FrancophonIA/ELRC3.0 huggingface dataset:
English: Edarbi 80 mg tablets Each tablet contains 80 mg of azilsartan medoxomil (as potassium).
Danish: Edarbi 80 mg tabletter Hver tablet indeholder 80 mg azilsartan medoxomil (som kalium)
English: - For patients who recently have lost body fluids e.g. through vomiting or diarrhoea, or by taking water tablets, your doctor may recommend a lower starting dose of 20 mg once a day.
Danish: - Din læge kan anbefale en lavere startdosis på 20 mg én gang dagligt, til patienter, der har haft et væsketab for nylig, f.eks. gennem opkastning eller diarré, eller ved at tage vanddrivende lægemidler.
English: Because no information is available regarding the use of azilsartan medoxomil during breastfeeding, Edarbi is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while breast-feeding a newborn or preterm infant.
Danish: Som alternativ anbefales behandlingsregimer med bedre etablerede sikkerhedsprofiler ved amning, specielt ved amning af nyfødte og præmature spædbørn.
English: Takeda Italia S.p.A. Tel: +39 06 5026 01
Danish: Tel: +39 06 5026 01
English: The use of angiotensin II receptor antagonists is contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Danish: I 2. og 3. trimester er behandling med angiotensin II-receptorantagonister kontraindiceret (se pkt.
English: Edarbi 20 mg tablets Azilsartan medoxomil
Danish: Edarbi 20 mg tabletter Azilsartan medoxomil
English: Edarbi 20 mg tablets Each tablet contains 20 mg of azilsartan medoxomil (as potassium).
Danish: Edarbi 20 mg tabletter Hver tablet indeholder 20 mg azilsartan medoxomil (som kalium).
English: Edarbi 80 mg tablets Azilsartan medoxomil
Danish: Edarbi 80 mg tabletter Azilsartan medoxomil
English: Suomi/Finland Takeda Oy
Danish: Suomi/Finland
English: EU/1/11/734/001 14 tablets EU/1/11/734/002 28 tablets EU/1/11/734/012 30 tablets EU/1/11/734/003 56 tablets EU/1/11/734/013 90 tablets EU/1/11/734/004 98 tablets EU/1/11/734/005 14 tablets EU/1/11/734/006 28 tablets EU/1/11/734/014 30 tablets EU/1/11/734/007 56 tablets EU/1/11/734/015 90 tablets EU/1/11/734/008 98 tablets EU/1/11/734/016 14 tablets EU/1/11/734/009 28 tablets EU/1/11/734/017 30 tablets EU/1/11/734/010 56 tablets EU/1/11/734/018 90 tablets EU/1/11/734/011 98 tablets EU/1/11/734/019 14 tablets EU/1/11/734/020 28 tablets EU/1/11/734/021 56 tablets EU/1/11/734/022 98 tablets EU/1/11/734/023 14 tablets EU/1/11/734/024 28 tablets EU/1/11/734/025 56 tablets EU/1/11/734/026 98 tablets EU/1/11/734/027 14 tablets EU/1/11/734/028 28 tablets EU/1/11/734/029 56 tablets EU/1/11/734/030 98 tablets
Danish: EU/1/11/734/001 14 tabletter EU/1/11/734/002 28 tabletter EU/1/11/734/012 30 tabletter EU/1/11/734/003 56 tabletter EU/1/11/734/013 90 tabletter EU/1/11/734/004 98 tabletter EU/1/11/734/005 14 tabletter EU/1/11/734/006 28 tabletter EU/1/11/734/014 30 tabletter EU/1/11/734/007 56 tabletter EU/1/11/734/015 90 tabletter EU/1/11/734/008 98 tabletter EU/1/11/734/016 14 tabletter EU/1/11/734/009 28 tabletter EU/1/11/734/017 30 tabletter EU/1/11/734/010 56 tabletter EU/1/11/734/018 90 tabletter EU/1/11/734/011 98 tabletter EU/1/11/734/019 14 tabletter EU/1/11/734/020 28 tabletter EU/1/11/734/021 56 tabletter EU/1/11/734/022 98 tabletter EU/1/11/734/023 14 tabletter EU/1/11/734/024 28 tabletter EU/1/11/734/025 56 tabletter EU/1/11/734/026 98 tabletter
English: Uric acid
Danish: Urinsyre
English: Puh/Tel: +358 20 746 5000
Danish: Oy Leiras Takeda Pharmaceuticals Ab Puh/Tel: +358 20 746 5000
English: Each tablet contains 40 mg azilsartan medoxomil (as potassium)
Danish: Hver tablet indeholder 40 mg azilsartan medoxomil (som kalium)
English: Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Patienter, som planlægger graviditet, bør skifte til en alternativ antihypertensiv behandling, der er sikker at anvende for gravide, medmindre den fortsatte behandling med angiotensin II-receptorantagonist er påkrævet.
