natgillin/translations-raw huggingface dataset:
Egnede patienter var kvinder med stadie-IV ErbB2 metastatisk brystcancer med gen-amplifikation (eller protein-overekspression), som tidligere var blevet behandlet med antracykliner eller taxaner. 
Eligible patients were women with Stage IV ErbB2 gene amplified (or protein overexpressing) metastatic breast cancer who had been exposed to treatment with anthracyclines and taxanes.
Brug ikke lægemidlet efter den udløbsdato, der står på blisterpakningen eller beholderen og på kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the blister or bottle and the carton.
Randomiseringen var stratificeret efter sygdomsramte områder og tid siden seponering af tidligere, adjuverende antiøstrogenbehandling. 
Randomisation was stratified by sites of disease and by time from discontinuation of prior adjuvant anti-oestrogen therapy.
Udslættet var generelt let og resulterede ikke i afbrydelse af behandlingen med lapatinib. 
Rash was generally low grade and did not result in discontinuation of treatment with lapatinib.
Disse bivirkninger blev observeret, når lapatinib blev administreret i kombination med letrozol. 
These adverse reactions were observed when lapatinib was administered in combination with letrozole.
Indgift af Tyverb samtidig med stærke inhibitorer af CYP3A4 (f.eks. ritonavir, saquinavir, telithromycin, ketoconazol, itraconazol, voriconazol, posaconazol, nefazodon) bør undgås. 
Co-administration of Tyverb with strong inhibitors of CYP3A4 (e.g. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone) should be avoided.
Patienter egnede til inklusion havde lokalt avanceret eller metastatisk brystcancer med overekspression af HER2, progredierende efter tidligere behandling, der inkluderede taxan, antracyklin og trastuzumab. 
Patients eligible for enrolment had HER2-overexpressing, locally advanced or metastatic breast cancer, progressing after prior treatment that included taxanes, anthracyclines and trastuzumab.
Tyverb fås enten i blisterpakninger eller i beholdere: 
Tyverb is supplied in either blisters packs or bottles:
• kinidin, digoxin - medicin, der bruges til at behandle visse hjerteproblemer 
• quinidine, digoxin - medicines used to treat certain heart problems
Den anbefalede dosis af trastuzumab er 4 mg/kg administreret som en intravenøs støddosis efterfulgt af 2 mg/kg intravenøs ugentlig (se pkt. 
The recommended dose of trastuzumab is 4 mg/kg administered as an intravenous loading dose, followed by 2 mg/kg intravenous weekly (see section 5.1).
• blodprøveresultater, som viser ændringer i leverfunktionen (oftest milde og forbigående). 
• blood tests results that show changes in liver function (usually mild and temporary) Rare side effects (may affect up to 1 in 1,000 people):
Antal TTP-forekomster Median TTP, uger Hazard ratio (95 % CI) p-værdi 
Number of TTP events 121 Median TTP, weeks Hazard Ratio (95% CI) p value
Patienterne blev randomiseret til 2,5 mg letrozol en gang daglig og 1500 mg Tyverb en gang daglig eller letrozol i kombination med placebo. 
Patients were randomised to letrozole 2.5 mg once daily plus Tyverb 1500 mg once daily or letrozole with placebo.
En modelbaseret prognose viste, at når lapatinib tages i kombination med stærke inhibitorer af CYP3A4, kan QTc-intervallet forventes at blive forlænget med 16,1 ms (12,6-20,3 ms) (se pkt. 
When lapatinib is taken in combination with strong CYP3A4 inhibitors the QTc interval can be expected to be prolonged by 16.1 ms (12.6-20.3 ms) as demonstrated in a model-based prediction (see section 4.4).
Diarré optrådte inden for de første 6 dage af behandlingen hos næsten halvdelen af de patienter, som fik diarré. 
Diarrhoea generally occurs early during Tyverb treatment, with almost half of those patients with diarrhoea first experiencing it within 6 days.
• pimozid - medicin, der bruges til at behandle visse mentale lidelser 
• pimozide - a medicine used to treat certain mental health problems
I forhold til administration 1 time før et morgenmåltid med lavt fedtindhold var de gennemsnitlige AUC-værdier ca. 2 og 3 gange højere, når lapatinib blev administreret 1 time efter henholdsvis et måltid med lavt fedtindhold og et måltid med højt fedtindhold. 
