FrancophonIA/ELRC3.0 huggingface dataset:
English: Abbreviations: AML=acute myeloid leukaemia; CI=confidence interval; ELN=European LeukaemiaNet; mITT=modified intent-to-treat; n=number; N=number; NE=not estimable; OS=Overall Survival a. Median estimated by Kaplan-Meier method; CI based on the Brookmeyer and Crowley Method with log-log transformation.
Danish: Forkortelser: AML= akut myeloid leukæmi; CI=konfidenceinterval; ELN=European LeukaemiaNet; mITT=modificeret intent-to-treat; n=antal; N=antal; ; NE=ikke estimerbart; OS=Samlet overlevelse.
English: x. Oedema includes the following reported PTs: Oedema, Face oedema, Oedema peripheral, Swelling face, Generalised oedema, and Periorbital oedema.
Danish: Ødem omfatter følgende indberettede FT'er: ødem, ansigtsødem, perifert ødem, ansigtshævelse, generaliseret ødem og periorbitalt ødem.
English: Leukopeniae
Danish: Gulsot
English: The median time to neutrophil recovery to ANC of 500/mm3 and 1,000/mm3 was 25 days.
Danish: ANC på 500/mm 3 og 1.000/mm 3 var 25 dage.
English: Lower gastrointestinal haemorrhage (15.2%), Subcutaneous haemorrhage (28.5%), Other haemorrhage (32.9%), and
Danish: Blødning omfatter det centrale nervesystem (5,1%), øvre gastrointestinal blødning (21,3 %), nedre gastrointestinal blødning (15,2 %), subkutan blødning (28,5 %), anden blødning (32,9 %) og næseblod (28,5 %).
English: Haemorrhage*b
Danish: Fraktioneret b
English: Pfizer Polska Sp. z o.o.
Danish: Česká republika Pfizer PFE s r.o.
English: s r.o.
Danish: Rat e
English: Number of events, n (%) Median EFS in months [95% CI]a, 2-year EFS probability[95% CI]b 3-year EFS probability [95% CI]b
Danish: 2-årig EFS-sandsynlighed [95 % CI] 3-årig EFS-sandsynlighed [95 % CI] Hazard ratio [95 % CI] p-værdi
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial
Danish: Pulver til koncentrat til infusionsvæske, opløsning 1 hætteglas
English: • Fatigue
Danish: • Forstoppelse
English: Ratec
Danish: Udslæt
English: Alanine aminotransferase (ALT) increased Blood bilirubin increased Hyperuricaemia
Danish: Forhøjet alkalisk fosfatase Forhøjet alaninamino-transferase (ALAT)
English: The median times to platelet recovery to counts of 50,000/mm3 and 100,000/mm3 were 34 and 35 days, respectively.
Danish: 50.000/mm 3 og 100.000/mm 3 var henholdsvis 34 og 35 dage.
English: Bronchospasm, Drug hypersensitivity, and Injection site urticaria#.
Danish: eksfolierende dermatitis #, lægemiddeludslæt, allergikløe #, og erytematøst udslæt
English: • Each vial contains 5 mg gemtuzumab ozogamicin.
Danish: • Hvert hætteglas indeholder 5 mg gemtuzumab ozogamicin.
English: Gastrointestinal disorders Very common Vomiting
Danish: Vaskulære sygdomme Meget almindelig Blødning
English: • Chills
Danish: • Hudkløe
English: SN
Danish: *s
English: Blood and lymphatic system disorders Very common
Danish: Blod og lymfesystem Meget almindelig Febril neutropeni Trombocytopeni
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MYLOTARG 5 mg powder for concentrate gemtuzumab ozogamicin
Danish: MYLOTARG 5 mg pulver til koncentrat gemtuzumab ozogamicin i.v.
English: u. Rash includes the following reported PTs: Rash, Dermatitis#, Dermatitis allergic#, Dermatitis bullous, Dermatitis contact, Dermatitis exfoliative#, Drug eruption, Pruritus allergic# and Rash erythematous#, Rash macular#, Rash maculo papular, Rash papular, Rash pruritic, Rash vesicular#.
Danish: Udslæt omfatter følgende indberettede FT'er: udslæt, allergisk dermatitis #, blæredannende dermatitis, kontakteksem,
English: • Indigestion
Danish: • Kvalme
English: Dose modification for adverse reactions
Danish: yderligere information om dosisændringer.
