natgillin/translations-raw huggingface dataset:
Spørg lægen eller på apoteket, inden du begynder behandling med Tyverb, hvis der er noget, du er i tvivl om. 
Ask your doctor or pharmacist for advice before taking Tyverb if you are unsure.
AUC-værdierne for lapatinib var ca. 3 og 4 gange højere (Cmax ca. 2,5 og 3 gange højere), når lapatinib blev administreret sammen med henholdsvis et måltid med lavt fedtindhold (5 % fedt [500 kalorier]) og et måltid med højt fedtindhold (50 % fedt [1000 kalorier]) i forhold til administration i fastende tilstand. 
Lapatinib AUC values were approximately 3- and 4-fold higher (Cmax approximately 2.5 and 3-fold higher) when administered with a low fat (5% fat [500 calories]) or with a high fat (50% fat [1,000 calories]) meal, respectively, as compared with administration in the fasted state.
Kaplan-Meier-estimat 
Kaplan-Meier estimates
Lapatinib hæmmede ikke i signifikant grad følgende enzymer i humane levermikrosomer: CYP1A2, CYP2C9, CYP2C19 og CYP2D6 eller UGT-enzymer (in vitro-IC50værdierne var højere end eller lig med 6,9 µg/ml). 
Lapatinib did not significantly inhibit the following enzymes in human liver microsomes: CYP1A2, CYP2C9, CYP2C19, and CYP2D6 or UGT enzymes (in vitro IC50 values were greater than or equal to 6.9 µg/ml).
Inhibitorer (ketoconazol, itraconazol, kinidin, verapamil, ciclosporin og erythromycin) og induktorer (rifampicin og perikon) af disse proteiner kan ændre optagelsen og/eller fordelingen af lapatinib (se pkt. 
Inhibitors (ketoconazole, itraconazole, quinidine, verapamil, cyclosporine, and erythromycin) and inducers (rifampicin and St John's Wort) of these proteins may alter the exposure and/or distribution of lapatinib (see section 5.2).
LVEF blev evalueret hos alle patienter (vha. ekkokardiogram [ECHO] eller multiple gated acquisition [MUGA]) før initiering af behandling med Tyverb for at sikre, at baseline-LVEF lå inden for normalområdet. 
LVEF was evaluated in all patients (using echocardiogram [Echo] or multi gated acquisition scan [MUGA]) prior to initiation of treatment with Tyverb to ensure baseline LVEF was within the institutions normal limits.
Hvis der er mistanke om erythema multiforme eller livstruende lidelser såsom Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse (som progressivt hududslæt ofte med blistre eller mucosale læsioner) skal Tyverbbehandlingen diskontinueres. 
If erythema multiforme or life-threatening reactions such as Stevens-Johnson syndrome, or toxic epidermal necrolysis (e.g. progressive skin rash often with blisters or mucosal lesions) are suspected, discontinue treatment with Tyverb.
Fald i LVEF blev normaliseret eller forbedret i over 70 % af tilfældene, heraf ca. 60 % ved seponering af behandlingen med lapatinib og ca. 40 % ved fortsat behandling med lapatinib. 
LVEF decreases resolved or improved in more than 70 % of cases, in approximately 60 % of these on discontinuation of treatment with lapatinib, and in approximately 40 % of cases lapatinib was continued.
Tyverb er undersøgt i kombination med letrozol til behandling af postmenopausale kvinder med hormonreceptorpositiv (østrogenreceptorpositiv [ER-positiv] og/eller progesteronreceptorpositiv [PgR-positiv]) avanceret eller metastatisk brystcancer. 
Tyverb has been studied in combination with letrozole for the treatment of postmenopausal women with hormone receptor-positive (oestrogen receptor [ER] positive and / or progesterone receptor [PgR] positive) advanced or metastatic breast cancer.
I et klinisk fase III-studie med Tyverb i kombination med letrozol var 44 % af det samlede antal patienter med hormonreceptorpositiv metastatisk brystcancer ≥ 65 år (intent to treat (ITT)-population: n = 642). 
In the phase III clinical study of Tyverb in combination with letrozole, of the total number of hormone receptor positive metastatic breast cancer patients (Intent to treat population N= 642), 44 % were ≥ 65 years of age.
