FrancophonIA/ELRC3.0 huggingface dataset:
English: Especially if you are taking any of the following: - Other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive medicines (e.g. methotrexate) as these combinations are not advisible - Warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of side effects of this medicine - Teriflunomide for multiple sclerosis - Repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes - Daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer - Duloxetine for depression, urinary incontinence or in kidney disease in diabetics
Danish: Dette er særligt vigtigt, hvis du tager: - anden medicin mod reumatoid artrit, såsom malariamedicin (f.eks. chloroquin og hydroxychloroquin), intramuskulært eller oralt guld, penicillamin, azathioprin og andre immunundertrykkende lægemidler (f.eks. methotrexat), da disse kombinationer ikke er tilrådelige.
English: EU/1/11/674/001 30 film-coated tablets EU/1/11/674/002 100 film-coated tablets
Danish: EU/1/11/674/001 30 filmovertrukne tabletter EU/1/11/674/002 100 filmovertrukne tabletter
English: EU/1/11/674/006 30 film-coated tablets EU/1/11/674/007 100 film-coated tablets
Danish: EU/1/11/674/006 30 filmovertrukne tabletter EU/1/11/674/007 100 filmovertrukne tabletter
English: • The Summary of Product Characteristics
Danish: • Produktresumé • Informationsfolder til læger
English: urticaria
Danish: Hjerte
English: White, round film-coated tablets, engraved with “10” on one side and “L” on the other.
Danish: Repso 10 mg filmovertrukne tabletter Hvide, runde filmovertrukne tabletter, præget med “10” på den ene side og “L” på den anden.
English: - Alosetron for the management of severe diarrhoea - Theophylline for asthma - Tizanidine, a muscle relaxant - Oral contraceptives (containing ethinylestradiol and levonorgestrel) - Cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections - Indomethacin, ketoprofen for pain or inflammation - Furosemide for heart disease (diuretic, water pill) - Zidovudine for HIV infection - Rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol) - Sulfasalazine for inflammatory bowel disease or rheumatoid arthritis - Colestyramine (used to lower cholesterol levels and treat itching associated with jaundice) or activated charcoal as these medicines can reduce the amount of Repso absorbed by your body.
Danish: - colitis - kvalme - opkastning - mundsår eller betændelsestilstand i munden - mavesmerter - øget hårtab - eksem - udslæt - kløe - tør hud - smerter, hævelse og ømhed, som regel i hænder, håndled eller fødder - en stigning af visse enzymer i blodet (kreatininphosphokinase) - appetitløshed - vægttab (sædvanligvis ubetydeligt) - mangel på eller tab af styrke (slaphed) - milde allergiske reaktioner - en stigning i nogle leverprøveresultater - gener fra nerverne i arme eller ben (perifer neuropati).
English: - Abdominal pain.
Danish: - theophyllin mod astma.
English: - Mouth ulcers or inflammation.
Danish: - indomethacin, ketoprofen mod smerter eller inflammation.
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret 03/2015
English: Drinking alcohol while taking Repso may increase the chance of liver damage.
Danish: Brug af Repso sammen med mad, drikke og alkohol Da eventuelle leverskader forvoldt af alkohol kan forværres af behandling med Repso, anbefales det ikke at drikke alkohol under behandling med Repso.
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Danish: Spørg lægen, på apoteket eller sundhedspersonalet, hvis du har evt. yderligere spørgsmål om brugen af dette lægemiddel.
English: This is to monitor your blood cells and liver.
Danish: Din læge vil tage regelmæssige blodprøver før og under behandling med Repso for at overvåge dine blodceller og din lever.
English: Cutaneous use Bottle (PET)
Danish: Flaske (PET)
English: 1 bottle Not applicable
Danish: 1 flaske
English: Dogs
Danish: Hunde kutanspray
English: Cutaneous spray, solution
Danish: Kutanspray, opløsning.
English: • Go to step 8 immediately after these 5 minutes.
Danish: • Gå straks til trin 8 efter disse 5 minutter.
English: The recommended treatment is
Danish: Den anbefalede behandling er
English: A risk to the child cannot be excluded.
Danish: En risiko for barnet kan ikke udelukkes.
English: Date removed from refrigerator: ________________________
Danish: Dato for udtagning fra køleskab: ________________________
English: Date of first authorisation: 31 August 2018
Danish: Dato for første tilladelse: 31. august 2018
English: Differences in the different subpopulations were investigated.
Danish: Forskelle i de forskellige delpopulationer blev undersøgt.
English: Patients were followed for 1 month after discontinuation of treatment.