English: Hepatic impairment
Danish: Venookklusiv leversygdom
English: The PK of gemtuzumab ozogamicin has not been studied in patients with severe renal impairment.
Danish: Der er ikke udført PK-studier af gemtuzumab ozogamicin hos patienter med svært nedsat nyrefunktion.
English: Management of some adverse reactions may require dose interruptions or permanent discontinuation of MYLOTARG (see sections 4.4 and 4.8).
Danish: Det kan være nødvendigt med dosisafbrydelse eller permanent seponering af MYLOTARG ved visse bivirkninger (se pkt.
English: ≤ 2.5 × ULN.
Danish: 9/l eller 50 x 10
English: Vascular disorders Very common Haemorrhage*k Hypotensionl Hypertensionm
Danish: Interstitiel lungebetændelse Mave-tarm-kanalen Meget almindelig Opkastning
English: Unopened vial
Danish: Lever og galdeveje Almindelig
English: Multi-organ failure*
Danish: Organklasse Hyppighed
English: • Bleeding
Danish: • Blødning
English: Common Pancytopeniaf Lymphopeniag
Danish: INFORMATION I BRAILLESKRIFT
English: If not used immediately, store at room temperature (below 25°C) for up to 6 hours, which includes the 2-hour infusion time and 1 hour, if needed, to allow the refrigerated diluted solution to equilibrate to room temperature (below 25°C).
Danish: Dette inkluderer 2 timers infusion og 1 time til at opnå stuetemperatur (under 25°C), hvis opløsningen har været nedkølet.
English: Immunogenicity
Danish: Hypertension
English: Abdominal paino
Danish: Veno-okklusiv leversygdom
English: Dilution
Danish: Dyspepsi
English: • Infuse the diluted solution for 2 hour.
Danish: Infusionen gives gradvist over 2 timer.
English: This summary was last updated in 09-2007.
Danish: Dette sammendrag blev sidst ajourført i 09-2007.
English: The marketing authorisation was renewed on 14 August 2002 and 14 August
Danish: Markedsføringstilladelsen blev fornyet den 14. august 2002 og den 14. august 2007.
English: There are no known side effects of the test.
Danish: Der er ingen kendte bivirkninger ved testen.
English: This means that it contains 13C, a rare form of the carbon atom, instead of carbon-12 (12C), the form that is the most common in nature.
Danish: Dette betyder, at det indeholder 13C, en sjælden form af kulstofatomet, i stedet for kulstof-12 (12C), som er den mest almindelige form i naturen.
English: In children aged three to 11 years, the ‘test meal' should be 100 ml of pure orange juice.
Danish: Hos børn i alderen 3-11 år skal 'testmåltidet' bestå af 100 ml ren appelsinjuice.
English: This labelled carbon dioxide can be measured by specialised laboratories using a technique called mass spectrometry.
Danish: Dette mærkede kuldioxid kan måles af specialiserede laboratorier ved brug af en teknik, som kaldes massespektrometri.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om grundlaget for CHMP's anbefalinger, kan du læse de faglige drøftelser (også en del af denne EPAR).
English: However, if the patient vomits during the test, the test will need to be done again, but not until at least the following day.
Danish: Hvis patienten kaster op under testen, skal testen dog gentages, men tidligst den efterfølgende dag.
English: The powder is the active substance 13C-urea (45 mg for children or 75 mg for adults).
Danish: Pulveret er det aktive stof 13C-urea (45 mg til børn eller 75
English: If there is no labelled carbon dioxide in the breath, this means there are no bacteria in the stomach or duodenum.
Danish: Hvis der ikke er mærket kuldioxid i udåndingsluften, betyder det, at der ikke er bakterier i maven eller tolvfingertarmen.
English: Finally, 30 minutes after drinking the solution, the patient collects a further two breath samples.
Danish: Endelig skal patienten 30 minutter efter at have drukket opløsningen indsamle endnu to prøver af udåndingsluften.
English: If there is labelled carbon dioxide in the breath sample after 30 minutes (a positive test), this means that the patient is infected with H. pylori.
Danish: Hvis der er mærket kuldioxid i den prøve med udåndingsluft, som er taget efter 30 minutter (et positivt resultat), betyder det, at patienten har en infektion med H. pylori.
English: The patient then takes a ‘test meal' (either 200 ml of pure orange juice or 1 g of citric acid dissolved in 200 ml water), followed by the solution of Helicobacter Test INFAI dissolved in water.
