FrancophonIA/ELRC3.0 huggingface dataset:
English: The PEGASUS TIMI-54 study was a 21,162 patient, event-driven, randomised, double-blind, placebo-controlled, parallel group, international multicentre study to assess the prevention of atherothrombotic events with ticagrelor given at 2 doses (either 90 mg twice daily or 60 mg twice daily) combined with low dose ASA (75-150 mg), compared to ASA therapy alone in patients with history of MI and additional risk factors for atherothrombosis.
Danish: Studiet skulle vurdere forebyggelse af aterotrombotiske hændelser, hvor ticagrelor blev givet i 2 doser (enten 90 mg to gange dagligt eller 60 mg to gange dagligt) i kombination med en lav dosis ASA (75-150 mg), sammenlignet med ASA-behandling alene til patienter med tidligere MI og yderligere risikofaktorer for aterotrombose.
English: What Brilique looks like and contents of the pack Film-coated tablet (tablet): The tablets are round, biconvex, pink, film-coated marked with a “60” above “T” on one side.
Danish: Filmovertrukket tablet (tablet): Tabletterne er runde, bikonvekse, pink, filmovertrukne, præget med "60" over "T" på den ene side.
English: What Brilique looks like and contents of the pack Film-coated tablet (tablet): The tablets are round, biconvex, yellow, film-coated marked with a “90” above “T” on one side.
Danish: Filmovertrukket tablet (tablet): Tabletterne er runde, bikonvekse, gule, filmovertrukne, præget med "90" over "T" på den ene side.
English: rd degree AV block or bradycardic-related syncope) have been excluded from the main studies evaluating the safety and efficacy of ticagrelor.
Danish: Patienter med øget risiko for bradykardi-hændelser (f.eks. patienter uden en pacemaker som har syg sinus-knude, 2. eller 3. grads AV-blok eller bradykardi-relateret synkope) var udelukket fra hovedstudierne, der vurderede sikkerheden og effekt af ticagrelor.
English: PERFORATED UNIT DOSE BLISTER
Danish: Perforeret enkeltdosisblister
English: Round, flat, bevelled edged, white to pale pink, orodispersible tablets marked with ‘90' above ‘TI' on one side and plain on the other.
Danish: Runde, flade, hvide til svagt lyserøde tabletter med skrå kanter, præget med "90" over "TI" på den ene side og glat på den anden.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.8).
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: P-gp substrates (including digoxin, cyclosporine) Concomitant administration of ticagrelor increased the digoxin Cmax by 75% and AUC by 28%.
Danish: Samtidig administration af ticagrelor øgede digoxins Cmax med 75 % og AUC med 28 %.
English: What Brilique is and what it is used for What you need to know before you take Brilique How to take Brilique
Danish: Det skal du vide, før du begynder at tage Brilique Sådan skal du tage Brilique Bivirkninger
English: • Severe hepatic impairment (see sections 4.2, 4.4 and 5.2).
Danish: 4.2, 4.4 og 5.2).
English: No dose adjustment is necessary for patients with mild hepatic impairment (see section 5.2).
Danish: Dosisjustering er ikke nødvendig for patienter med let nedsat leverfunktion (se pkt.
English: Brilique 60 mg tablets ticagrelor
Danish: Brilique 60 mg tabletter ticagrelor
English: Ear haemorrhage
Danish: Nyrer og urinveje
English: How to take Brilique
Danish: Sådan skal du tage Brilique
English: Brilique 60 mg film-coated tablets
Danish: Brilique 60 mg filmovertrukne tabletter
English: Use of ticagrelor is contraindicated in patients with severe hepatic impairment (see sections 4.2 and 4.3).
Danish: Anvendelsen af ticagrelor er kontraindiceret til patienter med svært nedsat leverfunktion (se pkt.
English: Brilique 90 mg tablets ticagrelor
Danish: Brilique 90 mg tabletter ticagrelor
English: Pruritus
Danish: Hæmoptyse
English: Vascular disorders
Danish: Muskelblødninger
English: Renal and urinary disorders
Danish: Podagra/Urinsyre gigt
English: Brilique 60 mg film-coated tablets ticagrelor
Danish: Brilique 60 mg filmovertrukne tabletter ticagrelor
English: Brilique 90 mg film-coated tablets
Danish: Brilique 90 mg filmovertrukne tabletter
English: Brilique 90 mg film-coated tablets ticagrelor
Danish: Brilique 90 mg filmovertrukne tabletter ticagrelor
English: Orodispersible tablet.
