FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, pazopanib should be administered at least 1 hour before or 2 hours after a meal.
Danish: Derfor skal pazopanib administreres mindst 1 time før eller 2 timer efter et måltid.
English: Table 6 Overall efficacy results in STS by independent assessment (VEG110727)
Danish: Tabel 6 Samlede effektresultater for STS bedømt ved uafhængig vurdering (VEG110727)
English: Signs and symptoms may include: - severe stomach pain - nausea and/or vomiting - fever - development of a hole (perforation) in the stomach, intestine or bowel from which bloody or foul smelling pus is released
Danish: Tegn og symptomer kan omfatte: - alvorlige mavesmerter - kvalme og/eller opkastning - feber - udvikling af et hul (perforering) i mave, tyndtarm eller tyktarm, hvorfra blodigt eller uklart,
English: Co-administration of pazopanib with a CYP3A4, P-gp, and BCRP inhibitor, such as lapatinib, will result in an increase in plasma pazopanib concentrations.
Danish: Samtidig administration af pazopanib med en CYP3A4-, P-gp- og BCRP-hæmmer, f.eks. lapatinib, vil resultere i en stigning i plasmakoncentrationen af pazopanib.
English: Similar proportions of patients in each arm had prior nephrectomy (89% and 88% in the pazopanib and placebo arms, respectively) and/or prior radiotherapy (22% and 15% in the pazopanib and placebo arms, respectively.
Danish: Lige mange patienter i hver behandlingsarm havde tidligere gennemgået nefrektomi (hhv. 89 % og 88 % i pazopanib- og placebo-armen) og/eller strålebehandling (hhv. 22 % og 15 % i pazopanib- og placebo-armen).
English: Adipocytic sarcoma (all subtypes), all rhabdomyosarcoma that were not alveolar or pleomorphic, chondrosarcoma, osteosarcoma, Ewing tumours/primitive neuroectodermal tumours (PNET), GIST, dermofibromatosis sarcoma protuberans, inflammatory myofibroblastic sarcoma, malignant mesothelioma and mixed mesodermal tumours of the uterus.
Danish: Adipocytisk sarkom (alle undertyper), alle rabdomyosarkomer, som ikke var alveolære eller pleomorfe, kondrosarkom, osteosarkom, Ewing tumorer/primitive neuroektodermale tumorer (PNET), GIST, dermatofibrosarkoma protuberans, inflammatorisk myofibroblastisk sarkom, malignt mesoteliom og blandede mesodermale uterustumorer.
English: Votrient 400 mg film-coated tablets are capsule-shaped, white with “GS UHL” marked on one side.
Danish: Votrient 400 mg filmovertrukne tabletter er kapselformede og hvide med “GS UHL” trykt på den ene side.
English: Tell your doctor if any of these apply to you.
Danish: Fortæl det til lægen, hvis ovenstående gælder for dig.
English: Grade 4 n (%)
Danish: Grad 4 n (%)
English: The safe use of pazopanib during breast-feeding has not been established.
Danish: Sikkerheden ved brug af pazopanib under amning er ikke påvist.
English: Pazopanib did not cause genetic damage when tested in genotoxicity assays (Ames assay, human peripheral lymphocyte chromosome aberration assay and rat in vivo micronucleus).
Danish: I genotoksicitetsassays medførte pazopanib ingen genetiske skader ved testning (Ames-test, analyse af kromosomaberrationer i humane perifere lymfocytter og in vivo mikronukleus-assay hos rotter).
English: Grapefruit juice should be avoided during treatment with pazopanib (see section 4.5).
Danish: Grapefrugtjuice skal undgås under behandling med pazopanib (se pkt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Votrient in all subsets of the paediatric population in 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).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Votrient i alle undergrupper af den pædiatriske population ved behandling af nyre- og nyrebækkenkarcinom (eksklusive nefroblastom, nefroblastomatose, clear cell sarkom, mesoblastisk nefrom, medullært nyrekarcinom og rabdoid nyretumor) (se pkt.
English: In clinical studies with pazopanib, venous thromboembolic events including venous thrombosis and fatal pulmonary embolus have occurred.