Lapatinibs virkning på andre lægemidler 
Effects of lapatinib on other medicinal products
Lapatinib hæmmer ErbB-drevet tumorcellevækst in vitro og i forskellige dyremodeller. 
Lapatinib inhibits ErbB-driven tumour cell growth in vitro and in various animal models.
In vitro-studier indikerer, at lapatinib er substrat for transportørerne BCRP (ABCG1) og p-glykoprotein (ABCB1). 
In vitro studies indicate that lapatinib is a substrate for the transporters BCRP (ABCG1) and p-glycoprotein (ABCB1).
• Hvis du bliver gravid, mens du er i behandling med Tyverb, skal du fortælle det til lægen. 
• If you become pregnant during treatment with Tyverb, tell your doctor.
(95% CI), p-værdi b 
(95% CI), p-value b
• ritonavir, saquinavir - medicin, der bruges til at behandle hiv 
• ritonavir, saquinavir - medicines used to treat HIV
Der sås ingen teratogen effekt, dog var der mindre anomalier (venstresidig umbilicus-arterie, cervikalt ribben og tidlig knogledannelse) hos rotter ved ≥ 60 mg/kg/døgn (4 gange den forventede, kliniske optagelse hos mennesker). 
There were no teratogenic effects; however, minor anomalies (left-sided umbilical artery, cervical rib and precocious ossification) occurred in rats at ≥60 mg/kg/day (4 times the expected human clinical exposure).
YDRE KARTON OG ETIKET PÅ BEHOLDER 
OUTER CARTON AND BOTTLE LABEL
En daglig dosering på 1250 mg medfører geometriske middel-(variationskoefficient) Cmax-værdier ved steady state på 2,43 (76 %) µg/ml og AUC-værdier på 36,2 (79 %) µg∙time/ml. 
Daily dosing of 1250 mg produces steady state geometric mean (coefficient of variation) Cmax values of 2.43 (76%) µg/ml and AUC values of 36.2 (79%) µg*hr/ml.
Der var en øget forekomst af kardiel toksicitet, men disse bivirkninger havde samme karakter og sværhedsgrad som dem, der blev rapporteret i forbindelse med lapatinibs kliniske program (se pkt. 
There was an increased incidence of cardiac toxicity, but these events were comparable in nature and severity to those reported from the lapatinib clinical programme (see section 4.4cardiac toxicity).
Når lapatinib blev administreret i kombination med trastuzumab mod metastatisk sygdom i det pivotale studie var incidencen af kardielle bivirkninger, herunder fald i LVEF, imidlertid højere (7 %) i forhold til lapatinib administreret alene (2 %). 
However, when lapatinib was administered in combination with trastuzumab in the metastatic setting, the incidence of cardiac events including LVEF decreases was higher (7%) versus the lapatinib alone arm (2%) in the pivotal trial.
Bivirkningerne er beskrevet i punkt 4. 
These effects are described in section 4, ‘Possible side effects'.
b. Pike-estimat af behandlings hazard ratio, hvor < 1 indikerer en lavere risiko ved Tyverb plus capecitabin sammenlignet med trastuzumab + capecitabin. 
b. Pike estimate of the treatment hazard ratio, <1 indicates a lower risk for Tyverb plus capecitabine compared with Trastuzumab plus capecitabine.
I et stort randomiseret klinisk studie med Tyverb-monoterapi (n=1.194) var den kumulative frekvens af alvorlige leverskader (ALAT > 5-gange øvre normalgrænse, NCI CTCAE grad 3) samlet set 2,8 % efter 1 års behandling. 
In a large, randomised clinical trial of Tyverb monotherapy (n=1,194), the cumulative frequency of severe liver injury (ALT >5 times the upper limit of normal, NCI CTCAE grade 3) at 1 year of treatment was 2.8% overall.
Kardiel toksicitet 
Cardiac toxicity
Mens du tager Tyverb 
While you are taking Tyverb
Meget almindelig Hovedpine Almindelig 
Very common Headache
Patienter, som er bærere af HLA-allellerne DQA1*02:01 og DRB1*07:01, har øget risiko for Tyverb-associeret levertoksicitet. 
Patients who carry the HLA alleles DQA1*02:01 and DRB1*07:01 have increased risk of Tyverb-associated hepatotoxicity.
