FrancophonIA/ELRC3.0 huggingface dataset:
English: OUTER CARTON, MULTIPACK OF 3 X (4 SINGLE-DOSE KITS) - INCLUDING THE BLUE BOX
Danish: Ydre karton, multipakning med 3 x (4 enkeltdosissæt) - inklusive blå box
English: This medicine is available in a pack size of 4 single-dose pre-filled pens (BCise) and a multipack containing 12 (3 packs of 4) single-dose pre-filled pens (BCise).
Danish: Dette lægemiddel fås i pakningsstørrelser med 4 fyldte penne med enkeltdosis (BCise) og en multipakning indeholdende 12 (3 pakninger a 4) fyldte penne med enkeltdosis (BCise).
English: Tabulated list of adverse reactions
Danish: Liste af bivirkninger i tabelform
English: Change from baseline (± SE) Mean difference in change from baseline between treatments (95% CI)
Danish: Ændring fra baseline (± SE) Gennemsnitlig forskel i ændring fra baseline mellem behandlingerne (95 % CI)
English: Table 8: Results of one 28-week study of prolonged-release exenatide versus placebo in combination with insulin glargine alone or with metformin (intent to treat patients)
Danish: Tabel 8: Resultat af et 28-ugers studie af exenatid depotformulering versus placebo i kombination med insulin glargin alene eller med metformin (intent-to-treat-patienter)
English: With your thumb, push down the plunger until it stops and hold your thumb in place.
Danish: Brug tommelfingeren til at trykke stemplet ned, indtil det standser.
English: Table 5: Results of one 26-week study of prolonged-release exenatide versus insulin glargine in combination with metformin alone or metformin and sulphonylurea (intent to treat patients)
Danish: Tabel 5: Resultatet af et 26-ugers studie af exenatid depotformulering versus insulin glargin i kombination med metformin alene eller metformin og sulfonylurinstof (intent to treat-patienter)
English: Do not over tighten.
Danish: Pas på ikke at stramme for meget.
English: Do not throw the container in your household waste.
Danish: Beholderen må ikke smides i skraldespanden.
English: Immediate-release exenatide 10 mcg BID
Danish: Exenatid opløsning til injektion 10 mikrog BID
English: After suspension, the mixture should only be used if it is white to off white and cloudy.
Danish: Efter suspension må blandingen kun bruges, hvis den er hvid til offwhite og uklar.
English: In your other hand, hold the vial.
Danish: Hold på kanylehætten med den anden hånd.
English: Tap!
Danish: Bank!
English: Adjusted least squares means (LS Means) and treatment group difference(s) in the change from baseline values at Week 28 are modelled using a mixed model with repeated measures (MMRM) including treatment, region, baseline HbA1c stratum (< 9.0% or ≥ 9.0%), week, and treatment by week interaction as fixed factors, and baseline value as a covariate.
Danish: Justeret mindste kvadraters metode (LA Means) og behandlingsgruppers forskel(le) i ændringer fra baselineværdier ved uge 28 er fastsat ved anvendelse af blandet model med gentagne målinger (MMRM), inklusive behandling, region, baseline HbA1c strata (<0,9 % eller ≥9,0 %), uge og behandling per ugentlig interaktion som faste faktorer samt baselineværdi som kovariat.
English: After mixing, use the suspension only if the mixture is white to off white and cloudy.
Danish: Efter opblanding må suspensionen kun bruges, hvis blandingen er hvid til offwhite og uklar.
English: Table 5: Results of one 28-week study of prolonged-release exenatide and dapagliflozin versus prolonged-release exenatide alone and dapagliflozin alone, in combination with metformin (intent to treat patients)
Danish: Tabel 5: Resultater af et 28-ugers studie med depotformulering af exenatid og dapagliflozin versus depotformulering af exenatid alene og dapagliflozin alene, i kombination med metformin (intent to treat-patienter)
English: Patients (%) achieving HbA1c ≤ 7% Change in fasting plasma glucose (mmol/l) (± SE) Mean body weight (kg)
Danish: Patienter (%), der opnåede HbA1c ≤ 7 % Ændring i fastende plasmaglucose (mmol/l) (± SE) Gennemsnitlig kropsvægt (kg)
English: You should inject this medicine immediately after mixing the suspension.
