FrancophonIA/ELRC3.0 huggingface dataset:
English: Zonisamide Mylan also acts on the neurotransmitter gamma‑aminobutyric acid (GABA, a chemical that allows nerve cells to communicate with each other).
Danish: Zonisamid Mylan virker desuden på signalstoffet gammaaminosmørsyre (GABA, et kemisk stof, der anvendes af nervecellerne i deres indbyrdes kommunikation).
English: Because Zonisamide Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Zonegran.
Danish: Da Zonisamid Mylan er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Zonegran.
English: For practical information about using Zonisamide Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Zonisamid Mylan, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: When Zonisamide Mylan is used as an ‘add-on' to existing treatment in adults, the recommended starting dose is 25 mg twice a day.
Danish: Når Zonisamid Mylan anvendes som tillægsbehandling til voksne, der allerede er under behandling, er den anbefalede startdosis 25 mg to gange dagligt.
English: Why is Zonisamide Mylan approved?
Danish: Hvorfor blev Zonisamid Mylan godkendt?
English: When Zonisamide Mylan is used on its own in newly diagnosed adults, the recommended starting dose is 100 mg once a day for two weeks, which may be increased by 100 mg at intervals of two weeks.
Danish: Når Zonisamid Mylan anvendes alene hos nydiagnosticerede voksne, er den anbefalede startdosis 100 mg én gang dagligt i to uger.
English: Dose increases may need to be made less frequently in patients with liver or kidney problems or those taking certain other medicines.
Danish: Hos patienter, der har lever- eller nyresygdom, eller som er i behandling med visse andre lægemidler, kan det være nødvendigt med længere mellemrum mellem dosisforøgelserne.
English: By blocking these channels, zonisamide is expected to prevent abnormal electrical activity spreading through the brain, thereby reducing the chances of an epileptic fit.
Danish: Når kalcium og natrium trænger ind i nervecellerne, kan elektriske impulser overføres mellem dem. Ved at blokere disse kanaler forventes zonisamid at forhindre unormal elektrisk aktivitet i at sprede sig i hjernen, og derved reduceres risikoen for et epileptisk anfald.
English: Zonisamide Mylan can be given once or twice a day after an appropriate dose is reached.
Danish: Når der er nået en egnet dosis, kan Zonisamid Mylan gives én eller to gange dagligt.
English: How has Zonisamide Mylan been studied?
Danish: Hvordan blev Zonisamid Mylan undersøgt?
English: How is Zonisamide Mylan used?
Danish: Hvordan anvendes Zonisamid Mylan?
English: How does Zonisamide Mylan work?
Danish: Hvordan virker Zonisamid Mylan?
English: When Zonisamide Mylan is used as an ‘add-on' to existing treatment in children aged six years and above, the dose depends on body weight; the recommended starting dose is 1 mg per kg of body weight daily.
Danish: Når Zonisamid Mylan anvendes som tillægsbehandling til børn fra seksårsalderen, der allerede er under behandling, afhænger dosen af legemsvægten.
English: 1 bottle + 1 bottle adaptor + 1 dosing syringe 10 ml
Danish: 1 flaske + 1 flaskeadapter + 1 oral 10 mlinjektionssprøjte
English: Oral use bottle (glass)
Danish: Oral opløsning Oral anvendelse glasflaske 60 ml
English: Safety was the primary endpoint and efficacy was a secondary endpoint.
Danish: Sikkerhed var det primære endepunkt, og effekt var et sekundært endepunkt.
English: These complications can be severe and can lead to death.
Danish: Disse komplikationer kan være alvorlige og medføre døden.
English: These changes were not considered clinically relevant.
Danish: Disse ændringer blev ikke anset for klinisk relevante.
English: Follow-up was ongoing at the time of data submission.
Danish: Opfølgningsperioden var igangværende på tidspunktet for indsendelse af data.
English: • subjects under the age of 18 years.
Danish: • personer under 18 år.
English: These patients were not evaluated as part of the primary efficacy population.
