natgillin/translations-raw huggingface dataset:
Ca. 2% blev elimineret som omdannet osimertinib med 0,8 % i urin og 1,2 % i fæces.
Unchanged osimertinib accounted for approximately 2% of the elimination with 0.8% in urine and 1.2% in faeces.
47 % af patienterne havde metastatisk knoglesygdom.
Forty-seven percent (47%) of patients had metastatic bone disease.
Det primære effektmål var progressionsfri overlevelse (PFS) vurderet af investigator.
The primary efficacy outcome was progression-free survival (PFS) as assessed by investigator.
På baggrund af en farmakokinetisk populationsanalyse blev serumalbumin identificeret som en signifikant kovariat med en forventet ændring på <30 % i osimertinibs AUCss over albuminintervallet på henholdsvis 29 til 46 g/l (95 % til 5 % kvantiler) ved sammenligning med AUCss for den mediane baseline-albumin på 39 g/l.
Based on population PK analysis, serum albumin was identified as a significant covariate with a <30% change in osimertinib AUCss expected across the albumin range of 29 to 46 g/L respectively (95% to 5% quantiles) when compared to the AUCss for the median baseline albumin of 39 g/L.
Æske med 28 x 1 tabletter (4 blisterkort).
Cartons of 28 x 1 tablets (4 blisters).
Æske med 30 x 1 tabletter (3 blisterkort).
Cartons of 30 x 1 tablets (3 blisters).
In vitro hæmmer osimertinib ikke OAT1, OAT3, OATP1B1, OATP1B3, MATE1, OCT2 og MATE2K i klinisk relevante koncentrationer.
In vitro, osimertinib does not inhibit OAT1, OAT3, OATP1B1, OATP1B3, MATE1, OCT2 and MATE2K at clinically relevant concentrations.
Effektresultater fra AURA3 efter investigators vurdering er sammenfattet i tabel 5, og Kaplan-Meier-kurverne for PFS er vist i figur 3.
Efficacy results from AURA3 by investigator assessment are summarised in Table 5, and the Kaplan-Meier curve for PFS is shown in Figure 3.
T790M-mutationsstatus blev også vurderet retrospektivt under anvendelse af ctDNA, ekstraheret fra en plasmaprøve taget under screening.
The T790M mutation status was also assessed retrospectively using ctDNA extracted from a plasma sample taken during screening.
42 % af patienterne havde metastatisk knoglesygdom.
Forty-two percent (42%) of patients had metastatic bone disease.
• behandling af voksne patienter med lokalt fremskreden eller metastatisk EGFR T790Mmutationspositiv NSCLC.
• the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.
Graviditet - information til mænd
Pregnancy - information for men
Patienter, der samtidig tager medicin, hvis eksponering er afhængig af BCRP, og som har et snævert terapeutisk indeks, bør monitoreres nøje for tegn på ændret tolerance for det samtidige medikament på grund af øget eksponering under behandling med TAGRISSO (se pkt.
Patients taking concomitant medications with disposition dependent upon BCRP and with narrow therapeutic index should be closely monitored for signs of changed tolerability of the concomitant medication as a result of increased exposure whilst receiving TAGRISSO (see section 5.2).
Der skal udvises forsigtighed ved behandling af patienter med svært nedsat nyrefunktion og nyresygdom i slutstadiet (se pkt.
Caution should be exercised when treating patients with severe and end-stage renal impairment (see section 5.2).
Al/Al-perforerede enkeltdosisblisterkort.
Al/Al perforated unit dose blisters.
Perikon må ikke anvendes sammen med TAGRISSO (se pkt.
St. John's Wort should not be used together with TAGRISSO (see section 4.5).
Hvis en bivirkning af grad 3 eller højere forbedres til grad 0-2 efter afbrydelse af TAGRISSO i op til 3 uger
Grade 3 or higher adverse reaction Withhold TAGRISSO for up to 3 weeks If Grade 3 or higher adverse reaction improves to Grade 0-2 after withholding of TAGRISSO for up to
TAGRISSO forbedrede patientrapporterede symptomer på lungecancer sammenlignet med kemoterapi ved at udvise statistisk signifikant forskel i den gennemsnitlige ændring fra baseline for 5 præspecificerede primære PRO-symptomer (appetitløshed, hoste, brystsmerter, dyspnø og træthed) versus kemoterapi i den samlede tidsperiode fra randomisering og indtil 6 måneder, se tabel 7.