Danish: Herefter skal patienten indtage et 'testmåltid' (enten 200 ml ren appelsinjuice eller 1 g citronsyre opløst i 200 ml vand) efterfulgt af Helicobacter Test INFAI opløst i vand.
English: Helicobacter Test INFAI has been tested in four studies in adult patients involving a total of 561 patients and one study in 335 children and adolescents.
Danish: Helicobacter Test INFAI blev undersøgt i fire undersøgelser, hvor i alt 561 voksne patienter medvirkede, og i én undersøgelse med 335 børn og unge.
English: It is available as a jar containing a powder to be made up into a solution for drinking.
Danish: Den fås i form af en beholder med et pulver, som skal blandes til en opløsning, der kan drikkes.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Helicobacter Test INFAI to INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH on 14 August 1997.
Danish: Andre oplysninger om Helicobacter Test INFAI Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Helicobacter Test INFAI til INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH den 14. august 1997.
English: The active substance in Helicobacter Test INFAI, 13C-urea, is the natural chemical urea that has been labelled with carbon-13 (13C).
Danish: Det aktive stof i Helicobacter Test INFAI, 13C-urea, er det naturlige kemikalie urea, der er blevet mærket med kulstof-13 (13C).
English: For full information on how the test is carried out, see the Package Leaflet.
Danish: De nærmere oplysninger om, hvordan testen udføres, fremgår af indlægssedlen.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) HELICOBACTER TEST INFAI EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) HELICOBACTER TEST INFAI EPAR - sammendrag for offentligheden
English: The Committee for Medicinal products for Human Use (CHMP) decided that Helicobacter Test INFAI's benefits are greater than its risks for the in vivo diagnosis of gastroduodenal H. pylori infection in adults, adolescents who are likely to have peptic ulcer disease, and children aged three to 11 years for the evaluation of the success of eradication treatment, or when invasive tests cannot be performed, or when there are discordant results arising from invasive tests.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Helicobacter Test INFAI er større end risiciene, når lægemidlet anvendes til in vivo-diagnosticering af gastroduodenal H. pylori-infektion hos voksne, hos unge, der er disponeret for peptisk ulcus, samt hos børn i alderen 3-11 år til vurdering af, hvor vellykket eradikationsbehandlingen er, eller når der ikke kan foretages invasive undersøgelser, eller når invasive undersøgelser giver resultater, der ikke stemmer overens.
English: H. pylori is a bacterium that is a factor in diseases such as dyspepsia (heartburn, bloating and nausea), gastritis (inflammation of the stomach), and peptic ulcer disease (ulcers in the stomach or the duodenum).
Danish: H. pylori er en bakterie, der spiller en rolle i forbindelse med sygdomme som dyspepsi (halsbrand, oppustethed og kvalme), gastritis (betændelse i maven) og peptisk ulcus (mavesår eller sår på tolvfingertarmen).
English: In all studies, the results of the test done using Helicobacter Test INFAI agreed with the results obtained with the endoscopy and histology in over 95% of cases.
Danish: I alle undersøgelser stemte resultaterne af testen udført med Helicobacter Test INFAI i over 95 % af tilfældene overens med resultaterne fra endoskopien med den histologiske undersøgelse.
English: To carry out the test, the patient must collect four samples, two before taking Helicobacter Test INFAI and two thereafter.
Danish: Patienten skal i forbindelse med testen indsamle fire prøver, to før indtagelse af Helicobacter Test INFAI og to bagefter.
English: In all studies, patients underwent an endoscopy and histology (when a probe is inserted in the stomach to take a sample and the sample is then analysed) as well as a breath test with Helicobacter Test INFAI, and the results of the two tests were compared.
Danish: Patienterne fik i alle undersøgelser foretaget en endoskopi med en histologisk undersøgelse (en sonde føres ind i maven for at tage en prøve, og prøven bliver herefter analyseret) samt en test af udåndingsluften med Helicobacter Test INFAI, og resultaterne af de to undersøgelser blev sammenlignet.
English: Helicobacter Test INFAI is a breath test: breath samples are collected, which are then sent out for analysis to a specialised laboratory.
Danish: Helicobacter Test INFAI er en test af udåndingsluften: der tages prøver af udåndingsluften, som herefter sendes til analyse på et specialiseret laboratorium.
English: It can only be used in children when invasive tests (taking a sample from the stomach using a probe) cannot be carried out or have given questionable results, or to check that H. pylori has been eliminated after a specific treatment to clear up the infection.
Danish: Testen kan kun anvendes til børn, når det ikke er muligt at foretage invasive undersøgelser (udtagning af en prøve fra maven ved hjælp af en sonde), hvis de invasive undersøgelser har givet tvivlsomme resultater, eller for at kontrollere, at H. pylori er blevet elimineret efter en specifik behandling mod infektionen.
English: Helicobacter Test INFAI can be used to test adults, adolescents who are likely to have peptic ulcer disease, and children aged three to 11 years.
Danish: Helicobacter Test INFAI kan anvendes til at teste voksne, unge, der er disponeret for peptisk ulcus, og børn i alderen 3-11 år.
English: When the patient takes Helicobacter Test INFAI, the 13C-urea contained in the test is broken down by H Pylori into carbon dioxide that also contains 13C.
Danish: Når patienten tager Helicobacter Test INFAI, nedbrydes 13C-ureaet i testen af H. pylori til kuldioxid, der også indeholder 13C.
English: Helicobacter Test INFAI should not be used in patients who have, or may have gastric (stomach) infection or atrophic gastritis (stomach inflammation that causes the breakdown of the stomach lining), as these might interfere with the breath test.
Danish: Helicobacter Test INFAI må ikke anvendes til patienter, som har eller kan have en gastrisk infektion (maveinfektion) eller atrofisk gastritis (maveinfektion, der medfører en nedbrydning af mavesækkens slimhinde), da disse tilstande kan påvirke testen af udåndingsluften.
English: Helicobacter Test INFAI is used to diagnose Helicobacter pylori infection in the stomach and duodenum (the part of the gut just below the stomach).
Danish: Helicobacter Test INFAI anvendes til diagnosticering af infektion med Helicobacter pylori i maven og tolvfingertarmen (den del af tarmen, som ligger lige under mavesækken).
English: children under the age of 11 who received 45 mg. One of the studies in adults was carried out in patients after they had received antibiotics to treat their infection.
Danish: De fik alle 75 mg 13C-urea, med undtagelse af 204 børn under 11 år, som fik 45 mg. En af undersøgelserne med voksne blev udført hos patienter, som allerede havde fået antibiotika til behandling af deres infektion.
English: The Committee recommended that Helicobacter Test INFAI be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Helicobacter Test INFAI.
English: The full EPAR for Helicobacter Test INFAI is available here.
Danish: Den fuldstændige EPAR om Helicobacter Test INFAI findes her.
English: Helicobacter Test INFAI is a diagnostic test.
Danish: Helicobacter Test INFAI er en diagnostisk test.
English: H. pylori contain enzymes called ureases that make it able to break down urea into carbon dioxide, which is then removed in the breath.
Danish: H. pylori indeholder enzymer, der kaldes ureaser.
English: What is the risk associated with Helicobacter Test INFAI?
Danish: Hvilken risiko er der forbundet med Helicobacter Test INFAI?
English: Why has Helicobacter Test INFAI been approved?
Danish: Hvorfor blev Helicobacter Test INFAI godkendt?
English: What is Helicobacter Test INFAI?
Danish: Hvad er Helicobacter Test INFAI?
English: The patient should not eat for at least six hours, preferably overnight, before taking the test. Firstly, the patient collects two breath samples, using the tubes or bags supplied with Helicobacter Test INFAI.
Danish: Først skal patienten indsamle to prøver af udåndingsluften ved at benytte de rør eller poser, der følger med Helicobacter Test INFAI.
English: How has Helicobacter Test INFAI been studied?
Danish: Hvordan blev Helicobacter Test INFAI undersøgt?
English: What is Helicobacter Test INFAI used for?
Danish: Hvad anvendes Helicobacter Test INFAI til?
English: How is Helicobacter Test INFAI used?
Danish: Hvordan anvendes Helicobacter Test INFAI?
English: What benefit has Helicobacter Test INFAI shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Helicobacter Test INFAI?
English: How does Helicobacter Test INFAI work?
Danish: Hvordan virker Helicobacter Test INFAI?
English: Their frequency is defined using the following conventions: 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: Hyppighed defineres i henhold til følgende konvention: 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: • You should tell your doctor if a surgery (including dental) is planned.
Danish: • bør du fortælle din læge, hvis du skal have foretaget en planlagt operation (også hos tandlægen).
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre at pharmacovigilance-systemet, som er beskrevet i Modul 1.8.1 i markedsføringstilladelsen, er på plads og fungerer, før og mens produktet markedsføres.