Danish: Disse patienter blev ikke evalueret som en del af den primære effektpopulation.
English: This will be provided for the approved indications:
Danish: Dette skal tilvejebringes for de godkendte indikationer:
English: a median follow-up 11.5 months.
Danish: a medianopfølgning 11,5 måneder.
English: ≥ 75 years
Danish: ≥ 75 år
English: Seventy-nine percent of patients were former/current smokers.
Danish: 79 % af patienterne var tidligere/nuværende rygere.
English: 3.6 (Not available)
Danish: 3,6 (Ikke tilgængelig)
English: Grade 3 (first occurrence)
Danish: Grad 3 (første forekomst)
English: the total volume of infusion must not exceed 160 mL.
Danish: den totale infusionsvolumen må ikke overstige 160 ml.
English: • Details on how to minimise the safety concern through appropriate monitoring and management
Danish: • Oplysninger om, hvordan sikkerhedsproblemerne kan begrænses ved hjælp af relevant monitorering og behandling
English: OPDIVO should not be frozen.
Danish: OPDIVO må ikke nedfryses.
English: All patients had either progressed, were censored, or lost to follow-up a
Danish: Alle patienter var enten progredieret, blevet censureret eller tabt for opfølgning a
English: The frequency is based on the program-wide exposure.
Danish: Hyppigheden er baseret på eksponering i programmet.
English: Your doctor may give you other medicines in order to prevent complications and reduce your symptoms,
Danish: Din læge vil muligvis give dig anden medicin for at forebygge komplikationer og mildne dine symptomer,
English: Hazard ratio in each subgroup derived from a Cox proportional hazards model with treatment as the only covariate.
Danish: Hazard ratio i hver undergruppe er udledt af en Cox-proportional risikomodel med behandling som eneste kovariat.
English: “Numerous” and “intermediate” groups were combined to define the “abundant” group.
Danish: Grupperne “talrig” og “intermediær” blev lagt sammen for at definere gruppen “udbredt”.
English: Patients had to have a Karnofsky Performance Score (KPS) ≥ 70%.
Danish: Patienterne skulle have en Karnofsky Performance-Score (KPS) ≥ 70 %.
English: Combination phase, every 3 weeks for 4 dosing cycles
Danish: Kombinationsfase, hver 3. uge for 4 doseringscyklusser
English: Indication*
Danish: Indikation*
English: Children and adolescents OPDIVO should not be used in children and adolescents below 18 years of age.
Danish: Børn og unge OPDIVO må ikke anvendes til børn og unge under 18 år.
English: Efficacy from both studies was evaluated by the same IRRC.
Danish: Virkningen i de 2 studier blev evalueret af den samme IRRC.
English: Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4).
Danish: Bemærk: Toksicitetsgrader er i henhold til National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4).
English: Reported also in studies outside the pooled dataset.
Danish: Er også rapporteret i studier uden for det puljede datasæt.
English: Do not try to treat your symptoms with other medicines on your own.
Danish: Du må ikke forsøge selv at behandle dine symptomer med anden medicin.
English: N responders/ N evaluablea 95% CIb a includes confirmed and unconfirmed responses, scans were mandatory only at week 8/9 and week 52.
Danish: 95 % CIb a inkluderer bekræftet og ubekræftet respons, scanninger var kun obligatoriske i uge 8/9 og uge 52.
English: Changes in test results
Danish: Ændringer i prøveresultater
English: For patients weighing less than 40 kg, the total volume of infusion must not exceed 4 mL per kilogram of patient weight.
Danish: For patienter der vejer mindre end 40 kg, må den totale infusionsvolumen ikke overstige 4 ml per kilogram af patientens vægt.
English: Number (n)/ minimum follow-up (months)
Danish: Antal (n)/minimum opfølgningsperiode (måneder)
English: For instructions on the preparation and handling of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om forberedelse og håndtering af lægemidlet før administration, se pkt.