Danish: I kliniske studier med pazopanib er der set venøse tromboemboliske hændelser, herunder venetrombose og letal lungeemboli.
English: ‘Other STS' subgroups
Danish: ‘Andre' undertyper af STS
English: Signs and symptoms of a hypertensive crisis may include: - severe chest pain - severe headache - blurred vision - confusion - nausea - vomiting - severe anxiety - shortness of breath - seizures (fits) - fainting
Danish: Tegn og symptomer på en hypertensiv krise kan omfatte: - alvorlige brystsmerter - alvorlig hovedpine - sløret syn - forvirring - kvalme - opkastning - alvorlig angst - stakåndethed - krampeanfald - besvimelse
English: Votrient can affect how well your heart pumps or can increase the likelihood of having a heart attack.
Danish: Nedsat hjertefunktion/hjertesvigt, hjerteanfald Votrient kan påvirke hvor godt dit hjerte pumper eller kan øge sandsynligheden for at få et hjerteanfald.
English: Possible serious side effects
Danish: Alvorlige bivirkninger
English: Other medicines and Votrient
Danish: Brug af anden medicin sammen med Votrient
English: If a patient receiving concomitant simvastatin develops ALT elevations, follow guidelines for pazopanib posology and discontinue simvastatin (see section 4.4).
Danish: Hvis en patient, der samtidig får simvastatin, får forhøjet ALAT-niveau, skal doseringsvejledningen for pazopanib følges og simvastatin seponeres (se pkt.
English: Fibroblastic (adult fibrosarcoma, myxofibrosarcoma, sclerosing epithelioid fibrosarcoma, malignant solitary fibrous tumours), so-called fibrohistiocytic (pleomorphic malignant fibrous histiocytoma [MFH], giant cell MFH, inflammatory MFH), leiomyosarcoma, malignant glomus tumours, skeletal muscles (pleomorphic and alveolar rhabdomyosarcoma), vascular (epithelioid hemangioendothelioma, angiosarcoma), uncertain differentiation (synovial, epithelioid, alveolar soft part, clear cell, desmoplastic small round cell, extra-renal rhabdoid, malignant mesenchymoma, PEComa, intimal sarcoma), malignant peripheral nerve sheath tumours, undifferentiated soft tissue sarcomas not otherwise specified (NOS) and other types of sarcoma (not listed as ineligible).
Danish: Fibroblastisk (modent fibrosarkom, myksofibrosarkom, skleroserende epiteloid fibrosarkom, maligne solitære fibrøse tumorer), såkaldt fibrohistiocytiske (pleomorfisk malignt fibrøst histiocytom [MFH], gigantcelle MFH, inflammatorisk MFH), leiomyosarkom, maligne glomus-tumorer, tværstribet muskulatur (pleomorf og alveolært rabdomyosarkom), vaskulær (epiteloid hæmangioendoteliom, angiosarkom), uvis differentiering (synovial, epiteloid, alveolært bløddels, clear cell, desmoplastisk small round cell, ekstra-renal rabdoid, malignt mesenkymom, PECom, intimal sarkom), maligne perifere nerveskede-tumorer, udifferentieret bløddelssarkom ikke specificeret andetsteds (NOS) og andre sarkomtyper (ikke angivet som uegnede).
English: Co-administration of pazopanib with potent P-gp or BCRP inducers may alter the exposure and distribution of pazopanib, including distribution into the CNS.
Danish: Samtidig administration af pazopanib med potente P-gp- eller BCRP-induktorer kan ændre eksponeringen for og fordelingen af pazopanib, herunder i CNS.
English: Signs and symptoms may include: - sharp chest pain - shortness of breath - rapid breathing - leg pain - swelling of your arms and hands or legs and feet
Danish: Tegn og symptomer kan omfatte: - stærke brystsmerter - stakåndethed - hurtig vejrtrækning - smerter i benene - hævelse af dine arme og hænder eller ben og fødder
English: No dose adjustment is required in patients with creatinine clearance above 30 ml/min.
Danish: Der kræves ingen dosisjustering til patienter med en kreatininclearance på over 30 ml/minut.
