FrancophonIA/ELRC3.0 huggingface dataset:
English: As data on patients with renal impairment are limited, Vedrop should be administered with caution and under close monitoring of the renal function in patients with renal impairment e.g. dehydrated patients (see section 4.2).
Danish: Da der er begrænsede data for patienter med nedsat nyrefunktion, skal Vedrop administreres med forsigtighed og under tæt monitorering af nyrefunktionen hos patienter med nyreinsufficiens, f.eks. dehydrerede patienter.
English: CONDITIONS OR RESTRICTIONS REGARDING THE SUPPLY AND USE
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: - Vedrop must not be used in newborn premature babies.
Danish: - Vedrop må ikke gives til præmature spædbørn.
English: Doses for administration should be extracted from the bottle using the oral syringes which are provided in the pack.
Danish: Doser til indgivelse udtages af glasset med den orale sprøjte, der er vedlagt i æsken.
English: Do not take a double dose to make up for a forgotten dose.
Danish: Spring den glemte dosis over og tag din næste dosis på almindelig vis. Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Each box contains one bottle and one oral syringe (a 1 ml syringe with a 10 ml or 20 ml bottle, a 2 ml syringe with a 60 ml bottle).
Danish: Hver æske indeholder ét glas og én oral sprøjte (én 1 ml sprøjte med ét 10 ml eller 20 ml glas, én 2 ml sprøjte med ét 60 ml glas).
English: Dose of Vedrop (in ml) = dose of d-alpha-tocopherol (in mg)
Danish: Dosis Vedrop (i ml) = dosis d-alfa-tocopherol (i mg)
English: It should be taken into consideration by patients on a controlled sodium diet.
Danish: Patienter på natriumfattig diæt, skal tage hensyn til dette.
English: The active substance d-alpha-tocopherol-polyethylene glycol 1000 succinate (tocofersolan) is a pro-drug; the active metabolite is the d-alpha-tocopherol.
Danish: Det aktive stof d-alfa-tocopherol-polyethylenglycol 1000 succinat (tocofersolan) er et prodrug.
English: INFORMATION IN BRAILLE Vedrop 50 mg/ml
Danish: Vedrop 50 mg/ml
English: Uncommon: serum sodium abnormal, serum potassium abnormal, transaminases increase
Danish: Ikke almindelig: Forskydninger i serum-natrium og serumkalium, øget niveau af transaminaser
English: Each ml contains 6 mg sodium methyl parahydroxybenzoate (E219), 4 mg sodium ethyl parahydroxybenzoate (E215) and 0.18 mmoles (4.1 mg) of sodium.
Danish: Hver ml indeholder 6 mg natriummethylparahydroxybenzoat (E219), 4 mg natriumethylparahydroxybenzoat (E215) og 0,18 mmol (4,1 mg) natrium.
English: 10 ml 20 ml 60 ml
Danish: Oral opløsning 10 ml 20 ml 60 ml
English: Boxes containing: one 10 ml bottle and one 1 ml oral syringe one 20 ml bottle and one 1 ml oral syringe one 60 ml and one 2 ml oral syringe
Danish: ét 10 ml glas og én 1 ml oral sprøjte ét 20 ml glas og én 1 ml oral sprøjte ét 60 ml glas og én 2 ml oral sprøjte
English: • Rash (eruption on the skin)
Danish: • Udslæt på huden
English: Common: diarrhoea
Danish: Almindelig: Diaré Ikke kendt: mavesmerter
English: Discard one month after opening
Danish: EXP Bortskaffes én måned efter åbning.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 July 2009
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Vedrop contains sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215) which may cause allergic reactions (possibly delayed).
Danish: Vedrop indeholder natriummethylparahydroxybenzoat (E219) og natriumethylparahydroxybenzoat (E215), der kan forårsage allergiske reaktioner (eventuelt forsinket).
English: Each bottle contains 10 ml, 20 ml or 60 ml of oral solution.