TAGRISSO improved patient-reported lung cancer symptoms compared to chemotherapy by demonstrating a statistically significant difference in mean change from baseline versus chemotherapy during the overall time period from randomisation until 6 months for 5 pre-specified primary PRO symptoms (appetite loss, cough, chest pain, dyspnoea, and fatigue) as shown in Table 7.
Baseret på farmakokinetisk populationsanalyse, er dosisjustering ligeledes ikke nødvendig hos patienter med let nedsat leverfunktion (total-bilirubin ≤ øvre normalgrænse (ULN) og aspartataminotransferase (ASAT) > ULN eller total-bilirubin > 1,0-1,5 x ULN og en hvilken som helst ASAT) eller moderat nedsat leverfunktion (total-bilirubin fra 1,5-3,0 x ULN og en hvilken som helst ASAT).
Similarly, based on population pharmacokinetic analysis, no dose adjustment is recommended in patients with mild hepatic impairment (total bilirubin ≤upper limit of normal (ULN) and aspartate aminotransferase (AST) >ULN or total bilirubin >1.0 to 1.5x ULN and any AST) or moderate hepatic impairment (total bilirubin between 1.5 to 3 times ULN and any AST).
Der er ikke udført kliniske studier med patienter med de novo-EGFR T790M-mutationspositiv NSCLC.
Clinical studies have not been conducted in patients with de novo EGFR T790M mutation-positive NSCLC.
Inkluderer tilfælde rapporteret inden for termgruppen: Pruritus, generaliseret pruritus, øjenlågspruritus.
Includes cases reported within the clustered terms: pruritus, pruritus generalised, eyelid pruritus.
Der blev konsekvent observeret klinisk betydende forbedringer i PFS med HR under 0,50 i de patienters favør, som fik TAGRISSO, sammenlignet med dem, der fik kemoterapi, i alle analyserede prædefinerede undergrupper, herunder etnicitet, alder, køn, rygehistorie og EGFR-mutation (Exon 19-deletion og L858R).
Clinically meaningful improvements in PFS with HRs less than 0.50 in favour of patients receiving TAGRISSO compared to those receiving chemotherapy were consistently observed in all predefined subgroups analysed, including ethnicity, age, gender, smoking history and EGFR mutation (Exon 19 deletion and L858R).
CNS objektiv responsrate
CNS Objective Response Rate
En prædefineret PFS-undergruppe baseret på CNS-metastasestatus (identificeret ved CNS-læsionssted ved baseline, anamnese og/eller tidligere kirurgi og/eller tidligere strålebehandling for CNSmetastaser) ved studieinklusion blev udført i FLAURA og er vist i figur 2.
A pre-specified PFS subgroup based on CNS metastases status (identified by CNS lesion site at baseline, medical history, and/or prior surgery, and/or prior radiotherapy to CNS metastases) at study entry was performed in FLAURA and is shown in Figure 2.
Antal dødsfald, (25 % modenhed)
Number of deaths, (25% maturity)
Spørg lægen, hvis du har spørgsmål til, hvordan dette lægemiddel virker, eller hvorfor du skal have denne medicin.
If you have any questions about how this medicine works or why this medicine has been prescribed for you, ask your doctor.
T790M-mutationsstatus blev også vurderet under anvendelse af ctDNA, ekstraheret fra en plasmaprøve taget under screening.
The T790M mutation status was also assessed using ctDNA extracted from a plasma sample taken during screening.
I et klinisk farmakokinetisk studie øgede samtidig administration af TAGRISSO og rosuvastatin (sensitivt BCRP-substrat) AUC og Cmax af rosuvastatin med henholdsvis 35 % og 72 %.
In a clinical PK study, co-administration of TAGRISSO with rosuvastatin (sensitive BCRP substrate) increased the AUC and Cmax of rosuvastatin by 35% and 72%, respectively.
Afbryd TAGRISSO-behandlingen, indtil QTc-intervallet er under 481 msek eller vendt tilbage til baseline-niveau, hvis baseline-QTc er over eller lig med 481 msek.
Withhold TAGRISSO until QTc interval is less than 481 msec or recovery to baseline if baseline QTc is greater than or equal to 481 msec, then restart at a reduced dose (40 mg)
Det skal du vide, før du begynder at tage TAGRISSO
What you need to know before you take TAGRISSO
Den samlede undersøgelsespopulations demografiske og sygdomskarakteristika ved baseline var: medianalder 64 år (interval 26-93 år), ≥75 år (14 %), kvinder (63 %), kaukasere (36 %), asiater (62 %), aldrig røget (64 %), Verdenssundhedsorganisationens (WHO) performance status på 0 eller 1 (100 %), metastatisk knoglesygdom (36 %), ekstra thorakal viscerale metastaser (35 %), CNS-metastaser (21 %, identificeret ved CNS-læsionssted ved baseline, anamnese og/eller tidligere kirurgi og/eller tidligere strålebehandling for CNS-metastaser).
The baseline demographic and disease characteristics of the overall study population were: median age 64 years (range 26-93 years), ≥75 years old (14%), female (63%), White (36%), Asian (62%), never smokers (64%), World Health Organization (WHO) performance status of 0 or 1 (100%), metastatic bone disease (36%), extra-thoracic visceral metastases (35%), CNS metastases (21%, identified by CNS lesion site at baseline, medical history, and/or prior surgery, and/or prior radiotherapy to CNS metastases).
Effektresultaterne fra FLAURA, ud fra investigators vurdering, er opsummeret i tabel 3, og Kaplan-Meier-kurven for PFS er vist i figur 1.
Efficacy results from FLAURA by investigator assessment are summarised in Table 3, and the Kaplan-Meier curve for PFS is shown in Figure 1.
- Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
- If you get any side effects, talk to yourdoctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet.
Baseret på in vitro-studier hæmmer osimertinib ikke UGT1A1 og UGT2B7 hepatisk ved klinisk relevante koncentrationer.
Based on in vitro studies, osimertinib is not an inhibitor of UGT1A1 and UGT2B7 at clinically relevant concentrations hepatically.
CNS-responsrate % (n/N) (95 % CI)
CNS response rate % (n/N) (95% CI)
Der er ingen data tilgængelige for patienter med svært nedsat leverfunktion (se pkt.
There are no data available on patients with severe hepatic impairment (see section 4.2).
Ved en dosis på 80 mg forudsagde en farmakokinetisk/farmakodynamisk analyse en lægemiddelrelateret forlængelse af QTc-intervallet på 14 msek med en øvre grænse på 16 msek (90 % KI).
A pharmacokinetic/pharmacodynamic analysis predicted a drug-related QTc interval prolongation at 80 mg of 14 msec with an upper bound of 16 msec (90% CI).
Effektdata for CNS-metastaser i AURA3-studiet
CNS metastases efficacy data in AURA3 study
Baseret på in vitro-data hæmmer osimertinib BCRP og P-gp (se pkt.
Based on in vitro data, osimertinib is an inhibitor of BCRP and P-gp (see section 4.5).
Af de 1.142 patienter i FLAURA- og AURA-studierne behandlet med TAGRISSO 80 mg havde 0,9 % (n=10) QTc længere end 500 msek, og 3,6 % (n=41) havde en stigning i forhold til baseline-QTc på mere end 60 msek.
Of the 1142 patients in FLAURA and AURA studies treated with TAGRISSO 80 mg, 0.9% of patients (n=10) were found to have a QTc greater than 500 msec, and 3.6% of patients (n=41) had an increase from baseline QTc greater than 60 msec. A pharmacokinetic/pharmacodynamic analysis with TAGRISSO predicted a concentration-dependent increase in QTc interval prolongation.
Hos raske forsøgspersoner, der fik en 80 mg tablet, og hvor ventriklens pH blev hævet ved administration af omeprazol i 5 dage, blev osimertinibeksponeringen ikke påvirket (AUC og Cmax stiger med henholdsvis 7 % og 2 %) med 90 % KI for eksponeringsforholdet inden for 80-125 % grænserne.
In healthy volunteers administered an 80 mg tablet where gastric pH was elevated by dosing of omeprazole for 5 days, osimertinib exposure was not affected (AUC and Cmax increase by 7% and 2%, respectively) with the 90% CI for exposure ratio contained within the 80-125% limit.
Nedsat antal neutrofilocytter
Neutrophils decreased
Virkning af syrenedsættende substanser på osimertinib I et klinisk farmakokinetisk studie resulterede samtidig administration af omeprazol ikke i klinisk relevante ændringer i osimertinibeksponeringen.
Effect of gastric acid reducing active substances on osimertinib In a clinical pharmacokinetic study, co-administration of omeprazole did not result in clinically relevant changes in osimertinib exposures.
• TAGRISSO kan påvirke, hvor godt svangerskabsforebyggende tabletter (f.eks. p-piller) virker.
• TAGRISSO may interfere with how well oral hormonal contraceptives work.
Virkning og sikkerhed med TAGRISSO til behandling af patienter med EGFR-mutationspositiv lokalt fremskreden NSCLC, der ikke er egnet til kurativ kirurgi eller strålebehandling, eller metastatisk NSCLC, som ikke tidligere havde fået systemisk behandling for fremskreden sygdom, blev påvist i et randomiseret, dobbeltblindet, aktiv-kontrolleret studie (FLAURA).
Previously untreated EGFR mutation positive locally advanced or metastatic NSCLC - FLAURA The efficacy and safety of TAGRISSO for the treatment of patients with EGFR mutation positive locally advanced, not amenable to curative surgery or radiotherapy, or metastatic NSCLC, who had not received previous systemic treatment for advanced disease, was demonstrated in a randomised, double-blind, active-controlled study (FLAURA).
Inkluderer tilfælde rapporteret inden for termgruppen: Neglelejesygdom, neglelejeinflammation, neglelejeinfektion, neglemisfarvning, neglepigmentering, neglesygdom, negletoksicitet, negledystrofi, negleinfektion, negleriller, neglesmerter, onykoklase, onykolyse, onykomadose, onykomalacia, paronychion.
Includes cases reported within the clustered terms: Nail bed disorder, nail bed inflammation, nail bed infection, nail discolouration, nail pigmentation, nail disorder, nail toxicity, nail dystrophy, nail infection, nail ridging, onychalgia, onychoclasis, onycholysis, onychomadesis, onychomalacia, paronychia.
Meget almindelig (68 %) 1,5 %
Very common (68%) 1.5%
Nedsat antal leukocytter
Leucocytes decreased
Alle patienter skulle have EGFR T790M-mutationspositiv NSCLC identificeret med cobas EGFR-mutationstest udført i et centralt laboratorium inden behandling.
All patients were required to have EGFR T790M mutation-positive NSCLC identified by the cobas EGFR mutation test performed in a central laboratory prior to treatment.
BICR hos patienter med CNS-metastaser ved en baseline-hjernescanning i AURA3
CNS efficacy by BICR in patients with CNS metastases on a baseline brain scan in AURA3
Meget almindelig (20 %) 0,2 %
Very common (20%) 0.2%
Samlet PFS efter investigators vurdering efter status for CNS-metastaser ved studiets start, Kaplan-Meier-plot (fuldt analysesæt) i FLAURA
Overall PFS by investigator assessment by CNS metastases status at study entry, Kaplan-Meier plot (full analysis set) in FLAURA
Meget almindelig (49 %) 1,2 %
Very common (49%) 1.2%
TAGRISSOs sikkerhed og virkning er ikke klarlagt hos patienter med svært nedsat leverfunktion.
The safety and efficacy of this medicinal product has not been established in patients with severe hepatic impairment.
Det primære virknings-endepunkt var progressionsfri overlevelse (PFS) vurderet af investigator.
The primary efficacy end-point was progression-free survival (PFS) as assessed by investigator.
Tidligere behandlede T790M-positive NSCLC-patienter - AURAex og AURA2 Der blev udført to åbne, enkeltarmede kliniske studier, AURAex (fase 2-forlængelses kohorte (n=201)) og AURA2 (n=210) med patienter med EGFR T790M-mutationspositiv lungecancer, som havde progredieret på en eller flere tidligere systemiske behandlinger, herunder en EGFR TKI.
Two single-arm, open-label clinical studies, AURAex (Phase 2 Extension cohort, (n=201)) and AURA2 (n=210) were conducted in patients with EGFR T790M mutation-positive lung cancer who have progressed on one or more prior systemic therapies, including an EGFR TKI.
Patienter med klinisk betydningsfulde anormaliteter i rytme og ledning målt ved hvilende elektrokardiogram (EKG) (fx QTc-interval over 470 ms) blev udelukket fra disse studier (se pkt.
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 (see section 4.8).
Fortæl det straks til lægen, hvis du bemærker denne alvorlige bivirkning:
Serious side effects Tell your doctor straight away if you notice the following serious side effects:
I et klinisk farmakokinetisk studie reducerede samtidig administration af TAGRISSO og simvastatin (sensitivt CYP3A4-substrat) AUC og Cmax af simvastatin med henholdsvis 9 % og 23 %.
In a clinical PK study, co-administration of TAGRISSO with simvastatin (sensitive CYP3A4 substrate) decreased the AUC and Cmax of simvastatin by 9% and 23% respectively.
Samlet PFS efter investigators vurdering efter status for CNS-metastaser ved studiets start, Kaplan-Meier-plot (fuldt analysesæt) i AURA3
Overall PFS by investigator assessment by CNS metastases status at study entry, Kaplan-Meier plot (full analysis set) in AURA3
Beige, 7,25 x 14,5 mm oval, bikonveks tablet, præget med “AZ” og “80” på den ene side og uden prægning på den anden side.
Beige, 7.25 x 14.5 mm, oval, biconvex tablet, debossed with “AZ” and “80” on one side and plain on the reverse.
54 % af patienterne havde ekstra-torakale viscerale metastaser, herunder 34 % med CNS-metastaser (identificeret som CNS-læsion ved baseline, anamnese og/eller tidligere kirurgi og/eller tidligere strålebehandling for CNS-metastaser) og 23 % med levermetastaser.
Fifty-four percent (54%) of patients had extra-thoracic visceral metastases, including 34% with CNS metastases (identified by CNS lesion site at baseline, medical history, and/or prior surgery, and/or prior radiotherapy to CNS metastases) and 23% with liver metastases.
En populationsfarmakokinetisk analyse indikerede, at legemsvægt var en signifikant kovariat med en forventet ændring på < 20 % i osimertinib-AUCss over et interval på henholdsvis 88 kg til 43 kg (95 % til 5 % fraktiler) i sammenligning med AUCss for den mediane legemsvægt på 61 kg.
Population PK analysis indicated that body weight was a significant covariate with a less than 20% change in osimertinib AUCss expected across a body weight range of 88 kg to 43 kg respectively (95% to 5% quantiles) when compared to the AUCss for the median body weight of 61 kg.
Interstitiel lungesygdom (ILD)
Interstitial lung disease (ILD)
Inkluderer tilfælde rapporteret inden for termgruppen: Keratitis, punktat keratitis, corneaerosion, defekt i corneaepitelet.
Includes cases reported within the clustered terms: Keratitis, punctate keratitis, corneal erosion, corneal epithelium defect.
Meget almindelig (47 %) 0,9 %
Very common (47%) 0.9%
Det var et krav, at alle patienter skulle have EGFR-T790M-mutationspositiv NSCLC, identificeret ved hjælp af cobas EGFR-mutationstest udført af et centralt laboratorium inden randomisering.
All patients were required to have EGFR T790M mutation-positive NSCLC identified by the cobas EGFR mutation test performed in a central laboratory prior to randomisation.
59 % af patienterne havde ekstra-torakale viscerale metastaser, herunder 39 % med CNS-metastaser (defineret som CNS-læsion ved baseline, anamnese og/eller tidligere operation og/eller tidligere strålingsbehandling af CNS-metastaser) og 29 % med levermetastaser.
Fifty-nine percent (59%) of patients had extra-thoracic visceral metastasis including 39% with CNS metastases (identified by CNS lesion site at baseline, medical history, and/or prior surgery and/or prior radiotherapy to CNS metastases) and 29% with liver metastases.
Antal døde (% modenhed)
Number of Deaths (% maturity)
CNS-metastase-effektdata fra FLAURA-studiet
CNS metastases efficacy data in FLAURA study
AstraZeneca AB Gärtunavägen SE-151 85 Södertälje Sverige
Gärtunavägen SE-151 85 Södertälje Sweden
Appetitløshed
Appetite Loss
Bivirkninger indberettet i FLAURA- og AURA-studierne
Adverse reactions reported in FLAURA and AURA studies
TAGRISSO 80 mg leveres som beige, filmovertrukne, ovale og bikonvekse tabletter, præget med “AZ” og “80” på den ene side og uden prægning på den anden side.
TAGRISSO 80 mg is supplied as beige, film-coated, oval and biconvex tablets, marked with “AZ” and “80” on one side, and plain on the other.
Meget almindelig (54 %) 1,6 %
Very common (54%) 1.6%
Demografiske data og sygdomskarakteristika ved baseline i den samlede studiepopulation var: medianalder 62, ≥75 år (15 %), kvinder (64 %), hvide (32 %), asiatere (65 %), aldrig-rygere (68 %), WHO performance-status 0 eller 1 (100 %).
The baseline demographic and disease characteristics of the overall study population were: median age 62, ≥75 years old (15%), female (64%), white (32%), Asian (65%), never smoker (68%), WHO performance status 0 or 1 (100%).
Der blev ikke rapporteret tilfælde af arytmi i FLAURA- eller AURA-studierne (se pkt.
No arrhythmic events were reported in FLAURA or AURA studies (see section 4.8).
Justeret middelværdi Estimeret forskel (95 %CI) p-værdi p <0,001
Difference (95%CI) p-value p <0.001
Antal hændelser (% modenhed)
Number of Events (% maturity)
Seponering af TAGRISSO (se pkt.
Discontinue TAGRISSO (see Section 4.4)
MedDRA SOC MedDRA-term CIOMS-beskrivelse/ samlet frekvens (alle
CIOMS descriptor/ overall frequency (all CTCAE grades)
Paronychion
Paronychia
Meget almindelig (35 %) 4,1 %
Very common (35%) 4.1%
Tidlige reduktioner i medianlaborietorietællinger af leukocytter, lymfocytter, neutrofilocytter og blodplader er observeret hos patienter behandlet med TAGRISSO.
Early reductions in the median laboratory counts of leukocytes, lymphocytes, neutrophils and platelets have been observed in patients treated with TAGRISSO, which stabilised over time and then remained above the lower limit of normal.
BICR hos patienter med CNS-metastaser ved en baselinehjernescanning i FLAURA
CNS efficacy by BICR in patients with CNS metastases on a baseline brain scan in FLAURA
Antal med respons (n), responsrate (95 % CI)
Number of responses (n), Response Rate (95% CI)
Hæmatologiske tilfælde
Haematological events
Antal med respons, responsrate (95 % CI)
Number of responses, Response Rate (95% CI)
• Modafinil - bruges mod overdreven søvntrang (narkolepsi)
• Modafinil -used for sleep disorders.
Den geometriske middelværdi (90% CI) for osimertinib AUC og Cmax var 63,3% (47,3; 84,5) og 51,4% (36,6; 72,3) hos patienter med let nedsat leverfunktionog 68,4% (49,6; 94,2) og 60,7% (41,6; 88,6) hos patienter med moderat nedsat leverfunktion.
The geometric mean ratio (90% CI) of osimertinib AUC and Cmax was 63.3% (47.3, 84.5) and 51.4% (36.6, 72.3) in patients with mild hepatic impairment and 68.4% (49.6, 94.2) and 60.7% (41.6, 88.6) in patients with moderate hepatic impairment; for the metabolite AZ5104 the AUC and Cmax were 66.5% (43.4, 101.9) and 66.3% (45.3, 96.9) in patients with mild hepatic impairment and 50.9% (31.7, 81.6) and 44.0% (28.9, 67.1) in patients with moderate hepatic impairment, compared to the exposure in patients with normal hepatic function.
Samtidig anvendelse af perikon er kontraindiceret (se pkt.
Concomitant use of St. John's Wort is contraindicated (see section 4.3).
Hver 40 mg filmovertrukket tablet indeholder 40 mg osimertinib.
Each 40mg film-coated tablet contains 40mg of osimertinib.
Hver 80 mg filmovertrukket tablet indeholder 80 mg osimertinib.
Each 80 mg film-coated tablet contains 80 mg of osimertinib.
Beige, 9 mm rund, bikonveks tablet, præget med “AZ” og “40” på den ene side og uden prægning på den anden side.
Beige, 9 mm, round, biconvex tablet, debossed with “AZ” and “40” on one side and plain on the reverse.
Meget almindelig (17 %) 0,1 %
Very common (17%) 0.1%
Meget almindelig (31 %) 0,3 %
Very common (31%) 0.3%
Sådan skal du tage TAGRISSO
How to take TAGRISSO
• Orale (taget gennem munden) hormonelle svangerskabsforebyggende tabletter (f.eks. P-piller).
• Oral hormonal contraceptive pill- used to prevent pregnancy.