FrancophonIA/ELRC3.0 huggingface dataset:
English: Ofatumumab may cause foetal B-cell depletion based on findings from animal studies and on its mechanism of action (see section 5.1).
Danish: Baseret på dyrestudier og ofatumumabs virkningsmekanisme (se afsnit 5.1) kan ofatumumab forårsage føtal B-celle-depletion.
English: • breathlessness, cough
Danish: • åndenød, hoste
English: Arzerra 100 mg concentrate for solution for infusion
Danish: Arzerra 100 mg koncentrat til infusionsvæske
English: Live attenuated or inactivated vaccine efficacy may be impaired with ofatumumab.
Danish: Ofatumumab kan nedsætte effekten af svækkede levende eller inaktiverede vacciner.
English: Arzerra 100 mg concentrate for solution for infusion Arzerra 1000 mg concentrate for solution for infusion
Danish: Arzerra 100 mg koncentrat til infusionsvæske, opløsning Arzerra 1000 mg koncentrat til infusionsvæske, opløsning
English: For the first and second infusion, administer over 6.5 hours (see section 4.2), through a peripheral line or indwelling catheter, according to the schedule below:
Danish: Den første og anden infusion skal administreres over 6,5 timer (se punkt 4.2 i produktresuméet) gennem et perifert eller permanent kateter i henhold til nedenstående skema.
English: If the second infusion was completed without a severe adverse reaction, the remaining infusions (3-12) should be administered over 4 hours (see section 4.2), through a peripheral line or indwelling catheter, according to the schedule below.
Danish: Hvis den anden infusion blev gennemført uden alvorlige bivirkninger, administreres de resterende infusioner over 4 timer (se punkt 4.2 i produktresumeet) gennem et perifert eller permanent kateter i henhold til nedenstående skema.
English: If the preceding infusion(s) has (have) been completed without severe infusion-related ADRs, the subsequent infusions can start at a rate of 25 ml/hour and should be increased every 30 minutes up to a maximum of 400 ml/hour (see section 6.6).
Danish: Hvis de(n) forudgående infusion(er) blev gennemført uden alvorlige infusionsrelaterede bivirkninger, kan de efterfølgende infusioner påbegyndes med en hastighed på 25 ml/time.
English: Diluted infusion solution
Danish: Fortynding af infusionsvæsken
English: • allergic reactions, sometimes severe where symptoms include raised and itchy rash (hives),
Danish: • allergiske reaktioner som kan være alvorlige, hvor symptomer omfatter hævet og kløende udslæt (nældefeber), hævelse af ansigtet eller munden (angioødem), som kan give vejrtræningsbesvær
English: For the first infusion, administer over 4.5 hours (see section 4.2 of the SmPC), through a peripheral line or indwelling catheter, according to the schedule below:
Danish: Første infusion administreres over 4,5 timer (se punkt 4.2 i produktresuméet) gennem et perifert eller permanent kateter i henhold til nedenstående skema:
English: Median, all patients 95% CI
Danish: Median, alle patienter 95 % konfidensinterval Hazard ratio P-værdi p <0,001
English: • Withdraw 50 ml of ofatumumab from each of the two 1000 mg vials and inject into the 1000 ml bag;
Danish: • Udtag 50 ml ofatumumab fra hvert af de 2 hætteglas, og injicer i 1000 ml posen.
English: • Withdraw 5 ml of ofatumumab from each of the three 100 mg vials and inject into the 1000 ml bag;
Danish: • Udtag 5 ml ofatumumab fra hvert af de tre 100 mg hætteglas, og injicer de i alt 15 ml i 1000 ml
English: Previously untreated chronic lymphocytic leukaemia (CLL)
Danish: Progressiv multifokal leukoencefalopati (PML)
English: If any infusion-related adverse reactions are observed, infusion should be interrupted and restarted when the patient's condition is stable (see section 4.2 for further information).
Danish: Hvis der observeres infusionsrelaterede bivirkninger, skal infusionen afbrydes og genstartes, når patientens tilstand er stabil (se afsnit 4.2 i produktresumeet).
English: Uncommon side effects These may affect up to 1 in 100 people:
Danish: Almindelige bivirkninger Kan forekomme hos op til 1 ud af 10 personer:
English: Cardiovascular
Danish: Infusionsantal
English: Discard any unused solution after this time.