Danish: Hvert glas indeholder 10 ml, 20 ml eller 60 ml oral opløsning.
English: Skin and subcutaneous tissue disorders Uncommon: alopecia, pruritus, rash General disorders and administration site conditions
Danish: Ikke almindelig: Alopeci, pruritus, udslæt
English: Slightly viscous, pale yellow solution.
Danish: Let tyktflydende, lys gul opløsning.
English: One graduation of the 1 ml oral syringe corresponds to 2.5 mg of d-alpha-tocopherol in the form of tocofersolan.
Danish: Én streg på den 1 ml orale sprøjte svarer til 2,5 mg d-alfa-tocopherol i form af tocofersolan.
English: Oral syringes with housing of LDPE and piston of polystyrol.
Danish: Orale sprøjter i LDPE-beholder og med polystyrolstempel.
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Vedrop til dig personligt.
English: Sodium methyl parahydroxybenzoate (E219) Sodium ethyl parahydroxybenzoate (E215) Glycerol
Danish: Natriummethylparahydroxybenzoat (E219) Natriumethylparahydroxybenzoat (E215) Glycerol
English: Bottle of 60 ml and 2 ml oral syringe.
Danish: Glas med 60 ml og 2 ml oral sprøjte.
English: Taken up by cells, the alpha-tocopherol moiety appears in chylomicrons in the lymph in a manner identical to vitamin E absorbed from the diet. Cellular uptake does not require receptors, binding proteins or metabolic processes and does not occur by pinocytosis.
Danish: Celleoptagelsen er ikke afhængig af receptorer, bindingsproteiner eller stofskifteprocesser og sker ikke ved pinocytose.
English: The bottles contain 10 ml, 20 ml or 60 ml of oral solution.
Danish: Glasset indeholder 10 ml, 20 ml eller 60 ml oral opløsning.
English: Excipients: sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215).
Danish: Hjælpestoffer: Natriummethylparahydroxybenzoat (E219), natriumethylparahydroxybenzoat (E215).
English: How to take Vedrop
Danish: Sådan skal du tage Vedrop
English: NAME OF THE MEDICINAL PRODUCT Vedrop 50 mg/ml oral solution
Danish: Vedrop 50 mg/ml oral opløsning
English: NAME OF THE MEDICINAL PRODUCT Vedrop 50 mg/ml oral solution.
Danish: Vedrop 50 mg/ml oral opløsning.
English: Bottle of 20 ml and 1 ml oral syringe.
Danish: Glas med 20 ml og 1 ml oral sprøjte.
English: For tocofersolan no clinical data on exposed pregnancies are available.
Danish: Der er ingen erfaring med anvendelse af tocofersolan til gravide.
English: Bottle of 10 ml and 1 ml oral syringe.
Danish: Glas med 10 ml og 1 ml oral sprøjte.
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
English: One graduation of the 2-ml oral syringe corresponds to 5 mg of d-alpha-tocopherol in the form of tocofersolan.
Danish: Èn streg på den 2 ml orale sprøjte svarer til 5 mg d-alfa-tocopherol i form af tocofersolan..
English: 2- Put the oral syringe included in the pack in the bottle.
Danish: 2- Før den orale sprøjte fra æsken ned i glasset.
English: • Loss of hair
Danish: • Hårtab
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Bottle label - 10 ml, 20 ml and 60 ml bottles
Danish: Glassets etiket - 10 ml, 20 ml og 60 ml glas
English: Potassium sorbate
Danish: Kaliumsorbat
English: Hepatic or renal impairment
Danish: Hud og subkutane væv
English: If you take more Vedrop than you should
Danish: Hvis du har taget for meget Vedrop
English: PHARMACEUTICAL FORM Oral solution.
Danish: Receptpligtigt lægemiddel.
English: Each ml contains 50 mg of d-alpha-tocopherol in the form of tocofersolan, corresponding to 74.5 IU of tocopherol.
