FrancophonIA/ELRC3.0 huggingface dataset:
English: Tavanic solution for infusion is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1):
Danish: Tavanic, infusionsvæske, 5 mg/ml Tavanic, infusionsvæske, er indiceret til behandling af følgende infektioner hos voksne (se afsnit 4.4 og
English: Due to the combination of the MRP and National granted MAs some divergent information has been identified in the product information (PI) for Tavanic.
Danish: I produktinformationen for Tavanic er konstateret visse divergenser, som er fremkommet ved kombinationen af den gensidige anerkendelsesprocedure og de nationalt udstedte markedsføringstilladelser.
English: Respiratory Tract Infections (RTIs)
Danish: Luftvejsinfektioner
English: Acute bacterial sinusitis (ABS)
Danish: Akut bakteriel sinuitis
English: Package Leaflet (PL)
Danish: Indlægsseddel
English: Based on the current available data, considering the current treatment guidelines and also taking into account the current SmPC wording for other fluororoquinolones products with regards this indication, the MAH proposed the following restricted wording:
Danish: Indehaveren af markedsføringstilladelsen foreslog følgende begrænsede ordlyd, der er baseret på de foreliggende data og tager hensyn til gældende behandlingsretningslinjer og ordlyden af denne indikation i de gældende produktresuméer for andre fluorquinolon-produkter:
English: • CAP (tablets and IV solution): 500 mg once or twice daily for 7 - 14 days;
Danish: • Samfundserhvervet pneumoni (tabletter og i.v.-opløsning): 500 mg én eller to gange dagligt i 7
English: Urinary tract infections (UTIs)
Danish: Urinvejsinfektioner
English: • cSSTIs (IV solution): 500 mg twice daily;
Danish: • Komplicerede infektioner i hud og underliggende væv (i.v.-opløsning): 500 mg to gange dagligt
English: • cSSTIs (tablets): 250mg once daily or 500 mg once or twice daily for 7 to 14 days;
Danish: 500 mg én eller to gange dagligt i 7-14 dage
English: Film-coated tablet Oral use blister (PVC/PE/PCTFE/Alu)
Danish: Oral anvendelse blisterfolie (PVC/PE/PCTFE/Alu)
English: 56 (4x14) tablets (multipack)
Danish: 56 (4x14) tabletter (multipakni ng)
English: EMA Number
Danish: EMA's procedurenr MF (EU)-nummer
English: Immediate Packaging Pack size
Danish: Filmovertrukket tablet
English: - 5.0 µg in 0.5 ml.
Danish: i 0,5 ml.
English: Suspension for injection Intramuscular use vial (glass)
Danish: Injektionsvæske, suspension Intramuskulær anvendelse Hætteglas (glas)
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging
Danish: Særnavn Styrke Lægemiddelform
English: Polyribosylribitol phosphate (PRP) from Haemophilus influenzae type b as PRP-OMPC -7.5 µg Neisseria meningitidis OMPC (outer membrane protein complex of the B11 strain of Neisseria meningitidis subgroup B) - 125 µg Adsorbed hepatitis B surface antigen produced in recombinant yeast cells(Saccharomyces cerevisiae)
Danish: Neisseria meningitidis OMPC (ydermembran-proteinkompleks fra stammen B11 af Neisseria meningitidis, undergruppe B)
English: This schedule is repeated in cycles of 4 weeks.
Danish: Denne tidsplan gentages i cyklusser på 4 uger.
English: It was reported as serious in one patient.
Danish: Den blev rapporteret som alvorlig hos én patient.
English: The following terms have been combined:
Danish: Følgende termer er blevet sammenfattet:
English: • Do not take Fotivda if you are pregnant.
Danish: • Tag ikke Fotivda, hvis du er gravid.
English: • Both you and your partner must use effective contraception.
Danish: • Både dig selv og din partner skal bruge en effektiv prævention.
English: In the ITT population there was a small numerical difference between the two arms in terms of overall survival.
Danish: I ITT populationen var der en lille numerisk forskel mellem de to arme, hvad angår den samlede overlevelse.
English: There was no effect of food on the overall exposure (AUC).