Danish: Hvis du har problemer med at sluge tabletten
English: nd or 3
Danish: 4.2 og 4.3).
English: What Brilique looks like and contents of the pack The orodispersible tablets are round, flat, bevelled edged, white to pale pink, marked with a “90” above “TI” on one side.
Danish: Smeltetabletterne er runde, flade med skrå kanter, hvide til svagt lyserøde præget med "90" over "TI" på den ene side.
English: CV death, MI (excl. silent MI) or stroke Invasive intent Medical intent CV death
Danish: CV-dødsfald/MI (tavst MI undtaget) eller apopleksi
English: No dose adjustment is recommended in patients with moderate hepatic impairment (see sections 4.2 and 4.4).
Danish: Der anbefales ikke dosisjustering hos patienter med moderat nedsat leverfunktion (se pkt.
English: Each film-coated tablet contains 60 mg ticagrelor.
Danish: Hver filmovertrukket tablet indeholder 60 mg ticagrelor.
English: Each film-coated tablet contains 90 mg ticagrelor.
Danish: Hver filmovertrukket tablet indeholder 90 mg ticagrelor.
English: Musculoskeletal connective tissue and bone
Danish: Knogler, led, muskler og bindevæv
English: Oral contraceptives
Danish: Vaskulære sygdomme
English: België/Belgique/Belgien AstraZeneca S.A./N.V.
Danish: België/Belgique/Belgien
English: However, more PLATO combined Major + Minor bleeding occurred with ticagrelor compared with clopidogrel.
Danish: Der forekom dog flere kombinerede Major + Minor bleedings iht.
English: No dose adjustment is required in elderly (see section 5.2).
Danish: Dosisjustering er ikke nødvendig for ældre patienter (se pkt.
English: If you take more Brilique than you should
Danish: Hvis du har taget for mange Brilique
English: Brilique 90 mg orodispersible tablets
Danish: Brilique 90 mg smeltetabletter
English: Reproductive system bleedings
Danish: Blødninger i det reproduktive system
English: AstraZeneca S.p.A. Tel: +39 02 9801 1
Danish: Tel: + 39 02 9801 1
English: Each orodispersible tablet contains 90 mg ticagrelor.
Danish: Hver smeltetablet indeholder 90 mg ticagrelor.
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Brilique til dig personligt.
English: Eye haemorrhage
Danish: Muskelblødninge
English: Date of latest renewal: 23 April 2007
Danish: Dato for seneste fornyelse: 23. april 2007
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:19 April 2002
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 19. april 2002
English: Additional information on individual components
Danish: Yderligere oplysninger om de enkelte komponenter
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number} {product code}
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC: {nummer} [produktkode]
English: It is important that you take MicardisPlus every day until your doctor tells you otherwise.
Danish: Det er vigtigt, at du tager MicardisPlus hver dag, så længe din læge ikke siger andet.
English: Protect your skin from sun exposure and UV rays while taking MicardisPlus.
Danish: Beskyt huden mod sollys og UV-stråler, mens du tager MicardisPlus.
English: If MicardisPlus is used during breast feeding, doses should be kept as low as possible.
Danish: Hvis MicardisPlus anvendes under amning, skal dosis holdes så lav som muligt.
English: MicardisPlus can have influence on the ability to drive and use machines.
Danish: MicardisPlus kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: See also information under the heading “Do not take MicardisPlus”.
Danish: Se også information under overskriften ”Tag ikke MicardisPlus”
English: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take MicardisPlus” and “Warnings and precautions”).
Danish: - Hvis du samtidig tager en ACE-hæmmer eller aliskiren - se også information under overskriften ”Tag ikke MicardisPlus” og ”Advarsler og forsigtighedsregler”.
English: C-labelled telmisartan the glucuronide represents approximately 11 % of the measured radioactivity in plasma.
