FrancophonIA/ELRC3.0 huggingface dataset:
English: Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Danish: Angiotensin II er en kraftig vasokonstriktor (et stof, der indsnævrer blodkarrene).
English: By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
Danish: Ved at nedsætte blodtrykket mindskes de risici, som er forbundet med højt blodtryk, såsom slagtilfælde.
English: Irbesartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Danish: Irbesartan er en 'angiotensin II-receptorantagonist', hvilket betyder, at den blokerer virkningen af et hormon i kroppen, der kaldes angiotensin II.
English: It works by increasing urine output, reducing the amount of fluid in the blood and lowering the blood pressure.
Danish: Det fremkalder øget urinproduktion og dermed en reduktion af mængden af væske i blodet og en nedsættelse af blodtrykket.
English: By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen.
Danish: Ved at blokere de receptorer, som angiotensin II normalt binder sig til, forhindrer irbesartan hormonet i at virke, hvorved blodkarrene udvider sig.
English: The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Danish: Det vigtigste mål for virkningen var faldet i det diastoliske blodtryk (dvs. blodtrykket målt i hvilefasen mellem to hjerteslag).
English: The most common side effects with Irbesartan Hydrochlorothiazide BMS (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscle).
Danish: De mest almindelige bivirkninger ved Irbesartan Hydrochlorothiazide BMS (der ses hos mellem 1 og 10 patienter ud af 100) er svimmelhed, kvalme eller opkastning, uregelmæssig vandladning, træthed, stigninger i urinkvælstof (BUN, et spaltningsprodukt af protein), forhøjet indhold af kreatinin (et spaltningsprodukt af musklerne) og kreatinkinase (et enzym i musklerne).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) IRBESARTAN HYDROCHLOROTHIAZIDE BMS EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) IRBESARTAN HYDROCHLOROTHIAZIDE BMS EPAR - sammendrag for offentligheden
English: The studies of Karvea/Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Irbesartan Hydrochlorothiazide BMS.
Danish: De undersøgelser, der blev foretaget med Karvea/Aprovel i kombination med hydrochlorothiazid som særskilte tabletter, blev brugt til at understøtte brugen af Irbesartan Hydrochlorothiazide BMS.
English: It is available as oval tablets (peach: 150 mg or 300 mg irbesartan and 12.5 mg hydrochlorothiazide; pink: 300 mg irbesartan and 25 mg hydrochlorothiazide).
Danish: Det fås som ovale tabletter (ferskenfarvede: 150 eller 300 mg irbesartan og 12,5 mg hydrochlorothiazid, lyserøde: 300 mg irbesartan og 25 mg hydrochlorothiazid).
English: It can be used with hydrochlorothiazide to treat hypertension.
Danish: Det kan anvendes sammen med hydrochlorothiazid til behandling af hypertension.
English: The company that makes Karvezide has agreed that its scientific data can be used for Irbesartan Hydrochlorothiazide BMS.
Danish: Virksomheden, som fremstiller Karvezide, har givet tilladelse til, at dets videnskabelige oplysninger må anvendes for Irbesartan Hydrochlorothiazide BMS.
English: Further studies were also carried out with doses of 300 mg irbesartan in combination with 25 mg hydrochlorothiazide.
Danish: Der blev desuden gennemført undersøgelser med doser på 300 mg irbesartan i kombination med 25 mg hydrochlorothiazid.
English: Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension.
Danish: Hydrochlorothiazid er et diuretikum, som er en anden type behandling mod hypertension.
English: Increasing the dose to 300 mg irbesartan and 25 mg hydrochlorothiazide may give a further decrease in blood pressure.
Danish: Ved en dosisforøgelse til 300 mg irbesartan og 25 mg hydrochlorothiazid kan der muligvis opnås en yderligere reduktion af blodtrykket.
English: Irbesartan Hydrochlorothiazide BMS was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure.
