FrancophonIA/ELRC3.0 huggingface dataset:
English: • You must not become pregnant while you are being treated with SYLVANT and for 3 months after your treatment has finished.
Danish: • Du må ikke blive gravid, mens du får SYLVANT, og indtil der er gået 3 måneder efter, at behandlingen er afsluttet.
English: Protocol:
Danish: Protokol:
English: Highest total dose in clinical trials
Danish: Højeste totaldosis i kliniske studier
English: • high blood pressure
Danish: • forhøjet blodtryk
English: Hypoglobulinaemia was observed in 4 to 11.3% of patients in the clinical study.
Danish: Hypoglobulinnæmi blev observeret hos 4 - 11,3 % af patienterne i det kliniske studie.
English: The registry should be continued for the either 100 patients, or 5 years, whichever is greater.
Danish: Registerundersøgelsen skal fortsættes enten med 100 patienter eller i 5 år afhængigt af, hvad der udgør den højeste værdi.
English: The overall tumour response rate was evaluated based on modified Cheson criteria both by independent review and investigator assessment.
Danish: Den samlede tumorresponsrate blev evalueret ud fra modificerede Cheson-kriterier både ved uvildig gennemgang og vurdering af investigator.
English: Tell your doctor straight away if you have a severe allergic reaction during or after the infusion.
Danish: Kontakt straks din læge, hvis du får en alvorlig allergisk reaktion under eller efter infusionen.
English: < 1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10000 and <1/1000); very rare (<1/10000).
Danish: ikke almindelig (≥1/1.000 og <1/100); sjælden (≥1/10.000 og <1/1.000); meget sjælden (<1/10.000).
English: These infections may be serious, such as pneumonia or blood poisoning (also called “sepsis”).
Danish: Disse infektioner kan være alvorlige som f.eks. lungebetændelse eller blodforgiftning (også kaldet sepsis).
English: The following factors had no clinical effect on the clearance of siltuximab: gender, age, and ethnicity.
Danish: Følgende faktorer havde ingen klinisk virkning på clearance af siltuximab: køn, alder og etnisk herkomst.
English: If you are pregnant or breast-feeding, think that you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: • you are due to have a vaccination or may need to have one in the near future - this is because some vaccines should not be given with SYLVANT.
Danish: • hvis du står for at skulle vaccineres eller kan få behov for vaccination i en nær fremtid - dette skyldes, at nogle vacciner ikke bør gives sammen med SYLVANT.
English: Use with caution in patients who may be at increased risk for GI perforation.
Danish: Anvend med forsigtighed til patienter, som kan have en øget risiko for GIperforering.
English: Name and address of the manufacturers of the biological active substances
Danish: Navn og adresse på fremstillerne af det biologisk aktive stof
English: Immunomodulatory medicinal products may increase the risk of malignancy.
Danish: Immunmodulerende lægemidler kan øge risikoen for maligne sygdomme.
English: Treatment was continued until treatment failure (defined as disease progression based on increase in symptoms, radiologic progression or deterioration in performance status) or unacceptable toxicity.
Danish: Behandlingen fortsatte indtil behandlingssvigt (defineret som sygdomsprogression baseret på stigning i symptomerne, radiologisk progression eller nedsættelse af funktionsniveau) eller uacceptabel toksicitet.
English: Histological subtype was similar in both treatment arms, with 33% hyaline vascular subtype, 23% plasmacytic subtype and 44% mixed subtype.
Danish: Den histologiske subtype var ens i begge behandlingsarme, med 33 % hyalin-vaskulær subtype, 23 % plasmacytisk subtype og 44 % blandet subtype.
English: You should use effective methods of contraception during this time.
Danish: Du skal anvende sikker prævention i denne periode.
English: A total of 79 patients with symptomatic MCD were randomised and treated.
Danish: I alt blev 79 patienter med symptomatisk MCD randomiseret og behandlet.
English: No case of overdose has been reported in clinical trials.
Danish: Der er ikke rapporteret tilfælde af overdosering i kliniske forsøg.
English: Concurrent active serious infections
Danish: Samtidige aktive alvorlige infektioner
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis det ikke anvendes umiddelbart efter åbning, er brugeren ansvarlig for opbevaringstid og -betingelser.
English: All tumour responses were durable for > 18 weeks.
Danish: I alle tilfælde varede tumorrespons i > 18 uger.
English: The results showed no significant difference in the PK of siltuximab in patients older than 65 years compared to patients age 65 years or younger.
Danish: Resultaterne viser ingen signifikant forskel i siltuximabs farmakokinetik hos patienter, der er over 65 år sammenlignet med patienter, der er 65 år eller yngre.
English: Siltuximab must be administered as an intravenous infusion.
Danish: Siltuximab skal administreres som intravenøs infusion.
English: It is not known if SYLVANT may affect the baby or a pregnant or breast-feeding woman.
Danish: Det vides ikke, om SYLVANT kan påvirke barnet eller en kvinde, der er gravid eller ammer.
English: This helps reduce the size of the affected lymph nodes, which reduces the symptoms of the illness and should help you carry out your normal daily tasks.
Danish: Derved er det med til at reducere størrelsen af de berørte lymfeknuder, hvorved symptomerne på sygdommen reduceres, så du bliver bedre i stand til at få en normal dagligdag.
English: Data from all patients treated with siltuximab monotherapy (n = 370) form the overall basis of the safety evaluation.
Danish: Data fra alle patienter behandlet med siltuximab som monoterapi (n = 370) udgør det samlede grundlag for sikkerhedsevalueringen.
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelige (kan berøre flere end 1 ud af 10):
English: • In some cases, if you are pregnant and need treatment for MCD, your doctor may advise that the benefit of taking SYLVANT for your health outweighs the possible risks to your unborn baby, including increased risk of infection and use of certain vaccines in babies born to mothers exposed to SYLVANT while pregnant.
Danish: • Hvis du er gravid og samtidig har behov for behandling for MCD, kan din læge i nogle tilfælde nå frem til, at fordelene for dit helbred ved at tage SYLVANT opvejer de mulige risici for dit ufødte barn, herunder øget risiko for infektion og brug af visse vacciner til børn af mødre, der har fået SYLVANT under graviditeten.
English: If you stop treatment with SYLVANT
Danish: Hvis du stopper behandlingen med SYLVANT
English: Haematology laboratory tests should be performed prior to each dose of SYLVANT therapy for the first 12 months and every third dosing cycle thereafter.
Danish: Der skal udføres hæmatologiske laboratorieprøver før hver dosis SYLVANT i de første 12 måneder og derefter for hver tredje behandlingscyklus.
English: As with all therapeutic proteins, there is potential for the generation of anti-medicine antibodies (immunogenicity).
Danish: Ligesom for alle terapeutiske proteiner kan der potentielt genereres antistoffer mod lægemidlet (immunogenicitet).
English: Live, attentuated vaccines should not be given concurrently or within 4 weeks before initiating SYLVANT as clinical safety has not been established.
Danish: Levende, svækkede vacciner må ikke gives samtidig med eller inden for 4 uger før initiering af SYLVANT, da klinisk sikkerhed ikke er klarlagt.
English: • warfarin, a blood thinner
Danish: • warfarin, et blodfortyndende middel
English: Patients should be managed according to current clinical guidelines for management of hyperlipidaemia.
Danish: Patienterne bør behandles i henhold til gældende kliniske retningslinjer for behandling af hyperlipidæmi.
English: Infusion related reactions and hypersensitivity
Danish: Infusionsrelaterede reaktioner og overfølsomhed
English: Neutropenia, thrombocytopenia
Danish: Neutropeni, trombocytopeni
English: Use aseptic technique.
Danish: Anvend en aseptisk teknik.
English: • you have high level of fats in your blood (hypertriglyceridaemia) - this is because SYLVANT may increase these levels.
Danish: • hvis du har et højt indhold af fedtstoffer i blodet (hypertriglyceridæmi) - dette skyldes, at SYLVANT kan øge dette niveau.
English: In this study 37 patients with CD (35 MCD patients) were treated with siltuximab.
Danish: I dette studie blev 37 patienter med CD (35 patienter med MCD) behandlet med siltuximab.
English: There are no data from the use of siltuximab in pregnant women.
Danish: Der er ingen data fra anvendelse af siltuximab til gravide kvinder.
English: • you have an infection at the moment - this is because SYLVANT may lower your ability to feel or fight infections, and infections may get worse.
Danish: • hvis du har en infektion for tiden - dette skyldes, at SYLVANT kan hæmme din evne til at mærke eller bekæmpe infektioner, hvilket kan forværre infektioner.
English: For patients who do not tolerate the infusion following these interventions, SYLVANT should be discontinued.
Danish: Hos patienter, der ikke kan tåle infusionen efter disse tiltag, bør SYLVANT seponeres.
English: In the event of an overdose, the patient should be monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment should be instituted immediately.
Danish: I tilfælde af overdosering skal patienten overvåges for tegn og symptomer på bivirkninger, og der skal straks iværksættes passende behandling af eventuelle symptomer.
English: A registry should be conducted to collect information on patients with Castleman's disease, who are candidates to receive Sylvant or are currently receiving treatment with Sylvant.
Danish: Der skal udføres en registerundersøgelse for at indsamle oplysninger om patienter med Castlemans sygdom, der er kandidater til behandling med Sylvant, eller som aktuelt er i behandling med Sylvant.
English: Consequently, infants born to women treated with siltuximab may be at increased risk of infection, and caution is advised in the administration of live vaccines to these infants (see section 4.4).
Danish: Som følge deraf kan spædbørn født af kvinder behandlet med siltuximab have en øget risiko for infektioner, og forsigtighed tilrådes ved administration af levende vacciner til disse spædbørn (se pkt.
English: The safety and efficacy of siltuximab in children aged 17 years and younger have not been established.
Danish: Siltuximabs sikkerhed og virkning hos børn i alderen 17 år eller yngre er ikke klarlagt.
English: The product is a freeze-dried white powder.
Danish: Lægemidlet er et frysetørret hvidt pulver.
English: Common (may affect up to 1 in 10 people):
Danish: Almindelige (kan berøre op til 1 ud af 10):
English: • During the infusion with SYLVANT, you will be monitored for side effects.
Danish: • Mens du får droppet med SYLVANT, kontrolleres du for bivirkninger.
English: • drop in the number of white blood cells (neutropenia)
Danish: • et fald i antallet af hvide blodlegemer (neutropeni)
English: Time to treatment failure
Danish: Tid til behandlingssvigt
English: At baseline, 55% of patients in the siltuximab arm and 65% of patients in the placebo arm had received prior systemic therapies for MCD and 30% of patients in the siltuximab arm and 31% in the placebo arm were using corticosteroids.
Danish: Ved baseline havde 55 % af patienterne i siltuximabarmen og 65 % af patienterne i placeboarmen tidligere fået systemisk behandling for MCD, og 30 % af patienterne i siltuximabarmen og 31 % i placeboarmen anvendte kortikokosteroider.
English: Women of childbearing potential must use effective contraception during and up to 3 months after treatment (see section 4.5).
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen og i op til 3 måneder efter behandlingen (se pkt.
English: • you have liver disease or changes that show up in blood tests of the liver.
Danish: • hvis du har en leversygdom eller leverændringer, som kan påvises i blodprøver.
English: Intravenous infusion after reconstitution and dilution.
Danish: Intravenøs infusion efter rekonstitution og fortynding.
English: Two cases of reactivated hepatitis B have been reported when SYLVANT was administered concomitantly with high dose dexamethasone, and bortezomib, melphalan and prednisone in multiple myeloma patients.
Danish: Der er indberettet to tilfælde af reaktiveret hepatitis B, hvor SYLVANT blev administreret samtidig med en høj dosis af dexamethason og bortezomib, melphalan og prednison hos patienter med myelomatose.
English: You may be more likely to get infections while you are being treated with SYLVANT.
Danish: Du kan være mere tilbøjelig til at få infektioner, mens du er i behandling med SYLVANT.
English: A total score of all symptoms (referred to as the MCD-related Overall Symptom Score) is the sum of the severity grades (NCI-CTCAE grade) of the MCD-related signs and symptoms [general MCD-related (fatigue, malaise, hyperhidrosis, night sweats, fever, weight loss, anorexia, tumour pain, dyspnea, and pruritus), autoimmune phenomena, fluid retention, neuropathy, and skin disorders].
Danish: Totalscoren for alle symptomer (omtalt som den samlede score for symptomer relateret til MCD) er summen af sværhedsgraderne (NCI-CTCAE-grader) for symptomer relateret til MCD [generelle symptomer relateret til MCD (træthed, utilpashed, hyperhidrose, natlige svedeture, feber, vægttab, anoreksi, tumorsmerter, dyspnø og pruritus), autoimmune fænomener, væskeretention, neuropati og hudsygdomme].
English: • SYLVANT is available in packs containing 1 vial.
Danish: • SYLVANT fås i pakninger, der indeholder 1 hætteglas.
English: If you think you have been given too much SYLVANT, tell your doctor or nurse straight away.
Danish: Hvis du tror, at du har fået for meget SYLVANT, skal du omgående fortælle det til lægen eller sundhedspersonalet.
English: Within the system organ class, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to
Danish: For hver systemorganklasse angives bivirkningerne efter hyppighed inden for følgende kategorier: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10);
English: On the basis of limited experience with siltuximab the present data do not suggest any increased risk of malignancy.
Danish: Ud fra de begrænsede erfaringer med siltuximab tyder de foreliggende data ikke på en øget risiko for maligne sygdomme.
English: SYLVANT is a medicine that contains the active substance siltuximab.
Danish: SYLVANT er et lægemiddel, der indeholder det aktive stof siltuximab.
English: SYLVANT will be given to you by your doctor or nurse, in a hospital or clinic only.
Danish: Du vil kun få SYLVANT af en læge eller sygeplejerske på hospitalet eller en klinik.
English: Tell your doctor straight away if you get any signs of infection during treatment with SYLVANT.
Danish: Kontakt straks lægen, hvis du får tegn på infektion under behandlingen med SYLVANT.
English: Treatment criteria
Danish: Behandlingskriterier
English: Analyses for both primary and secondary endpoints on various subgroups including age (< 65 years and ≥ 65 years); race (White and Non-White); region (North America, Europe, Middle East and Africa, and Asia Pacific); baseline corticosteroid use (yes and no); prior therapy (yes and no); and MCD histology (plasmatic and mixed histology) consistently showed that the treatment effect favoured the siltuximab arm except for the hyaline vascular subgroup in which no patient achieved the definition of the primary endpoint.
Danish: Analyser af både primære og sekundære endepunkter for forskellige undergrupper inklusive alder (< 65 år og ≥ 65 år), race (hvid/ikke-hvid), region (Nordamerika, Europa, Mellemøsten og Afrika samt Asien og Stillehavsområdet), brug af kortikosteroider ved baseline (ja/nej), tidligere behandling (ja/nej) og MCD histologi (plasma og blandet histologi) viste konsekvent, at virkningen af behandlingen var størst i siltuximabarmen undtagen i den hyaline vaskulære subtype, hvor ingen af patienterne opnåede definitionen af det primære endepunkt.
English: Tell your doctor straight away if you notice the following side effects, as he or she may need to stop your treatment:
Danish: Kontakt straks din læge, hvis du bemærker følgende alvorlige bivirkninger, da lægen kan være nødt til at stoppe behandlingen:
English: It is not known what the possible side effects could be from having too much SYLVANT.
Danish: De mulige bivirkninger af at få for meget SYLVANT kendes ikke.
English: Therefore, an increased susceptibility to specific tumours cannot be entirely ruled out.
Danish: Det kan derfor ikke helt udelukkes, at der er en øget modtagelighed over for specifikke tumorer.
English: The management of severe infusion reactions should be dictated by the signs and symptoms of the reaction.
Danish: Håndteringen af svære reaktioner på infusionen afhænger af symptomerne på reaktionen.
English: Janssen Sciences Ireland UC
Danish: Janssen Sciences Ireland UC Barnahely
English: Histopathological examination of lymphoid tissues from GD140 fetuses showed no morphological abnormalities in the development of the immune system.
Danish: En histopatologisk undersøgelse af lymfevæv fra GD140-fostre viste ingen morfologiske anomalier i udviklingen af immunsystemet.
English: Patients with MCD produce too much IL-6 and this is thought to contribute to the abnormal growth of certain cells in lymph nodes.
Danish: Patienter med MCD frembringer for meget IL6, og det menes at bidrage til unormal vækst af visse celler i lymfeknuderne.
English: Siltuximab clearance increased with increasing body weight; however, no dose adjustment is required for body weight since administration is on an mg/kg basis.
Danish: Clearance af siltuximab steg med stigende legemsvægt, men der er ikke behov for dosisjustering pga. legemsvægten, da doseringen er baseret på mg/kg.
English: You are severely allergic to siltuximab or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du har en alvorlig allergi over for siltuximab eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Paediatric population No interaction studies have been performed in this population.
Danish: Pædiatrisk population Der er ikke udført interaktionsstudier.
English: Siltuximab treatment in MCD results in rapid and sustained decreases in CRP serum concentrations.
Danish: Behandling med siltuximab for MCD resulterer i et hurtigt og vedvarende fald i serumkoncentrationen af CRP.
English: Further immunogenicity analyses were conducted for all positive samples from the 4 patients with detectable anti-siltuximab antibodies.
Danish: Yderligere immunogenicitetsanalyser blev udført for alle positive prøver fra de 4 patienter med påviselige anti-siltuximab-antistoffer.
English: SYLVANT may mask signs and symptoms of acute inflammation including suppression of fever and of acute-phase reactants, such as C-reactive protein (CRP).
Danish: SYLVANT kan maskere symptomer på akut inflammation inklusive suppression af feber og af akutfase-reaktanter såsom C-reaktivt protein (CRP).
English: In non-clinical studies, interleukin-6 (IL-6) is known to decrease the activity of cytochrome P450 (CYP450).
Danish: I prækliniske studier er interleukin-6 (IL-6) kendt for at nedsætte aktiviteten af cytokrom P450 (CYP450).
English: • SYLVANT will be given as an “intravenous infusion” (a drip into a vein, usually in your arm).
Danish: • SYLVANT gives som intravenøs infusion - dvs. som drop i en vene, sædvanligvis i armen.
English: Infections (including upper respiratory tract infections), pruritus, rash, arthralgia, and diarrhoea were the most common adverse reactions , occurring in > 20% of siltuximab-treated patients in Castleman's disease (CD) clinical studies.
Danish: Infektioner (inklusive øvre luftvejsinfektioner), pruritus, udslæt, artralgi og diarré var de mest almindelige bivirkninger, som forekom hos > 20 % af de patienter, der fik siltuximab under kliniske studier af Castlemans sygdom (CD).
English: SYLVANT does not contain preservatives; therefore do not store any unused portion of the infusion solution for re-use.
Danish: SYLVANT indeholder ikke konserveringsmidler, og ikke anvendt infusionsopløsning må derfor ikke gemmes til senere brug.
English: Pharmacotherapeutic group: Immunosuppresants, interleukin inhibitors, ATC code: L04AC11.
Danish: Farmakoterapeutisk klassifikation: immunsuppressiva, interleukinhæmmere, ATC-kode: L04AC11.
English: If the patient develops a severe infusion related reaction, anaphylaxis, severe allergic reaction, or cytokine release syndrome related to the infusion, further administration of SYLVANT should be discontinued.
Danish: Hvis patienten får en svær reaktion relateret til infusionen, anafylaksi, en svær allergisk reaktion eller cytokin-frigivelsessyndrom relateret til infusionen, skal yderligere administration af SYLVANT seponeres.
English: Following the single dose administration at the recommended dose regimen (11 mg/kg given once every 3 weeks), the clearance was 3.54 ± 0.44 mL/kg/day and half-life was 16.3 ± 4.2 days.
Danish: Efter en enkelt administration i den anbefalede dosering (11 mg/kg en gang hver 3. uge) var clearance 3,54 ± 0,44 ml/kg/dag og halveringstiden 16,3 ± 4,2 dage.
English: • theophylline, used to treat asthma
Danish: • theophyllin til behandling af astma
English: Your doctor may stop your treatment with SYLVANT straight away.
Danish: Din læge vil måske vælge at stoppe behandlingen med SYLVANT med det samme.
English: You and your doctor should decide if you will continue to take SYLVANT, or breast-feed and discontinue SYLVANT.
Danish: Du og din læge bør sammen tage stilling til, om du skal fortsætte med at bruge SYLVANT eller amme og stoppe med SYLVANT.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: BILAG II A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Therefore, prescribers should diligently monitor patients receiving treatment in order to detect serious infections.
Danish: Den ordinerende læge skal derfor omhyggeligt monitorere patienter, der behandles med SYLVANT, med henblik på at opdage alvorlige infektioner.
English: However, there is also evidence to suggest that IL-6 inhibition may suppress immune responses, immune surveillance and lower defense against established tumours.
Danish: Der foreligger dog også materiale, der indikerer, at IL6-hæmning kan undertrykke immunrespons og immunovervågning og nedsætte forsvaret mod udviklede tumorer.
English: The highest total amount of siltuximab administered in any clinical trial so far per dose was 2,190 mg (11 mg/kg).
Danish: Den største samlede mængde siltuximab, der hidtil er administreret i et klinisk studie, var 2.190 mg (11 mg/kg).
English: All clinical studies with SYLVANT excluded patients with clinically significant infections, including those known to be hepatitis B surface antigen positive.
Danish: Alle kliniske studier med SYLVANT ekskluderede patienter med klinisk signifikante infektioner, herunder patienter med påviselig hepatitis B-overfladeantigen (HbsAg positive).
English: The most serious adverse reaction associated with the use of siltuximab was anaphylactic reaction.
Danish: Den mest alvorlige bivirkning associeret med anvendelse af siltuximab var anafylaktisk reaktion.