Danish: Du skal indsprøjte medicinen straks efter at du har blandet den.
English: Table 6: Results of one 28-week study of prolonged-release exenatide versus placebo in combination with insulin glargine alone or with metformin (intent to treat patients)
Danish: Tabel 6: Resultater af et 28-ugers studie med depotformulering af exenatid versus placebo i kombination med insulin glargin alene eller sammen med metformin (intent to treat-patienter)
English: INNER CARTON, MULTIPACK OF 3 X (4 SINGLE-DOSE KITS) - WITH NO BLUE BOX
Danish: INDRE KARTON, multipakning med 3 x (4 enkeltdosissæt) - uden blå boks
English: Prolonged-release exenatide demonstrated superiority to placebo in reducing HbA1c from baseline to Week 28 (Table 6).
Danish: Depotformulering af exenatid viste sig at være bedre end placebo til at reducere HbA1c fra baseline til uge 28 (tabel 6).
English: Change from baseline (± SE) Mean difference in change from baseline versus sitagliptin (95% CI) Mean difference in change from baseline versus placebo (95% CI) Patients (%) achieving HbA1c < 7% Mean body weight (kg)
Danish: Ændring fra baseline (± SE) Gennemsnitlig ændring fra baseline versus exenatid opløsning til injektion (95 % CI) Patienter (%), der opnåede HbA1c < 7 % Gennemsnitlig legemsvægt (kg) Baseline
English: Orange connector
Danish: Orange forbindingsled
English: Each pre-filled pen contains 2 mg of exenatide.
Danish: Hver fyldt pen indeholder 2 mg exenatid.
English: Table 3: Results of one 26-week study of prolonged-release exenatide versus insulin glargine in combination with metformin alone or metformin and sulphonylurea (intent to treat patients)
Danish: Tabel 3: Resultater af et 26-ugers studie med depotformulering af exenatid versus insulin glargin i kombination med metformin alene eller metformin og sulfonylurinstof (intent to treatpatienter)
English: Remember, before preparing your dose, leave the pen out of the refrigerator for at least 15 minutes.
Danish: Husk, at pennen skal være ude af køleskabet i mindst 15 minutter, inden du blander din dosis.
English: What is in this leaflet
Danish: Se din pen her
English: Mean difference change from baseline between treatments (95% CI) versus sitagliptin
Danish: Gennemsnitlig ændring fra baseline mellem behandlinger (95 % CI) versus sitagliptin
English: Table 7: Results of one 28-week study of prolonged-release exenatide and dapagliflozin versus prolonged-release exenatide alone and dapagliflozin alone, in combination with metformin (intent to treat patients)
Danish: Tabel 7: Resultat af et 28-ugers studie af exenatid depotformulering og dapagliflozin versus exenatid depotformulering alene og dapagliflozin alene, i kombination med metformin (intent-totreat-patienter)
English: Stroke
Danish: Håndtag
English: OUTER CARTON MULTIPACK OF 3 X (4 SINGLE-DOSE PRE-FILLED PENS) - INCLUDING THE BLUE BOX
Danish: Ydre karton multipakning med 3 x (4 fyldte penne med enkeltdosis) - inklusive blå box
English: INNER CARTON MULTIPACK OF 3 X (4 SINGLE-DOSE PRE-FILLED PENS) - WITH NO BLUE BOX
Danish: INDRE KARTON multipakning med 3 x (4 fyldte penne med enkeltdosis) - uden blå boks
English: Bydureon 2 mg prolonged-release suspension for injection in pre-filled pen exenatide
Danish: Bydureon 2 mg depotinjektionsvæske, suspension i fyldt pen exenatid
English: Bydureon 2 mg powder and solvent for prolonged-release suspension for injection
Danish: Bydureon 2 mg pulver og solvens til depotinjektionsvæske, suspension
English: Put the vial down.
Danish: Bræk hætten af.
English: This medicine is available in pack of 4 single-dose pre-filled pens, and a multipack containing 12 (3 packs of 4) single-dose pre-filled pens.
Danish: Dette lægemiddel fås i pakningsstørrelser med 4 fyldte penne med enkeltdosis og en multipakning med 12 (3 pakninger a 4) fyldte penne med enkeltdosis.