Danish: Efter en enkelt dosis C-mærket telmisartan repræsenterer glucuronid ca. 11% af den målte radioaktivitet i plasma.
English: Increased incidence of sepsis has been observed with telmisartan only, however can not be ruled out for MicardisPlus.
Danish: En øget forekomst af sepsis er kun set med telmisartan, men kan ikke udelukkes for MicardisPlus.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Remove your MicardisPlus tablet from the blister only directly prior to intake.
Danish: Tag først din MicardisPlus-tablet ud af blisteren lige før indtagelse.
English: Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.
Danish: Telmisartan hæmmer ikke "angiotensin-converting- enzyme" (kininase-II-enzymet), som også nedbryder bradykinin.
English: The European Medicines Agency has waived the obligation to submit the results of studies with MicardisPlus in all subsets of the paediatric population in hypertension (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med MicardisPlus i alle undergrupper af den pædiatriske population med hypertension (se pkt.
English: Some people feel dizzy or tired when taking MicardisPlus.
Danish: Man kan føle sig svimmel eller blive træt, når man tager MicardisPlus.
English: Your doctor will normally advise you to stop taking MicardisPlus before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of MicardisPlus.
Danish: Normalt vil din læge anbefale dig at stoppe med at tage MicardisPlus, før du bliver gravid eller så snart du ved, du er gravid.
English: Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Danish: Telmisartan displacerer angiotensin II med meget høj affinitet fra dets bindingssted på AT1receptorsubtypen, som er ansvarlig for de kendte virkninger af angiotension II.
English: Such conditions should be corrected before the administration of MicardisPlus.
Danish: Sådanne tilstande bør korrigeres, før behandling med MicardisPlus initieres.
English: MicardisPlus once daily produces effective and smooth reductions in blood pressure across the therapeutic dose range.
Danish: MicardisPlus administreret én gang dagligt giver en effektiv og jævn reduktion i blodtrykket i hele det terapeutiske dosisinterval.
English: If you forget to take MicardisPlus
Danish: Hvis du har glemt at tage MicardisPlus
English: Greece and
Danish: Grækenland og
English: If you take more MicardisPlus than you should If you accidentally take too many tablets you may experience symptoms such as low blood pressure and rapid heartbeat.
Danish: Hvis du har taget for mange MicardisPlus tabletter Hvis du har taget for mange tabletter, kan du få symptomer såsom lavt blodtryk og hjertebanken.
English: MicardisPlus is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet.
Danish: MicardisPlus er en kombination af to aktive stoffer - telmisartan og hydrochlorthiazid - i én tablet.
English: Do not take MicardisPlus
Danish: Tag ikke MicardisPlus
English: MicardisPlus contains milk sugar (lactose) and sorbitol.
Danish: MicardisPlus indeholder mælkesukker (laktose) og sorbitol.
English: Talk to your doctor before taking MicardisPlus:
Danish: Kontakt lægen, før du tager MicardisPlus:
English: In addition, MicardisPlus should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Danish: Desuden skal MicardisPlus anvendes med forsigtighed til patienter med nedsat leverfunktion eller progredierende leversygdom, idet små forskydninger i væske- og elektrolytbalancen kan udløse hepatisk coma.
English: These could be symptoms of an increase of pressure in your eye and can happen within hours to weeks of taking MicardisPlus.
Danish: Dette kan være symptomer på forhøjet tryk i øjet og kan udvikles indenfor få timer til uger, efter behandling med MicardisPlus er startet.
English: Telmisartan is an orally effective and specific angiotensin II receptor subtype 1 (AT1) antagonist.
Danish: Telmisartan er en oralt administreret effektiv specifik angiotensin II-receptorsubtype 1(AT1)-antagonist.
English: Hydrochlorothiazide: Following oral administration of MicardisPlus peak concentrations of hydrochlorothiazide are reached in approximately 1.0 - 3.0 hours after dosing.
Danish: Hydrochlorthiazid: Ved oral administration af MicardisPlus nås peak-koncentrationerne af hydrochlorthiazid i løbet af 1,0-3,0 time efter indgift.
