FrancophonIA/ELRC3.0 huggingface dataset:
English: The main risk with LysaKare is a dangerous rise of blood potassium levels but this side effect can be managed if recognised and treated appropriately.
Danish: Den største risiko ved LysaKare er en farlig stigning i blodets indhold af kalium, men denne bivirkning kan håndteres, hvis den konstateres og behandles korrekt.
English: What are the risks associated with LysaKare?
Danish: Hvilke risici er der forbundet med LysaKare?
English: Because the use of arginine and lysine to protect the kidneys during this type of cancer treatment is well established, the company presented data from the scientific literature.
Danish: Da brugen af arginin og lysin til at beskytte nyrerne under denne type kræftbehandling er veletableret, fremlagde virksomheden data fra faglitteraturen.
English: As a result, the radioactive medicine leaves the body in the urine and the kidneys are exposed to less radiation.
Danish: Det radioaktive lægemiddel udskilles derfor gennem urinen, og nyrerne udsættes for mindre stråling.
English: Because LysaKare can cause nausea (feeling sick) and vomiting, patients will be given medicines to prevent nausea and vomiting before receiving LysaKare.
Danish: Da LysaKare kan give kvalme og opkastning, får patienterne medicin til at forebygge kvalme og opkastning, inden de modtager LysaKare.
English: LysaKare (arginine / lysine) EMA/378037/2019
Danish: LysaKare (arginin/lysin) EMA/314645/2019
English: For the full list of side effects and restrictions with LysaKare, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved LysaKare fremgår af indlægssedlen.
English: Infusion with LysaKare is started 30 minutes before the patient is given lutetium (177Lu) oxodotreotide (also by infusion).
Danish: Infusionen med LysaKare indledes 30 minutter, før patienten får lutetium (177Lu) oxodotreotid (også ved infusion).
English: LysaKare is a medicine used to protect the kidneys from radiation damage during cancer treatment with a radioactive medicine called lutetium (177Lu) oxodotreotide.
Danish: LysaKare er et lægemiddel, der anvendes til at beskytte nyrerne mod strålingsskader under kræftbehandling med et radioaktivt lægemiddel, der kaldes lutetium (177Lu) oxodotreotid.
English: How is LysaKare used?
Danish: Hvordan anvendes LysaKare?
English: In another published study involving 229 patients, measurement of creatinine clearance (an indication of how well the kidneys are working) did not show kidney damage 14 months after patients were treated with arginine and lysine at the same time as lutetium (177Lu) oxodotreotide.
Danish: I et andet offentliggjort studie med deltagelse af 229 patienter viste målinger af kreatinin-clearance (en indikator for nyrefunktion) ingen nyreskade 14 måneder efter behandling med arginin og lysin samtidigt med lutetium (177Lu) oxodotreotid.
English: Radiation from lutetium (177Lu) oxodotreotide can cause damage when the medicine passes through tubules in the kidney.
Danish: Stråling fra lutetium (177Lu) oxodotreotid kan forvolde skade, når lægemidlet passerer gennem nyrens tubuli.
English: What benefits of LysaKare have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved LysaKare?
English: The active substances in LysaKare, arginine and lysine, interfere with the passage of lutetium (177Lu) oxodotreotide through these kidney tubules.
Danish: De aktive stoffer i LysaKare, arginin og lysin, hindrer lutetium (177Lu) oxodotreotids passage gennem disse nyretubuli.
English: The use of arginine and lysine during treatment with lutetium (177Lu) oxodotreotide has been shown to reduce kidney damage and allow patients to be given an effective dose of radioactive treatment for their cancer.
Danish: Brugen af arginin og lysin under behandling med lutetium (177Lu) oxodotreotid har vist sig at reducere nyreskader og at gøre det muligt for patienter at modtage en virksom dosis af radioaktiv behandling for deres kræftlidelse.
English: How does LysaKare work?
Danish: Hvordan virker LysaKare?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of LysaKare have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af LysaKare.
English: These included data from over 1,200 cancer patients treated with lutetium (177Lu) oxodotreotide, which showed that arginine and lysine were effective at preventing kidney damage.
Danish: kræftpatienter behandlet med lutetium (177Lu) oxodotreotid, som viste, at arginin og lysin var effektive til at forebygge nyreskade.
