FrancophonIA/ELRC3.0 huggingface dataset:
English: They also tested the safety of three standard production batches of Nobilis Influenza H5N6.
Danish: Desuden har firmaet undersøgt sikkerheden ved tre standardproducerede batcher af Nobilis Influenza H5N6.
English: Nobilis Influenza H5N6 is a vaccine.
Danish: Nobilis Influenza H5N6 er en vaccine.
English: This strain has been chosen because it protects birds against virulent H5N1 field strains (cross-protection), while allowing differentiation of vaccinated from infected birds.
Danish: Den pågældende virusstamme er valgt, fordi den beskytter fuglene mod de sygdomsfremkaldende H5N1-feltstammer (krydsbeskyttelse).
English: This vaccine has some of the same ingredients but different antigens (viruses), two of which are produced using the same process to that used for the avian influenza antigen of Nobilis Influenza.
Danish: To af disse antigener fremstilles ved samme proces som den, der anvendes til fugleinfluenzaantigenet i Nobilis Influenza.
English: Other information about Nobilis Influenza H5N6:
Danish: Andre oplysninger om Nobilis Influenza H5N6:
English: What is the risk associated with Nobilis Influenza H5N6?
Danish: Hvilken risiko er der forbundet med Nobilis Influenza H5N6?
English: Why has Nobilis Influenza H5N6 been approved?
Danish: Hvorfor blev Nobilis Influenza H5N6 godkendt?
English: What is Nobilis Influenza H5N6?
Danish: Hvad er Nobilis Influenza H5N6?
English: How has Nobilis Influenza H5N6 been studied?
Danish: Hvordan blev Nobilis Influenza H5N6 undersøgt?
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) NOBILIS INFLUENZA H5N6 EPAR - sammendrag for offentligheden
English: How does Nobilis Influenza H5N6 work?
Danish: Hvordan virker Nobilis Influenza H5N6?
English: What benefit has Nobilis Influenza H5N6 shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Nobilis Influenza H5N6?
English: What is Nobilis Influenza H5N6 used for?
Danish: Hvad anvendes Nobilis Influenza H5N6 til?
English: Following administration of an oral [
Danish: Efter administration af en oral dosis [
English: Thereafter, eGFR was maintained during continued treatment.
Danish: Derefter blev eGFR opretholdt under vedvarende behandling.
English: It is unknown if this medicine is harmful to the unborn child.
Danish: Det er ukendt om dette lægemiddel er skadeligt for det ufødte barn.
English: It is unknown whether this constitutes a class effect.
Danish: Det er uvist, om der er tale om en klasseeffekt.
English: Metformin may act via 3 mechanisms:
Danish: Metformin kan virke via 3 mekanismer:
English: However, animal studies have shown adverse effects on postnatal development.
Danish: Dyrestudier har imidlertid påvist negative virkninger på den postnatale udvikling.
English: What is type 2 diabetes?
Danish: Hvad er type 2-sukkersyge?
English: Copovidone (K-value nominally 28)
Danish: Copovidon (nominel K-værdi 28)
English: This medicine can also help prevent heart disease.
Danish: Dette lægemiddel kan også hjælpe med at forhindre hjertesygdom.
English: These changes were not considered to be clinically meaningful.
Danish: Disse ændringer blev ikke betragtet som klinisk betydende.
English: The mean volume of distribution (Vd) ranged between 63 - 276 l.
Danish: Det gennemsnitlige fordelingsvolumen (Vd) var 63-276 l.
English: The recommended dose is one tablet twice a day.
Danish: Den anbefalede dosis er én tablet to gange daglig.
English: • if you are 85 years old or older as you should not start taking Synjardy;
Danish: • hvis du er 85 år eller derover, bør du ikke begynde at tage Synjardy
English: • Swallow the tablet whole with water.
Danish: • Synk tabletterne hele sammen med vand.
English: The reduction of cardiovascular death in these patients was consistent with the overall study population.
Danish: Reduktion i kardiovaskulær død hos disse patienter var konsistent med den samlede studiepopulation.
English: Diet and exercise can help your body use its blood sugar better.
Danish: Diæt og motion kan hjælpe din krop med at udnytte blodsukkeret bedre.
English: Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above.
