FrancophonIA/ELRC3.0 huggingface dataset:
English: Repaglinide Teva may also be used with metformin (another anti-diabetes medicine) in type 2 diabetes patients whose blood glucose levels are not satisfactorily controlled on metformin alone.
Danish: Repaglinid Teva kan også anvendes i kombination med metformin (et andet lægemiddel mod diabetes) til patienter med type 2-diabetes, hvis glukoseniveau ikke er tilstrækkeligt kontrolleret med metformin alene.
English: Repaglinide Teva can also be used for type 2 diabetes patients whose blood glucose levels are usually controlled well on diet, but are experiencing temporary loss of blood glucose control.
Danish: Repaglinid Teva kan også anvendes til patienter med type 2-diabetes, hvis blodglukoseniveau normalt kontrolleres tilfredsstillende med diæt, men hvor blodglukosen midlertidigt ikke er under kontrol.
English: What is Repaglinide Teva?
Danish: Hvad er Repaglinid Teva?
English: How has Repaglinide Teva been studied?
Danish: Hvordan blev Repaglinid Teva undersøgt?
English: What is Repaglinide Teva used for?
Danish: Hvad anvendes Repaglinid Teva til?
English: How is Repaglinide Teva used?
Danish: Hvordan anvendes Repaglinid Teva?
English: How does Repaglinide Teva work?
Danish: Hvordan virker Repaglinid Teva?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aerius on 15 January 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Aerius den 15. januar 2001.
English: The full EPAR for Aerius can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Aerius findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Aerius.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Aerius.
English: Other information about Aerius
Danish: Andre oplysninger om Aerius
English: Aerius has also been studied in 416 patients with urticaria.
Danish: Aerius blev også undersøgt hos 416 patienter med urticaria.
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 Aerius.
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 Aerius.
English: In all studies, the effectiveness of Aerius was compared with that of placebo (a dummy treatment).
Danish: I alle undersøgelserne blev virkningen af Aerius sammenlignet med placebo (virkningsløs behandling).
English: The active substance in Aerius, desloratadine, is an antihistamine.
Danish: Det aktive stof i Aerius, desloratadin, er et antihistamin.
English: Aerius is a medicine containing the active substance desloratadine.
Danish: Aerius er et lægemiddel, der indeholder det aktive stof desloratadin.
English: For more information about treatment with Aerius, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Aerius, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In the two studies in urticaria, the decrease in symptom score after six weeks of treatment with Aerius was 58 and 67%, compared with 40 and 33% in placebo-treated patients.
Danish: I de to undersøgelser af urticaria var faldet i symptomscoren efter seks ugers behandling med Aerius 58 % og 67 % sammenlignet med 40 % og 33 % for patienter behandlet med placebo.
English: Aerius has been studied in a total of eight studies involving about 4,800 adult and adolescent patients with allergic rhinitis (including four studies in seasonal allergic rhinitis, and two studies in patients who also had asthma).
Danish: Aerius blev undersøgt i otte undersøgelser i alt, som omfattede 4 800 voksne og unge med allergisk rhinitis (herunder fire undersøgelser af sæsonbestemt allergisk rhinitis og to undersøgelser af patienter, som også havde astma).
English: The CHMP decided that Aerius's benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Aerius opvejer risiciene ved lindring af symptomer forbundet med allergisk rhinitis eller urticaria og anbefalede udstedelse af markedsføringstilladelse.
English: Aerius must not be used in people who are hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.
Danish: Aerius må ikke anvendes til personer, som er overfølsomme (allergiske) over for desloratadin, loratadin eller et af de øvrige indholdsstoffer.
English: What is the risk associated with Aerius?
Danish: Hvilken risiko er der forbundet med Aerius?
English: In children less than two years of age, the most common side effects are diarrhoea (3.7%), fever (2.3%) and insomnia (difficulty sleeping; 2.3%).