Danish: Hver ml indeholder 50 mg d-alfa-tocopherol i form af tocofersolan, der svarer til 74,5 IE tocopherol.
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Danish: Tabelliste over bivirkninger
English: Marketing Authorisation Holder Recordati Rare Diseases Immeuble “Le Wilson” 70 avenue du General de Gaulle 92800 Puteaux
Danish: Indehaver af markedsføringstilladelsen Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du General de Gaulle F-92800 Puteaux
English: • Itching
Danish: • Kløe
English: Each ml of solution contains 50 mg of d-alpha-tocopherol in the form of tocofersolan, corresponding to 74.5 IU of tocopherol.
Danish: Hver ml opløsning indeholder 50 mg d-alfa-tocopherol i form af tocofersolan svarerende til 74,5 IE tocopherol.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis du vil have yderligere oplysninger om Vedrop, skal du henvende dig til den lokale repræsentant:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton box - 10 ml, 20 ml and 60 ml bottle
Danish: Æske - 10 ml, 20 ml og 60 ml glas
English: - The other ingredients are: potassium sorbate, sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215) (see end of section 2 for further information on these 2 ingredients), glycerol, disodium phosphate dodecahydrate, concentrated hydrochloric acid, purified water.
Danish: - Øvrige indholdsstoffer: Kaliumsorbat, natriummethylparahydroxybenzoat (E219) og natriumethylparahydroxybenzoat (E215) (se sidste del af pkt.
English: Recordati Rare Diseases Immeuble “le Wilson” 70 avenue du Général de Gaulle 92800 Puteaux
Danish: Recordati Rare Diseases Immeuble “le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux Frankrig
English: This summary was last updated in 07-2010.
Danish: Dette sammendrag blev sidst ajourført i 07-2010.
English: EMA/439640/2010
Danish: EMA/439640/2010 EMEA/H/C/295
English: Their breathing should be monitored for up to three
Danish: Deres vejrtrækning bør overvåges i op til tre dage efter
English: • polioviruses (types 1, 2 and 3) that have been inactivated (killed) so that they do not cause any
Danish: • poliovira (type 1, 2 og 3), der er blevet inaktiveret (dræbt), så de ikke er sygdomsfremkaldende.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Infanrix Penta.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Infanrix Penta.
English: This means that the active substances are fixed onto aluminium compounds, to stimulate a better response.
Danish: Dette betyder, at de aktive stoffer er bundet til aluminiumholdige forbindelser, hvorved reaktionen forstærkes.
English: The choice of which vaccine to use depends on official recommendations.
Danish: Valget af vaccine afhænger af de officielle anbefalinger.
English: The European Commission granted a marketing authorisation valid throughout the EU for Infanrix Penta to GlaxoSmithKline Biologicals s.a. on 23 October 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Infanrix Penta til GlaxoSmithKline Biologicals s.a. den 23. oktober 2000.
English: This document is a summary of the European public assessment report (EPAR) for Infanrix Penta.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Infanrix Penta.
English: The CHMP decided that Infanrix Penta's benefits are greater than its risks and recommended that it be
Danish: CHMP besluttede, at fordelene ved Infanrix Penta er større end risiciene, og anbefalede udstedelse af
English: The marketing authorisation is valid for
Danish: Markedsføringstilladelsen er gyldig på ubegrænset tid.
English: The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the bacteria or viruses.
Danish: Derefter vil immunsystemet fremover kunne producere antistoffer hurtigere, når personen udsættes for disse bakterier eller vira på naturlig vis.
English: It contains the following
Danish: Lægemidlet indeholder
English: After one month, between 86 and 100% of the infants had developed protective levels of antibodies against all of the active substances in Infanrix Penta.
Danish: Efter en måned havde mellem 86 og 100 % af børnene dannet beskyttende antistoffer mod alle de aktive stoffer i Infanrix Penta.
English: The main measure of effectiveness was the production of antibodies against the active substances after vaccination.
Danish: Den vigtigste målestok for virkningen var dannelsen af antistoffer mod de aktive stoffer efter vaccination.
English: The studies involved over 10,000 infants, about three quarters of whom received Infanrix Penta, given according to various time schedules.
Danish: Undersøgelserne omfattede over 10 000 børn, hvoraf ca. tre fjerdedele fik Infanrix Penta i henhold til forskellige tidsplaner.
English: When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘foreign' and makes antibodies against them.
Danish: Når barnet får vaccinen, opfatter immunsystemet delene af bakterier og vira som "fremmede" og producerer antistoffer mod dem.
English: The most common side effects with Infanrix Penta (seen in more than 1 in 10 doses of the vaccine) are loss of appetite, fever of 38ºC or more, local swelling, pain and redness at the injection site, fatigue (tiredness), abnormal crying, irritability and restlessness.
Danish: De hyppigste bivirkninger ved Infanrix Penta (som ses ved flere end 1 ud af 10 doser af vaccinen) er appetitløshed, feber på 38 ºC eller derover, hævelse, smerte og rødme på injektionsstedet, træthed, usædvanlig gråd, irritabilitet og rastløshed.
English: • surface antigen (proteins from the surface) of the hepatitis B virus;
Danish: • overfladeantigen (proteiner fra overfladen) af hepatitis B-virus,
English: After booster vaccination, there was an increase in the number of infants with protective levels of antibodies against the active substances.
Danish: Efter boostervaccination sås en stigning i antallet af børn med beskyttende antistofniveauer mod de aktive stoffer.
English: Infanrix Penta has also been studied in nine studies of booster vaccination involving over 4,000 infants, 714 of whom received Infanrix Penta as a booster.
Danish: Infanrix Penta er også blevet undersøgt i ni undersøgelser af boostervaccination med deltagelse af over 4 000 børn, hvoraf 714 fik Infanrix Penta som booster.
English: Infanrix Penta has been studied in 16 studies looking at the first course of vaccination.
Danish: Infanrix Penta er blevet undersøgt i 16 undersøgelser af det primære vaccinationsforløb.
English: Infanrix Penta can be given to infants who received a hepatitis B vaccine at birth.
Danish: Infanrix Penta kan gives til børn, der har fået en hepatitis B-vaccine ved fødslen.
English: A booster dose of Infanrix Penta or a similar vaccine must be given at least six months after the last dose of the initial course.
Danish: En boosterdosis af Infanrix Penta eller en tilsvarende vaccine skal gives mindst seks måneder efter den sidste dosis af primærvaccinationen.
English: Infanrix Penta must not be used in infants who have had encephalopathy (brain disease) of unknown cause within seven days of receiving a vaccine containing pertussis components in the past.
Danish: Infanrix Penta må ikke gives til børn, som tidligere har haft encephalopati (en hjernesygdom) som følge af en ukendt årsag inden for syv dage efter at have modtaget en vaccine indeholdende pertussiskomponenter.
English: • toxoids from the bacteria that cause diphtheria and tetanus;
Danish: • toxoider fra bakterien, der forårsager difteri og tetanus,
English: Infanrix Penta should not be used in infants who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients of the vaccine, or to neomycin and polymyxin (antibiotics).
Danish: Infanrix Penta bør ikke gives til børn, der kan være overfølsomme (allergiske) over for nogle af de aktive stoffer, over for nogle af de øvrige indholdsstoffer i vaccinen eller over for neomycin og polymyxin (antibiotika).
English: It must not be used in infants who have had an allergic reaction after receiving a vaccine containing diphtheria, tetanus, pertussis, hepatitis B or polio in the past.
Danish: Det må ikke gives til børn, som tidligere har haft en allergisk reaktion efter at have modtaget en vaccine indeholdende difteri, tetanus, pertussis, hepatitis B eller polio.
English: The studies showed that a first course of vaccination with Infanrix Penta led to the development of protective levels of antibodies.
Danish: Undersøgelserne viste, at primærvaccination med Infanrix Penta medførte dannelse af beskyttende antistoffer.
English: The site of injection should be alternated for subsequent injections.
Danish: Injektionsstedet bør varieres ved hver injektion.
English: The recommended vaccination schedule for Infanrix Penta is two or three doses, given at least one month apart, usually within the first six months of life.
Danish: Det anbefalede vaccinationsprogram for Infanrix Penta er to eller tre doser, som gives med mindst en måneds mellemrum, sædvanligvis inden barnet er seks måneder gammelt.
English: Infanrix Penta is a combination of components that have been available in the European Union (EU) in other vaccines: diphtheria, tetanus, pertussis and hepatitis B were available in Infanrix HepB from 1997 until 2005, and diphtheria, tetanus, pertussis and polioviruses are available in other vaccines.
Danish: Infanrix Penta er en kombination af komponenter, der har været tilgængelige i Den Europæiske Union (EU) i andre vacciner: difteri, tetanus, pertussis og hepatitis B indgik i Infanrix HepB fra 1997 til 2005, og difteri, tetanus, pertussis og poliovira indgår i andre vacciner.
English: For more information about treatment with Infanrix Penta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Infanrix Penta, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte
English: Infanrix Penta is given by deep injection into a muscle.
Danish: Infanrix Penta gives som en dyb injektion i en muskel.
English: diphtheria (D), tetanus (T), pertussis (acellular, component) (PA), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
Danish: difteri (D)-, tetanus (T)-, pertussis (acellulær, komponent) (PA)-, hepatitis B (rDNA) (HBV)-, poliomyelitis (inaktiveret) (IPV)-vaccine (adsorberet)
English: The full EPAR for Infanrix Penta can be found here.
Danish: Den fuldstændige EPAR for Infanrix Penta findes her.
English: • toxoids and other proteins purified from B. pertussis;
Danish: • toxoider og andre proteiner oprenset fra B. pertussis,
English: • toxoids (chemically weakened toxins) from diphtheria and tetanus; • parts of Bordetella pertussis (B. pertussis, a bacterium that causes whooping cough);
Danish: • toxoider (kemisk svækkede toksiner) fra difteri og tetanus, • dele af Bordetella pertussis (B. pertussis, en bakterie, der forårsager kighoste),
English: Infanrix Penta is a vaccine.
Danish: Infanrix Penta er en vaccine.
English: What is the risk associated with Infanrix Penta?
Danish: Hvilken risiko er der forbundet med Infanrix Penta?
English: Infanrix Penta is used to protect infants under three years of age against diphtheria, tetanus, pertussis (whooping cough), hepatitis B and poliomyelitis (polio).
Danish: Infanrix Penta anvendes til at beskytte børn under tre år mod difteri, tetanus (stivkrampe), pertussis (kighoste), hepatitis B og poliomyelitis (polio).
English: Infanrix Penta is a vaccine, which is available as a suspension for injection.
Danish: Infanrix Penta er en vaccine, der leveres som en suspension til injektion.
English: For the full list of all side effects reported with Infanrix Penta, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Infanrix Penta fremgår af indlægssedlen.
English: Infanrix Penta contains small amounts of:
Danish: Infanrix Penta indeholder små mængder
English: The surface antigens of the hepatitis B virus are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Danish: De produceres af en gærart, der har fået indsat et gen (dna), som sætter den i stand til at producere proteinerne.
English: How is Infanrix Penta used?
Danish: Hvordan anvendes Infanrix Penta?
English: As for all vaccines, if Infanrix Penta is used in babies born very prematurely, there is a risk of them experiencing apnoea (brief pauses in breathing).
Danish: Som ved alle vacciner er der risiko for apnø (korte pauser i vejrtrækningen), hvis Infanrix Penta gives til spædbørn, der er født meget for tidligt.
English: What benefit has Infanrix Penta shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Infanrix Penta?
English: Infanrix Penta should be postponed in infants
Danish: Vaccination med Infanrix Penta bør udskydes, hvis barnet får pludselig høj feber.
English: - if you have ever had problems with your liver.
Danish: - hvis du nogensinde har haft problemer med din lever.
English: *from the following studies: INTEREST, ISEL, INTACT 1&2, IDEAL 1&2, INVITE
Danish: *fra følgende studier: INTEREST, ISEL, INTACT 1&2, IDEAL 1&2, INVITE
English: 1China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Taiwan and Thailand.
Danish: 1Kina, Hong Kong, Indonesien, Japan, Malaysia, Filippinerne, Singapore, Taiwan og Thailand.
English: 31110 Noáin (Navarra) Spain
Danish: 31110 Noáin (Navarra) Spanien
English: NR Not reached.
Danish: NR Ikke opnået (not reached).
English: In that study, sensitivity was 43.1%, specificity was 100%.
Danish: I dette studie var sensibiliteten 43,1 % og specificiteten 100 %.
English: This may affect about 1 in 100 patients taking gefitinib and can be life-threatening.
Danish: Dette kan påvirke ca. 1 ud af 100 patienter, der tager gefitinib og kan være livstruende.
English: • You can take the tablet with or without food.
Danish: • Du kan tage tabletten sammen med mad eller uden mad.
English: These medicines may affect the way this medicine works.
Danish: Disse lægemidler kan påvirke virkningen af dette lægemiddel.
English: d Asian ethnicity excludes patients of Indian origin and refers to the racial origin of a patient group and not necessarily their place of birth.
Danish: Asiatisk etnisk oprindelse ekskluderer patienter af indisk herkomst og refererer til racen af patientgruppen og ikke nødvendigvis deres fødested.
English: Allergic reactions (1.1%), including angioedema and urticaria.
Danish: Allergiske reaktioner (1,1 %), inklusive angioødem og urticaria.
English: Gefitinib Mylan should not be used during pregnancy unless clearly necessary.
Danish: Gefitinib Mylan må derfor ikke anvendes under graviditet, medmindre det er strengt nødvendigt.
English: The tablet may be taken with or without food, at about the same time each day.
Danish: Tabletten tages sammen med eller uden mad på cirka det samme tidspunkt hver dag.
English: Gefitinib did not prolong survival in the overall population.
Danish: Gefitinib forlængede ikke overlevelsen hos den totale population.
English: Number of patients evaluable for quality of life analyses.
Danish: Antal patienter, der kan evalueres ved livskvalitetsanalyser.
English: LCS symptom improvement ratea
Danish: LCS symptomforbedringsratea
English: “m” is medians in months.
Danish: “m” er medianer angivet i måneder.
English: • Take the tablet at about the same time each day.
Danish: • Tag tabletten på ca. samme tidspunkt hver dag.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1321/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1321/001
English: - Warfarin (a so-called oral anticoagulant, to prevent blood clots).
Danish: - Warfarin (et såkaldt oralt antikoagulationsmiddel, til forebyggelse af blodpropper).
English: b “m” is medians in months.
Danish: b “m” er medianer angivet i måneder.
English: Figures 1 and 2 - Efficacy outcomes in subgroups of non-Asian patients in the INTEREST study (N patients = Number of patients randomised)
Danish: Figur 1 og 2 - Data for virkning i undergrupper af ikke-asiatiske patienter i INTEREST-studiet (N patienter = antal randomiserede patienter)
English: Never smoker
Danish: Personer som aldrig har røget
English: NC Not calculated for overall survival HR as the number of events is too few.
Danish: NC Ikke udregnet (not calculated) for HR ved total overlevelse, fordi antal tilfælde er for lavt.
English: Uncommon Hepatitis**
Danish: Ikke almindelig Hepatitis**