English: CARTON - 4 SINGLE-DOSE KITS
Danish: Karton med 4 enkeltdosissæt
English: The pre-filled pen may be kept for up to 4 weeks below 30ºC prior to use.
Danish: Den fyldte pen kan opbevares i op til 4 uger under 30 ºC før brug.
English: Mean change from baseline in 2-hour postprandial plasma glucose (mmol/l) (SE)
Danish: Gennemsnitlig ændring fra baseline i 2-timers postprandial plasmaglucose (mmol/l) (SE)
English: Exenatide slows gastric emptying, thereby reducing the rate at which meal-derived glucose appears in the circulation.
Danish: Exenatid forsinker ventrikeltømningen og medfører dermed, at glucose fra et måltid optræder senere i kredsløbet end normalt.
English: Clinical studies with prolonged-release exenatide have indicated improved beta-cell function, using measures such as the homeostasis model assessments (HOMA-B).
Danish: Ved brug af Homeostasis Model Assessment (HOMA-B) tyder kliniske studier på, at depotformulering af exenatid forbedrer betacelle-funktionen.
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or diabetes nurse.
Danish: Hvis du vil vide mere om Bydureon BCise pen • Spørg din læge, på apoteket eller diabetessygeplejersken
English: Decreased appetite
Danish: Nedsat appetit Dehydrering
English: Solvent carmellose sodium sodium chloride polysorbate 20 sodium dihydrogen phosphate monohydrate disodium phosphate heptahydrate water for injections sodium hydroxide (for pH adjustment)
Danish: Solvens carmellosenatrium natriumchlorid polysorbat 20 natriumdihydrogenphosphat, monohydrat dinatriumphosphat, heptahydrat vand til injektionsvæsker natriumhydroxid (til pH-justering)
English: Bydureon 2 mg powder and solvent for prolonged-release suspension for injection exenatide
Danish: Bydureon 2 mg pulver og solvens til depotinjektionsvæske, suspension exenatid
English: Mean difference in change from baseline between treatments (95% CI)
Danish: Gennemsnitlig forskel i ændring fra baseline mellem behandlingerne (95 % CI)
English: • injection site itchiness or redness
Danish: • kløe eller rødme på indstiksstedet
English: Bydureon 2 mg prolonged-release suspension for injection exenatide
Danish: Bydureon 2 mg depotinjektionsvæske, suspension exenatid s.c.
English: Top of plunger
Danish: Stemplets top
English: SE = standard error, CI = confidence interval, * p < 0.05
Danish: SE = standardafvigelse, CI = konfidensinterval, * p < 0,05
English: In either your stomach, thigh, or back of the upper arm, see Figure D. Each week you can use the same area of your body, but choose a different injection site in that area of your body.
Danish: I maven, låret eller bagsiden af overarmen, se Figur D.
English: Then remove the pen and needle.
Danish: Tag derefter pen og kanyle ud.
English: Rapid weight loss
Danish: Nedsat nyrefunktion
English: Bydureon 2 mg powder and solvent for prolonged-release suspension for injection in pre-filled pen exenatide
Danish: Bydureon 2 mg pulver og solvens til depotinjektionsvæske, suspension i fyldt pen exenatid
English: Sulphonylureas
Danish: Sulfonylurinstof
English: Mean difference in change from baseline versus immediate-release exenatide (95 %
Danish: Ændring fra baseline (±SE) Gennemsnitlig ændring fra baseline versus exenatid opløsning til injektion (95 % CI)
English: Pack size of 4 single-dose pre-filled pens (BCise) and a multipack containing 12 (3 packs of 4) single-dose pre-filled pens (BCise).
Danish: Pakningsstørrelse på 4 fyldte penne med enkeltdosis (BCise) og en multipakning indeholdende 12 (3 pakninger a 4) fyldte penne med enkeltdosis (BCise).
English: Solvent: carmellose sodium sodium chloride polysorbate 20 sodium dihydrogen phosphate monohydrate disodium phosphate heptahydrate water for injections sodium hydroxide
Danish: Solvens: carmellosenatrium natriumchlorid polysorbat 20 natriumdihydrogenphosphat, monohydrat dinatriumphosphat, heptahydrat vand til injektionsvæsker natriumhydroxid
English: To inject your full dose, push down on the plunger with your thumb until it stops.
Danish: Tryk stemplet ind med tommelfingeren, indtil stemplet standser, for at indsprøjte hele din dosis.
English: Solvent: carmellose sodium sodium chloride polysorbate 20 sodium dihydrogen phosphate monohydrate disodium phosphate heptahydrate water for injections
Danish: Solvens: carmellosenatrium natriumchlorid polysorbat 20 natriumdihydrogenphosphat, monohydrat dinatriumphosphat, heptahydrat vand til injektionsvæsker
English: Bydureon 2 mg powder and solvent for prolonged-release suspension for injection in pre-filled pen
Danish: Bydureon 2 mg pulver og solvens til depotinjektionsvæske, suspension i fyldt pen
English: The pen may be kept for up to 4 weeks below 30°C prior to use.
Danish: Pennen kan opbevares i op til 4 uger ved temperaturer under 30 ºC før brug.
English: Each vial contains 2 mg of exenatide.
Danish: Hvert hætteglas indeholder 2 mg exenatid.
English: For more information on injection techniques talk with your health care professional.
Danish: Tal med din læge eller sygeplejersken, hvis du har brug for mere information om indsprøjtningsteknikkerne.
English: Orange Rod
Danish: Orange stempel
English: Solvent carmellose sodium sodium chloride polysorbate 20 sodium dihydrogen phosphate monohydrate disodium phosphate heptahydrate water for injections
Danish: Solvens carmellosenatrium natriumchlorid polysorbat 20 natriumdihydrogenphosphat, monohydrat dinatriumphosphatheptahydrat vand til injektionsvæsker
English: Blue cap Needle Needle Cover
Danish: Blå hætte Kanyle Kanylehætte
English: Hold upright & firmly unscrew
Danish: Hold lodret og åbn med fast greb
English: Getting Started
Danish: Kom godt i gang
English: Mean change from baseline in fasting plasma glucose (mmol/l) (±SE)
Danish: Gennemsnitlig ændring fra baseline i fastende plasmaglucose (mmol/l) (± SE)
English: Mean change from baseline in fasting plasma glucose (mmol/l) (± SE)
Danish: Gennemsnitlig ændring fra baseline i fastende plasmaglucose (mmol/l) (±SE)
English: After removing the connector be careful not to push in the plunger.
Danish: Vær forsigtig med ikke at presse stemplet ned.
English: While twisting, be sure to hold the orange connector.
Danish: Sørg for at holde på det orange forbindingsled, mens du drejer.
English: Pack size of 4 single-dose kits and a multipack consisting of 12 (3 packs of 4) single-dose kits.
Danish: Produktet fås i pakningsstørrelser med 4 enkeltdosissæt og en multipakning indeholdende 12 (3 pakker a 4) enkeltdosissæt.
English: Gastrointestinal disorders Intestinal obstruction Acute pancreatitis (see section 4.4)
Danish: Mave-tarm-kanalen Tarmobstruktion Akut pancreatitis (se pkt.
English: Mean difference change from baseline between treatments (95% CI)
Danish: Gennemsnitlig ændring fra baseline mellem behandlingerne (95 % CI)
English: Syringe
Danish: Lår
English: The kit may be kept for up to 4 weeks below 30°C prior to use.
Danish: Sættet kan opbevares i op til 4 uger ved temperaturer under 30 ºC før brug.
English: SE = standard error, CI = confidence interval, * p < 0.05, **p < 0.0001
Danish: SE = standardafvigelse, CI= konfidensinterval, * p < 0,05, **p < 0,0001
English: Bydureon 2 mg prolonged-release suspension for injection in pre-filled pen.
Danish: Bydureon 2 mg depotinjektionsvæske, suspension i fyldt pen
English: Lock
Danish: Låst
English: Eructation
Danish: Obstipation
English: - In the solvent: carmellose sodium, sodium chloride, polysorbate 20, sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate, water for injection and sodium hydroxide (for pH adjustment).
Danish: natriumdihydrogenphosphat monohydrat, dinatriumphosphat-heptahydrat, vand til injektionsvæsker og natriumhydroxid (til justering af pH-værdien (surhed)).
English: To prevent losing medicine, do not push in the plunger while attaching the needle.
Danish: Tryk ikke på stemplet, når du sætter kanylen på, da du kan spilde noget af medicinen.
English: The patient should be instructed to discard the syringe safely, with the needle still attached after each injection.
Danish: Patienten skal informeres om at bortskaffe sprøjten på forsvarlig vis og uden, at kanylen er fjernet (kanylen skal blive siddende efter injektion).
English: Unless a trained person can help to inject this medicine it is not recommended for people who are blind or cannot see well.
Danish: Patienter, der er blinde eller har nedsat syn, anbefales kun at bruge pennen, hvis en trænet person kan hjælpe med at indsprøjte medicinen.
English: To reduce the risk of hypoglycaemia associated with the use of a sulphonylurea, reduction in the dose of sulphonylurea may be considered (see sections 4.2 and 4.4).
Danish: Nedsættelse af dosis af sulfonylurea bør overvejes for at reducere risikoen for hypoglykæmi i forbindelse med anvendelsen af et sulfonylurea (se pkt.
English: Patients (%) achieving HbA1c < 7% Change in fasting plasma glucose (mmol/l) (± SE) Mean body weight (kg)
Danish: Patienter (%), der opnåede HbA1c < 7 % 58 Ændring i fastende plasmaglucose (mmol/l) (± SE)
English: PEN GRIP LABEL
Danish: FYLDT PEN ETIKET
English: If you feel you should stop using this medicine, please consult your doctor first.
Danish: Spørg først din læge til råds, hvis du mener, at du bør holde op med at bruge dette lægemiddel.
English: 4 single-dose pre-filled pens.
Danish: 4 fyldte penne med enkeltdosis.
English: − other medicines that are used to treat type 2 diabetes such as medicines that work like Bydureon (for example: liraglutide or other exenatide containing products), as taking these medicines with Bydureon is not recommended.
Danish: Brug af anden medicin sammen med Bydureon Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig, især: - anden medicin mod type 2-diabetes, såsom medicin, der virker ligesom Bydureon (f.eks. liraglutid eller andre produkter, der indeholder exenatid), da det frarådes at tage disse lægemidler sammen med Bydureon.
English: Even mix
Danish: Ikke blandet
English: Knob
Danish: Stempel
English: If you use more Bydureon than you should
Danish: Hvis du har brugt for meget Bydureon
English: by pulling straight off. DO NOT twist.
Danish: ved at hive den lige af.
English: However, the clinical relevance is unknown.
Danish: Den kliniske relevans er imidlertid ukendt.
English: In 6 cases the treatment was ineffective.
Danish: I 6 tilfælde var behandlingen uden virkning.
English: In 8 cases full remission was achieved and in 3 cases the frequency and intensity of the attacks were significantly reduced.
Danish: I otte tilfælde opnåedes fuldstændig remission, og i tre tilfælde blev anfaldenes hyppighed og intensitet væsentligt reduceret.
English: The seriousness of such adverse effects and their possible fatal outcome is underlined.
Danish: Alvorligheden af sådanne bivirkninger og deres potentielle fatale udfald understreges,
English: Overall summary of the scientific evaluation of nicergoline containing medicinal products (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af lægemidler, der indeholder nicergolin (se bilag I)
English: Insufficient information was reported in five cases precluding any meaningful assessment.
Danish: I fem tilfælde var der givet utilstrækkelige oplysninger, hvilket udelukkede en meningsfuld vurdering.
English: On admission to the study, patients were suffering from 1-3 attacks per week.
Danish: Ved inkluderingen i undersøgelsen havde patienterne 1-3 anfald ugentligt.
English: A complete relief of migraine attacks was achieved in 45% of patients, while a reduction of migraine attacks by at least 50% occurred in 18% patients.
Danish: Der opnåedes fuldstændig lindring af migræneanfald hos 45 % af patienterne og mindst 50 % reduktion af migræneanfald hos 18 % af patienterne.
English: Four cases of fibrotic events were excluded from the analysis.
Danish: Fire tilfælde af fibrotiske hændelser blev udelukket fra analysen.
English: Patients were given 10 mg of nicergoline three times daily for the first 10 days followed by 5 mg three times daily for 3-5 weeks.
Danish: Patienterne fik 10 mg nicergolin tre gange dagligt de første ti dage, efterfulgt af 5 mg tre gange dagligt i 3-5 uger.
English: When documented, the reactions occurred with recommended daily dose.
Danish: I de tilfælde hvor dosis var oplyst, fandt reaktionerne sted ved den anbefalede daglige dosis.
English: • Fibrosis is also a slow and insidious reaction that occurs after a long period of treatment and with delayed diagnosis
Danish: • fibrose desuden er en langsom og snigende reaktion, der opstår efter lang tids behandling og diagnosticeres med forsinkelse.
English: Therefore, none of the studies can be considered as conclusively supporting the evidence of efficacy in the indications under assessment.
Danish: Ingen af disse undersøgelser kan derfor anses for konklusivt at underbygge virkningen ved de vurderede indikationer.
English: Indeed, this publication described the metaanalysis of 13 double-blind, placebo-controlled, randomised studies performed by the Cochrane Collaboration in 2001.
Danish: Denne publikation beskrev således en metaanalyse af 13 dobbeltblindede, placebokontrollerede, randomiserede undersøgelser, der blev udført af Cochrane Collaboration i 2001.
English: Most of the studies that became available after the granting of the initial marketing authorisation were very old and of poor methodological quality, notably non-randomised and with a low number of patients.
Danish: Størstedelen af de undersøgelser, der blev til rådighed efter udstedelse af den oprindelige markedsføringstilladelse, var meget gamle og af ringe metodemæssig kvalitet; de var således ikke randomiserede og omfattede kun et lille antal patienter.
English: In these cases, the event occurred after 5 months to 30 years of nicergoline treatment and in patients aged between 59 and 90 years.
Danish: I disse tilfælde indtraf hændelsen efter mellem 5 måneders og 30 års behandling med nicergolin og hos patienter mellem 59 og 90 år.
English: As a result, the reliability and the clinical relevance of the studies is questionable.
Danish: Disse undersøgelsers pålidelighed og kliniske relevans er derfor tvivlsom.
English: A total of 30 cases related to fibrotic events have been reported.
Danish: Der er i alt beskrevet 30 tilfælde vedrørende fibrotiske hændelser.
English: Results show statistically significant difference between nicergoline and placebo in favour of nicergoline.
Danish: Resultaterne viser statistisk signifikant forskel mellem nicergolin og placebo til fordel for nicergolin.
English: Nevertheless, the MAH also provided an analysis regarding all spontaneous reports for the last 40 years (n=390, including 205 medically-confirmed cases).
Danish: Indehaveren af markedsføringstilladelsen fremlagde alligevel også en analyse vedrørende alle spontane indberetninger fra de seneste 40 år (n=390, herunder 205 lægeligt bekræftede tilfælde).
English: Taking into account the limited information presented from these studies (only summary of these studies were provided), the unclear inclusion/exclusion criteria and statistical analyses employed, no conclusion can be drawn from the data provided.
Danish: På baggrund af de begrænsede oplysninger fra disse undersøgelser (der blev kun forelagt sammenfatninger af undersøgelserne) og uklarheden om de anvendte inklusions- og eksklusionskriterier og statistiske analyser kan der ikke drages nogen konklusion af de fremlagte data.
English: In order to lift the suspension, MAHs must identify a specific patient population for which the benefits of the product outweigh the risk.
Danish: For at ophæve suspenderingen skal indehaverne af markedsføringstilladelse udpege en konkret patientpopulation, for hvilken fordelene ved produktet er større end risikoen.
English: Therefore, the CHMP was of the opinion that it is not possible to rule out the possibility that these actually correspond to the development of ergotism.
Danish: CHMP var derfor af den opfattelse, at det ikke kan udelukkes, at disse faktisk svarer til udvikling af ergotisme.
English: Therefore, in accordance with Article 116 of Directive 2001/83/EC, the CHMP recommends:
Danish: anbefaler CHMP derfor i overensstemmelse med artikel 116 i direktiv 2001/83/EF: