FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 2: Immune Responses Among Individuals 11 to 18 Years of Age Administered Trumenba After Various 2- and 3-Dose Schedules (Study B1971012) Group 1
Danish: Skema 2: Immunrespons hos forsøgspersoner i alderen 11-18 år, der fik Trumenba i henhold til forskellige 2- og 3-dosisplaner (studie B1971012)
English: Table 1: Immune Responses Among Individuals 11 to 18 Years of Age Administered Trumenba After Various 2- and 3-Dose Schedules (Study B1971012) Group 1
Danish: Skema 1: Immunrespons hos forsøgspersoner i alderen 11-18 år, der fik Trumenba i henhold til forskellige 2- og 3-dosisplaner (studie B1971012)
English: (0, 2, and 6 Months)
Danish: (0, 2 og 6 måneder)
English: The presence of a minor infection, such as a cold, should not require postponement of the vaccination,
Danish: Milde infektioner, som forkølelse, kræver ikke udsættelse af vaccinationen, men tal med lægen om det først.
English: Abbreviations: hSBA=serum bactericidal assay using human complement; fHbp=factor H binding protein.
Danish: Forkortelser: hSBA = serum-baktericid assay der anvender humant komplement, fHbp = faktor H-bindingsprotein.
English: Other medicines and Trumenba
Danish: HAV/saltvand Trumenba
English: A
Danish: Eller
English: % hSBA ≥ 1:16 Dose 2 351
Danish: % hSBA ≥ 1:16 Dosis 2
English: ≥ 4-Fold rise in hSBA titre (%) Dose 2 339
Danish: ≥4-dobbelt stigning i hSBA-titer (%) Dosis 2
English: Immune Responses Among Individuals 10 to 25 Years of Age 1 Month Following the Third Dose of Trumenba or Control Given on a 0-, 2-, 6-Month Schedule (Study B1971009 and B1971016)
Danish: Immunrespons hos personer i alderen 10-25 år 1 måned efter tredje dosis Trumenba eller kontrol i henhold til en 0, 2, 6 måneders dosisplan (studie B1971009 og B1971016)
English: Table 4.
Danish: Skema 4.
English: % hSBA ≥ 1:8 Dose 2 341
Danish: % hSBA ≥ 1:8 Dosis 2
English: Abbreviations: GMT=geometric mean titre; hSBA=serum bactericidal assay using human complement; fHBP=factor H binding protein.
Danish: Forkortelser: GMT = geometrisk gennemsnitstiter, hSBA = serum-baktericid assay der anvender humant komplement, fHBP = faktor H-bindingsprotein.
English: Immune Responses Among Individuals 10 to 25 Years of Age Against 10 Additional Strains 1 Month Following the Third Dose of Trumenba Given on a 0-, 2-, 6-Month Schedule (Study B1971009 and Study B1971016) Study B1971009
Danish: Immunrespons hos forsøgspersoner i alderen 10-25 år mod 10 yderligere stammer 1 måned efter tredje dosis Trumenba eller kontrol i henhold til en 0, 2, 6 måneders plan (studie B1971009 og B1971016)
English: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Danish: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel.: + 386 (0) 1 52 11 400
English: Pre-filled syringe label
Danish: Etiket til fyldt injektionssprøjte
English: General disorders and administration site conditions Very Common: Chills; fatigue; redness (erythema), swelling (induration) and pain at injection site Common:
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig: Kulderystelser, træthed.
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: - Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere du vil vide.
English: Posology
Danish: Opkastning
English: • Changes in behaviour, especially in children.
Danish: • Adfærdsændringer, særligt hos børn.
English: This generally occurs within the first year of treatment.
Danish: Dette forekommer sædvanligvis i det første behandlingsår.
English: • Taste changes, such as an unpleasant taste in the mouth.
Danish: • Smagsændringer, såsom en ubehagelig smag i munden.
English: Specific treatment should be initiated for these conditions.
Danish: Der skal iværksættes specifik behandling af disse tilstande.
English: The difference is considered not to have an impact on clinical safety.
Danish: Forskellen anses ikke for at have nogen indvirkning på den kliniske sikkerhed.
English: The resulting plasma concentrations were not determined.
Danish: De resulterende plasmakoncentrationer blev ikke bestemt.
English: Elderly patients (≥65 years old)
Danish: Ældre patienter (≥ 65 år)
English: The duration of effect is at least 12 hours after a single dose.
Danish: Virkningsvarigheden er mindst 12 timer efter en enkelt dosis.
English: After opening the foil wrap: 6 months.
