natgillin/translations-raw huggingface dataset:
o Optag ekg ved afslutningen af 6-timers-monitoreringsperioden. 
o Perform an ECG at the end of the 6-hour monitoring period.
At der skal optages et ekg efter 6 timer, og at monitorering under visse omstændigheder kan betyde en overnatning. 
They will need an ECG at 6 hours and in some circumstances monitoring may involve an overnight stay.
• Lægers tjekliste inden ordination af Gilenya 
• Physician's checklist prior to prescribing GILENYA
• Nyopstået AV-blok af 2. grad eller derover. 
• New onset second degree or higher AV block.
Forlæng monitorering af hjertefrekvens mindst natten over på sygehus, og indtil tilstanden er ophørt, hos patienter: o Som har krævet farmakologisk intervention under monitoreringen ved behandlingsstart. 
Extend heart rate monitoring for at least overnight in a medical facility and until resolution of findings in patients: o Requiring pharmacological intervention during monitoring at treatment initiation.
Lægernes tjekliste skal indeholde følgende vigtige oplysninger: 
The physician's checklist shall contain the following key messages:
o Nødvendigheden af at udlevere et informationskort til patienterne. 
o The need to provide patients with the patient reminder card.
o Gilenya reducerer lymfocyttallet i det perifere blod. 
o GILENYA reduces peripheral blood lymphocyte counts.
o Specifikke anbefalinger vedrørende vaccination af patienter, der skal starte eller er i behandling med Gilenya. 
o Specific recommendations regarding vaccination for patients initiating or currently on GILENYA treatment.
o Den teratogene risiko ved Gilenya: vigtigheden af at undgå graviditet under behandling med Gilenya og nødvendigheden af, at der foreligger en negativ graviditetstest, inden behandlingen påbegyndes. 
o The teratogenic risk of GILENYA: the importance of avoiding pregnancy when undergoing treatment with GILENYA and the need for a negative pregnancy test result prior to treatment initiation.
o Nødvendigheden af straks at indberette symptomer, som indikerer lav hjertefrekvens (som fx svimmelhed, følelse af at snurre rundt (vertigo), kvalme eller hjertebanken) efter den første Gilenya-dosis. 
o The need to report immediately symptoms indicating low heart rate (such as dizziness, vertigo, nausea or palpitations) after the first dose of GILENYA.
• Patient-informationskort 
• Patient reminder card
Medlemslandene skal sikre, at MAH udleverer en opdateret lægeminformationspakke til alle læger, som forventes at ordinere Gilenya ved lancering og efter lancering, som indeholder følgende elementer: 
The Member States shall ensure that, at launch and after launch, the MAH provides all physicians who intend to prescribe GILENYA with an updated physician information pack containing the following elements:
o Nødvendigheden af at monitorere leverfunktionen ved måned 1, 3, 6, 9 og 12 under behandling med Gilenya og periodisk derefter. 
o The need for liver function monitoring at months 1, 3, 6, 9 and 12 during GILENYA therapy and periodically thereafter.
Patientinformationskortet skal indholde følgende vigtige oplysninger: 
The patient reminder card shall contain the following key messages:
o Foretag leverfunktionstest inden behandlingsstart. 
o Perform a liver function test prior to treatment initiation.
o Gilenya anbefales ikke til patienter, som samtidig tager lægemidler, der er kendt for at sænke hjertefrekvensen. 
o GILENYA is not recommended in patients concomitantly taking medicines which are known to decrease the heart rate.
Det er nødvendigt at måle patientens perifere lymfocyttal (komplet blodtælling, CBC) inden behandlingsstart og at monitorere det under Gilenya-behandlingen. 
There is a need to check the patient's peripheral lymphocyte count (CBC) prior to initiation and to monitor during treatment with GILENYA.
o Gilenya anbefales ikke til patienter, som samtidig tager klasse Ia- eller klasse III-antiarytmika. 
o GILENYA is not recommended in patients concomitantly taking Class Ia or Class III antiarrhythmic medicines.
o Gilenya anbefales ikke til patienter med hjertesygdomme, eller som samtidig tager medicin kendt for at nedsætte hjertefrekvensen, og at patienterne skal fortælle alle læger, som tilser dem, at de er i behandling med Gilenya. 
o GILENYA is not recommended in patients with cardiac disease or those taking medicines concomitantly known to decrease heart rate and they should tell any doctor they see that they are being treated with GILENYA.
Under alvorlige infektioner skal seponering af behandlingen overvejes. 
Suspension of treatment during serious infections should be considered.
o Nødvendigheden af, at der udføres en leverfunktionstest, inden behandlingen påbegyndes, og for at monitorere leverfunktionen ved måned 1, 3, 6, 9 og 12 under behandlingen med Gilenya og periodisk derefter. 
o The need for a liver function test prior to treatment initiation and for liver function monitoring at months 1, 3, 6, 9 and 12 during GILENYA therapy and periodically thereafter.
o Nødvendigheden af en komplet oftalmologisk undersøgelse 3-4 måneder efter behandlingsstart med Gilenya for tidligt at opdage nedsat syn pga. lægemiddelinduceret maculaødem. 
o The need for a full ophthalmological assessment 3-4 months after starting GILENYA therapy for the early detection of visual impairment due to drug-induced macular oedema.
Hvis behandling med Gilenya overvejes til disse patienter, skal de forventede fordele opveje de mulige risici, og der skal søges rådgivning hos en kardiolog om skift til en behandling, som ikke sænker hjertefrekvensen, eller hvis dette ikke er muligt for at fastlægge passende monitorering. 
If GILENYA treatment is considered in these patients anticipated benefits must outweigh potential risks and a cardiologist must be consulted to switch to non heart-rate-lowering therapy or, if not possible, to determine appropriate monitoring.
Indtil 6 timer efter første dosis (eller hvis den seneste dosis af Gilenya blev administreret for mere end to uger siden) o Monitorer patienten i 6 timer efter den første dosis af Gilenya er blevet administreret for tegn og symptomer på bradykardi, inklusive måling af puls og blodtryk hver time. 
Until 6 hours after first dose (or if the last dose of GILENYA was more than two weeks previously) o Monitor the patient for 6 hours after the first dose of GILENYA has been administered for signs and symptoms of bradycardia, including hourly pulse and blood pressure checks.
• Hjertefrekvens <45 slag pr. minut. 
• Heart rate <45 bpm.
o Nødvendigheden af at informere kvinder i den fertile alder om de alvorlige risici for fosteret og om, at der skal anvendes effektiv antikonception under behandlingen og i mindst to måneder efter ophør med Gilenya-behandling. 
o The need to advise women of child-bearing potential on the serious risk to the foetus and the need to practice effective contraception during treatment and for at least two months following discontinuation of treatment with GILENYA.
o At Gilenya frarådes til patienter med: o Mobitz Type II AV-blok af 2.grad eller derover o Syg sinus-syndrom o Sinuatrialt blok o QTc-forlængelse >470 msek. 
o That GILENYA is not recommended in patients with: o Second degree Mobitz Type II or higher AV block o Sick-sinus syndrome o Sino-atrial heart block o QTc prolongation >470 msec (females) or >450 msec (males) o Ischaemic cardiac disease including angina pectoris o Cerebrovascular disease o History of myocardial infarction o Congestive heart failure o History of cardiac arrest o Severe sleep apnoea o History of symptomatic bradycardia o History of recurrent syncope o Uncontrolled hypertension
Hvis behandling med Gilenya overvejes til disse patienter, skal de forventede fordele opveje de mulige risici, og der skal søges rådgivning hos en kardiolog for at fastlægge den mest hensigtsmæssige monitorering. 
If GILENYA treatment is considered in these patients anticipated benefits must outweigh potential risks and a cardiologist must be consulted to determine appropriate monitoring, at least overnight extended monitoring is recommended.
o Inden behandlingsstart med Gilenya planlægges en oftalmologisk undersøgelse hos patienter med diabetes mellitus eller med uveitis i anamnesen. 
o Arrange ophthalmological assessment prior to initiation with GILENYA in patients with diabetes mellitus or with a history of uveitis.
o At det er nødvendigt at monitorere hjertefrekvensen i 6 timer eller mere efter den første Gilenya-dosis (eller hvis sidste dosis blev administreret for mere end 2 uger siden), inklusive måling af puls og blodtryk hver time. 
o That their heart rate will need to be monitored for 6 or more hours after the first dose of GILENYA (or when the last dose of GILENYA has been administered more than two weeks ago), including hourly pulse and blood pressure checks.
>6 til 8 timer efter den første dosis (eller hvis den seneste dosis af Gilenya blev administreret for mere end to uger siden) o Hvis hjertefrekvensen ved 6-timers-målingen er den laveste værdi efter den første dosering, skal monitorering af hjertefrekvensen forlænges med mindst 2 timer, og indtil hjertefrekvensen igen stiger. 
>6 to 8 hours after first dose (or if the last dose of GILENYA was more than two weeks previously) o If, at the 6-hour time point, the heart rate is at the lowest value following the first dose,
o Tegn og symptomer på infektion og nødvendigheden af straks at indberette disse til den ordinerende læge under behandlingen og i op til to måneder efter, behandling med Gilenya er stoppet. 
o The signs and symptoms of infection and the need to report these immediately to the prescriber during and up to two months after treatment with GILENYA.
o Straks indberette enhver (tilsigtet eller utilsigtet) graviditet under behandlingen og i to måneder efter behandlingsophør til den ordinerende læge. 
o Report any (intended or unintended) pregnancy during and two months following discontinuation of treatment with GILENYA immediately to the prescriber.
• Produktresumé 
• The Summary of Product Characteristics
o Nødvendigheden af at informere patienten om straks at indberette tegn og symptomer på infektioner til den ordinerende læge under behandlingen og i op til to måneder efter behandling med Gilenya. 
o The need to instruct patients to report signs and symptoms of infections immediately to their prescriber during and for up to two months after treatment with GILENYA.
o Anbefalinger for monitorering natten over efter første dosis (eller hvis den seneste dosis af Gilenya blev administreret for mere end to uger siden). 
o Recommendation for overnight monitoring after the first dose (or if the last dose of GILENYA was more than two weeks previously).
o Nødvendigheden af oftalmologisk vurdering af patienter med diabetes mellitus eller med uveitis i anamnesen under Gilenya-behandling. 
o The need for ophthalmological assessment during treatment with GILENYA in patients with diabetes mellitus or with a history of uveitis.
o At der skal optages baseline-ekg og måles blodtryk før den første dosis af Gilenya (eller hvis sidste dosis blev administreret for mere end 2 uger siden). 
o That they will have a baseline ECG and blood pressure measurement prior to the first dose of GILENYA (or when the last dose of GILENYA has been administered more than two weeks ago).
o Påkrævet monitorering ved behandlingsstart Inden første dosis o Optag baseline-ekg før den første dosis af Gilenya (eller hvis den seneste dosis blev administreret for mere end to uger siden). 
o Monitoring requirements at treatment initiation Before first dose o Perform baseline ECG prior to the first dose of GILENYA (or when the last dose of GILENYA was more than two weeks previously).
o Nødvendigheden af straks at indberette ethvert tegn på nedsat syn til den ordinerende læge under behandlingen og i op til to måneder efter, behandling med Gilenya er stoppet. 
o The need to report any symptoms of visual impairment immediately to the prescriber during and for up to two months after the end of treatment with GILENYA.
o Foretag blodtryksmåling før den første dosis af Gilenya (eller hvis den seneste dosis blev administreret for mere end to uger siden). 
o Perform blood pressure measurement prior to the first dose of GILENYA (or when the last dose of GILENYA was more than two weeks previously).
o At Gilenya er teratogent, og derfor skal kvinder i den frugtbare alder: o Være testet negative for graviditet. 
o That GILENYA is teratogenic so women with childbearing potential must: o Have a negative pregnancy test. o Be using effective contraception during and for at least two months following discontinuation of treatment with GILENYA.
Dette øger immunsystemets evne til at dræbe kræftceller. 
This increases the ability of the immune system to kill cancer cells.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Nivolumab BMS findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR and risk management plan summary for Nivolumab BMS can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Lægemidlet indeholder det aktive stof nivolumab. 
The medicine contains the active substance nivolumab.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Nivolumab BMS. 
This is a summary of the European public assessment report (EPAR) for Nivolumab BMS.
Der er udarbejdet en risikostyringsplan for at sikre, at Nivolumab BMS anvendes så sikkert som muligt. 
A risk management plan has been developed to ensure that Nivolumab BMS is used as safely as possible.
Når nivolumab bindes til PD-1, blokerer det receptoren og hindrer den i at slukke for disse immunceller. 
When it attaches to PD-1, nivolumab blocks the receptor and prevents it from switching off these immune cells.
De hyppigste bivirkninger ved Nivolumab BMS (som optræder hos mere end 1 ud af 10 personer) er træthed, nedsat appetit og kvalme (utilpashed), der i de fleste tilfælde er milde eller moderate. 
The most common side effects with Nivolumab BMS (which may affect more than 1 in 10 people) are tiredness, decreased appetite, and nausea (feeling sick), which are mostly mild or moderate in severity.
Patienter, hvis cancer klart udtrykte PD-1, synes at drage størst nytte, men da andre patienter også responderede, er yderligere studier nødvendige for at afklare, hvilke patientgrupper der mest sandsynligt drager nytte af lægemidlet. 
Patients whose cancer clearly expressed PD-1 seem to show most benefit, but as other patients also responded, further study to clarify patient groups most likely to benefit from the medicine is needed.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Nivolumab BMS opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU. 
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Nivolumab BMS's benefits are greater than its risks and recommended that it be approved for use in the EU.
Middeloverlevelsen blandt 135 patienter, der fik Nivolumab BMS, var ca. 9 måneder, hvorimod den blandt de 137 patienter, der fik docetaxel, var 6 måneder. 
The average survival among 135 patients given Nivolumab BMS was around 9 months, whereas among the 137 patients given docetaxel it was 6 months.
Det aktive stof i Nivolumab BMS er et monoklonalt antistof. 
The active substance in Nivolumab BMS is a monoclonal antibody.
Nivolumab BMS er sædvanligvis forbundet med bivirkninger, der er knyttet til immunsystemets aktivitet på kroppens organer. 
Nivolumab BMS is also commonly associated with side effects related to the activity of the immune system on body organs.
Virksomheden skal desuden udlevere et advarselskort til patienterne med oplysninger om risiciene ved lægemidlet samt anvisninger for, hvornår de skal kontakte lægen, hvis de får symptomer på bivirkninger. 
The company will also provide an alert card for patients with information on the risks of the medicine, as well as instructions on when to contact their doctor if they experience symptoms of side effects.
Behandling med Nivolumab BMS blev sammenlignet med et andet kræftlægemiddel, docetaxel, og hovedmålet for effektivitet var samlet overlevelse (hvor længe patienter levede). 
Treatment with Nivolumab BMS was compared with another cancer medicine, docetaxel, and the main measure of effectiveness was overall survival (how long patients lived).
Underbyggende oplysninger blev også leveret fra et andet studie, der angav, at Nivolumab BMS kunne frembringe en respons hos patienter, hvis sygdom var fremskreden på trods af flere tidligere behandlinger. 
Supportive information was also provided from another study indicating that Nivolumab BMS could produce a response in patients whose disease had progressed despite several previous treatments.
Nivolumab BMS er et cancerlægemiddel, der anvendes til behandling af voksne med en type lungecancer, der kaldes planocellulært ikke-småcellet lungecancer (NSCLC). 
Nivolumab BMS is a cancer medicine used to treat adults with a type of lung cancer called squamous non-small cell lung cancer (NSCLC).
Bivirkninger fandtes at være overskuelige ved passende forholdsregler og blev opvejet af 
Side effects were considered manageable with appropriate measures and were outweighed by the benefits.
Det antigen, som nivolumab er opbygget til at bindes til, er en receptor, kaldet "programmeret celledød-1" (PD-1), som slukker for aktiviteten af visse celler i immunsystemet (kroppens naturlige forsvar), kaldet T-celler. 
The antigen to which nivolumab has been designed to attach is a receptor called ‘programmed cell death-1' (PD-1), which switches off the activity of certain cells of the immune system (the body's natural defences) called T cells.
Hvis du ønsker yderligere oplysninger om behandling med Nivolumab BMS, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Nivolumab BMS, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Et monoklonalt antistof er et antistof (en type protein), der er opbygget til at genkende og bindes til en specifik struktur (et antigen), der findes i visse celler i kroppen. 
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body.
Det anvendes til patienter, hvis sygdom har spredt sig lokalt eller til andre dele af kroppen, og som tidligere er blevet behandlet 
It is used in patients whose disease has spread locally or to other parts of the body and who have previously been treated with other cancer medicines (chemotherapy).
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Nivolumab BMS, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge. 
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nivolumab BMS, including the appropriate precautions to be followed by healthcare professionals and patients.
Lægemidlet fås som et koncentrat til fremstilling af en opløsning til infusion (drop) i en vene. 
The medicine is available as a concentrate for making up a solution for infusion (drip) into a vein.
Hvad er Nivolumab BMS, og hvad anvendes det til? 
What is Nivolumab BMS and what is it used for?
Det er ikke en praktisk vejledning i, hvordan Nivolumab BMS bør anvendes. 
It is not intended to provide practical advice on how to use Nivolumab BMS.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske 
The European Commission granted a marketing authorisation valid throughout the European Union for Nivolumab BMS on 20.
Lægemidlet blev forbundet med forbedret overlevelse i forhold til docetaxel hos patienter med fremskreden, tidligere behandlet planocellulært NSCLC, en patientgruppe, der har få behandlingsmuligheder. 
The medicine was associated with improved survival over docetaxel in patients with advanced, previously treated squamous NSCLC, a patient group who have few treatment options.
Nivolumab BMS udleveres kun efter recept, og behandlingen skal påbegyndes og overvåges af en læge 
Nivolumab BMS can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced in the treatment of cancer.
Den fuldstændige liste over alle bivirkninger og begrænsninger ved Nivolumab BMS fremgår af 
For the full list of all side effects and restrictions with Nivolumab BMS, see the package leaflet.
Virksomheden skal derudover gennemføre yderligere studier over de langsigtede fordele ved Nivolumab samt prøve at udpege de patienter, der mest sandsynligt forventes at få gavn af behandling med lægemidlet. 
It will also conduct further studies on the long-term benefits of Nivolumab BMS, and try to identify which patients are most likely to benefit from treatment with the medicine.
Den anbefalede dosis er 3 mg nivolumab pr. kg kropsvægt givet i en vene over 60 minutter hver anden uge, så længe patienten responderer positivt på den. 
The recommended dose is 3 mg of nivolumab per kilogram body weight given into a vein over 60 minutes, every two weeks for as long as the patient continues to benefit from it. Doses may need to be delayed or treatment stopped altogether if the patient develops certain severe side effects.
Hvilke risici er der forbundet med Nivolumab BMS? 
What are the risks associated with Nivolumab BMS?
Det er blevet påvist i ét hovedstudie, der involverede 272 patienter med tidligere behandlet planocellulært NSCLC, der var fremskreden eller havde spredt sig til hele kroppen, at Nivolumab BMS havde forbedret patienternes overlevelse. 
Nivolumab BMS have been shown to improve patients' survival in one main study involving 272 patients with previously treated squamous NSCLC that was advanced or had spread throughout the body.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv 
What measures are being taken to ensure the safe and effective use of Nivolumab BMS?
Hvilke fordele viser undersøgelserne, at der er ved Nivolumab BMS? 
What benefits of Nivolumab BMS have been shown in studies?
Hvordan virker Nivolumab BMS? 
How does Nivolumab BMS work?
De fleste bivirkninger svinder ved passende behandling eller ved ophør 
Most will resolve following appropriate treatment or on stopping Nivolumab BMS.
Desuden skal den virksomhed, der markedsfører Nivolumab BMS, udlevere oplysningsmateriale til læger, der forventes at ordinere lægemidlet. 
In addition, the company that markets Nivolumab BMS will provide educational packs for doctors who are expected to prescribe the medicine, containing information on how it should be used and how to manage side effects, particularly side effects related to the activity of the immune system.
De nærmere oplysninger fremgår af 
nivolumab
15 ml (20 mg/ml) 1 hætteglas 
Intravenous use Vial (glass) 15 ml (20 mg/ml) 1 vial
300 mg Koncentrat til infusionsvæske, opløsning 
300mg Concentrate for solution for infusion
EMA's procedurenr. 
EMA procedure number
(Særnavn) Navn Styrke 
(Invented) name Strength
Disse virkninger er sædvanligvis reversible. 
These effects are usually reversible.
Dette er den indikation, som ansøgeren nu foreslår, og som er blevet registreret i 15 medlemsstater i EU. 
This is the indication currently proposed by the applicant and has been registered in 15 member states of the EU.
Ikke kendt: (kan ikke estimeres ud fra forhåndenværende data) 
Not known: (cannot be estimated from the available data)
Klinisk og biologisk monitorering er påkrævet. 
Clinical and biological monitoring is required.
De kliniske konsekvenser af disse interaktioner er ikke blevet evalueret. 
The clinical consequences of these interactions have not been evaluated.
Børn og unge (<18 år) 
Use in children and adolescents (< 18 years)
Patienterne bør rehydreres før administration. 
Patients should be rehydrated before the administration.
Begrænsede data er tilgængelige med hensyn til overdosering hos mennesker. 
Limited data are available in regard to overdosage in humans.