FrancophonIA/ELRC3.0 huggingface dataset:
English: Dupixent 200 mg solution for injection in a pre-filled syringe with needle shield dupilumab
Danish: Dupixent 200 mg injektionsvæske, opløsning i en fyldt injektionssprøjte med kanylebeskyttelseshylster dupilumab
English: Open here
Danish: Må ikke omrystes Åbn her
English: QUEST (Baseline Blood Eosinophil Levels ≥ 150 and ≥ 300 cells/mcL)
Danish: Eosinofiltal i blodet ved baseline ≥ 150 celler/mikrol
English: • the Dupixent pre-filled syringe
Danish: • Dupixent fyldt injektionssprøjte
English: Dupixent 300 mg solution for injection in a pre-filled syringe with needle shield dupilumab
Danish: Dupixent 300 mg injektionsvæske, opløsning i en fyldt injektionssprøjte med kanylebeskyttelseshylster dupilumab
English: EN
Danish: DA
English: [E.g. medicinal products for which negligible systemic exposure/negligible pharmacodynamic systemic activity has been demonstrated in clinical situation]
Danish: [For eksempel medicin hvor der er vist neglegiabel systemisk eksponering/farmakodynamisk systemisk aktivitet i kliniske situationer]
English: Animal studies do not indicate reproductive toxicity (see section 5.3).
Danish: Dyreforsøg indikerer ikke reproduktionstoksicitet (se pkt 5.3).
English: [9] <No effects during pregnancy are anticipated, since systemic exposure to {Active substance} is negligible.>
Danish: [9] <Der forventes ingen virkning på graviditeten, da sytemisk eksponering af {Aktivt stof} er neglegiabel.>
English: [4] <There are no or limited amount of data from the use of {Active substance} in pregnant women.
Danish: [4] <Der er ingen eller utilstækkelige data fra anvendelse af {Aktivt stof} til gravide kvinder.
English: {Invented name} can be used during pregnancy.
Danish: {(Sær)navn} kan anvendes under graviditeten.
English: <A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from {Invented name} therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.>
Danish: <Det skal besluttes, om amning skal ophøre eller behandling med {(Sær)navn} seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.>
English: [1]<Based on human experience [specify] {Active substance} causes <congenital malformations [specify] when administered during pregnancy.> [or] <harmful pharmacological effects during pregnancy and/or on the fetus/newborn child.>
Danish: [1]<Baseret på humane data [specificer] medfører {Aktivt stof} <medfødte misdannelser [specificer], når det anvendes under graviditeten.> [eller] <skadelige farmakologiske virkninger på graviditeten og/eller fostret/det nyfødte barn.>
English: <Breast-feeding should be discontinued during treatment with {Invented name}.>
Danish: <Amning skal ophøre under behandling med {(Sær)navn}.>
English: [5] <There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of {Active substance} in pregnant women.
Danish: [5] <Der er ingen eller utilstrækkelige data (mindre end 300 gravide forsøgspersoner) fra anvendelse af {Aktivt stof} til gravide kvinder.
English: [2] <It is unknown whether {Active substance}/metabolites are excreted in human milk.>
Danish: [2] <Det er ukendt, om {Aktivt stof}/metabolitter udskilles i human mælk.>
English: <{Active substance}/metabolites are not excreted in human milk.>
Danish: <{Aktivt stof}/metabolitter udskilles ikke i human mælk.>
English: <{Active substance}/metabolites are excreted in human milk to such an extent that effects on the breastfed newborns/infants are likely.>
Danish: <{Aktivt stof}/metabolitter udskilles i human mælk i så stor en mængde, at en påvirkning af ammede nyfødte/spædbørn er sandsynlig.>
English: <Available pharmacodynamic/toxicological data in animals have shown excretion of {Active substance}/metabolites in milk (for details see 5.3).>
Danish: <De tilgængelige farmakodynamiske/toksikologiske data fra dyreforsøg viser, at {Aktivt stof}/metabolitter udskilles i mælk (se pkt.
English: [2] <Based on human experience [specify] {Active substance} is suggested / suspected to cause congenital malformations [specify] when administered during pregnancy.
Danish: [2] <Baseret på humane data [specificer] er {Aktivt stof} under mistanke for at medføre medfødte misdannelser [specificer], når det anvendes under graviditeten.
English: [3] <Based on human experience [specify] {Active substance} is suggested / suspected to cause congenital malformations [specify] when administered during pregnancy.