Danish: Eventuelt ubrugt opløsning, der er tilovers efter dette tidspunkt, skal kasseres.
English: CR (%) CR with MRD negativity (% of CR) Median duration of response, all patients, months 95% CI P value p<0.001
Danish: CR (%) CR med MRD negativitet (% af CR)
English: Dilution
Danish: Fortynding
English: 2000 mg dose: Use 2 vials (100 ml total, 50 ml per vial) - Withdraw and discard 100 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection; - Withdraw 50 ml of ofatumumab from each of 2 vials and inject into the 1000 ml bag; - Do not shake; mix diluted solution by gentle inversion.
Danish: Dosis på 300 mg - Brug tre 100 mg/5 ml hætteglas (15 ml i alt, 5 ml pr. hætteglas): • Udtag og kassér 15 ml fra en pose med 1000 ml 9 mg/ml (0,9 %)
English: OTHER
Danish: IN
English: You need to take this into account if you are on a controlled sodium diet.
Danish: Hvis du er på natrium- eller saltfattig diæt, skal du tage hensyn hertil.
English: Breast-feeding
Danish: Infusionskema
English: All responses were confirmed after 4 weeks.
Danish: Alle respons blev bekræftet efter 4 uger.
English: 31 May 2022
Danish: 31. maj 2022
English: No formal studies have been performed to assess the effects of these demographic factors.
Danish: Der er ikke udført formelle studier til vurdering af effekten af disse demografiske faktorer.
English: You may require medical attention.
Danish: Du kan have brug for lægebehandling.
English: 2 patients had more than 1 mutation in this category.
Danish: 2 patienter havde mere end 1 mutation i denne kategori.
English: The safety analyses included data from an ongoing extension study.
Danish: Sikkerhedsanalyserne indeholdt data fra et løbende udvidet studie.
English: Date of first authorisation: 27 March 2013 Date of latest renewal: 18 February 2019
Danish: Dato for første markedsføringstilladelse: 27. marts 2013 Dato for seneste fornyelse: 18. februar 2019
English: Final Clinical Study Report:
Danish: Endelige kliniske studierapport:
English: Seventy-five percent of the dose was recovered within 96 hours.
Danish: 75 % af dosis blev genfundet inden for 96 timer.
English: Following a single oral (10 mg/kg) administration of [
Danish: Efter en enkelt oral dosis (10 mg/kg) af [
English: - if your doctor has told you that your liver has been damaged and is not working normally.
Danish: - hvis din læge har fortalt dig, at din lever er skadet og ikke fungerer normalt.
English: This is always important, but especially if you are experiencing frequent or prolonged diarrhoea as described above.
Danish: Dette er altid vigtigt, men særligt vigtigt hvis du får hyppig eller langvarig diarré som beskrevet ovenfor.
English: * For efficacy results in the subgroup of patients corresponding to the approved indication, see text above.
Danish: *For effektresultater i undergruppen af patienter med den godkendte indikation, se ovenstående tekst.
English: When your disease is very severe, your body may not be able to clear all the waste products from the dying cancer cells.
Danish: Hvis din sygdom er meget alvorlig, vil din krop muligvis ikke kunne udskille alle affaldsstoffer fra de døende kræftceller.
English: No additional deaths or transformations occurred in the ITT population.
Danish: Der forekom ikke yderligere dødsfald eller transformeringer i ITT-populationen.
English: Take the tablet(s) in the morning with food.
Danish: Tag tabletten om morgenen sammen med mad.
English: Since there is limited information in the elderly, caution should be exercised in these patients.
Danish: Da der er begrænset information vedrørende ældre, skal der udvises forsigtighed hos disse patienter.
English: The efficacy results are summarised in Table 3.
Danish: Resultaterne er opsummeret i skema 3.
English: Therefore, clinical activity in patients with these mutations is not expected.
Danish: Der forventes derfor ikke klinisk aktivitet hos patienter med disse mutationer.
English: The relationship between the observed effects and medicinal product treatment were inconclusive.
Danish: Sammenhængen mellem de observerede effekter og lægemiddelbehandlingen var uklar.
English: Note: Percentages were based on number of patients in each treatment group.
Danish: Bemærk: Procentdelen er baseret på antallet af patienter i hver behandlingsgruppe.
English: Concentration of radioactivity in milk was up to 8-fold higher than in plasma.
Danish: Koncentrationen af radioaktivitet i mælken var op til 8 gange højere end i plasma.