Danish: Hos børn under toårsalderen var de hyppigste bivirkninger diarré (3,7 %), feber (2,3 %) og søvnløshed (2,3 %).
English: For the full list of all side effects reported with Aerius, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Aerius fremgår af indlægssedlen.
English: In allergic rhinitis, looking at the results of all studies taken together, two weeks of treatment with 5 mg Aerius led to an average decrease in symptom score of 25 to 32%, compared with a decrease of 12 to 26% in the patients receiving placebo.
Danish: Til allergisk rhinitis førte en to ugers behandling med Aerius 5 mg, hvis man ser på resultaterne af alle undersøgelserne taget under et, til et fald i symptomscoren på gennemsnitlig 25 til 32 % sammenlignet med et fald på 12 til 26 % hos patienter, som fik placebo.
English: Aerius is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Danish: Aerius anvendes til lindring af symptomer på allergisk rhinitis (betændelse i næsepassagerne, som forårsages af allergi, f.eks. høfeber eller allergi over for støvmider) eller urticaria (en hudlidelse forårsaget af allergi med symptomer, der omfatter kløe og nældefeber).
English: The effectiveness of Aerius was measured by looking at the change in the symptoms (nasal discharge, itching, sneezing and congestion) before and after two or four weeks of treatment.
Danish: Effekten af Aerius blev målt ved at se på ændringen i symptomerne (næseflåd, kløe, nysen, tilstopning) før og efter to eller fire ugers behandling.
English: What is Aerius?
Danish: Hvad er Aerius?
English: Why has Aerius been approved?
Danish: Hvorfor blev Aerius godkendt?
English: What is Aerius used for?
Danish: Hvad anvendes Aerius til?
English: What benefit has Aerius shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Aerius?
English: How has Aerius been studied?
Danish: Hvordan blev Aerius undersøgt?
English: How is Aerius used?
Danish: Hvordan anvendes Aerius?
English: How does Aerius work?
Danish: Hvordan virker Aerius?
English: -1- - Synthetic peptide analogue of GnRF conjugated to a carrier protein of min. 300 µg per 2 ml dose
Danish: -1- Syntetisk peptidanalog af GnRF konjugeret til et carrierprotein på min. 300 µg pr. 2 ml dosis
English: Pharmaceutical form
Danish: EU Nummer Særnavn Styrke Lægemiddelform
English: Date of first authorisation: 16 December 1998 Date of last renewal: 16 December 2008
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 16. december 1998 Dato for seneste fornyelse: 16. december 2008
English: Some people feel dizzy or tired when taking Micardis.
Danish: Nogle vil føle sig svimle eller blive trætte, når de tager Micardis.
English: See also information under the heading “Do not take Micardis”.
Danish: Se også information under overskriften ”Tag ikke Micardis”
English: You can take Micardis with or without food.
Danish: Micardis kan både tages med mad og uden.
English: Micardis contains sorbitol.
Danish: Micardis indeholder sorbitol.
English: Volume and/or sodium depletion should be corrected prior to administration of Micardis.
Danish: Volumen- og/eller natriumdepletering bør korrigeres før behandling med Micardis.
English: * The event may have happened by chance or could be related to a mechanism currently not known.
Danish: * Observationen kan være en tilfældighed eller kan være relateret til en mekanisme, som på nuværende tidspunkt ikke er kendt.
English: If you forget to take Micardis
Danish: Hvis du har glemt at tage Micardis
English: Your doctor may need to change the dose of these other medicines or take other precautions.
Danish: Det er muligt, at lægen er nødt til at ændre din dosis og/eller tage andre forholdsregler.
English: Talk to your doctor before taking Micardis if you are suffering or have ever suffered from any of the following conditions or illnesses:
Danish: Kontakt lægen, før du tager Micardis, hvis du har eller har haft nogen af nedenstående sygdomme eller tilstande:
English: Do not take Micardis
Danish: Tag ikke Micardis
English: If you have the impression that the effect of Micardis is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du tror, at virkningen af Micardis er for stærk eller svag, så sig det til lægen eller på apoteket.
