FrancophonIA/ELRC3.0 huggingface dataset:
English: These active substances include e.g.: alfuzosin amiodarone, bepridil, dronedarone,ivabradine,quinidine, ranolazine astemizole, terfenadine colchicine when used in patients with renal and/or hepatic impairment (see section 4.5) ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) elbasvir/grazoprevir cisapride dapoxetine domperidone naloxegol lurasidone, pimozide, quetiapine, sertindole (see section 4.5) triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5) sildenafil - when used for the treatment of pulmonary arterial hypertension, avanafil simvastatin lovastatin and lomitapide (see section 4.5) dabigatran, ticagrelor (see section 4.5).
Danish: Voriconazol må kun tages efter en medicinsk udredning - Rifabutin (mod bakterieinfektioner) - Sildenafil, vardenafil, tadalafil (mod impotens eller for højt blodtryk i lungekredsløbet) - Amitriptylin, desipramin, imipramin, nortriptylin, paroxetin, sertralin, trazodon (til behandling af depression og angst) - Maraviroc (til hiv-infektion) - Methadon (til behandling af opioidafhængighed) - Carbamazepin, clonazepam (til forebyggelse af krampeanfald eller til behandling af visse typer nervesmerter) - Colchicin (til behandling af urinsur gigt eller familiær middelhavsfeber) - Bosentan (til behandling af for højt blodtryk i lungekredsløbet) - Buspiron, clorazepat, diazepam, estazolam, flurazepam, midazolam, når det tages som injektion, zoldipem (beroligende midler) - Perphenazin, risperidon, thioridazin (til behandling af psykiske lidelser).
English: with products that contain St John's wort (Hypericum perforatum).
Danish: må ikke kombineres med naturlægemidler, der indeholder perikon (Hypericum perforatum).
English: Darunavir co-administered with low dose ritonavir and dolutegravir can be used without dose adjustment.
Danish: Darunavir kan administreres sammen med lavdosis ritonavir og dolutegravir uden dosisjusteringer.
English: Elimination After a 400/100 mg
Danish: (2tabletter a 400mg
English: Buprenorphine/naloxone 8/2 mg-16/4 mg once daily buprenorphine AUC ↓ 11% buprenorphine Cmin ↔ buprenorphine Cmax ↓ 8% norbuprenorphine AUC ↑ 46% norbuprenorphine Cmin ↑ 71%
Danish: 8/2 mg-16/4 mg en gang daglig buprenorphin AUC ↓ 11%
English: Recommended dose for treatment-experienced paediatric patients (3 to 17 years) with darunavir tablets and ritonavir
Danish: Anbefalet dosis af darunavir tabletter og ritonavir a til behandlingserfarne pædiatriske patienter (3 til 17 år) Legemsvægt (kg) Dosis (en gang dagligt i forbindelse med et måltid)
English: Take Darunavir Krka d.d.
Danish: Brug af Darunavir Krka d.d.
English: Boceprevir (hepatitis C infection)
Danish: - Glecaprevir/pibrentasvir, simeprevir (til behandling af hepatitis C-infektion).
English: Darunavir boosted with cobicistat is more sensitive for CYP3A induction: concomitant use of darunavir/cobicistat and strong CYP3A inducers is therefore contraindicated (see section 4.3),and concomitant use with weak to moderate CYP3A inducers is not recommended (see section 4.5).
Danish: samtidig brug af darunavir/cobicistat og potente CYP3A-induktorer er derfor kontraindiceret (se pkt.
English: Maraviroc (to treat HIV infection)
Danish: tuberkolose) - Saquinavir (til hiv-infektion).
English: Treatment-naïve darunavir/cobicistat 800/150 mg once daily + OBR N=295
Danish: Resultater ved uge 48 Behandlingsnaive darunavir/cobicistat 800/150 mg en gang dagligt + OBR N=295
English: Posology
Danish: celletal
English: Artemether/lumefantrine (a combination medicineto treat malaria) Dasatinib, everolimus,irinotecan,nilotinib, vinblastine, vincristine (to treat cancer) Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension)
Danish: - Dasatinib, everolimus, irinotecan, nilotinib, vinblastin, vincristin (til behandling af kræft).
English: ↑ ND
Danish: Udslæt
English: In the morning, take one 600 milligram Darunavir Krkad.d.tablettogether with 100 milligram ritonavir.
Danish: virker ikke korrekt uden ritonavir - Om morgenen skal du tage en 600 mg Darunavir Krka d.d.-tablet sammen med 100 mg ritonavir - Om aftenen skal du tage en 600 mg Darunavir Krka d.d.-tablet sammen med 100 mg ritonavir - Tag Darunavir Krka d.d.