English: When Edarbi is taken with chlortalidone (a water tablet), higher levels of certain chemicals in the blood (such as creatinine), which are indicators of kidney function, have been seen commonly (in less than 1 in 10 users), and low blood pressure is also common.
Danish: Der er ofte (forekommer hos færre end 1 ud af 10 brugere) set forhøjet indhold af visse stoffer i blodet (såsom kreatinin), hvilket viser hvordan nyrerne fungerer, når Edarbi tages sammen med chlortalidon (vanddrivende lægemiddel).
English: Each tablet contains 80 mg azilsartan medoxomil (as potassium)
Danish: Hver tablet indeholder 80 mg azilsartan medoxomil (som kalium)
English: Each tablet contains 20 mg azilsartan medoxomil (as potassium)
Danish: Hver tablet indeholder 20 mg azilsartan medoxomil (som kalium)
English: Hepatic impairment
Danish: Træthed Perifert ødem
English: Diarrhoea Nausea
Danish: Diarré
English: Takeda AS
Danish: Vianex S.A
English: - have low blood pressure or feel dizzy or lightheaded.
Danish: Lavt blodtryk er også almindeligt.
English: EU/1/11/734/016 14 tablets EU/1/11/734/009 28 tablets EU/1/11/734/017 30 tablets EU/1/11/734/010 56 tablets EU/1/11/734/018 90 tablets EU/1/11/734/011 98 tablets EU/1/11/734/027 14 tablets EU/1/11/734/028 28 tablets EU/1/11/734/029 56 tablets EU/1/11/734/030 98 tablets
Danish: EU/1/11/734/016 14 tabletter EU/1/11/734/009 28 tabletter EU/1/11/734/017 30 tabletter EU/1/11/734/010 56 tabletter EU/1/11/734/018 90 tabletter EU/1/11/734/011 98 tabletter EU/1/11/734/027 14 tabletter EU/1/11/734/028 28 tabletter EU/1/11/734/029 56 tabletter EU/1/11/734/030 98 tabletter
English: How to store Edarbi
Danish: Brug af anden medicin sammen med Edarbi
English: EU/1/11/734/005 14 tablets EU/1/11/734/006 28 tablets EU/1/11/734/014 30 tablets EU/1/11/734/007 56 tablets EU/1/11/734/015 90 tablets EU/1/11/734/008 98 tablets EU/1/11/734/023 14 tablets EU/1/11/734/024 28 tablets EU/1/11/734/025 56 tablets EU/1/11/734/026 98 tablets
Danish: EU/1/11/734/005 14 tabletter EU/1/11/734/006 28 tabletter EU/1/11/734/014 30 tabletter EU/1/11/734/007 56 tabletter EU/1/11/734/015 90 tabletter EU/1/11/734/008 98 tabletter EU/1/11/734/023 14 tabletter EU/1/11/734/024 28 tabletter EU/1/11/734/025 56 tabletter EU/1/11/734/026 98 tabletter
English: Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Patienter, som planlægger graviditet, bør skifte til alternativ antihypertensiv behandling, der er sikker at anvende for gravide, med mindre fortsat behandling med angiotensiv II-receptorantagonister er påkrævet.