English: For the 28x1 tablets pack size, you can check the day on which you last took the tablet by referring to the calendar printed on the blister.
Danish: For pakningsstørrelsen med 28x1 tabletter kan du tjekke dagen, hvor du sidst tog en tablet ved at kigge på kalenderen printet på blisterpakningen.
English: The ACTIVE-A study included patients who could not receive VKA therapy because they were unable or unwilling to receive the treatment.
Danish: ACTIVE-A-studiet inkluderede patienter, som ikke kunne behandles med VKA, fordi de ikke var i stand til eller uvillige til at få behandlingen.
English: The mean CHADS2 score was 2.0 (range 0-6).
Danish: Den gennemsnitlige CHADS2-score var 2,0 (interval 0-6).
English: Medicinal products associated with bleeding risk: There is an increased risk of bleeding due to the potential additive effect.
Danish: Lægemidler, der er forbundet med risiko for blødning: Der er en øget risiko for blødning på grund af mulig additiv virkning.
English: Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98 % and 94 % respectively).
Danish: Clopidogrel og den cirkulerende (inaktive) hovedmetabolit binder reversibelt in vitro til humane plasmaproteiner (henholdsvis 98 % og 94 %).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented in the table below.
Danish: Bivirkninger, der opstod enten under de kliniske studier, eller der spontant blev indberettet, er beskrevet i tabellen nedenfor.
English: Some other medicines may influence the use of Clopidogrel Teva Pharma or vice versa.
Danish: Visse andre lægemidler kan påvirke brugen af Clopidogrel Teva Pharma eller omvendt.
English: Date of latest renewal: 8 May 2014
Danish: Dato for første markedsføringstilladelse: 21. september 2009 Dato for seneste fornyelse: 8. maj 2014
English: Platelets are very small structures in the blood, which clump together during blood clotting.
Danish: Blodplader er meget små bestanddele i blodet, og de klumper sig sammen, når blodet størkner.
English: Patients who had developed a previous monitored allergic reaction and/or haematological reaction to one thienopyridine may have an increased risk of developing the same or another reaction to another thienopyridine.
Danish: Patienter, der tidligere har udviklet en allergisk og/eller hæmatologisk reaktion over for en thienopyridin, kan have en øget risiko for at udvikle den samme eller en anden reaktion over for en anden thienopyridin.
English: Prevention of atherothrombotic events
Danish: Forebyggelse af aterotrombotiske hændelser
English: The incidence of severe cases was similar for clopidogrel and ASA.
Danish: Forekomsten af alvorlige tilfælde var ens for clopidogrel og ASA.
English: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Danish: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenien TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Tyskland Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, Holland
English: If you experience prolonged bleeding when taking Clopidogrel Teva Pharma If you cut or injure yourself, it may take slightly longer than usual for bleeding to stop.
Danish: Hvis du får langvarige blødninger, mens du tager Clopidogrel Teva Pharma Hvis du skærer dig eller kommer til skade, kan det tage lidt længere end normalt, før blødningen stopper.
English: You should take Clopidogrel Teva Pharma for as long as your doctor continues to prescribe it.
Danish: Du skal fortsætte med at tage Clopidogrel Teva Pharma, så længe som din læge udskriver det til dig.
English: If you take more Clopidogrel Teva Pharma than you should Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Danish: Hvis du har taget for mange Clopidogrel Teva Pharma Kontakt din læge eller nærmeste skadestue, på grund af den øgede risiko for blødning.
English: You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel Teva Pharma and acetylsalicylic acid for this condition.
Danish: Du bør være blevet informeret om, at ”orale antikoagulantia” er mere effektive mod denne sygdom end acetylsalicylsyre eller kombinationen af Clopidogrel Teva Pharma og acetylsalicylsyre.
English: The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed below.
Danish: De klinisk relevante bivirkninger observeret i CAPRIE-, CURE-, CLARITY-, COMMITog ACTIVE-A-studierne beskrives nedenfor.
English: Other medicinal products: A number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic interactions.
Danish: Der er gennemført en række andre kliniske studier med clopidogrel og anden samtidig medicinering for at undersøge muligheden for farmakodynamisk og farmakokinetisk interaktion.
English: If you become pregnant while taking Clopidogrel Teva Pharma, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Danish: Hvis du bliver gravid, mens du tager Clopidogrel Teva Pharma, skal du omgående kontakte din læge, da det frarådes at tage clopidogrel, mens du er gravid.