English: Not available as median unstable due to low number of patients and censoring with 24 months of follow-up
Danish: Ikke tilgængelig eftersom medianen var ustabil grundet lavt antal patienter og som følge af censurering med 24 måneders opfølgningperiode.
English: With available safety data, these decreases in CL were not clinically meaningful.
Danish: I henhold til de tilgængelige sikkerhedsdata var disse fald i CL uden klinisk relevans.
English: Reported in clinical studies and in the post-marketing setting.
Danish: Rapporteret i kliniske studier og efter markedsføring.
English: RFS results are shown in Table 13 and Figure 7 (all randomised population).
Danish: RFS-resultaterne er vist i tabel 13 og figur 7 (hele den randomiserede population).
English: For adjuvant therapy, the maximum treatment duration with OPDIVO is 12 months.
Danish: For adjuverende behandling er den maksimale behandlingsvarighed med OPDIVO 12 måneder.
English: Patients were stratified by IMDC prognostic score and region.
Danish: Patienterne blev stratificeret efter IMDC-prognosescore og region.
English: Most patients present with asymptomatic increases in serum creatinine.
Danish: Størstedelen af patienterne får asymptomatisk stigning i serumkreatinin.
English: Effective contraception should be used for at least 5 months following the last dose of nivolumab.
Danish: Der skal anvendes effektiv prævention i mindst 5 måneder efter den sidste dosis nivolumab.
English: The effects of OPDIVO in pregnant women are not known, but it is possible that the active substance, nivolumab, could harm an unborn baby.
Danish: Man kender ikke OPDIVOs virkning hos gravide kvinder, men det er muligt, at det aktive stof nivolumab kan skade det ufødte barn.
English: It is important that you also read the package leaflet for this medicine.
Danish: Det er vigtigt, at du også læser indlægssedlen for dette lægemiddel.
English: The differences between the two nivolumab-containing groups were evaluated descriptively.
Danish: Forskellene mellem de to arme indeholdende nivolumab blev deskriptivt evalueret.
English: Unopened vial 3 years
Danish: Uåbnet hætteglas 3 år
English: OPDIVO infusion is compatible with:
Danish: OPDIVO-infusionsvæske er kompatibel med:
English: No new safety signals were identified in all treated patients and the overall safety profile of nivolumab was similar across subgroups.
Danish: Der blev ikke identificeret nye sikkerhedssignaler hos nogen af de behandlede patienter, og den overordnede sikkerhedsprofil for nivolumab var sammenlignelig på tværs af undergrupper.
English: Data unstable due to the limited duration of response for Cohort B resulting from censoring.
Danish: Ustabile data på grund af begrænset responsvarighed for kohorte B som følge af censurering.
English: One of the Grade 3 pneumonitis cases worsened over 11 days with a fatal outcome.
Danish: Et tilfælde af grad 3 pneumonitis forværredes over en periode på 11 dage med dødelig udgang.
English: See “Description of selected adverse reactions; laboratory abnormalities” below.
Danish: Se “Beskrivelse af udvalgte bivirkninger; laboratorietestabnormiteter” nedenfor.
English: Treatment must be initiated and supervised by physicians experienced in the treatment of cancer.
Danish: Behandlingen skal initieres og superviseres af en læge med erfaring i cancerbehandling.
English: Minimum follow-up for the analysis of ORR was 28 months.
Danish: Opfølgningsperioden for analysen af ORR var minimum 28 måneder.
English: Guidelines for permanent discontinuation or withholding of doses are described in Table 4.
Danish: Retningslinjer for permanent seponering eller udsættelse af doser fremgår af tabel 4.
English: Rapid tapering may lead to worsening or recurrence of the adverse reaction.
Danish: Hurtig nedtrapning kan medføre forværring eller tilbagevenden af bivirkningen.
English: These subgroup analyses should be interpreted with caution given the small size of the subgroups and lack of statistically significant difference in OS in the all randomised population.
