FrancophonIA/ELRC3.0 huggingface dataset:
English: Irbesartan Zentiva 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Danish: Irbesartan Zentiva 300 mg tabletter leveres i blisterpakninger af 14, 28, 56 eller 98 tabletter.
English: Irbesartan Zentiva 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Danish: Irbesartan Zentiva 150 mg tabletter leveres i blisterpakninger af 14, 28, 56 eller 98 tabletter.
English: Package leaflet: Information for the user Irbesartan Zentiva 75 mg tablets irbesartan
Danish: Indlægsseddel: Information til brugeren Irbesartan Zentiva 75 mg tabletter irbesartan
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 300 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN Irbesartan Zentiva 300 mg filmovertrukne tabletter.
English: MARKETING AUTHORISATION NUMBERS EU/1/06/376/016-021
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/06/376/011-015
English: Package leaflet: Information for the user Irbesartan Zentiva 300 mg tablets irbesartan
Danish: Indlægsseddel: Information til brugeren Irbesartan Zentiva 300 mg tabletter irbesartan
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid Irbesartan Zentiva nøjagtigt efter lægens anvisning.
English: Package leaflet: Information for the user Irbesartan Zentiva 75 mg film-coated tablets irbesartan
Danish: Indlægsseddel: Information til brugeren Irbesartan Zentiva 75 mg filmovertrukne tabletter irbesartan
English: Irbesartan Zentiva 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Danish: Irbesartan Zentiva 300 mg filmovertrukne tabletter leveres i blisterpakninger af 14, 28, 30, 56, 84, 90 eller 98 filmovertrukne tabletter.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 150 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN Irbesartan Zentiva 150 mg filmovertrukne tabletter.
English: EU/1/06/376/011 - 14 tablets EU/1/06/376/012 - 28 tablets EU/1/06/376/013 - 56 tablets EU/1/06/376/014 - 56 x 1 tablets EU/1/06/376/015 - 98 tablets
Danish: EU/1/06/376/011 - 14 tabletter EU/1/06/376/012 - 28 tabletter EU/1/06/376/013 - 56 tabletter EU/1/06/376/014 - 56 x 1 tabletter EU/1/06/376/015 - 98 tabletter
English: What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Danish: Irbesartan Zentiva 75 mg tabletter er hvide til mathvide, bikonvekse og ovale med et hjerte præget på den ene side og nummeret 2771 på den anden side.
English: Irbesartan Zentiva 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Danish: Irbesartan Zentiva 75 mg filmovertrukne tabletter leveres i blisterpakninger af 14, 28, 30, 56, 84, 90 eller 98 filmovertrukne tabletter.
English: Package leaflet: Information for the user Irbesartan Zentiva 150 mg tablets irbesartan
Danish: Indlægsseddel: Information til brugeren Irbesartan Zentiva 150 mg tabletter irbesartan
English: Irbesartan Zentiva 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Danish: Irbesartan Zentiva 150 mg filmovertrukne tabletter leveres i blisterpakninger af 14, 28, 30, 56, 84, 90 eller 98 filmovertrukne tabletter.
English: MARKETING AUTHORISATION NUMBERS EU/1/06/376/028-033
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/06/376/001-005
English: Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Danish: Patienter med højt blodtryk og type 2 diabetes med nyresygom Hos patienter med højt blodtryk og type 2 diabetes er 300 mg 1 gang dagligt (fire tabletter dagligt) den foretrukne vedligeholdelsesdosis til behandling af ledsagende nyresygdom.
English: Package leaflet: Information for the user Irbesartan Zentiva 300 mg film-coated tablets irbesartan
Danish: Indlægsseddel: Information til brugeren Irbesartan Zentiva 300 mg filmovertrukne tabletter irbesartan
English: What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Danish: Irbesartan Zentiva 75 mg filmovertrukne tabletter er hvide til mathvide, bikonvekse og ovale med et hjerte præget på den ene side og nummeret 2871 på den anden side.
English: Package leaflet: Information for the user Irbesartan Zentiva 150 mg film-coated tablets irbesartan
Danish: Indlægsseddel: Information til brugeren Irbesartan Zentiva 150 mg filmovertrukne tabletter irbesartan
English: What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 300 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.
Danish: Irbesartan Zentiva 300 mg tabletter er hvide til mathvide, bikonvekse og ovale med et hjerte præget på den ene side og nummeret 2773 på den anden side.
English: EU/1/06/376/006 - 14 tablets EU/1/06/376/007 - 28 tablets EU/1/06/376/008 - 56 tablets EU/1/06/376/009 - 56 x 1 tablets EU/1/06/376/010 - 98 tablets
Danish: EU/1/06/376/006 - 14 tabletter EU/1/06/376/007 - 28 tabletter EU/1/06/376/008 - 56 tabletter EU/1/06/376/009 - 56 x 1 tabletter EU/1/06/376/010 - 98 tabletter
English: Other medicines and Irbesartan Zentiva
Danish: Børn og unge må ikke få Irbesartan Zentiva
English: EU/1/06/376/001 - 14 tablets EU/1/06/376/002 - 28 tablets EU/1/06/376/003 - 56 tablets EU/1/06/376/004 - 56 x 1 tablets EU/1/06/376/005 - 98 tablets
Danish: EU/1/06/376/001 - 14 tabletter EU/1/06/376/002 - 28 tabletter EU/1/06/376/003 - 56 tabletter EU/1/06/376/004 - 56 x 1 tabletter EU/1/06/376/005 - 98 tabletter
English: What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.
Danish: Irbesartan Zentiva 300 mg filmovertrukne tabletter er hvide til mathvide, bikonvekse og ovale med et hjerte præget på den ene side og nummeret 2873 på den anden side.
English: Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme).
Danish: Almindelig (kan påvirke op til 1 ud af 10 patienter): svimmelhed, kvalme/opkastning, træthed og blodprøver, der viser en forhøjet mængde af et enzym, der måler muskel- og hjertefunktionen (kreatinin-kinase-enzym).Der er hos patienter med forhøjet blodtryk og type 2-diabetes med nyresygdom også indberettet svimmelhed, når man rejser sig op fra liggende eller siddende stilling, lavt blodtryk når man rejser sig op fra liggende eller siddende stilling, led- og muskelsmerter og en nedsat mængde protein i de røde blodlegemer (hæmoglobin).
English: MARKETING AUTHORISATION NUMBERS EU/1/06/376/022-027
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/06/376/006-010
English: EU/1/06/376/022 - 14 tablets EU/1/06/376/023 - 28 tablets EU/1/06/376/036 - 30 tablets EU/1/06/376/024 - 56 tablets EU/1/06/376/025 - 56 x 1 tablets EU/1/06/376/026 - 84 tablets EU/1/06/376/037 - 90 tablets EU/1/06/376/027 - 98 tablets
Danish: EU/1/06/376/022 - 14 tabletter EU/1/06/376/023 - 28 tabletter EU/1/06/376/036 - 30 tabletter EU/1/06/376/024 - 56 tabletter EU/1/06/376/025 - 56 x 1 tabletter EU/1/06/376/026 - 84 tabletter EU/1/06/376/037 - 90 tabletter EU/1/06/376/027 - 98 tabletter
English: What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Danish: Irbesartan Zentiva 150 mg filmovertrukne tabletter er hvide til mathvide, bikonvekse og ovale med et hjerte præget på den ene side og nummeret 2872 på den anden side.
English: EU/1/06/376/016 - 14 tablets EU/1/06/376/017 - 28 tablets EU/1/06/376/034 - 30 tablets EU/1/06/376/018 - 56 tablets EU/1/06/376/019 - 56 x 1 tablets EU/1/06/376/020 - 84 tablets EU/1/06/376/035 - 90 tablets EU/1/06/376/021 - 98 tablets
Danish: EU/1/06/376/016 - 14 tabletter EU/1/06/376/017 - 28 tabletter EU/1/06/376/034 - 30 tabletter EU/1/06/376/018 - 56 tabletter EU/1/06/376/019 - 56 x 1 tabletter EU/1/06/376/020 - 84 tabletter EU/1/06/376/035 - 90 tabletter EU/1/06/376/021 - 98 tabletter
English: What Irbesartan Zentiva looks like and contents of the pack Irbesartan Zentiva 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
Danish: Irbesartan Zentiva 150 mg tabletter er hvide til mathvide, bikonvekse og ovale med et hjerte præget på den ene side og nummeret 2772 på den anden side.
English: Österreich Zentiva, k.s.
Danish: Danmark Zentiva, k.s.
English: EU/1/06/376/028 - 14 tablets EU/1/06/376/029 - 28 tablets EU/1/06/376/038 - 30 tablets EU/1/06/376/030 - 56 tablets EU/1/06/376/031 - 56 x 1 tablets EU/1/06/376/032 - 84 tablets EU/1/06/376/039 - 90 tablets EU/1/06/376/033 - 98 tablets
Danish: EU/1/06/376/028 - 14 tabletter EU/1/06/376/029 - 28 tabletter EU/1/06/376/038 - 30 tabletter EU/1/06/376/030 - 56 tabletter EU/1/06/376/031 - 56 x 1 tabletter EU/1/06/376/032 - 84 tabletter EU/1/06/376/039 - 90 tabletter EU/1/06/376/033 - 98 tabletter
English: Irbesartan Zentiva prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Danish: Irbesartan Zentiva forebygger at angiotensin-II binder sig til disse receptorer.
English: Metabolism and nutrition disorders
Danish: Blod og lymfesystem
English: Aliskiren-containing products or ACE-inhibitors: clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Danish: II-receptorblokkere eller aliskiren er forbundet med en højere frekvens af bivirkninger såsom hypotension, hyperkaliæmi og nedsat nyrefunktion (inklusive akut nyresvigt) sammenlignet med brug af et enkelt RAAS-virkende stof (se pkt.
English: PV-Greece@zentiva.com
Danish: PV-Norway@zentiva.com
English: PV-Austria@zentiva.com
Danish: PV-Estonia@zentiva.com
English: Annex III Conditions for lifting the suspension
Danish: Bilag III Betingelser for ophævelse af suspenderingen
English: New clinical and bioanalytical studies are performed and submitted to the relevant national competent authorities.
Danish: Der udføres nye kliniske og bioanalytiske undersøgelser, og disse indsendes til de relevante kompetente nationale myndigheder.
English: Prior to the lifting of the suspension of the marketing authorisations, the national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Danish: Før suspenderingen af markedsføringstilladelserne kan ophæves, skal de nationale kompetente myndigheder koordineret af referencemedlemsstaten sikre, at følgende betingelser opfyldes af indehaveren af markedsføringstilladelsen:
English: The marketing authorisation holder should demonstrate therapeutic equivalence based on a clinical and bioanalytical study performed in compliance with GCP requirements.
Danish: Indehaveren af markedsføringstilladelsen skal påvise den terapeutiske ækvivalens ud fra en klinisk og bioanalytisk undersøgelse udført i overensstemmelse med GCP-kravene.
English: Read this before you start
Danish: Læs dette, inden du starter
English: Hold this breath for as long as possible (at least 3-4 seconds).
Danish: Hold vejret så længe som muligt (i mindst 3-4 sekunder).
English: This will help to keep you free of symptoms throughout the day and night.
Danish: Det vil hjælpe med at holde dig symptomfri hele dagen og hele natten.
English: Date of latest renewal: 26 July 2018
Danish: Dato for seneste fornyelse: 26. juli 2018
English: How much to use
Danish: Hvor meget skal der tages
English: No risk factors were identified.
Danish: Der blev ikke identificeret nogen risikofaktorer.
English: Ratio vs VI
Danish: Ratio versus VI
English: Results for the primary and key secondary endpoints in these studies are described in Table 1.
Danish: Resultaterne af de primære og vigtigste sekundære endepunkter i disse studier er angivet i tabel 1.
English: Elderly patients (> 65 years old)
Danish: Ældre patienter (> 65 år)
English: These differences are unlikely to be of clinical relevance.
Danish: Disse forskelle har sandsynligvis ikke klinisk relevans.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 November 2013
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 13. november 2013
English: When it is taken regularly, it helps the small air passages to remain open.
Danish: Når det tages regelmæssigt, er det med til at holde de små luftveje åbne.
English: It should be administered at the same time of the day, each day.
Danish: Den skal administreres på samme tidspunkt hver dag.
English: Children aged under 12 years
Danish: Børn under 12 år
English: A risk to breastfed newborns/infants cannot be excluded.
Danish: En risiko for ammede nyfødte/spædbørn kan ikke udelukkes.
English: Do not block the air-vents with your fingers.
Danish: Spær ikke for luftkanalerne med dine fingre.
English: Studies > 1 year duration
Danish: Studier > 1 års varighed
English: Just take your next dose at the usual time.
Danish: Tag blot den næste dosis på det sædvanlige tidspunkt.
English: Symptoms and signs
Danish: Symptomer og tegn
English: Treatment Dose of FF/VI*(micrograms)
Danish: Behandlingsdosis af FF/VI*(mikrogram)
English: This dose is also used once daily at the same time each day.
Danish: Denne dosis skal også tages én gang dagligt på samme tidspunkt hver dag.
English: • suddenly feeling weak or light headed (which may lead to collapse or loss of consciousness)
Danish: • pludselig svaghedsfornemmelse eller svimmelhed (kan føre til kollaps eller bevidstløshed).
English: It is not known whether the ingredients of this medicine can pass into breast milk.
Danish: Det vides ikke, om indholdsstofferne i dette lægemiddel kan gå over i modermælken.
English: Gender, weight and BMI
Danish: Køn, vægt og BMI
English: See section 4 for information on symptoms to look out for while you are using this medicine.
Danish: Se punkt 4 for oplysninger om de symptomer, du skal være opmærksom på, mens du tager dette lægemiddel.
English: When you take these two active substances together regularly, they will help to control your breathing difficulties more than either medicine alone.
Danish: Når du regelmæssigt tager disse to aktive stoffer sammen, hjælper de med at holde dine vejrtrækningsproblemer under kontrol i højere grad, end hvis du tog de to lægemidler hver for sig.
English: Allergic reactions to Relvar Ellipta are rare (may affect up to 1 in 1,000 people).
Danish: Allergiske reaktioner over for Relvar Ellipta er sjældne (kan forekomme hos op til 1 ud af 1.000 personer).
English: There are no fertility data in humans.
Danish: Der foreligger ingen data vedrørende fertilitet hos mennesker.
English: Adverse reactions are listed by system organ class and frequency.
Danish: Bivirkningerne står anført efter systemorganklasser og hyppighed.
English: Multipack: 90 (3 packs of 30) doses
Danish: Multipakning: 90 (3 pakninger med 30) doser
English: Use Relvar Ellipta at the same time each day as it is effective over 24 hours It is very important that you use this medicine every day, as instructed by your doctor.
Danish: Tag Relvar Ellipta på samme tidspunkt hver dag, da det virker i 24 timer Det er meget vigtigt, at du tager dette lægemiddel hver dag i henhold til lægens anvisninger.
English: No dosage adjustment is necessary based on gender, weight or BMI.
Danish: Dosisjustering på baggrund af køn, vægt eller BMI er ikke nødvendig.
English: You may notice that your heart is beating faster than usual, you feel shaky or have a headache.
Danish: Du kan opleve, at dit hjerte slår hurtigere end normalt, at du ryster, eller at du får hovedpine.
English: Concurrent use of both non-selective and selective beta2-adrenergic blockers should be avoided unless there are compelling reasons for their use.
Danish: Samtidig brug af både ikke-selektive og selektive beta2-adrenerge blokkere bør undgås, medmindre der er tvingende grunde hertil.
English: Moderate and severe exacerbations Adjusted mean annual rate
Danish: Moderate og svære eksacerbationer Justeret gennemsnitlig årlig rate
English: NAME OF THE MARKETING AUTHORISATION HOLDER GSK Logo
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN GSK logo
English: Table 2: Analysis of Exacerbation Rates following 12 months of treatment
Danish: Tabel 2: Analyse af eksacerbationsrater efter 12 måneders behandling
English: Adults aged 18 years and over
Danish: Voksne på 18 år og derover
English: • pain and irritation in the back of the mouth and throat
Danish: • smerte og irritation bagest i munden og svælget
English: You do not need to prepare Relvar Ellipta in any special way, not even the first time you use it.
Danish: Du behøver ikke at klargøre Relvar Ellipta på nogen særlig måde, ikke engang den første gang du skal bruge den.
English: Some medicines may affect how this medicine works, or make it more likely that you will have side effects.
Danish: Nogle lægemidler kan påvirke virkningen af dette lægemiddel eller gøre det mere sandsynligt, at du får bivirkninger.
English: **Fractures
Danish: **Frakturer
English: The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Danish: Dosis skal titreres til laveste dosis, der giver effektiv symptomkontrol.
English: The primary endpoint was the annual rate of moderate and severe exacerbations.
Danish: Det primære endepunkt var årlig rate af moderate og svære eksacerbationer.
English: These effects are much less likely to occur than with oral corticosteroids.
Danish: Disse bivirkninger er langt mindre sandsynlige end ved oral steroidbehandling.
English: • weakening of the bones, leading to fractures
Danish: • svækkelse af knoglerne, hvilket kan medføre knoglebrud
English: • swelling, sometimes of the face or mouth (angioedema)
Danish: • hævelse, nogle gange i ansigtet eller i munden (angioødem)
English: If a dose is missed the next dose should be taken at the usual time the next day.
Danish: Hvis patienten glemmer en dosis, skal den næste dosis tages på det sædvanlige tidspunkt dagen efter.
English: • Remove the inhaler from your mouth.
Danish: • Fjern inhalatoren fra munden.
English: Pneumonia*
Danish: Pneumoni*
English: HZA106837 was of variable treatment duration (from a minimum of 24 weeks to a maximum of 76 weeks with the majority of patients treated for at least 52 weeks).
Danish: HZA106837 var med variabel behandlingstid (fra minimum 24 uger til maksimalt 76 uger, hvor de fleste patienter blev behandlet i mindst 52 uger).
English: The dose counter counts down by 1 to confirm.
Danish: Dosistælleren har talt 1 ned som bekræftelse.
English: Table 1 - Results of primary and key secondary endpoints in HZA106827 and HZA106829
Danish: Tabel 1 - Resultat af primære og vigtigste sekundære endepunkter i HZA106827 og HZA106829
English: In the 12 months prior to the study, 61% of subjects reported no COPD exacerbations and 39% of subjects reported ≥1 moderate/severe COPD exacerbation.
Danish: I de 12 måneder forud for studiet, rapporterede 61 % af personerne ingen KOL eksacerbationer og 39 % af personerne rapporterede ≥1 moderat/svær KOL eksacerbation.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (Pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl
English: The step-by-step instructions should be followed.
Danish: Den trinvise brugervejledning skal følges.
English: Your medicine is now ready to be inhaled.
Danish: Din medicin er nu klar til at blive inhaleret.
English: No dose adjustment is required in this population (see section 5.2).
Danish: Dosisjustering er ikke nødvendig i denne population (se pkt.
English: Adults and adolescents aged 12 years and over
Danish: Voksne og unge i alderen 12 år og derover
English: The final decision on evening or morning dosing should be left to the discretion of the physician.
Danish: Den endelige beslutning om, hvorvidt der skal doseres om aftenen eller om morgenen, bør træffes af lægen.
English: This is because larger doses of Relvar Ellipta may reduce the amount of steroid hormones produced naturally by your body.
Danish: Det skyldes, at store doser af Relvar Ellipta kan nedsætte mængden af det steroidhormon, du danner naturligt i kroppen.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet efter faldende grad af alvorlighed.
English: • increase in blood sugar (hyperglycaemia)
Danish: • stigning i blodsukker (hyperglykæmi).
English: • sore, raised patches in the mouth or throat caused by a fungal infection (candidiasis).
Danish: • ømme, hævede pletter i munden eller svælget på grund af en svampeinfektion (candidiasis).
English: 92/22 micrograms
Danish: 92/22 mikrogram
English: Take one long, steady, deep breath in.
Danish: Foretag en lang, stabil, dyb indånding.
English: If you have used more than instructed for a long period of time, it is particularly important that you ask your doctor or pharmacist for advice.
Danish: Hvis du har taget mere, end lægen har anvist, i en længere periode, er det særligt vigtigt, at du kontakter lægen eller apoteket med henblik på rådgivning.
English: Immediate breathing difficulties after using Relvar Ellipta are rare.
Danish: Akutte vejrtrækningsproblemer efter brug af Relvar Ellipta er sjældne.
English: All subjects had to have been on a stable dose of an ICS for at least 4 weeks prior to visit 1 (screening visit) and the use of LABAs was not permitted within 4 weeks of visit 1.
Danish: Alle patienter skulle have været på en stabil dosis af ICS i mindst 4 uger inden besøg 1 (screeningsbesøg), og det var ikke tilladt at anvende LABA i 4 uger inden besøg 1.
English: However, there was no evidence for the higher systemic exposure in this population to be associated with greater effect on 24 hour urinary cortisol excretion.
Danish: Der var dog ingen evidens for, at den højere systemiske eksponering i denne population var forbundet med større effekt på urinudskillelsen af kortisol over 24 timer.
English: The following convention has been used for the classification of frequencies: 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: Følgende konvention er anvendt til klassificering af hyppighed: 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: METHOD AND ROUTE(S) OF ADMINISTRATION ONCE DAILY
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) ÉN GANG DAGLIG
English: With the exception of pneumonia and fractures, the safety profile was similar in patients with asthma and COPD.
Danish: Med undtagelse af pneumoni og frakturer var sikkerhedsprofilen ens hos patienter med astma og KOL.