Danish: Din læge fortæller dig, hvordan du skal behandle et lavt blodsukker, og hvad du skal gøre, hvis du bemærker nogle af ovenstående tegn.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 May 2015
Danish: Dato for første markedsføringstilladelse: 27. maj 2015
English: There is no experience with doses above 800 mg in humans.
Danish: Der er ingen erfaring med doser på over 800 mg til mennesker.
English: If you note an increase in such symptoms, you should also contact your doctor.
Danish: Hvis du mærker tiltagende symptomer af denne slags, skal du også kontakte lægen.
English: In that case, the missed dose should be skipped.
Danish: I et sådant tilfælde skal den glemte dosis springes over.
English: The following statements reflect the information available on the individual active substances.
Danish: Teksten herunder afspejler den information, der er tilgængelig for de enkelte aktive stoffer.
English: Systemic exposure of empagliflozin increased in a dose-proportional manner.
Danish: Den systemiske eksponering for empagliflozin blev øget på en dosisproportional måde.
English: Do not take Synjardy if you are pregnant.
Danish: Tag ikke Synjardy, hvis du er gravid.
English: No interaction studies have been performed for Synjardy.
Danish: Der er ikke udført interaktionsstudier med Synjardy.
English: Thereafter, plasma concentrations declined in a biphasic manner with a rapid distribution phase and a relatively slow terminal phase.
Danish: Derefter faldt plasmakoncentrationerne på en bifasisk måde med en hurtig fordelingsfase og en relativt langsom terminalfase.
English: The dose should be adjusted to or maintained at a maximum daily dose of 10 mg.
Danish: Dosis bør justeres til eller bibeholdes på den maksimale daglige dosis på 10 mg.
English: The difference in frequency was less pronounced in male patients.
Danish: Forskellen i hyppighed var mindre udtalt hos mænd.
English: The safety and efficacy of Synjardy in children and adolescents aged 0 to 18 years has not been established.
Danish: Synjardys sikkerhed og virkning hos børn og unge i alderen 0 til 18 år er ikke klarlagt.
English: Improvement of surrogate markers of beta cell function including Homeostasis Model Assessment-β (HOMA-β) was noted.
Danish: Der blev set en forbedring i surrogatmarkører for beta-cellefunktionen, herunder Homeostasis Model Assessment-β (HOMA-β).
English: Both doses provided similar statistically significant reductions in body weight, expressed as kg and percentage change.
Danish: Begge doser udviste sammenlignelige statistisk signifikante reduktioner i kropsvægt, udtrykt som kg og procentvis ændring.
English: Figure 1 Time to occurrence of cardiovascular death in the EMPA-REG OUTCOME study
Danish: Figur 1 Tid til forekomst af kardiovaskulær død i EMPA-REG OUTCOME-studiet
English: • if you drink alcohol to excess, either every day or only from time to time (see section “Synjardy with alcohol”).
Danish: • hvis du drikker meget alkohol, enten hver dag eller kun fra tid til anden (se 'Synjardy sammen med alkohol')
English: During treatment with Synjardy, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Danish: Under behandlingen med Synjardy vil lægen kontrollere din nyrefunktion mindst en gang om året eller hyppigere, hvis du er ældre, og/eller hvis din nyrefunktion bliver dårligere.
English: • if you have “type 1 diabetes” - this type usually starts when you are young and your body does not produce any insulin;
Danish: • hvis du har “type 1-sukkersyge” - denne type starter som regel hos unge og her laver kroppen slet ikke noget insulin
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Danish: Efter en oral dosis var den ikke-absorberede del, der blev genfundet i fæces, 20-30 %.
English: • if you have problems with your liver;
Danish: • hvis du har problemer med leveren
English: Treatment with empagliflozin may be restarted when the ketone values are normal and the patient's condition has stabilised.
Danish: Behandlingen med empagliflozin kan genoptages, når ketonstofværdierne er normale, og patientens tilstand er stabiliseret.
English: • excessive hunger, headache
Danish: • Meget kraftig sult, hovedpine
English: • urine that appears cloudy
Danish: • Urinen ser uklar ud
English: • if you are allergic to empagliflozin, metformin or any of the other ingredients of this medicine (listed in section 6);
Danish: • hvis du er allergisk over for empagliflozin, metformin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6)
English: Blood sugar levels, which are too high because of your type 2 diabetes, are thereby reduced.
Danish: Blodsukkerniveauet, som er for højt på grund af din type 2-diabetes, sænkes herved.
English: 2 hour post-prandial glucose
Danish: Postprandial glucose efter 2 timer
English: At baseline, 74% of patients were being treated with metformin, 48% with insulin, and 43% with a sulfonylurea.
Danish: Ved baseline blev 74 % af patienterne behandlet med metformin, 48 % med insulin og 43 % med et sulfonylurinstof.
English: No metabolites have been identified in humans.
Danish: Der er ikke påvist nogen metabolitter hos mennesker.
English: Body Weight (kg) at week 52
Danish: Legemsvægt (kg) i uge 52
English: Film-coating Hypromellose Macrogol 400
Danish: Filmovertræk Hypromellose Macrogol 400
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVRING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: • decreased vitamin B12 levels in the blood
Danish: • Nedsat vitamin B12 i blodet
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), or very rare (<1/10,000), and not known (cannot be estimated from the available data).
Danish: Hyppigheden defineres på følgende måde: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment with such medicinal products.
Danish: Patienten bør informeres herom, og blodglucose bør kontrolleres hyppigere, især i starten af behandling med sådanne lægemidler.
English: • fainting or loss of consciousness
Danish: • Besvimelse eller bevidsthedstab
English: • if you have severely reduced kidney function;
Danish: • hvis du har alvorligt nedsat nyrefunktion
English: Like for all diabetic patients it is important to check your feet regularly and adhere to any other advice regarding foot care given by your health care professional.
Danish: Som det gælder for alle diabetespatienter, er det vigtigt, at du kontrollerer dine fødder regelmæssigt og følger alle råd vedrørende fodpleje, som du får af sundhedspersonalet.
English: After an oral dose of metformin, tmax is reached in 2.5 hours.
Danish: Efter en oral dosis metformin opnås tmax efter 2,5 timer.
English: A limited amount of data suggests that the use of metformin in pregnant women is not associated with an increased risk of congenital malformations.
Danish: Begrænsede data tyder på, at brug af metformin til gravide kvinder ikke er forbundet med en øget risiko for medfødte misdannelser.
English: Empagliflozin is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP).
Danish: Empagliflozin er et substrat for P-glykoprotein (P-gp) og for breast cancer resistance protein (BCRP).
English: Metformin increases the transport capacity of all types of membrane glucose transporters (GLUTs) known to date.
Danish: Metformin øger transportkapaciteten af alle hidtil kendte typer membranglucosetransportører (GLUT).
English: Both tumours are common in rats and are unlikely to be relevant to humans.
Danish: Begge tumorer er almindelige hos rotter, og det er ikke sandsynligt, at dette fund har betydning for mennesker.
English: The intensity of urinary tract infections (i.e. mild/moderate/severe) was similar to placebo.
Danish: Intensiteten af urinvejsinfektioner (dvs. mild/moderat/svær) var den samme som for placebo.
English: • Severe renal failure (GFR <30 ml/min).
Danish: • Svær nyreinsufficiens (GFR < 30 ml/min).
English: The frequency of reported nocturia was comparable between placebo and empagliflozin (<1%).
Danish: Hyppigheden af nocturi var sammenlignelig for placebo og empagliflozin (< 1 %).
English: Experience in New York Heart Association (NYHA) class I-II is limited, and there is no experience in clinical studies with empagliflozin in NYHA class III-IV.
Danish: Erfaringen med New York Heart Association (NYHA) klasse I-II patienter er begrænset, og der er ingen erfaringer fra kliniske studier med empagliflozin til NYHA klasse III-IV patienter.
English: Possible signs of losing too much fluid from your body are listed in section 4 ‘Possible side effects'.
Danish: Mulige tegn på for stort væsketab fra kroppen er anført i afsnit 4, “Bivirkninger”
English: Necrotising fasciitis of the perineum (Fournier´s gangrene)
Danish: Nekrotiserende fasciitis i perineum (Fourniers gangræn)
English: Treatment with empagliflozin provided reductions in seated SBP and DBP.
Danish: Behandling med empagliflozin medførte fald i siddende SBP og DBP.
English: The blood peak is lower than the plasma peak and appears at approximately the same time.
Danish: Maksimum for blod er lavere end maksimum for plasma og forekommer på ca. samme tid.
English: Type 2 diabetes is a disease that comes from both your genes and your lifestyle.
Danish: Type 2-sukkersyge er en sygdom, der skyldes både gener og livsstil.