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Graviditet
English: Experience with MicardisPlus is modest in the patients with mild to moderate renal impairment, therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Danish: Erfaringer med MicardisPlus er begrænsede hos patienter med let til moderat nedsat nyrefunktion, og derfor anbefales periodisk kontrol af serumværdierne for kalium, kreatinin og urinsyre.
English: The safety and efficacy of MicardisPlus in children and adolescents aged below 18 have not been established.
Danish: MicardisPlus' sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Coadministration of lithium and MicardisPlus is not recommended (see section 4.4).
Danish: Samtidig administration af lithium og MicardisPlus kan ikke anbefales (se pkt.
English: The hazard ratio for telmisartan vs. ramipril was 1.01 (97.5 % CI 0.931.10, p (non-inferiority) = 0.0019 at a margin of 1.13).
Danish: Hazard ratio for telmisartan vs. ramipril var 1,01 (97,5 % CI 0,93-1,10; p (noninferioritet) = 0,0019 ved en margin på 1,13).
English: Possible side effects of MicardisPlus:
Danish: Bivirkninger ved MicardisPlus:
English: MicardisPlus should be kept in the sealed blister due to the hygroscopic property of the tablets.
Danish: MicardisPlus skal opbevares i den forseglede blister på grund af tabletternes hygroskopiske egenskaber.
English: Precautions to be taken before handling or administering the medicinal product MicardisPlus should be kept in the sealed blister due to the hygroscopic property of the tablets.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet MicardisPlus skal forblive i den forseglede blister pga. hygroskopiske egenskaber.
English: Talk to your doctor before taking MicardisPlus if you are suffering or have ever suffered from any of the following conditions or illnesses:
Danish: Kontakt lægen, før du tager MicardisPlus, hvis du har eller har haft en medicinsk lidelse eller sygdom, især hvis det er en af dem, der er nævnt nedenfor:
English: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Danish: Der er øget risiko for alvorlig hypotension og nyreinsufficiens, når patienter med bilateral nyrearteriestenose eller stenose af arterien til en enkelt fungerende nyre behandles med lægemidler, som påvirker reninangiotensin-aldosteronsystemet.
English: MicardisPlus may be less effective in lowering the blood pressure in black patients.
Danish: MicardisPlus kan have en mindre blodtrykssænkende virkning hos sorte patienter.
English: If any of the above applies to you, tell your doctor or pharmacist before taking MicardisPlus.
Danish: Hvis et af ovennævnte punkter gælder for dig, skal du tale med din læge eller apoteket om det, inden du tager MicardisPlus.
English: As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Danish: Som ved brug af andre vasodilatatorer bør særlig forsigtighed udvises hos patienter, der lider af aorta- eller mitralstenose eller obstruktiv hypertrofisk kardiomyopati.
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 MicardisPlus (angivet i punkt 6).
English: • if you are taking any of the following medicines used to treat high blood pressure: - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Danish: • hvis du samtidig tager et af følgende lægemidler til behandling af for højt blodtryk: - en ACE-hæmmer (f.eks. enalapril, lisinopril, ramipril), især hvis du har nyrerproblemer i forbindelse med sukkersyge - aliskiren
English: MicardisPlus 40 mg/12.5 mg tablets EU/1/02/213/001-005, 011, 013-014
Danish: MicardisPlus 40 mg/12,5 mg tabletter EU/1/02/213/001-005, 011, 013-014
English: In case of surgery or anaesthetics, you should tell your doctor that you are taking MicardisPlus.
Danish: Før en operation eller bedøvelse bør du fortælle din læge, at du tager MicardisPlus.
English: Based on the pharmacological mechanism of action of hydrochlorothiazide its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.
Danish: Baseret på hydrochlorthiazids farmakologiske virkningsmekanisme kan brug i andet og tredje trimester kompromittere den føto-placentale perfusion og forårsage føtale og neonatale bivirkninger såsom ikterus, forstyrrelser i elektrolytbalancen og trombocytopeni.
English: MicardisPlus tablets are for once-daily oral administration and should be taken with liquid, with or without food.
Danish: MicardisPlus tabletter administreres oralt én gang daglig med væske, med eller uden mad.
English: The concomitant use of MicardisPlus 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 MicardisPlus og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: Although clinically significant hyperkalaemia has not been documented with MicardisPlus, risk factors for the development of hyperkalaemia include renal insufficiency and/or heart failure, and diabetes mellitus.
Danish: Skønt der ikke er set nogen klinisk signifikant hyperkaliæmi i forbindelse med MicardisPlus, så omfatter risikofaktorerne for udvikling af hyperkaliæmi blandt andet nyreinsufficiens og/eller hjertesvigt samt diabetes mellitus.
English: Skin and subcutaneous tissue disorders Not known:
Danish: Hud og subkutant væv Ikke kendt:
English: MicardisPlus is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
Danish: MicardisPlus er en kombination af en angiotensin II-receptorantagonist, telmisartan og thiazidet hydrochlorthiazid.
English: (It is also better to avoid MicardisPlus in early pregnancy - see pregnancy section.)
Danish: MicardisPlus tidligt i graviditeten - se afsnittet om Graviditet)
English: Rottendorf Pharma GmbH Ostenfelder Straße 51 - 61 D-59320 Ennigerloh Germany
Danish: Rottendorf Pharma GmbH Ostenfelder Straße 51 - 61 D-59320 Ennigerloh Tyskland
English: Adverse reactions known to occur with each component given singly but which have not been seen in clinical trials may occur during treatment with MicardisPlus.
Danish: Bivirkninger, der er kendt for de enkelte komponenter, men som ikke er forekommet i de kliniske forsøg, kan forekomme ved behandling med MicardisPlus.
English: In patients with mild to moderate hepatic impairment the posology should not exceed MicardisPlus 40 mg/12.5 mg once daily.
Danish: Hos patienter med let eller moderat nedsat leverfunktion bør dosis ikke overskride MicardisPlus 40 mg/12,5 mg én gang daglig.
English: Rare cases have also been reported with angiotensin II receptor antagonists (including MicardisPlus).
Danish: I sjældne tilfælde er dette også set ved behandling med angiotensin II-receptorantagonister (som MicardisPlus).
English: In preclinical safety studies performed with co-administration of telmisartan and hydrochlorothiazide in normotensive rats and dogs, doses producing exposure comparable to that in the clinical therapeutic range caused no additional findings not already observed with administration of either substance alone.
Danish: I prækliniske sikkerhedsforsøg med samtidig indgift af telmisartan og hydrochlorthiazid i normotensive rotter og hunde i doser, der gav en eksponering sammenlignelig med den i det klinisk- terapeutiske område, fandt man ikke andre resultater end dem, der allerede var set ved indgift af de to stoffer hver for sig.
English: MicardisPlus 80 mg/12.5 mg tablets EU/1/02/213/006-010, 012, 015-016
Danish: MicardisPlus 80 mg/12,5 mg tabletter EU/1/02/213/006-010, 012, 015-016
English: There are no adequate data from the use of MicardisPlus in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af telmisartan til gravide kvinder.
English: MicardisPlus 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: MicardisPlus kan øge den blodtrykssænkende virkning, både af anden blodtrykssænkende medicin og af medicin, der potentielt kan sænke blodtrykket (f.eks. baclofen eller amifostin).
English: The cytochrome P450 isoenzymes are not involved in the metabolism of telmisartan.
Danish: CYPisoenzymer er ikke involveret i metaboliseringen af telmisartan.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/213/017-023
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/02/213/017-023
English: Therefore, in these patients blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required, when indicated.
Danish: Derfor bør monitorering af glucose hos disse patienter overvejes, og dosisjustering af insulin eller antidiabetika kan være nødvendig.
English: Therefore, the use of MicardisPlus is not recommended.
Danish: Derfor frarådes brug af MicardisPlus.
English: Dizziness or drowsiness may occasionally occur when taking MicardisPlus.
Danish: Der kan lejlighedsvis forekomme svimmelhed eller døsighed ved behandling med MicardisPlus.
English: Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes should be co-administered cautiously with MicardisPlus (see section 4.5).
Danish: Kaliumbesparende diuretika, kaliumsupplementer eller kaliumholdige saltsubstitutter skal indgives med forsigtighed sammen med MicardisPlus (se pkt.