Danish: Disse undergruppeanalyser skal fortolkes med forsigtighed på grund af den lille størrelse af undergrupperne og manglen på statistisk signifikant forskel i OS hos den helt randomiserede population.
English: The average EQ-VAS increased over time for both treatment groups, indicating better overall health status for patients remaining on treatment.
Danish: Gennemsnitligt EQ-VAS steg over tid for begge behandlingsgrupper, hvilket indikerer bedre overordnet helbredsstatus for de patienter, der fortsatte behandlingen.
English: Talk to your doctor if you are not sure.
Danish: Tal med lægen, hvis du er i tvivl.
English: With a minimum of 63 months follow-up in NSCLC, no new safety signals were identified.
Danish: Efter opfølgningperiode på minimum 24 måneder hos NSCLC-patienter blev ingen nye sikkerhedssignaler identificeret.
English: Use of nivolumab in melanoma patients with rapidly progressing disease
Danish: Brug af nivolumab hos patienter med melanom med hurtigt progredierende sygdom
English: Thus, the effect of nivolumab on male and female fertility is unknown.
Danish: Derfor er nivolumabs påvirkning af fertiliteten hos kvinder og mænd ukendt.
English: Nine of 49 patients (18.4%) died from complications of allogeneic HSCT after nivolumab.
Danish: Ni ud af 49 patienter (18,4 %) døde af komplikationer ved allogen HSCT efter nivolumab.
English: • Physician educational material • Patient alert card
Danish: • Undervisningsmateriale til lægen • Patient-informationskort
English: Responses are summarised in Table 12.
Danish: Respons er sammenfattet i tabel 12.
English: There was no statistically significant difference between nivolumab and chemotherapy in the final OS analysis.
Danish: Der var ingen statistisk signifikant forskel mellem nivolumab og kemoterapi i den endelige OS-analyse.
English: 4Q2020
Danish: 4. kvartal 2020
English: Frequencies of laboratory terms reflect the proportion of patients who experienced a worsening from baseline in laboratory measurements.
Danish: Hyppighederne af laboratorietermer afspejler den andel af patienter, som i laboratoriemålinger oplevede forværring i forhold til baseline.
English: Infectious and other aetiologies of diarrhoea should be ruled out, therefore appropriate laboratory tests and additional examinations must be performed.
Danish: Infektiøse og andre årsager til diarré bør udelukkes, og der skal derfor udføres passende laboratorietests og yderligere undersøgelser.
English: These results should be interpreted with caution due to the small sample size within the subgroups.
Danish: Disse resultater bør fortolkes med forsigtighed på grund af den lille populationsstørrelse i undergrupperne.
English: Strata adjusted difference.
Danish: Strata-justeret forskel.
English: There was a dosedependent increase in foetal losses and increased neonatal mortality beginning in the third trimester.
Danish: Der blev observeret en dosisafhængig stigning i fosterdødelighed og øget neonatal dødelighed startende i tredje trimester.
English: Based on a stratified log-rank test.
Danish: Udledt af en stratificeret log-rank test.
English: Ask your doctor if you can breast-feed during or after treatment with OPDIVO.
Danish: Spørg lægen, om du kan amme under eller efter behandlingen med OPDIVO.
English: The estimated 1-year survival rate was
Danish: Den estimerede overlevelsesrate efter 1 år var 41 %.
English: OPDIVO is for intravenous use only.
Danish: OPDIVO er kun til intravenøs anvendelse.
English: investigator's choice (n = 121)
Danish: investigators valg (n = 121)
English: PD-L1+ TAIC in the tumour microenvironment were qualitatively assessed, and characterised as “numerous”, “intermediate”, and “rare” based on pathologist assessments.
Danish: PD-L1+ TAIC i tumormikromiljøet blev kvalitativt vurderet og karakteriseret som “talrig”, “intermediær” og “sjælden” på baggrund af patologers vurderinger.
English: The preliminary results show that systemic immunosuppression after starting nivolumab treatment does not appear to preclude the response on nivolumab.
Danish: De foreløbige resultater viser, at systemisk immunsuppression efter initiering af nivolumab-behandling ikke synes at hindre respons på nivolumab.
English: Based on the stratified DerSimonian-Laird test.
Danish: Baseret på stratificeret DerSimonian & Laird-test.
English: In addition, levels of myeloid-derived suppressor cells in circulation will be explored in study CA209038.
Danish: Derudover vil niveauet af cirkulerende myeloid-afledte suppressorceller blive undersøgt i studie CA209038.
English: Data unstable due to the limited duration of response.
Danish: Data er ustabile pga. begrænset responsvarighed.
English: No clear cut off for PD-L1 expression can reliably be established when considering the relevant endpoints of tumour response and PFS and OS.
Danish: Der kan ikke på pålidelig vis fastsættes nogen klar cut-off for PD-L1-ekspression, når de relevante endepunkter for tumorrespons og PFS og OS tages i betragtning.
English: OS may be confounded by dropout, imbalance of subsequent therapies and differences in baseline factors.
Danish: OS kan være konfunderetaf frafald, ubalance i efterfølgende behandlinger og forskelle i baselinefaktorer.
English: CR+PR, confidence interval based on the Clopper and Pearson method
Danish: CR+PR, konfidensinterval baseret på Clopper-Pearson-metoden
English: Treatment should be continued in the presence of hormone replacement therapyb as long as no symptoms are present
Danish: Behandlingen bør fortsættes under hormonsubstitutionsbehandlingb så længe, der ikke er symptomer
English: OPDIVO acts on your immune system and may cause inflammation in parts of your body.
Danish: OPDIVO virker på dit immunsystem og kan forårsage inflammation i dele af kroppen.
English: Atypical responses (i.e., an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage) have been observed.
Danish: Der er set atypisk respons (dvs. en indledende forbigående øgning af tumorstørrelse eller små nye læsioner i de første få måneder efterfulgt af tumorreduktion).
English: Patients with cardiac or cardiopulmonary symptoms should be assessed for potential myocarditis.
Danish: Patienter med hjerte- eller hjertelunge-symptomer skal vurderes for potentiel myocarditis.
English: c included 4 drug-related deaths: 1 pneumonitis, 1 acute respiratory failure, 1 respiratory failure, and 1 cardiovascular failure.
Danish: c omfattede 4 lægemiddelrelaterede dødsfald: 1 pneumonitis, 1 akut respirationsinsufficiens, 1 respirationsinsufficiens og 1 hjertesvigt.
English: Talk to your doctor before using OPDIVO as it may cause:
Danish: Kontakt lægen, før du bruger OPDIVO, da det kan medføre:
English: Sixteen percent of patients had received prior adjuvant therapy; the most common adjuvant treatment was interferon (9%).
Danish: 16 % af patienterne havde tidligere fået adjuverende behandling; den mest almindelige adjuverende behandling var interferon (9 %).
English: Efficacy results based on investigator-assessed response rates at week 12 are presented in Table 10 below.
Danish: Effektresultater baseret på investigatorvurderede responsrater i uge 12 kan ses i tabel 10 nedenfor.
English: Proportion ≥12 months in duration
Danish: Andel ≥12 måneders i varighed
English: Derived from a stratified proportional hazards model.
Danish: Udledt af en stratificeret proportional risikomodel.
English: You will receive treatment with OPDIVO in a hospital or clinic, under the supervision of an experienced doctor.
Danish: Sådan får du OPDIVO Du vil få OPDIVO på et hospital eller en klinik under opsyn af en erfaren læge.
English: The OS analysis was not adjusted to account for subsequent therapies received.
Danish: OS-analysen blev ikke justeret for at tage højde for efterfølgende modtagne behandlinger.
English: Do not use OPDIVO if you are pregnant unless your doctor specifically tells you to.
Danish: Du må ikke bruge OPDIVO, hvis du er gravid, medmindre lægen specifikt beder dig om det.
English: No cases of overdose have been reported in clinical trials.
