FrancophonIA/ELRC3.0 huggingface dataset:
English: Polydextrose (E1200) Titanium dioxide (E171) Hypromellose (E464) Macrogol 4000
Danish: Polyglucose (E1200) Titandioxid (E171) Hypromellose (E464) Macrogol 4000
English: The predefined blood pressure goal was ≤ 135/85 mm Hg.
Danish: Den foruddefinerede blodtryksværdi var ≤ 135/85 mmHg.
English: See also information under the heading “Do not take Irbesartan Teva”.
Danish: Se også information under overskriften ”Tag ikke Irbesartan Teva”.
English: List of side effects:
Danish: Liste over bivirkninger:
English: Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
Danish: Irbesartan er en potent, oralt aktiv, selektiv angiotensin-II-receptor (type AT1) antagonist.
English: Irbesartan Teva is indicated in adults for the treatment of essential hypertension.
Danish: Irbesartan Teva er indiceret til voksne til behandling af essentiel hypertension.
English: Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.
Danish: Hyperkaliæmi* forekommer hyppigere blandt diabetiske patienter behandlet med irbesartan end med placebo.
English: If a child swallows some tablets, contact your doctor immediately.
Danish: Hvis et barn sluger nogle tabletter, skal du kontakte lægen med det samme.
English: In rabbits, abortion or early resorption were noted at doses causing significant maternal toxicity, including mortality.
Danish: Hos kaniner sås der abort eller tidlig resorption ved doser, som forårsagede signifikant maternel toksicitet, inklusive mortalitet.
English: At 24 hours the reduction of blood pressure was 60-70 % of the corresponding peak diastolic and systolic responses at the recommended doses.
Danish: Efter 24 timer var blodtryksreduktionen 60-70 % af den tilsvarende diastoliske og systoliske spidsrespons ved de anbefalede doser.
English: If you receive Irbesartan Teva for diabetic kidney disease.
Danish: • hvis du får Irbesartan Teva for diabetisk nyresygdom.
English: Irbesartan Teva is unlikely to affect your ability to drive or use machines.
Danish: Irbesartan Teva påvirker sandsynligvis ikke din evne til at køre bil eller betjene maskiner.
English: Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or allcause mortality.
Danish: Irbesartan reducerede signifikant den relative risiko i det kombinerede primære endepunkt med fordobling af serum-kreatinin, nyresygdom i slutstadiet (ESRD) eller total mortalitet.
English: Therefore, the use of irbesartan is not recommended.
Danish: Derfor frarådes brug af irbesartan.
English: For therapeutic doses of irbesartan in humans, the hyperplasia/hypertrophy of the renal juxtaglomerular cells does not appear to have any relevance.
Danish: Ved terapeutiske doser af irbesartan hos mennesker synes hyperplasi/hypertrofi af de renale juxtaglomerulære celler ikke at have nogen relevans.
English: Results showed that Cmax, AUC and clearance rates were comparable to those observed in adult patients receiving 150 mg irbesartan daily.
Danish: Resultaterne viste, at Cmax, AUC og clearance var sammenlignelig med det hos voksne, der er blevet behandlet med 150 mg irbesartan daglig.
English: IDNT was a double blind, controlled, morbidity and mortality trial comparing irbesartan, amlodipine and placebo.
Danish: IDNT var et kontrolleret dobbelt-blindt morbiditets- og mortalitetsstudie, som sammenlignede irbesartan, amlodipin og placebo.
English: Subgroups consisting of gender, race, age, duration of diabetes, baseline blood pressure, serum creatinine, and albumin excretion rate were assessed for treatment effect.
Danish: Subgrupper opdelt efter køn, race, alder, varighed af diabetes, baseline-blodtryk, serum-kreatinin og udskillelseshastighed af albumin blev undersøgt for behandlingseffekt.
English: Metabolism and nutrition disorders Not known:
Danish: Metabolisme og ernæring Ikke kendt:
English: An increased incidence of non-fatal MI and stroke was seen in females in the irbesartan-based regimen versus the amlodipine-based regimen, while hospitalization due to heart failure was reduced in the overall population.
Danish: Der sås øget hyppighed af ikke-fatalt MI og slagtilfælde hos kvinder i det irbesartan-baserede regime versus det amlodipin-baserede regime, mens frekvensen af hospitalsindlæggelse på grund af hjertefejl blev reduceret i den samlede population.
English: Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Danish: 4.8 , 5.1 og 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Danish: Patienter med primær aldosteronisme responderer generelt ikke på antihypertensive lægemidler, der virker gennem hæmning af renin-angiotensinsystemet.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest revideret { MM/ÅÅÅÅ }
English: It is important that you continue to take Irbesartan Teva until your doctor tells you otherwise.
Danish: Det er vigtigt, at du fortsætter med at tage Irbesartan Teva, indtil lægen siger du kan stoppe.
English: Regression to normoalbuminuria (< 30 mg/day) was more frequent in the irbesartan 300 mg group (34 %) than in the placebo group (21 %).
Danish: Regression til normoalbuminuri (< 30 mg/dag) forekom hyppigere i gruppen, der fik irbesartan 300 mg (34 %) end i placebogruppen (21 %).
English: Diuretics and other antihypertensive agents
Danish: Diuretika og andre antihypertensive lægemidler
English: While this is not documented with irbesartan, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Danish: Selvom dette ikke er dokumenteret for irbesartan, kan der forventes en lignende effekt med angiotensin-II-receptorantagonister.
English: If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.
Danish: Hvis du tager en bestemt slags smertestillende medicin, der kaldes nonsteroide antiinflammatoriske lægemidler, kan virkningen af irbesartan nedsættes.
English: Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects (18-40 years).
Danish: Irbesartan AUC- og Cmax-værdier var også noget højere hos ældre patienter (≥ 65 år) end hos yngre patienter (18-40 år).
English: Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Inhibitors (AIIRAs), similar risks may exist for this class of drugs.
Danish: Der findes ingen kontrollerede epidemiologiske data vedrørende risikoen med angiotensin II-receptor-antagonister (AIIRA'er), men lignende risici kan findes for denne lægemiddelgruppe.
English: Following oral or intravenous administration of 14C irbesartan, 80-85 % of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Danish: Efter oral eller intravenøs administration af 14C irbesartan, kan 80-85 % af den cirkulerende radioaktivitet i plasma tilskrives uomdannet irbesartan.
English: Sixty per cent (60 %) of patients in the placebo group reached this target blood pressure whereas this figure was 76 % and 78 % in the irbesartan and amlodipine groups respectively.
Danish: Tres procent (60 %) af patienterne i placebogruppen nåede denne blodtryksværdi, mens tallet var henholdsvis 76 % og 78 % for irbesartan- og amlodipin-gruppen.
English: Patients were titrated from 75 mg to a maintenance dose of 300 mg irbesartan, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Danish: Patienterne blev titreret fra 75 mg til en vedligeholdelsesdosis på 300 mg irbesartan, fra 2,5 mg til 10 mg amlodipin eller placebo i henhold til tolerance.
English: If you get any of these symptoms or get short of breath, stop taking Irbesartan Teva and contact your doctor immediately.
Danish: Hvis du får et eller flere af disse symptomer eller får åndenød, skal du holde op med at tage Irbesartan Teva og straks søge lægehjælp.
English: Irbesartan has been studied in paediatric populations aged 6 to 16 years old but the current data are insufficient to support an extension of the use in children until further data become available (see sections 4.8, 5.1 and 5.2).
Danish: Irbesartan er undersøgt i pædiatriske populationer i aldersgruppen 6 til 16 år, men de aktuelle data er ikke tilstrækkelige til at understøtte udvidelse af brug til at omfatte børn, før der foreligger yderligere data (se pkt.
English: Irbesartan Teva 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: Irbesartan Teva anbefales ikke til ammende mødre, og lægen vil sædvanligvis vælge en anden behandling til dig, hvis du ønsker at amme dit barn, især hvis dit barn er nyfødt eller født for tidligt.
English: If you forget to take Irbesartan Teva
Danish: Hvis du har glemt at tage Irbesartan Teva
English: After either oral or IV administration of 14C irbesartan, about 20 % of the radioactivity is recovered in the urine, and the remainder in the faeces.
Danish: Efter enten oral eller intravenøs administration af 14C irbesartan, genfindes ca. 20 % radioaktivitet i urinen og resten i afføringen.
English: Furthermore, irbesartan induced hyperplasia/hypertrophy of the juxtaglomerular cells (in rats at ≥ 90 mg/kg/day, in macaques at ≥ 10 mg/kg/day).
Danish: Herudover inducerede irbesartan hyperplasi/hypertrofi af de juxtaglomerulære celler (hos rotte ved ≥ 90 mg/kg/dag, hos makakaber ved ≥ 10 mg/kg/dag).
English: Your doctor will normally advise you to stop taking Irbesartan Teva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan Teva.
Danish: Din læge vil normalt anbefale, at du stopper med at tage Irbesartan Teva, inden du bliver gravid, eller så snart du ved, at du er gravid og vil anbefale, at du tager anden medicin i stedet for Irbesartan Teva.
English: In the 26-week open-label period of this trial the most frequent laboratory abnormalities observed were creatinine increases (6.5 %) and elevated CK values in 2 % of child recipients.
Danish: I den 26-ugers åbne periode i forsøget var de hyppigst observerede laboratoriemæssige abnormaliteter stigninger i kreatinin (6,5 %) og øgede kreatinkinase (CK)-værdier hos 2 % af børnene.
English: There is no experience regarding the administration of irbesartan in patients with a recent kidney transplantation.
Danish: Der foreligger ingen erfaring vedrørende administration af irbesartan til nyligt nyretransplanterede patienter.
English: One side of the tablet debossed with the number “93”.
Danish: Den ene side af tabletten er præget med tallet "93".
English: The study examined the long-term effects (2 years) of irbesartan on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30 % from baseline).
Danish: Studiet undersøgte langtidsvirkningerne (2 år) af irbesartan med henblik på progression til klinisk proteinuri (urinalbumin udskillelsesrate (UAER) > 300 mg/dag, og en stigning i UAER på mindst 30 % i forhold til baseline).
English: In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with irbesartan (see section 4.5).
Danish: Specielt har tillæg af diuretika som hydrochlorthiazid vist sig at have en additiv virkning med Irbesartan Teva (se pkt.
English: Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Danish: Behandling med angiotensin-II-receptor-antagonister (AIIRA'er) bør ikke påbegyndes under graviditet.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Danish: Der er rapporteret reversibel øgning af serum-lithiumkoncentrationer og toksicitet ved samtidig administration af lithium og angiotensin-konverterende enzymhæmmere.
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see also sections 4.3 and 4.4).
Danish: Spædbørn, hvis mødre har taget AIIRA'er skal observeres omhyggeligt for hypotension (se også pkt.
English: The usual recommended initial and maintenance dose is 150 mg once daily, with or without food.
Danish: Sædvanlig start- og vedligeholdelsesdosering er 150 mg, 1 gang dagligt, med eller uden samtidig fødeindtagelse.
English: Although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dose adjustment is not usually necessary for elderly people.
Danish: Selvom initialdosis på 75 mg bør overvejes til patienter > 75 år, er det sædvanligvis ikke nødvendigt at dosisjustere ældre patienter.
English: In a randomised trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following adverse reactions occurred in the 3-week double-blind phase: headache (7.9 %), hypotension (2.2 %), dizziness (1.9 %), cough (0.9 %).
Danish: I et randomiseret forsøg med 318 hypertensive børn og unge i aldersgruppen 6 til 16 år sås følgende bivirkninger i den 3-ugers dobbeltblinde fase: Hovedpine (7,9 %), hypotension (2,2 %), svimmelhed (1,9 %), hoste (0,9 %).
English: Pack size of 28 film-coated tablets in non-perforated calendar blisters.
Danish: Pakningsstørrelse a 28 filmovertrukne tabletter i ikke-perforerede kalenderblistre.
English: Pack sizes of 7, 14, 28, 30, 56, 60, 80, 84, 90, 98, 100 film-coated tablets in non-perforated blisters.
Danish: Pakningsstørrelser a 7, 14, 28, 30, 56, 60, 80, 84, 90, 98, 100 filmovertrukne tabletter i ikkeperforerede blistre.
English: The other side of the tablet debossed with number
Danish: Den anden side af tabletten er præget med tallet
English: significant increases in plasma creatine kinase were commonly observed (1.7 %) in irbesartan treated subjects.
