FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies with axitinib, the systemic exposure to axitinib was approximately two-fold higher in subjects with moderate hepatic impairment (Child-Pugh class B) compared to subjects with normal hepatic function.
Danish: I kliniske studier var den systemiske exposure for axitinib ca. 2 gange højere hos patienter med moderat nedsat leverfunktion (Child-Pugh klasse B) end hos patienter med normal leverfunktion.
English: j Including acute myocardial infarction, embolism, myocardial infarction, retinal artery occlusion and transient ischaemic attack.
Danish: Inklusive akut myokardieinfarkt, emboli, myokardieinfarkt, retinalarterieokklusion og transitorisk cerebral iskæmi
English: These findings were observed in mice at exposure levels approximately 12-fold the expected human exposure, and in dogs at exposure levels below the expected human exposure.
Danish: Disse fund blev set hos mus ved doser ca. 12 gange human-terapeutiske doser og hos hunde ved doser lavere end human-terapeutiske doser.
English: One-sided p-value from Cochran-Mantel-Haenszel test of treatment stratified by ECOG performance status.
Danish: Én-sidet p-værdi fra Cochran-Mantel-Haenszel test af behandling stratificeret efter ECOG performance status og tidligere behandling.
English: Axitinib has not been studied in patients who had an arterial embolic or thrombotic event within the previous 12 months.
Danish: Axitinib er ikke undersøgt hos patienter, som har haft arterielle tromboemboliske hændelser inden for de sidste 12 måneder.
English: During routine laboratory assessments, in patients who had TSH < 5 μU/mL before treatment, elevations of TSH to ≥ 10 μU/mL occurred in 32.2% of patients receiving axitinib.
Danish: Ved rutinemæssige laboratorieundersøgelser sås stigninger i TSH til ≥10 µU/ml hos 32,2% af de axitinib-behandlede patienter, som havde TSH <5 µU/ml før behandlingsstart.
English: i Including Budd-Chiari syndrome, deep vein thrombosis, jugular vein thrombosis, pelvic venous thrombosis, pulmonary embolism, retinal vein occlusion, retinal vein thrombosis, subclavian vein thrombosis, venous thrombosis, and venous thrombosis limb.
Danish: Inklusive Budd-Chiari's syndrom, dyb venetrombose, vena jugularis trombose, bækkenvenetrombose, lungeemboli, retinalveneokklusion, retinalvenetrombose, vena subclavia trombose, venøs trombose og trombose i ekstremitetvene
English: Although axitinib dose adjustment has not been studied in patients receiving strong CYP3A4/5 inducers, if a strong CYP3A4/5 inducer must be co-administered, a gradual dose increase of axitinib is recommended.
Danish: Selvom dosisjustering af axitinib ikke er undersøgt hos patienter i behandling med potente CYP3A4/5induktorer, anbefales det at øge axititinib dosis gradvist.
English: Please tell your doctor, pharmacist or nurse about all the medicines you have recently taken, are currently taking, or plan to take, including medicines obtained without a prescription, vitamins, and herbal medicines.
Danish: Fortæl altid lægen, apoteket eller sundhedspersonalet, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: Compared to subjects with normal hepatic function, systemic exposure following a single dose of axitinib was similar in subjects with mild hepatic impairment (Child-Pugh class A) and higher (approximately two-fold) in subjects with moderate hepatic impairment (Child-Pugh class B).
Danish: Systemisk eksposure efter enkeltdosis axitinib var sammenlignelig hos patienter med normal leverfunktion og patienter med let nedsat leverfunktion (Child-Pugh class A) og højere (ca. to gange) hos patienter med moderat nedsat leverfunktion (Child-Pugh class B).
English: In monotherapy studies with axitinib (N = 850), haemoptysis was reported in 3.9% of patients; Grade > 3 haemoptysis was reported in 0.5% of patients.
Danish: I studier med axitinib givet som monoterapi (N = 850) så man hæmoptyse hos 3,9% af patienterne; hæmoptyse af grad ≥3 blev rapporteret hos 0,5 % af patienterne.