English: It is important that you take Micardis every day until your doctor tells you otherwise.
Danish: Du skal fortsætte med at tage Micardis hver dag, så længe lægen ikke har givet dig besked på andet.
English: Talk to your doctor before taking Micardis:
Danish: Kontakt lægen, før du tager Micardis:
English: Such conditions should be corrected before the administration of Micardis.
Danish: Sådanne tilstande bør korrigeres før behandling med Micardis.
English: Treatment of essential hypertension in adults.
Danish: Hypertension Behandling af essentiel hypertension hos voksne.
English: D-55216 Ingelheim am Rhein Germany
Danish: D-55216 Ingelheim am Rhein
English: • if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for telmisartan eller et af de øvrige indholdsstoffer i Micardis (angivet i punkt 6).
English: Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting
Danish: Abdominalsmerter, diare, dyspepsi, flatulens, opkastning
English: Micardis is used to treat essential hypertension (high blood pressure) in adults.
Danish: Micardis bruges til behandling af essentiel hypertension (forhøjet blodtryk) hos voksne.
English: The safety and efficacy of Micardis in children and adolescents aged below 18 years have not been established.
Danish: Micardis' sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Your doctor will normally advise you to stop taking Micardis before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Micardis.
Danish: Normalt vil din læge anbefale dig at stoppe med at tage Micardis, før du bliver gravid eller så snart du ved, du er gravid.
English: Remove your Micardis tablet from the blister only directly prior to intake.
Danish: Tag først din Micardistablet ud af blisteren lige før indtagelse.
English: (It is also better to avoid Micardis in early pregnancy see pregnancy section.)
Danish: (Du skal desuden helst undgå at bruge Micardis tidligt i graviditeten - se afsnittet om Graviditet)
English: When Micardis is used in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended.
Danish: Når Micardis anvendes til patienter med nedsat nyrefunktion, anbefales periodisk kontrol af serumniveauerne for kalium og kreatinin.
English: Micardis blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
Danish: Micardis blokerer angiotensin II´s virkning, så blodkarrene afslappes og blodtrykket falder.
English: Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to <1/1,000) , and acute renal failure.
Danish: Alvorlige bivirkninger omfatter anafylaktisk reaktion og angioødem, som kan forekomme i sjældne tilfælde (≥1/10.000 til <1/1.000), samt akut nyresvigt.
English: Micardis may be less effective in lowering the blood pressure in black patients.
Danish: Micardis kan have en mindre blodtrykssænkende virkning hos sorte patienter.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Unit dose-blister
English: Possible side effects of Micardis
Danish: Bivirkninger ved Micardis
English: If any of the above applies to you, tell your doctor or pharmacist before taking Micardis.
Danish: Hvis du har nogen af ovenstående tilstande, så fortæl det til lægen eller på apoteket før du tager Micardis.
English: Pruritus, hyperhidrosis, rash
Danish: Pruritus, hyperhidrose, udslæt
English: The concomitant use of Micardis with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Danish: Samtidig brug af Micardis og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: There is no experience regarding the administration of Micardis in patients with recent kidney transplantation.
Danish: Der er ingen erfaring med anvendelse af Micardis til patienter, der kort tid forinden har fået foretaget en nyretransplantation.
English: There are no adequate data from the use of Micardis in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af telmisartan til gravide kvinder.
English: When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy such as Micardis.
Danish: Når der føres motorkøretøj eller betjenes maskiner bør man være opmærksom på, at der ved antihypertensiv behandling, som for eksempel med Micardis, lejlighedsvis kan forekomme svimmelhed eller døsighed.
English: 14 tablets 28 tablets 56 tablets 98 tablets
Danish: 14 tabletter 28 tabletter 56 tabletter 98 tabletter
English: Micardis is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Danish: Din læge vil vælge en anden behandling til dig, hvis du ønsker at amme, specielt hvis dit barn er nyfødt eller er født for tidlig.
English: What Micardis contains
Danish: Micardis indeholder:
English: If you are intolerant to some sugars, consult your doctor before taking Micardis.
Danish: Hvis du ikke tåler visse sukkerarter, bør du kontakte lægen, før du tager Micardis.
English: The other ingredients are povidone, meglumine, sodium hydroxide, sorbitol (E420) and magnesium stearate.
Danish: Øvrige indholdsstoffer: povidon, meglumin, natriumhydroxid, sorbitol (E420), magnesiumstearat Udseende og pakningsstørrelser
English: • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea,
Danish: • For lavt blodtryk (hypotension), som kan forekomme, hvis du er dehydreret (overdrevent tab af kropsvæske) eller er i saltunderskud efter anvendelse af vanddrivende medicin eller er på saltfattig kost, har diarré eller ved opkastning.
English: Rottendorf Pharma GmbH Ostenfelder Straße 51 - 61 59320 Ennigerloh Germany
Danish: Rottendorf Pharma GmbH Ostenfelder Straße 51 - 61 59320 Ennigerloh Tyskland
English: However, sometimes your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Micardis may be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Micardis.
Danish: Nogle patienter får anbefalet en lavere dosis på 20 mg eller en højere dosis på 80 mg. Micardis kan også ordineres i kombination med diuretika (vanddrivende medicin) såsom hydrochlorthiazid, der har vist sig at øge den blodtryksnedsættende virkning af Micardis.
English: Micardis may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine).
Danish: Micardis kan øge den blodtrykssænkende virkning, både af anden blodtrykssænkende medicin og af medicin, der potentielt kan sænke blodtrykket (f.eks. baclofen eller amifostin).
English: Urinary tract infection including cystitis, upper respiratory tract infection including pharyngitis and sinusitis Sepsis including fatal outcome
Danish: Urinvejsinfektion herunder cystitis, infektion i øvre luftveje herunder faryngitis og sinuitis
English: 10 rue Colonel Charbonneaux 51100 Reims
Danish: Delpharm Reims S.A.S 10 Rue Colonel Charbonneaux 51100 Reims
English: What you need to know before you take Micardis
Danish: Det skal du vide, før du begynder at tage Micardis
English: Micardis is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Danish: Det frarådes at anvende Micardis tidligt i graviditeten, og det må ikke tages senere end 3 måneder henne i graviditeten, da det kan forårsage alvorlige fosterskader.
English: In case of surgery or anaesthesia, you should tell your doctor that you are taking Micardis.
Danish: Hvis du skal opereres eller have anden form for bedøvelse, så fortæl lægen, at du tager Micardis.
English: Micardis may also be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Micardis.
Danish: Micardis kan også ordineres i kombination med diuretika (vanddrivende medicin) såsom hydrochlorthiazid, der har vist sig at øge den blodtryksnedsættende virkning af Micardis.
English: Micardis 20 mg tablets Pack sizes: Blister with 14, 28, 56 or 98 tablets.
Danish: Micardis 20 mg tabletter Pakningsstørrelser: Blister med 14, 28, 56 eller 98 tabletter.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/090/022
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/98/090/022
English: Other medicines and Micardis
Danish: Brug af anden medicin sammen med Micardis
English: For reduction of cardiovascular events, the usual dose of Micardis is one 80 mg tablet once a day.
Danish: Til nedsættelse af risikoen for hjerte-kar-hændelser er den sædvanlige dosis Micardis 80 mg én gang daglig.
English: Before considering the concomitant use of medicinal products that affect the renin-angiotensinaldosterone system, the benefit risk ratio should be evaluated.
Danish: Før start af behandling med flere typer medicin, der påvirker renin-angiotensin-aldosteronsystemet bør man nøje afveje fordele og ulemper mod hinanden.
English: • if you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of the bile from the liver and gall bladder) or any other severe liver disease.
Danish: • hvis du har alvorlige leverproblemer, såsom kolestase eller galdevejsobstruktion (problem med udskillelse af galde fra leveren eller fra galdeblæren) eller anden alvorlig leversygdom
English: Micardis should be used only with caution in patients with mild to moderate hepatic impairment.
Danish: Der bør udvises forsigtighed, når Micardis bruges til patienter med let til moderat nedsat leverfunktion.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Micardis 20 mg tablets
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Micardis 20 mg tabletter
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/090/021
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/98/090/021
English: Symptomatic hypotension, especially after the first dose of Micardis, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting.
Danish: Specielt efter den første dosis af Micardis kan der forekomme symptomatisk hypotension hos patienter, som har for lavt volumen i blodbanen eller natriummangel på grund af kraftig diuretisk behandling, saltfattig diæt, diarré eller opkastning.
English: 14 tablets 28 tablets 56 tablets 98 tablets 28 x 1 tablets 84 tablets 30 x 1 tablets 90 x 1 tablets
Danish: 14 tablets 28 tabletter 56 tabletter 98 tabletter 28 x 1 tabletter 84 tabletter 30 x 1 tabletter 90 x 1 tabletter
English: You should store your medicine in the original package in order to protect the tablets from moisture.
Danish: Du skal opbevare Micardis i den originale yderpakning for at beskytte tabletterne mod fugt.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug
English: Micardis is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Micardis er kontraindiceret hos patienter med svært nedsat leverfunktion (se pkt.
English: PHARMACEUTICAL FORM AND CONTENTS Component of a multipack comprising 4 packs, each containing 90 x 1 tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Del af multipakning med 4 pakninger, hver med 90 x 1 tabletter
English: The overall incidence of adverse reactions reported with telmisartan was usually comparable to placebo (41,4% vs 43.9 %) in controlled trials in patients treated for hypertension.
Danish: I kontrollerede studier med hypertensionspatienter var den samlede forekomst af bivirkninger ved brug af telmisartan, sædvanligvis sammenlignelig med placebo (41,4% vs. 43,9%).
English: PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 4 packs, each containing 90 x 1 tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakning med 4 pakninger, hver med 90 x 1 tabletter
English: Pack sizes: Blister with 14, 28, 56, 84 or 98 tablets or perforated unit dose blisters with 28 x 1, 30 x 1 or 90 x 1 tablets; multipacks containing 360 (4 packs of 90 x 1) tablets
Danish: Pakningsstørrelser: Blister med 14, 28, 56, 84 eller 98 tabletter eller perforeret enkeltdosis-blister med 28 x 1, 30 x 1 eller 90 x 1 tabletter; multipakninger indeholder 360 (4 pakninger af 90 x 1) tabletter.
English: The effect of Micardis may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.
Danish: Den blodtrykssænkende virkning med Micardis kan blive mindre, hvis du samtidig tager medicin mod gigt og lette smerter (non-steroid antiinflammatorisk medicin (NSAID) såsom acetylsalicylsyre eller ibuprofen) eller kortikosteroider.
English: If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Danish: Hvis du har taget for meget Micardis Hvis du har taget for mange tabletter, så kontakt lægen, skadestuen eller apoteket.
English: Children and adolescents The use of Micardis in children and adolescents up to the age of 18 years is not recommended.
Danish: Børn og unge Børn og unge under 18 år bør ikke behandles med Micardis.
English: Micardis is available in blister packs containing 14, 28, 56 or 98 tablets.
Danish: Micardis 20 mg er pakket i blisterpakninger med 14, 28, 56, eller 98 tabletter.
English: Angioedema (also with fatal outcome), eczema, erythema, urticaria, drug eruption, toxic skin eruption
Danish: Angioødem (også med letalt udfald), eksem, erytem, urticaria, medikamentelt udløst udslæt, toksisk hududslæt Knogler, led, muskler og bindevæv Ikke almindelig: