natgillin/translations-raw huggingface dataset:
I et klinisk studie med axitinib til behandling af patienter med RCC, fik 1 patient uforvarende en dosis på 20 mg 2 gange dagligt i 4 dage og oplevede svimmelhed (grad 1). 
In a controlled clinical study with axitinib for the treatment of patients with RCC, one patient inadvertently received a dose of 20 mg twice daily for 4 days and experienced dizziness (Grade 1).
Synk tabletten hel sammen med vand. 
Swallow the tablets whole with water, with or without food.
- Øvrige indholdsstoffer: mikrokrystallinsk cellulose, lactosemonohydrat, croscarmellosenatrium, magnesiumstearat, hypromellose 2910 (15 mPa·s), titandioxid (E171), triacetin E1518), rød jernoxid (E172) (se pkt. 
• The other ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose 2910 (15 mPa·s), titanium dioxide (E171), triacetin (E1518), iron oxide red (E172) (see section 2 Inlyta contains lactose (milk sugar)).
Brug ikke dette lægemiddel, hvis du bemærker at pakningen er ødelagt eller viser tegn på at have været åbnet. 
Do not use any pack that is damaged or shows signs of tampering.
% (95% CI) 
ORR b,e % (95% CI)
Sammenlignet med intravenøs administration er den gennemsnitlige absolutte biotilgængelighed 58% efter oral administration af axitinib tabletter. 
After oral administration of axitinib tablets, the mean absolute bioavailability is 58% compared to intravenous administration.
• Luft i maven, hæmorider, blødende gummer, blødning fra endetarmen, en brændende eller sviende fornemmelse i munden 
• Flatulence (wind), haemorrhoids, bleeding from gums, bleeding from the rectum, a burning or stinging sensation in the mouth
Pædiatrisk population Axitinib er ikke undersøgt hos patienter under 18 år. 
Axitinib has not been studied in patients < 18 years of age.
Medicin nævnt herunder kan muligvis øge risikoen for bivirkninger af Inlyta: 
The following medicines may increase the risk of side effects with Inlyta:
Inklusive hjertesvigt, kronisk venstresidig hjerteinsufficiens, kardiopulmonalt svigt, nedsat uddrivningfraktion, venstre ventrikeldysfunktion og højre ventrikelsvigt Inklusive accelereret hypertension, blodtryksstigning, hypertension og hypertensiv krise Inklusive forlængelse af aktiveret partiel tromboplastin-tid, anal blødning, arteriel blødning, blod i urinen, blødning i centralnervesystemet, hjerneblødning, forlænget koagulationstid, konjunktival blødning, kontusion, hæmoragisk diarré, dysfunktionel uterinblødning, epistaxis, gastrisk blødning, gastrointestinal blødning, gingival blødning, hæmatemese, hæmatokesi, nedsat hæmatokrit, hæmatom, hæmaturi, nedsat hæmoglobin, hæmoptyse, blødning, blødning i koronararterie, blødning i urinvejen, hæmorideblødning, hæmostase, øget tendens til blå mærker, stigning i INR (international normalised ratio), nedre gastrointestinal blødning, melæna, petekkier, faryngealblødning, forlænget protrombintid, pulmonal blødning, purpura, rektalblødning, nedsat antal røde blodlegemer, renalblødning, skleralblødning, skrotal hæmatocele, milthæmatom, splinthæmoragi, subaraknoidalblødning, tungeblødning, øvre gastrointestinal blødning og vaginal blødning. 
h Including activated partial thromboplastin time prolonged, anal haemorrhage, arterial haemorrhage, blood urine present, central nervous system haemorrhage, cerebral haemorrhage, coagulation time prolonged, conjunctival haemorrhage, contusion, diarrhea haemorrhagic, dysfunctional uterine bleeding, epistaxis, gastric haemorrhage, gastrointestinal haemorrhage, gingival bleeding, haematemesis, haematochezia, haematocrit decreased, haematoma, haematuria, haemoglobin decreased, haemoptysis, haemorrhage, haemorrhage coronary artery, haemorrhage urinary tract, haemorrhoidal haemorrhage, haemostasis, increased tendency to bruise, international normalized ratio increased, lower gastrointestinal haemorrhage, melaena, petechiae, pharyngeal haemorrhage, prothrombin time prolonged, pulmonary haemorrhage, purpura, rectal haemorrhage, red blood cell count decreased, renal haemorrhage, scleral haemorrhage, scrotal haematocoele, splenic haemotoma, splinter haemorrhage, subarachnoid haemorrhage, tongue haemorrhage, upper gastrointestinal haemorrhage and vaginal haemorrhage.
Tidligere cytokinbehandling 
Prior cytokine treatment
Efterfølgende kan patienter, som tåler axitinib 7 mg 2 gange dagligt, få øget deres dosis til højst 10 mg 2 gange dagligt ud fra de samme kriterier. 
Subsequently, using the same criteria, patients who tolerate an axitinib dose of 7 mg twice daily may have their dose increased to a maximum of 10 mg twice daily.
Inlyta må ikke bruges til børn og unge under 18 år. 
Inlyta is not recommended for people aged under 18.
Ved rutinemæssige laboratorieundersøgelser fandt man hæmoglobinniveauer over det normale hos 9,7% af patienterne i behandling med axitinib. 
Routine laboratory assessments detected elevated haemoglobin above ULN in 9.7% of patients receiving axitinib.
• Hovedpine, smagforstyrrelser eller manglende smagssans 
• Headache, taste disturbance or loss of taste
Samtidig administration af axitinib og potente CYP3A4/5hæmmere (f.eks. ketoconazol, itraconazol, clarithromycin, erythromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir og telithromycin) kan øge plasmakoncentrationen af axitinib. 
Co-administration of axitinib with strong CYP3A4/5 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, erythromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin) may increase axitinib plasma concentrations.
I et klinisk dosis-respons studie med axitinib observerede man hos forsøgspersoner, der modtog startdoser på 10 mg eller 20 mg 2 gange dagligt, bivirkninger omfattende hypertension, kramper i forbindelse med hypertension og dødelig hæmoptyse. 
In a clinical dose finding study with axitinib, subjects who received starting doses of 10 mg twice daily or 20 mg twice daily experienced adverse reactions which included hypertension, seizures associated with hypertension, and fatal haemoptysis.
Stigning i hæmoglobin eller hæmatokrit 
Elevation of haemoglobin or haematocrit
Det er blevet vist, at axitinib er en potent hæmmer af endotelcellers proliferation og -overlevelse, der medieres via VEGF. 
Axitinib has been shown to potently inhibit VEGF-mediated endothelial cell proliferation and survival.
Lægen vil tage blodprøver før og under behandlingen med Inlyta. 
Your doctor should do blood tests to check your liver function before and during treatment with Inlyta.
Samtidig administration af axitinib og CYP1A2-substrater kan medføre en stigning i koncentrationen af CYP1A2-substrater (f.eks. teofyllin). 
Therefore, coadministration of axitinib with CYP1A2 substrates may result in increased plasma concentrations of CYP1A2 substrates (e.g. theophylline).
• Blødninger. 
• Bleeding.
• Du må ikke amme, mens du er i behandling med Inlyta. 
• Do not breast-feed during treatment with Inlyta.
In vitro studier af CYP- og UGT-hæmning og -induktion In vitro studier antyder, at axitinib ikke hæmmer CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5 eller UGT1A1 ved terapeutiske plasmakoncentrationer. 
In vitro studies of CYP and UGT inhibition and induction In vitro studies indicated that axitinib does not inhibit CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5, or UGT1A1 at therapeutic plasma concentrations.
• Åndenød, hoste, hæshed 
• Shortness of breath, cough, hoarseness
Ved doseringen 5 mg 2 dagligt til ikke-fastende patienter med RCC er den gennemsnitlige peak-plasmakoncentration og 24-timers AUC henholdsvis 27,8 ng/ml og 265 ng.time/ml. 
At the 5 mg twice daily dose in the fed state, the geometric mean peak plasma concentration and 24-hour AUC were 27.8 ng/mL and 265 ng.h/mL, respectively, in patients with advanced RCC.
In vitro studier antyder, at axitinib hæmmer P-glykoprotein. 
In vitro studies indicated that axitinib inhibits P-glycoprotein.
Forsigtighed bør udvises, hos patienter der tager potente hæmmere af disse isoenzymer, på grund af risikoen for stigning i plasmakoncentrationen af axitinib. 
Caution should be exercised due to the risk of increased axitinib plasma concentrations in patients taking strong inhibitors of these isozymes.
Én-sidet p-værdi fra en log-rank test af behandling stratificeret efter ECOG performance status i. 
h One-sided p-value from a log-rank test of treatment stratified by ECOG performance status.
CI = Confidence interval; HR=Hazard ratio (axitinib/sorafenib); IE: Ikke estimerbart; IS: Ikke significant; ITT: Intent-to-treat; ORR: Objective response rate; OS: Overall survival; PFS: Progression-free survival a. 
CI = Confidence interval, HR = Hazard ratio (axitinib/sorafenib); ITT: Intent-to-treat; NE: not estimable; NS:
Delvis reversibel dentalcaries ses hos mus behandlet i mere end 1 måned med doser svarende til human-terapeutiske doser. 
Partially reversible dental caries were observed in mice treated for more than 1 month at exposure levels similar to the expected human exposure.
De hyppigste bivirkninger (>20%), som ses ved behandling med axitinib er diarré, hypertension, træthed, nedsat appetit, kvalme, vægttab, dysfoni, palmo-plantar erytrodysæstesi (hånd- og fodsyndrom), blødning, hypotyreose, opkastning, proteinuri, hoste og obstipation. 
The most common (≥ 20%) adverse reactions observed following treatment with axitinib were diarrhoea, hypertension, fatigue, decreased appetite, nausea, weight decreased, dysphonia, palmar-plantar erythrodysaesthesia (hand-foot) syndrome, haemorrhage, hypothyroidism, vomiting, proteinuria, cough, and constipation.
Fund hos hunner omfatter tegn på forsinket seksuel modning, reduceret eller manglende corpora lutea, nedsat uterusvægt og uterinatrofi ved doser svarende til human-terapeutiske doser. 
Findings in females included signs of delayed sexual maturity, reduced or absent corpora lutea, decreased uterine weights and uterine atrophy at exposures approximately equivalent to the expected human exposure.
Det anbefales at nedsætte dosis ved behandling af patienter med moderat nedsat leverfunktion (ChildPugh klasse B) (f.eks. fra startdosis på 5 mg 2 gange dagligt til 2 mg 2 gange dagligt). 
A dose decrease is recommended when administering axitinib to patients with moderate hepatic impairment (Child-Pugh class B) (e.g. the starting dose should be reduced from 5 mg twice daily to 2 mg twice daily).
Drægtige mus eksponeret for axitinib udviste stigning i ganespalte og skeletforandringer, herunder forsinket ossifikation ved doser under human-terapeutiske doser. 
Pregnant mice exposed to axitinib showed an increased occurrence of cleft palate malformations and skeletal variations, including delayed ossification, at exposure levels below the expected human exposure.
I et klinisk dosis-respons studie sås en samtidig stigning af ALAT (12 gange [ULN]) og bilirubin (2,3 gange ULN), vurderet til at være lægemiddelrelateret levertoksicitet, hos 1 patient ved en startdosis på 20 mg 2 gange dagligt (4 gangeden anbefalede daglige dosis). 
In a clinical dose-finding study, concurrent elevations of ALT (12 times the ULN) and bilirubin (2.3 times the ULN), considered to be drug-related hepatotoxicity, were observed in 1 patient who received axitinib at a starting dose of 20 mg twice daily (4 times the recommended starting dose).
Arterielle emboliske og trombotiske hændelser 
Arterial embolic and thrombotic events
Hvis du har glemt at tage Inlyta 
If you forget to take Inlyta
Medicin nævnt herunder kan muligvis nedsætte virkningen af Inlyta: 
The following medicines may reduce the effectiveness of Inlyta:
Fortæl lægen, hvis du får voldsomme mavesmerter. 
Tell your doctor if you have severe abdominal pain.
Figur 1 Kaplan-Meier kurve over progressionsfri overlevelse udfra uafhængig vurdering i den samlede population. 
Kaplan-Meier curve of progression-free survival by independent assessment for the overall population
Dosisjustering på grund af alder eller race er ikke nødvendig (se pkt. 
No dosage adjustment is required on the basis of patient age or race (see sections 4.2 and 5.2).
Fortæl det til lægen, hvis du hurtigt bliver træt, føler dig kuldskær eller hvis din stemme bliver dybere, mens du tager Inlyta. 
Tell your doctor if you get tired more easily, generally feel colder than other people, or your voice deepens whilst taking this medicine.
Hvis du holder op med at tage Inlyta 
If you stop taking Inlyta
Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption. 
Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Dosering Den anbefalede dosis er 5 mg axitinib 2 gange dagligt. 
The recommended dose of axitinib is 5 mg twice daily.
- Aktivt stof: axitinib. 
• The active substance is axitinib.
Hvis du kaster op, mens du tager Inlyta 
If you vomit while taking Inlyta
Samtidig administration af axitinib forventes ikke at reducere plasmakoncentrationen af CYP1A1, CYP1A2 eller CYP3A4/5 substrater in vivo. 
Therefore co-administration of axitinib is not expected to reduce the plasma concentration of co-administered CYP1A1, CYP1A2, or CYP3A4/5 substrates in vivo.
• Hul i mavesæk eller tarm eller fistel-dannelse (unormal rør-lignende passage fra et hulrum i kroppen til et andet eller til huden). 
• 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).
Skema 2. 
Figure 2.
60 tabletter 
56 tablets
Beslutning om at genoptage behandlingen bør baseres på klinisk vurdering af tilfredsstillende sårheling. 
The decision to resume axitinib therapy after surgery should be based on clinical judgment of adequate wound healing.
Gentagne dosistoksicitetsforsøg 
Repeat dose toxicity
• Hvis du under behandlingen med Inlyta får symptomer såsom hovedpine, forvirring, kramper (krampeanfald) eller synsforstyrrelser med eller uden højt blodtryk. 
• If during treatment with this medicine, you get symptoms such as headache, confusion, seizures (fits), or changes in vision with or without high blood pressure.
Venøse emboliske og trombotiske hændelser 
Venous embolic and thrombotic events
Axitinib må ikke anvendes under amning. 
Axitinib should not be used during breast-feeding.
I et randomiseret overkrydsningsforsøg, fik 35 raske forsøgspersoner en enkeltdosis axitinib (5 mg) med og uden samtidig dosering af 400 mg ketokonazol i 7 dage. 
In a randomised, 2-way crossover study, 35 healthy subjects were administered a single oral dose of axitinib (5 mg) in the absence and presence of 400 mg ketoconazole for 7 days.
Anæmia Trombocytopeni Polycytæmi 
Thrombocytopenia Polycythaemiac
In vitro studier med humane hepatocytter viste, at axitinib ikke inducerede CYP1A1, CYP1A2 eller CYP3A4/5. 
In vitro studies in human hepatocytes also indicated that axitinib does not induce CYP1A1, CYP1A2, or CYP3A4/5.
Bivirkningerne hos patienter i behandling med axitinib inkluderede epistaxis (7,8%), hæmaturi (3,6%), hæmoptyse (2,5%), rektalblødning (2,2%), gingival blødning (1,1%), gastrisk blødning (0,6%), hjerneblødning (0,3%) og nedre gastrointestinal blødning (0,3%). 
The haemorrhagic adverse reactions in patients treated with axitinib included epistaxis (7.8%), haematuria (3.6%), haemoptysis (2.5%), rectal haemorrhage (2.2%), gingival bleeding (1.1%), gastric haemorrhage (0.6%), cerebral haemorrhage (0.3%) and lower gastrointestinal haemorrhage (0.3%).
Baseret på axitinibs farmakologiske egenskaber, kan axitinib være fosterskadende. 
Based on the pharmacological properties of axitinib, it may cause foetal harm when administered to a pregnant woman.
Meget almindelig Hypotyreose Almindelig 
Very common Hypothyroidismc Common
Ketoconazol, en potent hæmmer af CYP3A4/5, administreret i doser på 400 mg 1 gang dagligt i 7 dage, øgede middelarealet under kurven (AUC) 2 gange og Cmax 1,5 gange i forhold til 1 enkelt oral dosis på 5 mg hos raske forsøgspersoner. 
Ketoconazole, a strong inhibitor of CYP3A4/5, administered at a dose of 400 mg once daily for 7 days, increased the mean area under the curve (AUC) 2-fold and Cmax 1.5-fold of a single 5-mg oral dose of axitinib in healthy volunteers.
Axitinib metaboliseres primært i leveren af CYP3A4/5 og i mindre grad af CYP1A2, CYP2C19 og UGT1A1. 
Axitinib is metabolised primarily in the liver by CYP3A4/5 and to a lesser extent by CYP1A2, CYP2C19, and UGT1A1.
Det er vigtigt, at blodtrykket bliver målt inden behandlingen startes og regelmæssigt under behandlingen. 
It is important to check your blood pressure before you take this medicine, and regularly while you are taking it.
Inlyta er medicin, der bruges til behandling af fremskreden nyrekræft (fremskreden renalcellekræft) hos voksne, når anden medicin mod kræft (sunitinib eller et cytokin) ikke virker længere. 
Inlyta is indicated for the treatment of advanced kidney cancer (advanced renal cell carcinoma) in adults, when another medicine (called sunitinib or a cytokine) is no longer stopping disease from progressing.
