natgillin/translations-raw huggingface dataset:
En alvorlig overfølsomhedsreaktion er en sjælden bivirkning (kan forekomme hos op til 1 ud af 1.000 personer) og kan opstå hurtigt.
A severe allergic reaction is a rare side effect (may affect up to 1 in 1,000 people) and may develop rapidly.
I alt 952 patienter havde HER2-negative tumorer, og hos i alt 115 patienter kunne tumorernes HER2-status ikke bekræftes (ingen tumorprøve, intet analyseresultat eller anden årsag).
There were 952 patients with HER2-negative tumours, and a total of 115 patients whose tumour HER2 status was unconfirmed (no tumour sample, no assay result, or other reason).
Opløseligheden af lapatinib er pH-afhængig.
The solubility of lapatinib is pH-dependent.
Du kan finde råd om, hvordan du nedsætter risikoen for diarré i slutningen af punkt 4.
There is more advice on reducing the risk of diarrhoea at the end of section 4.
Ved behandlingsstart skal patienterne informeres om risikoen for levertoksicitet.
At the initiation of treatment, patients should be advised of the potential for hepatotoxicity.
• hævede øjenlåg, læber eller tunge
• swollen eyelids, lips or tongue
Samtidig administration af Tyverb med irinotecan (når det blev administreret som en del af FOLFIRIregimet) resulterede i en ca. 40 % stigning i AUC af SN-38 - den aktive metabolit af irinotecan.
Co-administration of Tyverb with irinotecan (when administered as part of the FOLFIRI regimen) resulted in an approximate 40% increase in the AUC of SN-38, the active metabolite of irinotecan.
Studiet blev afbrudt, da interimanalysen (n = 475) viste en lav incidens af CNSrelaterede hændelser og bedre effekt i armen med trastuzumab plus capecitabin med hensyn til progressionsfri overlevelse og samlet overlevelse (se resultaterne af den endelige analyse i tabel 3).
The study was halted as the interim analysis (N=475) showed a low incidence of CNS events and, superior efficacy of the trastuzumab plus capecitabine arm in terms of progression-free survival and overall survival (see results of final analysis in Table 3).
Du må ikke drikke grapejuice, mens du er i behandling med Tyverb.
Don't drink grapefruit juice while you are being treated with Tyverb.
Tumorer med overekspression af HER2 (ErbB2) er karakteriseret ved IHC3+ eller IHC2+ med genamplifikation eller gen-amplifikation alene.
HER2 (ErbB2) overexpressing tumours are defined by IHC3+, or IHC2+ with gene amplification or gene amplification alone.
Data har vist, at Tyverb i kombination med kemoterapi er mindre effektivt end trastuzumab i kombination med kemoterapi.
Data have shown that Tyverb combined with chemotherapy is less effective than trastuzumab when combined with chemotherapy.
Den uafhængige vurdering af data viste også, at når Tyverb blev givet sammen med capecitabin, blev tiden til progression øget signifikant (hazard ratio 0,57 [95 % CI 0,43; 0,77], p = 0,0001) sammenlignet med capecitabin alene.
The independent assessment of the data also demonstrated that Tyverb when given in combination with capecitabine significantly increased time to progression (Hazard Ratio 0.57 [95 % CI 0.43, 0.77] p=0.0001) compared to capecitabine alone.
Lapatinib blev undersøgt hos gravide rotter og kaniner, der fik orale doser på 30, 60 og 120 mg/kg/døgn.
Lapatinib was studied in pregnant rats and rabbits given oral doses of 30, 60, and 120 mg/kg/day.
Sådan skal du tage dine tabletter
Taking your tablets
Lapatinib bevarede betydelig aktivitet over for HER2amplificerende brystcancercellelinjer selekteret til langtidsvækst i trastuzumab-holdigt medium in vitro, og i kombination med trastuzumab var der en synergistisk virkning i disse cellelinjer.
Lapatinib retained significant activity against HER2-amplified breast cancer cell lines selected for long-term growth in trastuzumab-containing medium in vitro and was synergistic in combination with trastuzumab in these cell lines.
Mindre end 2 % af den indgivne orale dosis blev udskilt i urinen (som lapatinib og metabolitter).