Danish: Der er ikke blevet rapporteret om tilfælde af overdosering i kliniske studier.
English: Data available indicate that the onset of nivolumab effect is delayed such that benefit of nivolumab above chemotherapy may take 2-3 months.
Danish: Tilgængelige data indikerer, at nivolumabs virkning er forsinket, således at fordelen ved nivolumab i forhold til kemoterapi muligvis først indtræder efter 2-3 måneder.
English: A steroid-requiring febrile syndrome, without an identified infectious cause, was reported in six patients (12%) within the first 6 weeks post-transplantation, with three patients responding to steroids.
Danish: Der blev rapporteret om et steroidkrævende febrilt syndrom uden nogen identificeret infektiøs årsag hos seks patienter (12 %) i løbet af de første 6 uger efter transplantationen, hvoraf tre patienter responderede på steroider.
English: Do not stop treatment with OPDIVO unless you have discussed this with your doctor.
Danish: Du må ikke stoppe behandlingen med OPDIVO, medmindre du har aftalt det med lægen.
English: Proportion ≥24 months in duration
Danish: Andel ≥24 måneders i varighed
English: Baseline characteristics were similar across the two studies and cohorts (see Table 20 below).
Danish: Baseline-karakteristika var sammenlignelige i de to studier (se tabel 20 nedenfor).
English: Use separate infusion bags and filters for each infusion.
Danish: Der skal anvendes separate infusionsposer og -filtre til hver infusion.
English: Nivolumab was continued beyond progression in 44% of patients.
Danish: Behandling med nivolumab blev fortsat efter progression hos 44 % af patienterne.
English: Minimum follow-up was approximately 24 months.
Danish: Opfølgningperioden var som minimum 24 måneder.
English: Withdraw the required volume of OPDIVO concentrate using an appropriate sterile syringe.
Danish: Udtag det nødvendige volumen OPDIVO-koncentrat ved brug af en passende steril sprøjte.
English: Preparation and administration of OPDIVO
Danish: Klargøring og administration af OPDIVO
English: Among these 37 patients, treatment with nivolumab resulted in an ORR of 59.5% (22/37).
Danish: Blandt disse 37 patienter resulterede behandling med nivolumab i en ORR på 59,5 % (22/37).
English: Human IgG4 is known to cross the placental barrier and nivolumab is an IgG4; therefore, nivolumab has the potential to be transmitted from the mother to the developing foetus.
Danish: Humant IgG4 passerer placentabarrieren, og nivolumab er et IgG4; nivolumab har derfor potentiale til at blive overført fra moderen til fosteret.
English: Recommended dose and infusion time
Danish: Anbefalet dosis og infusionstid
English: High blood pressure (hypertension)
Danish: Forhøjet blodtryk (hypertension)
English: RFS, assessed by investigator, was defined as the time between the date of randomisation and the date of first recurrence (local, regional, or distant metastasis), new primary melanoma, or death due to any cause, whichever occurred first.
Danish: RFS blev vurderet af investigator og defineret som tiden imellem randomiseringsdatoen og datoen for det første tilbagefald (lokale, regionale eller fjernmetastaser), nyt primær melanom eller dødsfald uanset årsag, uagtet hvilken der forekom først.
English: No Grade 5 endocrinopathy was reported.
Danish: Ingen grad 5 endokrinopati blev rapporteret.
English: Common hypertension
Danish: Almindelig hypertension
English: Other side effects that have been reported (frequency not known) with nivolumab alone and/or nivolumab in combination with ipilimumab include:
Danish: Andre bivirkninger, som er blevet rapporteret (hyppighed ikke kendt) med nivolumab alene og/eller nivolumab i kombination med ipilimumab, inkluderer:
English: Prior adjuvant or neoadjuvant therapy was allowed if it was completed at least 6 weeks prior to randomisation.
Danish: Tidligere adjuverende eller neoadjuverende behandling var tilladt, hvis den var afsluttet mindst 6 uger inden randomisering.