Danish: [3] <Baseret på humane data [specificer] er {Aktivt stof} under mistanke for at medføre medfødte misdannelser [specificer], når det anvendes under graviditeten.
English: <{Active substance}/metabolites have not been identified in plasma of breastfed newborns/infants of treated mothers.>
Danish: <{Aktivt stof}/metabolitter er ikke påvist i plasma hos nyfødte/spædbørn, ammet af mødre, som er i behandling.>
English: <Physico-chemical data suggest excretion of {Active substance}/metabolites in human milk.>
Danish: <Fysisk-kemiske data indikerer, at {Aktivt stof}/metabolitter udskilles i human mælk.>
English: [1] <{Active substance}/metabolites are excreted in human milk and effects have been shown in breastfed newborns/infants of treated women.>
Danish: [1] <{Aktivt stof}/metabolitter udskilles i human mælk, og påvirkning er set hos nyfødte/spædbørn, ammet af kvinder, der er i behandling med {Aktivt stof}.>
English: <The effect of {Active substance} on newborns/infants is unknown.> [or] <There is insufficient information on the effects of {Active substance} in newborns/infants.>>
Danish: <{Aktivt stof}/metabolitter er påvist hos nyfødte/spædbørn, ammet af kvinder, som er i behandling med {Aktivt stof}.> <Virkningen af {Aktivt stof} på det ammede barn er ukendt.> [eller] <Der foreligger utilstrækkelige data for virkningen af {Aktivt stof} på det ammede barn.>>
English: {Invented name} should not be used <during pregnancy><during {trimester} of pregnancy> unless the clinical condition of the woman requires treatment with {Active substance}.
Danish: trimester>, medmindre kvindens kliniske tilstand kræver behandling med {Aktivt stof}.
English: <No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to {Active substance} is negligible.>
Danish: <Der forventes ingen påvirkning af nyfødte/spædbørn, ammet af mødre i behandling med {Aktivt stof}, da den systemiske eksponering er neglegiabel.>
English: [8] <A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicate no malformative nor feto/ neonatal toxicity of {Active substance}.>
Danish: [8] <Data fra anvendelse af {Aktivt stof} hos et stort antal gravide kvinder (mere end 1000) indikerer ingen misdannelser eller føtal/neonatal toksicitet af {Aktivt stof}.>
English: <{Active substance}/metabolites are excreted in human milk, but at therapeutic doses of {Invented name} no effects on the breastfed newborns/infants are anticipated.>
Danish: <{Aktivt stof}/metabolitter udskilles i human mælk, men der forventes ingen påvirkning af det ammede barn ved terapeutiske doser af {(Sær)navn}.>
English: [3] <No effects of {Active substance} have been shown in breastfed newborns/infants of treated mothers.>
Danish: [3] <Der er ikke set nogen påvirkning af nyfødte/spædbørn, ammet af mødre i behandling med {Aktivt stof}.>
English: {Invented name} can be used during breast-feeding.
Danish: {(Sær)navn} kan anvendes under amning.
English: [7] <A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of {Active substance}.>
Danish: [7] < Data fra anvendelse af {Aktivt stof} hos et begrænset antal gravide kvinder (mellem 300 og 1000) indikerer ingen misdannelser eller føtal/neonatal toksicitet af {Aktivt stof}.>
English: [6] <A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of {Active substance}.
Danish: [6] <Data fra anvendelse af {Aktivt stof} hos et begrænset antal gravide kvinder (mellem 300 og 1000) indikerer ingen misdannelser eller føtal/neonatal toksicitet af {Aktivt stof}.
English: <There is insufficient information on the excretion of {Active substance}/metabolites in human milk.>
Danish: <Data for udskillelse af {Aktiv stof}/metabolitter i human mælk er utilstrækkelige.>
English: <There is insufficient information on the excretion of {Active substance}/metabolites in animal milk.>
Danish: <Data for udskillelse af {Aktivt stof}/metabolitter i mælk hos dyr er utilstrækkelige.>
English: {Invented name} can be used <during pregnancy><during {trimester} of pregnancy> if clinically needed.
Danish: {(Sær)navn} kan anvendes <under graviditeten><i graviditetens {antal.}
English: {Invented name} is contraindicated <during pregnancy><during {trimester} of pregnancy> [this case is a strict contraindication] (see section 4.3).
Danish: <{(Sær)navn} <er kontraindiceret under amning (se pkt.
English: As a precautionary measure, it is preferable to avoid the use of {Invented name} <during pregnancy> <during {trimester} of pregnancy>.