English: Reversible physeal dysplasia was observed in mice and dogs given axitinib for at least 1 month at exposure levels approximately six-fold higher than the expected human exposure.
Danish: Reversibel epifysedysplasi ses hos mus og hunde efter indgift af axitinib i mindst 1 måned med doser ca. seks gange human-terapeutiske doser.
English: Get emergency help right away and call your doctor.
Danish: Kontakt omgående læge eller skadestue.
English: Table 1 presents adverse reactions reported in a pooled dataset of 672 patients who received axitinib in clinical studies for the treatment of patients with RCC (see section 5.1).
Danish: Skema 1 viser bivirkninger set i et poolet datasæt for 672 patienter med RCC behandlet med axitinib i kliniske studier (se pkt.
English: Kaplan-Meier curve of progression-free survival by independent assessment for the prior sunitinib subgroup
Danish: Figur 2 Kaplan-Meier kurve over progressionsfri overlevelse udfra uafhængig vurdering i undergruppen med tidligere sunitinib-behandling.
English: What Inlyta is and what it is used for What you need to know before you take Inlyta How to take Inlyta
Danish: Virkning og anvendelse Det skal du vide, før du begynder at tage Inlyta Sådan skal du tage Inlyta Bivirkninger
English: Axitinib has not been studied in patients who had a venous embolic or thrombotic event within the previous 6 months.
Danish: Axitinib er ikke undersøgt hos patienter, som har haft venøse tromboemboliske hændelser inden for de sidste 6 måneder.
English: • Changes in the levels of different chemicals/enzymes in the blood (may show in your blood tests)
Danish: • Ændringer i stoffer/enzymer i blodet.
English: • If you have had a recent problem with blood clots in your veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.
Danish: • Hvis du for nylig har haft problemer med blodpropper, inklusive slagtilfælde og hjertetilfælde.
English: HDPE bottle with a silica gel desiccant and a polypropylene closure containing 60 film-coated tablets.
Danish: HDPE beholder med silicagel tørrekapsel og polypropylenlåg indeholdende 60 filmovertrukne tabletter.
English: Adverse reactions reported in RCC studies in patients who received axitinib (N = 672)
Danish: Bivirkninger set i RCC-studier hos patienter behandlet med axitinib (N = 672) Systemorganklasse Hyppighed
English: How to take Inlyta
Danish: Sådan skal du tage Inlyta
English: • Presence of red blood cells in the urine (may show in your urine tests)
Danish: • Røde blodlegemer i urinen (ses i urinprøver)
English: In vitro data indicate that axitinib is metabolised primarily by CYP3A4/5 and, to a lesser extent, CYP1A2, CYP2C19, and uridine diphosphate-glucuronosyltransferase (UGT) 1A1.
Danish: In vitro data antyder, at axitinib primært metaboliseres via CYP3A4/5 og i mindre udstrækning via CYP1A2, CYP2C19 og uridindiphosphat-glucuronosyltranferase (UGT) 1A1.
English: All Gradesb
Danish: Alle grader
English: A dose decrease is recommended when administering axitinib to patients with moderate hepatic impairment (Child-Pugh class B) (see section 4.2).
Danish: Dosisreduktion anbefales til patienter med moderat nedsat leverfunktion (Child-Pugh klasse B) (se pkt.
English: Although axitinib dose adjustment has not been studied in patients receiving strong CYP3A4/5 inhibitors, if a strong CYP3A4/5 inhibitor must be co-administered, a dose decrease of axitinib to approximately half the dose (e.g. the starting dose should be reduced from 5 mg twice daily to 2 mg twice daily) is recommended.
Danish: Selvom dosisjustering af axitinib ikke er undersøgt hos patienter i behandling med potente CYP3A4/5hæmmere, anbefales det at reducere axitinib-dosis til ca. halvdelen (f.eks bør startdosis nedsættes fra 5 mg 2 gange dagligt til 2 mg 2 gange dagligt), hvis axitinib skal administreres sammen med en kraftig CYP/3A4/5-hæmmer.
English: Cutoff date: 03 June 2011. b Assessed by independent radiology review according to Response Evaluation Criteria in Solid
Danish: Vurderet ved uafhængig radiologisk gennemgang i henhold til Response Evaluation Criteria in Solid Tumours (RECIST).
English: • Fistula (abnormal tube like passage from one normal body cavity to another body cavity or the skin)
Danish: • Fistel-dannelse (unormal rør-lignende passage fra et hulrum i kroppen til et andet eller til huden)
English: Cardiac failure eventsc,d,f
Danish: Hjertesvigt c, d, f
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, hypothyroidism was reported in 20.9% of patients and hyperthyroidism was reported in 1.1% of patients.
Danish: I et klinisk studie med axitinib til behandling af patienter med RCC, så man hypotyreose hos 20,9% af patienterne og hypertyreose hos 1,1% af patienterne.
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, 34% of patients treated with axitinib were ≥ 65 years of age.
Danish: I et kontrolleret klinisk studie med axitinib til behandling af patienter med RCC var 34% af patienterne over 65 år gamle.
English: Get emergency help right away and call your doctor if you get symptoms such as headache, confusion, seizures (fits), or changes in vision with or without high blood pressure.
Danish: Ring straks til lægen, hvis du får symptomer såsom hovedpine, forvirring, kramper og synsforstyrrelser, med eller uden for højt blodtryk.
English: Inlyta 1 mg film-coated tablets Inlyta 3 mg film-coated tablets Inlyta 5 mg film-coated tablets Inlyta 7 mg film-coated tablets
Danish: Inlyta 1 mg filmovertrukne tabletter Inlyta 3 mg filmovertrukne tabletter Inlyta 5 mg filmovertrukne tabletter Inlyta 7 mg filmovertrukne tabletter
English: Arterial embolic and thrombotic eventsc,d,j
Danish: Arterielle tromboemboliske hændelser c, d, j
English: Not known: frequency cannot be estimated from the available data
Danish: Bivirkninger, hvor hyppigheden ikke er kendt
English: Symptoms of gastrointestinal perforation or fistula should be periodically monitored for throughout treatment with axitinib.
Danish: Der skal monitoreres for symptomer på gastrointestinal perforation og fistler under hele behandlingen med axitinib.
English: Unchanged axitinib is not detected in the urine.
Danish: Nedsat nyrefunktion Uomdannet axitinib genfindes ikke i urin.
English: What Inlyta contains
Danish: Inlyta indeholder:
English: Efficacy results Endpoint / study population axitinib sorafenib HR (95% CI) p-value
Danish: Effekt Endepunkt/ studiepopulation axitinib sorafenib
English: Management of some adverse reactions may require temporary or permanent discontinuation and/or dose reduction of axitinib therapy (see section 4.4).
Danish: Håndteringen af nogle af bivirkningerne kan kræve midlertidig eller permanent afbrydelse af behandlingen og/eller dosisnedsættelse af axitinib (se pkt.
English: Magnetic resonance imaging is necessary to confirm the diagnosis of PRES.
Danish: Det er nødvendigt at MR-skanne patienten for at stille PRES-diagnosen.
English: Figure 1.
Danish: Skema 1.
English: Co-administration of axitinib with strong CYP3A4/5 inducers (e.g. rifampicin, dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentin, phenobarbital, and Hypericum perforatum [St.
Danish: Samtidig administration af axitinib og potente CYP3A4/5-induktorer (f.eks. rifampicin, dexamethason, phenytoin, carbamazepin, rifabutin, rifapentin, phenobarbital og perikon) kan nedsætte plasmakoncentrationen af axitinib.
English: You should check with your doctor, pharmacist or nurse if you are not sure.
Danish: Spørg lægen, på apotekespersonalet eller sygeplejersken, hvis der er noget, du er i tvivl om.
English: Kaplan-Meier curve of progression-free survival by independent assessment for the prior cytokine subgroup
Danish: Figur 3 Kaplan-Meier kurve over progressionsfri overlevelse udfra uafhængig vurdering i undergruppen med tidligere cytokin-behandling.
English: No dose adjustment is required when administering axitinib to patients with mild hepatic impairment (Child-Pugh class A).
Danish: Dosisjustering er ikke nødvendig hos patienter med let nedsat leverfunktion (Child-Pugh klasse A).
English: If axitinib is interrupted, patients receiving antihypertensive medicinal products should be monitored for hypotension (see section 4.2).
Danish: Hvis behandlingen med axitinib afbrydes, bør blodtrykket kontrolleres med henblik på hypotension hos patienter i antihypertensiv behandling (se pkt.
English: In clinical studies with axitinib for the treatment of patients with RCC, hypertension was very commonly reported (see section 4.8).
Danish: I kliniske studier med axitinib til behandling af patienter med RCC, blev hypertension meget hyppigt rapporteret (se pkt.
English: In vitro studies also indicated that axitinib has the potential to inhibit CYP2C8.
Danish: In vitro studier antyder, at axitinib er en potentiel hæmmer af CYP2C8.
English: Axitinib is a potent and selective tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2 and VEGFR-3.
Danish: Axitinib er en potent og selektiv hæmmer af VEGF (Vascular Endothelial Growth Factor).
English: • Reduction in the number of blood platelets (cells that help blood to clot) (may show in your blood tests)
Danish: • Fald i antal blodplader (der gør at blodet har sværere ved at størkne) (ses i blodprøver)
English: Get emergency help right away and call your doctor if you get symptoms such as chest pain or pressure; pain in your arms, back, neck or jaw; shortness of breath; numbness or weakness on one side of your body; trouble talking; headache; vision changes; or dizziness while on treatment with this medicine.
Danish: Kontakt omgående læge eller skadestue, ved symptomer som smerter eller trykken for brystet, smerter i armene, ryggen, nakken eller kæben, åndenød, følelsesløshed eller svaghed i den ene side af kroppen, problemer med at tale, hovedpine, synsforstyrrelser eller svimmelhed, mens du bliver behandlet med dette lægemiddel.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3 September 2012
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: If your thyroid gland is not producing enough thyroid hormone before, or while on treatment with this medicine, you should be treated with thyroid hormone replacement.
Danish: Hvis skjoldbruskkirtlen ikke producerer nok hormon, kan der gives et medicinsk tilskud af skjoldbruskkirtelhormon.
English: There was no effect on mating or fertility in male mice at exposure levels approximately 57-fold the expected human exposure.
Danish: Der sås ingen virkning på parringsevne og fertilitet hos hanmus ved doser ca. 57 gange human-terapeutiske doser.
English: Your thyroid function should be checked before you take Inlyta and regularly while you are taking it.
Danish: Skjoldbruskkirtlens funktion skal måles, inden du begynder at tage Inlyta og regelmæssigt under behandlingen.
English: Tell your doctor if you experience excessive tiredness, swelling of the abdomen, legs, or ankles, shortness of breath, or protruding neck veins.
Danish: Fortæl det til lægen, hvis du oplever usædvanlig træthed, opsvulmet mave, hævede ben eller ankler, åndenød eller fremstående blodårer på halsen.
English: In vitro studies indicated that axitinib has a potential to inhibit CYP1A2.
Danish: In vitro studier antyder, at axitinib er en potentiel hæmmer af CYP1A2.
English: Inlyta 1 mg film-coated tablets Inlyta 3 mg film-coated tablets Inlyta 5 mg film-coated tablets Inlyta 7 mg film-coated tablets axitinib
Danish: Inlyta 1 mg filmovertrukne tabletter Inlyta 3 mg filmovertrukne tabletter Inlyta 5 mg filmovertrukne tabletter Inlyta 7 mg filmovertrukne tabletter axitinib
English: In clinical studies with axitinib for the treatment of patients with RCC, cardiac failure events (including cardiac failure, cardiac failure congestive, cardiopulmonary failure, left ventricular dysfunction, ejection fraction decreased, and right ventricular failure) were reported (see section
Danish: I kliniske studier med axitinib til behandling af patienter med RCC blev der rapporteret hændelser med hjertesvigt (herunder hjertesvigt, kongestivt hjertesvigt, kardiopulmonalt svigt, venstre ventrikeldysfunktion, nedsat uddrivningsfraktion og højre ventrikelsvigt) (se pkt.