English: Content (concentration) Package size
Danish: Indhold Pakningsstørrelse
English: Intravenous use Vial (glass)
Danish: Intravenøs brug Hætteglas
English: 50 mg Powder for solution for infusion
Danish: Pulver til infusionsvæske, opløsning
English: ASAS partial remission BASDAI
Danish: ASAS delvis remission BASDAI
English: Results from the overall UC-II study population are shown in table 22.
Danish: Resultater fra den samlede UC-II studiespopulation er vist i tabel 22.
English: Double-Blind Response at week
Danish: Dobbelt-blind respons ved uge 12
English: Not known (frequency cannot be estimated from available data):
Danish: Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data):
English: SOLYMBIC can also be given alone.
Danish: SOLYMBIC kan også anvendes alene.
English: The decision to stop using SOLYMBIC should be discussed with your doctor.
Danish: Beslutningen om at stoppe med at bruge SOLYMBIC skal diskuteres med din læge.
English: Following the administration of 24 mg/m
Danish: Efter administration af 24 mg/m
English: SOLYMBIC works by reducing this inflammation.
Danish: SOLYMBIC virker ved at reducere denne inflammation.
English: If an alternate dose is required, other adalimumab products offering such an option should be used.
Danish: Hvis der er behov for en anden dosis, bør der bruges andre adalimumabprodukter, som giver mulighed for dette.
English: Patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as non-responders
Danish: Patienter, som opfylder protokol-specifikke kriterier for tab af respons eller ingen forbedring, var forpligtet til at udgå af studierne og blev optalt som non-respondere
English: It is a medicine that decreases the inflammation process of these diseases.
Danish: Det er et lægemiddel, der reducerer disse sygdommes inflammatoriske proces.
English: Your child's doctor will tell you the correct dose to use.
Danish: Lægen vil fortælle dig den korrekte dosis.
English: Significant response was first observed at week 2 and maintained through 24 weeks (table 8).
Danish: Første signifikante respons blev observeret ved uge 2 og blev opretholdt frem til uge 24 (Tabel 8).
English: ≥30% Reduction in Skin Pain b
Danish: ≥30 % reduktion af hudsmerter b
English: It is not known whether SOLYMBIC passes into breast milk.
Danish: Det vides ikke, om SOLYMBIC passerer over i mælk.
English: TNF-antagonists, such as SOLYMBIC affect the immune system and their use may affect the body's defence against infection and cancer.
Danish: TNF-antagonister, så som SOLYMBIC påvirker immunsystemet og brugen af dem kan påvirke kroppens forsvar mod infektion og cancer.
English: Side effects may occur at least up to 4 months after the last SOLYMBIC injection.
Danish: Bivirkninger kan forekomme op til 4 måneder efter den sidste SOLYMBIC injektion.
English: Do not use SOLYMBIC:
Danish: Tag ikke SOLYMBIC:
English: • lupus-like syndrome.
Danish: • lupus-lignende syndrom.
English: PGA: Clear/minimal c a
Danish: PGA: Clear/minimal b a
English: SOLYMBIC in combination with methotrexate, is indicated for:
Danish: SOLYMBIC i kombination med methotrexat er indiceret til:
English: 2-sided P value from log rank test. c NE = not estimable.
Danish: 2-sidet p-værdi fra log rank test. c NE = ikke estimerbar.
English: ASDAS Inactive Disease hs-CRP
Danish: ASDAS inaktiv sygdom hs-CRP
English: SOLYMBIC is a biosimilar medicinal product.
Danish: SOLYMBIC er et biosimilært lægemiddel.
English: Keep this Patient Alert Card with you.
Danish: Opbevar patientkortet på dig.
English: Not known (frequency cannot be estimated from available data): • liver failure.
Danish: Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data): • leversvigt.
English: You should continue to inject SOLYMBIC for as long as your doctor has told you.
Danish: Du skal fortsætte med at injicere SOLYMBIC så længe, din læge har fortalt dig.
English: It is not known whether adalimumab is excreted in human milk or absorbed systemically after ingestion.
Danish: Det vides ikke, om adalimumab udskilles i humanmælk eller absorberes systemisk efter indgift.
English: Your doctor should test you for HBV. SOLYMBIC can cause reactivation of HBV in people who carry this virus.
Danish: Lægen vil teste dig for HBV. SOLYMBIC kan forårsage reaktivering af HBV hos mennesker, der bærer denne virus.
English: You and your doctor should pay special attention to signs of infection while you are being treated with SOLYMBIC.