Relative to dosing 1 hour before a low fat breakfast, mean AUC values were approximately 2- and 3-fold higher when lapatinib was administered 1 hour after a low fat or high fat meal, respectively.
Fortæl det til lægen, hvis du bruger, eller for nylig har brugt, noget af denne medicin. 
Tell your doctor if you are taking, or have recently taken, any of these.
• hvis du har leverproblemer 
• if you have any liver problems
Tyverb er ovale, bikonvekse, gule, filmovertrukne tabletter, der er præget "GS XJG" på den ene side. 
Tyverb film-coated tablets are oval, biconvex, yellow film-coated, with ‘GS XJG' marked on one side.
Behandlingen med Tyverb bør afbrydes ved alvorlige ændringer i leverfunktionen, og behandlingen bør ikke genoptages hos disse patienter. 
Tyverb dosing should be discontinued if changes in liver function are severe and patients should not be retreated.
Patienterne i registreringsstudiet var ikke tidligere blevet behandlet med trastuzumab eller en aromatasehæmmer (se pkt. 
The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor (see sections 4.4. and 5.1).
Tabel 6 Progressionsfri overlevelse fra studie EGF30008 (Tyverb/letrozol) 
Table 6 Progression free survival data from Study EGF30008 (Tyverb / letrozole)
Patienterne blev randomiseret til enten oral lapatinib 1000 mg en gang om dagen og trastuzumab 4 mg/kg administreret som intravenøs støddosis efterfulgt af 2 mg/kg intravenøs ugentlig (n = 148) eller til oral lapatinib 1500 mg en gang om dagen (n = 148). 
Patients were randomised to receive either oral lapatinib 1000 mg once daily plus trastuzumab 4 mg/kg administered as an intravenousloading dose, followed by 2 mg/kg intravenous weekly (N = 148), or oral lapatinib 1500 mg once daily (N = 148).
Multipakninger indeholder 140 (2 pakker af 70 stk.) filmovertrukne tabletter. 
Multipacks contain 140 (2 packs of 70) film-coated tablets.
Risikoen for lapatinib-induceret levertoksicitet var associeret med bærertilstand af HLA-allellerne DQA1*02:01 og DRB1*07:01 (se pkt. 
The risk of lapatinib-induced hepatotoxicity was associated with carriage of the HLA alleles DQA1*02:01 and DRB1*07:01 (see section 4.4).
Hos raske frivillige, der fik ketoconazol, en stærk CYP3A4-inhibitor, i en dosis på 200 mg to gange daglig i 7 dage, øgedes den systemiske optagelse af lapatinib (100 mg/dag) med ca. 3,6 gange og halveringstiden øgedes 1,7 gange. 
In healthy volunteers receiving ketoconazole, a strong CYP3A4 inhibitor, at 200 mg twice daily for 7 days, systemic exposure to lapatinib (100 mg daily) was increased approximately 3.6-fold, and half-life increased 1.7-fold.
Tabel 1 viser investigators analyse af data ved inklusionsafslutning. 
Investigator analysis on data at the end of enrolment is presented in Table 1.
Det bør overvejes at ophøre eller midlertidigt afbryde behandlingen med Tyverb, hvis en patient udvikler toksicitet, der ifølge NCI CTCAE svarer til eller er større end grad 2. 
Discontinuation or interruption of dosing with Tyverb may be considered when a patient develops toxicity greater than or equal to grade 2 on the NCI CTCAE.
Andre lægemidlers virkning på lapatinib 
Effects of other medicinal products on lapatinib
Jernoxid, gul (E172) Jernoxid, rød (E172) 
Iron oxide yellow (E172) Iron oxide red (E172)
Kvinder i den fertile alder skal anvende sikker kontraception og undgå at blive gravide under behandlingen med Tyverb og i mindst 5 dage efter den sidste dosis. 
Women of childbearing potential should be advised to use adequate contraception and avoid becoming pregnant while receiving treatment with Tyverb and for at least 5 days after the last dose.
Grapefrugtjuice kan hæmme CYP3A4 i tarmvæggen og dermed øge biotilgængeligheden af lapatinib. 
Grapefruit juice may inhibit CYP3A4 in the gut wall and increase the bioavailability of lapatinib and should therefore be avoided during treatment with Tyverb.
hævelse eller rødme) 
pain, swelling or reddening)
Af det samlede antal patienter, der var randomiseret til behandling, havde 219 patienter tumorer med overekspression af HER2-receptoren. 
Of all patients randomised to treatment, 219 patients had tumours overexpressing the HER2 receptor, and this was the pre-specified primary population for the analysis of efficacy.
Nedsat uddrivningsfraktion fra venstre ventrikel og forlængelse af QT-intervallet 
Decreased left ventricular ejection fraction and QT interval prolongation
Alvorlige hudlidelser er set ved brug af Tyverb. 
Serious skin reactions have been seen with Tyverb.
Tabel 1 Tid til progression (TTP) fra studie EGF100151 (Tyverb/capecitabin) 
Table 1 Time to progression data from Study EGF100151 (Tyverb / capecitabine)
Der foreligger ikke tilstrækkelige data fra anvendelse af Tyverb til kvinder i den fertile alder. 
There are no adequate data from the use of Tyverb in women of childbearing potential.
• phenytoin, carbamazepin - medicin, der bruges til at behandle krampeanfald 
• phenytoin, carbamazepine - medicines used to treat seizures
Se endvidere produktinformationen for trastuzumab. 
Please refer to the full prescribing information of trastuzumab.
Fortæl det til lægen med det samme, hvis du får nogen af disse symptomer. 
Tell your doctor immediately if you get any of these symptoms.
Tyverb fås både i blisterpakninger og i beholdere. 
Tyverb is supplied in either blister packs or bottles.
Behandlingen med Tyverb skal afbrydes hos patienter, der får symptomer associeret med nedsat uddrivningsfraktion fra venstre ventrikel (Left ventricular ejection fraction (LVEF)), der ifølge ”National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)” svarer til eller er større end grad 3, eller hvis patienternes LVEF falder til under normalområdets nedre grænse (se pkt. 
Tyverb should be discontinued in patients with symptoms associated with decreased left ventricular ejection fraction (LVEF) that are National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade 3 or greater or if their LVEF drops below the institutions lower limit of normal (see section 4.4).
Se produktinformationen for den samtidigt administrerede aromatasehæmmer for nærmere oplysninger om dosering. 
Please refer to the full prescribing information of the co-administered aromatase inhibitor for dosing details.
Der blev ikke rapporteret om yderligere bivirkninger forbundet med lapatinib i kombination med trastuzumab. 
No additional adverse reactions were reported to be associated with lapatinib in combination with trastuzumab.
Nedsættelse af risikoen for diarré og udslæt 
Reducing the risk of diarrhoea and skin rash
Fortæl det til lægen så hurtigt som muligt, hvis du oplever nogle af disse symptomer. 
Tell your doctor as soon as possible if you get any of these symptoms.
Tabel 2 Samlet overlevelse fra studie EGF100151 (Tyverb/capecitabin) 
Table 2 Overall survival data from Study EGF100151 (Tyverb / capecitabine)
I tiden fra interim-analysen og til inklusionen standsede blev der inkluderet yderligere 75 patienter i studiet. 
An additional 75 patients were enrolled in the study between the time of the interim analysis and the end of the enrolment.
Midlertidig afbrydelse af behandling og nedsættelse af dosis 
Dose delay and dose reduction
Tyverb kan eventuelt genoptages ved en lavere dosis (nedsat fra 1000 mg/dag til 750 mg/dag, fra 1250 mg/dag til 1000 mg/dag eller fra 1500 mg/dag til 1250 mg/dag), når diarréen er bedret til grad 1 eller mindre. 
Tyverb may be reintroduced at a lower dose (reduced from 1000 mg/day to 750 mg/day, from 1250 mg/day to 1000 mg/day or from 1500 mg/day to 1250 mg/day) when diarrhoea resolves to grade 1 or less.
Tyverb 1500 mg / dag + letrozol 2,5 mg /dag n = 111 
Tyverb 1500 mg / day + Letrozole 2.5 mg /day N=111
Diarré var den bivirkning, der hyppigst medførte seponering af behandlingen, når lapatinib blev givet i kombination med capecitabin eller letrozol. 