Danish: Efter åbning af folien: 6 måneder.
English: Breathe in through your mouth as deeply and as hard as you can.
Danish: Træk vejret ind gennem munden så dybt og så kraftigt, som du kan.
English: Contact your doctor immediately if:
Danish: Kontakt lægen med det samme, hvis:
English: Take care not to block the air vents.
Danish: Pas på ikke at blokere for luftventilen.
English: Special populations:
Danish: Særlige populationer:
English: Supportive and symptomatic treatment may be indicated.
Danish: Understøttende og symptomatisk behandling kan være nødvendig.
English: However, an initial small but transient reduction in growth (approximately 1 cm) has been observed.
Danish: Der er dog blevet set en initial lille, men forbigående vækstreduktion (cirka 1 cm).
English: If you are to take a second inhalation, repeat steps 1 to 7.
Danish: Hvis du skal tage endnu en inhalation, skal du gentage trin 1 til 7.
English: • Disturbed sleep.
Danish: • Urolig søvn.
English: Contact your doctor immediately as you may need to have your treatment changed.
Danish: Kontakt lægen med det samme, da det kan være nødvendigt at ændre din behandling.
English: 6.2 Incompatibilities Not applicable.
Danish: 6.2 Uforligeligheder Ikke relevant.
English: These tend to be mild and usually disappear within a few days of treatment.
Danish: Disse har tendens til at være lette og forsvinder normalt efter nogle få dages behandling.
English: This should be considered not only when treatment with combination medicinal products is initiated but also when the maintenance dose is adjusted.
Danish: Dette skal ikke blot overvejes, når behandling med kombinationspræparat iværksættes, men også når vedligeholdelsesdosis justeres.
English: However, these animal experimental results do not seem to be relevant in humans.
Danish: Disse eksperimentelle resultater hos dyr forekommer imidlertid ikke at være relevante for mennesker.
English: If this is not possible the time interval between administrations of the interacting medicinal products should be as long as possible.
Danish: Hvis dette ikke er muligt, skal tidsintervallet mellem administration af de interagerende lægemidler være så lang som muligt.
English: ATC code: R03AK07
Danish: ATC-kode: R03AK07
English: When the numbers become red in the window, you should consult your doctor and obtain a new inhaler.
Danish: Når tallene bliver røde i vinduet, bør du kontakte din læge og få en ny inhalator.
English: These are used to treat high blood pressure.
Danish: De bruges til at behandle for højt blodtryk.
English: • you have severe liver problems.
Danish: • Du har alvorlige leverproblemer.
English: Your inhaler is now ready for use.
Danish: Din inhalator er nu klar til brug.
English: • Feeling restless, nervous, agitated, anxious or angry.
Danish: • Følelse af at være rastløs, nervøs, ophidset, ængstelig eller vred.
English: These signs could mean that your asthma is not being properly controlled and you may need different or additional treatment immediately.
Danish: Disse tegn kan betyde, at din astma ikke kontrolleres ordentligt, og du kan have brug for en anden eller yderligere behandling med det samme.
English: The mechanisms of action of the two substances respectively are discussed below.
Danish: De to stoffers respektive virkningsmekanismer er beskrevet nedenfor.
English: It is not known whether formoterol passes into human breast milk.
Danish: Det vides ikke, om formoterol passerer over i human mælk.
English: Depression, behavioural changes (predominantly in children)
Danish: Meget sjælden Depression, adfærdsændringer (primært hos børn)
English: Keep your Spiromax dry and clean.
Danish: Hold Spiromax tør og ren.
English: This will help to open the airways and help you to breathe more easily.
Danish: Dette vil hjælpe med at åbne luftvejene og gøre det lettere for dig at trække vejret.
English: Additional blood glucose controls should be considered in diabetic patients.
Danish: Ekstra foranstaltninger til kontrol af blodglucose bør overvejes hos diabetespatienter.
English: • Changes in your blood pressure.
Danish: • Ændringer i blodtrykket.
English: Do not bite the mouthpiece.
Danish: Du må ikke bide i mundstykket.
English: It is recommended that serum potassium levels are monitored during these circumstances.
Danish: Det anbefales, at serum-kalium monitoreres under disse omstændigheder.
English: • The mouthpiece will still ‘click' even when your Spiromax is empty.
Danish: • Mundstykket vil stadig klikke, også selv om din Spiromax er tom.
English: • Your breathing is getting worse or you often wake up at night with breathlessness and wheezing.
Danish: • Din vejrtrækning bliver værre, eller du ofte vågner om natten med åndenød og hvæsende vejrtrækning.