Less than 2% of the administered oral dose (as lapatinib and metabolites) excreted in urine.
Tyverb er indiceret til behandling af voksne patienter med brystcancer, hvis tumorer har overekspression af HER2 (ErbB2):
Tyverb is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2);
Forhåndsplanlagt OS-analyse (foretaget på tidspunktet for den endelige PFS-analyse, 03. juni
Pre-planned OS analysis (conducted at the time of the final PFS analysis, 03 June 2008) Median follow-up (yrs)
Systemisk optagelse (AUC) af lapatinib efter en enkelt 100 mg dosis øgedes hhv. ca. 56 % og 85 % hos patienterne med moderat og svært nedsat leverfunktion.
Systemic exposure (AUC) to lapatinib after a single oral 100 mg dose increased approximately 56% and 85% in patients with moderate and severe hepatic impairment, respectively.
Der er dog set få tilfælde af akut nyresvigt, hvilket er opstået som følge af svær dehydrering pga. diarré.
However, a few cases of acute renal failure have been reported secondary to severe dehydration due to diarrhoea.
Virkningen af Tyverb på graviditet kendes ikke.
The effect of Tyverb during pregnancy is not known.
Palmoplantar erytrodysæstesi (PPE) (hånd-fod-syndrom) var også almindeligt (> 25 %), når lapatinib blev administreret i kombination med capecitabin.
Palmar-plantar erythrodysesthesia (PPE) was also common (>25%) when lapatinib was administered in combination with capecitabine.
Tyverb påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
Tyverb has no influence on the ability to drive and use machines.
Tyverb skal tages enten mindst en time før eller mindst en time efter et måltid.
Tyverb should be taken either at least one hour before, or at least one hour after food.
Diarré kan potentielt være livstruende, hvis der opstår dehydrering, nyreinsufficiens, neutropeni og /eller ubalance i elektrolytter, og tilfælde med dødelig udgang er rapporteret.
Diarrhoea can be potentially life-threatening if accompanied by dehydration, renal insufficiency, neutropenia and/or electrolyte imbalances and fatal cases have been reported.
I nogle tilfælde kan fald i LVEF være svære og medføre hjerteinsufficiens.
In some cases, LVEF decrease may be severe and lead to cardiac failure.
I et enkelt tilfælde, hvor en patient tog 9000 mg Tyverb, sås sinus-takykardi (patienten havde et ellers normalt ekg).
In a single case of a patient who took 9000 mg of Tyverb, sinus tachycardia (with otherwise normal ECG) was also observed.
Levertoksicitet er set ved brug af Tyverb og kan i sjældne tilfælde være letal.
Hepatotoxicity has occurred with Tyverb use and may in rare cases be fatal.
Lapatinibs virkning på QT-intervallet blev evalueret i et enkeltblindet, placebo-kontrolleret, enkeltsekvens (placebo og aktiv behandling) crossover-studie hos patienter med fremskredne, solide tumorer (EGF114271) (n=58).
The effect of lapatinib on the QT-interval was evaluated in a single-blind, placebo-controlled, single sequence (placebo and active treatment) crossover study in patients with advanced solid tumours (EGF114271) (n=58).
Lapatinib er ikke undersøgt hos patienter med symptomatisk hjerteinsufficiens.
Lapatinib has not been evaluated in patients with symptomatic cardiac failure.
Hvis du har taget for meget Tyverb
If you take too much Tyverb
EU/1/07/440/004 70 tabletter EU/1/07/440/005 140 tabletter EU/1/07/440/006 84 tabletter EU/1/07/440/007 105 tabletter
EU/1/07/440/004 70 tablets EU/1/07/440/005 140 tablets EU/1/07/440/006 84 tablets EU/1/07/440/007 105 tablets
Endelig OS-analyse (post-hoc-analyse, 07. august 2013) Median follow-up (år) Døde (%) Hazard ratio (95% CI), p-værdi Medianværdier fra Kaplan-Meier-analyser; HR (hazard ratio) og p-værdier fra Coxregressionsmodeller, korrigeret for vigtige prognostiske faktorer.
Final OS analysis (post-hoc analysis, 07 August 2013) Median follow-up (yrs) Deaths (%) Hazard ratio (95% CI), p-value Median values from Kaplan-Meier analysis; HR and p-values from Cox regression models adjusting for important prognostic factors.
De almindeligste bivirkninger (> 25 %) undervejs i behandlingen med lapatinib var gastrointestinale hændelser (f.eks. diarré, kvalme og opkastning) samt udslæt.
The most common adverse reactions (>25%) during therapy with lapatinib were gastrointestinal events (such as diarrhoea, nausea, and vomiting) and rash.
Hvis du har glemt at tage Tyverb
If you forget to take Tyverb
Beholdere 3 år
Bottles 3 years
Hos rotter var forekomsten af benign hæmangiom i mesenteriallymfeknuder højere i nogle grupper end i sideløbende kontrolgrupper.
In rats, the incidence of benign haemangioma of the mesenteric lymph nodes was higher in some groups than in concurrent controls.
Diarré på grund af Tyverb er normalt af lav grad, alvorlig diarré NCI CTCAE grad 3 og 4 ses hos henholdsvis < 10 % og < 1 % af patienterne.
Tyverb-induced diarrhoea is usually low-grade, with severe diarrhoea of NCI CTCAE grades 3 and 4 occurring in <10% and <1% of patients, respectively.
I tillæg hertil, og som beskrevet i protokollen, skulle investigatorerne have rapporteret patienterne som værende progredieret under deres seneste trastuzumabholdige regime for metastatisk sygdom.
In addition, per the protocol, patients were to be reported by the investigators as having progressed on their most recent trastuzumab containing regimen in the metastatic setting.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Tyverb i alle undergrupper af den pædiatriske population ved behandling af brystkræft (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with Tyverb in all subsets of the paediatric population in the treatment of breast carcinoma (see section 4.2 for information on paediatric use).
17,2 måneder (13,9; 19,2)
17.2 mos (13.9, 19.2)
Tabel 7 Resultatet for samlet overlevelse (OS) fra studie EGF30008 (kun i HER2-positiv population)
Table 7 Overall survival (OS) results from study EGF30008 (in the HER2-positive population only)
Det vides ikke, om Tyverb går over i modermælken.
It is not known whether Tyverb passes into breast-milk.
elektrokardiogrammer (EKG'er) og farmakokinetiske prøver ved baseline samt på de samme tidspunkter på dag 2 og dag 4.
Measurements, including electrocardiograms (ECGs) and pharmacokinetic samples, were taken at baseline and at the same time points on Day 2 and Day 4.
Hver filmovertrukken tablet indeholder lapatinibditosylatmonohydrat svarende til 250 mg lapatinib.
Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib.
Forudgående behandling med en protonpumpehæmmer (esomeprazol) nedsatte lapatinib-eksponeringen med i gennemsnit 27 % (interval: 6 % til 49 %).
Pre-treatment with a proton pump inhibitor (esomeprazole) decreased lapatinib exposure by an average of 27% (range: 6% to 49%).
• vask huden med et renseprodukt uden sæbe
• wash with a soap-free cleanser
Disse data er baseret på 149 patienter, der blev behandlet med denne kombination i det pivotale studie.
These data are based on exposure to this combination in 149 patients in the pivotal trial.
Patienter, som viste objektiv sygdomsprogression efter mindst 4 ugers behandling med lapatinib-monoterapi, var egnede til at overgå til kombinationsbehandling.
Patients who had objective disease progression after receiving at least 4 weeks of treatment with lapatinib monotherapy were eligible to crossover to combination therapy.
a. Estimat af behandlings-hazard-ratio, hvor < 1 indikerer en lavere risiko med letrozol 2,5 mg + lapatinib 1500 mg sammenlignet med letrozol 2,5 mg + placebo.
a. Estimate of the treatment hazard ratio, where <1 indicates a lower risk with letrozole 2.5 mg + lapatinib 1500 mg compared with letrozole 2.5 mg + placebo.
Der foreligger ikke tilstrækkelige data om brugen af Tyverb hos gravide kvinder.
There are no adequate data from the use of Tyverb in pregnant women.