English: EU/1/11/734/001 14 tablets EU/1/11/734/002 28 tablets EU/1/11/734/012 30 tablets EU/1/11/734/003 56 tablets EU/1/11/734/013 90 tablets EU/1/11/734/004 98 tablets EU/1/11/734/019 14 tablets EU/1/11/734/020 28 tablets EU/1/11/734/021 56 tablets EU/1/11/734/022 98 tablets
Danish: EU/1/11/734/001 14 tabletter EU/1/11/734/002 28 tabletter EU/1/11/734/012 30 tabletter EU/1/11/734/003 56 tabletter EU/1/11/734/013 90 tabletter EU/1/11/734/004 98 tabletter EU/1/11/734/019 14 tabletter EU/1/11/734/020 28 tabletter EU/1/11/734/021 56 tabletter EU/1/11/734/022 98 tabletter
English: Uncommon Hypotension
Danish: Hypotension
English: Posology
Danish: Æske
English: Nimenrix received a marketing authorisation valid throughout the EU on 20 April 2012.
Danish: Nimenrix fik en markedsføringstilladelse med gyldighed i hele EU den 20. april 2012.
English: Further information on Nimenrix can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/nimenrix.
Danish: Yderligere information om Nimenrix findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/nimenrix.
English: Other information about Nimenrix
Danish: Andre oplysninger om Nimenrix
English: As for all medicines, data on the use of Nimenrix are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Nimenrix løbende overvåget.
English: Nimenrix can only be obtained with a prescription and should be used according to available official recommendations.
Danish: Nimenrix fås kun på recept og bør anvendes i henhold til de officielle anbefalinger.
English: What measures are being taken to ensure the safe and effective use of Nimenrix?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Nimenrix?
English: Nimenrix is well tolerated and the Agency considered that it can be safely given together with other routinely used vaccines in the different age groups.
Danish: Nimenrix tolereres godt, og agenturet mente, at den kan gives sikkert sammen med andre rutinemæssigt anvendte vacciner i de forskellige aldersgrupper.
English: An overview of Nimenrix and why it is authorised in the EU
Danish: En oversigt over Nimenrix, og hvorfor det er godkendt i EU
English: Nimenrix is given as an injection into the thigh or shoulder muscle.
Danish: Nimenrix gives som en injektion i lår- eller skuldermusklen.
English: The ability of Nimenrix to trigger the production of antibodies (immunogenicity) was assessed in five main studies involving over 4,000 participants aged 1 year or more.
Danish: Nimenrix' evne til at udløse dannelse af antistoffer (immunogen aktivitet) blev vurderet i fem hovedstudier, som omfattede over 4.000 deltagere på 1 år eller derover.
English: For more information about using Nimenrix, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Nimenrix, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Side effects reported with Nimenrix are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Nimenrix vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: When the person comes into contact with the bacterium, these antibodies, together with other components of the immune system, will be able to kill the bacteria and help protect against the disease.
Danish: Hvis personen senere kommer i kontakt med bakterien, vil disse antistoffer sammen med andre komponenter i immunsystemet være i stand til at dræbe den og hjælpe med at beskytte mod sygdommen.
English: Based on data from this study and additional data from a supporting study in 187 infants, this dose of Nimenrix was also considered to be effective in children between 12 weeks and less than 6 months of age.
Danish: På grundlag af data fra dette studie og supplerende data fra et underbyggende studie hos 187 spædbørn blev denne dosis af Nimenrix også anset for at være effektiv hos børn i alderen 12 uger til 6 måneder.
English: Therefore, the Agency decided that the benefits of Nimenrix are greater than its risks and recommended that it be granted marketing authorisation.
Danish: Agenturet var derfor af den opfattelse, at fordelene ved Nimenrix opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Nimenrix.
English: Invasive disease occurs when the bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spine) and septicaemia (blood poisoning).
Danish: Invasiv sygdom opstår, når bakterien spreder sig i kroppen og forårsager alvorlige infektioner såsom meningitis (infektion i hinderne rundt om hjernen og rygmarven) og septikæmi (blodforgiftning).
English: Nimenrix (meningococcal group A, C, W-135 and Y conjugate vaccine)
Danish: Nimenrix (konjugeret meningokokgruppe A-, C-, W-135og Y-vaccine)
English: Nimenrix contains small amounts of capsular polysaccharides (sugars from the outer coat) extracted from the four groups of the N. meningitidis bacterium: A, C, W135 and Y. These have been purified and then ‘conjugated' (attached) to a protein carrier called tetanus toxoid (a weakened toxin of tetanus which does not cause disease, also used in tetanus vaccine), because this improves the immune response to the vaccine.
Danish: Nimenrix indeholder små mængder af kapsulære polysaccharider (sukker fra bakteriens ydre kapsel), som er udvundet af de fire grupper af N. meningitidis-bakterien: A, C, W135 og Y. Disse er blevet renset og dernæst "konjugeret" (bundet) til en proteinbærer kaldet tetanus toxoid (et svækket toksin af tetanus, som ikke er sygdomsfremkaldende, og som også anvendes i tetanus-vaccine), fordi dette forbedrer immunsystemets respons på vaccinen.
English: Why is Nimenrix authorised in the EU?
Danish: Hvorfor er Nimenrix godkendt i EU?
English: What is Nimenrix and what is it used for?
Danish: Hvad er Nimenrix, og hvad anvendes det til?
English: Side effects after booster vaccination with Nimenrix are generally similar to those after initial vaccination, but diarrhoea, vomiting and nausea are also very common.
Danish: Bivirkningerne efter boostervaccinationen med Nimenrix svarer generelt til bivirkningerne efter den første vaccination, men diarré, opkast og kvalme er også meget almindelige.
English: The vaccine contains substances from the outer coat of the bacterium N. meningitidis.
Danish: Vaccinen indeholder stoffer fra den ydre kapsel af bakterien N. meningitidis.
English: Nimenrix may also be used as a booster vaccine in people from 1 year of age who have already been vaccinated with another meningococcal vaccine, to reinforce the level of protection.
Danish: Nimenrix kan også anvendes som boostervaccine hos personer på 1 år eller derover, som allerede er blevet vaccineret med en anden meningokokvaccine, for at forstærke beskyttelsesniveauet.
English: The company that markets Nimenrix will carry out a study to assess how long the protective immune response provided by one or two doses of Nimenrix lasts in young children between 1 and 2 years old.
Danish: Virksomheden, der markedsfører Nimenrix, vil gennemføre et studie for at vurdere, hvor lang tid den beskyttende immunreaktion som følge af én eller to doser af Nimenrix varer hos små børn mellem 1 og 2 år.
English: When a person is given the vaccine, the immune system recognises the parts of the bacterium in the vaccine as ‘foreign' and makes antibodies against them.
Danish: Når en person vaccineres, opfatter immunsystemet bakteriedelene i vaccinen som "fremmede" og danner antistoffer mod dem.
English: Nimenrix is a vaccine used to protect adults, adolescents and children from the age of 6 weeks against invasive meningococcal disease caused by four groups of the bacterium Neisseria meningitidis (group A, C, W-135, and Y).
Danish: Nimenrix er en vaccine, der anvendes til beskyttelse af voksne og unge og af børn fra 6-ugersalderen mod invasiv meningokoksygdom forårsaget af fire grupper af bakterien Neisseria meningitidis (gruppe A, C, W-135 og Y).
English: What are the risks associated with Nimenrix?
Danish: Hvilke risici er der forbundet med Nimenrix?
English: The most common side effects from initial vaccination with Nimenrix (which may affect more than 1 patient in 10) are loss of appetite, irritability, drowsiness, headache, fever, swelling, pain and redness at the site of injection, and tiredness.
Danish: De hyppigste bivirkninger ved Nimenrix (som kan forekomme hos mere end 1 ud af 10 personer) fra og med første vaccination er appetittab, irritabilitet, døsighed, hovedpine, feber, hævelse, smerter og rødme på injektionsstedet, og træthed.
English: The number of people who had an immune response against the polysaccharides with Nimenrix was similar to the other vaccines.
Danish: Antallet af personer, hos hvem der blev fremkaldt en immunreaktion mod polysacchariderne med Nimenrix, var det samme som for sammenligningsvaccinerne.
English: Nimenrix was compared with several other similar vaccines against N. meningitidis.
Danish: Nimenrix blev sammenlignet med en række andre tilsvarende vacciner mod N. meningitidis).
English: The powder is available in a vial, and the solvent is available in a pre-filled syringe or in an ampoule (a sealed container).
Danish: Pulveret findes i et hætteglas, og solvensen i en fyldt injektionssprøjte eller i en ampul (en forseglet beholder).
English: For children between 6 months and one year of age, the available data allowed to conclude that a single dose of Nimenrix was sufficient to stimulate an immune response against N. meningitidis.
Danish: For børn i alderen 6 måneder til 1 år kunne det af de tilgængelige data konkluderes, at en enkelt dosis Nimenrix var tilstrækkelig til at fremkalde en immunrespons mod N. meningitidis.
English: For the full list of side effects and restrictions of Nimenrix, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Nimenrix fremgår af indlægssedlen.
English: The Agency noted that Nimenrix offered the benefits of conjugated vaccines over conventional vaccines, including producing a strong immune response in young children.
Danish: Agenturet noterede sig, at Nimenrix i forhold til konventionelle vacciner havde den fordel at være konjugeret, inklusive at fremkalde en kraftig immunreaktion hos små børn.
English: Results showed that a single injection of Nimenrix was as effective as the other vaccines in stimulating an immune response against all four types of N. meningitidis polysaccharides.
Danish: Resultaterne viste, at en enkelt injektion af Nimenrix var lige så effektiv som de andre vacciner til at fremkalde en immunreaktion mod alle fire typer af N. meningitidis-polysaccharider.
English: The European Medicines Agency considered that Nimenrix had been shown to be at least as effective as comparable vaccines at stimulating an immune response to the four groups of the N. meningitidis bacterium in people of different age groups.
Danish: Det Europæiske Lægemiddelagentur var af den opfattelse, at det var blevet påvist, at Nimenrix var mindst lige så effektivt som sammenligningsvaccinerne til at fremkalde en immunreaktion på de fire grupper af N. meningitidis-bakterien hos personer fra forskellige aldersgrupper.
English: It is available as a powder and solvent that are mixed together to make a solution for injection.
Danish: Det findes som et pulver og en solvens, som blandes til en injektionsvæske, opløsning.
English: Children from 6 months of age, adolescents and adults should be given one dose of Nimenrix, but an additional dose may be considered for some children at high risk of invasive meningococcal disease (at least 2 months after the last dose of Nimenrix).
Danish: Børn fra 6-månedersalderen samt unge og voksne bør have én dosis Nimenrix, men en yderligere dosis kan overvejes for nogle børn med stor risiko for invasiv meningokoksygdom (mindst to måneder efter den sidste dosis Nimenrix).
English: A sixth study in over 2,000 children first vaccinated between 6 and 12 weeks of age showed that Nimenrix (given as 2 doses 2 months apart) was as effective as two other vaccines against N. meningitidis in stimulating an immune response.
Danish: Et sjette studie med mere end 2.000 børn, som var blevet vaccineret første gang, da de var 6-12 uger gamle, viste, at Nimenrix (givet som to doser med to måneders mellemrum) var lige så effektivt til at fremkalde en immunreaktion mod N. meningitidis som to andre vacciner.
English: In infants from 6 weeks to less than 6 months of age, two doses of Nimenrix are recommended (the first dose is given from 6 weeks of age, the second dose 2 months afterwards).
Danish: Hos spædbørn i alderen 6 uger til 6 måneder anbefales to doser Nimenrix (den første dosis gives fra 6-ugersalderen, den anden dosis to måneder efter).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nimenrix have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Nimenrix.
English: What benefits of Nimenrix have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Nimenrix?
English: Studies also showed that, in people vaccinated with Nimenrix or another meningococcal vaccine when they were 1 year of age or older, Nimenrix given as a booster several years after they had been vaccinated increased the level of antibodies.
Danish: Studierne viste desuden, at indholdet af antistoffer forøgedes hos personer, som var blevet vaccineret med Nimenrix eller en anden meningokokvaccine, da de var 1 år eller derover, når Nimenrix blev givet som booster flere år efter, at de sidst var blevet vaccineret.
English: How does Nimenrix work?
Danish: Hvordan virker Nimenrix?
English: Children who received the initial dose (or doses) of Nimenrix between 6 weeks and one year of age should receive a booster dose at 1 year of age, at least 2 months after the last dose of Nimenrix.
Danish: Børn på mellem 6 uger og 1 år, der fik de(n) oprindelige dosis/doser af Nimenrix, bør have en boosterdosis, når de er fyldt 1 år, mindst to måneder efter den sidste dosis Nimenrix.
English: How is Nimenrix used?
Danish: Hvordan anvendes Nimenrix?
English: Strength Pharmaceutical form
Danish: Styrke Lægemiddelform Administration Indre emballage
English: Your doctor will decide this.
Danish: Din læge vil afgøre dette.
English: Combination should be avoided.
Danish: Kombination bør undgås.
English: Only water should be used as the vehicle.
Danish: Kun vand bør anvendes som vehikel.
English: No change Increase
Danish: Ingen ændring Stigning
English: There was evidence of reversibility.
Danish: Der var tegn på reversibilitet.
English: You can take them either with or without food, but you need to do this in the same way each day.
Danish: Du kan tage dem enten sammen med eller uden mad, men du skal gøre det på samme måde hver dag.
English: Take them at the same time every day.
Danish: Tag dem på samme tidspunkt hver dag.
English: 9/l) and no fever.
Danish: 9/l) og ingen feber.
English: • At the request of the European Medicines Agency;
Danish: • på anmodning fra det Europæiske Lægemiddelagentur
English: if you have an infection.
Danish: hvis du har en infektion.
English: Steady-state was achieved within 2 weeks.
Danish: Steady state blev opnået inden for 2 uger.
English: Using a small glass
Danish: Brug af et lille glas
English: Urgent treatment may be necessary.
Danish: Hurtig behandling kan være nødvendig.
English: You will need:
Danish: Du skal bruge:
English: Follow all the doctor's instructions carefully.
Danish: Følg alle lægens anvisninger omhyggeligt.
English: Date of first authorisation: 02 September 2011 Date of latest renewal: 28 July 2015
Danish: Dato for første markedsføringstilladelse: 02 september 2011 Dato for seneste fornyelse: 28. juli 2015
English: Family-wise error rate of 2.5% one-sided
Danish: Family-wise error rate på 2,5 % ensidet
English: Store them in a dry and clean place until next time.
Danish: Opbevar dem på et tørt og rent sted indtil næste gang.
English: Important information:
Danish: Vigtig information:
English: Do not use juice or any other liquids.
Danish: Brug ikke juice eller andre væsker.
English: Wash and dry your hands.
Danish: Vask og tør dine hænder.
English: Some infections may be severe and may have fatal consequences in adults and children.
Danish: Nogle infektioner kan være alvorlige og få dødlige følger hos voksne og børn.
English: Do not swallow them whole.
Danish: Du må ikke synke dem hele.
English: Increased exposure expected (the effect varies widely).
Danish: Eksponeringen forventes forhøjet (effekten varierer meget).
English: Reported experience with overdose in humans is very limited.
Danish: Rapporteret erfaring med overdosering hos mennesker er meget begrænset.
English: Active substance by interaction
Danish: Aktivt stof per interaktion
English: The efficacy results for the primary endpoint are summarised in Table 5.
Danish: Effektresultaterne for det primære endepunkt er opsummeret i tabel 5.
English: 95% confidence interval
Danish: 95 % konfidensinterval