FrancophonIA/ELRC3.0 huggingface dataset:
English: These measures will help protect the environment.
Danish: Nødvendige forholdsregler skal tages for at undgå kontaminering.
English: However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Danish: Det er ikke nødvendigt at udsætte vaccinationen ved tilstedeværelse af lette infektioner som f.eks. forkølelse.
English: The content of the pre-filled syringe should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Danish: Før administration og både før og efter omrystning skal indholdet i hætteglasset inspiceres visuelt for fremmede partikler og/eller ændringer i det fysiske udseende.
English: EU/1/09/508/007 - pack of 10
Danish: EU/1/09/508/007 - pakningsstørrelse på 10
English: Vaccine serotype
Danish: Vaccineserotype
English: If your child misses an injection, it is important that you make another appointment.
Danish: Hvis du kommer til at springe en planlagt indsprøjtning over, er det vigtigt, at du laver en ny aftale, så du kan tale med lægen om, hvordan dit barn bliver beskyttet.
English: • The other ingredients are: sodium chloride (see section 2 for further information), 2-phenoxyethanol and water for injections
Danish: • Øvrige indholdsstoffer: natriumchlorid (se punkt 2 for yderligere informaton) og vand til injektionsvæsker
English: Pneumococcal polysaccharide serotype 51,2
Danish: Pneumokokpolysaccharid serotype 51,2
English: In children as of 2 years of age, fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if your child fainted with a previous injection.
Danish: Børn fra 2-årsalderen kan besvime efter og endda før vaccination med nål.
English: The vaccine should be allowed to reach room temperature before use Shake well before use
Danish: Vaccinen skal have stuetemperatur, inden den administreres Omrystes omhyggeligt før administration
English: In Quebec, Canada, Synflorix was introduced into the infant immunisation programme (2 primary doses to infants less than 6 months of age and a booster dose at 12 months) following 4.5 years of use of 7-valent Prevenar.
Danish: Efter 4,5 års anvendelse af 7-valent Prevenar blev Synflorix indført i børnevaccinationsprogrammet (2 primære doser til spædbørn under 6 måneder og en boosterdosis ved 12 måneder) i Quebec, Canada.
English: In a clinical study conducted in South Africa the immunogenicity of Synflorix administered as a 3-dose primary vaccination course (at 6, 10 and 14 weeks of age) followed by a booster dose (at 9 to 10 months of age) was assessed in 70 HIV positive (HIV+/+) infants, 91 HIV negative infants born from HIV positive mothers (HIV+/-) and 93 HIV negative infants born from HIV negative mothers (HIV-/-).
Danish: (ved 9 til 10 måneders alderen) hos 70 hiv-positive spædbørn (hiv+/+), 91 hiv-negative spædbørn født af hiv-positive mødre (hiv +/-) og 93 hiv-negative spædbørn født af hiv-negative mødre (hiv -/-).
English: Pneumococcal polysaccharide serotype 11,2
Danish: Pneumokokpolysaccharid serotype 11,2
English: 1 vial 1 dose (0.5 ml)
Danish: 1 hætteglas 1 dosis (0,5 ml)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Synflorix injection
Danish: LÆGEMIDLETS NAVN Synflorix injektionsvæske i.m.
English: Pneumococcal polysaccharide serotype 41,2
Danish: Pneumokokpolysaccharid serotype 41,2
English: How Synflorix works
Danish: Sådan virker Synflorix
English: Pneumococcal polysaccharide serotype 141,2
Danish: Pneumokokpolysaccharid serotype 141,2
English: A minor infection such as a cold should not be a problem.
Danish: Mindre infektioner, f.eks. forkølelse, er normalt ikke et problem, men tal alligevel med lægen om det først.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Synflorix suspension for injection
Danish: LÆGEMIDLETS NAVN Synflorix injektionsvæske, suspension i.m.
English: NAME OF THE MEDICINAL PRODUCT Synflorix suspension for injection in multidose container (2 doses) Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Danish: Synflorix injektionsvæske, suspension i flerdosisbeholder (2 doser) Konjugeret pneumokokpolysaccharidvaccine (adsorberet)
English: • The other ingredients are: sodium chloride (see section 2 for further information) and water for injections
Danish: • Øvrige indholdsstoffer: natriumchlorid (se punkt 2 for yderligere information), 2
English: • pain, redness and swelling where the injection is given
Danish: • smerter, rødmen og hævelse på administrationsstedet
English: Pre-filled syringe
Danish: • nældefeber.
English: NAME OF THE MEDICINAL PRODUCT Synflorix suspension for injection in multidose container (4 doses) Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Danish: Synflorix injektionsvæske, suspension i flerdosisbeholder (4 doser) Konjugeret pneumokokpolysaccharidvaccine (adsorberet)
English: • Suspension for injection in pre-filled syringe
Danish: • Injektionsvæske, suspension i fyldt injektionssprøjte.
English: NAME OF THE MEDICINAL PRODUCT Synflorix suspension for injection Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Danish: Synflorix injektionsvæske, suspension Konjugeret pneumokokpolysaccharidvaccine (adsorberet)
English: The difference between both vaccines in terms of percentage of subjects with OPA titres ≥ 8 was <5% for all serotypes in common, including 6B and 23F.
Danish: Forskellen mellem de to vacciner mht. procentdelen af personer med OPA-titer ≥ 8 var under 5 % for alle de serotyper, der er fælles for Synflorix og 7-valent Prevenar inkl.
English: Synflorix should not be given if any of the above applies to your child.
Danish: Hvis noget af ovenstående gælder for dit barn, må Synflorix ikke gives.
English: 4-dose vial
Danish: Hætteglas med 4 doser
English: Multidose vial 2-dose vial EU/1/09/508/009 4-dose vial EU/1/09/508/012 EU/1/09/508/013
Danish: Hætteglas med 4 doser EU/1/09/508/012
English: NAME OF THE MEDICINAL PRODUCT Synflorix suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Danish: Synflorix injektionsvæske, suspension i fyldt injektionssprøjte Konjugeret pneumokokpolysaccharidvaccine (adsorberet)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Pakningsstørrelse EU/1/12/809/001 Betmiga
English: This medicine is the same as Vidaza, which is already authorised in the EU.
Danish: Lægemidlet er identisk med Vidaza, som allerede er godkendt i EU.
English: It can only be obtained with a prescription and treatment should be started and monitored under the supervision of a doctor experienced in the use of cancer medicines.
Danish: Det fås kun på recept, og behandlingen bør indledes og overvåges af en læge med erfaring i brug af kræftlægemidler.
English: The effect of Azacitidine Celgene was similar in all three diseases.
Danish: Effekten af Azacitidine Celgene var omtrent den samme ved alle tre sygdomme.
English: The recommended dose of Azacitidine Celgene is 75 mg per square metre body surface area (calculated using the patient's height and weight).
Danish: Den anbefalede startdosis for Azacitidine Celgene er 75 mg pr. kvadratmeter legemsflade (beregnet ud fra patientens højde og vægt).
English: As for all medicines, data on the use of Azacitidine Celgene are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Azacitidine Celgene løbende overvåget.
English: The company that makes Vidaza has agreed that its scientific data can be used for Azacitidine Celgene (‘informed consent').
Danish: Virksomheden, som fremstiller Vidaza, har indvilget i, at dens videnskabelige oplysninger må anvendes for Azacitidine Celgene ("informeret samtykke").
English: The active substance in Azacitidine Celgene, azacitidine, belongs to the group ‘antimetabolites' and can be incorporated into the genetic material of cells (RNA and DNA) instead of their natural building-block, cytidine.
Danish: Det aktive stof i Azacitidine Celgene, azacitidin, tilhører gruppen "antimetabolitter" og kan inkorporeres i cellernes genetiske materiale (RNA og DNA) i stedet for deres naturlige byggesten, cytidin.
English: Side effects reported with Azacitidine Celgene are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Azacitidine Celgene vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: For more information about using Azacitidine Celgene, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Azacitidine Celgene, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: The European Medicines Agency decided that Azacitidine Celgene's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Azacitidine Celgene opvejer risiciene, og det kan godkendes til anvendelse i EU.
English: In this study, patients receiving Azacitidine Celgene survived for an average of 24.5 months, compared with 15.0 months in patients receiving conventional care.
Danish: I det første studie overlevede de patienter, der fik Azacitidine Celgene, i gennemsnit i 24,5 måneder sammenlignet med 15,0 måneder for de patienter, der fik konventionel behandling.
English: Azacitidine Celgene (azacitidine)
Danish: Azacitidine Celgene (azacitidin)
English: What measures are being taken to ensure the safe and effective use of Azacitidine Celgene?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Azacitidine Celgene?
English: Azacitidine Celgene is used for the treatment of adults with the following diseases, if they cannot have haematopoietic stem cell transplantation (when the patient receives stem cells to restore the bone marrow's ability to produce healthy blood cells):
Danish: Azacitidine Celgene anvendes til at behandle voksne med følgende sygdomme, hvis de ikke kan gennemgå en hæmatopoietisk stamcelletransplantation (hvor patienten modtager stamceller med henblik på at gendanne knoglemarvens evne til at producere sunde blodceller):
English: The most common side effects of Azacitidine Celgene, which may affect more than 60% of patients with myelodysplastic syndromes, CMML or AML (20 to 30% abnormal cells), are blood reactions including thrombocytopenia (low platelet counts), neutropenia (low levels of neutrophils, a type of white blood cell) and leucopenia (low white blood cell counts), side effects affecting the stomach and gut including nausea and vomiting, and injection site reactions.
Danish: De hyppigste bivirkninger ved Azacitidine Celgene, som kan forekomme hos mere end 60 % af patienter med myelodysplastiske syndromer, CMML eller AML (20-30 % abnorme celler), er bivirkninger i blodet, herunder trombocytopeni (lavt antal blodplader), neutropeni (lavt niveau af neutrofiler, en art hvide blodlegemer) og leukopeni (lavt antal hvide blodlegemer), bivirkninger i maveog tarmregionen, herunder kvalme og opkastning, og reaktioner på injektionsstedet.
English: Azacitidine Celgene is used when the bone marrow consists of 10 to 29% abnormal cells and the bone marrow is not producing large numbers of white blood cells;
Danish: Azacitidine Celgene anvendes, når knoglemarven består af 10-29 % abnorme celler, og knoglemarven ikke producerer et større antal af hvide blodlegemer
English: Azacitidine Celgene must not be used in patients with advanced liver cancer or in women who are breastfeeding.
Danish: Azacitidine Celgene må ikke anvendes hos patienter med fremskreden levercancer eller hos kvinder, som ammer.
English: An overview of Azacitidine Celgene and why it is authorised in the EU
Danish: En oversigt over Azacitidine Celgene, og hvorfor det er godkendt i EU
English: Azacitidine Celgene is used in patients with an intermediate to high risk of progressing to AML or death;
Danish: Azacitidine Celgene anvendes hos patienter med intermediær til høj risiko for at udvikle AML eller dø
English: The first study involved 358 adults with intermediate to high-risk myelodysplastic syndromes, CMML or AML who were unlikely to go on to have a stem cell transplant.
Danish: Det første studie omfattede 358 voksne med intermediære til højrisikobetingede myelodysplastiske syndromer, CMML eller AML, som sandsynligvis ikke ville få foretaget en knoglemarvstransplantation.
English: In the second study, which involved 488 patients with AML who could not have haematopoietic stem cell transplantation and whose bone marrow contained more than 30% abnormal cells, patients receiving Azacitidine Celgene survived for an average of 10.4 months, compared with 6.5 months in patients receiving conventional care.
Danish: I det andet studie, som omfattede 488 patienter med AML, som ikke kunne gennemgå en hæmatopoietisk stamcelletransplantation, og hvis knoglemarv indeholdt mere end 30 % abnorme celler, overlevede de patienter, der fik Azacitidine Celgene, i gennemsnit 10,4 måneder, sammenlignet med 6,5 måneder hos patienter, der fik konventionel behandling.
English: This helps to correct the problems with the maturation and growth of young blood cells in the bone marrow that cause myelodysplastic disorders, and to kill cancerous cells in leukaemia.
Danish: Dette menes at løse de problemer med modning og vækst af unge blodceller i knoglemarven, der medfører myelodysplastiske sygdomme, samt at dræbe cancerceller ved leukæmi.
English: Other information about Azacitidine Celgene
Danish: Andre oplysninger om Azacitidine Celgene
English: • AML that has developed from a myelodysplastic syndrome and the bone marrow consists of 20 to 30% abnormal cells;
Danish: • AML, der har udviklet sig fra et myelodysplastisk syndrom, og knoglemarven består af 20-30 %
English: Azacitidine Celgene is available as a powder to be made up into a suspension for injection.
Danish: Azacitidine Celgene findes som et pulver til fremstilling af injektionsvæske, suspension.
English: What is Azacitidine Celgene and what is it used for?
Danish: Hvad er Azacitidine Celgene, og hvad anvendes det til?
English: Why is Azacitidine Celgene authorised in the EU?
Danish: Hvorfor er Azacitidine Celgene godkendt i EU?
English: Azacitidine Celgene contains the active substance azacitidine.
Danish: Azacitidine Celgene indeholder det aktive stof azacitidin.
English: Azacitidine Celgene was shown to be more effective than conventional care in extending survival in two main studies.
Danish: Af to hovedstudier fremgik det, at Azacitidine Celgene var mere effektivt end konventionel behandling med hensyn til at forlænge overlevelsen.
English: For the full list of side effects and restrictions of Azacitidine Celgene, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Azacitidine Celgene fremgår af indlægssedlen.
English: • myelodysplastic syndromes, a group of conditions where too few blood cells are produced by the bone marrow.
Danish: • myelodysplastiske syndromer (MDS), en gruppe tilstande, hvor knoglemarven producerer for få blodlegemer.
English: What are the risks associated with Azacitidine Celgene?
Danish: Hvilke risici er der forbundet med Azacitidine Celgene?
English: • chronic myelomonocytic leukaemia (CMML, a cancer affecting white blood cells called monocytes).
Danish: • kronisk myelomonocytleukæmi (CMML, en cancertype, som påvirker de hvide blodlegemer, der kaldes monocytter).
English: Patients should be given medicines to prevent nausea (feeling sick) and vomiting before receiving Azacitidine Celgene.
Danish: Patienter bør medicineres mod kvalme og opkastning, før behandling med Azacitidine Celgene påbegyndes.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Azacitidine Celgene 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 Azacitidine Celgene.
English: How is Azacitidine Celgene used?
Danish: Hvordan anvendes Azacitidine Celgene?
English: How does Azacitidine Celgene work?
Danish: Hvordan virker Azacitidine Celgene?
English: What benefits of Azacitidine Celgene have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Azacitidine Celgene?
English: The results obtained were compared to see if they agreed.
Danish: De opnåede resultater blev sammenlignet for at se, om de stemte overens.
English: The marketing authorisation was renewed on 7 May 2003 and on 7 May 2008.
Danish: Markedsføringstilladelsen blev fornyet den 7. maj 2003 og den 7. maj 2008.
English: These samples are then sent for analysis at a specialised laboratory.
Danish: Disse prøver sendes herefter til analyse på et specialiseret laboratorium.
English: The marketing authorisation holder is Torbet Laboratories Limited.
Danish: Indehaveren af markedsføringstilladelsen er Torbet Laboratories Limited.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pylobactell on 7 May 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pylobactell den 7. maj 1998.
English: The carbon dioxide is then removed from the body in the breath.
Danish: Kuldioxiden fjernes herefter fra kroppen via udåndingsluften.
English: This 13C-labelled carbon dioxide can be measured by specialised laboratories using a technique called mass spectrometry.
Danish: Denne 13C-mærkede kuldioxid kan måles af specialiserede laboratorier ved brug af en teknik, som kaldes massespektrometri.
English: If the patient has eaten a heavy meal then they should fast for six hours before the test.
Danish: Hvis patienten har spist et stort måltid, skal der fastes i seks timer inden prøverne.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PYLOBACTELL EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) PYLOBACTELL EPAR - sammendrag for offentligheden
English: Pylobactell is a diagnostic test.
Danish: Pylobactell er en diagnostisk test.
English: First, the patient takes a ‘test meal' (such as 200 ml of pure undiluted orange juice).
Danish: Først skal patienten indtage et ”prøvemåltid” (såsom200 ml ren, ufortyndet appelsinjuice).
English: The patient should fast for four hours before the test so that it is done on an empty stomach.
Danish: Patienten skal faste i fire timer inden prøverne tages, så de tages på tom mave.
English: After a further five minutes, the patient takes the Pylobactell tablet dissolved in water.
Danish: Efter yderligere fem minutter skal patienten tage én Pylobactell-tablet, som er opløst i vand.
English: Pylobactell was more than 95% sensitive in detecting infection with H. pylori.
Danish: Pylobactell havde en følsomhed på over 95 % i forbindelse med at spore infektion med H. pylori.
English: The active substance in Pylobactell, 13C-urea, is the natural chemical urea that has been labelled with carbon-13 (13C).
Danish: Det aktive stof i Pylobactell, 13C-urea, er det naturlige kemikalie urea, der er blevet mærket med kulstof-13 (13C).
English: Pylobactell is not recommended for use in patients below 18 years of age because there is insufficient information on its effectiveness in this group.
Danish: Pylobactell anbefales ikke til børn under 18 år på grund af manglende data om effekt hos denne aldersgruppe
English: The data to support the use of Pylobactell comes from two main studies of the use of antibiotics to treat H. pylori infection, where it was used as a test. A total of 366 patients underwent both a Pylobactell test and a standard biopsy test (where a sample from the stomach is analysed to see if it is infected).
Danish: Dataene til understøttelse af anvendelsen af Pylobactell kommer fra to hovedundersøgelser vedrørende brugen af antibiotika til behandling af infektion med H. pylori, hvor det blev benyttet som en test. I alt 366 patienter fik foretaget både testen med Pylobactell og en standardbiopsi (hvor en prøve fra maven analyseres for at se, om den er inficeret).
English: To carry out the test, the patient must collect six breath samples, three before taking the Pylobactell tablet and three after taking it.
Danish: Patienten skal i forbindelse med prøven indsamle seks udåndingsprøver, tre før indtagelse af Pylobactell-tabeletten og tre efter at have taget den.
English: Finally, 30 minutes later (40 minutes after the test meal), the patient collects a further three breath samples.
Danish: Endelig skal patienten 30 minutter senere (40 minutter efter testmåltidet) indsamle endnu tre prøver af udåndingsluften.
English: The full EPAR for Pylobactell is available here.
Danish: Den fuldstændige EPAR om Pylobactell findes her.
English: It is available as a kit that includes a white soluble tablet containing 100 mg of the active substance 13C-urea.
Danish: Den fås i en pakke med en hvid, opløselig tablet, som indeholder 100 mg af det aktive stof 13C-urea.
English: Pylobactell should not be used in people who may be hypersensitive (allergic) to 13C-urea or any of the other ingredients in the tablet.
Danish: Pylobactell må ikke anvendes til personer, der kan være overfølsomme (allergiske) over for 13C-urea eller over for nogen af indholdsstofferne i tabletterne.
English: The Committee recommended that Pylobactell be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Pylobactell.
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: The Committee for Medicinal Products for Human Use (CHMP) decided that Pylobactell's benefits are greater than its risks for the in vivo diagnosis of gastroduodenal H. pylori infection.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Pylobactell er større end risiciene, når lægemidlet anvendes til in vivo-diagnosticering af gastroduodenal H. pyloriinfektion.
English: Five minutes later, the patient collects three breath samples.
Danish: Fem minutter senere skal patienten indsamle tre prøver af udåndingsluften.
English: Pylobactell should not be used in patients who have, or may have gastric (stomach) infection, which might interfere with the breath test.
Danish: Pylobactell må ikke anvendes til patienter, som har eller kan have en gastrisk infektion (maveinfektion), da infektionen kan påvirke testen af udåndingsluften.
English: Pylobactell is a breath test: breath samples are collected in the tubes provided in the kit.
Danish: Pylobactell er en test af udåndingsluften: der tages prøver af udåndingsluften, som indsamles i de rør, der følger med pakken.
English: If there is no increased level of labelled carbon dioxide in the breath, the patient might not have H. pylori in the stomach or duodenum.
Danish: Hvis der ikke er mærket øget kuldioxid i udåndingsluften, betyder det, at patienten muligvis ikke har H. pylori i maven eller tolvfingertarmen.
English: If there is an increased level of labelled carbon dioxide in the breath sample after 30 minutes (a positive test), the patient may have H. pylori in the stomach or duodenum.
Danish: Hvis der er mærket et forhøjet kuldioxidniveau i den prøve med udåndingsluft, som er taget efter 30 minutter (et positivt resultat), betyder det, at patienten kan have en infektion med H. pylori i maven eller tolvfingertarmen.
English: Other information about Pylobactell:
Danish: Andre oplysninger om Pylobactell