Danish: Patienterne blev fulgt i 1 måned efter ophør af behandlingen.
English: The plunger may rise up by itself again - this is normal.
Danish: Stemplet kan gå op igen af sig selvdet er helt normalt.
English: Unopened vial 4 years.
Danish: Uåbnet hætteglas 4 år.
English: Patient age ranged from 18 to 79 years, with a mean of 46 years.
Danish: Patienternes alder varierede fra 18 til 79 år med et gennemsnit på 46 år.
English: Never expose to temperatures above 30 °C.
Danish: Må aldrig udsættes for temperaturer over 30 °C.
English: Do not warm them up in any other way.
Danish: De må ikke opvarmes på nogen anden måde.
English: Total volume of plasma used (liter)
Danish: Totalt volumen af anvendt plasma (liter)
English: Contact your doctor or nurse if this happens.
Danish: Kontakt din læge eller sygeplejerske, hvis dette sker.
English: Although in some cases these events were serious and required medical attention, most were self-limited and all resolved.
Danish: Selv om disse hændelser i nogle tilfælde var alvorlige og krævede lægehjælp, var de fleste selvbegrænsede og alle blev løst.
English: The line can be flushed with 0.9% sodium chloride.
Danish: Linjen kan skylles med 0,9 % natriumklorid.
English: Tell your doctor if you:
Danish: Fortæl din læge hvis du:
English: • are going to have an operation or dental treatment.
Danish: • skal have en operation eller tandbehandling.
English: *Bleeding events: see below
Danish: *Blødningshændelser: Se nedenfor
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt, medmindre rekonstitutionsmetoden udelukker risikoen for mikrobiel kontaminering, bør produktet anvendes straks.
English: Contact your doctor immediately if any of the following serious side effects occur.
Danish: Kontakt straks din læge, hvis en af følgende alvorlige bivirkninger opstår.
English: Side effects in a clinical study were reported with the following frequencies:
Danish: Bivirkninger i et klinisk studie er rapporteret med følgende hyppigheder:
English: Tell your doctor if you are pregnant or plan to get pregnant.
Danish: Fortæl din læge, hvis du er gravid eller planlægger at blive gravid.
English: Body weight was allometrically included in the model.
Danish: Kropsvægten blev allometrisk inkluderet i modellen.
English: Length of hospitalization (days)
Danish: Længde af hospitalsindlæggelse (dage)
English: Do not touch the adapter itself.
Danish: Rør ikke ved selve adapteren.
English: Study ALX0681-C301
Danish: Studie ALX0681-C301
English: Never use the kit for another injection.
Danish: Brug aldrig kittet til en anden injektion.
English: Half of the patients were experiencing their first episode of aTTP.
Danish: Halvdelen af patienterne oplevede deres første aTTP-episode.
English: Based on a carcinogenicity risk assessment, dedicated studies were not deemed necessary.
Danish: På baggrund af en karcinogenicitetsrisikovurdering blev dedikerede studier vurderet som værende ikke nødvendige.
English: Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C.
Danish: Kemisk og fysisk stabilitet efter rekonstitution er blevet påvist i 4 timer ved 25 °C.
English: Your doctor will decide how you should be treated.
Danish: Din læge vil beslutte, hvordan du skal behandles.
English: Component of a multipack, cannot be sold separately.
Danish: Dele af en flerstyks pakning må ikke sælges separat.
English: If not used immediately, in-use storage times and conditions are the responsibility of user.
Danish: Hvis det ikke anvendes straks, er opbevaringstid og -betingelser efter rekonstitution brugerens ansvar.
English: To get the most benefit from your treatment, it is important to use Cablivi as prescribed and for as long as your doctor tells you to use it.
Danish: For at få mest mulig gavn af din behandling er det vigtigt at bruge Cablivi som ordineret og så længe, som din læge siger, du skal bruge det.
English: In patients with aTTP the central volume of distribution was estimated at 6.33 L.
Danish: Hos patienter med aTTP blev det centrale fordelingsvolumen estimeret til 6,33 l.
English: Target disposition
Danish: Målrettet disposition
English: Very common, may affect more than 1 in 10 people
Danish: Meget almindelig, kan forekomme hos flere end 1 ud af 10 personer
English: - your doctor may ask you to continue daily treatment until the underlying signs of your disease are resolved
Danish: - din læge vil måske bede dig om at fortsætte den daglige behandling, indtil de underliggende tegn på din sygdom er behandlet.
English: Your doctor may decide to keep you under closer observation or change your treatment.
Danish: Din læge kan beslutte at holde dig under tættere overvågning eller ændre din behandling.
