eller afgik ved døden (%)
Number of patients who had second subsequent treatment or died (%)
CNS-sygdomskontrolrate
CNS disease control rate
Baseret på en farmakokinetisk populationsanalyse med 593 patienter med let nedsat nyrefunktion (CLcr 60 til < 90 ml/min), 254 patienter med moderat nedsat nyrefunktion (CLcr 30 til < 60 ml/min), 5 patienter med svært nedsat nyrefunktion (CLcr 15 til < 30 ml/min) og 502 patienter med normal nyrefunktion (CLcr ≥ 90 ml/min) var osimertinibeksponeringerne sammenlignelige.
Based on a population pharmacokinetic analysis of 593 patients with mild renal impairment (CLcr 60 to less than 90 mL/min), 254 patients with moderate renal impairment (CLcr 30 to <than 60 mL/min), 5 patients with severe renal impairment (CLcr 15 to <than 30 mL/min) and 502 patients with normal renal function (greater than or equal to 90 mL/min), osimertinib exposures were similar.
Effektdata for CNS-metastaser i Fase 2-studier (AURAex and AURA2) Der blev udført en BICR-vurdering af CNS-effekt ved RECIST v 1.1 i en undergruppe med 50 (ud af 411) patienter, der var identificeret som havende målbare CNS-metastaser ved en baseline-hjernescanning.
CNS metastases efficacy data in Phase 2 studies (AURAex and AURA2) A BICR assessment of CNS efficacy by RECIST v 1.1 was performed in a subgroup of 50 (out of 411) patients identified to have measurable CNS metastases on a baseline brain scan.
Patienter med klinisk betydende anormaliteter i rytme og overledning, målt ved hvile-elektrokardiogram (EKG) (f.eks. QTc-interval længere end 470 ms), blev udelukket fra disse studier.
Patients with clinically important abnormalities in rhythm and conduction as measured by resting electrocardiogram (ECG) (e.g. QTc interval greater than 470 ms) were excluded from these studies.
I et klinisk farmakokinetisk studie med patienter havde samtidig administration af 200 mg itraconazol to gange dagligt (en potent CYP3A4-hæmmer) ingen klinisk signifikant indvirkning på eksponeringen af osimertinib (areal under kurven (AUC) steg med 24 %, og Cmax faldt med 20 %).
In a clinical pharmacokinetic study in patients, co-administration with 200 mg itraconazole twice daily (a strong CYP3A4 inhibitor) had no clinically significant effect on the exposure of osimertinib (area under the curve (AUC) increased by 24% and Cmax decreased by 20%).
Inkluderer tilfælde rapporteret inden for termgruppen: Interstitiel lungesygdom, pneumonitis.
Includes cases reported within the clustered terms: Interstitial lung disease, pneumonitis.
Amning bør afbrydes under behandling med TAGRISSO.
Breast-feeding should be discontinued during treatment with TAGRISSO.
Tidligere behandlede T790M-positive NSCLC-patienter - AURA3
Pre-treated T790M positive NSCLC patients-AURA3
Inkluderer tilfælde rapporteret inden for termgruppen: Tør hud, hudfissurer, xerose, eksem, xeroderma.
Includes cases reported within the clustered terms: Dry skin, skin fissures, xerosis, eczema, xeroderma.
Analyse af væsentlige symptomer på lungecancer
Key lung cancer symptoms analysis
Patienter med symptomer, der kunne tyde på keratitis, såsom akut opståen eller forværring af okulær inflammation, tåreflåd, lysfølsomhed, sløret syn, øjensmerter og/eller røde øjne, skal straks henvises til en øjenlæge (se pkt.
Patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist (see section 4.2 Table 1).
QTc: QT-interval korrigeret for hjertefrekvens
ECGs: Electrocardiograms; QTc: QT interval corrected for heart rate
Interstitiel lungesygdom (ILD)/ pneumonitis
Pulmonary ILD/Pneumonitis
CNS progressionsfri overlevelse Antal hændelser (%) Median, måneder (95 % CI)
CNS Progression-free survival Number of Events (%) Median, Months (95% CI)
CNS-progressionsfri og i live efter 6 måneder (%) (95 % CI) CNS-progressionsfri og i live efter 12 måneder (%) (95 % CI)
CNS progression free and alive at 6 months (%) (95% CI) CNS progression free and alive at 12
Patienter med ILD i anamnesen, lægemiddelinduceret ILD, strålepneumonitis, der krævede steroidbehandling, eller med påvist klinisk aktiv ILD blev udelukket fra de kliniske studier.
Patients with a medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD were excluded from clinical studies.
Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager TAGRISSO, hvis:
Talk to your doctor, pharmacist or nurse before taking TAGRISSO if:
TAGRISSO leveres i blisterkort indeholdende 30 x 1 filmovertrukne tabletter, pakket i æsker indeholdende 3 blisterkort med hver 10 tabletter.
TAGRISSO is supplied in blisters containing 30 x 1 film-coated tablets, packed in cartons containing 3 blisters of 10 tablets each.
Patienter, der samtidig tager medicin med disposition afhængig af P-gp og med smalt terapeutisk indeks (f.eks. digoxin, dabigatran, aliskiren) bør overvåges nøje for tegn på ændret tolerabilitet som følge af øget eksponering af samtidig behandling med TAGRISSO (se pkt.
Patients taking concomitant medications with disposition dependent upon P-gp and with narrow therapeutic index (e.g. digoxin, dabigatran, aliskiren) should be closely monitored for signs of changed tolerability as a result of increased exposure of the concomitant medication whilst receiving TAGRISSO (see section 5.2).
TAGRISSO leveres i blisterkort indeholdende 28 x 1 filmovertrukne tabletter, pakket i æsker indeholdende 4 blisterkort med hver 7 tabletter.
TAGRISSO is supplied in blisters containing 28 x 1 film-coated tablets, packed in cartons containing 4 blisters of 7 tablets each.
Antal hændelser (62 % modenhed)
Number of Events (62% maturity)
Inden for hver frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.