Danish: Irbesartan Hydrochlorothiazide BMS var mere effektivt end placebo (en virkningsløs behandling) og hydrochlorothiazid alene til at reducere det diastoliske blodtryk.
English: Doses higher than 300 mg irbesartan and 25 mg hydrochlorothiazide once a day are not recommended.
Danish: Doser på mere end 300 mg irbesartan og 25 mg hydrochlorothiazid en gang dagligt anbefales ikke.
English: Irbesartan Hydrochlorothiazide BMS should not be used in people who may be hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Danish: Irbesartan Hydrochlorothiazide BMS bør ikke anvendes til personer, som kan være overfølsomme (allergiske) over for irbesartan, hydrochlorothiazid, sulfonamider eller andre af indholdsstofferne.
English: The dose of Irbesartan Hydrochlorothiazide BMS to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before.
Danish: Dosen af Irbesartan Hydrochlorothiazide BMS afhænger af den dosis af irbesartan eller hydrochlorothiazid, som patienten tog tidligere.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Irbesartan Hydrochlorothiazide BMS's benefits are greater than its risks for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Irbesartan Hydrochlorothiazide BMS er større end risiciene ved behandling af essentiel hypertension hos voksne patienter, hvis blodtryk ikke kan reguleres tilfredsstillende ved hjælp af irbesartan eller hydrochlorothiazid alene.
English: Care must be taken when using Irbesartan Hydrochlorothiazide BMS with other medicines that have an effect on blood potassium levels.
Danish: Der skal udvises forsigtighed, når Irbesartan Hydrochlorothiazide BMS anvendes sammen med andre lægemidler, som kan påvirke indholdet af kalium i blodet.
English: Irbesartan Hydrochlorothiazide BMS may be added to other treatments for hypertension.
Danish: Irbesartan Hydrochlorothiazide BMS kan bruges som tillægsbehandling til andre behandlinger mod hypertension.
English: Irbesartan Hydrochlorothiazide BMS must also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Danish: Irbesartan Hydrochlorothiazide BMS må heller ikke gives til patienter, som har svære lever-, nyre- eller galdeproblemer, for lavt indhold af kalium i blodet eller for højt indhold af kalcium i blodet.
English: The full EPAR for Irbesartan Hydrochlorothiazide BMS is available here.
Danish: Den fuldstændige EPAR for Irbesartan Hydrochlorothiazide BMS findes her.
English: Irbesartan Hydrochlorothiazide BMS is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Danish: Irbesartan Hydrochlorothiazide BMS er et lægemiddel, der indeholder to aktive stoffer, irbesartan og hydrochlorothiazid.
English: Other information about Irbesartan Hydrochlorothiazide BMS:
Danish: Andre oplysninger om Irbesartan Hydrochlorothiazide BMS:
English: The Committee recommended that Irbesartan Hydrochlorothiazide BMS be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Irbesartan Hydrochlorothiazide BMS.
English: Irbesartan Hydrochlorothiazide BMS contains two active substances, irbesartan and hydrochlorothiazide.
Danish: Irbesartan Hydrochlorothiazide BMS indeholder to aktive stoffer, irbesartan og hydrochlorothiazid.
English: For the full list of all side effects reported with Irbesartan Hydrochlorothiazide BMS, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Irbesartan Hydrochlorothiazide BMS fremgår af indlægssedlen.
English: Irbesartan Hydrochlorothiazide BMS is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled on irbesartan or hydrochlorothiazide alone.
Danish: Irbesartan Hydrochlorothiazide BMS anvendes til voksne med essentiel hypertension (forhøjet blodtryk), når blodtrykket ikke kan reguleres tilfredsstillende ved hjælp af irbesartan eller hydrochlorothiazid alene.
English: Irbesartan Hydrochlorothiazide BMS is taken by mouth, with or without food.
Danish: Irbesartan Hydrochlorothiazide BMS indtages oralt enten ved et måltid eller mellem måltiderne.
English: What is the risk associated with Irbesartan Hydrochlorothiazide BMS?
Danish: Hvilken risiko er der forbundet med Irbesartan Hydrochlorothiazide BMS?
English: Why has Irbesartan Hydrochlorothiazide BMS been approved?
Danish: Hvorfor blev Irbesartan Hydrochlorothiazide BMS godkendt?
English: What is Irbesartan Hydrochlorothiazide BMS?
Danish: Hvad er Irbesartan Hydrochlorothiazide BMS?
English: How has Irbesartan Hydrochlorothiazide BMS been studied?
Danish: Hvordan blev Irbesartan Hydrochlorothiazide BMS undersøgt?
English: How is Irbesartan Hydrochlorothiazide BMS used?
Danish: Hvordan anvendes Irbesartan Hydrochlorothiazide BMS?
English: What is Irbesartan Hydrochlorothiazide BMS used for?
Danish: Hvad anvendes Irbesartan Hydrochlorothiazide BMS til?
English: What benefit has Irbesartan Hydrochlorothiazide BMS shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Irbesartan Hydrochlorothiazide BMS?
English: How does Irbesartan Hydrochlorothiazide BMS work?
Danish: Hvordan virker Irbesartan Hydrochlorothiazide BMS?
English: You may need to read it again.
Danish: Du kan få brug for at læse den igen.
English: This will help to keep you free of symptoms throughout the day and night.
Danish: Dette vil hjælpe med at holde dig symptomfri igennem hele dagen og natten.
English: Hold this breath in for as long as possible (at least 3-4 seconds).
Danish: Hold vejret så længe som muligt (i mindst 3-4 sekunder).
English: An updated RMP should be submitted:
Danish: En opdateret RMP skal fremsendes:
English: • Risk Management Plan (RMP)
Danish: • Risikostyringsplan (RMP)
English: • At the request of the European Medicines Agency;
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur
English: Date of first authorisation: 20th March 2017
Danish: Dato for første markedsføringstilladelse: 20. marts 2017
English: A risk to breastfed newborns/infants cannot be excluded.
Danish: En risiko for nyfødte/spædbørn kan ikke udelukkes.
English: 55 micrograms
Danish: 55 mikrogram
English: If your symptoms do not improve
Danish: Hvis dine symptomer ikke aftager
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING
English: No formal statistical testing was performed on this endpoint.
Danish: Der blev ikke foretaget nogen formel statistisk testning på dette endepunkt.
English: You only need to inhale once a day because the effect of this medicine lasts for 24 hours.
Danish: Du behøver kun at inhalere én gang om dagen, da virkningen af denne medicin holder i 24 timer.
English: This medicinal product is subject to additional monitoring.
Danish: Dette lægemiddel er underlagt supplerende overvågning.
English: Component of a multipack can't be sold separately.
Danish: Del af en multipakning, må ikke sælges separat.
English: Systemic exposure to the metabolites is low.
Danish: Den systemiske eksponering over for metabolitterne er lav.
English: Once daily
Danish: Én gang daglig
English: Allergic reactions are uncommon (may affect up to 1 in 100 people).
Danish: Allergiske reaktioner er ikke almindeligt (kan forekomme hos op til 1 ud af 100 personer).
English: Health-related quality of life:
Danish: Helbredsrelateret livskvalitet:
English: See section 4.
Danish: Se punkt 4.
English: Do not store above 30°C.
Danish: Må ikke opbevares ved temperaturer over 30 °C.
English: Children and adolescents Do not give this medicine to children or adolescents below the age of 18 years.
Danish: Giv ikke denne medicin til børn eller unge under 18 år.
English: Not all pack sizes may be marketed.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: Deterioration of disease
Danish: Forværring af sygdom
English: Just inhale your next dose at the usual time.
Danish: Fortsæt blot med den næste dosis på det sædvanlige tidspunkt.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som alle andre lægemidler give bivirkninger, men ikke alle får bivirkninger.
English: This includes 576 patients who received the recommended dose of 55 micrograms once daily.
Danish: Dette omfatter 576 patienter, der fik den anbefalede dosis på 55 mikrogram én gang daglig.
English: Characteristics in specific groups of subjects or patients
Danish: Karakteristika hos specifikke grupper af raske personer eller patienter
English: Rolufta Ellipta should be administered once daily at the same time of the day each day to maintain bronchodilation.
Danish: Rolufta Ellipta skal administreres én gang daglig på samme tidspunkt hver dag for at opretholde bronkodilatation.
English: • infection of nose and throat
Danish: • infektion i næsen og halsen
English: Other side effects have occurred in a very small number of people but their exact frequency is unknown (cannot be estimated from the available data):
Danish: Andre bivirkninger er forekommet hos et mindre antal personer, den præcise hyppighed kendes ikke (kan ikke estimeres ud fra forhåndenværende data):
English: This will allow quick identification of new safety information.
Danish: Dermed kan der hurtigt tilvejebringes nye oplysninger om sikkerheden.
English: In vitro plasma protein binding in human plasma was on average 89%.
Danish: In vitro var human plasmaproteinbinding i gennemsnit 89 %.
English: *A step-down statistical testing procedure was used in this study and this comparison was below a comparison that did not achieve statistical significance.
Danish: ∗ En statistisk testprocedure med trinvis reduktion blev benyttet i dette studie, og denne sammenligning lå under en sammenligning, hvor der ikke blev opnået statistisk signifikans.
English: You can help by reporting any side effects you may get.
Danish: Du kan hjælpe ved at indberette alle de bivirkninger, du får.
English: System Organ Class
Danish: Systemorganklasse
English: Elderly patients
Danish: Ældre patienter
English: 4.7 Effects on ability to drive and use machines
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner
English: It will only be effective as long as you are using it. Don't stop unless your doctor advises you to, even if you feel better, as your symptoms may get worse.
Danish: Medicinen virker kun, så længe du tager den. Du må ikke stoppe behandlingen, medmindre lægen foreskriver det, heller ikke selvom du får det bedre, da dine symptomer kan blive værre.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: You may notice that your heart is beating faster than usual, you have visual disturbances or have a dry mouth.
Danish: Du kan opleve, at dit hjerte slår hurtigere end normalt, at du får synsforstyrrelser eller at du får tør mund.
English: In addition, patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies.
Danish: Patienter med klinisk signifikant ukontrolleret kardiovaskulær sygdom blev udelukket fra de kliniske studier.
English: Use this medicine for as long as your doctor recommends.
Danish: Tag denne medicin så længe, som lægen anbefaler.
English: After this date the inhaler should no longer be used.
Danish: Efter denne dato må inhalatoren ikke længere anvendes.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ENHEDER
English: This leaflet was last revised in Other sources of information
Danish: Denne indlægsseddel blev senest ændret Andre informationskilder
English: It is unlikely that this medicine will affect your ability to drive or use machines.
Danish: Det er ikke sandsynligt, at denne medicin vil påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: Allergic reactions
Danish: Allergiske reaktioner
English: These studies were not specifically designed to evaluate the effect of treatments on COPD exacerbations and patients were withdrawn from the study if an exacerbation occurred.
Danish: Disse studier var ikke specifikt designet til at evaluere effekten af behandling på KOLeksacerbationer og patienter blev trukket ud af studiet, hvis en eksacerbation opstod.
English: • Breathe out slowly and gently.
Danish: • Pust stille og roligt ud.
English: Not known Not known
Danish: Ikke kendt Ikke kendt
English: Umeclidinium bromide should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the fetus.
Danish: Umeclidiniumbromid bør kun anvendes under graviditet, hvis den forventede fordel for moderen opvejer den potentielle risiko for fostret.
English: It is not possible to accidentally take extra medicine or a double dose in one inhalation.
Danish: Det er ikke muligt ved et tilfælde at komme til at tage for meget medicin eller tage en dobbelt dosis i én inhalation.
English: 4.6 Fertility, pregnancy and lactation
Danish: 4.6 Fertilitet, graviditet og amning
English: Umeclidinium bromide was not teratogenic in rats or rabbits.
Danish: Umeclidiniumbromid var ikke teratogent i rotter eller kaniner.
English: - if you are allergic to umeclidinium or any of the other ingredients of this medicine (listed in section
Danish: - hvis du er allergisk over for umeclidinium, eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Metabolic and transporter based interactions
Danish: Metaboliske og transporterrelaterede interaktioner
English: Following intravenous administration to healthy subjects, the mean volume of distribution was 86 litres.
Danish: Efter intravenøs administration til raske personer var det gennemsnitlige distributionsvolumen 86 liter.
English: The recommended dose is one inhalation every day at the same time of day.
Danish: Den anbefalede dosis er én inhalation hver dag på samme tidspunkt.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendix V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår reproduktionstoksicitet (se pkt.
English: When used regularly, it can help control your breathing difficulties and reduce the effects of COPD on your everyday life.
Danish: Når medicinen tages regelmæssigt, kan den hjælpe med at holde dine vejrtrækningsproblemer under kontrol og mindske påvirkningen af KOL i din dagligdag.
English: This medicine blocks the tightening of these muscles, making it easier for air to get in and out of the lungs.
Danish: Denne medicin modvirker stramning af disse muskler, så luften lettere kan komme ind og ud af lungerne.
English: Plasma clearance following intravenous administration was 151 litres/hour.
Danish: Efter intravenøs administration var plasmaclearance 151 liter/time.
English: BATCH NUMBER
Danish: BATCHNUMMER
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: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: Paradoxical bronchospasm
Danish: Paradoks bronkospasme
English: It is very important that you use Rolufta Ellipta every day, as instructed by your doctor.
Danish: Det er meget vigtigt, at du tager Rolufta Ellipta hver dag nøjagtigt efter lægens anvisning.
English: See the end of section 4 for how to report side effects.
Danish: Se sidst i punkt 4, hvordan du indberetter bivirkninger.
English: Paediatric population
Danish: Pædiatrisk population
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Therefore, statistical significance on this comparison cannot be inferred.
Danish: Derfor kan der ud fra denne sammenligning ikke udledes statistisk signifikans.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Danish: I tilfælde af overdosering skal patienten have understøttende behandling og monitoreres efter behov.
English: Warnings and precautions
Danish: Advarsler og forsigtighedsregler
English: Description
Danish: Beskrivelse
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Danish: KLINISKE OPLYSNINGER 4.1 Terapeutiske indikationer
English: Do not pass it on to others.
Danish: Lad derfor være med at give medicinen til andre.
English: Hypersensitivity reactions including: Rash, urticaria and pruritus
Danish: Overfølsomhedsreaktioner, herunder: udslæt, urticaria og pruritus
English: Acute symptoms should be treated with an inhaled short-acting bronchodilator.
Danish: Akutte symptomer bør behandles med en inhaleret korttidsvirkende bronkodilatator.
English: These may affect up to 1 in 1,000 people: • eye pain
Danish: Kan forekomme hos op til 1 ud af 1000 personer: • øjensmerter.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic Safety Update Reports
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: • Remove the inhaler from the mouth.
Danish: • Fjern inhalatoren fra munden.
English: Supporting efficacy studies
Danish: Understøttende virkningsstudier
English: Umeclidinium bromide should not be used in patients with asthma since it has not been studied in this patient population.
Danish: Umeclidiniumbromid bør ikke anvendes til patienter med astma, da det ikke er undersøgt hos denne patientpopulation.