- Øvrige indholdsstoffer: mikrokrystallinsk cellulose, povidon (K30), natriumstivelsesglycolat (Type A), magnesiumstearat, hypromellose, titandioxid (E171), macrogol (400), polysorbat 80, jernoxid gul (E172) og jernoxid rød (E172).
- The other ingredients are: microcrystalline cellulose, povidone (K30), sodium starch glycolate (Type A), magnesium stearate, hypromellose, titanium dioxide (E171), macrogol (400), polysorbate 80, iron oxide yellow (E172), and iron oxide red (E172).
Den væksthæmmende effekt af lapatinib blev vurderet i trastuzumab-konditionerede cellelinjer.
The growth inhibitory effects of lapatinib were evaluated in trastuzumab-conditioned cell lines.
Den primære udskillelsesvej for lapatinib og dets metabolitter er med fæces.
The primary route of excretion for lapatinib and its metabolites is in faeces.
Den systemiske eksponering for lapatinib påvirkes også af administrationstidspunktet i forhold til fødeindtagelsen.
Systemic exposure to lapatinib is also affected by the timing of administration in relation to food intake.
Samtidig administration af lapatinib og intravenøst paclitaxel øgede paclitaxel-eksponeringen med 23 % på grund af lapatinibs hæmning af CYP2C8 og/eller Pgp.
Co-administration of lapatinib with intravenous paclitaxel increased the exposure of paclitaxel by 23%, due to lapatinib inhibition of CYP2C8 and/or Pgp.
De kardielle bivirkninger set i dette studie havde samme karakter og sværhedsgrad som dem, der tidligere er set med lapatinib.
The cardiac events observed in this study were comparable in nature and severity to those previously seen with lapatinib.
LVEF bør evalueres, så længe der behandles med Tyverb for at sikre, at LVEF ikke falder til et uacceptabelt niveau (se pkt.
LVEF should continue to be evaluated during treatment with Tyverb to ensure that LVEF does not decline to an unacceptable level (see section 4.2).
Hver blisterpakning er perforeret på midten og kan opdeles i to dele med 5 eller 6 tabletter i hver, afhængigt af pakningsstørrelsen.
Each foil has a perforation down the middle and can be divided into two blisters with 5 or 6 tablets in each, depending on the pack size.
Alvorlige hudlidelser
Serious skin reactions
Farmakoterapeutisk klassifikation: Antineoplastiske midler, andre antineoplastiske midler, proteinkinase-hæmmere, ATC-kode: L01XE07
Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, protein kinase inhibitors, ATC code: L01XE07
Studiet blev standset på grund af resultaterne af en planlagt interim-analyse, der viste en forbedring i TTP hos de patienter, der fik Tyverb og capecitabin.
The study was halted based on the results of a pre-specified interim analysis that showed an improvement in TTP for patients receiving Tyverb plus capecitabine.
Randomiseringen blev stratificeret efter tidligere behandling med trastuzumab og antallet af tidligere behandlinger mod metastatisk sygdom.
Randomisation was stratified by prior trastuzumab treatment and number of prior treatments for metastatic disease.
telithromycin - medicin, der bruges til at behandle infektioner
telithromycin - medicines used to treat infections
Indgift af Tyverb til patienter med moderat til svært nedsat leverfunktion bør ske med forsigtighed pga. øget eksponering for lægemidlet.
Administration of Tyverb to patients with moderate to severe hepatic impairment should be undertaken with caution due to increased exposure to the medicinal product.
Spørg lægen, hvis du vil vide mere om disse lægemidler.
Ask your doctor to give you information about these other medicines.
Brug af Tyverb sammen med mad og drikke
Tyverb with food and drink
Ved behandlingsstart bør patientens afføringsmønster og eventuelle andre symptomer (f.eks. feber, krampelignende mavesmerter, kvalme, opkastning, svimmelhed og tørst) fastlægges for at gøre det muligt at opdage ændringer under behandlingen og gøre det nemmere at identificere patienter med øget risiko for diarré.
At the start of therapy, the patients bowel pattern and any other symptoms (e.g. fever, cramping pain, nausea, vomiting, dizziness and thirst) should be determined, to allow identification of changes during treatment and to help identify patients at greater risk of diarrhoea.
Lapatinibs biotilgængelighed øges op til fire gange, når det indtages sammen med mad afhængigt af f.eks. fedtindholdet i måltidet.
The bioavailability of lapatinib is increased up to about 4 times by food, depending on e.g. the fat content in the meal.
Lapatinib viste en maksimal middelkoncentration på 3920 (3450-4460) ng/ml (geometrisk middelværdi/95 % CI), der oversteg geometrisk middel- Cmax.ss og 95 % CI værdier, som blev observeret efter godkendte doseringer.
Lapatinib produced a maximum mean concentration of 3920 (3450-4460) ng/ml (geometric mean/95% CI), exceeding the geometric mean Cmax.ss and 95% CI values observed following the approved dosing regimens.
For at minimere variationen hos den enkelte patient bør indtagelsen af Tyverb standardiseres i forhold til måltiderne, så Tyverb f.eks. altid tages en time før et måltid (for oplysninger om absorption, se pkt.
To minimise variability in the individual patient, administration of Tyverb should be standardised in relation to food intake, for example always to be taken one hour before a meal (see sections 4.5 and 5.2 for information on absorption).
Lægen fastlægger doseringen af Tyverb på baggrund af den type brystkræft, der skal behandles.
Your doctor will decide on the correct dose of Tyverb depending on the type of breast cancer being treated.
Samtidig administration af Tyverb og capecitabin, letrozol eller trastuzumab ændrede ikke farmakokinetikken for disse lægemidler (eller metabolitterne af capecitabin) eller lapatinib i betydelig grad.
Concomitant administration of Tyverb with capecitabine, letrozole or trastuzumab did not meaningfully alter the pharmacokinetics of these medicinal products (or the metabolites of capecitabine) or lapatinib.
Median (95 % CI) Stratificeret hazard ratio b
Median (95% CI) Stratified Hazard ratio b
Effekten og sikkerheden ved Tyverb i kombination med capecitabin til brystcancerpatienter med god performance status blev evalueret i et randomiseret fase III-studie.
The efficacy and safety of Tyverb in combination with capecitabine in breast cancer patients with good performance status was evaluated in a randomised, phase III study.
• topotecan, paclitaxel, irinotecan, docetaxel - medicin, der bruges til at behandle visse former for kræft
• topotecan, paclitaxel, irinotecan, docetaxel - medicines used to treat certain types of cancer
• smerter i muskler eller led
• pains in muscles or joints
Dette blev efterfulgt af en tilsvarende administration af tre doser lapatinib på 2000 mg. Der blev foretaget målinger inkl.
This was followed by three doses of lapatinib 2000 mg administered in the same way.
• leverproblemer, som kan medføre kløe, at dine øjne og din hud bliver gul (gulsot), mørkfarvning af urinen, smerter eller ubehag i den højre side af den øverste maveregion
• liver problems, which may cause itching, yellow eyes or skin (jaundice), or dark urine or pain or discomfort in the right upper area of the stomach.
Tyverb indeholder:
What Tyverb contains
Immunsystemet Sjælden
Immune system disorders Rare
Der henvises til produktinformationen for lægemidler, der administreres samtidig med Tyverb, for relevante oplysninger om dosering, herunder eventuelle dosisreduktioner, kontraindikationer og sikkerhedsoplysninger.
The full prescribing information of the co-administered medicinal product should be consulted for relevant details of their posology including any dose reductions, contraindications and safety information.
Farmakokinetikken for lapatinib blev undersøgt hos patienter med moderat (n = 8) eller svært (n = 4) nedsat leverfunktion (Child-Pugh-score på hhv. 7-9 eller højere end 9) og hos 8 raske kontrolpersoner.
The pharmacokinetics of lapatinib were examined in patients with moderate (n = 8) or severe (n = 4) hepatic impairment (Child-Pugh scores of 7-9, or greater than 9, respectively) and in 8 healthy control patients.
Nedsat uddrivningsfraktion fra venstre ventrikel (LVEF) er rapporteret hos ca. 1 % af de patienter, der har fået lapatinib, og var asymptomatisk i mere end 70 % af tilfældene.
