FrancophonIA/ELRC3.0 huggingface dataset:
English: Capsule shell Hypromellose Titanium dioxide (E171) Iron oxide yellow (E172)
Danish: Kapselskal Hypromellose Titandioxid (E 171) Jernoxid, gul (E 172)
English: Methotrexate (5 g/m2 over 24 hours, IV): days 1 and 15 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6 doses)iii:
Danish: ): dag 1 og 15 Leucovorin (75 mg/m2 i time 36, i.v.
English: Imatinib Actavis 400 mg capsules imatinib
Danish: Imatinib Actavis 400 mg kapsler imatinib
English: Imatinib Actavis 100 mg film-coated tablets imatinib
Danish: Imatinib Actavis 100 mg filmovertrukne tabletter imatinib
English: Imatinib Actavis 400 mg film-coated tablets imatinib
Danish: Imatinib Actavis 400 mg filmovertrukne tabletter imatinib
English: Eyelid oedema, lacrimation increased, conjunctival haemorrhage, conjunctivitis, dry eye, blurred vision
Danish: Øjenlågsødem, øget tåreflåd, konjunktivalblødning, konjunktivitis, øjentørhed, sløret syn
English: Consolidation therapy
Danish: Konsoliderende behandling
English: Tablet coat
Danish: Tabletovertræk
English: Therefore, this SPC, labelling and package leaflet may not necessarily represent the current text.
Danish: Produktresume, etikettering og indlægsseddel herunder repræsenterer derfor ikke nødvendigvis den gældende tekst.
English: Note: This SPC, labelling and packages leaflet is the version valid at the time of Commission decision.
Danish: Bemærk: Produktresume, etikettering og indlægsseddel herunder er den gældende version på tidspunktet for Kommissionens afgørelse.
English: Then wait until…
Danish: Vent indtil…
English: Wait 30 minutes min
Danish: Vent 30 minutter min
English: • if you have had cancer.
Danish: • hvis du har haft kræft.
English: Efficacy was evaluated in 448 patients.
Danish: Virkningen blev evalueret hos 448 patienter.
English: The injection may take up to 15 seconds to complete.
Danish: Injektionen kan tage op til 15 sekunder at færdiggøre.
English: **Applies to subcutaneous formulation only.
Danish: **Gælder kun for subkutane formuleringer.
English: Look out for important symptoms
Danish: Vær opmærksom på vigtige symptomer
English: Date of first authorisation: 13 July 2011 Date of latest renewal: 18 February 2016
Danish: Dato for første markedsføringstilladelse: 13. juli 2011 Dato for seneste fornyelse: 18. februar 2016
English: Time (weeks)
Danish: Tid (uger)
English: Symptoms of PML include:
Danish: Symptomerne på PML inkluderer:
English: You might ask them to tell you if they are worried about changes in your mood or behaviour.
Danish: Du kan bede dem fortælle dig, hvis de bliver bekymrede over ændringer i dit humør eller opførsel.
English: Exp: Month - Year
Danish: EXP: Måned - År
English: Allergic reactions - get medical help immediately
Danish: Allergiske reaktioner - søg omgående lægehjælp
English: (not included)
Danish: (ikke inkluderet)
English: The patient's condition should be evaluated continuously.
Danish: Patientens tilstand skal vurderes kontinuerligt.
English: In both studies the primary efficacy endpoint was evaluated at 52 weeks.
Danish: I begge studier blev det primære effekt-endepunkt evalueret ved 52 uger.
English: Adults and children (5 years of age and older)
Danish: Voksne og børn (5 år og ældre)
English: The study was not powered for any statistical comparisons and all data are descriptive.
Danish: Studiet havde ikke styrke til at foretage statistiske sammenligninger og alle data er beskrivende.
English: The majority (94.6%) of patients were female.
Danish: Størstedelen (94,6 %) af patienterne var piger.
English: • Hold the pen comfortably so that you can view the inspection window.
Danish: • Hold pennen bekvemt, så du kan se inspektionsvinduet.
English: If a dose is missed, it should be administered as soon as possible.
Danish: Hvis en dosis glemmes, skal den administreres hurtigst muligt.
English: Your doctor will decide on the correct dose depending on your body weight.
Danish: Lægen vil fastlægge den rigtige dosis afhængig af din kropsvægt.
English: • pain in hands or feet
Danish: • smerter i hænder eller fødder
English: There may be a small amount of blood at the injection site.
Danish: Der kan forekomme en lille smule blod på injektionsstedet.
English: • if you are planning to have a vaccination or have had a vaccination within the last 30 days.
Danish: • hvis du planlægger at skulle vaccineres eller er blevet vaccineret inden for de sidste 30 dage.
English: For example, do not warm it in a microwave oven, hot water or direct sunlight.
Danish: Du må f.eks. ikke opvarme den i en mikrobølgeovn, i varmt vand eller i direkte sollys.
English: 28 February
Danish: 28. februar
English: If you wish to change your dosing day:
Danish: Hvis du ønsker at ændre din ugentlige dosisdag:
English: • difficulty with talking or walking
Danish: • besvær med at tale eller gå
English: Small air bubbles, however, are expected and acceptable.
Danish: Det forventes dog, at der er små luftbobler, og disse er acceptable.
English: There was no significant impact on efficacy and safety based on weight.
Danish: Der var ingen signifikant effekt af virkning og sikkerhed baseret på vægt.
English: Allow the skin to air dry.
Danish: Lad huden lufttørre.
English: • trouble in thinking
Danish: • besvær med at tænke
English: Safety data in children younger than 12 years of age (n=10) are limited.
Danish: Sikkerhedsdata hos børn yngre end 12 år (n=10) er begrænsede.
English: It is normal to see one or more air bubbles in the solution.
Danish: Det er normalt at se en eller flere luftbobler i opløsningen.
English: The response for the individual components of the endpoint were consistent with that of the SRI (Table 3).
Danish: Responset for de enkelte komponenter af endepunktet var konsistent med det for SRI (Tabel 3).
English: There are insufficient data to draw conclusions regarding response to other vaccines.
Danish: Der er ikke tilstrækkelige data til at drage konklusioner om responset af andre vacciner.
English: No suicide was reported in either group.
Danish: Ingen selvmord blev rapporteret i nogen af grupperne.
English: • no worsening (<0.30 point increase) in Physician's Global Assessment score (PGA)
Danish: • ingen forværring (en stigning på < 0,30 point) af Physician's Global Assessment scoren (PGA).
English: • bacterial infections (see ‘Infections' above)
Danish: • infektioner forårsaget af bakterier (se ”Infektioner” ovenover)
English: If you experience new or worsening symptoms at any time:
Danish: Hvis du oplever nye eller forværrede symptomer på noget tidspunkt:
English: If you get any of the following symptoms of an infection:
Danish: Hvis du får nogle af følgende symptomer på en infektion:
English: Slowly move your thumb back
Danish: Før langsomt tommelfingeren tilbage
English: It is not necessary to administer two doses on the same day.
Danish: Det er ikke nødvendigt at administrere to doser den samme dag.
English: Take a dose on the new day (even if it is less than a week since your last dose).
Danish: Du kan tage en dosis på den nye dag (også selvom det er mindre end en uge siden den sidste dosis).
English: The safety data presented include data beyond Week 52 in some patients.
Danish: De præsenterede sikkerhedsdata omfatter data fra efter uge 52 hos nogle patienter.
English: No formal studies have been conducted.
Danish: Der er ikke udført nogen formelle studier.
English: After this, Benlysta is usually given once every 4 weeks.
Danish: Herefter gives Benlysta normalt én gang hver 4. uge.
English: • Do not inject into the exact same site each time.
Danish: • Du må ikke injicere på præcist samme sted hver gang.
English: Steadystate exposure was reached after approximately 11 weeks of subcutaneous administration.
Danish: Steady-state-eksponeringen blev opnået efter cirka 11 ugers subkutan administration.
English: This medicine is not intended for use in children younger than 5 years of age.
Danish: Dette lægemiddel er ikke beregnet til brug hos børn yngre end 5 år.
English: BLISS-76 was conducted primarily in North America and Western Europe.
Danish: BLISS-76 blev primært udført i Nordamerika og Vesteuropa.
English: It is not known if belimumab could be an indirect modulator of such cytokines.
Danish: Det vides ikke, om belimumab kan være en indirekte modulator af sådanne cytokiner.
English: Classical biotransformation studies have not been conducted.
Danish: Klassiske biotransformationsstudier er ikke udført.
English: This is to avoid the skin becoming hardened.
Danish: Dette er for at undgå, at din hud bliver hård.
English: Data on patients ≥65 years are limited to <1.8% of the studied population.
Danish: Data for patienter ≥ 65 år er begrænset til < 1,8 % af den undersøgte population.
English: • high temperature or fever
Danish: • høj temperatur eller feber
English: Depression can affect up to 1 in 10 people, suicidal thoughts and suicide attempts can affect up to 1 in 100 people.
Danish: Depression kan påvirke op til 1 ud af 10 personer, selvmordstanker og selvmordsforsøg kan påvirke op til 1 ud af 100 personer.
English: Reconstitution is typically complete within 10 to 15 minutes after the water has been added, but it may take up to 30 minutes.
Danish: Rekonstitution er normalt færdig i løbet af 10 til 15 minutter efter, at vandet er blevet tilsat, men det kan tage op til 30 minutter.
English: • low white blood cell count (can be seen in blood tests)
Danish: • lavt antal hvide blodlegemer (kan ses i blodprøver)
English: Intravenous infusion in adults
Danish: Intravenøs infusion hos voksne
English: Increased risk of brain infection
Danish: Forhøjet risiko for hjerneinfektion
English: This could increase your risk of a serious infection.
Danish: Dette kan øge din risiko for at udvikle en alvorlig infektion.
English: Tell your doctor.
Danish: Fortæl det til lægen.
English: The package leaflet should be available to the patient.
Danish: Indlægssedlen skal være tilgængelig for patienten.
English: Medicine given before an infusion
Danish: Medicin, der gives før en infusion
English: Read the information ‘Increased risk of brain infection' in section 4 of this leaflet.
Danish: Læs informationen ”Forhøjet risiko for hjerneinfektion” i punkt 4 i denne indlægsseddel.
English: Psychiatric disorders also includes data from a post-marketing study.
Danish: Psykiske forstyrrelser inkluderer også data fra et postmarketing studie.
English: Patients should be instructed to seek immediate medical attention if they experience any of these symptoms.
Danish: Patienterne skal instrueres i omgående at søge læge, hvis de oplever nogen af disse symptomer.
English: Tell your doctor immediately if you have any of these symptoms, or similar problems that have lasted over several days.
Danish: Fortæl det straks til lægen, hvis du har nogle af disse symptomer eller lignende problemer, der har varet flere dage.
English: If PML is suspected, further dosing must be suspended until PML has been excluded.
Danish: Hvis PML mistænkes, skal yderligere dosering stoppes, indtil PML er udelukket.
English: Data from post-marketing reports are also included.
Danish: Data efter markedsføring er også inkluderet.
English: Some infections were severe or fatal.
Danish: Visse infektioner var alvorlige eller letale.
English: It can affect almost any organ in the body, and is thought to involve a type of white blood cells called B cells.
Danish: Sygdommen kan påvirke næsten alle organer i kroppen, og det menes, at en type hvide blodlegemer, som kaldes B-celler, er involveret.
English: Other possible side effects: Very common side effects
Danish: Andre mulige bivirkninger: Meget almindelige bivirkninger
English: If you already had these symptoms before you started treatment with Benlysta: Tell your doctor immediately if you notice any changes in these symptoms.
Danish: Hvis du allerede havde disse symptomer, før du begyndte behandlingen med Benlysta: Fortæl det straks til lægen, hvis du bemærker nogen ændring i disse symptomer.
English: Some vaccines should not be given just before or during treatment with Benlysta
Danish: Nogle vacciner bør ikke gives lige før eller under behandling med Benlysta
English: A risk for indirect reduction of CYP activity by belimumab cannot be excluded.
Danish: En risiko for at belimumab indirekte reducerer CYP-aktivitet kan ikke udelukkes.
English: • Find a comfortable, well-lit and clean surface and place the following supplies within reach:
Danish: • Find en behagelig, veloplyst og ren oveflade og placer følgende inden for rækkevidde:
English: The risk of using Benlysta in patients with active or latent tuberculosis is unknown.
Danish: Risikoen ved at anvende Benlysta hos patienter med aktiv eller latent tuberkulose kendes ikke.
English: BATCH NUMBER, DONATION AND PRODUCT CODES
Danish: BATCHNUMMER, DONATION OG PRODUKTKODER
English: Store in a refrigerator (2°C to 8°C).
Danish: Opbevares i køleskab (2 ºC til 8 ºC).
English: • swelling of the face, lips, mouth or tongue
Danish: • hævelse af ansigtet, læberne, munden eller tungen
English: The systemic clearance was 204 ml/day.
Danish: Den systemiske clearance var 204 ml/dag.
English: BMI-dependent changes in exposure did not lead to corresponding changes in efficacy.
Danish: BMI-afhængige ændringer i eksponeringen medførte ingen tilsvarende ændringer i virkningen.
English: Continue with the new weekly schedule from that day.
Danish: Du skal fortsætte med den nye ugentlige rutine fra den dag.
English: In particular tell your doctor if you are being treated with medicines that affect your immune system:
Danish: Det er særlig vigtigt, at du fortæller det til lægen, hvis du bliver behandlet med medicin, der påvirker dit immunsystem:
English: Maximum serum concentrations of belimumab were generally observed at, or shortly after, the end of the infusion.
Danish: De maksimale serumkoncentrationer af belimumab blev generelt observeret under eller kort tid efter afslutning af infusionen.
English: No new safety signals were observed in the paediatric population 12 years of age and above (n=43).
Danish: Der blev ikke observeret nye sikkerhedssignaler hos den pædiatriske population på 12 år og derover (n=43).
English: It is recommended that you make a note of this information in case you are asked for it in the future.
Danish: Det anbefales at du skriver dette ned, hvis du bliver spurgt til det i fremtiden.
English: The recommended dose is 10 mg for each kilogram (kg) of your body weight.
Danish: Den anbefalede dosis er 10 mg for hvert kilogram (kg) kropsvægt.
English: Transition from intravenous to subcutaneous administration
Danish: Overgang fra intravenøs til subkutan administration
English: The total time from reconstitution of Benlysta to completion of infusion should not exceed 8 hours.
Danish: Den samlede tid fra rekonstitution af Benlysta til afslutning af infusionen må ikke overstige 8 timer.
English: In patients who experience such symptoms, treatment discontinuation should be considered.
Danish: Hos patienter, der oplever sådanne symptomer, skal det overvejes at stoppe behandlingen.
English: You may hear a first “click” at the start of the injection.
Danish: Du kan høre et første ”klik”, når injektionen begynder.
English: • cyclophosphamide (a medicine to treat some cancers and autoimmune disorders)
Danish: • cyclophosphamid (medicin til behandling af visse former for kræft og autoimmune sygdomme)
English: There were two suicides in Benlysta-treated patients (including one receiving 1 mg/kg Benlysta).
Danish: Der var to tilfælde af selvmord hos patienter i behandling med Benlysta (herunder en, der fik 1 mg/kg Benlysta).
English: The differences between the treatment groups were apparent by Week 16 and sustained through Week 52 (Figure 1).
Danish: Forskellene mellem behandlingsgrupperne var tydelige ved uge 16 og forblev sådan til og med uge 52 (se Figur 1).
English: There were no serious depression-related events or suicides reported in either group.
Danish: Der var ingen alvorlige depressionsrelaterede bivirkninger eller selvmord rapporteret i nogen af grupperne.
English: • Hold the syringe in one hand.
Danish: • Hold injektionssprøjten i én hånd.
English: • any medicine that affects your B cells (to treat cancer or inflammatory diseases).
Danish: • alle typer medicin, der påvirker dine B-celler (til behandling af kræft eller betændelsestilstande).
English: If you feel depressed, have thoughts about harming yourself or other distressing thoughts, or if you are depressed and notice that you feel worse or develop new symptoms:
Danish: Hvis du føler dig deprimeret, har tanker om at skade dig selv eller har andre foruroligende tanker eller hvis du er deprimeret og opdager at du får det værre eller udvikler nye symptomer:
English: If you do not notice that you have missed a dose until it is already time for your next dose, then just inject this next dose as planned.
Danish: Hvis du først opdager, at du har glemt en dosis, når det er tid til næste dosis, skal du blot injicere næste dosis som planlagt.
English: Lupus is a disease in which the immune system (the system that fights infection) attacks your own cells and tissues, causing inflammation and organ damage.
Danish: Lupus er en sygdom, hvor immunsystemet (systemet, der bekæmper infektioner) angriber dine egne celler og væv, hvilket medfører betændelsestilstande og organskade.
English: The majority did not necessitate drug discontinuation.
Danish: Størstedelen krævede ikke seponering af lægemidlet.
English: Discontinuation of treatment with Benlysta should be considered if there is no improvement in disease control after 6 months of treatment.
Danish: Seponering af behandlingen med Benlysta bør overvejes, hvis der ikke ses en forbedring af sygdomskontrollen efter 6 måneders behandling.
English: You are usually given Benlysta on the first day of treatment then again 14 and 28 days later.
Danish: Du vil normalt få Benlysta på den første behandlingsdag og herefter igen 14 og 28 dage senere.
English: Continue to hold the pen down until the purple indicator has stopped moving.
Danish: Du skal blive ved med at holde pennen nede, indtil den lilla indikator ikke længere bevæger sig.
English: • if you have a current or long-term infection or if you often get infections.
Danish: • hvis du har en nuværende eller længerevarende infektion, eller hvis du ofte får infektioner.
English: • if you have a current or long-term infection or if you often get infections (see section 4).
Danish: • hvis du har en nuværende eller længerevarende infektion, eller hvis du ofte får infektioner (se punkt 4).
English: Subgroup
Danish: Subgruppe
English: second “click”
Danish: andet “klik”
English: For information on infections observed in paediatric patients see Paediatric population section below.
Danish: For information om observerede infektioner hos pædiatriske patienter, se afsnittet Pædiatrisk population nedenfor.
English: The infusion rate may be slowed or interrupted if the patient develops an infusion reaction.
Danish: Infusionshastigheden kan sænkes eller infusionen afbrydes, hvis patienten udvikler en infusionsrelateret reaktion.
English: There is insufficient knowledge to determine whether premedication could diminish the frequency or severity of infusion reactions.
Danish: Der er ikke tilstrækkelig erfaring til at afgøre, hvorvidt præmedicinering reducerer hyppigheden eller sværhedsgraden af infusionsrelaterede reaktioner.
English: first “click”
Danish: første “klik”
English: In one study in paediatric patients (6 to 17 years of age) the pharmacodynamic response was consistent with the adult data.
Danish: I et studie hos pædiatriske patienter (i alderen 6 til 17 år) var det farmakodynamiske respons konsistent med data for voksne.
English: There is limited clinical experience with overdose of Benlysta.
Danish: Der er begrænset klinisk erfaring med overdosering af Benlysta.
English: If patients wish to change their weekly dosing day, a new dose can be given on the newly preferred day of the week.
Danish: Hvis patienter ønsker at ændre deres ugentlige dosisdag, kan en ny dosis administreres på den nye foretrukne ugedag.
English: You will be given Benlysta as well as your usual treatment for lupus.
Danish: Du vil få Benlysta sammen med din sædvanlige lupus-behandling.
English: • if you have, or have had, hepatitis B or C
Danish: • hvis du har eller har haft hepatitis B eller C
English: • Keep refrigerated until 30 minutes before use.
Danish: • Opbevares på køl indtil 30 minutter før brug
English: Due to overlap in signs and symptoms, it is not possible to distinguish between hypersensitivity reactions and infusion reactions in all cases.
Danish: Da nogle tegn og symptomer overlapper hinanden, er det ikke muligt at skelne mellem overfølsomhedsreaktioner og infusionsrelaterede reaktioner i alle tilfælde.
English: Limited data suggest that Benlysta does not significantly affect the ability to maintain a protective immune response to immunisations received prior to administration of Benlysta.
Danish: Et begrænset antal data tyder på, at Benlysta ikke signifikant påvirker evnen til at opretholde et beskyttende immunrespons på immuniseringer, som er modtaget før administration af Benlysta.
English: Reconstitution and dilution must be carried out under aseptic conditions.
Danish: Rekonstitution og fortynding skal foregå under aseptiske forhold.
English: Your doctor or nurse will show you or your caregiver how to inject Benlysta.
Danish: Din læge eller sygeplejerske vil vise dig eller dit plejepersonale, hvordan du skal injicere Benlysta.
English: They can occasionally be severe (uncommon, affecting up to 1 in 100 people), and could be life-threatening.
Danish: De kan i nogle tilfælde være alvorlige (ikke almindelige, kan forekomme hos op til 1 ud af 100 personer) og kan blive livstruende.
English: The SLE Responder Index measures improvement in SLE disease activity, without worsening in any organ system, or in the patient's overall condition.
Danish: SLE Responder Index giver et mål for reduktionen af SLE-sygdomsaktivitet, når der ikke er forværringer i noget organsystem eller af patientens overordnede tilstand.
English: A nurse or doctor will give you Benlysta through a drip in your vein (intravenous infusion) over one hour.
Danish: En sygeplejerske eller læge vil give dig Benlysta via et drop i en blodåre (intravenøs infusion) over en periode på 1 time.
English: If possible show them the pack, or this leaflet.
Danish: Hvis det er muligt, skal du vise dem pakningen eller denne indlægsseddel.
English: This was consistent with the findings from the adult intravenous clinical trials.
Danish: Dette var konsistent med fundene fra de intravenøse kliniske studier hos voksne.
English: Patients were on a stable SLE treatment regimen (standard of care) and had similar inclusion criteria as the adult studies.
Danish: Patienterne var på et stabilt SLE behandlingsregime (standardbehandling) og havde lignende inklusionskriterier som i studierne med voksne.
English: Thereafter the patient should continue with the new weekly schedule from that day, even if the dosing interval may be temporarily less than a week.
Danish: Herefter skal patienten fortsætte med den nye ugentlige rutine fra den dag, også selvom dosisintervallet midlertidig er mindre end en uge.
English: The needle will automatically rise up into the needle guard.
Danish: Kanylen vil automatisk blive trukket op i sikkerhedshætten.
English: No incompatibilities between Benlysta and polyvinylchloride or polyolefin bags have been observed.
Danish: Der er ikke set uforligeligheder mellem Benlysta og polyvinylchlorid- eller polyolefinposer.
English: Important information about the contents of Benlysta
Danish: Vigtig information om indholdet i Benlysta
English: Patient median age was 37 years (range: 18 to 77 years), and the majority (94%) were female.
Danish: Patienternes medianalder var 37 år (interval: 18 til 77 år) og størstedelen (94 %) var kvinder.
English: There are no data on the effects of belimumab on human fertility.
Danish: Der foreligger ingen data om belimumabs påvirkning af human fertilitet.
English: Of the anti-phospholipid antibodies, only anti-cardiolipin antibody was measured.
Danish: Ud af gruppen af anti-phospholipid-antistoffer, blev kun anti-cardiolipin-antistoffer målt.