English: If Fournier´s gangrene is suspected, Synjardy should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Danish: Hvis der er mistanke om Fourniers gangræn, bør Synjardy seponeres, og øjeblikkelig behandling (herunder antibiotika og kirurgisk debridement) bør iværksættes.
English: Temporary interruption of treatment should be considered in patients with complicated urinary tract infections.
Danish: Midlertidig afbrydelse af behandlingen skal overvejes hos patienter med komplicerede urinvejsinfektioner.
English: No Met mg mg
Danish: Ingen met mg mg
English: This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDL cholesterol and triglyceride levels.
Danish: Dette er påvist ved terapeutiske doser i kontrollerede mellemlange eller langvarige kliniske studier: metformin nedsætter niveauerne for totalkolesterol, LDL-kolesterol og triglycerider.
English: After the first 12 weeks glycaemic control was optimized independent of investigative treatment.
Danish: Efter de første 12 uger var den glykæmiske kontrol optimeret, uafhængigt af den undersøgte forsøgsbehandling.
English: The mean age was 63 years, the mean HbA1c was 8.1%, and 71.5% were male.
Danish: Gennemsnitsalderen var 63 år, gennemsnitlig HbA1c var 8,1 %, og 71,5 % var mænd.
English: If no adequate strength of Synjardy is available, individual monocomponents should be used instead of the fixed dose combination.
Danish: Hvis der ikke findes en passende styrke af Synjardy, bør enkeltstofferne anvendes enkeltvist i stedet for fastdosis-kombinationen.
English: Like for all diabetic patients it is important to counsel patients on routine preventative footcare.
Danish: Det gælder for alle diabetespatienter, at det er vigtigt at rådgive patienterne om rutinemæssig forebyggende fodpleje.
English: Renal clearance of metformin is >400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Danish: Den renale clearance for metformin er > 400 ml/min, hvilket tyder på, at metformin elimineres ved glomerulær filtration og tubulær sekretion.
English: C]-empagliflozin solution to healthy volunteers, approximately 96% of the drug-related radioactivity was eliminated in faeces (41%) or urine (54%).
Danish: C]-empagliflozin til raske frivillige blev ca. 96 % af den lægemiddelrelaterede radioaktivitet udskilt i fæces (41 %) eller urin (54 %).
English: Analysis of the results for overweight patients treated with metformin after failure of diet alone showed:
Danish: Analyse af resultaterne for overvægtige patienter, der blev behandlet med metformin efter manglende effekt af diæt alene, viste:
English: If necessary, the dose of the anti hyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Danish: Om nødvendigt bør dosis af det antihyperglykæmiske lægemiddel justeres under behandling med det andet lægemiddel og ved seponering af dette.
English: If you are already taking both medicines separately, your doctor will start treatment with tablets of Synjardy that will supply the same amount of both.
Danish: Hvis du allerede tager begge lægemidler, vil din læge starte behandlingen med Synjardy-tabletter, der svarer til de særskilte tabletter.
English: Your doctor may want to lower the dose of these other medicines, to prevent your blood sugar levels from getting too low (hypoglycaemia).
Danish: Din læge vil måske sænke din dosis af disse lægemidler for at forhindre, at dit blodsukker bliver for lavt (hypoglykæmi)
English: Adults with normal renal function (GFR ≥90 ml/min) The recommended dose is one tablet twice daily.
Danish: Voksne med normal nyrefunktion (GFR ≥ 90 ml/min) Den anbefalede dosis er én tablet to gange daglig.
English: Synjardy with alcohol
Danish: Brug af Synjardy sammen med alkohol
English: The amount of glucose removed by the kidney through this glucuretic mechanism is dependent on blood glucose concentration and GFR.
Danish: Mængden af glucose, der fjernes af nyrerne via denne glukuretiske mekanisme, afhænger af koncentrationen af glucose i blodet og af GFR.
English: If you need to have major surgery you must stop taking Synjardy during and for some time after the procedure.
Danish: Hvis du skal have en større operation, skal du stoppe med at tage Synjardy under indgrebet og i nogen tid herefter.
English: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Synjardy before or at the time of the injection.
Danish: Hvis du skal have sprøjtet et kontrastmiddel, som indeholder jod, ind i dit blod, for eksempel i forbindelse med en røntgenundersøgelse eller scanning, skal du stoppe med at tage Synjardy forud for eller på tidspunktet for injektionen.
English: After oral administration, metformin absorption is saturable and incomplete.
Danish: Efter oral administration kan absorptionen af metformin mættes og være ufuldstændig.
English: The inter-subject and residual variabilities for empagliflozin oral clearance were 39.1% and 35.8%, respectively.
Danish: Variabiliteten mellem patienter og restvariabiliteten for oral clearance for empagliflozin var henholdsvis 39,1 % og 35,8 %.
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Synjardy.
Danish: Nedenstående information afspejler de farmakokinetiske egenskaber for hvert af de aktive stoffer i Synjardy.
English: It is assumed that the pharmacokinetics of metformin absorption are non-linear.
Danish: Det antages, at farmakokinetikken for absorption af metformin er ikke-lineær.
English: Empagliflozin is a reversible, highly potent (IC50 of 1.3 nmol) and selective competitive inhibitor of SGLT2.
Danish: Empagliflozin er en reversibel, yderst potent (IC50 på 1,3 nmol) og selektiv kompetitiv hæmmer af SGLT2.
English: • severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing)
Danish: • Alvorlig allergisk reaktion (kan omfatte hævelse af ansigt, læber, mund, tunge eller hals, der kan føre til åndedrætsbesvær eller besvær ved synkning)
English: All patients should continue their diet with an adequate distribution of carbohydrate intake during the day.
Danish: Alle patienter skal fortsætte med deres kostplan, der skal indebære et jævnt indtag af kulhydrater i løbet af dagen.
English: This medicine is not recommended for use in children and adolescents under 18 years, because it has not been studied in these patients.
Danish: Børn og unge Synjardy anbefales ikke til børn og unge under 18år, da det ikke er undersøgt hos disse patienter.
English: In the event of an overdose, treatment should be initiated as appropriate to the patient‘s clinical status.
Danish: I tilfælde af overdosering skal der initieres en relevant behandling under hensyntagen til patientens kliniske tilstand.
English: Higher baseline HbA1c was associated with a greater reduction in HbA1c.
Danish: Højere baseline-HbA1c var forbundet med et større fald i HbA1c.
English: • in patients already being treated with the combination of empagliflozin and metformin as separate tablets.
Danish: • hvis patienten allerede er i behandling med en kombination af empagliflozin og metformin som særskilte tabletter.
English: The signs of low blood sugar may include:
Danish: Følgende er tegn på for lavt blodsukker:
English: At the recommended metformin doses and dosing schedules, steady-state plasma concentrations are reached within 24 to 48 hours and are generally less than 1 microgram/ml.
Danish: Ved de anbefalede metformindoser og -doseringsskemaer opnås steady state plasmakoncentrationer inden for 24 til 48 timer, og de er generelt under 1 mikrogram/ml.
English: Genital tract infections were mild and moderate in intensity, none was severe in intensity.
Danish: Genitale infektioner var af mild eller moderat intensitet, og ingen var af svær intensitet.
English: The dose of Synjardy varies depending on your condition and the doses of diabetes medicines you currently take.
Danish: Den mængde, du skal tage af Synjardy, afhænger af din tilstand og de doser, som du aktuelt tager af diabetesmedicin.
English: • Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)
Danish: • Enhver type af akut metabolisk acidose (såsom laktatacidose, diabetisk ketoacidose).
English: However, as metformin is recommended to be given with meals, Synjardy is also proposed to be given with food.
Danish: Da det anbefales, at metformin tages sammen med måltider, anbefales det også, at Synjardy tages sammen med mad.
English: • if you are treated for acute heart failure or have recently had a heart attack, have severe problems with your circulation (such as shock) or have breathing difficulties.
Danish: • hvis du er behandlet for akut hjertesvigt eller for nylig har haft et hjerteanfald, har alvorlige kredsløbsproblemer (f.eks. shock) eller vejrtrækningsbesvær.
English: • if you have lost a lot of water from your body (dehydration), e.g. due to long-lasting or severe diarrhoea, or if you have vomited several times in a row.
Danish: • hvis du har mistet en masse vand fra kroppen (dehydrering), f.eks. på grund af langvarig eller svær diarré eller hvis du har kastet op flere gange efter hinanden.
English: • loss of appetite
Danish: • Manglende appetit
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står efter EXP på blister og pakning.