natgillin/translations-raw huggingface dataset:
Inlyta kan muligvis øge bivirkningerne ved teofyllin, der anvendes til behandling af astma eller andre lungesygdomme. 
Inlyta may increase side effects associated with theophylline, used to treat asthma or other lung diseases.
Hos patienter, som udvikler alvorlig hypertension, bør behandlingen med axitinib afbrydes midlertidigt og genstartes ved en lavere dosis, når patienten er normotensiv. 
For patients who develop severe hypertension, temporarily interrupt axitinib and restart at a lower dose once the patient is normotensive.
Demografi og sygdomskarakteristika ved behandlingsstart var sammenlignelige mellem axitinib og sorafenib grupperne med hensyn til alder, køn, race, Eastern Cooperative Oncology Group (ECOG) performance-status, geografisk område og tidligere behandling. 
The baseline demographic and disease characteristics were similar between the axitinib and sorafenib groups with regard to age, gender, race, Eastern Cooperative Oncology Group (ECOG) performance status, geographic region, and prior treatment.
Virkningen af potente hæmmere af disse isoenzymer på farmakokinetikken af axitinib er ikke undersøgt. 
The effect of strong inhibitors of these isozymes on axitinib pharmacokinetics has not been studied.
Glossodyni 
Glossodynia
I tilfælde af alvorlig eller vedvarende arteriel hypertension og symptomer på posteriort reversibelt encefalopati-syndrom (PRES) (se nedenfor), bør det overvejes, om der skal foretages en diagnostisk magnetisk resonans (MR) scanning af hjernen. 
In case of severe or persistent arterial hypertension and symptoms suggestive of posterior reversible encephalopathy syndrome (PRES) (see below), a diagnostic brain magnetic resonance image (MRI) should be considered.
Hypotyreose eller hypertyreose skal behandles efter gældende medicinsk praksis for at opretholde euthyroid tilstand. 
Hypothyroidism or hyperthyroidism should be treated according to standard medical practice to maintain euthyroid state.
In vitro er den humane proteinbindingsgrad af axitinib >99% med overvejende binding til albumin og moderat binding til α1-syre-glykoprotein. 
In vitro binding of axitinib to human plasma proteins is > 99% with preferential binding to albumin and moderate binding to α1-acid glycoprotein.
En signifikant stigning i polyploidi ses in vitro ved koncentrationer > 0,22 mikrog/ml, og en stigning i mikronuclære polykromatiske erytrocytter ses in vivo med No Observed Effect Level (NOEL) 69 gange forventet human eksponering. 
A significant increase in polyploidy was observed in vitro at concentrations > 0.22 µg/mL, and an elevation in micronucleated polychromatic erythrocytes was observed in vivo with No Observed Effect Level (NOEL) 69-fold the expected human exposure.
Efter oral administration af en dosis på 5 mg radioaktivt axitinib genfindes 30-60% af radioaktiviteten i fæces og 23% i urinen. 
Following oral administration of a 5 mg radioactive dose of axitinib, 30-60% of the radioactivity was recovered in faeces and 23% of the radioactivity was recovered in urine.
Axitinib kan tages med eller uden mad (se pkt. 
Axitinib may be administered with or without food (see section 4.2).
Ikke almindelige: forekommer hos op til 1 ud af 100 personer • Nedsat antal hvide blodlegemer (ses i blodprøver) 
Uncommon: may affect up to 1 in 100 people • Reduction in the number of white blood cells (may show in your blood tests)
Hver pakning indeholder 28 eller 56 filmovertrukne tabletter. 
Each pack contains 28 or 56 film-coated tablets.
Det gennemsnitlige Cmax og AUC stiger proportionalt i doseringsområdet 5 til 10 mg axitinib. 
The average Cmax and AUC increased proportionally over an axitinib dosing range of 5 to 10 mg.
Plasmahalveringstiden varierer fra 2,5 til 6,1 timer. 
The plasma half life of axitinib ranges from 2.5 to 6.1 hours.
Axitinib er ikke mutagent eller klastogent i konventionelle studier in vitro. 