English: Age, gender and race
Danish: Alder, køn og race
English: QTc syndrome)
Danish: QTc-syndrom)
English: Bosulif is indicated for the treatment of adult patients with:
Danish: Bosulif er indiceret til behandling af voksne patienter med:
English: This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Danish: Dette er en betinget markedsføringstilladelse, og i henhold til artikel 14, stk. 7, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: - if you have an infection.
Danish: - hvis du har en infektion.
English: Do not stop taking Bosulif unless your doctor tells you to do so.
Danish: Stop ikke med at tage Bosulif, medmindre lægen beder dig om det.
English: Do not take a double dose to make up for the forgotten tablets.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte tablet.
English: You should inform your doctor if you are taking medicines containing active substances such as those listed below:
Danish: Du skal fortælle det til din læge, hvis du tager lægemidler, der indeholder aktive stoffer såsom dem på listen nedenfor:
English: These adverse reactions are presented by system organ class and frequency.
Danish: Bivirkningerne er angivet efter systemorganklasse og hyppighed.
English: This medicine has not been studied in children and adoloscents.
Danish: Dette lægemiddel er ikke blevet undersøgt hos børn og teenagere.
English: If you are not able to take the medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor right away.
Danish: Hvis du ikke længere kan tage lægemidlet, som anvist af din læge, eller hvis du føler, at du ikke har brug for det mere, skal du straks kontakte lægen.
English: It should only be used, if other medicinal products are not efficacious.
Danish: Domperidon bør kun anvendes, hvis andre lægemidler ikke er effektive.
English: Number (%) of subjects with MMR
Danish: Antal (%) forsøgspersoner med MMR
English: - allergic reaction.
Danish: - allergisk reaktion.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer og offentliggjort på den europæiske webportal for lægemidler.
English: - ringing in the ears (tinnitus).
Danish: - ringen for ørerne (tinnitus).
English: - Do not use this medicine after the expiry date which is stated on the blister foil and carton after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på blisterfolien og kartonen efter "EXP".
English: The patient should take the usual prescribed dose on the following day.
Danish: Patienten skal tage den sædvanlige, ordinerede dosis den næste dag.
English: Patients should be monitored and managed using standard-of-care treatment.
Danish: Patienterne skal monitoreres og behandles med standardbehandling.
English: The presence of hypokalaemia and hypomagnesaemia may further enhance this effect.
Danish: Hypokaliæmi og hypomagnesiæmi kan forstærke denne effekt yderligere.
English: The medicines listed here may not be the only ones that could interact with Bosulif.
Danish: De lægemidler, der er nævnt her, er ikke nødvendigvis de eneste lægemidler, der kan interagere med Bosulif.
English: A potential risk to the breast-feeding infant cannot be excluded.
Danish: En potentiel risiko for det ammede spædbarn kan ikke udelukkes.
English: - if you have been told that you have problems with your kidneys.
Danish: - hvis du har fået at vide, at du har problemer med dine nyrer.
English: - decrease of appetite.
Danish: - nedsat appetit.
English: A delayed increase in heart rate was observed.
Danish: Der blev set en forsinket stigning i hjertefrekvens.
English: In these situations an individual benefit-risk assessment is mandatory and patients should be monitored for occurrence of QTc prolongation.
Danish: I så fald er en individuel risk/benefit-vurdering obligatorisk, og patienten skal monitoreres for QTc-forlængelse.
English: Complete blood counts should be performed weekly for the first month and then monthly thereafter, or as clinically indicated.
Danish: Der skal foretages komplet blodtælling hver uge i den første måned og herefter månedligt eller efter klinisk behov.
English: In addition, the patient should be advised that vomiting or diarrhoea may reduce the efficacy of oral contraceptives by preventing full absorption.
Danish: Derudover skal patienten informeres om, at opkastning eller diarré kan nedsætte virkningen af orale kontraceptiva, ved at hindre fuldstændig absorption.
English: Absorption was relatively slow, with a median time-to-peak concentration (tmax) reached after 6 hours.
Danish: Absorptionen var relativt langsom, og den maksimale koncentration (tmax) blev i gennemsnit nået efter 6 timer.
English: Patients who take an overdose of bosutinib should be observed and given appropriate supportive treatment.
Danish: Patienter, der tager en overdosis bosutinib, skal observeres og have passende understøttende behandling.
English: It is unknown whether bosutinib and its metabolites are excreted in human milk.
Danish: Det vides ikke, om bosutinib og dets metabolitter udskilles i human mælk.
English: - if you have heart problems.
Danish: - hvis du har hjerteproblemer.
English: The liver was also identified as a target organ in rats.
Danish: Leveren blev også identificeret som et målorgan hos rotter.
English: Uncommon Pericarditis
Danish: Ikke almindelig Pericarditis
English: You must immediately contact your doctor if you experience any of those serious side effects (see also section 2 “What you need to know before you take Bosulif”):
Danish: Du skal straks kontakte lægen, hvis du får en eller flere af disse alvorlige bivirkninger (se også punkt 2 ”Det skal du vide, før du begynder at tage Bosulif”).
English: Frequency categories are defined as: very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppighederne defineres som: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Resume treatment with bosutinib at the same dose if recovery occurs within 2 weeks.
Danish: Genoptag behandlingen med bosutinib i samme dosis, hvis bedring indtræder inden for 2 uger.
English: Some medicines can affect the levels of Bosulif in your body.
Danish: Visse lægemidler kan påvirke mængderne af Bosulif i kroppen.
English: 9/L and less than 1.0×10
Danish: 9/l og under 1,0 x 10
English: One patient with the E255V mutation previously treated with nilotinib achieved CHR as best response.
Danish: En patient med E255V-mutation og tidligere behandlet med nilotinib opnåede CHR som bedste respons.
English: - changes in blood test to determine if Bosulif is affecting your liver and/or pancreas.
Danish: - forandringer i blodprøver til bestemmelse af, om Bosulif påvirker din lever og/eller bugspytkirtel.
English: Ph-positive CML is a cancer of the blood which makes the body produce too many of a specific type of white blood cell called granulocytes.
Danish: Ph-positiv CML er en kræftsygdom i blodet, der får kroppen til at danne for mange hvide blodlegemer af en bestemt type, der kaldes granulocytter.
English: The p-values for endpoints other than MMR at 12 months and CCyR by 12 months have not been adjusted for multiple comparisons.
Danish: P-værdierne for effektendepunkt ud over MMR efter 12 måneder og CCyR efter 12 måneder er ikke blevet justeret for flere sammenligninger.
English: Includes patients (N) who attained or maintained MCyR.
Danish: Inkluderer patienter (N), der opnåede eller fastholdt MCyR.
English: Bosutinib was highly bound to human plasma proteins in vitro (94%) and ex vivo in healthy subjects (96%), and binding was not concentration-dependent.
Danish: Bosutinib blev i høj grad bundet til humane plasmaproteiner in vitro (94 %) og ex vivo hos raske frivillige (96 %), og bindingen var ikke koncentrationen afhængig.
English: One patient on bosutinib and 7 patients on imatinib died while on study.
Danish: Én patient på bosutinib og 7 patienter på imatinib døde i løbet af studiet.
English: The percentage is based on number of patients with baseline mutation assessment.
Danish: Procentdelen er baseret på antal patienter med mutationsvurderingen ved baseline.
English: - mibefradil, diltiazem and verapamil, used to lower blood pressure in people with high blood pressure.
Danish: - mibefradil, diltiazem og verapamil, der anvendes til at sænke blodtrykket hos personer med forhøjet blodtryk.
English: Concomitant medicinal products were given to treat diarrhoea in 662 (66%) patients.
Danish: Der blev givet samtidig medicinering mod diarré hos 662 patienter (66 %).
English: No specific dose recommendation is necessary in the elderly.
Danish: Dosisjustering er ikke nødvendig hos ældre.
English: Return to chronic phase (RCP)=disappearance of features defining accelerated or blast phases but still in chronic phase.
Danish: Tilbagevenden til kronisk fase (RCP) = fravær af de karakteristika, der definerer den accelererede fase eller blastfasen men stadig i kronisk fase.
English: - increase in blood pressure.
Danish: - forhøjet blodtryk.
English: • At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af at der er nået en vigtig milepæl (lægemiddelovervågning eller risikominimering).
English: Bosulif is not recommended for people whose age is under 18 years.
Danish: Bosulif anbefales ikke til personer under 18 år.
English: This is called tumour lysis syndrome and can cause kidney failure and heart problems within 48 hours of the first dose of Bosulif.
Danish: Dette kaldes tumorlysesyndrom og kan forårsage nyresvigt og hjerteproblemer inden for 48 timer efter den første dosis Bosulif.
English: - fever, swelling of hands, feet or face, fatigue, weakness.
Danish: - feber, hævelse af hænder, fødder eller ansigt, træthed, svaghed.
English: - haloperidol, used to treat psychotic disease such as schizophrenia.
Danish: - haloperidol, der anvendes til behandling af psykotiske tilstande såsom skizofreni.
English: In clinical trials for both indications, treatment with bosutinib continued until disease progression or intolerance to therapy.
Danish: I de kliniske studier for begge indikationer fortsatte behandlingen med bosutinib, indtil sygdomsprogression eller intolerance over for behandlingen.
English: Females were observed with increased embryonic resorptions, and decreases in implantations and viable embryos.
Danish: Hos hundyrene blev der set øget embryonal resorption og fald i implantationer og levedygtige embryoer.
English: Hepatitis B reactivation
Danish: Reaktivering af hepatitis B
English: Effects of bosutinib on other medicinal products
Danish: Bosutinibs virkning på andre lægemidler
English: MCyR attained or maintained Resp/Eval b
Danish: MCyR opnået eller opretholdt Resp/Eval b (%)
English: If a dose is missed by more than 12 hours, the patient should not be given an additional dose.
Danish: Hvis en dosis glemmes i mere end 12 timer, skal patienten ikke have en ekstra dosis.
English: Hypokalaemia or hypomagnesaemia must be corrected prior to bosutinib administration and should be monitored periodically during therapy.
Danish: Hypokaliæmi eller hypomagnesiæmi skal korrigeres inden administration af bosutinib og monitoreres periodisk under behandlingen.
English: - crizotinib, used to treat a type of lung cancer called non-small cell lung cancer.
Danish: - crizotinib, der anvendes til at behandle en type lungekræft, der hedder ikke-småcelletlungekræft
English: Other efficacy endpoints include transformation to AP/BP, progression free survival and OS for all cohorts.
Danish: Øvrige effektmål omfattede transformation til AP/BP, progressionsfri overlevelse og samlet overlevelse for alle kohorter.
English: Bosutinib has no or negligible influence on the ability to drive and use machines.
Danish: Bosutinib påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: - Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Danish: Brug ikke dette lægemiddel, hvis du bemærker, at pakningen er beskadiget, eller hvis det ser ud som om, nogen har pillet ved den.
English: Experience with bosutinib overdose in clinical studies was limited to isolated cases.
Danish: Erfaringen med overdosering af bosutinib i kliniske studier begrænser sig til enkeltstående tilfælde.
English: - if you suffer from bleeding problems.
Danish: - hvis du lider af blødningsproblemer.
English: Carcinogenicity Bosutinib was not carcinogenic in the 2-year rat carcinogenicity study.
Danish: Karcinogenicitet Bosutinib var ikke karcinogent i det 2-årige karcinogenicitetsforsøg med rotter.
English: Doses greater than 600 mg/day have not been studied and, therefore, should not be given.
Danish: Doser over 600 mg/dag er ikke blevet undersøgt og bør derfor ikke anvendes.
English: - if you notice any of these symptoms: pain in your side, blood in your urine or reduced amount of urine.
Danish: - hvis du bemærker nogen af disse symptomer: smerter i siden, blod i urinen eller nedsat mængde urin.
English: - if you have any of these symptoms: serious skin rashes.
Danish: - hvis du har nogen af disse symptomer på alvorligt hududslæt.
English: Patients will be carefully checked by their doctor for signs of this infection before treatment is started.
Danish: Du skal undersøges omhyggeligt af lægen for tegn på denne type smitte, før behandlingen påbegyndes.
English: Table 4 - Comparison of MMR at Months 3, 6, and 9 by treatment in the mITT population
Danish: Skema 4 - Sammenligning af MMR ved måned 3, 6 og 9 efter behandling i mITT-populationen
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: In addition, 5.6% of patients in the bosutinib treatment group had further dose escalations to 600 mg.
Danish: Desuden fik 5,6 % af patienterne i bosutinib-behandlingsgruppen dosis yderligere øget til 600 mg.
English: Including patients (N) who received at least 1 dose of bosutinib.
Danish: Inklusive patienter (N), der fik mindst en dosis bosutinib .