English: Arterial thrombotic events
Danish: Arterielle trombotiske hændelser
English: Serum liver tests should be performed before initiation of treatment with pazopanib, at weeks 3, 5, 7 and 9, then at months 3 and 4, with additional tests as clinically indicated.
Danish: Levertallene skal undersøges, inden behandling med pazopanib påbegyndes, ved uge 3, 5, 7 og 9.
English: Therefore, no dose adjustment is required in patients with creatinine clearance above 30 ml/min.
Danish: Der kræves derfor ingen dosisjustering ved behandling af patienter med en kreatininclearance på over 30 ml/minut.
English: Pharmacokinetic parameter comparisons of pazopanib Cmax (range of means 27.5 to 58.1 µg/ml) and AUC(0-24) (range of means 48.7 to 1040 µg*h/ml) after administration of pazopanib 800 mg alone and after administration of pazopanib 400 mg plus ketoconazole 400 mg (mean Cmax 59.2 µg/ml, mean AUC(0-24)1300 µg*h/ml) indicated that, in the presence of a strong CYP3A4 and P-gp inhibitor a dose reduction to pazopanib 400 mg once daily will, in the majority of patients, result in systemic exposure similar to that observed after administration of 800 mg pazopanib once daily alone.
Danish: Sammenligning af de farmakokinetiske parametre af pazopanib Cmax (interval for middelværdier 27,5 til 58,1 µg/ml) og AUC(0-24) (interval for middelværdier 48,7 til 1040 µg∙time/ml) efter administration af pazopanib 800 mg alene og efter administration af pazopanib 400 mg plus ketoconazol 400 mg (middelværdi for Cmax 59,2 µg/ml og middelværdi for AUC(0-24)1300 µg∙time/ml) indikerer, at ved tilstedeværelse af en kraftig CYP3A4- og P-gp-hæmmer vil reduktion af pazopanibdosis til 400 mg én gang daglig hos størstedelen af patienterne resultere i en systemisk eksponering svarende til den, der er observeret efter administration af 800 mg pazopanib én gang daglig alene.
English: Venous thromboembolic events
Danish: Venøse tromboemboliske hændelser
English: Therefore, activity of pazopanib is mainly dependent on parent pazopanib exposure.
Danish: Derfor afhænger pazopanibs aktivitet primært af pazopanib-eksponeringen og ikke af metabolitterne.
English: 800 mg pazopanib once daily is the recommended dose in patients with mild abnormalities of serum liver tests (see section 4.2).
Danish: 800 mg pazopanib én gang daglig er den anbefalede dosis til patienter med let afvigende leverfunktionsprøver målt i serum (se pkt.
English: Signs and symptoms include: - irregular or fast heartbeat - rapid fluttering of your heart - fainting - chest pain or pressure - pain in your arms, back, neck or jaw - shortness of breath - leg swelling
Danish: Tegn og symptomer omfatter: - uregelmæssige eller hurtige hjerteslag - hurtig hjerteflakken - besvimelse - smerter i eller trykken for brystet - smerter i dine arme, ryg, hals eller kæbe - stakåndethed - hævelse i benet
English: Caution is advised in patients with creatinine clearance below 30 ml/min as there is no experience of pazopanib in this patient population (see section 4.2).
Danish: Der skal udvises forsigtighed ved anvendelse til patienter med en kreatininclearance på under 30 ml/minut, da der ikke er erfaring med anvendelse af pazopanib hos denne patientpopulation (se pkt.
English: Grade 3 n (%)
Danish: Grad 3 n (%)
English: Symptoms include: - passing blood in the stools or passing black stools - passing blood in the urine - stomach pain - coughing or vomiting up blood
Danish: Symptomerne omfatter: - blod i afføringen eller sort afføring - blod i urinen - mavesmerter - ophostning eller opkastning af blod
English: Patients developing PRES/RPLS should permanently discontinue treatment with pazopanib.
Danish: Patienter, som udvikler PRES/RPLS, skal seponere pazopanib permanent.
English: If pazopanib is used during pregnancy, or if the patient becomes pregnant while receiving pazopanib, the potential hazard to the foetus should be explained to the patient.
Danish: Hvis pazopanib anvendes under graviditet, eller hvis patienten bliver gravid under behandlingen med pazopanib, skal patienten have oplyst den potentielle risiko for fosteret.
English: “Other STS” subgroups*
Danish: “Andre” undertyper af STS*
English: Results from in vitro studies demonstrated that metabolism of pazopanib is mediated primarily by CYP3A4, with minor contributions from CYP1A2 and CYP2C8.
Danish: Resultater fra in vitro-forsøg viste, at metaboliseringen af pazopanib primært medieres af CYP3A4, mens CYP1A2 og CYP2C8 spiller en mindre rolle.
English: Other important serious adverse reactions identified in STS studies included venous thromboembolic events, left ventricular dysfunction and pneumothorax.
Danish: Andre alvorlige bivirkninger identificeret i STS-studierne omfatter venøse tromboemboliske bivirkninger, påvirkning af funktionen af venstre ventrikel og pneumothorax.
English: Capsule-shaped, white, film-coated tablet with GS UHL debossed on one side.
Danish: Kapselformet, hvid, filmovertrukken tablet med GS UHL præget på den ene side.
English: How to take Votrient
Danish: Sådan skal du tage Votrient
English: CYP3A4 inducers such as rifampin may decrease plasma pazopanib concentrations.
Danish: CYP3A4-induktorer, f.eks. rifampin, kan nedsætte plasmakoncentrationen af pazopanib.
English: The most common adverse reactions (experienced by at least 10% of the patients) of any grade in the RCC and STS trials included: diarrhoea, hair colour change, skin hypopigmentation, exfoliative rash, hypertension, nausea, headache, fatigue, anorexia, vomiting, dysgeusia, stomatitis, weight decreased, pain, elevated alanine aminotransferase and elevated aspartate aminotransferase.
Danish: De mest almindelige bivirkninger (forekom hos mindst 10 % af patienterne) i RCC- og STS-studierne omfattede: diarré, ændringer i hårfarve, hypopigmentering af huden, eksfoliativt udslæt, hypertension, kvalme, hovedpine, træthed, nedsat appetit, opkastning, dysgeusi, stomatitis, vægttab, smerte samt forhøjet ALAT- og ASAT-niveauer.
English: Pazopanib is eliminated slowly with a mean half-life of 30.9 hours after administration of the recommended dose of 800 mg.
Danish: Pazopanib elimineres langsomt med en gennemsnitlig halveringstid på 30,9 timer efter administration af den anbefalede dosis på 800 mg. Pazopanib elimineres primært via fæces og <4 % elimineres via nyrerne.
English: Administration of 1500 mg lapatinib (a substrate for and weak inhibitor of CYP3A4 and P-gp and a potent inhibitor of BCRP) with 800 mg pazopanib resulted in an approximately 50% to 60% increase in mean pazopanib AUC(0-24) and Cmax compared to administration of 800 mg pazopanib alone.
Danish: Administration af 1500 mg lapatinib (et substrat for og en svag hæmmer af CYP3A4- og P-gp samt en potent hæmmer af BCRP) sammen med 800 mg pazopanib resulterede i en ca. 50 % til 60 % stigning i middelværdien af henholdsvis AUC(0-24) og Cmax af pazopanib sammenlignet med administration af 800 mg pazopanib alene.
English: United Kingdom
Danish: Storbrittannien
English: Renal impairment is unlikely to have a clinically relevant effect on pazopanib pharmacokinetics given the low renal excretion of pazopanib and metabolites (see section 5.2).
Danish: Det er usandsynligt, at nedsat nyrefunktion påvirker pazopanibs farmakokinetik i klinisk relevant grad, da den renale udskillelse af pazopanib, og metabolitter heraf, er lille (se pkt.
English: Venous thromboembolic event, deep vein thrombosis, pulmonary embolism and thrombosis
Danish: Venøs tromboembolisk bivirkning, dyb venetrombose, lungeemboli og trombose
English: - heart becomes less effective at pumping blood around the body (cardiac dysfunction) - slow heart beat - bleeding in the mouth, rectum or lung - dizziness - blurred vision - hot flushes - swelling caused by fluid of face, hands, ankles, feet or eyelids - tingling, weakness or numbness of the hands, arms, legs or feet - skin disorders, redness, itching, dry skin - nail disorders - burning, prickling, itching or tingling skin sensation - sensation of coldness, with shivering - excessive sweating - dehydration - muscle, joint, tendon or chest pain, muscle spasms - hoarseness - shortness of breath - cough - coughing up blood - hiccups - collapsed lung with air trapped in the space between the lung and chest, often causing shortness of breath (pneumothorax)
Danish: - hjertet er mindre effektivt til at pumpe blod rundt i kroppen (kardiel dysfunktion) - langsomme hjerteslag - blødning i munden, fra endetarmen eller i lungerne - svimmelhed - uklart syn - hedeture - hævelse på grund af væskeophobning i ansigt, hænder, ankler, fødder eller øjenlåg - prikken, svaghed eller følelsesløshed i hænder, arme, ben eller fødder - hudlidelse, rødme, kløe, tør hud - neglelidelser - brændende, prikkende, kløende eller snurrende følelse i huden - kuldefølelse med kulderystelser - udtalt svedtendens - væskemangel (dehydrering) - muskel-, led- eller senesmerter eller smerter i brystet, muskelkramper - hæshed - åndenød - hoste - ophostning af blod - hikke - punkteret lunge, hvor luften bliver fanget mellem lungen og brystet, hvilket ofte forårsager åndenød (pneumothorax)
English: In vitro, pazopanib inhibited human organic anion transporting polypeptide (OATP1B1).
Danish: In vitro hæmmede pazopanib polypeptidet OATP1B1, der er en human, organisk anion-transporter.
English: Votrient can, on rare occasions, cause lung inflammation (interstitial lung disease, pneumonitis), which in some people can be fatal.
Danish: Betændelseslignende reaktion (inflammation) i lungerne Votrient kan, i sjældne tilfælde, give inflammation i lungerne (interstitiel lungesygdom, betændelseslignende reaktion), som hos nogle patienter kan være dødelig.
English: See Table 1 for dose modification guidance for patients with baseline values of total bilirubin 1.5 x ULN and AST and ALT 2 x ULN:
Danish: Se tabel 1 for retningslinjer for dosisreduktion hos patienter med total-bilirubin ≤1,5 gang den øvre normalgrænse og ASAT og ALAT ≤2 gange den øvre normalgrænse ved baseline:
English: Uncommon Mucosal inflammation e
Danish: Slimhindeinflammation e
English: - increase in the number of red blood cells - sudden shortness of breath, especially when accompanied with sharp pain in the chest and /or rapid breathing (pulmonary embolism) - severe bleeding in the digestive system (such as stomach, oesophagus or intestine), or the kidneys, vagina and brain - heart rhythm disturbance (QT prolongation) - hole (perforation) in stomach or intestine - abnormal passages forming between parts of the intestine (fistula) - heavy or irregular menstrual periods - sudden sharp increase in blood pressure (hypertensive crisis) - inflammation of the pancreas (pancreatitis) - liver inflamed, not working well or damaged - yellowing of the skin or whites of the eyes (jaundice) - inflammation of the lining of the abdominal cavity (peritonitis) - runny nose - rashes which may be itchy or inflamed (flat or raised spots or blisters) - frequent bowel movements - increased sensitivity of the skin to sunlight - decreased feeling or sensitivity, especially in the skin
Danish: - forhøjet antal røde blodlegemer - pludselig åndenød, især når den er ledsaget af en skarp smerte i brystet og/eller hurtig vejrtrækning (lungeemboli) - alvorlig blødning i fordøjelsessystemet (f.eks. maven, spiserøret eller tarmen) eller i nyrerne, vagina og hjernen - forstyrrelse af hjerterytmen (QT-forlængelse) - hul (perforation) i maven eller tarmen - dannelse af unormale passager mellem dele af tarmen (fistler) - voldsom eller uregelmæssig menstruation - pludselig markant øgning af blodtrykket (hypertensiv krise) - betændelse i bugspytkirtlen (pankreatitis) - leverbetændelse, dårlig funktion af leveren eller leverskade - gulfarvning af huden eller det hvide i øjnene (gulsot) - bughindebetændelse (peritonitis) - løbende næse - udslæt, der kan være kløende eller betændt (flade eller hævede områder eller blærer) - hyppig afføring - øget følsomhed af huden over for sollys - nedsat følelse eller følsomhed, specielt i huden
English: Fatal events have been observed.
