FrancophonIA/ELRC3.0 huggingface dataset:
English: Efavirenz Teva is a medicine that contains the active substance efavirenz.
Danish: Efavirenz Teva er et lægemiddel, der indeholder det aktive stof efavirenz.
English: What are the benefits and risks of Efavirenz Teva?
Danish: Hvilken fordel og risiko er der forbundet med Efavirenz Teva?
English: Efavirenz Teva must be given in combination with other antiviral medicines.
Danish: Efavirenz Teva skal gives sammen med anden antiviral medicin.
English: Other information about Efavirenz Teva
Danish: Andre oplysninger om Efavirenz Teva:
English: Efavirenz Teva is a ‘generic medicine'.
Danish: Efavirenz Teva er et ‘generisk lægemiddel'.
English: The Committee recommended that Efavirenz Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Efavirenz Teva.
English: Why has Efavirenz Teva been approved?
Danish: Hvorfor blev Efavirenz Teva godkendt?
English: Efavirenz Teva is an antiviral medicine.
Danish: Efavirenz Teva er et antirviralt lægemiddel.
English: How has Efavirenz Teva been studied?
Danish: Hvordan blev Efavirenz Teva undersøgt?
English: What is Efavirenz Teva?
Danish: Hvad er Efavirenz Teva?
English: The dose of Efavirenz Teva needs to be reduced in patients taking voriconazole (used to treat fungal infections).
Danish: Hos patienter, der tager voriconazol (anvendes ved svampeinfektioner), skal dosis af Efavirenz Teva reduceres.
English: How is Efavirenz Teva used?
Danish: Hvordan anvendes Efavirenz Teva?
English: How does Efavirenz Teva work?
Danish: Hvordan virker Efavirenz Teva?
English: What is Efavirenz Teva used for?
Danish: Hvad anvendes Efavirenz Teva til?
English: The average follow-up was approximately two years.
Danish: Den gennemsnitlige opfølgningsperiode var ca. 2 år.
English: • Improve your physical function.
Danish: • Forbedre din fysiske funktionsevne.
English: Some of these patients died.
Danish: Nogle af disse patienter døde.
English: Date of first authorisation: 1 October 2009 Date of latest renewal: 19 June 2014
Danish: Dato for første markedsføringstilladelse: 1. oktober 2009 Dato for seneste fornyelse: 19. juni 2014
English: These are both normal and do not need to be removed.
Danish: Dette er normalt og ikke nødvendigt at fjerne.
English: • You will also notice an air bubble, which is normal.
Danish: • Du vil også bemærke en luftboble, hvilket er normalt.
English: 24 months
Danish: 24 måneder
English: Hold firmly.
Danish: Hold fast.
English: This trend was not observed in the PsA population.
Danish: Denne tendens blev ikke observeret i PsA-populationen.
English: You may also see one or more air bubbles.
Danish: Du kan eventuelt også se en eller flere luftbobler.
English: ASAS Partial Remission ASDAS-C
Danish: ASAS Partiel Remission ASDAS-C
English: Component of a multipack, cannot be sold separately
Danish: Del af en multipakke, må ikke sælges separat
English: *Removing air bubbles helps make sure the right dose is given.
Danish: *Fjernelse af luftbobler er med til at sikre, at der gives den korrekte dosis.
English: • Again, all sites mentioned can be used regardless of your body type or size.
Danish: • Alle de nævnte områder kan anvendes uanset din kropstype eller størrelse.
English: Approximately half the cases were lymphomas.
Danish: Ca. halvdelen af tilfældene var lymfomer.
English: • You will hear a loud ‘click' sound - don't be alarmed.
Danish: • Du vil høre et ”klik” - bliv ikke urolig.
English: This appearance is not unusual for solutions containing protein.
Danish: Dette er ikke usædvanligt for opløsninger indeholdende protein.
English: Switching between biological DMARDs
Danish: Skift mellem biologiske DMARDs
English: Show this card to any doctor involved in your treatment.
Danish: Vis dette kort til enhver læge, der er involveret i din behandling.
English: • Certain vaccinations may cause infections.
Danish: • Visse vaccinationer kan forårsage infektioner.
English: Most of these patients were adolescent or young adult males.
Danish: De fleste af disse patienter var unge eller yngre voksne mænd.
English: At week 48,
Danish: Ved uge 48
English: Consequently, these infants may be at increased risk of infection.
Danish: Som følge deraf kan disse spædbørn have en øget risiko for infektioner.
English: This usually takes about 3-6 seconds, but it may take up to 15 seconds for you to hear the second ‘click' sound.
Danish: Det varer som regel 3-6 sekunder, men det kan tage op til 15 sekunder, før du hører det andet ”klik”.
English: Corticosteroids were to be tapered at the start of the maintenance study.
Danish: Kortikosteroider skulle nedtrappes ved starten af vedligeholdelsesstudiet.
English: • The yellow indicator will fill about half of the viewing window.
Danish: • Den gule indikator vil fylde omkring halvdelen af vinduet.
English: Your doctor may decide to stop treatment.
Danish: Din læge kan beslutte at stoppe behandlingen.
English: • You will choose from 2 injection methods.
Danish: • Du kan vælge mellem to injektionsmetoder.
English: These medicines are used for the treatment of rheumatic diseases.
Danish: Disse lægemidler anvendes til behandling af reumatoide sygdomme.
English: Week 14 Week 24
Danish: Uge 14 Uge 24
English: Because the elimination of golimumab may take up to 5 months, monitoring should be continued throughout this period.
Danish: Da eliminationen af golimumab kan tage op til fem måneder, bør monitorering fortsætte i denne periode.
English: It is normal to see some drug still visible in the viewing window.
Danish: Det er normalt, at der stadig er noget medicin synligt i inspektionsvinduet.
English: Side effects may appear up to several months after the last injection.
Danish: Bivirkninger kan opstå i flere måneder efter sidste indsprøjtning.
English: Before you begin using this pre-filled pen, you should know how to:
Danish: Før du begynder at bruge den fyldte pen, skal du vide, hvordan:
English: The number of patients with other PsA subtypes was too small to allow meaningful assessment.
Danish: Antallet af patienter med andre PsA-subtyper var for lavt til at give en meningsfuld evaluering.
English: Do not ever re-use a pre-filled syringe, for your safety and health and for the safety of others.
Danish: Genbrug aldrig injektionssprøjten af hensyn til din egen sikkerhed og helbred samt af hensyn til andres menneskers sikkerhed.
English: Check the window - a yellow indicator confirms proper administration (see figure 9)
Danish: Tjek vinduet - en gul indikator bekræfter rigtig håndtering (se figur 9)
English: The significance of this finding is unknown.
Danish: Betydningen af dette er ukendt.
English: Your injection is now complete!
Danish: Indsprøjtningen er nu færdig!
English: Defined as a Mayo score ≤ 2 points, with no individual subscore > 1
Danish: Defineret som en Mayo-score ≤ 2 point, uden individuel subscore > 1
English: Ask your doctor if you don't know if these fungal infections are common in the area in which you have lived or travelled.
Danish: Spørg din læge, hvis du ikke ved, om disse infektioner er almindelige i det område, du har boet eller rejst i.
English: The next dose should be administered based on the following guidance:
Danish: Den næste dosis skal administreres efter følgende retningslinjer:
English: • Reduce the signs and symptoms of your disease.
Danish: • Reducere sygdomstegn og symptomer på din sygdom.
English: • You should not take Simponi with medicines containing the active substance anakinra or abatacept.
Danish: • Du må ikke tage Simponi sammen med lægemidler, der indeholder de aktive stoffer anakinra eller abatacept.
English: • Once the button is pressed, it will remain pressed in so you do not need to keep pressure on it.
Danish: • Så snart knappen er trykket ind, vil den forblive inde, så det er ikke nødvendigt fortsat at trykke på den.
English: This type of cancer has usually resulted in death.
Danish: Denne kræfttype har sædvanligvis haft dødelig udgang.
English: Physicians global assessment of disease (VAS
Danish: Lægers globale vurdering af sygdomsaktivitet (VAS
English: If the yellow indicator is not shown in the window, the plunger has not advanced adequately, and the injection has not occurred.
Danish: Hvis den gule indikator ikke vises i vinduet, er stemplet ikke kommet langt nok frem, og indsprøjtningen har ikke fundet sted.
English: The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression.
Danish: De andre tilfælde repræsenterede en variation af forskellige maligniteter inklusive sjældne maligniteter, som oftest associeret med immunsuppression.
English: • Children weighing at least 40 kg:
Danish: • Børn, der vejer mindst 40 kg:
English: For all of the endpoints described above, statistically significant results were also demonstrated in the OSI population at week 16.
Danish: For alle endepunkterne beskrevet ovenfor blev der også påvist statistisk signifikante resultater i OSIpopulationen ved uge 16.
English: EXP EXP, if stored at room temperature___________________
Danish: EXP EXP, hvis opbevaret ved stuetemperatur___________________
English: Talk to your child's doctor regarding vaccinations for your child.
Danish: Tal med barnets læge om vaccinationer til barnet.
English: • Please make sure you also have a list of all other medicines that you are using with you at any visit to a health care professional.
Danish: • Sørg for at du har en liste over al anden medicin, som du anvender når du besøger en sundhedsprofessionel.
English: • Provision to record the type, date, and result of TB screenings.
Danish: • Mulighed for at notere type, dato og resultater af TB-screeninger.
English: Similar rates were shown across rheumatologic indications.
Danish: Tilsvarende hyppighed blev vist på tværs af de reumatologiske indikationer.
English: GO-FORWARD Active RA despite MTX
Danish: GO-FORWARD Aktiv RA til trods for MTX
English: The long half-life should be taken into consideration if a surgical procedure is planned.
Danish: Den lange halveringstid bør tages i betragtning, hvis et kirurgisk indgreb er planlagt.
English: In addition, some previous infections may reappear.
Danish: Endvidere kan tidligere infektioner dukke op igen.
English: Cases reported in clinical studies in asthma
Danish: Tilfælde af astma rapporteret i kliniske studier
English: Tuberculosis (TB)
Danish: Tuberkulose (TB)
English: Single doses up to 10 mg/kg intravenously have been administered in a clinical study without dose-limiting toxicity.
Danish: Enkeltdoser på op til 10 mg/kg er administreret intravenøst i et klinisk studie uden dosisbegrænsende toksicitet.
English: • Positive blood lupus test
Danish: • Positiv blodprøve for lupus
English: • Some of these reactions may be serious or, rarely, life-threatening.
Danish: • Nogle af disse reaktioner kan være alvorlige eller i sjældne tilfælde livstruende.
English: Defined as 0 or 1 on the endoscopy subscore of the Mayo score.
Danish: Defineret som 0 eller 1 på endoskopi-subscoren i Mayo-scoren.
English: Wash your hands well with soap and warm water.
Danish: Vask hænderne grundigt med sæbe og varmt vand.
English: The potential risk with the combination of AZA or 6-MP and golimumab should be carefully considered.
Danish: Den potentielle risiko ved kombination af AZA eller 6-MP og golimumab bør overvejes nøje.
English: • You are pregnant or are planning to become pregnant while using Simponi.
Danish: • Du er gravid eller planlægger at blive gravid, mens du er i behandling med Simponi.
English: Mean change in SPARCC
Danish: Gennemsnitlig ændring i SPARCC
English: Patient's Name: _____________________ Doctor's Name: _____________________ Doctor's Phone: _____________________
Danish: Patientens navn: _____________________ Lægens navn:
English: This evaluation should include colonoscopy and biopsies per local recommendations.
Danish: Vurderingen bør indbefatte koloskopi og biopsier i henhold til lokale retningslinjer.
English: If a small dose is set, the plunger will only move a short distance.
Danish: Hvis der er indstillet en lille dosis, vil stemplet kun bevæge sig et lille stykke.
English: Some orange will still be showing.
Danish: Lidt orange vil stadig være synligt.
English: Height (cm)
Danish: Højde (cm)
English: The prescribed volume of injection should be selected according to patient's height and weight as shown in Table 1.
Danish: Den ordinerede volumen af injektionen skal vælges i henhold til patientens højde og vægt, som vist i tabel 1.
English: Common: Depression, insomnia
Danish: Almindelig: Depression, søvnløshed
English: A patient had to be in remission at both weeks 30 and 54 (without demonstrating a loss of response at any time point through week 54) to achieve durable remission.
Danish: En patient skulle være i remission i både uge 30 og 54 (uden at udvise manglende respons på noget tidspunkt til og med uge 54) for at opnå varig remission.
English: This instruction guide does not take the place of talking with your doctor about your medical condition or your treatment.
Danish: Denne vejledning er ikke ment som erstatning for samtaler med din læge om din sygdom eller din behandling.
English: This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Danish: Denne sjældne type T-celle-lymfom har et meget aggressivt sygdomsforløb og er sædvanligvis dødelig.
English: Your doctor will tell you the correct dose to use.
Danish: Lægen vil fortælle dig den korrekte dosis, som du skal bruge.
English: During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Danish: Under vedligeholdelsesbehandlingen kan kortikosteroider nedtrappes i henhold til de kliniske retningslinjer.
English: Know your dose
Danish: Kend din dosis
English: The effects of this medicine in pregnant women are not known.
Danish: Virkningen af dette lægemiddel er ukendt hos gravide.
English: • Simponi is given by injection under the skin (subcutaneously).
Danish: • Simponi gives som indsprøjtning under huden (subkutant).
English: The dose you delivered can be confirmed by viewing the dose selection notch.
Danish: Den dosis, du har givet, kan du få bekræftet ved at kigge på indhakket til valg af dosis.
English: In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding.
Danish: Hos nogle patienter kan kroppen ikke producere nok blodceller, som kan hjælpe med at bekæmpe infektioner eller hjælpe med at stoppe blødning.
English: Result _______________ • Tell your doctor if you know or suspect you are a carrier of the hepatitis B virus.
Danish: Resultat ______________ • Fortæl det til din læge, hvis du ved eller har mistanke om, at du er bærer af hepatitis B-virus.
English: Please also read the ‘Package Leaflet: Information for the user' carefully before starting your injection.
Danish: Læs også ‘Indlægsseddel: Information til brugeren' grundigt, inden du begynder din indsprøjtning.
English: • Wash your hands thoroughly with soap and warm water.
Danish: • Vask hænderne grundigt med sæbe og varmt vand.
English: The systemic clearance of golimumab was estimated to be 6.9  2.0 mL/day/kg.
Danish: Den systemiske clearance af golimumab blev estimeret til 6,9 ± 2,0 ml/dag/kg.
English: Select from the following areas for your injection:
Danish: Vælg mellem følgende områder til din indsprøjtning:
English: Additional analyses were performed in subsets representative of the indicated population of patients with severe, active and progressive RA.
Danish: Yderligere analyser blev udført i undergrupper, som repræsenterede den nævnte population af patienter med svær, aktiv og progressiv RA.
English: • If you have tuberculosis (TB) or any other severe infection.
Danish: • Hvis du har tuberkulose (TB) eller en anden alvorlig infektion.
English: It should be noted that in the majority of these reports, tuberculosis was extrapulmonary presenting as either local or disseminated disease.
Danish: Det bør bemærkes, at der i størstedelen af disse tilfælde var tale om tuberkulose med ekstrapulmonal placering i form af enten lokal eller dissemineret sygdom.
English: Some patients may experience serious side effects and may require treatment.
Danish: Nogle patienter kan få alvorlige bivirkninger, der skal behandles.
English: Use of live vaccines could result in clinical infections, including disseminated infections.
Danish: Anvendelse af levende vacciner kan medføre kliniske infektioner herunder disseminerede infektioner.
English: You must not be treated with Simponi if you have tuberculosis (TB) or any other severe infection.
Danish: Du må ikke blive behandlet med Simponi, hvis du har tuberkulose (TB) eller andre alvorlige infektioner.
English: • Some patients treated with golimumab have developed certain kinds of skin cancer.
Danish: • Nogle patienter, der er blevet behandlet med golimumab, har udviklet visse former for hudkræft.
English: Push the pre-filled pen firmly against the skin (see figures 5 and 6) • Hold the pre-filled pen comfortably in your hand.
Danish: Pres den fyldte pen fast mod huden (se figur 5 og 6) • Hold den fyldte pen behageligt i hånden.
English: However, if you prefer, you may pinch the skin to create a firmer surface for your injection (Figure 5b).
Danish: Men hvis du foretrækker det, kan du klemme huden sammen for at danne en fast overflade til indsprøjtningen (figur 5b).
English: Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer.
Danish: Periodisk undersøgelse af huden anbefales hos alle patienter, især hos patienter med risikofaktorer for hudcancer.
English: After you remove the air bubbles, you may see a line inside the viewing window.
Danish: Efter at du har fjernet luftboblerne, kan du eventuelt se en streg inde i inspektionsvinduet.
English: • Severe infection throughout the body (sepsis), sometimes including low blood pressure (septic shock)
Danish: • Alvorlig infektion i kroppen (sepsis), i visse tilfælde inklusive lavt blodtryk (septisk shock)
English: • You should be screened for TB.
Danish: • Du skal undersøges for TB.
English: Please read this Instructions for Use before using the Simponi pre-filled pen and each time you get a new pre-filled pen.
Danish: Læs denne brugsvejledning før du bruger Simponi fyldt pen, og hver gang du får en ny fyldt pen.
English: • Children weighing less than 40 kg: The recommended dose of Simponi for children weighing less than 40 kg depends on their weight and height.
Danish: • Børn, der vejer under 40 kg: Den anbefalede dosering af Simponi til børn, der vejer under 40 kg, afhænger af deres højde og vægt.
English: No dose adjustment is required in the elderly.
Danish: Dosisjusteringer er ikke påkrævet hos ældre patienter.
English: Infections may progress more rapidly and may be more severe.
Danish: Infektioner kan udvikle sig hurtigere og kan være mere alvorlige.
English: Continue to hold until the second ‘click' (see figure 8)
Danish: Fortsæt med at holde indtil det andet ”klik” (se figur 8)
English: In these instructions:
Danish: I denne brugsvejledning:
English: Do not touch the needle or allow it to touch any surface.
Danish: Rør ikke ved nålen og lad den ikke røre andre overflader.
English: Simponi contains latex and sorbitol
Danish: Simponi indeholder latex og sorbitol
English: GO-BEFORE Active RA, MTX Naïve
Danish: GO-BEFORE Aktiv RA, MTX-naive
English: Change from baseline n reflects randomised patients * p = 0.015
Danish: Ændring fra baseline n angiver antal randomiserede patienter * p = 0,015
English: The relative deficiency of TNF caused by anti-TNF therapy may result in the initiation of an autoimmune process.
Danish: Den relative mangel på TNF som følge af anti-TNF-behandling kan medføre initiering af en autoimmun proces.
English: Patients had at least 4 swollen and 4 tender joints.
Danish: Patienterne havde mindst 4 hævede og 4 ømme led.
English: Simponi must be discarded if not used within the 30 days of room temperature storage.
Danish: Simponi skal kasseres, hvis det ikke er anvendt inden for de 30 dages opbevaring ved stuetemperatur.
English: Golimumab crosses the placenta.
Danish: Golimumab passerer placenta.
English: • allergic reactions which may be serious, or rarely, life-threatening (rare).
Danish: • Allergiske reaktioner, der kan være alvorlige eller i sjældne tilfælde livstruende (sjældne).
English: For administration instructions, see section 6.6.
Danish: 6.6 for håndteringsvejledning.
English: • Talk to your doctor or pharmacist if the yellow indicator is not visible in the window or if you suspect that you may not have received a complete dose.
Danish: • Tal med din læge eller apotekspersonalet, hvis den gule indikator ikke er synlig i vinduet, eller hvis du har mistanke om, at du ikke har fået den fulde dosis.
English: Some of these serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections.
Danish: Nogle af disse alvorlige infektioner forekom hos patienter i samtidig immunsuppressiv behandling, som udover deres underliggende sygdom kunne være disponeret for infektioner.
English: Name and address of the manufacturer of the biological active substance
Danish: Navn og addresse på fremstilleren af det biologisk aktive stof
English: This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy.
Danish: Denne vurdering skal omfatte en detaljeret anamnese vedrørende eventuel tidligere tuberkulose eller mulig tidligere kontakt med personer med tuberkulose samt tidligere og/eller nuværende immunsuppressiv behandling.
English: If possible, your child should be up to date with all vaccinations before using Simponi.
Danish: Hvis det er muligt, skal dit barn være ajour med alle vaccinationer, før behandling med Simponi startes.
English: No cases were reported in the controlled and uncontrolled periods of the nr-Axial SpA study (up to 1 year).
Danish: Ingen tilfælde blev rapporteret i de kontrollerede og ikke-kontrollerede perioder af nr-aksial SpA-studiet (op til 1 år).
English: This protein is involved in inflammatory processes of the body, and blocking it can reduce the inflammation in your body.
Danish: Dette protein er involveret i kroppens betændelsesprocesser, og blokering af proteinet kan mindske betændelsen i din krop.
English: The stated reasons for discontinuation of prior anti TNF therapies were lack of efficacy (58%), intolerance (13%), and/or reasons other than safety or efficacy (29%, mostly for financial reasons).
Danish: Årsager til seponering af tidligere anti-TNF behandling var mangel på effekt (58%), intolerance (13%) og/eller andre årsager end sikkerhed og effekt (29%, hovedsageligt økonomiske årsager).
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal det administrerede lægemiddels navn og batchnummer registreres tydeligt i patientjournalen.
English: Some of these infections have been fatal.
Danish: Nogle af disse infektioner var dødelige.
English: Always take the outer carton and this leaflet with you, even if it is empty.
Danish: Tag altid den ydre karton og denne indlægsseddel med dig, også selvom kartonen er tom.
English: In this study, the type and frequency of adverse events reported were generally similar to those seen in adult RA studies.
Danish: I dette studie var type og frekvens af de rapporterede bivirkninger generelt de samme som set i RA-studier med voksne.
English: It is not known whether this finding was due to effects on the males and/or the females.
Danish: Det er ukendt, om dette skyldes en effekt hos mus af hankøn og/eller hunkøn.
English: Do not use the 5-centimetre area around your belly-button.
Danish: Undlad at bruge et område på 5 centimeter omkring navlen.
English: When you are treated with Simponi, you might get infections more easily.
Danish: Når du bliver behandlet med Simponi, kan du muligvis lettere få infektioner.
English: Your doctor will test you to see if you have TB.
Danish: Lægen vil undersøge, om du har TB.