Danish: Du og din læge bør være særligt opmærksomme på tegn på infektion mens du er i behandling med SOLYMBIC.
English: ● Do not use the pre-filled pen if:
Danish: ● Brug ikke den fyldte pen, hvis:
English: Maintenance of remission and response rates are presented in table 18.
Danish: Rater for vedligeholdelse af remission- og respons er vist i Tabel 18.
English: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open-label extension studies 1) including spontaneous reporting data
Danish: 4.3, 4.4 og 4.8 ** inklusive åben-label forlængelsesstudie inklusive spontane rapporter
English: Administration of SOLYMBIC is not recommended during pregnancy.
Danish: Administration af SOLYMBIC kan ikke anbefales under graviditet.
English: Prior to launch of Solymbic in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Inden lancering af Solymbic i hvert medlemsland skal indehaveren af markedsføringstilladelsen være enig med den nationale kompetente myndighed om indholdet og formatet af uddannelsesprogrammet og det kontrollerede distributionsprogram, herunder kommunikationsmedier, distributionsmetoder og eventuelle andre aspekter af programmet.
English: K. Discard the used pre-filled pen and the yellow cap.
Danish: K. Kassér den brugte pen og den gule hætte.
English: For all of the above indications, available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Danish: For alle ovenstående indikationer tyder tilgængelige data på, at klinisk respons sædvanligvis opnås inden for 12 uger.
English: If retreatment with SOLYMBIC is indicated, the above guidance on dose and treatment duration should be followed.
Danish: Hvis genbehandling med SOLYMBIC er indiceret, bør ovenstående vejledning for dosering og behandligsvarighed følges.
English: The administered dose is selected based on the patients' weight (table 2).
Danish: Den administrerede dosis beregnes på baggrund af patientens vægt (tabel 2).
English: Week 52 Fistula remission
Danish: Uge 52 Remission af fistler
English: If you are over 65 years you may be more susceptible to infections while taking SOLYMBIC.
Danish: - Hvis du er over 65 år, kan du være mere modtagelig for infektioner, mens du tager SOLYMBIC.
English: The patient information pack should contain: • Patient information leaflet
Danish: Patientinformationspakken skal indeholde: • Indlægssedlen.
English: Re-introduction of SOLYMBIC after discontinuation for 70 days or longer should result in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Danish: Genopstart af SOLYMBIC efter doseringsindstilling i 70 dage eller længere bør resultere i et klinisk respons i samme størrelsesorden og med samme sikkerhedsprofil som før behandlingsafbrydelsen.
English: Vertigo and visual impairment may occur following administration of SOLYMBIC (see section 4.8).
Danish: Vertigo og svækket syn kan forekomme efter administration af SOLYMBIC, se pkt 4.8.
English: You should not take SOLYMBIC with medicines containing the active substance, anakinra or abatacept.
Danish: Du bør ikke tage SOLYMBIC sammen med medicin, der indeholder det aktive stof anakinra eller abatacept.
English: Rare side effects (may affect up to 1 in 1,000 people): • low blood measurements for white blood cells, red blood cells and platelet count.
Danish: Sjældne bivirkninger (kan påvirke op til 1 ud af 1.000 personer): • nedsat antal hvide blodlegemer, røde blodlegemer og blodplader.
English: SOLYMBIC should be used with caution in patients with mild heart failure (NYHA class I/II).
Danish: SOLYMBIC bør anvendes med forsigtighed til patienter med let hjerteinsufficiens (NYHA, klasse I/II).
English: Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with SOLYMBIC.
Danish: Patienter skal derfor monitoreres nøje for infektioner, herunder tuberkulose, før, under og efter behandling med SOLYMBIC.
English: If you become pregnant, you should consult your doctor.
Danish: Hvis du bliver gravid, skal du kontakte din læge.
English: Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leucocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 0.1-0.2 nM).
Danish: Adalimumab modulerer også de biologiske responser, som induceres eller reguleres af TNF, herunder ændringer i niveauerne af de adhæsionsmolekyler, som er ansvarlige for leukocytmigrationen (ELAM-1, VCAM-1 og ICAM-1 med en IC50 på 0,1-0,2 nM).
English: Non-infectious uveitis affecting the back of the eye
Danish: Ikke-infektiøs uveitis, som påvirker den bagerste del af øjet
English: Patients on SOLYMBIC may receive concurrent vaccinations, except for live vaccines.
Danish: Patienter i SOLYMBIC-behandling kan modtage samtidige vaccinationer, undtagen med levende vacciner.
English: SOLYMBIC may have a minor influence on the ability to drive and use machines.
Danish: SOLYMBIC kan have en mindre påvirkning af evnen til at føre motorkøretøj og betjene maskiner.
English: The volume for injection is selected based on the patients' height and weight (table 1).
Danish: Injektionsvolumenen beregnes på baggrund af patientens højde og legemsvægt (tabel 1).
English: In order to improve the traceability of this medicine, your doctor or pharmacist should record the tradename and the lot number of the product you have been given in your patient file.
Danish: Af hensyn til sporbarheden af dette lægemiddel bør din læge eller apotekspersonalet registrere handelsnavnet og lotnummeret på det produkt, du har fået, i din patientjournal.
English: Treatment with SOLYMBIC may result in the formation of autoimmune antibodies.
Danish: Behandling med SOLYMBIC kan medføre dannelse af autoimmune antistoffer.
English: The impact of long-term treatment with SOLYMBIC on the development of autoimmune diseases is unknown.
Danish: Det vides ikke, hvilken virkning langtidsbehandling med SOLYMBIC har på udviklingen af autoimmune sygdomme.
English: Certain vaccines may cause infections and should not be given while receiving SOLYMBIC.
Danish: - Visse vacciner kan forårsage infektioner og bør ikke gives under SOLYMBIC-behandling.
English: In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see table 7).
Danish: I RA-studie V blev strukturel ledskade vurderet radiografisk og udtrykt som ændringer i modificeret Total Sharp Score (se tabel 7).
English: SOLYMBIC can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Danish: SOLYMBIC kan gives som monoterapi i tilfælde af intolerans over for methotrexat eller hvis fortsat behandling med methotrexat er uhensigtsmæssig.
English: Children or adolescents weighing less than 40 kg:
Danish: Børn og unge, som vejer mindre end 40 kg:
English: Sodium hydroxide (for pH adjustment) Water for injections
Danish: Natriumhydroxid (til justering af pH) Vand til injektionsvæsker
English: Note: After you remove the pre-filled pen from your skin, the needle will be automatically covered.
Danish: Bemærk: Når du har fjernet den fyldte pen fra huden, dækkes
English: After proper training in injection technique, patients may self-inject with SOLYMBIC if their physician determines that it is appropriate and with medical follow-up as necessary.
Danish: Efter passende oplæring i injektionsteknik kan patienter selv injicere SOLYMBIC, såfremt lægen finder det hensigtsmæssigt, og med nødvendig lægelig opfølgning.
English: Keep SOLYMBIC in the outer carton in order to protect from light.
Danish: Opbevar SOLYMBIC i den ydre karton for at beskytte mod lys.
English: Hidradenitis Suppurativa Clinical Response (HiSCR)
Danish: Hidradenitis Suppurativa Clinical Respons (HiSCR)
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in table 3 below: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); and not known (cannot be estimated from the available data).
Danish: Nedenstående liste over bivirkninger er baseret på erfaring fra kliniske studier og erfaring efter markedsføring og er inddelt efter organklassesystem og hyppighed i tabel 3 nedenfor meget almindelig (≥1/10); almindelig (≥1/100 til < 1/10); ikke almindelig (≥1/1.000 til < 1/100), sjælden (≥1/10.000 til < 1/1.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If you take SOLYMBIC the risk of getting lymphoma, leukaemia, or other cancers may increase.
Danish: Når du tager SOLYMBIC, kan din risiko for at få et lymfom, leukæmi eller andre former for kræft øges.
English: It is important that you tell your baby's doctors and other health care professionals about your SOLYMBIC use during your pregnancy before the baby receives any vaccine (for more information see section on vaccination).
Danish: Det er vigtigt, at du fortæller barnets læge og andre sundhedspersoner, at du fik SOLYMBIC under graviditeten, før dit barn får nogen vaccinationer (for mere information, se afsnittet om vacciner).
English: The potential risk with the combination of azathioprine or 6-mercaptopurine and SOLYMBIC should be carefully considered.
Danish: Den potentielle risiko ved kombination af azathioprin eller 6-mercaptopurin med SOLYMBIC bør nøje overvejes.
English: H. Using slow and constant pressure, push the plunger rod all the way down until it stops moving.
Danish: H. Skub stempelstangen hele vejen ind med et langsomt og konstant tryk, indtil den ikke bevæger sig længere.
English: Children or adolescents weighing 40 kg or more:
Danish: Børn og unge, som vejer 40 kg eller mere:
English: Administration of SOLYMBIC should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Danish: Administration af SOLYMBIC bør ophøre, hvis en patient udvikler en ny alvorlig infektion eller sepsis, og passende antimikrobiel eller antimykotisk behandling iværksættes, indtil infektionen er under kontrol.
English: It is not possible to administer SOLYMBIC to paediatric patients that require less than a full 20 mg or 40 mg dose.
Danish: Det er ikke muligt at administrere SOLYMBIC til pædiatriske patienter, som skal have mindre end en fuld dosis på 20 mg eller 40 mg.
English: The conduct and results of these tests should be recorded on your Patient Alert Card.
Danish: Disse undersøgelser og resultaterne heraf bør registreres på dit patientkort.
English: - Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given SOLYMBIC and during treatment with SOLYMBIC.
Danish: - Din læge vil også udlevere et patientkort, der indeholder vigtige sikkerhedsinformationer, som du skal være opmærksom på før og under din behandling med SOLYMBIC.
English: If you accidentally inject SOLYMBIC more frequently than told to by your doctor or pharmacist, you should call your doctor or pharmacist and tell him/her that you have taken more.
Danish: Hvis du ved en fejltagelse injicerer SOLYMBIC hyppigere end forskrevet af lægen eller apoteket, bør du kontakte lægen eller apoteket og fortælle ham/hende, at du har taget mere.
English: The Guide for healthcare professionals shall contain the following key elements:
Danish: Vejledningen til sundhedspersonale skal indeholde følgende hovedpunkter:
English: In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske præparater skal handelsnavnet og batchnummeret for det administrerede præparat registreres tydeligt.
English: If you received SOLYMBIC while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately five months after the last dose you received during pregnancy.
Danish: Hvis du har fået SOLYMBIC, mens du var gravid, kan dit spædbarn have en højere risiko for at få en sådan infektion i op til ca. fem måneder efter din sidste dosis under graviditeten.
English: Treatment with SOLYMBIC should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Danish: Behandling med SOLYMBIC bør ikke initieres hos patienter med aktive infektioner, herunder kroniske eller lokaliserede infektioner, før infektionerne er under kontrol.
English: PGA-F clear/minimal and ≥ 2-grade improvement a a
Danish: PGA-F clear/minimal og ≥ 2 grader forbedring (%)
English: - The medicine is cloudy or discoloured, or contains flakes or particles.
Danish: - Medicinen er grumset eller misfarvet eller indeholder flager eller partikler.
English: Systemic lupus erythematosus Lupus-like syndrome
Danish: Systemisk lupus erythematosus Lupus-lignende syndrom
English: MRI Sacroiliac Joints d,i
Danish: MRI sakroiliakaleddene d,i
English: At week 4, subjects were randomised 1:1 based on their body weight at the time to either the low dose or standard dose maintenance regimens as shown in table 19.
Danish: Ved uge 4 blev patienterne på basis af deres legemsvægt på det tidspunkt randomiseret 1:1 til enten lavdosis-eller standard-dosis-vedligeholdelsesregime som vist i tabel 19.
English: Before initiation of therapy with SOLYMBIC, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Danish: Før behandling med SOLYMBIC påbegyndes, skal alle patienter undersøges for både aktiv og inaktiv (latent) tuberkulose.
English: • Signs or symptoms of the safety concern and when to seek attention from a HCP
Danish: • Information om tegn eller symptomer på de sikkerhedsmæssige problemer og om, hvornår man skal søge læge.
English: If you have mild heart failure and you are being treated with SOLYMBIC, your heart failure status must be closely monitored by your doctor.
Danish: - Hvis du har lettere hjerteinsufficiens og bliver behandlet med SOLYMBIC, skal status for din hjerteinsufficiens følges nøje af din læge.
English: Table 13 Ps study IV efficacy results at 16, 26 and 52 weeks
Danish: Tabel 13 Ps-studie IV - effektresultater ved uge 16, 26 og 52
English: Among all randomised patients b Among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0 - 10; 0 = no skin pain, 10 = skin pain as bad as you can imagine
Danish: Blandt patienter med baseline HS-relateret evaluering af hudsmerte ≥ 3, baseret på en numerisk vurderingsskala 0-10; 0 = ingen hudsmerte, 10 = hudsmerte så slem, som du kan forestille dig