Danish: Der er set hændelser med dødelig udgang.
English: No formal studies of the effect of pazopanib on wound healing have been conducted.
Danish: Der er ikke udført studier, hvor pazopanibs effekt på sårheling er blevet undersøgt.
English: Selection of alternative concomitant medicinal products with no or minimal potential to inhibit CYP3A4, P-gp or BCRP should be considered.
Danish: Det anbefales i stedet, at kombinere pazopanib med lægemidler uden eller med minimal hæmning af CYP3A4, P-gp eller BCRP.
English: How much to take
Danish: Hvor meget Votrient skal tages
English: Palmar-plantar erythrodysaesthesia syndrome
Danish: Palmoplantar erytrodysæstesisyndrom (hånd-fod-syndrom)
English: HR (95% CI)
Danish: HR (95 % konfidensinterval)
English: Pazopanib should be used with caution in patients with significant risk of haemorrhage.
Danish: Pazopanib skal anvendes med forsigtighed til patienter med en signifikant blødningsrisiko.
English: Pazopanib should be discontinued in patients with wound dehiscence.
Danish: Pazopanib skal seponeres hos patienter med sårruptur.
English: Synovial sarcoma subgroups* N = 25
Danish: Undertyper af synovialsarkom n = 25
English: Importantly, only patients with selective histological subtypes of STS were allowed to participate to the study, therefore efficacy and safety of pazopanib can only be considered established for those subgroups of STS and treatment with pazopanib should be restricted to such STS subtypes.
Danish: Derfor kan pazopanibs virkning og sikkerhed kun betragtes fastsat for disse undertyper af STS, og behandling med pazopanib bør begrænses til sådanne STS-undertyper.
English: Very common Decreased appetite e
Danish: Nedsat appetit e
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with pazopanib (see section 4.6).
Danish: Kvinder i den fertile alder frarådes at blive gravide, mens de er i behandling med pazopanib (se pkt.
English: Pazopanib is a UGT1A1 inhibitor.
Danish: Pazopanib hæmmer UGT1A1.
English: In a rat male fertility study, there was no effect on mating or fertility, but decreased testicular and epididymal weights were noted with reductions in sperm production rates, sperm motility, and epididymal and testicular sperm concentrations observed at exposures 0.3 times human exposure based on AUC.
Danish: Der blev dog observeret en nedsat vægt af testikler og bitestikler samt en nedsat spermproduktionsrate, spermmotilitet og spermkoncentration i testiklerne og bitestiklerne ved eksponeringer på 0,3 gange den humane eksponering (baseret på AUC).
English: Each film-coated tablet contains 400 mg pazopanib (as hydrochloride).
Danish: Hver filmovertrukken tablet indeholder 400 mg pazopanib (som hydrochlorid).
English: Symptoms include: - loss of speech - change of vision - seizure (fits) - confusion - high blood pressure
Danish: Symptomerne kan være: - tab af taleevne - synsændringer - krampeanfald - forvirring - højt blodtryk
English: % (95% CI)
Danish: % (95 % konfidensinterval)
English: HR = hazard ratio; PFS = progression-free survival;
Danish: HR = hazard ratio; PFS = progressionsfri overlevelse; a P-værdi = 0,245 (2-sidet).
English: Uncommon Blood bilirubin increased
Danish: Forhøjet bilirubin i blodet ASAT
English: Common Alopecia Skin disorder c
Danish: Eksfoliativt udslæt Almindelig Alopeci Hudlidelse c
English: Blood glucose decreased
Danish: Fald i glucose-niveau i blodet
English: Selection of an alternative concomitant medication with no or minimal enzyme or transporter induction potential is recommended.
Danish: Det anbefales derfor i stedet at kombinere pazopanib med et lægemiddel som ikke eller kun minimalt medfører enzym- eller transporter-induktion.
English: Decreased corpora lutea, increased cysts and ovarian atrophy have also been noted in rodents.
Danish: Hos gnavere er der også set et nedsat antal corpora lutea, flere cyster og ovarieatrofi.