Lapatinib hæmmer CYP3A (Ki 0,6-2,3 µg/ml) og CYP2C8 (0,3 µg/ml) in vitro ved klinisk relevante koncentrationer. 
Lapatinib inhibits CYP3A (Ki 0.6 to 2.3 µg/ml) and CYP2C8 (0.3 µg/ml) in vitro at clinically relevant concentrations.
Svære tilfælde af diarré kan nødvendiggøre indgift af orale eller intravenøse elektrolytter og væsker, brug af antibiotika såsom fluoroquinoloner (specielt, hvis diarréen har varet over 24 timer, eller hvis der er feber eller grad 3 eller 4 neutropeni) og afbrydelse eller seponering af Tyverb-behandlingen (se pkt. 
Severe cases of diarrhoea may require administration of oral or intravenous electrolytes and fluids, use of antibiotics such as fluoroquinolones (especially if diarrhoea is persistent beyond 24 hours, there is fever, or grade 3 or 4 neutropenia) and interruption or discontinuation of Tyverb therapy (see section 4.2 - dose delay and dose reduction -diarrhoea).
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEL ELLER SAMT AFFALD HERAF 
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Tyverb bruges til at behandle visse former for brystkræft (brystkræft med HER2-positive kræftceller), som har spredt sig ud over den oprindelige tumor eller til andre organer (avanceret eller metastatisk brystkræft). 
Tyverb is used to treat certain types of breast cancer (HER2-overexpressing) which have spread beyond the original tumour or to other organs (advanced or metastatic breast cancer).
8,9 måneder (6,7; 11,8) 
8.9 mos (6.7, 11.8)
Tag ikke Tyverb: 
Do not take Tyverb
Du kan finde råd om, hvordan du nedsætter risikoen for udslæt i slutningen af punkt 4. 
There is more advice on reducing the risk of skin rash at the end of section 4.
Lapatinib udskilles overvejende gennem metabolisering af CYP3A4/5. 
Lapatinib is predominantly eliminated through metabolism by CYP3A4/5.
YDRE KARTON (28-DAGS-MULTIPAKNING) 
OUTER CARTON (28-DAY, MULTIPACK)
Yderligere tiltag bør være som klinisk indiceret eller efter anbefalinger fra Giftlinjen. 
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Tal med lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke fremgår af denne indlægsseddel. 
Tell your doctor or pharmacist if you notice any side effects not listed in this leaflet.
Eksisterende data tyder på, at det ikke er nødvendigt med dosisændringer til patienter med mild til moderat nedsat nyrefunktion. 
Available data suggest that no dose adjustment is necessary in patients with mild to moderate renal impairment.
Ovale, bikonvekse, gule filmovertrukne tabletter, der er præget "GS XJG" på den ene side. 
Oval, biconvex, yellow film-coated tablets, with “GS XJG” debossed on one side.
Hos raske frivillige, der fik carbamazepin, en CYP3A4-induktor, i en dosis på 100 mg to gange daglig i 3 dage og 200 mg to gange daglig i 17 dage, faldt den systemiske optagelse af lapatinib med ca. 72 %. 
In healthy volunteers receiving carbamazepine, a CYP3A4 inducer, at 100 mg twice daily for 3 days and 200 mg twice daily for 17 days, systemic exposure to lapatinib was decreased approximately 72%.
I armen med Tyverb plus capecitabin var CNS det første sted med progression hos 8 patienter (3,2 %) sammenlignet med 12 patienter (4,8 %) i armen med trastuzumab plus capecitabin. 
In the Tyverb plus capecitabine arm 8 patients (3.2%) experienced CNS as site of first progression, compared with 12 patients (4.8%) in the trastuzumab plus capecitabine arm.
Ventrikulære arytmier/Torsades de Pointes, QT-forlængelse på elektrokardiogram 
Ventricular arrhythmias/Torsades de Pointes, electrocardiogram QT prolonged**
Det kan ikke udelukkes, at lapatinib påvirker farmakokinetikken af substrater for BCRP (f.eks. topotecan) og OATP1B1 (f.eks. rosuvastatin) (se pkt. 
It cannot be excluded that lapatinib will affect the pharmacokinetics of substrates of BCRP (e.g. topotecan) and OATP1B1 (e.g. rosuvastatin) (see section 5.2).
Sikkerheden ved lapatinib som monoterapi eller i kombination med andre kemoterapeutika mod forskellige cancerformer er blevet undersøgt hos over 20.000 patienter, herunder 198 patienter, som fik lapatinib i kombination med capecitabin, 149 patienter, som fik lapatinib i kombination med trastuzumab, og 654 patienter, som fik lapatinib i kombination med letrozol (se pkt. 
The safety of lapatinib has been evaluated as monotherapy or in combination with other chemotherapies for various cancers in more than 20,000 patients, including 198 patients who received lapatinib in combination with capecitabine, 149 patients who received lapatinib in combination with trastuzumab and 654 patients who received lapatinib in combination with letrozole (see section 5.1).
Der er også set en forøgelse af nyreinfarkt og papillær nekrose hos hunrotter ved eksponeringer, der var 7-10 gange større sammenlignet med mennesker, som fik 1250 mg lapatinib en gang daglig. 
There was also an increase in renal infarcts and papillary necrosis in female rats at exposures 7 and 10-fold compared to humans given 1250 mg of lapatinib once daily.
Lapatinibs virkning på CNS-metastaser 
Lapatinib effect on CNS metastasis
70 filmovertrukne tabletter 84 filmovertrukne tabletter 105 filmovertrukne tabletter 140 filmovertrukne tabletter 
70 film-coated tablets 84 film-coated tablets 105 film-coated tablets 140 film-coated tablets
Ydermere, afhængigt af hvilken type mad der indtages, er lapatinibs biotilgængelighed ca. 2-3 gange højere, når lapatinib indtages 1 time efter fødeindtagelse sammenlignet med indtagelse 1 time før dagens første måltid (se pkt. 
Furthermore, depending on type of food the bioavailability is approximately 2-3 times higher when lapatinib is taken 1 hour after food compared with 1 hour before the first meal of the day (see sections 4.2 and 5.2).
Samtidig administration af lapatinib og oralt administreret digoxin resulterede i ca. 80 % øgning af digoxins AUC. 
Co-administration of lapatinib with orally administered digoxin resulted in an approximate 80% increase in the AUC of digoxin.
• I kombination med trastuzumab til patienter med hormonreceptor-negativ metastatisk sygdom, som er progredieret under tidligere behandling(er) med trastuzumab i kombination med kemoterapi (se pkt. 
• in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy (see section 5.1).
Uomdannet lapatinib i fæces udgør i gennemsnit (median) 27 % (interval 3-67 %) af en oral dosis. 
Recovery of unchanged lapatinib in faeces accounts for a median 27% (range 3 to 67%) of an oral dose.
Farmakokinetikken for lapatinib er ikke undersøgt specifikt for patienter med nedsat nyrefunktion eller patienter, der får hæmodialyse. 
Lapatinib pharmacokinetics have not been specifically studied in patients with renal impairment or in patients undergoing haemodialysis.
Information om de nævnte lægemidler findes i de respektive indlægssedler. 
Information about these medicines is described in separate patient information leaflets.
YDRE KARTON (ENKELT 14-DAGS-PAKNING) 
OUTER CARTON (14 DAY, SINGLE PACK)
En koncentrationsafhængig forlængelse af QTcF (maksimalt gennemsnit ΔΔQTcF 8,75 ms; 90 % CI 4,08; 13,42) blev observeret i et specifikt QT-studie hos patienter med fremskredne, solide tumorer (se pkt. 
A concentration dependent increase in QTcF (maximum mean ΔΔQTcF 8.75 ms; 90% CI 4.08, 13.42) was observed in a dedicated QT study in patients with advanced solid tumours (see section 4.4).
Hos kaniner er lapatinib blevet forbundet med toksicitet hos moderen ved 60 og 120 mg/kg/døgn (hhv. 8 % og 23 % af den forventede, kliniske optagelse hos mennesker) og aborter ved 120 mg/kg/døgn. 
In rabbits, lapatinib was associated with maternal toxicity at 60 and 120 mg/kg/day (8% and 23% of the expected human clinical exposure, respectively) and abortions at 120 mg/kg/day.
Tyverb skal seponeres permanent hos patienter, der får diarré NCI CTCAE grad 4. 
Tyverb dosing should be permanently discontinued in patients with diarrhoea which is NCI CTCAE grade 4.
letrozol 2,5 mg /dag + placebo n = 108 
Letrozole 2.5 mg /day + placebo N=108
Indtagelse af grapefrugtjuice bør undgås under behandling med Tyverb (se pkt. 
Grapefruit juice should be avoided during treatment with Tyverb (see section 4.5).
En øgning af hyppigheden og sværhedsgraden af diarré og neutropeni er blevet observeret ved kombination af lapatinib og paclitaxel i kliniske studier. 
An increase in the incidence and severity of diarrhoea and neutropenia has been observed with this combination in clinical studies.
• rosuvastatin - medicin, der bruges til at behandle et højt kolesteroltal 
• rosuvastatin - a medicine used to treat high cholesterol
Resultaterne for den farmakodynamiske population (n=52) var konsistente med resultaterne fra den evaluérbare population (maksimal ΔΔQTcF (90 % CI) på 7,91 ms (4,13; 11,68), observeret 10 timer efter indtagelse af den tredje dosis lapatinib på 2000 mg). 
The results for the pharmacodynamics population (n=52) were consistent with those from the evaluable population (maximum ΔΔQTcF (90% CI) of 7.91 ms (4.13, 11.68) observed 10 hours after ingestion of the third dose of lapatinib 2000 mg).
Patienterne bør monitoreres for pulmonal toksicitet (dyspnø, hoste, feber), og behandlingen skal seponeres hos patienter, som får symptomer af NCI CTCAE-grad 3 eller derover. 
Patients should be monitored for symptoms of pulmonary toxicity (dyspnoea, cough, fever) and treatment discontinued in patients who experience symptoms which are NCI CTCAE grade 3 or greater.
Anden toksicitet 
Other toxicities
Indgift af Tyverb samtidig med moderate inhibitorer af CYP3A4 bør ske med forsigtighed, og kliniske bivirkninger bør monitoreres omhyggeligt. 
Co-administration of Tyverb with moderate inhibitors of CYP3A4 should proceed with caution and clinical adverse reactions should be carefully monitored.
• en hudreaktion på håndfladerne eller fodsålerne (herunder prikken, følelsesløshed, smerter, 
• a skin reaction on the palms of the hands or soles of the feet (including tingling, numbness,
8,2 uger (7,4; 9,3) 
8.2 wks (7.4, 9.3)
I studier i forbindelse med lapatinibs kliniske udviklingsprogram er der rapporteret kardielle bivirkninger hos ca. 1 % af patienterne, herunder fald i LVEF. 
In studies across the clinical development programme for lapatinib, cardiac events including LVEF decreases were reported in approximately 1% of patients.
Følgende bivirkninger er indberettet som havende en årsagsmæssig sammenhæng med lapatinib alene eller med lapatinib i kombination med capecitabin, trastuzumab eller letrozol. 
The following adverse reactions have been reported to have a causal association with lapatinib alone or lapatinib in combination with capecitabine, trastuzumab or letrozole.
Der blev vist en koncentrationsafhængig forlængelse af QT-intervallet i et specifikt placebokontrolleret, crossover-studie hos forsøgspersoner med fremskredne, solide tumorer. 
A concentration-dependent increase of the QTc interval was demonstrated in a dedicated placebo-controlled crossover study in subjects with advanced solid tumours.
- Aktivt stof: Lapatinib. 
- The active substance in Tyverb is lapatinib.
Lægen vil foretage undersøgelser for at tjekke, om dit hjerte fungerer, som det skal før og under din behandling med Tyverb. 
Your doctor will run tests to check that your heart is working properly before and during your treatment with Tyverb.
Ved udviklingsstudier med rotter før og efter fødslen sås et fald i overlevelse hos afkommet mellem fødsel og dag 21 efter doser på 60 mg/kg/døgn eller højere (5 gange den forventede, kliniske optagelse hos mennesker). 
In the rat preand postnatal development study, a decrease in pup survival occurred between birth and postnatal day 21 at doses of 60 mg/kg/day or higher (5 times the expected human clinical exposure).
Det skal du vide, før du begynder at tage Tyverb 
What you need to know before you take Tyverb
Det er særlig vigtigt, at du fortæller lægen, hvis du bruger eller for nylig har brugt noget af den nedenfor listede medicin. 
It is especially important to tell your doctor if you are taking, or have recently taken any of the following medicines.