English: Inlyta contains lactose (milk sugar)
Danish: Inlyta indeholder lactose
English: Venous embolic and thrombotic eventsc,d,i
Danish: Venøse tromboemboliske hændelser c, d, i
English: Amylase increased Aspartate aminotransferase increased
Danish: Stigning i lipase Stigning i alaninaminotransferase Stigning i amylase Stigning i aspartataminotransferase Stigning i basisk fosfatase Stigning i kreatinin Stigning i TSH
English: In monotherapy studies with axitinib (N = 672) for the treatment of patients with RCC, cardiac failure events (including cardiac failure, cardiac failure congestive, cardiopulmonary failure, left ventricular dysfunction, ejection fraction decreased, and right ventricular failure) were reported in 1.8% patients receiving axitinib.
Danish: I studier med axitinib givet som monoterapi (N = 672) til behandling af patienter med RCC blev der rapporteret hændelser med hjertesvigt (herunder hjertesvigt, kongestivt hjertesvigt, kardiopulmonalt svigt, venstre ventrikeldysfunktion, nedsat uddrivningsfraktion og højre ventrikelsvigt) hos 1,8 % af patienterne, der fik axitinib.
English: What you need to know before you take Inlyta Do not take Inlyta:
Danish: Det skal du vide, før du begynder at tage Inlyta
English: Axitinib should be used with caution in patients who are at risk for, or who have a history of, these events.
Danish: Axitinib bør anvendes med forsigtighed hos patienter med risiko for eller som tidligere har haft en arteriel tromboembolisk hændelse.
English: In clinical studies with axitinib for the treatment of patients with RCC, events of hypothyroidism and, to a lesser extent, hyperthyroidism, were reported (see section 4.8).
Danish: I kliniske studier med axitinib til behandling af patienter med RCC, blev der set tilfælde af hypotyreose, og i mindre udstrækning hypertyreose (se pkt.
English: 29.4 (24.5, NE)
Danish: 4.4 og 5.2).
English: Posterior reversible encephalopathy syndrome (PRES) In clinical studies with axitinib, events of PRES were reported (see section 4.8).
Danish: Posteriort reversibelt encefalopati-syndrom (PRES) Der er set PRES i kliniske studier (se pkt.
English: Abdominal pain Constipation
Danish: Øvre abdominale smerter Flatulens
English: This medicine has not been studied in children and adolescents.
Danish: Sikkerhed og virkning af dette lægemiddel til børn og unge er ikke klarlagt.
English: • Reduction in the number of red blood cells (may show in your blood tests)
Danish: • Fald i antal røde blodlegemer (ses i blodprøver)
English: Fatal pulmonary embolism was reported in one patient (0.3%) receiving axitinib.
Danish: Dødelig lungeemboli blev set hos 1 patient (0,3%) i behandling med axitinib.
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, liver-related adverse reactions were reported.
Danish: I et kontrolleret klinisk studie med axitinib som behandling af patienter med RCC er der set leverrelaterede bivirkninger.
English: Therefore, co-administration of axitinib is not expected to increase the plasma concentration of digoxin, or other P-glycoprotein substrates,
Danish: Men samtidig administration af axitinib forventes ikke at hæmme P-glykoprotein ved terapeutiske plasmakoncentrationer, og det forventes derfor ikke, at samtidig administration af axitinib vil medføre en stigning i plasmakoncentrationen af digoxin eller andre P-glykoproteinsubstrater in vivo.
English: The magnitude of median PFS effect was different in the subgroups by prior therapy.
Danish: Forlængelsen af den mediane progressionfri overlevelse var forskellig i de to undergrupper afhængigt af den tidligere behandling.
English: Get emergency help right away and call your doctor if you get symptoms such as chest pain or pressure; pain in your arms, back, neck or jaw; shortness of breath; numbness or weakness on one side of your body; trouble talking; headache; vision changes: or dizziness.