English: alfuzosin amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine astemizole, terfenadine colchicine when used in patients with renal and/or hepatic impairment (see section ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) elbasvir/grazoprevir cisapride dapoxetine domperidone naloxegol lurasidone, pimozide, quetiapine, sertindole (see section 4.5) triazolam, midazolam administered orally (for caution on parenterally administered midazolam,
Danish: methylergometrin) - elbasvir/grazoprevir - cisaprid - dapoxetin - domperidon - naloxegol - lurasidon, pimozid, quetiapin, sertindol (se pkt.
English: (induction of CYP450 enzymes) Concentrations of voriconazole may increase or decrease when co-administered with darunavir co-administered with cobicistat.
Danish: Koncentrationen af voriconazol kan øges eller nedsættes ved co
English: Even when you feel better, do not stop taking Darunavir Krka d.d.. Talk to your doctor first.
Danish: Selvom du har det bedre, må du ikke stoppe med at tage Darunavir Krka d.d..
English: tablets the child must take.
Danish: som tabletter.
English: 120 (3x40) capsules
Danish: 120 (3x40) kapsler
English: However, the member states were not able to reach an agreement and the UK medicines regulatory agency referred the matter to the CHMP for arbitration on 30 April 2009.
Danish: Disse medlemsstater kunne imidlertid ikke nå til enighed, og Det Forenede Kongeriges lægemiddelkontrolmyndighed henviste sagen til CHMP til voldgift den 30. april 2009.
English: This is a procedure when one Member State (the ‘reference Member State', in this instance the UK) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other member states (the ‘concerned Member States', in this instance the Czech Republic, Germany, Poland and Slovakia).
Danish: Det er en procedure, hvor en medlemsstat ("referencemedlemsstaten", i dette tilfælde Det Forenede Kongerige) vurderer et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, som gælder både nationalt og i andre medlemsstater (de "berørte medlemsstater", i dette tilfælde Den Tjekkiske Republik, Tyskland, Polen og Slovakiet).
English: Questions and answers on the referral for Pantoprazole Olinka pantoprazole 20 and 40 mg tablets
Danish: Spørgsmål og svar vedrørende indbringelsesproceduren for Pantoprazole Olinka pantoprazol 20- og 40-mg tabletter
English: Bioequivalnce studies are used to compare how a generic medicine is absorbed by the body in comparison to the reference medicine.
Danish: Bioækvivalensundersøgelser anvendes til at sammenligne, hvordan et generisk lægemiddel optages i kroppen i forhold til referencelægemidlet.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Pantoprazole Olinka.
Danish: Det Europæiske Lægemiddelagentur har afsluttet en voldgiftsprocedure som følge af uenighed blandt Den Europæiske Unions medlemsstater om godkendelsen af lægemidlet Pantoprazole Olinka.
English: Pantoprazole Olinka is a medicine used to treat diseases where the stomach produces too much acid.
Danish: Pantoprazole Olinka er et lægemiddel, der anvendes til behandling af sygdomme, hvor der produceres for meget syre i maven.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that Pantoprazole Olinka had been shown to be bioequivalent to the reference medicine, and therefore the marketing authorisation should be granted in the UK and all concerned member states.
Danish: På basis af en vurdering af de tilgængelige data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at Pantoprazole Olinka havde vist sig at være bioækvivalent med referencelægemidlet, og at der kunne udstedes markedsføringstilladelse i Det Forenede Kongerige og alle de berørte medlemsstater.
English: What is Pantoprazole Olinka?
Danish: Hvad er Pantoprazole Olinka?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Pantoprazole Olinka outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the European Union, the Czech Republic, Germany, Poland and Slovakia.
Danish: Agenturets Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Pantoprazole Olinka opvejer risiciene, og at der kan udstedes markedsføringstilladelse i Det Forenede Kongerige og i EU-medlemsstaterne Den Tjekkiske Republik, Tyskland, Polen og Slovakiet.
English: Olinka UK Ltd. submitted Pantoprazole Olinka to the United Kingdom medicines regulatory agency for a decentralised procedure.
Danish: Olinka UK Ltd. indgav en ansøgning for Pantoprazole Olinka til Det Forenede Kongeriges lægemiddelkontrolmyndighed med henblik på en decentral procedure.
English: Pantoprozole Olinka is a generic medicine based on the reference medicine Pantecta.
Danish: Pantoprozole Olinka er et generisk lægemiddel, der er baseret på referencelægemidlet Pantecta.
English: Why was Pantoprazole Olinka reviewed?
Danish: Hvorfor blev Pantoprazole Olinka vurderet igen?
English: The active substance in Pantoprazole Olinka, pantoprazole, is a proton pump inhibitor.
Danish: Det aktive stof i Pantoprazole Olinka, pantoprazol, er en protonpumpehæmmer.
English: The grounds for the referral were concerns expressed by the German medicines regulatory agency regarding the bioequivalence study comparing Pantoprazole Olinka and Pantecta.
Danish: Begrundelsen for indbringelsen var, at den tyske lægemiddelkontrolmyndighed havde givet udtryk for betænkeligheder vedrørende den bioækvivalensundersøgelse, hvor Pantoprazole Olinka og Pantecta var blevet sammenlignet.
English: Company responses provided on: 27 August 2009, 26 October 2009 Opinion date:
Danish: 27. august 2009, 26. oktober 2009
English: Pantoprazole Olinka is presented as gastro-resistant tablets.
Danish: Pantoprazole Olinka fås som enterotabletter.
English: Date of latest renewal: 18 July 2014
Danish: Dato for seneste fornyelse: 18. juli 2014.
English: - which days are your dosing days.
Danish: • hvilke dage, der er dine doseringsdage.
English: - if you have ever had or might now have a hepatitis B infection.
Danish: • hvis du nogensinde har haft eller ved at du kan have hepatitis B infektion.
English: This is because you must not be treated with Temomedac during pregnancy unless clearly indicated by your doctor.
Danish: Det skyldes, at De ikke må tage Temomedac under graviditet, medmindre det er klart angivet af din læge.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger
English: Dose during Cycles 2 - 6 in absence of toxicity
Danish: Dosis under serie 2 - 6 ved fravær af toksicitet
English: TMZ dose (mg/m²/day)
Danish: TMZ-dosis (mg/m²/dag)
English: Temomedac should not be administered to pregnant women.
Danish: Temomedac bør ikke anvendes til gravide kvinder.
English: † Including cases with fatal outcome * Frequencies estimated based on relevant clinical trials.
Danish: †Inklusive tilfælde med dødelig udgang * Hyppigheden er estimeret på basis af relevante kliniske undersøgelser
English: In some cases, it may be necessary to stop treatment with Temomedac.
Danish: I nogle tilfælde kan det være nødvendigt at stoppe behandlingen med Temomedac
English: As it cannot be excluded that the change in Cmax is clinically significant, Temomedac should be administered without food.
Danish: Da det ikke kan udelukkes, at ændringen i Cmax er klinisk signifikant, bør Temomedac indgives uden føde.
English: The 6 month event-free survival for the ITT population was 44 % with a median event-free survival of 4.6 months, which was similar to the results for the progression-free survival.
Danish: Den 6 måneders hændelses-frie overlevelse for ITT populationen var 44 % med en median event-fri overlevelse på 4,6 måneder, hvilket var i lighed med resultaterne for den progressionsfri overlevelse.
English: Temomedac may make you feel tired or sleepy.
Danish: Når du tager Temomedac, kan du føle dig træt eller søvnig.
English: PHARMACEUTICAL FORM Hard capsule (capsule).
Danish: LÆGEMIDDELFORM Hård kapsel (kapsel).
English: Temomedac treatment can cause a reduction in certain kinds of blood cells.
Danish: Behandling med Temomedac kan give et fald i antallet af visse typer blodceller.
English: capsule shell (including printing ink):
Danish: kapselskal (inklusive tryksværte):
English: During the monotherapy phase, the dose and way you take Temomedac will be different.
Danish: Under monoterapi-fasen vil dosis og måden, du tager Temomedac på være anderledes.
English: - as you may have a small risk of other changes in blood cells, including leukaemia.
Danish: • du kan have en lille risiko for andre ændringer i blodcellerne, inklusive leukæmi.
English: A treatment cycle with Temomedac lasts 28 days.
Danish: En behandlingscyklus med Temomedac varer 28 dage.
English: If Temomedac comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Danish: Hvis Temomedac kommer i kontakt med hud eller slimhinder bør området straks vaskes grundigt med sæbe og vand.
English: This is because Temomedac could cause hepatitis B to become active again, which can be fatal in some cases.
Danish: Dette skyldes, at Temomedac kan forårsage at hepatitis B bliver aktiv igen, hvilket kan være dødeligt i nogle tilfælde.
English: Myelosuppression was predictable (usually within the first few cycles, with the nadir between Day 21 and Day 28), and recovery was rapid, usually within 1 - 2 weeks.
Danish: Myelosuppression var forudsigelig (sædvanligvis inden for de første få serier med nadir mellem dag 21 og dag 28), og bedring indtraf hurtigt, sædvanligvis inden for 1-2 uger.
English: - if you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called DTIC).
Danish: • hvis du har haft en allergisk reaktion over for dacarbazin (en medicin mod kræft, som også kaldes DTIC).
English: Tell your pharmacist if you notice any change in the appearance of the capsules.
Danish: Underret apoteket, hvis du bemærker et ændret udseende af kapslerne.
English: The results from the trial were not consistent in the subgroup of patients with a poor performance status (WHO PS = 2, n = 70), where overall survival and time to progression were similar in both arms.
Danish: Resultaterne fra undersøgelsen var ikke konsistente i undergruppen af patienter med dårlig præstationsstatus (WHO PS = 2, n = 70), hvor total overlevelse og tid til progression var ens for de to grupper.
English: Take your prescribed dose of Temomedac once a day, preferably at the same time each day.
Danish: Tag Deres ordinerede dosis af Temomedac hver dag, helst på samme tidspunkt hver dag.
English: This led to hospitalisation and/or discontinuation of TMZ in 8 % and 4 %, respectively.
Danish: Dette medførte hospitalsindlæggelse og/eller seponering af TMZ hos henholdsvis 8 % and 4 %.
English: For patients on a 42-day treatment cycle liver function tests should be repeated midway during this cycle.
Danish: Hos patienter, der behandles med en 42-dages cyklus, bør leverfunktionsprøverne gentages midtvejs i denne cyklus.
English: - as you should be observed closely for the development of a serious form of chest infection called Pneumocystis jirovecii pneumonia (PCP).
Danish: • da du skal observeres tæt for udviklingen af en alvorlig form for lungebetændelse kaldet Pneumocystis jirovecii pneumoni (PCP).
English: In this case, do not drive or use any tools or machines or cycle until you see how this medicine affects you (see section 4).
Danish: I så fald må du ikke køre bil/motorcykel eller cykle eller arbejde med værktøj eller maskiner, før De ved, hvordan dette lægemiddel påvirker Dem (se pkt.
English: Response rate, based on the central reviewer assessment, was 35 % (13 CR and 43 PR) for the intent-to-treat population (ITT) n = 162.
Danish: Responsrate, baseret på den centrale reviewers vurdering, var 35 % (13 CR og 43 PR) for intent-to-treat populationen (ITT) n = 162.
English: - if you develop fever or symptoms of an infection, contact your doctor immediately.
Danish: • hvis du udvikler feber eller infektionssymptomer, skal du straks kontakte din læge.
English: drug reaction with eosinophilia and systemic symptoms (DRESS)
Danish: Lægemiddelreaktion med eosinofili og systemiske symptomer (DRESS)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 January 2010
Danish: Dato for første markedsføringstilladelse: 25. januar 2010.
English: TMZ monotherapy n = 224
Danish: TMZ-monoterapi n = 224
English: In some cases, your Temomedac dose will be reduced or treatment stopped.
Danish: I visse tilfælde vil din Temomedac-dosis nedsættes, eller din behandling vil blive stoppet.
English: If lymphopenia occurs, they are to continue the prophylaxis until recovery of lymphopenia to Grade ≤ 1.
Danish: Hvis der forekommer lymfopeni, skal de fortsætte den forebyggende behandling, indtil bedring af lymfopeni til grad ≤ 1.
English: Temomedac is used in these tumours if they return or get worse after standard treatment.
Danish: Temomedac bruges til behandling af disse svulster, hvis der er tegn på, at de vender tilbage eller bliver værre efter standardbehandling.
English: There is limited information in patients over 3 years of age who have taken Temomedac.
Danish: Der foreligger begrænset information om børn over 3 år, der har fået Temomedac.
English: Most haematologic adverse reactions were reported commonly or very commonly in both indications (Tables 4 and 5); the frequency of Grade 3 - 4 laboratory findings is presented after each table.
Danish: De fleste hæmatologiske bivirkninger blev rapporteret som værende almindelige eller meget almindelige for begge indikationer (Tabel 4 og 5); hyppighed af grad 3 - 4 laboratoriefund er angivet efter hver tabel.
English: Anti-emetic prophylaxis is recommended prior to the initial dose of concomitant phase and it is strongly recommended during the monotherapy phase.
Danish: Antiemetisk forebyggelse anbefales før den initiale dosis af den konkomitante fase, og det anbefales kraftigt under monoterapifasen.
English: CSF penetration was confirmed in one patient; CSF exposure based on AUC of TMZ was approximately 30 % of that in plasma, which is consistent with animal data.
Danish: CSF-penetration blev bekræftet hos en patient; CSFeksponering baseret på AUC for TMZ var cirka 30 % i forhold til plasma, hvilket er konsistent med data fra dyr.
English: - if you are older than 70 years of age, you might be more prone to infections, bruising or bleeding.
Danish: • hvis du er ældre end 70 år, kan du være mere modtagelig over for infektioner eller have øget tendens til at få blå mærker og bløde.
English: Before each new treatment cycle, your blood will be tested to see if the Temomedac dose needs to be adjusted.
Danish: Før hver ny behandlingscyklus vil dit blod blive undersøgt for, om Temomedac-dosen skal justeres.
English: - if you have low counts of red blood cells (anaemia), white blood cells and platelets, or blood clotting problems before starting the treatment, or if you develop them during treatment.
Danish: • hvis du har et lavt antal røde blodlegemer (anæmi), hvide blodlegemer og blodplader eller problemer med blodets størkning før behandling eller udvikler dem under behandling.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL FLASKE
English: In the noncomparative trial, the PFS at 6 months was 19 %, the median progression-free survival was 2.1 months, and the median overall survival 5.4 months.
Danish: I den ikke-randomiserede undersøgelse var PFS efter 6 måneder 19 %, median progressionsfri overlevelse var 2,1 måneder, og median samlet overlevelse 5,4 måneder.
English: - if you vomit frequently before or during treatment, ask your doctor about the best time to take Temomedac until the vomiting is under control.
Danish: Hvis du ofte kaster op før eller under behandlingen, så spørg din læge om, hvornår du helst skal tage Temomedac, indtil opkastningerne er under kontrol.
English: Effective contraceptive precautions must be taken by both male and female patients who are taking Temomedac (see also “Male fertility” below).
Danish: Både mandlige og kvindelige patienter skal anvende sikre præventionsmidler, mens de tager Temomedac (se også ”Frugtbarhed hos mænd” nedenfor).
English: Frequency groupings are defined according to the following convention: 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: (≥ 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: Patients receiving Temomedac in combination with radiotherapy may experience different side effects than patients taking Temomedac alone.
Danish: Patienter, der modtager Temomedac i kombination med strålebehandling kan opleve andre bivirkninger end patienter der kun får Temomedac.
English: In very rare cases, patients taking Temomedac and medicines like it may have a small risk of developing secondary cancers, including leukaemia.
Danish: Meget sjældent kan patienter, som tager Temomedac eller lignende medicin, have en lille risiko for at udvikle en sekundær kræftform, inklusive leukæmi.
English: Always take Temomedac exactly as your doctor has told you.
Danish: Tag altid Temomedac nøjagtigt efter lægens anvisning.
English: Temomedac contains lactose (a kind of sugar).
Danish: Temomedac indeholder lactose (en form for sukker).
English: The primary targets of toxicity included the bone marrow, lymphoreticular system, testes, the gastrointestinal tract and, at higher doses, which were lethal to 60 % to 100 % of rats and dogs tested, degeneration of the retina occurred.
Danish: De primære målorganer for toksicitet omfattede knoglemarven, det lymforetikulære system, testes, mave-tarm-kanalen og ved højere doser, der var dødelige hos 60 % til 100 % af de undersøgte rotter og hunde, forekom degeneration af retina.
English: - if you have liver or kidney problems, your dose of Temomedac may need to be adjusted.
Danish: • hvis du har problemer med leveren eller nyrerne, skal din Temomedac-dosis muligvis justeres.
English: Temomedac should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Danish: Temomedac bør kun ordineres af læger, der har erfaring med onkologisk behandling af hjernetumorer.
English: If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving Temomedac for 42 days in combination with radiotherapy.
Danish: Er du nydiagnosticeret patient (glioblastoma multiforme) får du muligvis Temomedac i 42 dage i kombination med strålebehandling.
English: You should stop breast-feeding while receiving treatment with Temomedac.
Danish: Du skal stoppe med at amme, mens du behandles med Temomedac.
English: You may be given other medicines (anti-emetics) to take before and/or after taking Temomedac to prevent or control nausea and vomiting.
Danish: Du vil eventuelt få ordineret anden medicin (kvalmestillende), der skal tages før og/eller efter, du har taget Temomedac, for at undgå eller regulere kvalme og opkastning.
English: Herpes simplex, herpes zoster, influenza-like symptoms
Danish: Herpes simplex, herpes zoster,influenzalignende symptomer