FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon Posterior reversible encephalopathy syndromee
Danish: Posterior reversibelt encefalopatisk syndrom
English: Dose adjustment is not required on the basis of patient age, race, gender, or body weight.
Danish: Dosisjusteringer i forhold til patientens alder, race, køn eller legemsvægt er ikke nødvendig.
English: Therefore, the product information should be updated to include cholecystitis as an ADR in section 4.8 of the SmPC and section 4 of the PL, with frequency ‘common'.
Danish: Derfor bør produktinformationen opdateres med med bivirkningen cholecystitis i punkt 4.8 i produktresuméet og afsnit 4 i indlægssedlen med hyppigheden ”almindelig”.
English: Virtually no data are available regarding axitinib treatment in patients with a creatinine clearance of < 15 mL/min.
Danish: Der er stort set ingen tilgængelige data vedrørende axitinib-behandling af patienter med en kreatin-clearance under 15 ml/min.
English: • Lack of energy, feeling weak or tired
Danish: • Manglende energi, svaghedsfølelse eller træthed
English: Pfizer Manufacturing Deutschland GmbH Betriebsstätte Freiburg Mooswaldallee 1
Danish: Pfizer Manufacturing Deutchland GmbH Betriebsstätte Freiburg Mooswaldallee 1
English: Aluminium/aluminium blister containing 14 film-coated tablets.
Danish: Aluminium/aluminiums blister indeholdende 14 filmovertrukne tabletter.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for axitinib, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for axitinib er CHMP nået frem til følgende videnskabelige konklusioner:
English: Inlyta may increase side effects associated with theophylline, used to treat asthma or other lung diseases.
Danish: Inlyta kan muligvis øge bivirkningerne ved teofyllin, der anvendes til behandling af astma eller andre lungesygdomme.
English: For patients who develop severe hypertension, temporarily interrupt axitinib and restart at a lower dose once the patient is normotensive.
Danish: Hos patienter, som udvikler alvorlig hypertension, bør behandlingen med axitinib afbrydes midlertidigt og genstartes ved en lavere dosis, når patienten er normotensiv.
English: 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.
Danish: 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.
English: The effect of strong inhibitors of these isozymes on axitinib pharmacokinetics has not been studied.
Danish: Virkningen af potente hæmmere af disse isoenzymer på farmakokinetikken af axitinib er ikke undersøgt.
English: Glossodynia
Danish: Glossodyni
English: 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.
Danish: 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.
English: Hypothyroidism or hyperthyroidism should be treated according to standard medical practice to maintain euthyroid state.
Danish: Hypotyreose eller hypertyreose skal behandles efter gældende medicinsk praksis for at opretholde euthyroid tilstand.
English: In vitro binding of axitinib to human plasma proteins is > 99% with preferential binding to albumin and moderate binding to α1-acid glycoprotein.
Danish: In vitro er den humane proteinbindingsgrad af axitinib >99% med overvejende binding til albumin og moderat binding til α1-syre-glykoprotein.
English: 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.
Danish: 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.
English: 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.
Danish: Efter oral administration af en dosis på 5 mg radioaktivt axitinib genfindes 30-60% af radioaktiviteten i fæces og 23% i urinen.
English: Axitinib may be administered with or without food (see section 4.2).
Danish: Axitinib kan tages med eller uden mad (se pkt.
English: Uncommon: may affect up to 1 in 100 people • Reduction in the number of white blood cells (may show in your blood tests)
Danish: Ikke almindelige: forekommer hos op til 1 ud af 100 personer • Nedsat antal hvide blodlegemer (ses i blodprøver)
English: Each pack contains 28 or 56 film-coated tablets.
Danish: Hver pakning indeholder 28 eller 56 filmovertrukne tabletter.
English: The average Cmax and AUC increased proportionally over an axitinib dosing range of 5 to 10 mg.
Danish: Det gennemsnitlige Cmax og AUC stiger proportionalt i doseringsområdet 5 til 10 mg axitinib.
English: The plasma half life of axitinib ranges from 2.5 to 6.1 hours.
Danish: Plasmahalveringstiden varierer fra 2,5 til 6,1 timer.
English: Axitinib was not mutagenic or clastogenic in conventional genotoxicity assays in vitro.
Danish: Axitinib er ikke mutagent eller klastogent i konventionelle studier in vitro.
English: Take your next dose at your regular time.
Danish: Tag den næste dosis til sædvanlig tid.
English: 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.
Danish: 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.
English: Very common Decreased appetite Common
Danish: Meget almindelig Nedsat appetit Almindelig
English: Administration of axitinib with a moderate fat meal resulted in 10% lower exposure compared to overnight fasting.
Danish: Administration af axitinib sammen med et moderat fedtrigt måltid medfører 10% mindre eksposure sammenlignet med faste natten over.
English: 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).
Danish: 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).
English: Studies in animals have shown reproductive toxicity including malformations (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet (se pkt 5.3).
English: Inlyta film-coated tablets come in different strengths.
Danish: Inlyta filmovertrukne tabletter findes i flere styrker.
English: Unchanged axitinib was not detected in urine; the carboxylic acid and sulfoxide metabolites accounted for the majority of radioactivity in urine.
Danish: Der genfindes ikke uomdannet axitinib i urinen; carboxylsyre og sulfoxidmetabolitter er ansvarlige for størstedelen af radioaktiviteten i urin.
English: 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.
Danish: Maksimal axitinib-plasmakoncentration nås almindeligvis indenfor 4 timer efter oral administration af axitinib med median Tmax varierende fra 2,5 til 4,1 timer.
English: • rifampicin, rifabutin or rifapentin, used to treat tuberculosis (TB);
Danish: • rifampicin, rifabutin og rifapentin, til behandling af tuberkulose (TB)
English: • High blood pressure, or increases in blood pressure
Danish: • For højt blodtryk eller blodtryksstigning
English: Very common Headache Dysgeusia
Danish: Meget almindelig Hovedpine Dysgeusi
English: Some medicines may affect Inlyta, or be affected by it.
Danish: Visse typer medicin kan påvirke Inlyta, eller blive påvirket af Inlyta.
English: The sulfoxide and N-glucuronide metabolites show approximately 400-fold and 8000-fold less in vitro potency, respectively, against VEGFR-2 compared to axitinib.
Danish: Sulfoxid- og N-glucoronidmetabolitter er henholdsvis ca. 400 gange og 8000 gange mindre potente in vitro i forhold til VEGFR-2 sammenlignet med axitinib.
English: Very common Palmar-plantar erythrodysaesthesia (hand-foot syndrome) Rash
Danish: Meget almindelig Palmo-plantar erytrodysæstesi (hånd-og fodsyndrom)
English: 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).
Danish: 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).
English: Carcinogenicity Carcinogenicity studies have not been performed with axitinib.
Danish: Karcinogenicitet Der er ikke udført karcinogenicitets-studier med axitinib.
English: Talk to your doctor before taking it if you are pregnant or might become pregnant.
Danish: Spørg lægen til råds før du tager dette lægemiddel, hvis du er eller planlægger at blive gravid.
English: Inlyta can raise your blood pressure.
Danish: Inlyta kan få blodtrykket til at stige.
English: When dose reduction is necessary, the axitinib dose may be reduced to 3 mg twice daily and further to 2 mg twice daily.
Danish: Hvis dosisnedsættelse er nødvendigt, kan dosis nedsættes til 3 mg 2 gange dagligt og yderligere ned til 2 mg 2 gange dagligt.
English: If you are allergic to axitinib or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Inlyta hvis du er allergisk over for axitinib eller et af de øvrige indholdsstoffer i Inlyta (angivet i afsnit 6).
English: PRES is a neurological disorder which can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances.
Danish: PRES er en neurologisk forstyrrelse med symptomer som hovedpine, krampeanfald, apati, konfusion, synstab og andre syns- og neurologiske forstyrrelser.
English: Elderly (≥ 65 years) and race
Danish: Ældre over 65 år og race
English: Based on non-clinical findings, axitinib has the potential to impair reproductive function and fertility in humans (see section 5.3).
Danish: På baggrund af ikke-kliniske fund, kan axitinib potentielt indvirke på human reproduktion og fertilitet (se pkt.
English: • clarithromycin, erythromycin or telithromycin, antibiotics used to treat bacterial infections;
Danish: • clarithromycin, erythromycin og telithromycin, antibiotika til behandling af bakterieinfektioner
English: You should not take these medicines during your treatment with Inlyta.
Danish: Tag ikke disse typer medicin under behandlingen med Inlyta.
English: 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).
Danish: 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).
English: Tell your doctor if you have a very high blood pressure, severe headache, or severe chest pain.
Danish: Fortæl lægen, hvis du har meget for højt blodtryk, stærk hovedpine eller kraftige brystsmerter.
English: 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.
Danish: 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.
English: 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.
Danish: Inlyta er indiceret til behandling af voksne med fremskreden renalcellekarcinom (RCC) efter svigt af tidligere behandling med sunitinib eller cytokiner.
English: • Sore throat or nose and throat irritation
Danish: • Ondt i halsen eller næsen og irritation i svælget
English: A fatal acute myocardial infarction and cerebrovascular accident was reported in one patient each (0.3%).
Danish: Et letalt akut myokardieinfarkt og et cerebrovaskulært tilfælde blev hver især rapporteret hos 1 patient (0,3%).
English: If you accidentally take too many tablets or a higher dose than you need, contact a doctor for advice right away.
Danish: 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.
English: Other toxicities of potential concern to paediatric patients have not been evaluated in juvenile animals.
Danish: Der er ikke foretaget andre toksicitetsundersøgelser i unge dyr med henblik på pædiatriske patienter.
English: 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.
Danish: 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.
English: There is no specific treatment for axitinib overdose.
Danish: Der er ingen specifik antidot for overdosering med axitinib.
English: • ketoconazole or itraconazole, used to treat fungal infections;
Danish: • ketokonazol og itraconazol, til behandling af svampeinfektioner
English: • If you suffer from bleeding problems.
Danish: • Hvis du har problemer med blødning.
English: 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.
Danish: 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.
English: If you are breast-feeding, your doctor should discuss with you whether to discontinue breast-feeding or discontinue Inlyta treatment.
Danish: Hvis du ammer, bør du diskutere med lægen, om du skal holde op med at amme, eller om behandlingen skal stoppes.
English: Each blister pack contains 28 tablets or 56 tablets.
Danish: Hver pakning indeholder 28 tabletter eller 56 tabletter.
English: Gastrointestinal perforation and fistulac,k
Danish: Gastrointestinal perforation og fistler c, k
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: Your doctor should make sure that your blood pressure is under control before starting Inlyta treatment, and while on treatment with this medicine.
Danish: Lægen skal sikre sig, at dit blodtryk er under kontrol, før behandlingen startes, og mens du bliver behandlet med Inlyta.
English: • If you have liver problems.
Danish: • Hvis du har problemer med leveren.
English: 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.
Danish: 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.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE17
Danish: Farmakoterapeutisk klassifikation: Protein-tyrosinkinase-hæmmer, ATC-kode: L01XE17.
English: • Protein in the urine (may show in your urine tests)
Danish: • Protein i urinen (ses i urinprøver)
English: Hyperbilirubinaemia Cholecystitisn
Danish: Hyperbilirubinæmi Cholecystitis
English: 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.
Danish: 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.
English: • atazanavir, indinavir, nelfinavir, ritonavir or saquinavir, used to treat HIV infections/AIDS;
Danish: • atazanavir, indinavir, nelfinavir, ritonavir og saquinavir, til behandling af hiv-infektioner/AIDS
English: 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.
Danish: 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.
English: Toxicity findings in immature animals
Danish: Toksicitetsfund i unge dyr
English: 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.
Danish: 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.
English: Tablet film-coating Hypromellose 2910 (15 mPa·s) Titanium dioxide (E171) Lactose monohydrate Triacetin (E1518) Iron oxide red (E172)
Danish: Tabletfilmovertræk Hypromellose 2910 (15 mPa·s) Titandioxid (E171) Lactosemonohydrat Triacetin (E1518) Rød jernoxid (E172)
English: 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.
Danish: 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.
English: Inlyta may increase the risk of developing heart failure events.
Danish: Inlyta kan øge risikoen for at udvikle hjertesvigt.
English: Do not use this medicine after the expiry date which is stated on the carton and on the blister foil or bottle after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: CYP1A2 and CYP2C19 constitute minor (< 10%) pathways in axitinib metabolism.
Danish: CYP1A2 og CYP2C19 bidrager mindre (<10%) til metaboliseringen af axitinib.
English: Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel.: + 386 (0)1 52 11 400
Danish: podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: +386 (0)1 52 11 400
English: • If during treatment with this medicine you get severe stomach (abdominal) pain or stomach pain that does not go away.
Danish: • Hvis du under behandlingen med dette lægemiddel får kraftige mavesmerter eller mavesmerter, som ikke forsvinder.
English: Mild to severe hypertension may be present.
Danish: Der ses også mild til alvorlig hypertension.
English: Unchanged axitinib, accounting for 12% of the dose, was the major component identified in faeces.
Danish: Uomdannet axitinib (svarende til 12% af dosis) var hovedkomponenten identificeret i fæces.
English: In vitro and in vivo data indicate that axitinib is primarily metabolised by the liver.
Danish: Nedsat leverfunktion In vitro og in vivo data tyder på, at axitinib hovedsageligt metaboliseres i leveren.
English: Dehydration Hyperkalaemia Hypercalcaemia
Danish: Dehydrering Hyperkaliæmi Hyperkalcæmi
English: The safety and efficacy of Inlyta in children and adolescents < 18 years have not been established.
Danish: Sikkerhed og virkning af Inlyta er ikke undersøgt hos børn og unge under 18 år.
English: 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).
Danish: 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).
English: Tell your doctor if you have severe abdominal pain while on treatment with this medicine.
Danish: Fortæl det til lægen, hvis du får kraftige mavesmerter, mens du er i behandling med dette lægemiddel.
English: Blood pressure should be well-controlled prior to initiating axitinib.
Danish: Blodtrykket skal være velkontrolleret, inden behandlingen med axitinib initieres.
English: 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.
Danish: Nedsat fertilitet og embryo-levedygtighed ses hos hunmus ved alle testede doser med laveste dosis ca. 10 gange højere end human-terapeutiske doser.
English: Your doctor may change the dose of these medicines, change the dose of Inlyta, or switch you to a different medicine.
Danish: Lægen vil muligvis ændre dosis på enten Inlyta eller det andet lægemiddel, eller skifte til et helt andet.
English: Inlyta is a medicine containing the active substance axitinib.
Danish: Inlyta indeholder det aktive stof axitinib.
English: Other medicines and Inlyta
Danish: Brug af anden medicin sammen med Inlyta
English: Your doctor should stop Inlyta at least 24 hours before your operation as it may affect wound healing.
Danish: Behandlingen med Inlyta bør stoppes mindst 24 timer før en operation, da Inlyta kan påvirke sårhelingen.