Danish: Der var ingen effekt af mad på den samlede eksponering (AUC).
English: 7 days (1 week)
Danish: 7 dage (1 uge)
English: 21 days (three weeks)
Danish: 21 dage (tre uger)
English: Do not take Fotivda:
Danish: Tag ikke Fotivda:
English: • if you need to have an operation or another form of surgery
Danish: • Hvis du har behov for at gennemgå en operation eller en anden form for kirurgi
English: The next dose should be taken at the next scheduled time.
Danish: Den næste dosis bør tages på det næste planlagte tidspunkt.
English: Each pack contains 1 bottle.
Danish: Hver pakning indeholder 1 beholder.
English: No more than one dose of Fotivda must be taken per day.
Danish: Der må ikke tages mere end én dosis Fotivda pr. dag.
English: Do not give Fotivda to children and adolescents under 18 years of age.
Danish: Giv ikke Fotivda til børn og unge under 18 år.
English: If you stop taking the capsules your condition may get worse.
Danish: Hvis du holder op med at tage kapslerne, kan din tilstand blive forværret.
English: This treatment schedule should be continued until disease progression or unacceptable toxicity.
Danish: Dette behandlingsskema skal fortsættes indtil sygdomsprogression eller uacceptabel toksicitet.
English: Fotivda may work less well when taken with some medicines.
Danish: Fotivda kan fungere mindre godt, når det tages sammen med visse lægemidler.
English: • Taste changes or loss of taste.
Danish: • Ændring eller tab af smag.
English: • if laboratory tests show that there is protein in your urine Your doctor will monitor this at the beginning and during your treatment.
Danish: • Hvis laboratorietest viser, at der findes protein i din urin Din læge vil overvåge det i begyndelsen og i løbet af din behandling.
English: • Blocked ears.
Danish: • Tilstoppede ører.
English: It is used where other treatments such as interferon-alpha or interleukin-2 have either not yet been used or have not helped to stop your disease.
Danish: Det bruges, hvor andre behandlinger som f.eks. interferon-alfa eller interleukin-2 enten endnu ikke er blevet brugt eller ikke har hjulpet med at standse din sygdom.
English: This medicine has not been studied in children and adolescents.
Danish: Denne medicin er ikke blevet undersøgt hos børn og unge.
English: High blood pressure is the most serious and a very common side effect (see also in section 2 “Warnings and Precautions”).
Danish: Højt blodtryk er den mest alvorlige og en meget almindelig bivirkning (se også under punkt 2 “Advarsler og forsigtighedsregler”).
English: This includes herbal medicines and other medicines you have bought without a prescription.
Danish: Dette omfatter naturlægemidler og anden medicin, som du har købt uden recept.
English: The capsules must be swallowed whole with a glass of water and must not be opened.
Danish: Kapslerne skal sluges hele med et glas vand og må ikke åbnes.
English: Do not stop taking this medicine unless your doctor tells you to.
Danish: Hold ikke op med at tage dette lægemiddel, med mindre din læge beder dig om det.
English: Fotivda must be taken with a glass of water and can be taken either with or without food.
Danish: Fotivda skal tages med et glas vand og kan tages med eller uden mad.
English: Tell your doctor immediately if you think you have high blood pressure.
Danish: Fortæl det straks til din læge, hvis du tror, at du har højt blodtryk.
English: • Increased amount of protein in the urine.
Danish: • Øget mængde protein i urin.
English: Treatment with Fotivda may need to be temporarily stopped.
Danish: Det kan være nødvendigt at standse behandlingen med Fotivda midlertidigt.
English: The majority of AST and ALT elevations were not accompanied with concomitant elevations of bilirubin.
Danish: De fleste forhøjelser af AST og ALT var ikke ledsaget af samtidig forhøjelse af bilirubin.
English: One patient experienced Grade 4 PRES and hypertension in Study AV-951-09-901.
Danish: En patient oplevede Grad 4 PRES og hypertension i Studie AV-951-09-901.