Danish: Ring straks til lægen ved symptomer som smerter eller trykken for brystet, smerter i armene, ryggen, nakken eller kæben, åndenød, følelsesløshed eller svaghed i den ene side af kroppen, problemer med at gå, hovedpine, synsforstyrrelser eller svimmelhed.
English: • Increase in the number of red blood cells (may show in your blood tests)
Danish: • Forhøjet antal røde blodlegemer (ses i blodprøver)
English: Your doctor should monitor for signs or symptoms of heart failure events periodically throughout treatment with axitinib.
Danish: Din læge vil jævnligt undersøge Dem for symptomer på hjertesvigt under behandlingen med axitinib.
English: INFORMATION IN BRAILLE Inlyta 1 mg
Danish: Inlyta 1 mg
English: The following risks, including appropriate action to be taken, are discussed in greater detail in section 4.4: cardiac failure events, hypertension, thyroid dysfunction, arterial thromboembolic events, venous thromboembolic events, elevation of haemoglobin or haematocrit, haemorrhage, gastrointestinal perforation and fistula formation, wound healing complications, PRES, proteinuria, and elevation of liver enzymes.
Danish: 4.4: hjertesvigt, hypertension, thyroideadysfunktion, arterielle tromboemboliske hændelser, venøse tromboemboliske hændelser, stigning i hæmoglobin eller hæmatokrit, blødning, gastrointestinal perforation og fisteldannelse, komplikationer ved sårheling, PRES, proteinuri og stigning i leverenzymer.
English: • Diarrhoea, feeling or being sick (nausea or vomiting), stomach ache, indigestion, soreness of the mouth, tongue or throat, constipation
Danish: • Diarré, kvalme, opkastning, mavesmerter, fordøjelsesproblemer, øm mund, tunge og svælg,
English: • Nose bleeding
Danish: • Næseblod
English: In monotherapy studies with axitinib (N = 850), arterial embolic and thrombotic adverse reactions (including transient ischemic attack, myocardial infarction, and cerebrovascular accident) were reported in 5.3% of patients receiving axitinib.
Danish: I studier med axitinib givet som monoterapi (N = 850) så man arterielle tromboemboliske bivirkninger (herunder transitoriske iskæmisk anfald, myokardieinfarkt og cerebrovaskulære hændelser) hos 5,3% af patienterne.
English: k Gastrointestinal perforation and fistula includes the following preferred terms: abdominal abscess, anal abscess, anal fistula, fistula, gastrointestinal anastomotic leak, gastrointestinal perforation, large intestine perforation, oesophagobronchial fistula and peritonitis.
Danish: Gastrointestinal perforation og fistler inkluderer følgende termer: abdominal absces, anal absces, anal fistel, fistel, gastrointestinal anastomose lækage, gastrointestinal perforation, tyktarmsperforation, øsofagobronkial fistel og peritonitis Proteinuri inkluderer følgende termer: protein i urinen, protein til stede i urinen og proteinuri Inklusive akut nyresvigt n Cholecystitis inkluderer akut cholecystitis, cholecystitis, infektiøs cholecystitis
English: Vascular disorders Very common Hypertensiong Haemorrhagec,d,h
Danish: Meget almindelig Hypertension Blødning c, d, h
English: In a controlled clinical study with axitinib (N = 359) for the treatment of patients with RCC, cardiac failure events were reported in 1.7 % patients receiving axitinib, including cardiac failure (0.6%), cardiopulmonary failure (0.6%), left ventricular dysfunction (0.3%), and right ventricular failure
Danish: I et kontrolleret klinisk studie med axitinib (N = 359) til behandling af patienter med RCC blev der rapporteret tilfælde af hjertesvigt hos 1,7 % af patienterne, der fik axitinib, herunder hjertesvigt (0,6 %), kardiopulmonalt svigt (0,6%), venstre ventrikeldysfunktion (0,3 %) og højre ventrikelsvigt (0,3 %).
English: i
Danish: IS
English: Τηλ: +30 210 6785 800
Danish: Pfizer Ελλάς A.E. Τλ: +30 210 6785 800