English: Frequencies are defined as follows: 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); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppigheden er defineret som: 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), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Tell your doctor if you think you have had an overdose.
Danish: Fortæl din læge, hvis du tror, at du har fået en overdosis.
English: • Use the second alcohol pad to clean the injection site you have chosen.
Danish: • Brug den anden alkoholserviet til at rense det injektionssted, du har valgt.
English: Your doctor may ask you to stop the treatment.
Danish: Din læge kan bede dig om at stoppe behandlingen.
English: N: number of patients evaluated; SE: Standard Error; ICU: Intensive Care Unit
Danish: N: antal evaluerede patienter; SE: Standardfejl
English: The doctor will say when you can start your treatment again.
Danish: Lægen vil fortælle dig, når du kan begynde behandlingen igen.
English: All powder must be dissolved and the solution must be clear.
Danish: Alt pulver skal være opløst, og opløsningen skal være klar.
English: The solvent should be added slowly and mixed gently to avoid foaming of the solution.
Danish: Solvensen skal tilsættes langsomt og blandes forsigtigt for at undgå, at opløsningen skummer.
English: Common, may affect up to 1 in 10 people
Danish: Almindelig, kan forekomme hos op til 1 ud af 10 personer
English: Children and adolescents Cablivi is not recommended for children under 18 years.
Danish: Cablivi anbefales ikke til børn under 18 år.
English: White lyophilised powder.
Danish: Hvidt frysetørret pulver.
English: In clinical studies, up to 9% of patients developed treatment-emergent anti-drug antibodies (ADA).
Danish: I kliniske studier udviklede op til 9 % af patienterne antistoffer mod lægemidlet (ADA).
English: Make sure the needle does not touch anything before the injection.
Danish: Sørg for, at kanylen ikke rører ved noget før injektionen.
English: The median treatment duration with caplacizumab in the double blind period was 35 days.
Danish: Den gennemsnitlige behandlingsvarighed med caplacizumab i den dobbeltblindede periode var 35 dage.
English: In patients with coagulopathies
Danish: Hos patienter med koagulopati
English: Do not use the vial if the green plastic cap is missing.
Danish: Brug ikke hætteglasset, hvis den grønne plastikhætte mangler.
English: By doing so, Cablivi reduces the risk of experiencing another episode of aTTP soon after the first.
Danish: Derved reducerer Cablivi risikoen for at få en ny episode af aTTP kort tid efter den første.
English: • to mitigate the risk of serious bleeding episode particularly in emergency situations (e.g. accident) to inform physicians about the medical blockage of the von Willebrand Factor.
Danish: • at mindske risikoen for alvorlig blødningsepisode, især i nødsituationer (f.eks. ulykker) for at informere læger om den medicinske blokering af von Willebrand Factor.
English: Baseline disease characteristics were typical of aTTP.
Danish: Baseline sygdomskarakteristika var typiske for aTTP.
English: • Do not use the kit if the packaging or the items in it are damaged in any way.
Danish: • Brug ikke kittet, hvis emballagen eller genstandene deri er beskadiget på nogen måde.
English: Step 2 - Before use
Danish: Trin 2 - Før brug
English: In patients undergoing surgery
Danish: Hos patienter, der skal opereres
English: An overdose is unlikely since one vial contains only a single dose.
Danish: En overdosis er usandsynlig, da et hætteglas kun indeholder en enkelt dosis.
English: Cablivi is for single use only.
Danish: Cablivi er kun til engangsbrug.
English: The most common serious adverse reaction was epistaxis.
Danish: Den mest almindelige alvorlige bivirkning var epistaxis.
English: Please talk to your doctor before you stop the treatment because stopping it too early can cause your condition to come back.
Danish: Tal med din læge, før du stopper behandlingen, da et for tidligt stop kan betyde at din sygdom vender tilbage.
English: • if you are allergic to caplacizumab or any of the other ingredients in this medicine (listed in section 6)
Danish: • hvis du er allergisk over for caplacizumab eller et af de øvrige indholdsstoffer i lægemidlet (angivet i punkt 6).
English: Use of Cablivi in this population requires a benefit/risk assessment and close clinical monitoring.
Danish: Brugen af Cablivi i denne population kræver en benefit/risk-vurdering og tæt klinisk monitorering.
English: • have severely reduced liver function.
Danish: • har en svært nedsat leverfunktion.
English: Close monitoring for signs and symptoms of bleeding is recommended.
Danish: Tæt monitorering af tegn og symptomer på blødning anbefales (se pkt.
English: See section 4.4 for special considerations in patients with severe hepatic impairment.
Danish: 4.4 for særlige overvejelser hos patienter med svært nedsat leverfunktion.
English: In case of active, clinically significant bleeding, treatment with Cablivi should be interrupted.
Danish: I tilfælde af aktiv, klinisk signifikant blødning bør behandling med Cablivi afbrydes.
English: If a dose of Cablivi is missed, it can be administered within 12 hours.
Danish: Hvis en dosis Cablivi bliver glemt, kan den administreres inden for 12 timer.
English: Do not use if the expiry date has passed.
Danish: Må ikke anvendes, hvis udløbsdatoen er overskredet.
English: If a patient is to undergo elective surgery or a dental procedure, the patient should be advised to inform the physician or dentist that they are using Cablivi, and treatment should be stopped at least 7 days before the planned intervention.
Danish: Hvis en patient skal gennemgå elektiv kirurgi eller tandbehandling, bør patienten rådes til at informere lægen eller tandlægen om, at de får Cablivi, og behandlingen bør stoppes mindst 7 dage før det planlagte indgreb.
English: Adverse reactions are listed below by MedDRA system organ class and by frequency.
Danish: Nedenstående bivirkninger er angivet efter MedDRA systemorganklasse og hyppighed.
English: Do not use Cablivi if you notice any particulate matter or discolouration prior to administration.
Danish: Brug ikke Cablivi, hvis du bemærker partikler eller misfarvning før administration.
English: Preparing a dose of Cablivi for intravenous injection should be done in the same way as for a subcutaneous injection (see Instructions for Use, step 1 to 9, in section 3).
Danish: Klargøring af en dosis Cablivi til intravenøs injektion skal udføres på samme måde som til en subkutan injektion (se Brugsanvisning, trin 1 til 9, i punkt 3).
English: Do not return Cablivi to refrigerated storage after storage at room temperature.
Danish: Sæt ikke Cablivi tilbage i køleskabet efter opbevaring ved stuetemperatur.
English: Foetal exposure to caplacizumab in primates and humans remains uncertain, as proteins lacking an Fc portion are not thought to freely pass the placental barrier.
Danish: Fostereksponering for caplacizumab hos primater og mennesker er stadig usikkert, da proteiner, der mangler en Fc-del, ikke menes at passere frit gennem placentamembranen.
English: Increased risk of bleeding
Danish: Øget risiko for blødning
English: The patient should also notify the physician who supervises the treatment with Cablivi about the planned procedure.
Danish: Patienten bør også informere den læge, der fører tilsyn med behandlingen med Cablivi, om den planlagte procedure.
English: After absorption, caplacizumab binds to the target and distributes to well perfused organs.
Danish: Efter absorption binder caplacizumab til målet og fordeles til godt perfunderede organer.
English: This is a rare blood clotting disorder in which clots form in small blood vessels.
Danish: Det er en sjælden blodstørkningsforstyrrelse, hvor der dannes blodpropper i små blodkar.
English: These clots can block blood vessels and damage the brain, heart, kidneys, or other organs.
Danish: Disse blodpropper kan blokere blodkar og beskadige hjernen, hjertet, nyrerne eller andre organer.
English: Target inhibition
Danish: Målrettet inhibition
English: Injections into the area around the navel should be avoided and consecutive injections should not be administered in the same abdominal quadrant.
Danish: Injektioner i området omkring navlen bør undgås, og efterfølgende injektioner bør ikke administreres i samme abdominale kvadrant.
English: Cablivi is provided as:
Danish: Cablivi leveres som:
English: Do not try to inject Cablivi until you have been taught how to do so by a healthcare professional.
Danish: Prøv ikke at indsprøjte Cablivi, før du er blevet undervist i det af sundhedspersonalet.
English: In clinical studies, bleeding events occurred in different body systems, independent of treatment duration.
Danish: I kliniske studier forekom blødningshændelser i forskellige legemsfunktioner, uafhængigt af behandlingsvarigheden.
English: Transfer the entire volume of the reconstituted solution back to the glass syringe and immediately administer the entire volume of the syringe (see section 6.3).
Danish: Overfør hele volumenet af den rekonstituerede opløsning tilbage til glassprøjten og administrer straks hele sprøjtens volumen (se pkt.
English: It must be visually inspected for particulate matter.
Danish: Den skal inspiceres visuelt for partikler.
English: After subcutaneous administration, caplacizumab is rapidly and almost completely absorbed (estimated F> 0.901) in the systemic circulation.