English: ALT increased / AST increased21
Danish: Forhøjet ALT / Forhøjet AST 21
English: Tell your doctor if you are taking any of the following medicines; they may decide to change your medication:
Danish: Fortæl det til din læge, hvis du tager en af følgende mediciner; han/hun kan beslutte at ændre din behandling:
English: The most important serious adverse reaction is hypertension.
Danish: Den vigtigste alvorlige bivirkning er hypertension.
English: Hypothyroidism should be treated according to standard medical practice.
Danish: Hypothyreoidisme bør behandles i henhold til standard medicinsk praksis.
English: Study AV-951-09-301
Danish: Studie AV-951-09-301
English: • Sight problems including blurred vision.
Danish: • Synsproblemer, som omfatter sløret syn.
English: Fotivda can increase your blood pressure.
Danish: Fotivda kan øge dit blodtryk.
English: Tell your doctor who will discuss with you the risks of taking Fotivda to you and your child.
Danish: Fortæl det til din læge, som vil forklare dig risikoen ved at tage Fotivda for dig og dit barn.
English: • Increase in number of red blood cells.
Danish: • Forhøjet antal røde blodlegemer.
English: • nafcillin, rifampicin, rifabutin, rifapentin (antibiotics);
Danish: • nafcillin, rifampicin, rifabutin, rifapentin (antibiotika);
English: Blocking the action of VEGF prevents the formation of new blood vessels.
Danish: Blokeringen af VEGF's handling forebygger dannelsen af nye blodkar.
English: Average Cmax and AUC0-24hr were not significantly affected (8% increase and 6% decrease respectively).
Danish: Gennemsnitlig Cmax og AUC0-24hr blev ikke signifikant påvirket (henholdsvis en øgning på 8% og en mindskning på 6%).
English: • if you have problems with your liver.
Danish: • Hvis du har problemer med din lever.
English: Tell your doctor right away as these may be symptoms of heart failure.
Danish: Fortæl det straks til din læge, da det kan være symptomer på hjertesvigt.
English: Tivozanib should not be used during pregnancy.
Danish: Tivozanib bør ikke bruges under graviditet.
English: Fotivda should be supervised by a physician experienced in the use of anticancer therapies.
Danish: Fotivda bør overvåges af en læge med erfaring i anvendelse af anticancer-terapier.
English: Avoid driving or using machines if you feel weak, tired, or dizzy.
Danish: Undgå at føre motorkøretøjer eller betjene maskiner, hvis du føler dig svag, træt eller svimmel.
English: Your doctor will check you regularly, and you will normally continue to take Fotivda as long as it is working, and you do not suffer unacceptable side effects.
Danish: Din læge vil kontrollere dig jævnligt, og du vil normalt fortsætte med at tage Fotivda, så længe det fungerer og du ikke lider af uacceptable bivirkninger.
English: • if you have high blood pressure.
Danish: • Hvis du har højt blodtryk.
English: No capsules are taken
Danish: Tag ingen kapsler
English: In approximately one-third of the patients, hypertension developed within the first 2 months of treatment.
Danish: Omkring en tredjedel af patienterne havde udviklet hypertension i løbet af de 2 første behandlingsmåneder.
English: It works by blocking the action of a protein called vascular endothelial growth factor (VEGF).
Danish: Det fungerer ved at blokere handlingen af et protein kaldet vaskulær endotelial vækstfaktor (VEGF).
English: The safety and efficacy of tivozanib in children and adolescents aged below 18 years have not been established.
Danish: Sikkerhed og virkning af tivozanib hos børn og unge under 18 år er ikke klarlagt.
English: • Do not breast-feed during treatment with Fotivda, as it is not known whether the active ingredient in Fotivda passes into breast-milk.
Danish: • Du må ikke amme dit barn i løbet af behandlingen med Fotivda, da det ikke vides, om det aktive stof i Fotivda passerer over i modermælken.
English: CYP and UGT in vitro studies
Danish: CYP og UGT in vitro studier
English: • Temporary reduced blood flow to the brain.
Danish: • Midlertidig reduceret blodstrømning til hjernen.
English: There is no specific treatment or antidote for tivozanib overdose.
Danish: Der findes ingen specifik behandling eller modgift for overdosering med tivozanib.
English: Do not take a double dose to make up for a forgotten capsule.
Danish: Tag ikke en dobbelt dosis for at opveje en glemt kapsel.
English: These are all symptoms of high blood pressure.
Danish: De er alle symptomer på højt blodtryk.
English: • If you are allergic to tivozanib or any of the other ingredients of this medicine (listed in section 6);
Danish: • Hvis du er allergisk over for tivozanib eller et af de øvrige indholdsstoffer i tivozanib (angivet i punkt 6);
English: QT/QTc interval prolongation may lead to an increased risk for ventricular arrhythmias.
Danish: Forlængelse af QT/QTc-interval kan føre til en øget risiko for ventrikulær arytmi.
English: One Fotivda capsule taken once daily
Danish: Tag én Fotivda kapsel én gang om dagen
English: • Abnormal electrocardiogram (ECG), rapid and/or irregular heart beat.
Danish: • Unormalt elektrokardiogram (EKG), hurtig og/eller uregelmæssig hjerterytme.
English: If you or your partner are taking hormonal contraceptives (the pill, an implant or patch) you must use an additional barrier method throughout treatment and for another month after completing treatment.
Danish: Hvis du eller din partner tager en hormonal prævention (p-pille, implantat eller patch), skal du bruge en ekstra barrieremetode i hele behandlingen og i endnu en måned efter at have fuldendt behandlingen.
English: Contains tartrazine.
Danish: Indeholder tartrazin.
English: Risk factors for proteinuria include high blood pressure.
Danish: Risikofaktorer for proteinuri omfatter højt blodtryk.
English: Mild to severe hypertension may be present.
Danish: Mild til svær hypertension kan være til stede.
English: Transporter in vitro studies
Danish: Transportør in vitro studier
English: • Tiredness and lack of energy.
Danish: • Rygsmerter • Træthed og mangel på energi.
English: • Talk to your doctor when planning a baby, as Fotivda may affect the fertility of men and women.
Danish: • Fortæl det til din læge, hvis du planlægger at blive gravid, da Fotivda kan indvirke på mænd og kvinders frugtbarhed.
English: Do not chew, dissolve or open the capsule before swallowing.
Danish: Kapslen skal ikke tygges, opløses eller åbnes, før den sluges.
English: Tell your doctor straightaway if you have taken more than your prescribed dose of 1 capsule per day.
Danish: Fortæl det straks til din læge, hvis du har taget mere end den ordinerede dosis på 1 kapsel pr. dag.
English: One patient died as a result of uncontrolled hypertension in the setting of a suspected overdose.
Danish: En patient døde på grund af ukontrolleret hypertension inden for rammerne af en mistænkt overdosering.
English: 21 hard capsules.
Danish: 21 hårde kapsler.
English: In studies that evaluated the terminal elimination phase, tivozanib had a mean t½ of 4.5 - 5.1 days.
Danish: I studier med evaluering af den terminale eliminationsfase havde tivozanib en gennemsnitlig t½ på 4,5 - 5,1 dage.
English: Following oral administration of tivozanib, peak serum levels are achieved after approximately 2 to 24 hours.
Danish: Efter oral administration af tivozanib blev de maksimale serumniveauer nået efter omkring 2 til 24 timer.
English: See also Section 4 “Possible side effects”.
Danish: Se også punkt 4 “Bivirkninger”.
English: There are no data from the use of tivozanib in pregnant women.
Danish: Der foreligger ingen data om brugen af tivozanib hos gravide kvinder.
English: • rosuvastatin (a medicine used to help lower cholesterol levels in your blood);
Danish: • rosuvastatin (en medicin, der bruges til at hjælpe med at sænke kolesterolindholdet i dit blod);
English: In the pivotal study, the dose was reduced for grade 3 events and interrupted for grade 4 events.
Danish: I det pivotale studie blev dosis reduceret for grad 3 hændelser og afbrudt for grad 4 hændelser.
English: In vitro protein binding studies have shown that tivozanib is > 99% bound to plasma proteins.
Danish: In vitro proteinbindingsstudier har vist, at tivozanib er > 99% bundet til plasmaproteiner.
English: Accumulation at steady-state is approximately 6- to 7- fold the exposure observed at single-dose levels.
Danish: Akkumulering ved stationær tilstand er cirka 6 til 7 gange den observerede eksponering ved enkeltdosis-niveauer.
English: After a single dose oral dose of [14C] tivozanib, approximately 79% of the radioactivity was recovered in the faeces and approximately 12% was found in the urine as metabolites.
Danish: Efter en enkelt oral dosis af [14C] tivozanib, var omkring 79% af radioaktiviteten genfundet i fæces og omkring 12% blev fundet i urin som metabolitter.
English: Taking with food and drink
Danish: Indtagning sammen med mad og drikke
English: • dexamethasone (a corticosteroid to reduce inflammation and treat disorders of the immune system);
Danish: • dexamethason (en kortikosteroid for at reducere inflammation og behandle forstyrrelser af immunsystemet);
English: The intent-to-treat (ITT) population included 517 patients, 260 randomised to tivozanib and 257 randomised to sorafenib.
Danish: Intent-to-treat (ITT) populationen omfattede 517 patienter, 260 randomiseret til tivozanib og 257 randomiseret til sorafenib.
English: Female partners of male patients taking tivozanib should also avoid pregnancy.
Danish: Kvindelige partnere til mandlige patienter, som tager tivozanib, bør ligeledes undgå at blive gravide.
English: The active substance is tivozanib.
Danish: Det aktive stof er tivozanib.
English: Taking too much Fotivda makes side effects more likely or to become more severe, especially high blood pressure.
Danish: Når man tager for meget Fotivda, er der større sandsynligvis for at få bivirkninger, eller at de er alvorlige, især højt blodtryk.
English: P-value (Log rank test)
Danish: P-værdi (Logrank test)
English: If any bleeding requires medical intervention, tivozanib should be temporarily interrupted.
Danish: Hvis en blødning kræver et medicinsk indgreb, bør tivozanib afbrydes midlertidigt.
English: The other ingredients are: - Capsule content: mannitol, magnesium stearate.
Danish: De øvrige indholdsstoffer er: - Kapselindhold: mannitol, magnesiumstearat.
English: Healthcare professions should be aware that elderly patients may be at increased risk of adverse reactions.
Danish: Sundhedspersonalet bør være opmærksomt på, at ældre patienter kan have en øget risiko for at få bivirkninger.
English: It is unknown whether tivozanib is excreted in human milk, but the potential exists.
Danish: Det vides ikke, om tivozanib udskilles i modermælk, men muligheden findes.
English: Albumin is the major tivozanib binding component in human plasma.
Danish: Albumin er den vigtigste tivozanib-bindingskomponent i humant plasma.
English: Decreased appetite
Danish: Manglende appetit
English: Palmar-plantar erythrodysaesthesia syndrome / Hand foot skin reaction (PPE/HFS)
Danish: Palmar-plantar erythrodysæstesi syndrome / Håndfod hudreaktion (PPE/HFS)
English: Epistaxis Rhinorrhoea Nasal congestion
Danish: Epistaxis Rhinorrhoea Nasal kongestion
English: No concentration dependence of plasma protein binding was observed over the range of 0.1 to 5 µmol/L tivozanib.
Danish: Der blev ikke observeret en koncentrationsafhængighed af plasmaproteinbindingen over et område fra 0,1 til 5 µmol/liter tivozanib.
English: Tivozanib reduces the supply of blood to the cancer, which slows down the growth and spread of cancer cells.
Danish: Tivozanib reducerer blodforsyningen til kræften, hvad der gør væksten og spredningen af kræftceller mere langsom.
English: White HDPE bottle with a child resistant closure containing 21 hard capsules.
Danish: Hvid HDPE-beholder med børnesikret lukning, som indeholder 21 hårde kapsler.
English: Before initiating Fotivda, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Danish: Inden indledning af behandling med Fotivda bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme.
English: [14C] Tivozanib was the predominant drug-related material in faeces.
Danish: [14C] Tivozanib var det fremherskende lægemiddelrelaterede materiale i fæces.