Left ventricular ejection fraction (LVEF) decreases have been reported in approximately 1% of patients receiving lapatinib and were asymptomatic in more than 70% of cases.
• verapamil - medicin, der bruges til at behandle for højt blodtryk eller hjerteproblemer
• verapamil - a medicine used to treat high blood pressure or heart problems (angina)
Der skal udvises forsigtighed, hvis Tyverb gives til patienter med tilstande, der kan hæmme venstre ventrikels funktion (herunder samtidig administration af potentielt kardiotoksiske lægemidler).
Caution should be taken if Tyverb is to be administered to patients with conditions that could impair left ventricular function (including coadministration with potentially cardiotoxic medicinal products).
Sikker anvendelse af Tyverb under amning er ikke etableret.
The safe use of Tyverb during breast-feeding has not been established.
I den HER2-negative population var der ingen forbedring af PFS ved behandling med letrozol og Tyverb i forhold til behandling med letrozol og placebo (se Tabel 6).
In the HER2-negative population, there was no benefit in PFS when letrozole plus Tyverb was compared with letrozole plus placebo (see Table 6).
Symptomerne kan inkludere hududslæt, blistre og hudafskalning.
Symptoms may include skin rash, blisters and skin peeling.
Lapatinib gennemgår omfattende metabolisering, primært via CYP3A4 og CYP3A5 med mindre bidrag fra CYP2C19 og CYP2C8, til en række oxiderede metabolitter, hvor ingen af metabolitterne udgør mere end 14 % af den dosis, der blev fundet i fæces, eller 10 % af lapatinib-koncentrationen i plasma.
Lapatinib undergoes extensive metabolism, primarily by CYP3A4 and CYP3A5, with minor contributions from CYP2C19 and CYP2C8 to a variety of oxidated metabolites, none of which account for more than 14% of the dose recovered in the faeces or 10% of lapatinib concentration in plasma.
Samtidig administration af Tyverb med oralt administreret midazolam resulterede i en ca. 45 % stigning i AUC af midazolam.
Co-administration of Tyverb with orally administered midazolam resulted in an approximate 45% increase in the AUC of midazolam.
Hjertefunktionen, herunder LVEF, skal måles hos alle patienter før initiering af behandling med Tyverb for at sikre, at patienten har en baseline-LVEF, der ligger inden for normalområdet.
Evaluation of cardiac function, including LVEF determination, should be conducted for all patients prior to initiation of treatment with Tyverb to ensure that the patient has a baseline LVEF that is within the institutions normal limits.
Lapatinib er også in vitro fundet at hæmme disse effluxtransportører samt leveroptagelsestransportøren OATP 1B1 ved klinisk relevante koncentrationer (IC50-værdier svarede til 2,3 µg/ml).
Lapatinib has also been shown in vitro to inhibit these efflux transporters, as well as the hepatic uptake transporter OATP 1B1, at clinically relevant concentrations (IC50 values were equal to 2.3 µg/ml).
Der bør udvises forsigtighed ved patienter med svært nedsat nyrefunktion, da der ikke er erfaring med Tyverb hos denne population (se pkt.
Caution is advised in patients with severe renal impairment as there is no experience of Tyverb in this population (see section 5.2).
• I kombination med en aromatasehæmmer til postmenopausale kvinder med hormonreceptorpositiv metastatisk sygdom, som det på nuværende tidspunkt ikke er hensigtsmæssigt at behandle med kemoterapi.
• in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy.
Meget almindelig Hedeture Luftveje, thorax og mediastinum Meget almindelig Epistaxis
Very common Hot flush Respiratory, thoracic and mediastinal disorders Very common Epistaxis
†, artralgi Almene symptomer og reaktioner på administrationsstedet Meget almindelig Træthed, slimhindebetændelse*, asteni * Disse bivirkninger blev observeret, når lapatinib blev administreret i kombination med capecitabin.
†, arthralgia General disorders and administration site conditions Very common Fatigue, mucosal inflammation*, asthenia * These adverse reactions were observed when lapatinib was administered in combination with capecitabine.