• træthed, svaghed 
• tiredness, feeling weak
Der blev observeret symptomatisk fald i LVEF hos ca. 0,3 % af de patienter, der fik lapatinib. 
Symptomatic LVEF decreases were observed in approximately 0.3% of patients who received lapatinib.
Tabel 4 Progressionsfri overlevelse og samlet overlevelse (Tyverb / trastuzumab) 
Table 4 Progression-free survival and overall survival data (Tyverb / trastuzumab)
Samtidig behandling med stoffer, der øger gastrisk pH, bør undgås, idet opløseligheden og absorptionen af lapatinib kan reduceres. 
Concomitant treatment with substances that increase gastric pH should be avoided, as lapatinib solubility and absorption may decrease.
Hovedpine* 
Headache*
EU/1/07/440/001 70 tabletter EU/1/07/440/003 84 tabletter 
EU/1/07/440/001 70 tablets EU/1/07/440/003 84 tablets
77 (52 %) af de 148 patienter, som fik monoterapi, blev ved sygdomsprogression udvalgt til at få kombinationsbehandling. 
Of the 148 patients who received monotherapy treatment, 77 (52%) patients elected at the time of disease progression to receive combination treatment.
Der foreligger data om effekten af og sikkerheden ved Tyverb i kombination med capecitabin i forhold til trastuzumab i kombination med capecitabin. 
Data are available on the efficacy and safety of Tyverb in combination with capecitabine relative to trastuzumab in combination with capecitabine.
Lapatinibs effekt og sikkerhed i kombination med trastuzumab ved metastatisk brystcancer blev evalueret i et randomiseret studie. 
The efficacy and safety of lapatinib in combination with trastuzumab in metastatic breast cancer were evaluated in a randomised trial.
Hos patienter med metastatisk brystcancer med overekspression af HER2 var den progressionsfrie overlevelse (PFS) efter investigators vurdering signifikant længere ved behandling med letrozol og Tyverb end ved behandling med letrozol og placebo. 
In patients with HER2-overexpressing MBC, investigator-determined progression-free survival (PFS) was significantly greater with letrozole plus Tyverb compared with letrozole plus placebo.
Den kumulative frekvens var 10,3 % hos bærere af allellerne DQA1*02:01 og DRB1*07:01 og 0,5 % hos ikke-bærere. 
The cumulative frequency in DQA1*02:01 and DRB1*07:01 allele carriers was 10.3% and in non-carriers was 0.5%.
Beholdere Tyverb fås også i plastikbeholdere med 70, 84, 105 eller 140 tabletter. 
Bottles Tyverb is also available in plastic bottles containing 70, 84, 105 or 140 tablets.
Samtidig administration af lapatinib og intravenøst administreret docetaxel påvirkede ikke i signifikant grad AUC eller Cmax af hverken lapatinib eller docetaxel. 
Co-administration of lapatinib with intravenously administered docetaxel did not significantly affect the AUC or Cmax of either active substance.
Systemisk eksponering for lapatinib øges, når lapatinib indtages sammen med føde. 
Systemic exposure to lapatinib is increased when administered with food.
Andre ikke almindelige bivirkninger: 
Other uncommon side effects include:
Der findes ikke tilstrækkelige data fra patienter med nedsat leverfunktion til at kunne anbefale en bestemt dosisjustering (se pkt. 
Insufficient data are available in patients with hepatic impairment to provide a dose adjustment recommendation (see section 5.2).
Behandling med Tyverb skal afbrydes hos patienter med diarré NCI CTCAE grad 3 eller med grad 1 eller grad 2 med komplikationer (moderate til svære abdominale kramper, kvalme eller opkastning mere end eller lig med NCI CTCAE grad 2, nedsat performance-status, feber, sepsis, neutropeni, synlig blødning eller dehydrering) (se pkt. 
Tyverb dosing should be interrupted in patients with diarrhoea which is NCI CTCAE grade 3 or grade 1 or 2 with complicating features (moderate to severe abdominal cramping, nausea or vomiting greater than or equal to NCI CTCAE grade 2, decreased performance status, fever, sepsis, neutropenia, frank bleeding or dehydration) (see sections 4.4 and 4.8).
140 filmovertrukne tabletter Multipakning: 140 (2 pakninger af 70) filmovertrukne tabletter. 
140 film-coated tablets Multipack: 140 (2 packs of 70) film-coated tablets.