Danish: Efter subkutan administration absorberes caplacizumab hurtigt og næsten fuldstændigt (estimeret F>0,901) i det systemiske kredsløb.
English: Prior to launch of Cablivi in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the patient alert card, including communication media, distribution modalities, and any other aspects, with the National Competent Authority.
Danish: Inden lanceringen af Cablivi i hvert medlemsland skal indehaveren af markedsføringstilladelsen aftale indholdet og formatet af patientens advarselskort, herunder kommunikationsmedier, distributionsmetode og andre aspekter med den nationale kompetente myndighed.
English: In the population PK/PD model, renal function (CRCL) had a statistically significant effect resulting in limited increase in predicted exposure (AUCss) in severe renal impairment.
Danish: I PK/PD populationsmodellen havde nyrefunktionen (CRCL) en statistisk signifikant effekt, der resulterede i begrænset øgning af forventet eksponering (AUCSS) ved svært nedsat nyrefunktion.
English: In case of recurrence during the follow up period (i.e. after all study drug treatment had been stopped), there was no re-initiation of study drug and the recurrence was to be treated according to the standard of care.
Danish: I tilfælde af tilbagevendende episode under opfølgningsperioden (dvs. når al behandling med studiemedicin var stoppet), var der ingen genoptagelse af studiemedicin, og tilbagefaldet skulle behandles i henhold til standardbehandlingen.
English: Cablivi prevents the formation of these blood clots by stopping platelets in the blood from clumping together.
Danish: Cablivi forebygger dannelsen af disse blodpropper ved at forhindre blodpladerne i blodet i at klumpe sammen.
English: They were again treated for the duration of daily plasma exchange and for 30 days thereafter.
Danish: De blev igen behandlet i varigheden af den daglige plasmaudskiftning og i 30 dage derefter.
English: Step 13 - After administration
Danish: Trin 13 - Efter administration
English: Pyrexia, Fatigue
Danish: Pyreksi, træthed
English: • Press the plunger down as far as it goes.
Danish: • Tryk stemplet så langt ned, som det kan komme.
English: In the absence of compatibility studies, Cablivi must not be mixed with other medicinal products.
Danish: Da der ikke foreligger studier af eventuelle uforligneligheder, må Cablivi ikke blandes med andre lægemidler.
English: For instructions on reconstitution of Cablivi before administration, see section 6.6.
Danish: For instruktioner om rekonstitution af Cablivi før administration, se pkt.
English: The efficacy and safety of caplacizumab in adults experiencing an episode of aTTP were established in 2 randomised, controlled studies: Phase III study ALX0681-C301 “HERCULES” and Phase II study ALX-0681-2.1/10 “TITAN”.
Danish: Effekten og sikkerheden af caplacizumab hos voksne, der oplever en episode af aTTP, blev fastlagt i 2 randomiserede, kontrollerede studier: Fase III studie ALX0681-C301 ”HERCULES” og Fase II studie ALX-0681-2.1/10 ”TITAN”.
English: For each injection, use a fresh kit package to prepare the injection solution.
Danish: Til hver injektion skal der bruges en ny kitpakning til at forberede injektionsopløsningen.
English: If you miss a dose you should still take it if it is within 12 hours of the scheduled time.
Danish: Hvis du glemmer en dosis, skal du stadig tage den, hvis det er inden for 12 timer i forhold til det planlagte tidspunkt.
English: There were no deaths in the caplacizumab group and 3 deaths in the placebo group during the study drug treatment period.
Danish: Der var ingen dødsfald i caplacizumab-gruppen og 3 dødsfald i placebogruppen i perioden med behandling med studiemedicin.
English: Injury, Poisoning And Procedural Complications
Danish: Traumer, forgiftninger og behandlingskomplikationer
English: Long or excessive bleeding.
Danish: Langvarig eller kraftig blødning.
English: Ablynx NV Technologiepark 21 9052 Zwijnaarde Belgium
Danish: Ablynx NV Technologiepark 21 9052 Zwijnaarde Belgien
English: * Caplacizumab is a humanised bivalent Nanobody produced in Escherichia coli by recombinant DNA technology.
Danish: * Caplacizumab er en humaniseret bivalent nanobody, der produceres i Escherichia coli ved rekombinant DNA-teknologi.
English: Your doctor may decide that you or your caregiver may inject Cablivi.
Danish: Din læge kan beslutte, at du eller din omsorgsperson kan injicere Cablivi.
English: Pharmacotherapeutic group: Other antithrombotic agents, ATC code: B01AX07.
Danish: Farmakoterapeutisk klassifikation: Andre antitrombotiske midler, ATC-kode: B01AX07.