Danish: For en sikkerheds skyld bør {(Sær)navn} undgås <under graviditeten><i graviditetens {antal.}
English: The use of {invented name} may be considered <during pregnancy><during {trimester} of pregnancy>, if necessary.
Danish: Hvis det er indiceret, kan anvendelse af {(Sær)navn} overvejes <under graviditeten><i graviditetens {antal.}
English: {Invented name} is not recommended <during pregnancy><during {trimester} of pregnancy> and in women of childbearing potential not using contraception.>
Danish: trimester> og til kvinder i den fertile alder, som ikke anvender sikker kontraception.>
English: <{Invented name}<is contraindicated during breast-feeding (see section 4.3)> [or] <should not be used during breast-feeding>.>
Danish: 4.3)> [eller] <må ikke anvendes under amning>.>
English: The marketing authorisation is valid for five years, after which it can be renewed.
Danish: Markedsføringstilladelsen er gyldig i fem år, hvorefter den kan fornyes.
English: This authorisation was based on the authorisation granted to Fosavance in 2005 (‘informed consent').
Danish: Markedsføringstilladelsen var baseret på den tilladelse, som blev udstedt for Fosavance i 2005 (‘informeret samtykke').
English: The European Commission granted a marketing authorisation valid throughout the European Union for Adrovance to Merck Sharp & Dohme Ltd. on 4 January 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Adrovance til Merck Sharp & Dohme Ltd. den 4. januar 2007.
English: The full EPAR for Adrovance can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Adrovance findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Adrovance.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Adrovance.
English: The recommended dose of Adrovance is one tablet once a week.
Danish: Den anbefalede dosis af Adrovance er én tablet én gang om ugen.
English: Blocking the action of these cells leads to less bone loss.
Danish: Blokeringen af disse cellers aktivitet bevirker et mindre tab af knoglemasse.
English: The tablet should be swallowed whole and not crushed, chewed or allowed to dissolve in the mouth.
Danish: Tabletten skal sluges hel og må ikke knuses, tygges eller opløses i munden.
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 Adrovance.
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 Adrovance.
English: Alendronic acid is a bisphosphonate that has been used in osteoporosis since the mid-1990s.
Danish: Alendronsyre er et bisphosphonat, som har været anvendt til behandling af osteoporose siden midten af 1990'erne.
English: The main measure of effectiveness was the reduction in the number of patients with low vitamin D levels after 15 weeks.
Danish: Virkningen blev hovedsagelig bedømt på reduktionen i antallet af patienter med lave D-vitaminniveauer efter 15 uger.
English: For more information about treatment with Adrovance, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Adrovance, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The patient must take the tablet with a full glass of water (but not mineral water), at least 30 minutes before any food, drink or other medicines (including antacids, calcium supplements and vitamins).
Danish: Patienten skal tage tabletten sammen med et helt glas vand (men ikke mineralvand) mindst 30 minutter før indtagelse af mad, drikke eller andre lægemidler (herunder antacider, calciumtilskud og vitaminer).
English: The CHMP decided that Adrovance's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Adrovance opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Other information about Adrovance
Danish: Andre oplysninger om Adrovance
English: Vitamin D3 is a nutrient that is found in some foods, but also made in the skin through exposure to natural sunlight.
Danish: D3-vitamin er et næringsstof, der findes i visse fødevarer, men som også dannes i huden, når den udsættes for almindeligt sollys.
English: The most common side effects with Adrovance are headache, abdominal pain (stomach ache), dyspepsia (heartburn), constipation, diarrhoea, flatulence (gas), oesophageal (gullet) ulcers, dysphagia (difficulty swallowing), abdominal distension (swollen tummy), acid regurgitation and musculoskeletal pain (pain in the muscles, bones and joints).
Danish: De hyppigste bivirkninger ved Adrovance er hovedpine, mavesmerter, dyspepsi (halsbrand), forstoppelse, diarré, flatulens (luft i maven), øsofagus-ulcus (sår i spiserøret), dysfagi (synkebesvær), udspilet mave og syreregurgitation (sure opstød) og muskel-, knogle- og ledsmerter.
English: To avoid irritation of the oesophagus (gullet), the patient should not lie down until after their first food of the day, which should be at least 30 minutes after taking the tablet.
Danish: For at undgå irritation af spiserøret (øsofagus) bør patienten undgå at ligge ned inden dagens første måltid, som skal indtages mindst 30 minutter efter tabletten.
English: Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.
Danish: Osteoporose er mest almindeligt hos kvinder efter overgangsalderen, hvor niveauet af det kvindelige kønshormon østrogen falder, idet østrogen er med til at holde knoglerne sunde.
English: Since patients with osteoporosis may not get enough vitamin D3 through exposure to sunlight, it is included in Adrovance.
Danish: Da patienter med osteoporose muligvis ikke får tilstrækkeligt med D3-vitamin via eksponering for sollys, indeholder Adrovance dette vitamin.
English: Adrovance reduces the risk of broken bones in the spine and the hip.
Danish: Adrovance mindsker risikoen for knoglebrud i rygsøjlen og hoften.
English: It must not be used in patients who have abnormalities of the oesophagus, who have hypocalcaemia (low calcium levels), or who cannot stand or sit upright for at least 30 minutes.
Danish: Det må ikke anvendes til patienter med abnormiteter i spiserøret (øsofagus), patienter med hypocalcæmi (lavt calciumniveau) eller patienter, som ikke kan stå eller sidde op i mindst 30 minutter.
English: The information presented by the company from earlier studies and the published literature showed that the dose of alendronic acid included in Adrovance was the same as the dose needed to prevent bone loss.
Danish: De oplysninger, som virksomheden fremlagde fra tidligere undersøgelser og fra den offentliggjorte faglitteratur, viste, at dosis af alendronsyre i Adrovance svarede til den dosis, der krævedes for at forebygge tab af knoglemasse.
English: Because alendronic acid and vitamin D3 are already used separately in authorised medicines in the European Union (EU), the company presented data obtained in earlier studies and from the published literature from women who had been through the menopause and who were taking alendronic acid and vitamin D as separate tablets.
Danish: Da alendronsyre og D3-vitamin allerede anvendes særskilt i godkendte lægemidler i EU, fremlagde virksomheden data, som var indsamlet i tidligere undersøgelser, og data fra den offentliggjorte faglitteratur om kvinder, som havde været gennem overgangsalderen og tog alendronsyre og Dvitamin som separate tabletter.
English: It slows the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Danish: Det nedsætter virkningen af osteoklasterne, som er de celler, der medvirker til at nedbryde knoglevævet.
English: Vitamin D3, along with other forms of vitamin D, is required for calcium absorption and normal bone formation.
Danish: Foruden andre former for D-vitamin er D3-vitamin nødvendig for optagelse af calcium og normal knogledannelse.
English: The additional studies showed that including vitamin D3 in the same tablet with alendronic acid could increase vitamin D levels.
Danish: De supplerende undersøgelser viste, at medtagelse af D3-vitamin i samme tablet, som indeholdt alendronsyre, kunne øge D-vitamenniveauerne.
English: Adrovance (containing either 2,800 or 5,600 IU colecalciferol) is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of low vitamin D levels.
Danish: Adrovance (indeholder enten 2 800 eller 5 600 IE colecalciferol) anvendes til behandling af osteoporose (en sygdom, som gør knoglerne skrøbelige) hos kvinder efter overgangsalderen, som har risiko for lave D-vitaminniveauer.
English: For the full list of all side effects reported with Adrovance, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Adrovance fremgår af indlægssedlen.
English: Adrovance should not be used in people who may be hypersensitive (allergic) to alendronic acid, vitamin D3 or any of the other ingredients.
Danish: Adrovance må ikke anvendes til personer, som kan være overfølsomme (allergiske) over for alendronsyre, D3-vitamin eller nogen af indholdsstofferne.
English: To support the combination of alendronic acid and vitamin D3 in the same tablet, the company also carried out a study in 717 patients with osteoporosis, including 682 women who had been through the menopause, to show Adrovance's ability to increase vitamin D levels.
Danish: Til understøttelse af kombinationen af alendronsyre og D3-vitamin i samme tablet gennemførte virksomheden ligeledes en undersøgelse af 717 patienter med osteoporose, herunder 682 kvinder efter overgangsalderen, for at påvise, at Adrovance er i stand til øge D-vitamin-niveauerne.
English: It is available as white tablets (capsule-shaped: 70 mg alendronic acid and 2,800 international units [IU] colecalciferol; rectangular: 70 mg alendronic acid and 5,600 IU colecalciferol).
Danish: Det fås som hvide tabletter (kapselformede: 70 mg alendronsyre og 2 800 internationale enheder [IE] colecalciferol, rektangulære: 70 mg alendronsyre og 5 600 IE colecalciferol).
English: Adrovance 70 mg/5,600 IU is for use in patients who are not taking vitamin D supplements.
Danish: Adrovance 70 mg/5 600 IE anvendes til patienter, som ikke tager Dvitamin-tilskud.
English: Adrovance alendronic acid / colecalciferol
Danish: Adrovance alendronsyre og colecalciferol
English: This study was extended in 652 patients for a further 24 weeks to compare the effects on continuing with Adrovance 70 mg/2,800 IU on its own or adding another 2,800 IU vitamin D3 (equivalent to using Adrovance 70 mg/5,600 IU).
Danish: Denne undersøgelse blev udvidet til at omfatte 652 patienter i yderligere 24 uger med henblik på at sammenligne virkningerne af at fortsætte med Adrovance 70 mg/2 800 IE alene eller ved tilføjelse af 2 800 IE D3-vitamin (svarende til at anvende Adrovance 70 mg/5 600 IE).
English: What is the risk associated with Adrovance?
Danish: Hvilken risiko er der forbundet med Adrovance?
English: After 15 weeks, fewer patients had low vitamin D levels when they took Adrovance 70 mg/2,800 IU (11%) than when they took alendronic acid only (32%).
Danish: Efter 15 uger havde færre patienter lave Dvitaminniveauer, når de fik Adrovance 70 mg/2 800 IE (11 %), end når de kun fik alendronsyre (32 %).
English: In the extension study, similar numbers of patients taking Adrovance 70 mg/2,800 IU and Adrovance 70 mg/5,600 IU had low vitamin D levels (below 6%), but the patients taking Adrovance 70 mg/5,600 IU had greater increases in vitamin D levels over the 24 weeks of the study.
Danish: I den udvidede undersøgelse havde et tilsvarende antal patienter, som tog Adrovance 70 mg/2 800 IE og Adrovance 70 mg/5 600 IE, lave D-vitamin-niveauer (under 6 %), men de patienter, der tog Adrovance 70 mg/5 600 IE, havde en større stigning i D-vitamin-niveauerne i løbet af de 24 uger, undersøgelsen varede.
English: What is Adrovance?
Danish: Hvad er Adrovance?
English: Patients received either Adrovance 70 mg/2,800 IU or alendronic acid only once a week.
Danish: Patienterne fik enten Adrovance 70 mg/2 800 IE eller alendronsyre én gang om ugen.
English: Why has Adrovance been approved?
Danish: Hvorfor blev Adrovance godkendt?
English: Adrovance contains two active substances: alendronic acid and colecalciferol (vitamin D3).
Danish: Adrovance indeholder to aktive stoffer: alendronsyre og colecalciferol (D3-vitamin).
English: Adrovance is a medicine that contains two active substances: alendronic acid and colecalciferol (vitamin D3).
Danish: Adrovance er et lægemiddel, der indeholder to aktive stoffer: alendronsyre og colecalciferol (D3vitamin).
English: What benefit has Adrovance shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Adrovance?
English: What is Adrovance used for?
Danish: Hvad anvendes Adrovance til?
English: How has Adrovance been studied?
Danish: Hvordan blev Adrovance undersøgt?
English: Patients should also take calcium supplements if they are not getting enough calcium from their diet. For more information, see the package leaflet.
Danish: Patienter, der ikke får tilstrækkeligt calcium via kosten, bør også tage calciumtilskud.
English: How is Adrovance used?
Danish: Hvordan anvendes Adrovance?
English: How does Adrovance work?
Danish: Hvordan virker Adrovance?
English: The steady state appeared to be reached by 6 weeks.
Danish: Steady state blev tilsyneladende nået efter 6 uger.
English: Let the alcohol air dry completely.
Danish: Lad alkoholen lufttørre fuldstændigt.
English: These will be monitored by your doctor.
Danish: Disse ændringer vil blive overvåget af Deres læge.
English: • tuberculosis or you have been in close contact with someone who has had tuberculosis;
Danish: • tuberkulose, eller hvis De har været i nærkontakt med en person, som har haft tuberkulose;
English: Most ISRs lasted for one to two days.
Danish: De fleste ISR'er varede i en eller to dage.
English: It may take up to 30 seconds to inject the entire dose.
Danish: Det kan tage op til 30 sekunder at injicere hele dosen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/582/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/09/582/001
English: Combinations not recommended
Danish: Ikke anbefalede kombinationer
English: T1/2 terminal (day)
Danish: T1/2 terminal (dag)
English: The next dose should be injected at the next regularly scheduled time.
Danish: Den næste dosis bør injiceres på det næste regelmæssigt skemalagte tidspunkt.