FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor immediately if you have any of these signs or symptoms or if they get worse.
Danish: Fortæl det straks til lægen, hvis du får et eller flere af disse tegn eller symptomer, eller hvis de bliver værre.
English: Feeling tired or weak
Danish: Træthed eller svaghedsfølelse
English: It is important that you keep this Alert Card and show it to your partner or caregivers.
Danish: Det er vigtigt, at du har patient-informationskortet på dig og viser det til din partner eller omsorgsperson.
English: Calculating the dose
Danish: Beregning af dosis
English: There was a dose-dependent 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: 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
English: Nivolumab BMS should not be frozen.
Danish: Nivolumab BMS må ikke nedfryses.
English: Dose escalation or reduction is not recommended.
Danish: Dosisstigning eller -reduktion frarådes.
English: See “Description of selected adverse reactions; laboratory abnormalities” below.
Danish: Se “Beskrivelse af udvalgte bivirkninger; laboratorieafvigelser” nedenfor.
English: Do not try to treat your symptoms with other medicines on your own.
Danish: Du må ikke forsøge at behandle dine symptomer med anden medicin.
English: Only 4 (0.8%) patients were persistent positive.
Danish: Kun 4 patienter (0,8%) blev anset for vedvarende positive.
English: The majority of adverse reactions were mild to moderate (Grade 1 or 2).
Danish: Størstedelen af bivirkningerne var lette til moderate (grad 1 eller 2).
English: Thirty-one percent had progressive disease reported as the best response to their most recent prior regimen and 45% received nivolumab within 3 months of completing their most recent prior regimen.
Danish: Hos 31% blev fremskreden sygdom rapporteret som det bedste respons på den seneste tidligere behandling, og 45% fik nivolumab inden for 3 måneder efter afslutning af deres seneste tidligere behandling.
English: The majority of patients were white (93%) and male (76%).
Danish: Størstedelen af patienterne var kaukasiere (93%) og mænd (76%).
English: Patients with mild or moderate infusion reaction may receive nivolumab with close monitoring.
Danish: Patienter med en let eller moderat infusionsreaktion kan få nivolumab under tæt monitorering.
English: It contains the active substance nivolumab, which is a monoclonal antibody, a type of protein designed to recognise and attach to a specific target substance in the body.
Danish: Det indeholder det aktive stof nivolumab, som er et monoklonalt antistof, en type protein, der er designet til at genkende og binde sig til et bestemt målstof i kroppen.
English: For instructions on the handling of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om håndtering af lægemidlet før administration, se pkt.
English: Nivolumab BMS acts on your immune system and may cause inflammation in parts of your body.
Danish: Nivolumab BMS virker på dit immunsystem og kan forårsage inflammation i dele af kroppen.
English: The value of biomarkers to predict the efficacy of nivolumab should be further explored, specifically:
Danish: Betydningen af biomarkører til at forudsige virkningen af nivolumab bør undersøges nærmere, især: 1.
English: Frequencies 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).
Danish: Hyppighederne er defineret 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) og meget sjælden (<1/10.000).
English: Stopping your treatment may stop the effect of the medicine.
Danish: Hvis du stopper behandlingen, kan virkningen af medicinen ophøre.
English: Key secondary efficacy outcome measures were investigator-assessed objective response rate (ORR) and progression-free survival (PFS).
Danish: De vigtigste sekundære effektparametre var investigatorvurderet objektiv responsrate (ORR) og progressionsfri overlevelse (PFS, progression-free survival).
English: The primary efficacy outcome measure was overall survival (OS).
Danish: Den primære effektparameter var samlet overlevelse (OS, overall survival).
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
Danish: Humant IgG4 passerer placentabarrieren, og nivolumab er et IgG4; nivolumab har derfor potentiale til at blive overført fra moderen til fosteret.
English: Inflammation may cause serious damage to your body and some inflammatory conditions may be life-threatening and need treatment or withdrawal of nivolumab.
Danish: Inflammation kan give alvorlige skader i din krop, og nogle inflammationstilstande kan være livstruende og kræve behandling eller ophør med nivolumab.
English: There were no reports of hypophysitis, diabetes mellitus, or diabetic ketoacidosis in these studies.