Bivirkninger med samme hyppighed er angivet i faldende orden indenfor hver organklasse. 
Within each system organ class, adverse reactions with the same frequency are presented in order of decreasing seriousness.
Farmakokinetiske populationsundersøgelser har vist, at axitinib-clearance ikke er påvirket hos patienter med nedsat nyrefunktion. 
Population pharmacokinetic analyses have shown that axitinib clearance was not altered in subjects with renal impairment and no dose adjustment of axitinib is required.
En risiko-ratio >1 indikerer større sandsynlighed for response i axitinib-armen; En risiko-ratio <1 indikerer større sandsynlighed for response i sorafenib-armen. 
A risk ratio > 1 indicated a higher likelihood of responding in the axitinib arm; a risk ratio < 1 indicated a higher likelihood of responding in the sorafenib arm. g One-sided p-value from Cochran-Mantel-Haenszel test of treatment stratified by ECOG performance status and prior therapy.
Én-sidet p-værdi fra en log-rank test af behandling stratificeret efter ECOG performance status og tidligere behandling. 
c One-sided p-value from a log-rank test of treatment stratified by ECOG performance status and prior therapy.
HDPE beholder med silicagel tørrekapsel og polypropylenlåg indeholdende 180 filmovertrukne tabletter. 
HDPE bottle with a silica gel desiccant and a polypropylene closure containing 180 film-coated tablets.
Akkumuleringen var mindre end det dobbelte ved indgift af 5 mg axitinib 2 gange dagligt sammenlignet med administration af 1 enkelt dosis. 
Dosing of axitinib at 5 mg twice daily resulted in less than two-fold accumulation compared to administration of a single dose.
Bivirkningerne er anført efter behandlingsrelateret hyppighed uanset årsag National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 Se beskrivelse af udvalgte bivirkninger i punktet herunder Dødelige tilfælde (Grad 5) er set 
b National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 c See Description of selected adverse reactions section.
Tidligere sunitinibbehandling 
Prior sunitinib treatment
Håndtering af hjertesvigt kan kræve midlertidig eller permanent afbrydelse af behandlingen og/eller dosisnedsættelse af axitinib. 
Management of cardiac failure events may require temporary interruption or permanent discontinuation and/or dose reduction of axitinib therapy.
Stigning i thyreoidea-stimulerende hormon (TSH) blev set som bivirkning hos 5,3% af patienterne i behandling med axitinib. 
Thyroid stimulating hormone (TSH) increased was reported as an adverse reaction in 5.3% of patients receiving axitinib.
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. 
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.
Inklusive akut myokardieinfarkt, emboli, myokardieinfarkt, retinalarterieokklusion og transitorisk cerebral iskæmi 
j Including acute myocardial infarction, embolism, myocardial infarction, retinal artery occlusion and transient ischaemic attack.
Disse fund blev set hos mus ved doser ca. 12 gange human-terapeutiske doser og hos hunde ved doser lavere end human-terapeutiske doser. 
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.
Én-sidet p-værdi fra Cochran-Mantel-Haenszel test af behandling stratificeret efter ECOG performance status og tidligere behandling. 
One-sided p-value from Cochran-Mantel-Haenszel test of treatment stratified by ECOG performance status.
Axitinib er ikke undersøgt hos patienter, som har haft arterielle tromboemboliske hændelser inden for de sidste 12 måneder. 
Axitinib has not been studied in patients who had an arterial embolic or thrombotic event within the previous 12 months.
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. 
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.
Inklusive Budd-Chiari's syndrom, dyb venetrombose, vena jugularis trombose, bækkenvenetrombose, lungeemboli, retinalveneokklusion, retinalvenetrombose, vena subclavia trombose, venøs trombose og trombose i ekstremitetvene 
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.
Selvom dosisjustering af axitinib ikke er undersøgt hos patienter i behandling med potente CYP3A4/5induktorer, anbefales det at øge axititinib dosis gradvist. 
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.
Fortæl altid lægen, apoteket eller sundhedspersonalet, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin. 
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.
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). 
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).
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. 
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.
Reversibel epifysedysplasi ses hos mus og hunde efter indgift af axitinib i mindst 1 måned med doser ca. seks gange human-terapeutiske doser. 
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.
Kontakt omgående læge eller skadestue. 
Get emergency help right away and call your doctor.
Skema 1 viser bivirkninger set i et poolet datasæt for 672 patienter med RCC behandlet med axitinib i kliniske studier (se pkt. 
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).