Axitinib was not mutagenic or clastogenic in conventional genotoxicity assays in vitro.
Tag den næste dosis til sædvanlig tid. 
Take your next dose at your regular time.
Hvis hæmoglobin- eller hæmatokritniveauet stiger til over det normale, skal patienten behandles efter gældende medicinsk praksis for at nedsætte hæmoglobin eller hæmatokrit til et acceptabelt niveau. 
If haemoglobin or haematocrit becomes elevated above the normal level, patients should be treated according to standard medical practice to decrease haemoglobin or haematocrit to an acceptable level.
Meget almindelig Nedsat appetit Almindelig 
Very common Decreased appetite Common
Administration af axitinib sammen med et moderat fedtrigt måltid medfører 10% mindre eksposure sammenlignet med faste natten over. 
Administration of axitinib with a moderate fat meal resulted in 10% lower exposure compared to overnight fasting.
Alvorlige toksicitetsfund i mus og hunde efter gentagne doser i op til 9 måneder er gastrointestinale, hæmatopoietiske, reproduktive, knogle- og tandpåvirkninger med ”No Observed Adverse Effect Levels” (NOAEL) generelt ækvivalent med eller under forventet human eksponering ved anbefalet klinisk startdosis (baseret på AUC). 
Major toxicity findings in mice and dogs following repeated dosing for up to 9 months were the gastrointestinal, haematopoietic, reproductive, skeletal and dental systems, with No Observed Adverse Effect Levels (NOAEL) approximately equivalent to or below expected human exposure at the recommended clinical starting dose (based on AUC levels).
Dyreforsøg har påvist reproduktionstoksicitet (se pkt 5.3). 
Studies in animals have shown reproductive toxicity including malformations (see section 5.3).
Inlyta filmovertrukne tabletter findes i flere styrker. 
Inlyta film-coated tablets come in different strengths.
Der genfindes ikke uomdannet axitinib i urinen; carboxylsyre og sulfoxidmetabolitter er ansvarlige for størstedelen af radioaktiviteten i urin. 
Unchanged axitinib was not detected in urine; the carboxylic acid and sulfoxide metabolites accounted for the majority of radioactivity in urine.
Maksimal axitinib-plasmakoncentration nås almindeligvis indenfor 4 timer efter oral administration af axitinib med median Tmax varierende fra 2,5 til 4,1 timer. 
Peak axitinib concentrations in plasma are generally reached within 4 hours following oral administration of axitinib with median Tmax ranging from 2.5 to 4.1 hours.
• rifampicin, rifabutin og rifapentin, til behandling af tuberkulose (TB) 
• rifampicin, rifabutin or rifapentin, used to treat tuberculosis (TB);
• For højt blodtryk eller blodtryksstigning 
• High blood pressure, or increases in blood pressure
Meget almindelig Hovedpine Dysgeusi 
Very common Headache Dysgeusia
Visse typer medicin kan påvirke Inlyta, eller blive påvirket af Inlyta. 
Some medicines may affect Inlyta, or be affected by it.
Sulfoxid- og N-glucoronidmetabolitter er henholdsvis ca. 400 gange og 8000 gange mindre potente in vitro i forhold til VEGFR-2 sammenlignet med axitinib. 
The sulfoxide and N-glucuronide metabolites show approximately 400-fold and 8000-fold less in vitro potency, respectively, against VEGFR-2 compared to axitinib.
Meget almindelig Palmo-plantar erytrodysæstesi (hånd-og fodsyndrom) 
Very common Palmar-plantar erythrodysaesthesia (hand-foot syndrome) Rash
I den samlede patientpopulation og de to største undergrupper (tidligere sunitinib behandling og tidligere cytokin behandling) var der en statistisk signifikant fordel for axitinib overfor sorafenib i forhold til det primære endepunkt, progressionsfri overlevelse (se skema 2 og figur 1, 2 og 3). 
In the overall patient population and the two main subgroups (prior sunitinib treatment and prior cytokine treatment), there was a statistically significant advantage for axitinib over sorafenib for the primary endpoint of PFS (see Table 2 and Figures 1, 2 and 3).
Karcinogenicitet Der er ikke udført karcinogenicitets-studier med axitinib. 
Carcinogenicity Carcinogenicity studies have not been performed with axitinib.
Spørg lægen til råds før du tager dette lægemiddel, hvis du er eller planlægger at blive gravid. 
Talk to your doctor before taking it if you are pregnant or might become pregnant.
Inlyta kan få blodtrykket til at stige. 
Inlyta can raise your blood pressure.
Hvis dosisnedsættelse er nødvendigt, kan dosis nedsættes til 3 mg 2 gange dagligt og yderligere ned til 2 mg 2 gange dagligt. 
When dose reduction is necessary, the axitinib dose may be reduced to 3 mg twice daily and further to 2 mg twice daily.
Tag ikke Inlyta hvis du er allergisk over for axitinib eller et af de øvrige indholdsstoffer i Inlyta (angivet i afsnit 6). 
If you are allergic to axitinib or any of the other ingredients of this medicine (listed in section 6).
PRES er en neurologisk forstyrrelse med symptomer som hovedpine, krampeanfald, apati, konfusion, synstab og andre syns- og neurologiske forstyrrelser. 
PRES is a neurological disorder which can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances.
Ældre over 65 år og race 
Elderly (≥ 65 years) and race
På baggrund af ikke-kliniske fund, kan axitinib potentielt indvirke på human reproduktion og fertilitet (se pkt. 
Based on non-clinical findings, axitinib has the potential to impair reproductive function and fertility in humans (see section 5.3).
• clarithromycin, erythromycin og telithromycin, antibiotika til behandling af bakterieinfektioner 
• clarithromycin, erythromycin or telithromycin, antibiotics used to treat bacterial infections;
Tag ikke disse typer medicin under behandlingen med Inlyta. 
You should not take these medicines during your treatment with Inlyta.
Patienterne (N = 723) med fremskreden RCC, hvis sygdom havde progredieret under eller efter én tidligere systemisk behandling, herunder sunitinib-, bevacizumab-, temsirolimus-, eller cytokinholdige behandlingsregimer, blev randomiseret (1:1) til behandling med axitinib (N = 361) eller sorafenib (N = 362). 
Patients (N = 723) with advanced RCC whose disease had progressed on or after treatment with one prior systemic therapy, including sunitinib-, bevacizumab-, temsirolimus-, or cytokinecontaining regimens were randomised (1:1) to receive axitinib (N = 361) or sorafenib (N = 362).
Fortæl lægen, hvis du har meget for højt blodtryk, stærk hovedpine eller kraftige brystsmerter. 
Tell your doctor if you have a very high blood pressure, severe headache, or severe chest pain.
Patienter, som tåler en startdosis på 5 mg 2 gange daglig i 2 på hinanden følgende uger, uden bivirkninger > Grad 2 (dvs. uden alvorlige bivirkninger i henhold til Common Terminology Criteria for Adverse Events [CTCAE] version 3.0), kan få øget dosis til 7 mg 2 gange dagligt, med mindre patientens blodtryk er > 150/90 mmHg, eller patienten behandles med antihypertensiva. 
Patients who tolerate the axitinib starting dose of 5 mg twice daily with no adverse reactions > Grade 2 (i.e. without severe adverse reactions according to the Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) for two consecutive weeks may have their dose increased to 7 mg twice daily unless the patient's blood pressure is > 150/90 mmHg or the patient is receiving antihypertensive treatment.
Inlyta er indiceret til behandling af voksne med fremskreden renalcellekarcinom (RCC) efter svigt af tidligere behandling med sunitinib eller cytokiner. 
Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.
• Ondt i halsen eller næsen og irritation i svælget 
• Sore throat or nose and throat irritation
Et letalt akut myokardieinfarkt og et cerebrovaskulært tilfælde blev hver især rapporteret hos 1 patient (0,3%). 
A fatal acute myocardial infarction and cerebrovascular accident was reported in one patient each (0.3%).
Hvis du har taget for mange tabletter eller en større dosis, end du behøver, skal du omgående kontakte lægen, da du måske kan få brug for lægehjælp. 
If you accidentally take too many tablets or a higher dose than you need, contact a doctor for advice right away.
Der er ikke foretaget andre toksicitetsundersøgelser i unge dyr med henblik på pædiatriske patienter. 
Other toxicities of potential concern to paediatric patients have not been evaluated in juvenile animals.
Farmakokinetiske populationsundersøgelser hos patienter med fremskreden cancer (herunder fremskreden RCC) og raske frivillige antyder, at der ikke er klinisk relevante forskelle pga. af alder, køn, legemsvægt, race, nyrefunktion, UGT1A1-genotype eller CYP2C19-genotype. 
Population pharmacokinetic analyses in patients with advanced cancer (including advanced RCC) and healthy volunteers indicate that there are no clinically relevant effects of age, gender, body weight, race, renal function, UGT1A1 genotype, or CYP2C19 genotype.
Der er ingen specifik antidot for overdosering med axitinib. 
There is no specific treatment for axitinib overdose.
• ketokonazol og itraconazol, til behandling af svampeinfektioner 
• ketoconazole or itraconazole, used to treat fungal infections;
• Hvis du har problemer med blødning. 
• If you suffer from bleeding problems.
Resultatet af studiet indicerede, at en plasmaeksponering op til 2 gange det forventede terapeutisk niveau efter en 5 mg dosis ikke medførte en klinisk signifikant forlængelse af QT-intervallet. 
Results of this study indicated that axitinib plasma exposures up to two-fold greater than therapeutic levels expected following a 5 mg dose, did not produce clinically-significant QT interval prolongation.
Hvis du ammer, bør du diskutere med lægen, om du skal holde op med at amme, eller om behandlingen skal stoppes. 
If you are breast-feeding, your doctor should discuss with you whether to discontinue breast-feeding or discontinue Inlyta treatment.
Hver pakning indeholder 28 tabletter eller 56 tabletter. 
Each blister pack contains 28 tablets or 56 tablets.
Gastrointestinal perforation og fistler c, k 
Gastrointestinal perforation and fistulac,k
Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/ 
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Lægen skal sikre sig, at dit blodtryk er under kontrol, før behandlingen startes, og mens du bliver behandlet med Inlyta. 
Your doctor should make sure that your blood pressure is under control before starting Inlyta treatment, and while on treatment with this medicine.
• Hvis du har problemer med leveren. 
• If you have liver problems.
Samtidig administration af axitinib og paclitaxel, et kendt CYP2C8-substrat, medførte dog ingen stigning i plasmakoncentrationen af paclitaxel hos patienter med fremskreden cancer, hvilket antyder manglende klinisk CYP2C8-hæmning. 
However, co-administration of axitinib with paclitaxel, a known CYP2C8 substrate, did not result in increased plasma concentrations of paclitaxel in patients with advanced cancer, indicating lack of clinical CYP2C8 inhibition.
Farmakoterapeutisk klassifikation: Protein-tyrosinkinase-hæmmer, ATC-kode: L01XE17. 
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE17
• Protein i urinen (ses i urinprøver) 
• Protein in the urine (may show in your urine tests)
Hyperbilirubinæmi Cholecystitis 
Hyperbilirubinaemia Cholecystitisn
Axitinib hæmmede fosforyleringen af VEGF-2 i xenotransplanteret tumorvaskulatur in vivo og medførte forsinket tumorvækst, regression og hæmning af metastasering i flere forsøgsmodeller af cancer. 
Axitinib inhibited the phosphorylation of VEGFR-2 in xenograft tumour vasculature that expressed the target in vivo and produced tumour growth delay, regression, and inhibition of metastases in many experimental models of cancer.
• atazanavir, indinavir, nelfinavir, ritonavir og saquinavir, til behandling af hiv-infektioner/AIDS 
• atazanavir, indinavir, nelfinavir, ritonavir or saquinavir, used to treat HIV infections/AIDS;
I et kontrolleret klinisk studie lå den mediane tid til udvikling af hypertension (systolisk blodtryk >150 mmHg eller diasystolisk blodtryk >100 mm Hg) inden for de første 4 måneder efter behandlingsstart med axitinib, og der er set blodtryksstigninger så tidligt som 4 dage efter behandlingsstart. 
In a controlled clinical study, the median onset time for hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg) was within the first month of the start of axitinib treatment and blood pressure increases have been observed as early as 4 days after starting axitinib.
Toksicitetsfund i unge dyr 
Toxicity findings in immature animals
Axitinib-relaterede fund i testikler og epididymis omfatter nedsat organvægt, atrofi eller degeneration, nedsat antal germinalceller, hypospermi eller abnorme spermstadier og nedsat sædkvalitet og densitet. 
Axitinib-related findings in the testes and epididymis included decreased organ weight, atrophy or degeneration, decreased numbers of germinal cells, hypospermia or abnormal sperm forms, and reduced sperm density and count.
Tabletfilmovertræk Hypromellose 2910 (15 mPa·s) Titandioxid (E171) Lactosemonohydrat Triacetin (E1518) Rød jernoxid (E172) 
Tablet film-coating Hypromellose 2910 (15 mPa·s) Titanium dioxide (E171) Lactose monohydrate Triacetin (E1518) Iron oxide red (E172)
N-glucoronid-metabolitter udgør størstedelen af radioaktiviteten (50% af cirkulerende radioaktivitet) i plasma og uomdannet axitinib og sulfoxid-metabolitter udgør hver ca. 20% af den cirkulerende radioaktivitet. 
In plasma, the N-glucuronide metabolite represented the predominant radioactive component (50% of circulating radioactivity) and unchanged axitinib and the sulfoxide metabolite each accounted for approximately 20% of the circulating radioactivity.
Inlyta kan øge risikoen for at udvikle hjertesvigt. 
Inlyta may increase the risk of developing heart failure events.
Brug ikke dette lægemiddel efter den udløbsdato, der står på æsken 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 carton and on the blister foil or bottle after “EXP”.
CYP1A2 og CYP2C19 bidrager mindre (<10%) til metaboliseringen af axitinib. 
CYP1A2 and CYP2C19 constitute minor (< 10%) pathways in axitinib metabolism.
podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: +386 (0)1 52 11 400 
Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel.: + 386 (0)1 52 11 400
• Hvis du under behandlingen med dette lægemiddel får kraftige mavesmerter eller mavesmerter, som ikke forsvinder. 
• If during treatment with this medicine you get severe stomach (abdominal) pain or stomach pain that does not go away.
Der ses også mild til alvorlig hypertension. 
Mild to severe hypertension may be present.
Uomdannet axitinib (svarende til 12% af dosis) var hovedkomponenten identificeret i fæces. 
Unchanged axitinib, accounting for 12% of the dose, was the major component identified in faeces.
Nedsat leverfunktion In vitro og in vivo data tyder på, at axitinib hovedsageligt metaboliseres i leveren. 
In vitro and in vivo data indicate that axitinib is primarily metabolised by the liver.
Dehydrering Hyperkaliæmi Hyperkalcæmi 
Dehydration Hyperkalaemia Hypercalcaemia
Sikkerhed og virkning af Inlyta er ikke undersøgt hos børn og unge under 18 år. 
The safety and efficacy of Inlyta in children and adolescents < 18 years have not been established.
Inlyta kan øge risikoen for at udvikle et hul i mavesækken eller i tarmene, eller øge risikoen for fistel-dannelse (en rør-lignende passage fra et hulrum i kroppen til et andet eller til huden). 
Inlyta may increase the risk of developing a hole in the stomach or intestine or formation of fistula (abnormal tube-like passage from one normal body cavity to another body cavity or the skin).
Fortæl det til lægen, hvis du får kraftige mavesmerter, mens du er i behandling med dette lægemiddel. 
Tell your doctor if you have severe abdominal pain while on treatment with this medicine.