English: Table 2: Efficacy analysis by independent radiology review (ITT population)
Danish: Tabel 2: Effektivitetsanalyse ved uafhængig radiologisk bedømmelse (ITT population)
English: The maximum change in QTcF from baseline was 9.3 ms (90% CI: 5, 13.6), which occurred 2.5 hours after dosing on Day 21.
Danish: Den maksimale ændring i QTcF fra baseline var 9,3 ms (90% CI: 5, 13,6), som opstod 2,5 timer efter dosering på Dag 21.
English: Unchanged tivozanib is the major circulating form of the molecule, and there were no major metabolites detected in serum at exposure equal to or greater than 10% of the total radioactivity exposure.
Danish: Uændret tivozanib er molekylets vigtigste cirkulerende form og der blev ikke detekteret vigtige metabolitter i serum ved en eksponering lig med eller større end 10% af samlet eksponering for radioaktivitet.
English: As CYP1A1 is primarily expressed in extrahepatic tissues such as the lung and intestine, it was considered unlikely that this isoform would be extensively involved in hepatic metabolism.
Danish: Da CYP1A1 primært udtrykkes i ekstrahepatisk væv såsom lunge og tarm, blev det anset for at være usandsynligt, at denne isoform ville være involveret i hepatisk metabolisme i stort omfang.
English: In a controlled clinical study (AV-951-09-301), in which 25% of patients receiving tivozanib were ≥ 65 years of age, no overall differences was observed in efficacy between elderly and younger patients (see section 4.2).
Danish: I et kontrolleret klinisk studie (AV-951-09-301), hvor 25% af patienter som modtog tivozanib var ≥ 65 år, blev der ikke observeret en global forskel i effektivitet mellem ældre og yngre patienter (se pkt.
English: Effective methods of contraception should be used by male and female patients and their partners during therapy, and for at least one month after completing therapy.
Danish: Mandlige og kvindelige patienter bør bruge effektive kontraceptionsmetoder under terapien og i mindst en måned efter at have gennemført terapien.
English: Both events were CTC Grade 3 (see section 4.4).
Danish: Begge hændelser var CTC Grad 3 (se pkt.
English: Based on these data, tivozanib can be dosed with or without food (see section 4.2).
Danish: På basis af disse data kan tivozanib doseres med eller uden mad (se pkt.
English: Tivozanib potently and selectively blocks all 3 Vascular Endothelial Growth Factor receptors (VEGFR) and has been shown to block various VEGF-induced biochemical and biologic responses in vitro, including VEGF-ligand-induced phosphorylation of all three VEGFR 1, 2 and 3, and proliferation of human endothelial cells.
Danish: Tivozanib blokerer potent og selektivt alle 3 vaskulære endotel-vækstfaktor-receptorer (VEGFR) og har vist sig at blokere forskellige VEGF-inducerede biokemiske og biologiske responser in vitro, inklusiv VEGF-ligand-induceret fosforylering af alle tre VEGFR 1, 2 og 3, og proliferation af humane endotelceller.
English: • Inflammation of the pancreas causing severe stomach pain which may spread to your back.
Danish: • Inflammation af bugspytkirtlen, som fremkalder stærke mavesmerter, der kan sprede sig til ryggen.
English: • phenobarbital, phenytoin, carbamazepine (used to treat epilepsy);
Danish: • phenobarbital, phenytoin, carbamazepin (bruges til at behandle epilepsi);
English: Fotivda can have side effects that may affect your ability to drive or use machines.
Danish: Fotivda kan have bivirkninger, som kan indvirke på din evne til at føre motorkøretøjer eller betjene en maskine.
English: Carcinogenesis Carcinogenicity studies have not been performed with tivozanib.
Danish: Karcinogenese Der er ikke udført karcinogenicitets-studier med tivozanib.
English: Your doctor will monitor the effect of Fotivda on your heart by recording the electrical activity of your heart (an electrocardiogram) or by measuring your blood calcium, magnesium and potassium levels during your treatment.
Danish: Din læge vil overvåge virkningen af Fotivda på dit hjerte ved at kortlægge dit hjertes elektriske aktivitet (med et elektrokardiogram) eller ved at måle dit blods indhold af calcium, magnesium og kalium i løbet af din behandling.