English: Place the mouthpiece between your teeth.
Danish: Anbring mundstykket mellem dine tænder.
English: In children 6-16 years of age the lung deposition falls in the same range as in adults for the same given dose.
Danish: Hos børn i alderen 6-16 år ligger lungedeponeringen i samme område som hos voksne for den samme afgivne dosis.
English: There was no sign of attenuation of the anti-asthmatic effect over time.
Danish: Der var ingen tegn på svækkelse af den antiastmatiske virkning med tiden.
English: • Medicines like digoxin, often used to treat heart failure.
Danish: • Lægemidler som digoxin, der ofte bruges til at behandle hjertesvigt.
English: No data on fertility are available.
Danish: Der findes ingen data vedrørende fertilitet.
English: There are no adequate data from use of formoterol in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af formoterol til gravide kvinder.
English: This may mean that you are having an allergic reaction, which may also include rash and itching.
Danish: Det kan betyde, at du har en allergisk reaktion, der også kan omfatte udslæt og kløe.
English: NL-2031 GA Haarlem The Netherlands
Danish: NL-2031 GA Haarlem Holland
English: • Budesonide belongs to a group of medicines called ‘corticosteroids' also known as ‘steroids'.
Danish: • Budesonid tilhører en gruppe lægemidler, der betegnes 'kortikosteroider', også kendt som ”steroider”.
English: • Disturbance of the heart's electrical system (prolongation of the QTc-interval).
Danish: • Forstyrrelse i hjertets elektriske system (forlængelse af QTc-interval)
English: Very few patients had PIFRs below 40L/min; when PIFRs were less than 40L/min there appeared to be no clustering by age or disease severity.
Danish: Meget få patienter havde PIF-hastigheder under 40 l/min; når PIFhastigheden var under 40 l/min, syntes der ikke at forekomme grupperinger i alder eller sygdommens sværhedsgrad.
English: In such circumstances hypothalamic pituitary adrenocortical (HPA) axis function should be monitored regularly.
Danish: Under sådanne omstændigheder bør hypothalamus-hypofyse-binyrebark (HPA) aksefunktionen overvåges regelmæssigt.
English: These are often used to treat asthma.
Danish: Disse bruges ofte til at behandle astma.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Inhalation use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til inhalation.
English: Important information about your asthma symptoms
Danish: Vigtig information om dine astmasymptomer
English: The exact mechanism responsible for the antiinflammatory effect of glucocorticosteroids is unknown.
Danish: Den nøjagtige virkningsmekanisme, der er ansvarlig for glukokortikoiders anti-inflammatoriske virkning, er ukendt.
English: If you have been taking steroid tablets for a long time, your doctor may want you to have regular blood tests.
Danish: Hvis du har taget steroidtabletter i lang tid, vil din læge muligvis have, at du får taget regelmæssige blodprøver.
English: Formoterol is inactivated via conjugation reactions (active O-demethylated and deformylated metabolites are formed, but they are seen mainly as inactivated conjugates).
Danish: Formoterol inaktiveres via konjugeringsreaktioner (aktive O-demetylerede og deformylerede metabolitter dannes, men de ses hovedsageligt som inaktiverede konjugater).
English: A dose of 90 micrograms administered during three hours in patients with acute bronchial obstruction raised no safety concerns.
Danish: En dosis på 90 mikrogram administreret over tre timer hos patienter med akut bronkieobstruktion gav ingen grund til bekymringer omkring sikkerheden.
English: If your symptoms are well controlled, your doctor may ask you to take your medicine once a day.
Danish: Hvis dine symptomer er helt under kontrol, vil din læge muligvis bede dig om at tage din medicin en gang dagligt.
English: Budesonide is eliminated via metabolism mainly catalysed by the enzyme CYP3A4.
Danish: Budesonid elimineres ved metabolisering hovedsageligt katalyseret af enzymet CYP3A4.
English: If the wheezing comes on suddenly after using this medicine stop using it and talk to your doctor immediately.
Danish: Hvis din hvæsen starter pludseligt efter brug af denne medicin, skal du holde op med at bruge den og straks tale med din læge.
English: Your doctor may consider adding steroid tablets to your usual treatment during periods of stress (for example, when you have a chest infection or before an operation).
Danish: Din læge kan overveje at føje steroidtabletter til din sædvanlige behandling i perioder med stress (f.eks. hvis du har en infektion i brystet eller før en operation).
English: 6.6 Special precautions for disposal and other handling No special requirements.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Ingen særlige forholdsregler.
English: High dose corticosteroids
Danish: Høje doser af kortikosteroider
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
Danish: Fortæl især lægen eller apotekspersonalet, hvis du tager nogen af følgende lægemidler:
English: Regular review of patients as treatment is stepped down is important.
Danish: Det er vigtigt regelmæssigt at evaluere patienten, efterhånden som behandlingen nedtrappes.
English: • Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.
Danish: • Du begynder at føle trykken for brystet om morgenen, eller din trykken for brystet varer længere end normalt.
English: Effects are probably dependent on dose, exposure time, concomitant and previous steroid exposure and individual sensitivity.
Danish: Virkningen er sandsynligvis afhængig af dosis, eksponeringstid, samtidig og tidligere steroideksponering og individuel følsomhed.
English: You may notice a taste when you take your inhalation.
Danish: Du vil muligvis bemærke en særlig smag, når du tager inhalationen.
English: Remove your inhaler from your mouth.
Danish: Tag inhalatoren ud af munden.
English: It is impossible to accidentally take extra medicine or a double dose in one inhalation.
Danish: Det er umuligt ved et uheld at tage ekstra medicin eller en dobbeltdosis i én indånding.
English: Limited data from long-term studies suggest that most children and adolescents treated with inhaled budesonide will ultimately achieve their adult target height.
Danish: Begrænsede data fra langtidsstudier antyder, at de fleste børn og unge, som behandles med inhaleret budesonid, i det lange løb vil nå deres forventede højde som voksne.
English: When ketoconazole was administered 12 hours after budesonide the concentration was on average increased only three-fold showing that separation of the administration times can reduce the increase in plasma levels.
Danish: Når ketoconazol blev administreret 12 timer efter budesonid, blev koncentrationen i gennemsnit kun forhøjet tre gange, hvilket viser, at separation af administrationstidspunkterne kan reducere stigningen i plasmaniveau.
English: In both studies, lung function was improved and the treatment was well tolerated compared to the corresponding dose of budesonide alone.
Danish: I begge studier blev lungefunktionen forbedret, og behandlingen var veltolereret sammenlignet med den tilsvarende dosis budesonid alene.
English: There are no special dosing requirements for elderly patients.
Danish: Speciel dosering er ikke nødvendig til ældre patienter.
English: Hold your breath for 10 seconds or as long as you comfortably can.
Danish: Hold vejret i 10 sekunder eller så længe du kan uden at føle ubehag.
English: The benefits of the corticosteroid therapy and the possible risks of growth suppression must be carefully weighed.
Danish: Fordelene ved kortikosteroidbehandling og eventuelle risici for væksthæmning skal nøje opvejes mod hinanden.
English: The bronchodilating effect is dose-dependant, with an onset of effect within 1-3 minutes.
Danish: Den bronkodilaterende effekt er dosisafhængig, og virkningen viser sig inden for 1-3 minutter.
English: The impact of enhanced training in dry powder inhaler inhalation technique on inhalation speed and volume was also assessed in these subject groups.
Danish: Effekten af bedre træning i inhalationsteknik for tørpulverinhalatorer på inhalationshastighed og volumen blev desuden vurderet i disse studiegrupper.
English: Acute overdose with budesonide, even in excessive doses, is not expected to be a clinical problem.
Danish: Akut overdosering med budesonid, selv med meget store doser, forventes ikke at udgøre et klinisk problem.
English: Oral infections
Danish: Orale infektioner
English: Data from an embryo-fetal development study in the rat, showed no evidence of any additional effect from the combination.
Danish: Data fra et embryo-føtalt udviklingsstudie med rotter viste ingen tegn på yderligere påvirkninger fra kombinationen.
English: Recommended dose:
Danish: Anbefalet dosis:
English: Teva Operations Sp. Z o.o ul, Mogilska 80; 31-546 Krakow, Poland.
Danish: Teva Operations Sp. Z o.o ul, Mogilska 80; 31-546 Krakow, Polen
English: Frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, < 1/100), rare (≥1/10,000, < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppigheder defineres som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til
English: Only negligible amounts of unchanged budesonide have been detected in the urine.
Danish: Der er kun detekteret ubetydelige mængder af uomdannet budesonid i urinen.
English: This is not likely to be relevant for humans given recommended doses.
Danish: Det vil sandsynligvis ikke være relevant for mennesker ved de anbefalede doser.
English: The marketing authorisation holder shall submit PSURs for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: • An increase in the amount of sugar (glucose) in your blood.
Danish: • Forhøjet sukker (glucose) i blodet.
English: In these cases a temporary increase in the dose of oral glucocorticosteroids is sometimes necessary.
Danish: I disse tilfælde er det undertiden nødvendigt midlertidigt at øge dosis af oralt glukokortikoid.
English: Plasma protein binding is approximately 50% for formoterol and 90% for budesonide.
Danish: Plasmaproteinbindingen er ca. 50 % for formoterol og 90 % for budesonid.
English: This dose will be securely held inside the inhaler for when the next inhalation is due.
Danish: Denne dosis holdes forsvarligt inde i inhalatoren, indtil den næste inhalation skal bruges.
English: Increased susceptibility to infections and impairment of the ability to adapt to stress may also occur.
Danish: Øget modtagelighed for infektioner og nedsat evne til at håndtere stress kan også forekomme.
English: Therefore additional systemic corticosteroid cover should be considered during periods of stress such as severe infections or elective surgery.
Danish: Supplerende systemisk kortikosteroidbehandling bør derfor overvejes i perioder med stress, såsom ved svære infektioner eller elektiv kirurgi.
English: Caution with special diseases
Danish: Forsigtighed ved bestemte sygdomme
English: Data on approximately 2000 exposed pregnancies indicate no increased teratogenic risk associated with the use of inhaled budesonide.
Danish: Data fra ca. 2.000 eksponerede graviditeter indikerer, at der ikke er en øget teratogen risiko forbundet med inhaleret budesonid.
English: Sudden and progressive deterioration in control of asthma is potentially life-threatening and the patient should undergo urgent medical assessment.
Danish: Pludselig og tiltagende forværring af kontrollen med astma er potentielt livstruende, og patienten skal øjeblikkeligt tilses af en læge.
English: Your doctor has prescribed this medicine to treat asthma.
Danish: Din læge har ordineret denne medicin til behandling af astma.
English: • you have high blood pressure or you have ever had a heart problem (including an uneven heartbeat, a very fast pulse, narrowing of the arteries or heart failure).
Danish: • Du har højt blodtryk eller nogensinde har haft en hjertelidelse (herunder uregelmæssig hjerterytme, meget hurtig puls, forsnævring af arterierne eller hjertesvigt).
English: • For inhalations remaining from 20 downwards to ‘8', 6','4','2' the numbers are displayed in red on a white background.
Danish: • Når der er 20 inhalationer tilbage, vises tallene nedefter til '8', '6', '4', '2' med rødt på en hvid baggrund.
English: However, do not adjust the number of inhalations your doctor has prescribed without talking to your doctor first.
Danish: Men husk, du må ikke justere antallet af inhalationer, som din læge har ordineret, uden først at have talt med din læge.
English: Budesonide
Danish: Budesonid
English: In this situation, consideration should be given to the need for increased therapy with corticosteroids, e.g. a course of oral corticosteroids, or antibiotic treatment if an infection is present.
Danish: I denne situation bør det overvejes, om der er behov for at intensivere behandlingen med kortikosteroid, f.eks. et forløb med oralt kortikosteroid, eller for antibiotikabehandling, hvis der er infektion.
English: When long-term control of symptoms is maintained with the lowest recommended dose, then the next step could include a test of inhaled corticosteroid alone.
Danish: Når langvarig symptomkontrol opretholdes med den laveste anbefalede dosis, kan det næste skridt omfatte en test af inhaleret kortikosteroid alene.
English: This leaflet was last revised in month YYYY.
Danish: Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ}.
English: • Bronchospasm (tightening of the muscles in the airways which causes wheezing and shortness of breath).
Danish: • Bronkospasme (stramning af musklerne i luftvejene, hvilket forårsager hvæsen og åndenød).
English: In rats, small amounts of formoterol have been detected in maternal milk.
Danish: Hos rotter er der fundet små mængder formoterol i mælken.
English: If you are regularly using up to 8 inhalations a day or you need to increase the amount of ‘reliever inhaler' you require, you should see your doctor as soon as possible.
Danish: Hvis du regelmæssigt anvender op til 8 inhalationer om dagen, eller du har behov for at øge mængden af inhalationer med anfaldsmedicin, bør du kontakte din læge så hurtigt som muligt.
English: Remove the Spiromax from mouth and hold the breath for 10 seconds or as long as comfortable for the patients.
Danish: Tag Spiromax ud af munden og hold vejret i 10 sekunder eller så længe, det føles behageligt.
English: • Do not shake your inhaler before use.
Danish: • Ryst ikke din inhalator før brug.
English: Other possible side effects:
Danish: Andre bivirkninger: