FrancophonIA/ELRC3.0 huggingface dataset:
English: What is Budesonide/Formoterol Teva Pharma B.V. and what is it used for?
Danish: Hvad er Budesonide/Formoterol Teva Pharma B.V., og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of Budesonide/Formoterol Teva Pharma B.V.?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Budesonide/Formoterol Teva Pharma B.V.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Budesonide/Formoterol Teva Pharma B.V. on 19 November 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Budesonide/Formoterol Teva Pharma B.V.
English: What are the benefits and risks of Budesonide/Formoterol Teva Pharma B.V.?
Danish: Hvilke fordele og risici er der forbundet med Budesonide/Formoterol Teva Pharma B.V.
English: Other information about Budesonide/Formoterol Teva Pharma B.V.
Danish: Andre oplysninger om Budesonide/Formoterol Teva Pharma B.V.
English: A risk management plan has been developed to ensure that Budesonide/Formoterol Teva Pharma B.V. is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Budesonide/Formoterol Teva Pharma B.V.
English: It is not intended to provide practical advice on how to use Budesonide/Formoterol Teva Pharma B.V.
Danish: Det er ikke en praktisk vejledning i, hvordan Budesonide/Formoterol Teva Pharma B.V.
English: The Committee recommended that Budesonide/Formoterol Teva Pharma B.V. be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Budesonide/Formoterol Teva Pharma B.V..
English: How is Budesonide/Formoterol Teva Pharma B.V. used?
Danish: Hvordan anvendes Budesonide/Formoterol Teva Pharma B.V.
English: Budesonide/Formoterol Teva Pharma B.V. is a medicine that contains the active substances budesonide and formoterol.
Danish: er et lægemiddel, der indeholder de to aktive stoffer budesonid og formoterol.
English: Why is Budesonide/Formoterol Teva Pharma B.V. approved?
Danish: Hvorfor er Budesonide/Formoterol Teva Pharma B.V.
English: How does Budesonide/Formoterol Teva Pharma B.V. work?
Danish: Hvordan virker Budesonide/Formoterol Teva Pharma B.V.
English: The reference medicine for Budesonide/Formoterol Teva Pharma B.V. is Symbicort Turbohaler.
Danish: Referencelægemidlet for Budesonide/Formoterol Teva Pharma B.V.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Prepandrix on 14 May 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Prepandrix den 14. maj 2008.
English: An additional study was also used to support the main study and to demonstrate the vaccine's safety.
Danish: Der blev desuden gennemført en yderligere undersøgelse til underbygning af hovedundersøgelsen og til påvisning af vaccinens sikkerhed.
English: The full EPAR for Prepandrix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Prepandrix findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Adults over 80 years of age may need a double dose of the vaccine (one injection into each shoulder).
Danish: Voksne over 80 år skal muligvis have en dobbeltdosis af vaccinen (én injektion i hver skulder).
English: This is a summary of the European public assessment report (EPAR) for Prepandrix.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Prepandrix.
English: This may help to protect against the disease caused by the virus.
Danish: Dette medvirker til at beskytte mod den sygdom, virusset forårsager.
English: The virus has first been inactivated (killed) so that it does not cause any disease.
Danish: Virusset er først blevet inaktiveret (dræbt), så det ikke er sygdomsfremkaldende.
English: The participants received two injections of Prepandrix 21 days apart.
Danish: Deltagerne fik to indsprøjtninger med Prepandrix med 21 dages mellemrum.
English: At 21 days after the second injection, over 90% of the people receiving the vaccine had levels of antibodies that would protect them against H5N1.
Danish: 21 dage efter den anden injektion havde over 90 % af de personer, der havde fået vaccinen, antistofniveauer, som kunne beskytte dem mod H5N1.
English: For more information about treatment with Prepandrix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Prepandrix, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Prepandrix is given by injection into the shoulder or thigh as two 0.5 ml doses, at least three weeks apart.
Danish: Prepandrix gives ved injektion i skulderen eller låret som to doser på 0,5 ml med mindst tre ugers mellemrum.
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 Prepandrix.
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 Prepandrix.
English: According to criteria laid down by the CHMP, a prepandemic vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
Danish: Ifølge de kriterier, der er fastsat af CHMP, skal en præpandemisk vaccine frembringe en beskyttende mængde antistoffer hos mindst 70 % af personerne for at kunne anses for egnet.
English: There are some data with a vaccine containing a similar H5N1 strain that support the use of half-doses (0.25 ml) in children three to nine years of age.
Danish: Der foreligger visse data fra en vaccine indeholdende en lignende H5N1-stamme, som underbygger brugen af halve doser (0,25 ml) til børn i alderen tre til ni år.
English: Prepandrix has been developed to provide protection against this strain, so that it can be used before or during a flu pandemic.
Danish: Prepandrix er blevet udviklet for at yde beskyttelse mod denne stamme, så den kan anvendes før eller under en pandemi.
English: Health experts are concerned that a future flu pandemic could be caused by the H5N1 strain of the virus.
Danish: Sundhedseksperter er bekymrede for, at en fremtidig influenzapandemi kan forårsages af H5N1-stammen af virusset.
English: The emulsion contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Danish: Emulsionen indeholder en ”adjuvans” (en olieholdig forbindelse), som giver en bedre immunrespons.
English: Vaccination with Prepandrix should be delayed in people who have a severe fever or a sudden infection.
Danish: Vaccination med Prepandrix bør udskydes hos personer, der har høj feber, eller som pludselig har fået en infektion.
English: The main study of Prepandrix included 675 healthy adults and compared the ability of Prepandrix, with or without the adjuvant, to trigger the production of antibodies (‘immunogenicity').
Danish: Hovedundersøgelsen af Prepandrix omfattede 675 raske voksne og sammenlignede Prepandrix' evne med eller uden adjuvansen til at danne antistoffer (”immunogenicitet”).
English: This is a special type of vaccine that is intended to protect against a strain of flu that may cause a future pandemic.
Danish: Det er en særlig form for vaccine, som har til formål at beskytte mod en influenzavirusstamme, der kan forårsage en fremtidig influenzapandemi.
English: Prepandrix contains a flu strain called ‘A/Indonesia/05/2005' (H5N1).
Danish: Prepandrix indeholder influenzastammen ”A/Indonesia/05/2005” (H5N1).
English: Prepandrix is a vaccine that is given by injection.
Danish: Prepandrix er en vaccine, der gives som injektion.
English: Prepandrix must not be given to people who are hypersensitive (allergic) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as eggs, chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate.
Danish: Prepandrix må ikke gives til patienter, der er overfølsomme (allergiske) over for nogen af vaccinens indholdsstoffer eller over for nogen af de sporstoffer, den indeholder, f.eks. æg, kyllingeprotein, ovalbumin (et protein i æggehvide), formaldehyd, gentamicinsulfat (et antibiotikum) og natriumdeoxycholat.
English: The CHMP decided that Prepandrix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Prepandrix opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Prepandrix.
English: Other information about Prepandrix
Danish: Andre oplysninger om Prepandrix:
English: For the full list of all side effects reported with Prepandrix, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Prepandrix fremgår af indlægssedlen.
English: The most common side effects with Prepandrix (seen in more than 1 patient in 10) are headache, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (hardening, swelling, pain and redness), fever and fatigue (tiredness).
Danish: De hyppigste bivirkninger af Prepandrix (som forekom hos 1 ud af 10 patienter) er hovedpine, ledsmerter, muskelsmerter, reaktioner på injektionsstedet (hårdhed, hævelse, smerte og rødme), feber og træthed.
English: The main study showed that Prepandrix containing the adjuvant produced an antibody response that met these criteria.
Danish: I hovedundersøgelsen udløste Prepandrix indeholdende adjuvansen en antistofrespons, der opfylder disse kriterier.
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivared, adjuvanted)
Danish: EPAR - sammendrag for offentligheden præpandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret)
English: Prepandrix is a ‘prepandemic' vaccine.
Danish: Prepandrix er en pandemivaccine.
English: Prepandrix contains small amounts of haemagglutinins (proteins from the surface) of the H5N1 virus.
Danish: Prepandrix indeholder små mængder af hæmagglutininer (overfladeproteiner) fra et virus, der kaldes H5N1.
English: What is the risk associated with Prepandrix?
Danish: Hvilken risiko er der forbundet med Prepandrix?
English: Prepandrix is a vaccine for use in adults to protect against flu caused by the H5N1 strain (type) of the influenza A virus.
Danish: Prepandrix er en vaccine til beskyttelse af voksne mod influenza forårsaget af H5N1-stammen (type) af influenzavirus A. Prepandrix gives i overensstemmelse med de officielle anbefalinger.
English: Why has Prepandrix been approved?
Danish: Hvorfor blev Prepandrix godkendt?
English: How has Prepandrix been studied?
Danish: Hvordan blev Prepandrix undersøgt?
English: What benefit has Prepandrix shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Prepandrix?
English: What is Prepandrix used for?
Danish: Hvad anvendes Prepandrix til?
English: What is Prepandrix?
Danish: Hvad er Prepandrix?
English: How is Prepandrix used?
Danish: Hvordan anvendes Prepandrix?
English: How does Prepandrix work?
Danish: Hvordan virker Prepandrix?
English: However, the majority were within 12 hours.
Danish: Flertallet var dog inden for 12 timer.
English: - You should not go home unaccompanied.
Danish: - Du skal ikke gå hjem uledsaget.
English: The PRAC endorsed this revision.
Danish: PRAC godkendte denne revision.
English: Under 1 month 1 to < 6 months 6 to < 12 months 12 to < 24 months 2 to < 6 years 6 to < 17 years
Danish: Under 1 måned 1 til < 6 måneder 6 til < 12 måneder 12 til < 24 måneder 2 til < 6 år 6 til < 17 år
English: Talk to your doctor about the use of these medicines and about the use of alcohol.
Danish: Tal med din læge om brugen af disse lægemidler og om brugen af alkohol.
English: Data on treatment for > 24 hours is not available.
Danish: Data for behandling i > 24 timer er ikke tilgængelige.
English: Adequate data is not available.
Danish: Tilstrækkelige data er ikke tilgængelige.
English: Your doctor will know how to treat you based on your condition.
Danish: Din læge vil vide, hvordan du skal behandles baseret på din tilstand.
English: The event was reported as mild in 1 and moderate in 3 cases.
Danish: Hændelsen blev rapporteret som let i 1 og moderat i 3 tilfælde.
English: The clinical significance is unknown.
Danish: Den kliniske signifikans er ukendt.
English: Uncontrolled hypotension.
Danish: Ukontrolleret hypotension.
English: Ask your doctor when you can start doing these activities again and when you can go back to this kind of work.
Danish: Spørg din læge, hvornår du kan begynde på disse aktiviteter, og hvornår du kan lave denne type arbejde igen.
English: - Risk Management Plan (RMP)
Danish: Risikostyringsprogram (RMP)
English: For hospital use only.
Danish: Kun til hospitalsanvendelse.
English: After dose adjustment, a new steady state sedation level may not be reached for up to one hour.
Danish: Efter en dosisjustering, kan et nyt steady state sedationsniveau ikke opnås i op til én time.
English: - The doctor will keep you under medical supervision for some hours after the sedation to make sure that you feel well.
Danish: - Lægen vil holde dig under medicinsk overvågning i nogle timer efter bedøvelsen for at sikre sig, at du har det godt.
English: These effects were associated with clear maternal toxicity.
Danish: Disse virkninger var forbundet med en tydelig maternel toksicitet.
English: There is no experience in the use of Dexdor for more than 14 days.
Danish: Der er ingen erfaring med anvendelse af Dexdor i mere end 14 dage.
English: The available data is summarised in the following table;
Danish: De tilgængelige data er opsummeret i nedenstående tabel:
English: The use of Dexdor for longer than this period should be regularly reassessed.
Danish: Anvendelse af Dexdor længere end denne periode skal revurderes regelmæssigt.
English: Mean (95% CI)
Danish: Gennemsnit (95 % CI)
English: The CHMP agrees with the scientific conclusions made by the PRAC.
Danish: CHMP tilslutter sig PRAC´s videnskabelige konklusioner.
English: Cl (l/h/kg)
Danish: Cl (l/t/kg)
English: No major pharmacokinetic differences have been observed based on gender or age.
Danish: Der er ikke observeret større farmakokinetiske forskelle baseret på køn eller alder.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og pakningen efter Exp.
English: The use in other environments is not recommended.
Danish: Anvendelse andre steder frarådes.
English: No human data on fertility are available.
Danish: Human data angående fertilitet er ikke tilgængelige.
English: t1/2 (h)
Danish: t1/2 (t)
English: Your doctor may change your dose if needed and will monitor your heart and blood pressure during the treatment.
Danish: Din læge kan ændre din dosis, hvis det er nødvendigt, og vil kontrollere dit hjerte og blodtryk under behandlingen.
English: Ask your doctor for advice before having this medicine
Danish: Spørg din læge til råds, før du får dette lægemiddel.
English: If not used immediately, in-use storage times and conditions prior to the use are the responsibility of the user and would not normally be longer than 24 hours at 2° to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes umiddelbart, er opbevaringstid og -betingelser inden anvendelse på brugerens eget ansvar og må normalt ikke overstige 24 timer ved 2-8 °C, medmindre fortynding er udført under kontrollerede og validerede aseptiske betingelser.
English: These metabolites have negligible pharmacological activity.
Danish: Disse metabolitter har ubetydende farmakologisk aktivitet.
English: The safety and efficacy of Dexdor in children aged 0 to 18 years have not been established.
Danish: Dexdors sikkerhed og virkning hos børn i alderen 0-18 år er ikke klarlagt.
English: Less than 1% of unchanged parent drug was recovered in the urine.
Danish: Mindre end 1 % af den uomdannede modersubstans blev genfundet i urinen.
English: Compared to both propofol and midazolam, patients were more easily roused, more cooperative and better able to communicate whether or not they had pain.
Danish: Sammenlignet med både propofol og midazolam, var patienterne lettere at vække, mere kooperative og bedre i stand til at kommunikere, uanset om de havde smerter eller ej.
English: After you have been given Dexdor you must not drive, operate machinery, or work in dangerous situations until the effects are completely gone.
Danish: Når du har fået Dexdor, må du ikke køre, betjene maskiner eller arbejde i farlige situationer, før virkningen er helt væk.
English: The mean body weight associated with these Vss and Cl estimates was 69 kg.
Danish: Den gennemsnitlige legemsvægt associeret med disse Vss- og Cl-estimater var 69 kg.
English: At high concentration hypertension may be more prominent than hypotension.
Danish: Ved høj koncentration kan hypertension være mere mere fremtrædende end hypotension.
English: No dose adjustment is normally required for elderly patients (see section 5.2).
Danish: Normalt kræves der ingen dosisjustering hos ældre patienter (se pkt 5.2).
English: Before you have this medicine, tell your doctor or nurse if any of the following apply as Dexdor should be used cautiously:
Danish: Før du får denne medicin, skal du fortælle det til din læge eller sygeplejerske hvis noget af det følgende gælder for dig, fordi Dexdor skal anvendes med forsigtighed:
English: Supplemental oxygen should be immediately available and provided when indicated.
Danish: Ilttilskud skal være umiddelbart tilgængeligt og gives, når det er indiceret.
English: Date of latest renewal: 26 May 2016
Danish: Dato for første markedsføringstilladelse: 16. september 2011 Dato for seneste fornyelse: 26. maj 2016
English: Your doctor will decide on a suitable dose for you.
Danish: Din læge bestemmer hvilken dosis der er egnet for dig.
English: Approximately 28% of the urinary metabolites are unidentified minor metabolites.
Danish: Cirka 28 % af metabolitterne i urin er ikke identificerede mindre metabolitter.
English: The maximum dose of 1.4 micrograms/kg/h should not be exceeded.
Danish: Den maksimale dosis på 1,4 mikrogram/kg/t bør ikke overskrides.
English: Users should therefore be ready to use an alternative sedative for acute control of agitation or during procedures, especially during the first few hours of treatment.
Danish: Brugerne skal derfor være klar til at anvende alternative sedativa til akut kontrol af agitation eller under procedurer, især i de første behandlingstimer.
English: Volume of diluent
Danish: Volumen af diluent
English: There are no or limited amount of data from the use of dexmedetomidine in pregnant women.
Danish: Der er ingen eller utilstrækkelige data om anvendelse af dexmedetomidin til gravide kvinder.
English: Acute cerebrovascular conditions.
Danish: Akutte cerebrovaskulære tilstande.
English: Patients with neurological disorders
Danish: Patienter med neurologiske forstyrrelser
English: When used in an outpatient setting close monitoring should continue for at least one hour (or longer based on the patient condition), with medical supervision continued for at least one further hour to ensure the safety of the patient.
Danish: Hvis anvendelsen sker på ambulant basis skal patienten monitoreres tæt i mindst 1 time (eller længere baseret på patientens tilstand), med lægetilsyn i yderligere 1 time for at sikre patientens sikkerhed.
English: It has a sympatholytic effect through decrease of the release of noradrenaline in sympathetic nerve endings.
Danish: Det har en sympatolytisk virkning via reduktion af noradrenalins frigørelse i de sympatiske nerveender.
English: Not known (frequency cannot be estimated from the available data) - increased need to pass urine
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data) - hyppig vandladning
English: During procedural sedation a small bolus of another sedative may be used if a rapid increase in sedation level is required.
Danish: Ved vågen sedation kan der gives en lille bolusdosis af et andet sedativum, hvis en hastig øgning i sedationsniveau er nødvendig.
English: Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: 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), very rare (<1/10,000).
Danish: Bivirkningerne er opstillet efter hyppighed, de hyppigste først, efter følgende konvention: 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).
English: Plasma protein binding is constant over the concentration range of 0.85 to 85 ng/ml.
Danish: Plasmaproteinbindingen er konstant i koncentrationsområdet fra 0,85 til 85 ng/ml.
English: The amount of Dexdor depends on your age, size, general condition of health, the level of sedation needed and how you respond to the medicine.
Danish: Hvor meget Dexdor du får, afhænger af din alder, størrelse, generel helbredstilstand, hvilket bedøvelsesniveau, der er behov for og hvordan du reagerer på denne medicin.
English: In cases of overdose with clinical symptoms, dexmedetomidine infusion should be reduced or stopped.
Danish: I tilfælde af overdosis med kliniske symptomer bør dexmedetomidininfusionen reduceres eller stoppes.
English: The observed exposure levels in the rat are below the clinical exposure range.
Danish: De observerede eksponeringsniveauerne hos rotten ligger under det kliniske eksponeringsområde.
English: In healthy volunteers it exhibits a rapid distribution phase with a central estimate of the distribution half-life (t1/2α) of about 6 minutes.
Danish: Hos raske frivillige udviser det en hurtig distributionsfase med en central estimeret distributionshalveringstiden (t½) på cirka 6 minutter.
English: - A loading infusion of 1.0 microgram/kg over 10 minutes.
Danish: En stødinfusion på 1,0 mikrogram/kg over 10 minutter.
English: If you are given too much Dexdor, your blood pressure may go up or down, your heartbeat may slow down, you may breathe more slowly and you may feel more drowsy.
Danish: Hvis du har fået for meget Dexdor, kan dit blodtryk stige eller falde, din puls kan blive langsommere, du kan trække vejret langsommere og du kan føle dig mere omtåget.
English: The risk of insufficient sedation was increased in patients who were difficult to sedate with standard care immediately prior to switching.
Danish: Risikoen for utilstrækkelig sedation var forhøjet hos patienter, som inden skift var vanskelige at sedere med standardbehandling.
English: The reported highest infusion rates of dexmedetomidine in these cases have reached up to 60 µg/kg/h for 36 minutes and 30 µg/kg/h for 15 minutes in a 20-month-old child and in an adult, respectively.
Danish: Den højeste rapporterede infusionshastighed af dexmedetomidin i disse tilfælde er på op til 60 µg/kg/t i 36 minutter og 30 µg/kg/t i 15 minuter hos henholdsvis et 20 måneder gammelt barn og hos en voksen.
English: Following IV administration of radiolabeled dexmedetomidine an average 95% of radioactivity was recovered in the urine and 4% in the faeces after nine days.
Danish: Efter en i.v.-administration af radiomærket dexmedetomidin blev en gennemsnitlig radioaktivitet på 95 % genfundet i urinen og 4 % i faeces efter ni dage.
English: Those patients who withdrew due to insufficient sedation were switched to either propofol or midazolam.
Danish: Hos de patienter, hvor behandlingen blev stoppet på grund af utilstrækkelig sedation, blev der skiftet enten til propofol eller midazolam.