FrancophonIA/ELRC3.0 huggingface dataset:
English: No treatment-related changes were noted in the male and female reproductive organs of sexually mature animals.
Danish: Der blev ikke set nogen behandlingsrelaterede forandringer i reproduktionsorganerne hos seksuelt modne han- og hundyr.
English: These severe reactions are more likely to happen on the day of your first or second treatment with Benlysta, but can be delayed and occur several days afterwards.
Danish: Disse alvorlige reaktioner forekommer med større sandsynlighed på dagen for din første eller din anden behandling med Benlysta, men kan være forsinkede og forekomme flere dage senere.
English: An informal assessment of menstrual cycling in females demonstrated no belimumab-related changes.
Danish: En uformel vurdering af hunnernes menstruationscyklus viste ingen belimumab-relaterede ændringer.
English: * All patients received standard therapy
Danish: * Alle patienter fik standardbehandling
English: Body weight/Body Mass Index (BMI)
Danish: Legemsvægt/Body Mass Index (BMI)
English: Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity and toxicity to reproduction.
Danish: Non-kliniske data viser ingen særlig risiko for mennesker vurderet ud fra studier af toksicitet efter gentagne doser og reproduktionstoksicitet.
English: No clinically significant reduction in systemic clearance as a result of renal impairment was observed.
Danish: Der blev ikke observeret nogen klinisk signifikant reduktion i systemisk clearance som resultat af nedsat nyrefunktion.
English: Therefore, the use of Benlysta in elderly patients is not recommended unless the benefits are expected to outweigh the risks.
Danish: Brugen af Benlysta til ældre patienter frarådes derfor, medmindre fordelene forventes at veje tungere end risiciene.
English: Physicians should advise patients (and caregivers where appropriate) to contact their health care provider about new or worsening psychiatric symptoms.
Danish: Læger skal råde patienter (og omsorgspersoner, hvis det skønnes relevant) til at kontakte en sundhedsperson omkring nye eller forværrede psykiske symptomer.
English: Patient median age was 15 years (range 6 to 17 years).
Danish: Patienternes medianalder var 15 år (6-17 år).
English: • no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B
Danish: • ingen ny British Isles Lupus Assessment Group (BILAG A)-organdomænescore eller 2 nye BILAG B
English: The safety and efficacy of Benlysta subcutaneous administration in children and adolescents (< 18 years of age) has not been established.
Danish: Benlystas sikkerhed og virkning ved subkutan administration hos børn og unge (< 18 år) er ikke klarlagt.
English: Patients should remain under clinical supervision for a prolonged period of time (for several hours), following at least the first 2 infusions, taking into account the possibility of a late onset reaction.
Danish: Patienter skal forblive under længerevarende klinisk observation (flere timer), som minimum efter de første to infusioner, idet der tages højde for risikoen for en forsinket indtrædende reaktion.
English: Data presented below are pooled from the intravenous clinical studies (10 mg/kg intravenous dose only) and the subcutaneous clinical study.
Danish: De data, der præsenteres nedenfor, er sammenlagt fra de intravenøse kliniske studier (kun 10 mg/kg intravenøs dosis) og det subkutane kliniske studie.
English: Summary of the safety profile in adults
Danish: Sammendrag af sikkerhedsprofilen for voksne
English: • hypogammaglobulinaemia (IgG <400 mg/dl) or IgA deficiency (IgA <10 mg/dl)
Danish: • hypogammaglobulinæmi (IgG < 400 mg/dl) eller IgA-mangel (IgA < 10 mg/dl)
English: • if you are HIV positive or have low immunoglobulin levels
Danish: • hvis du er hiv positiv eller har et lavt niveau af immunglobulin
English: Response, n (%)
Danish: Respons, n (%)
English: Of these patients, 64.5% had SELENA SLEDAI scores ≥ 10 at baseline.
Danish: Af disse patienter havde 64,5 % SELENA-SLEDAI-score ≥ 10 ved baseline.
English: Benlysta is not compatible with 5% glucose.
Danish: Benlysta er uforligelig med 5 % glucose.
English: In one study in 6 to 17-year-old paediatric patients (n=53), none of the patients developed anti-belimumab antibodies.
Danish: I et studie hos pædiatriske patienter i alderen 6 til 17 år (n=53), udviklede ingen af patienterne anti-belimumab antistoffer.
English: All patients received standard therapy.
Danish: Alle patienterne fik standardbehandling.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: Although proteinuria (≥2 g/day) increased belimumab clearance and decreases in creatinine clearance decreased belimumab clearance, these effects were within the expected range of variability.
Danish: Selvom proteinuri (≥ 2 g/dag) øgede belimumabs clearance, og et fald i kreatininclearance nedsatte belimumabs clearance, lå disse effekter inden for det forventede variabilitetsinterval.
English: If a mechanical reconstitution device is used to reconstitute Benlysta it should not exceed 500 rpm and the vial should be swirled for no longer than 30 minutes.
Danish: Hvis der benyttes en mekanisk enhed til rekonstitution af Benlysta, må den ikke køre med mere end 500 rpm, og hætteglasset må ikke roteres i mere end 30 minutter.
English: There are a limited amount of data from the use of Benlysta in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af Benlysta til gravide kvinder.
English: Make sure the gold needle guard is flat on the skin.
Danish: Vær opmærksom på, at den gyldne sikkerhedskanyle står fladt mod huden.
English: The systemic clearance was 215 ml/day (range: 69-622 ml/day).
Danish: Den systemiske clearance var 215 ml/dag (interval: 69-622 ml/dag).
English: The frequency given is the highest seen with either formulation.
Danish: For hver formulering, er den anførte hyppighed den højest observerede.
English: The maximum serum concentration (Cmax) of belimumab at steady state was 108 µg/ml.
Danish: Den maksimale serumkoncentration (Cmax) af belimumab ved steady-state var 108 µg/ml.
English: If you get any side effects, talk to your doctor or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge eller sygeplejersken.
English: Pharmacotherapeutic group: Selective immunosuppressants, ATC code: L04AA26
Danish: Farmakoterapeutisk klassifikation: Selektive immunsuppressiva, ATC-kode: L04AA26.
English: • ≥4-point reduction in the SELENA-SLEDAI score, and
Danish: • en reduktion af SELENA-SLEDAI-scoren på ≥ 4 point og
English: Immunomodulatory medicinal products, including Benlysta, may increase the risk of malignancy.
Danish: Immunmodulerende lægemidler, herunder Benlysta, kan øge risikoen for maligniteter.
English: None of these gastrointestinal events in obese patients were serious.
Danish: Ingen af disse gastrointestinale bivirkninger hos svært overvægtige patienter var alvorlige.
English: • Do not warm the pen in any other way.
Danish: • Du må ikke opvarme pennen på anden måde.
English: The clinical status of the subject and the adverse reaction profile of Benlysta should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills.
Danish: Der skal tages hensyn til personens kliniske status og Benlystas bivirkningsprofil i vurderingen af patientens evne til at udføre opgaver, som kræver dømmekraft, motoriske eller kognitive færdigheder.
English: Instructions for use and handling - reconstitution, dilution and administration In order to improve traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.
Danish: Instruktioner i brug og håndtering - rekonstitution, fortynding og administration For at forbedre sporbarheden af biologiske lægemidler skal det administrerede produkts navn og batchnummer tydeligt registreres.
English: The formation of some CYP450 enzymes is suppressed by increased levels of certain cytokines during chronic inflammation.
Danish: Dannelsen af visse CYP450 enzymer er hæmmet af øgede niveauer af visse cytokiner ved kronisk inflammation.
English: Using the Paediatric Rheumatology International Trials Organisation/American College of Rheumatology (PRINTO/ACR) Juvenile SLE Response Evaluation Criteria, a higher proportion of paediatric patients receiving Benlysta demonstrated improvement compared with placebo (Table 4).
Danish: Ved brug af Paediatric Rheumatology International Trials Organisation/American College of Rheumatology (PRINTO/ACR) Juvenile SLE Response Evaluation Criteria, viste en højere andel af pædiatriske patienter, der fik Benlysta, forbedringer sammenlignet med placebo (Tabel 4).
English: The syringe or pen must be protected from light, and discarded if not used within the 12 hour period.
Danish: Injektionssprøjten eller pennen skal beskyttes mod lys og kasseres, hvis den ikke anvendes inden for de 12 timer.
English: No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving Benlysta.
Danish: Der foreligger ingen data om den sekundære overførsel af infektion fra personer, som får levende vacciner, til patienter, som får Benlysta.
English: Elderly: Benlysta has been studied in a limited number of elderly patients.
Danish: Ældre: Behandling med Benlysta er blevet undersøgt hos et begrænset antal ældre patienter.
English: It is not necessary to inject two doses on the same day.
Danish: Det er ikke nødvendigt at injicere to doser den samme dag.
English: The maximum serum concentration was 313 µg/ml (range: 173-573 µg/ml) based on simulating the concentration time profile using the typical parameter values of the population pharmacokinetic model.
Danish: Den maksimale serumkoncentration var 313 µg/ml (interval: 173-573 µg/ml) baseret på en simulering af koncentrationen som funktion af tiden, ved brug af standard parameterværdier fra den farmakokinetiske populations-model.
English: Physicians should be particularly alert to symptoms suggestive of PML that patients may not notice (e.g., cognitive, neurological or psychiatric symptoms or signs).
Danish: Læger skal være særligt opmærksomme på symptomer, der indikerer PML, og som patienten kan overse (f.eks. kognitive, neurologiske eller psykiatriske symptomer og tegn).
English: Table 4 - PRINTO/ACR response rate at Week 52
Danish: Tabel 4 - PRINTO/ACR responsrate ved Uge 52
English: Memory cells increased initially and slowly declined toward baseline levels by Week 52.
Danish: Memory celler øgedes i begyndelsen men faldt i uge 52 langsomt mod baseline.
English: Therefore, no dose adjustment is recommended.
Danish: Det anbefales derfor ikke at justere dosis.
English: Live vaccines should not be given for 30 days before, or concurrently with Benlysta, as clinical safety has not been established.
Danish: Levende vacciner bør ikke gives 30 dage før eller samtidigt med administration af Benlysta, da den kliniske sikkerhed ikke er klarlagt.
English: Protect the reconstituted solution from sunlight.
Danish: Beskyt den rekonstituerede opløsning mod sollys.
English: Progressive multifocal leukoencephalopathy (PML) has been reported with Benlysta treatment for SLE.
Danish: Progressiv multifokal leukoencefalopati (PML) er blevet rapporteret ved behandling af SLE med Benlysta.
English: Because of its mechanism of action, belimumab may interfere with the response to immunisations.
Danish: På grund af virkningsmekanismen kan belimumab påvirke immuniseringsresponset.
English: How Benlysta is used How much to use Adults (18 years of age and older)
Danish: Sådan skal du tage Benlysta Hvor meget skal du tage Voksne (18 år og ældre)
English: Very common Diarrhoea, nausea
Danish: Meget almindelig Diarré, kvalme
English: It is recommended that a 21-25 gauge needle be used when piercing the vial stopper for reconstitution and dilution.
Danish: Det anbefales at anvende en 21-25 gauge nål til at stikke igennem gummiproppen ved rekonstitution og fortynding.
English: • Position the pen straight over the injection site (at a 90o angle).
Danish: • Placer pennen direkte over injektionsstedet (i en vinkel på 90 grader).
English: You may hear a second “click" a few seconds before the purple indicator stops moving.
Danish: Du kan måske høre det andet ”klik” få sekunder før, den lilla indikator ikke længere bevæger sig (Figur 10).
English: Check the expiry date
Danish: Tjek udløbsdatoen
English: After about 7 years, a 28% median reduction in IgG levels was observed, with 1.6% of subjects experiencing a decrease in IgG levels to below 400 mg/dl. Over the course of the study, the reported incidence of AEs generally remained stable or declined.
Danish: Efter omkring 7 år blev der observeret en median reduktion i IgG-niveau på 28 % og 1,6 % af patienterne oplevede et fald i IgG-niveau til under 400 mg/dl. I studiets forløb forblev den rapporterede incidens af bivirkninger generelt stabil eller reduceret.
English: Benlysta is administered intravenously by infusion, and must be reconstituted and diluted before administration.
Danish: Benlysta administreres intravenøst ved infusion og skal rekonstitueres og fortyndes inden administrationen.
English: • Obligation to complete post-authorisation measures
Danish: • Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse
English: • severe active lupus nephritis (see section 5.1)
Danish: • svær aktiv lupus nefritis (se pkt.
English: It is likely that Benlysta can pass into breast milk.
Danish: Det er sandsynligt, at Benlysta går over i modermælken.
English: On initiation or discontinuation of belimumab, therapeutic monitoring should be considered for patients being treated with CYP substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g. warfarin).
Danish: Ved opstart eller seponering af belimumab skal terapeutisk monitorering overvejes hos patienter, der bliver behandlet med CYP-substrater med snævert terapeutisk indeks, hvor dosis justeres individuelt (f.eks. warfarin).
English: The safety and efficacy of Benlysta administered intravenously have been studied in black patients.
Danish: Sikkerheden og virkningen af intravenøst administreret Benlysta er blevet undersøgt i sorte patienter.
English: These may include a type of medicine called an anti-histamine and a medicine to prevent a high temperature.
Danish: Denne medicin kan omfatte medicin, der kaldes antihistamin, og medicin til at forhindre feber.
English: Responders (%)
Danish: Respondenter (%)
English: If you feel depressed or have thoughts of harming yourself or committing suicide, you may find it helpful to tell a relative or close friend and ask them to read this leaflet.
Danish: Hvis du føler dig deprimeret eller tænker på at skade dig selv eller begå selvmord, kan det hjælpe at tale med et familiemedlem eller en god ven og bede dem læse denne indlægsseddel.
English: Anti-dsDNA positive AND low complement
Danish: Anti-dsDNA-positive OG lav komplement
English: Supplies you need for the injection
Danish: Dele du skal bruge til injektionen
English: • If needed, firm the injection site by pulling or stretching the skin.
Danish: • Om nødvendigt kan du gøre injektionsstedet mere fast ved at trække eller strække huden.
English: … purple indicator stops moving
Danish: …lilla indikator ikke længere bevæger sig
English: Depression and suicide
Danish: Depression og selvmord
English: A patient may self-inject or the patient caregiver may administer Benlysta after the healthcare professional determines that it is appropriate.
Danish: Patienten kan selv injicere, eller et plejepersonale kan administrere Benlysta, hvis sundhedspersonalet beslutter, at det er hensigtsmæssigt.
English: Using such medicines in combination with Benlysta may make your immune system less effective.
Danish: Brug af disse typer medicin i kombination med Benlysta kan svække dit immunsystem.
English: Belimumab + Standard Therapy (n = 554) Placebo + Standard Therapy (n = 279) * P<0.05
Danish: Belimumab + standardbehandling (n = 554) Placebo + standardbehandling (n = 279) * P < 0,05
English: Changes in biomarkers were seen in clinical trials with Benlysta administered intravenously.
Danish: Der blev set ændringer i biomarkører i kliniske studier med Benlysta administreret intravenøst.
English: Infusion reactions occurred more frequently during the first two infusions and tended to decrease with subsequent infusions (see section 4.8).
Danish: Infusionsrelaterede reaktioner forekom hyppigere under de to første infusioner og havde en aftagende tendens ved de efterfølgende infusioner (se pkt.
English: In the open-label extension phase there was one fatal infection in a patient receiving Benlysta.
Danish: I den åbne forlængelsesfase forekom en dødelig infektion hos en patient, der fik Benlysta.
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af påvirkningen af evnen til at føre motorkøretøj og betjene maskiner.
English: Belimumab was distributed to tissues with steady-state volume (Vss) of distribution of approximately 5 litres.
Danish: Belimumab blev fordelt i væv med et steady-state fordelingsvolumen (Vss) på ca. 5 liter.
English: • The active ingredient is belimumab.
Danish: • Aktivt stof: belimumab.
English: If you experience these symptoms, particularly if you get two or more of them together:
Danish: Hvis du oplever disse symptomer, især hvis du oplever en kombination af disse symptomer:
English: Histidine monohydrochloride Polysorbate 80
Danish: Histidinmonohydrochlorid Polysorbat 80
English: • a history of, or current, hepatitis B or C
Danish: • tidligere eller aktuel hepatitis B eller C
English: The primary efficacy endpoint was the SLE Responder Index (SRI) at Week 52 as described in the adult intravenous trials.
Danish: Det primære effekt-endepunkt var SLE Responder Index (SRI) ved Uge 52 som beskrevet i de intravenøse studier hos voksne.
English: The two studies were similar in design except that BLISS-76 was a 76-week study and BLISS-52 was a 52-week study.
Danish: De to studier havde det samme design bortset fra, at BLISS-76 varede 76 uger, og BLISS-52 varede 52 uger.
English: • The pre-filled pen should be used only once and then discarded.
Danish: • Den fyldte pen må kun bruges én gang og derefter kasseres.
English: • When the injection is complete, lift the pen from the injection site.
Danish: • Når injektionen er færdig, skal du løfte pennen væk fra injektionsstedet.
English: • injection site reactions, for example: rash, redness, itching or swelling of the skin where you have injected Benlysta.
Danish: • reaktioner på injektionsstedet, som f.eks. udslæt, rødmen, kløe eller hævelse af huden, hvor du har injiceret Benlysta.
English: • Do not perform the injection if you do not have all the supplies listed.
Danish: • Du må ikke foretage injektionen, hvis du ikke har alle de anførte dele.
English: (Figure 2) Injecting cold Benlysta may take longer and may be uncomfortable.
Danish: Injicering af kold Benlysta kan tage længere tid og kan være ubehageligt.
English: BLyS levels are elevated in patients with SLE and other autoimmune diseases.