Blodtrykket skal være velkontrolleret, inden behandlingen med axitinib initieres. 
Blood pressure should be well-controlled prior to initiating axitinib.
Nedsat fertilitet og embryo-levedygtighed ses hos hunmus ved alle testede doser med laveste dosis ca. 10 gange højere end human-terapeutiske doser. 
Reduced fertility and embryonic viability were observed in female mice at all doses tested, with exposure levels at the lowest dose approximately 10-fold the expected human exposure.
Lægen vil muligvis ændre dosis på enten Inlyta eller det andet lægemiddel, eller skifte til et helt andet. 
Your doctor may change the dose of these medicines, change the dose of Inlyta, or switch you to a different medicine.
Inlyta indeholder det aktive stof axitinib. 
Inlyta is a medicine containing the active substance axitinib.
Brug af anden medicin sammen med Inlyta 
Other medicines and Inlyta
Behandlingen med Inlyta bør stoppes mindst 24 timer før en operation, da Inlyta kan påvirke sårhelingen. 
Your doctor should stop Inlyta at least 24 hours before your operation as it may affect wound healing.
De hyppigst indberettede leverrelaterede bivirkninger var stigning i alanin-aminotransferase (ALAT), aspartat-aminotransferase (ASAT) og plasma-bilirubin (se pkt. 
The most commonly reported liver-related adverse reactions included increases in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and blood bilirubin (see section 4.8).
I dette studie havde 389 af de inkluderede patienter (53,8%) tidligere fået sunitinibbaseret behandling, 251 patienter (34,7%) havde tidligere fået cytokinbaseret behandling (interleukin-2 eller interferonalfa), 59 patienter (8,2%) havde tidligere fået bevacizumabbaseret behandling og 24 (3,3%) patienter havde tidligere fået temsirolimusbaseret behandling. 
Of the patients enrolled in this study, 389 patients (53.8%) had received one prior sunitinib-based therapy, 251 patients (34.7%) had received one prior cytokine-based therapy (interleukin-2 or interferon-alpha), 59 patients (8.2%) had received one prior bevacizumab-based therapy, and 24 patients (3.3%) had received one prior temsirolimus-based therapy.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med axitinib i alle undergrupper af den pædiatriske population til behandling af nyre- og nyrebækkenkarcinom (eksklusive nefroblastom, nefroblastomatose, clear-cell-sarkom, mesoblastisk nefrom, nyremarvskarcinom og rabdoid tumor i nyren) (se pkt. 
The European Medicines Agency has waived the obligation to submit the results of studies with axitinib in all subsets of the paediatric population for treatment of kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney) (see section 4.2 for information on paediatric use).
Maksimal induktion med CYP3A4/5induktorer er set indenfor 1 uges behandling med induktoren. 
Maximal induction with high-dose strong CYP3A4/5 inducers has been reported to occur within one week of treatment with the inducer.
Inklusive leukoencefalopati 
e Including Leukoencephalopathy.
• phenytoin, carbamazepin og phenobarbital, epilepsimedicin til at standse krampeanfald 
• phenytoin, carbamazepine or phenobarbital, anti-epileptics used to stop seizures or fits;
Rifampicin, en potent induktor af CYP3A4/5, administreret i doser på 600 mg 1 gang dagligt i 9 dage, reducerede AUC med 79% og Cmax med 71% i forhold til 1 enkelt oral dosis på 5 mg hos raske forsøgspersoner. 
Rifampicin, a strong inducer of CYP3A4/5, administered at a dose of 600 mg once daily for 9 days, reduced the mean AUC by 79% and Cmax by 71% of a single 5 mg dose of axitinib in healthy volunteers.
Den sædvanlige dosis er 5 mg 2 gange daglig. 
The recommended dose is 5 mg twice a day.
Patienternes blodtryk skal kontrolleres og om nødvendigt behandles med standard antihypertensiv behandling. 
Patients should be monitored for hypertension and treated as needed with standard antihypertensive therapy.
CYP1A2 og CYP2C19-hæmmere 
CYP1A2 and CYP2C19 inhibitors