Diarrhoea was the most common adverse reaction resulting in discontinuation of treatment when lapatinib was administered in combination with capecitabine, or with letrozole.
Indgift af Tyverb samtidig med kendte induktorer af CYP3A4 (f.eks. rifampicin, rifabutin, carbamazepin, phenytoin eller perikon (hypericum perforatum)) bør undgås. 
Co-administration of Tyverb with known inducers of CYP3A4 (e.g. rifampicin, rifabutin, carbamazepine, phenytoin or Hypericum perforatum [St John's Wort]) should be avoided.
Der sås en vækstreduktion hos rotteyngel, der fik lapatinib gennem modermælk. 
In rats, growth retardation was observed in pups which were exposed to lapatinib via breast milk.
• hvis du har en lungesygdom 
• if you have lung disease
Der blev observeret symptomatiske fald i LVEF hos ca. 0,3 % af de patienter, der fik lapatinib som monoterapi eller i kombination med andre lægemidler til behandling af cancer. 
Symptomatic LVEF decreases were observed in approximately 0.3% of patients who received lapatinib monotherapy or in combination with other anti-cancer medicinal products.
• nefazodon - medicin, der bruges til at behandle depression 
• nefazodone - a medicine used to treat depression
Forekomsten af PPE var sammenlignelig i behandlingsarmen med lapatinib og capecitabin og i behandlingsarmen med capecitabin alene. 
The incidence of PPE was similar in the lapatinib plus capecitabine and capecitabine alone treatment arms.
Diarré opstod hos ca. 65 % af de patienter, der blev behandlet med lapatinib i kombination med capecitabin, hos 64 % af de patienter, som fik lapatinib i kombination med letrozol, og hos 62 % af de patienter, som fik lapatinib i kombination med trastuzumab. 
Diarrhoea occurred in approximately 65 % of patients who received lapatinib in combination with capecitabine, in 64 % of patients who received lapatinib in combination with letrozole and in 62 % of patients who received lapatinib in combination with trastuzumab.
Lapatinib har været associeret med fald i LVEF (se pkt. 
Lapatinib has been associated with reports of decreases in LVEF (see section 4.8).
70 filmovertrukne tabletter 84 filmovertrukne tabletter 
70 film-coated tablets 84 film-coated tablets
Der var ingen virkning på gonadefunktion hos han- eller hunrotter, parring eller fertilitet ved doser på op til 120 mg/kg/døgn (hunrotter) og op til 180 mg/kg/døgn (hanrotter) (hhv. 8 og 3 gange den forventede, kliniske optagelse hos mennesker). 
There were no effects on male or female rat gonadal function, mating, or fertility at doses up to 120 mg/kg/day (females) and up to 180 mg/kg/day (males) (8 and 3 times the expected human clinical exposure, respectively).
Det er ikke nødvendigt med dosisændringer til patienter med let til moderat nedsat nyrefunktion. 
No dose adjustment is necessary in patients with mild to moderate renal impairment.
Effekt af fødeindtag på lapatinibs eksponering 
Food effects on lapatinib exposure
Responsrate, % (95 % CI) 
Response rate, % (95% CI)
Hvis du får diarré, mens du er i behandling med Tyverb, kan du gøre følgende: 
If you suffer from diarrhoea while taking Tyverb:
Forsøgsdeltagerne var ikke tidligere blevet behandlet for metastatisk sygdom. 
The study enrolled patients who had not received prior therapy for their metastatic disease.
Tal med lægen eller apoteket, hvis en bivirkning bliver alvorlig eller generende. 
Tell your doctor if any of these side effects get severe or troublesome.
2,5 mg letrozol/dag + placebo 
Letrozole 2.5 mg /day + placebo
• medicin mod mavesyre - bruges til at behandle mavesår eller fordøjelsesbesvær. 
• medicines that decrease stomach acidity - used to treat stomach ulcers or indigestion
Udslæt opstod hos ca. 28 % af de patienter, der blev behandlet med lapatinib i kombination med capecitabin, hos 45 % af de patienter, som fik lapatinib i kombination med letrozol, og hos 23 % af de patienter, som fik lapatinib i kombination med trastuzumab. 
Rash occurred in approximately 28 % of patients who received lapatinib in combination with capecitabine, in 45 % of patients who received lapatinib in combination with letrozole and in 23 % of patients who received lapatinib in combination with trastuzumab.
Der bør udvises forsigtighed ved administration af lapatinib samtidig med lægemidler, der er substrater for Pgp, og som har et smalt terapeutisk vindue. 
Caution should be exercised when dosing lapatinib concurrently with medicinal products with narrow therapeutic windows that are substrates of Pgp, and a reduction in the dose of the Pgp substrate should be considered.
Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se. bilag I: Produktresumé, pkt. 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Lapatinib metaboliseres hovedsageligt af CYP3A (se pkt. 
Lapatinib is predominantly metabolised by CYP3A (see section 5.2).
I et metastatisk og i et tidligt stadie af brystcancer var effekten til forebyggelse af CNSmetastaser begrænset. 
In the prevention of CNS metastases in the metastatic and early breast cancer settings the observed activity was limited.
Samtidig behandling med stærke inhibitorer af CYP3A4 bør undgås pga. risiko for øget optagelse af lapatinib (se pkt. 
Concomitant treatment with strong inhibitors of CYP3A4 should be avoided due to risk of increased exposure to lapatinib (see section 4.5).
Der skal udvises forsigtighed, hvis Tyverb gives til patienter med moderat eller svært nedsat leverfunktion og til patienter med svært nedsat nyrefunktion (se pkt. 
Caution is warranted if Tyverb is prescribed to patients with moderate or severe hepatic impairment and to patients with severe renal impairment (see sections 4.2 and 5.2).
• cisaprid - medicin, der bruges til at behandle visse lidelser i fordøjelsessystemet 
• cisapride - a medicine used to treat certain digestive system problems
Diarréen kan afhjælpes med pro-aktiv behandling (se pkt. 
Diarrhoea responds well to proactive management (see section 4.4).
Lapatinib hæmmer transportproteinerne BCRP og OATP1B1 (organisk anion-tranporter) in vitro. 
Lapatinib inhibits the transport proteins BCRP and OATP1B1 in vitro.
Dette gøres for at sikre, at du ikke tager noget, som ikke må tages samtidig med Tyverb. 
Your doctor will review the medicines you are currently taking to make sure you are not taking something that can't be taken with the Tyverb.
• repaglinid - medicin, der bruges til at behandle sukkersyge 
• repaglinide - a medicine used to treat diabetes
Stevens-Johnson syndrom (SJS) og toksisk epidermal nekrolyse (TEN) Knogler, led, muskler og bindevæv Meget almindelig Smerter i ekstremiteter* †, rygsmerter* 
Serious cutaneous reactions, including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)** Musculoskeletal and connective tissue disorders Very common Pain in extremity*
Fald i LVEF blev rapporteret hos 6,7 % af de patienter, der fik lapatinib i kombination med trastuzumab, sammenlignet med hos 2,1 % af de patienter, der fik lapatinib alene. 
LVEF decreases were reported in 6.7 % of patients who received lapatinib in combination with trastuzumab, as compared to 2.1 % of patients who received lapatinib alone.
Behandlingen med Tyverb bør afbrydes ved alvorlige ændringer i leverfunktionen, og behandlingen bør ikke genoptages hos disse patienter (se pkt. 
Tyverb should be discontinued if changes in liver function are severe and patients should not be retreated (see section 4.4).
Den anbefalede dosis af Tyverb er 1000 mg (dvs. fire tabletter) en gang daglig kontinuerligt. 
The recommended dose of Tyverb is 1000 mg (i.e. four tablets) once daily continuously.
Interstitiel lungesygdom/pneumonitis 
Interstitial lung disease / pneumonitis
• Hvis du ammer eller planlægger at amme, skal du fortælle det til lægen. 
• If you are breast-feeding or planning to breast-feed, tell your doctor.
Samtidig behandling med induktorer af CYP3A4 bør undgås pga. risiko for nedsat optagelse af lapatinib (se pkt. 
Concomitant treatment with inducers of CYP3A4 should be avoided due to risk of decreased exposure to lapatinib (see section 4.5).
Ved dosering af lapatinib én time efter et måltid øges den systemiske eksponering ca. 2-3 gange sammenlignet med dosering af lapatinib én time før et måltid (se pkt. 
Dosing of lapatinib one hour after a meal results in approximately 2-3 times higher systemic exposure, compared to dosing one hour before a meal (see sections 4.5 and 5.2).
Der kan også ske udskillelse med galden. 
Biliary excretion may also contribute to the elimination.
• påvirkning af hjertefunktionen. 
• an effect on how your heart works
†, hoste 
†, cough
Lapatinib hæmmer CYP3A4 in vitro ved klinisk relevante koncentrationer. 
Lapatinib inhibits CYP3A4 in vitro at clinically relevant concentrations.
Hos patienter, der tog op til 5000 mg lapatinib, sås allerede kendte symptomer relateret til lapatinib (se pkt. 
In patients who took up to 5000 mg of lapatinib, symptoms observed include known lapatinib associated events (see section 4.8) and in some cases sore scalp and/or mucosal inflammation.
Lapatinib er en 4-anilinoquinazolin-kinase-hæmmer af intracellulær tyrosin-kinase-domæner af både EGFR (ErbB1)- og HER2 (ErbB2)-receptorer (anslåede Ki app 
Lapatinib, a 4-anilinoquinazoline, is an inhibitor of the intracellular tyrosine kinase domains of both EGFR (ErbB1) and of HER2 (ErbB2) receptors (estimated Ki app values of 3nM and 13nM, respectively) with a slow off-rate from these receptors (half-life greater than or equal to 300 minutes).
Forsøgspersoner, der ikke tidligere havde fået trastuzumab* n 
Subjects who had not received prior trastuzumab* N
Lapatinib hæmmer transportproteinet Pgp in vitro ved klinisk relevante koncentrationer. 
Lapatinib inhibits the transport protein Pgp in vitro at clinically relevant concentrations.
Capecitabin (2500 mg/m2/dag, dag 1-14 hver 21. dag) 
capecitabine (2500 mg/m2/day, days 1-14 q21 days)
Tabletterne er pakket i blisterpakninger (polyamid/aluminium/polyvinylchorid/aluminium) med 10 stk. 
Each pack of Tyverb contains 70 film-coated tablets in foil blisters (polyamide / aluminium / polyvinyl chloride / aluminium) of 10 tablets each.
Patienterne blev enten randomiseret til 1250 mg Tyverb én gang dagligt (kontinuerligt) plus capecitabin (2000 mg/m2/dag på dag 1-14 hver 21. dag) eller trastuzumab (infusion med startdosis på 8 mg/kg efterfulgt af infusion af 6 mg/kg hver 3. uge) plus capecitabin (2500 mg/m2/dag på dag 1-14 hver 21. dag). 
Patients were randomised to either Tyverb 1250 mg once daily (continuously) plus capecitabine (2000 mg/m2/day on days 1-14 every 21 days), or trastuzumab (loading dose of 8mg/kg followed by 6mg/kg q3 weekly infusions) plus capecitabine (2500mg/m2/day, days 1-14, every 21 days).
svær diarré ved behandling med Tyverb (se pkt. 
Diarrhoea, including severe diarrhoea, has been reported with Tyverb treatment (see section 4.8).
Lapatinib er et substrat for transportproteinerne p-glykoprotein (Pgp) og brystcancer-resistent protein (BCRP). 
Lapatinib is a substrate for the transport proteins Pgp and BCRP.
Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har. 
even if their signs of illness seem the same as yours.
LVEF-fald blev rapporteret hos 2,5 % af de patienter, der fik lapatinib i kombination med capecitabin sammenlignet med 1,0 % ved capecitabin alene. 
LVEF decreases were reported in 2.5 % of patients who received lapatinib in combination with capecitabine, as compared to 1.0 % with capecitabine alone.
• hvis du har betændelse/irritation i lungerne 
• if you have inflammation of the lung
To af patienterne havde tidligere fået behandling med en aromatasehæmmer, og ca. halvdelen havde fået tamoxifen. 
In the HER2-overexpressing population, only 2 patients were enrolled who had received prior trastuzumab, 2 patients had received prior aromatase inhibitor therapy, and approximately half had received tamoxifen.
Interstitiel lungesygdom og pneumonitis 
Interstitial lung disease and pneumonitis
• hvis du har nyreproblemer 
• if you have any kidney problems