Danish: Niveauet af BLyS-protein er forhøjet hos patienter med SLE og andre autoimmune sygdomme.
English: Check with your doctor if this may apply to you.
Danish: Tal med lægen, hvis dette kan gælde for dig.
English: Benlysta treatment should be initiated and supervised by a qualified physician experienced in the diagnosis and treatment of SLE.
Danish: Behandling med Benlysta skal initieres og overvåges af en kvalificeret læge med erfaring i diagnosticering og behandling af SLE.
English: Benlysta must not be administered as an intravenous bolus.
Danish: Benlysta må ikke administreres som intravenøs bolus.
English: Changes in B cells (including naïve, memory and activated B cells, and plasma cells) and IgG levels occurring in patients during ongoing treatment with intravenous belimumab were followed in a long-term uncontrolled extension study.
Danish: Ændringer i B-celler (herunder naive, memory og aktiverede B-celler samt plasmaceller) og IgG-niveau hos patienter under igangværende intravenøs behandling med belimumab blev fulgt i et ukontrolleret langtidsopfølgningsstudie.
English: The risk of hypersensitivity reactions is greatest with the first two doses; however the risk should be considered for every administration.
Danish: Risikoen for overfølsomhedsreaktioner er størst ved de to første doser, men der skal tages hensyn til risikoen ved hver administration.
English: Proportion of patients with at least 30% improvement in 3 of 5 components* and no more than one of the remaining worsening more than 30%
Danish: Andel af patienter med mindst 30 % forbedring i 3 ud af 5 komponenter* og ikke flere end én komponent med mere end 30 % forværring i de resterende
English: Unopened vials 5 years.
Danish: Uåbnede hætteglas 5 år.
English: Effects on male and female fertility have not been formally evaluated in animal studies (see section 5.3).
Danish: Påvirkningen af fertiliteten hos dyr af hankøn og hunkøn er ikke blevet formelt vurderet i dyrestudier (se pkt.
English: Adverse reactions reported in association with cases of overdose have been consistent with those expected for belimumab.
Danish: Bivirkninger rapporteret i forbindelse med tilfælde af overdosering har været konsistente med de forventede bivirkninger ved belimumab.
English: • Remove the ring cap by pulling or twisting it off.
Danish: • Fjern hætten ved at trække eller dreje den af.
English: Dosing is not based on weight (see section 5.2).
Danish: Dosering er ikke baseret på vægt (se pkt.
English: Depression and suicidality
Danish: Depression og suicidalitet
English: Gastroenteritis viral, pharyngitis, nasopharyngitis, viral upper respiratory tract infection
Danish: Viral gastroenteritis, pharyngitis, nasopharyngitis, viral infektion i de øvre luftveje
English: Therefore, Benlysta should be administered in an environment where resources for managing such reactions are immediately available.
Danish: Derfor skal Benlysta administreres et sted, hvor ressourcer til behandling af sådanne reaktioner altid er til rådighed.
English: Benlysta subcutaneous injection must not be injected into a vein (intravenously).
Danish: Benlysta subkutan injektion må ikke injiceres i en vene (intravenøst).
English: • if you are allergic to belimumab or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for belimumab eller et af de øvrige indholdsstoffer i Benlysta (angivet i punkt 6).
English: This will insert the needle and start the injection.
Danish: Dette vil injicere kanylen og begynde injektionen.
English: Stopping treatment with Benlysta
Danish: Ophør af behandlingen med Benlysta
English: • nose, throat or stomach infection
Danish: • infektion i næsen, halsen eller maven
English: Percent of patients with no worsening by PGA
Danish: Procentdel af patienter uden forværring efter PGA
English: Flares in SLE were defined by the modified SELENA SLEDAI SLE Flare Index.
Danish: SLE-flares blev defineret efter det modificerede SELENA-SLEDAI SLE Flare-indeks.
English: Following subcutaneous administration the bioavailability of belimumab was approximately 74%.
Danish: Biotilgængeligheden var cirka 74 % efter subkutan administration af belimumab.
English: Keeping hold of the syringe, slowly move your thumb back, allowing the plunger to rise up (Figure 9).
Danish: Samtidig med at du holder fast på injektionssprøjten, fører du langsomt din tommelfinger tilbage og tillader at stemplet trykkes ud (Figur 9).
English: Black patients
Danish: Sorte patienter
English: On the basis of the available information, dose adjustment is not required in patients with mild, moderate or severe renal impairment.
Danish: Ud fra de tilgængelige oplysninger er dosisjustering ikke påkrævet hos patienter med let, moderat eller svært nedsat nyrefunktion.