Danish: Der var ingen rapporter om hypofysitis, diabetes mellitus eller diabetisk ketoacidose i disse studier.
English: Children and adolescents Nivolumab BMS should not be used in children and adolescents below 18 years of age.
Danish: Nivolumab BMS må ikke anvendes til børn og unge under 18 år.
English: Although hyperparathyroidism was not reported in CA209017, immune-related hyperparathyroidism might be considered especially if associated with hypophosphataemia (reported in 6 hypercalcemic patients in this study).
Danish: Selvom hyperparatyroidisme ikke blev rapporteret i CA209017, kan immunrelateret hyperparatyroidisme overvejes, især hvis det er associeret med hypofosfatæmi (rapporteret hos 6 patienter med hyperkalcæmi i dette studie).
English: Effective contraception should be used for at least 5 months following the last dose of Nivolumab BMS.
Danish: Der skal anvendes effektiv prævention i mindst 5 måneder efter den sidste dosis Nivolumab BMS.
English: Nivolumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Danish: Nivolumab forventes at blive nedbrudt til små peptider og aminosyrer via katabolske processer på samme måde som endogent IgG.
English: Rapid tapering may lead to worsening of the adverse reaction.
Danish: Hurtig nedtrapning kan medføre forværring af bivirkningen.
English: Results for growth indices, as well as teratogenic, neurobehavioral, immunological, and clinical pathology parameters throughout the 6-month postnatal period were comparable to the control group.
Danish: Resultater for vækstindeks såvel som teratogene, neuroadfærdsmæssige, immunologiske og klinisk patologiske parametre i løbet af den 6 måneders lange postnatale periode var sammenlignelige med kontrolgruppen.
English: The median age was 63 years (range: 39-85) with 44% ≥65 years of age and 11% ≥75 years of age.
Danish: Medianalderen var 63 år (39-85) med 44% ≥65 år og 11% ≥75 år.
English: Do not use Nivolumab BMS if you are pregnant unless your doctor specifically tells you to.
Danish: Du må ikke bruge Nivolumab BMS, hvis du er gravid, medmindre lægen specifikt beder dig om det.
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
English: • Relevant information (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) for the following safety concerns:
Danish: • Relevante oplysninger (f.eks. hvor alvorlig bivirkningen er, sværhedsgraden, hyppigheden, tid til opståen, reversibilitet) om følgende sikkerhedsproblemer:
English: No cases of overdose have been reported in clinical trials.
Danish: Der er ikke blevet rapporteret om tilfælde af overdosering i kliniske forsøg.
English: Polyolefin containers
Danish: Polyolefin-beholdere
English: None of these patients received high-dose corticosteroids.
Danish: Ingen af disse patienter fik højdosis kortikosteroid.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i
English: Take care to ensure aseptic handling when you prepare the infusion.
Danish: Vær opmærksom på aseptisk håndtering, mens infusionen forberedes.
English: The solution has a pH of approximately 6.0 and an osmolality of approximately 340 mOsm/kg.
Danish: Koncentratet har en pH på ca. 6,0 og en osmolaritet på ca. 340 mOsm/kg.
English: Median (95% CI) (months)
Danish: Median (95% CI) måneder
English: Other in-use storage time and conditions are the responsibility of the user.
Danish: Anden opbevaringstid og andre opbevaringsforhold er på eget ansvar.
English: Common (may affect up to 1 in 10 people)
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer)
English: Grade 3 anaphylactic reaction and Grade 4 hypersensitivity were each reported in 1 patient; both of these cases led to discontinuation and resolved with treatment.
Danish: Grad 3 anafylaktisk reaktion og grad 4 overfølsomhed blev hver især rapporteret hos 1 patient; i begge tilfælde medførte det seponering og resolution med behandling.
English: Your doctor will continue giving you Nivolumab BMS for as long as you keep benefitting from it or until you no longer tolerate the treatment.
Danish: Lægen vil fortsætte med at give dig Nivolumab BMS, så længe du har gavn af det, eller indtil du ikke længere tåler behandlingen.
English: Talk to your doctor if you are not
Danish: Tal med lægen, hvis du er i tvivl.
English: In the absence of data, nivolumab should be used with caution in these populations after careful consideration of the potential risk-benefit on an individual basis.
Danish: Da der ikke foreligger data, skal nivolumab anvendes med forsigtighed hos disse populationer og kun efter omhyggelig afvejelse af de potentielle risici og fordele for hver enkelt patient.
English: Ask your doctor if you can breast-feed during or after treatment with Nivolumab BMS.
Danish: Spørg lægen, om du kan amme under eller efter behandlingen med Nivolumab BMS.
English: Nivolumab BMS infusion is compatible with: PVC containers
Danish: Nivolumab BMS-infusionsvæske er kompatibel med: PVC-infusionssæt
English: Studies in animals have shown embryofoetal toxicity (see section 5.3).
Danish: Dyrestudier har påvist embryoføtal toksicitet (se pkt.
English: Prophylactic antibiotics should be used to prevent opportunistic infections in patients receiving immunosuppressive therapy.
Danish: Antibiotika bør anvendes profylaktisk for at forebygge opportunistiske infektioner hos patienter, der får immunsuppressiv behandling.
English: Nivolumab attaches to a target protein called programmed death-1 receptor (PD-1) that can switch off the activity of T cells (a type of white blood cell that forms part of the immune system, the body's natural defences).
Danish: Nivolumab kobler sig til et målprotein kaldet programmeret celledød-1 (PD-1), som kan slukke for aktiviteten af T-cellerne (en type hvide blodlegemer, der udgør en del af immunsystemet, kroppens naturlige forsvarssystem).
English: Patients should be monitored continuously (at least up to 5 months after the last dose) as an adverse reaction with nivolumab may occur at any time during or after discontinuation of nivolumab therapy.
Danish: Patienten bør monitoreres løbende (som minimum i op til 5 måneder efter den sidste dosis), da bivirkninger ved nivolumab kan opstå på et hvilket som helst tidspunkt under eller efter seponering af nivolumab.
English: There was no worsening to Grade 3 or 4 in increased ALT, increased alkaline phosphatase, and increased creatinine.
Danish: Der sås ingen forværring til grad 3 eller 4 af forhøjet ALAT, forhøjet alkalisk fosfatase
English: Patients treated with Nivolumab BMS must be given the patient alert card and be informed about the risks of Nivolumab BMS (see also package leaflet).
Danish: Patienter, der behandles med Nivolumab BMS, skal have udleveret patient-informationskortet og informeres om de risici, der er forbundet med Nivolumab BMS (se også indlægssedlen).
English: Nivolumab is not recommended during pregnancy and in women of childbearing potential not using effective contraception unless the clinical benefit outweighs the potential risk.
Danish: Nivolumab bør ikke anvendes under graviditet og til kvinder i den fertile alder, som ikke anvender sikker kontraception, medmindre den kliniske fordel opvejer den potentielle risiko.
English: The safety and efficacy of Nivolumab BMS in children below 18 years of age have not been established.
Danish: Nivolumab BMS' sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: The remaining offspring of nivolumab-treated females survived to scheduled termination, with no treatment-related clinical signs, alterations to normal development, organ-weight effects, or gross and microscopic pathology changes.
Danish: De resterende afkom af nivolumab-behandlede hunner overlevede til planlagt termin uden behandlingsrelaterede kliniske tegn, ændringer i normal udvikling, effekt på organvægt eller betydningsfulde eller mikroskopiske patologiske ændringer.
English: For suspected immune-related adverse reactions, adequate evaluation should be performed to confirm aetiology or exclude other causes.
Danish: Ved mistanke om immunrelaterede bivirkninger bør den nødvendige evaluering udføres for at bekræfte ætiologi eller udelukke andre årsager.
English: Prior to launch of Nivolumab BMS in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Forud for markedsføring af Nivolumab BMS i hvert enkelt medlemsland skal indehaveren af markedsføringstilladelsen blive enig med den relevante nationale myndighed om indholdet og udformningen af uddannelsesmaterialet, inklusive kommunikationsmedier, distributionsmetoder og andre aspekter af programmet.
English: 101 International Drive Portsmouth, New Hampshire
Danish: Portsmouth, New Hampshire
English: However, based on its mechanism of action, foetal exposure to nivolumab may increase the risk of developing immune-related disorders or altering the normal immune response and immune-related disorders have been reported in PD-1 knockout mice.
Danish: På baggrund af dets virkningsmekanisme kan føtal eksponering for nivolumab imidlertid øge risikoen for udvikling af immunrelaterede forstyrrelser eller ændring i normalt immunrespons, og der er rapporteret om immunrelaterede forstyrrelser hos PD-1 knockout-mus.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel, da den
English: Fertility studies have not been performed with nivolumab.
Danish: Der er ikke udført fertilitetsstudier med nivolumab.
English: Do not stop treatment with Nivolumab BMS unless you have discussed this with your doctor.
Danish: Du må ikke stoppe behandlingen med Nivolumab BMS, medmindre du har aftalt det med lægen.
English: Non-corticosteroid immunosuppressive therapy should be added if there is worsening or no improvement despite corticosteroid use.
Danish: Non-kortikosteroid immunsuppressiv behandling bør tilføjes, hvis der opstår forværring eller der ikke sker bedring, på trods af anvendelse af kortikosteroider.
English: Tell your doctor if you are taking or have recently taken any other medicines.
Danish: Fortæl det altid til lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: Survival benefit was observed regardless of whether patients had tumours that were designated PD-L1 negative or PDL1 positive (tumour membrane expression cut off of 1%, 5% or 10%).
Danish: Bedre overlevelse blev observeret, uanset om patienterne havde tumorer, som var kategoriseret som PD-L1-negative eller PD-L1-positive (tumormembran-ekspression cut-off-niveau på 1%, 5% eller 10%).
English: Study CA209017 included a limited number of patients ≥ 75 years (11 in the nivolumab group and 18 in the docetaxel group).
Danish: Studie CA209017 omfattede et begrænset antal patienter ≥ 75 år (11 i nivolumab-gruppen og 18 i docetaxel-gruppen).
English: To continue the exploration of the optimal cut-off for PD-L1 positivity based on current assay method used to further elucidate its value as predictive of nivolumab efficacy.
Danish: At fortsætte undersøgelsen af det optimale cut-off-niveau for PDL1-positivitet baseret på nuværende analysemetode til nærmere belysning af dets prædikative værdi for nivolumabs virkning.
English: The Adverse Reaction Management Guide shall contain the following key elements:
Danish: Behandlingsguiden til bivirkninger skal indeholde følgende hovedelementer:
English: Based on its pharmacodynamic properties, nivolumab is unlikely to affect the ability to drive and use machines.
Danish: Grundet dets farmakodynamiske egenskaber er det ikke sandsynligt, at nivolumab påvirker evnen til at føre motorkøretøj og betjene maskiner.
English: Nivolumab BMS is for intravenous use only.
Danish: Nivolumab BMS er kun til intravenøs anvendelse.
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal derefter fremsende PSUR'er i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for
English: Patients should be monitored for clinical signs and symptoms of endocrinopathies and for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation).
Danish: Patienten skal monitoreres for kliniske tegn og symptomer på endokrinopatier og for ændringer i thyroideafunktionen (i begyndelsen af behandlingen, regelmæssigt under behandlingen og som indiceret baseret på klinisk evaluering).
English: Grade 3 or 4 pneumonitis
Danish: Grad 3 eller 4 pneumonitis
English: The metabolic pathway of nivolumab has not been characterised.
Danish: Nivolumabs metaboliseringsvej er ikke belyst.
English: Body weight normalised dosing produced approximately uniform steady-state trough concentration over a wide range of body weights (34-162 kg).
Danish: Kropsvægtnormaliserede doser medførte nogenlunde samme steady state dal-koncentration over et bredt interval af kropsvægt (34-162 kg).
English: Nivolumab should not be resumed while the patient is receiving immunosuppressive doses of corticosteroids or other immunosuppressive therapy.
Danish: Behandling med nivolumab bør ikke genoptages, mens patienten får immunsuppressive doser af kortikosteroid eller anden immunsuppressiv behandling.
English: In the phase 1 study MDX1106-03, pneumonitis, including a Grade 4 case in 1 patient, was reported in 3/37 patients (8.1%) with NSCLC receiving nivolumab 3 mg/kg.
Danish: I fase 1-studiet MDX1106-03 blev pneumonitis, herunder et grad 4 tilfælde hos 1 patient, rapporteret hos 3/37 patienter (8,1%) med NSCLC, som fik nivolumab 3 mg/kg.
English: The patient will be provided with the Patient Alert Card with each prescription.
Danish: Patienten skal have udleveret patient-informationskortet ved hver ordination.
English: No Grade 3-5 thyroid disorders were reported.
Danish: Ingen grad 3-5 thyroidealidelser blev rapporteret.
English: Severe hepatitis has been observed with nivolumab treatment.
Danish: Svær hepatitis er observeret med nivolumab-behandling.
English: Efficacy results (CA209017)
Danish: Effektresultater (CA209017)
English: Two patients (1 with Grade 2 rash and 1 with Grade 3 rash) required permanent discontinuation of nivolumab.
Danish: Hos to patienter (1 med grad 2 udslæt og 1 med grad 3 udslæt) var det nødvendigt at seponere nivolumab permanent.
English: The educational programme is aimed at increasing the awareness about the potential immune mediated adverse events associated with Nivolumab BMS use, how to manage them and to enhance the awareness of patients or their caregivers on the signs and symptoms relevant to the early those adverse events.
Danish: Uddannelsesmaterialet har til formål at øge opmærksomheden omkring de potentielle immunmedierede bivirkninger, der er forbundet med Nivolumab BMS, hvordan de behandles, og at gøre patienterne eller omsorgspersonerne opmærksomme på tidlige tegn og symptomer på disse bivirkninger.
English: The rate of disease-related symptom improvement, as measured by LCSS, was similar between the nivolumab group (18.5%) and the docetaxel group (21.2%).
Danish: Hyppigheden af bedring i sygdomsrelaterede symptomer, målt med LCSS, var sammenlignelig i nivolumab-gruppen (18,5%) og docetaxel-gruppen (21,2%).
English: Eight patients, including the 4 patients with a Grade 3 case, required permanent discontinuation of nivolumab due to pneumonitis.
Danish: Hos otte patienter, herunder de 4 patienter med grad 3 pneumonitis, var det nødvendigt at seponere nivolumab permanent på grund af pneumonitis.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with nivolumab in all subsets of the paediatric population in the treatment of malignant solid tumours (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med nivolumab i alle undergrupper af den pædiatriske population ved behandling af maligne solide tumorer (se pkt.
English: Most patients
Danish: Ældre patienter
English: The study included patients (18 years or older) who have experienced disease progression during or after one prior platinum doublet-based chemotherapy regimen and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Danish: Studiet omfattede patienter (18 år eller ældre), som havde oplevet sygdomsprogression under eller efter et tidligere platinbaseret dublet-kemoterapiregime, og som havde en Eastern Cooperative Oncology Group (ECOG) performance-score på 0 eller 1.
English: Nivolumab is produced in Chinese hamster ovary cells by recombinant DNA technology.
Danish: Nivolumab fremstilles ved rekombinant DNA-teknologi i ovarieceller fra kinesiske hamstre.
English: In study CA209017, hypercalcaemia was more frequently reported in the nivolumab group (31/130, 24%) than in the docetaxel group (9/124, 7%).
Danish: I studie CA209017 blev hyperkalcæmi rapporteret hyppigere i nivolumab-gruppen (31/130, 24%) end i docetaxel-gruppen (9/124, 7%).
English: Use a separate infusion line for the infusion.
Danish: Anvend en separat infusionsslange til infusionen.
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
English: The prescribed dose for the patient is given in mg/kg.
Danish: Den ordinerede dosis til patienten angives i mg/kg.
English: Although ECOG status, baseline glomerular filtration rate (GFR), albumin, body weight, and mild hepatic impairment had an effect on nivolumab CL, the effect was not clinically meaningful.
Danish: På trods af, at ECOG-status, glomerulær filtrationshastighed (GFR) ved baseline, albumin, kropsvægt og let nedsat leverfunktion havde en effekt på nivolumabs CL, var effekten uden klinisk relevans.