Danish: Betydelige stigninger i plasma-kreatinkinase rapporteredes hyppigt (1,7 %) blandt irbesartanbehandlede patienter.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om Irbesartan Teva, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: • Tablet coating: polydextrose, titanium dioxide, hypromellose and macrogol 4000.
Danish: • Tabletovertræk: Polyglucose, titandioxid, hypromellose og macrogol 4000.
English: Do not use this medicine after the expiry date that is stated on the outer carton or foil after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og blisterpakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The blood pressure lowering effect of irbesartan is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
Danish: Irbesartans blodtrykssænkende effekt er tydelig i løbet af 1-2 uger, og den maksimale effekt viser sig 4-6 uger efter behandlingsstart.
English: Talk to your doctor before taking Irbesartan Teva and if any of the following apply to you:
Danish: Kontakt lægen, før du tager Irbesartan Teva, hvis noget af det følgende gælder for dig:
English: Microcrystalline cellulose Croscarmellose sodium Silica, colloidal hydrated Magnesium stearate
Danish: Mikrokrystallinsk cellulose Croscarmellosenatrium Silica, kolloid hydreret Magnesiumstearat
English: Detailed information on Irbesartan Teva is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Danish: Du kan finde yderligere information om Irbesartan Teva på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Danish: Såfremt samtidig administration skønnes nødvendig, anbefales det at kontrollere serumlithiumværdier omhyggeligt.
English: Irbesartan at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Danish: Ved en dosis på 150 mg, 1 gang dagligt, giver irbesartan generelt en bedre 24 timers blodtrykskontrol end 75 mg.
English: Irbesartan Teva belongs to a group of medicines known as angiotensin-II receptor antagonists.
Danish: Irbesartan Teva tilhører en medicingruppe, der kaldes angiotensin-II-receptorantagonister.
English: The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration.
Danish: Den selektive antagonisme mod angiotensin-II (AT1)-receptorerne resulterer i en forhøjelse af plasma-renin- og angiotensin-II-niveauerne og i nedsat aldosteron i plasma.
English: Intravascular volume depletion
Danish: Nedsat intravaskulært volumen
English: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan Teva” and “Warnings and precautions”).
Danish: Hvis du samtidig tager en ACE-hæmmer eller aliskiren (se også information under overskrifterne ”Tag ikke Irbesartan Teva” og ”Advarsler og forsigtighedsregler”).
English: • Tablet core: povidone, pregelatinized starch (maize), poloxamer 188, microcrystalline cellulose, croscarmellose sodium, colloidal hydrated silica and magnesium stearate.
Danish: • Tabletkerne: Povidon, prægelatineret stivelse (majs), poloxamer 188, mikrokrystallinsk cellulose, croscarmellosenatrium, kolloid hydreret silica og magnesiumstearat.
English: Discontinuation due to any clinical or laboratory adverse event was less frequent for irbesartan-treated patients (3.3 %) than for placebo-treated patients (4.5 %).
Danish: Seponering på grund af kliniske eller laboratoriemæssige bivirkninger var mindre hyppig blandt irbesartanbehandlede patienter (3,3 %) end blandt placebobehandlede (4,5 %).
English: Pack sizes of 50 x 1 and 56 x 1 film-coated tablet in unit dose blisters.
Danish: Pakningsstørrelser a 50 x 1 og 56 x 1 filmovertrukken tablet i enhedsblistre.
English: Terms marked with a star (*) refer to the adverse reactions that were additionally reported in > 2 % of diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria and in excess of placebo.
Danish: Termer mærket med stjerne (*) henviser til bivirkninger, som yderligere er indberettet hos > 2 % af diabetiske, hypertensive patienter med kronisk nyreinsufficiens og udtalt proteinuri og i højere grad end med placebo.
English: Brampton Road Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Danish: TEVA UK Ltd Brampton Road Hampden Park, Eastbourne East Sussex, BN22 9AG Storbritannien
English: • The concomitant use of Irbesartan Teva 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
Danish: • Samtidig brug af Irbesartan Teva og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: If you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for irbesartan eller et af de øvrige indholdsstoffer i Irbesartan Teva (angivet i punkt 6).
English: In the female and black subgroups which represented 32 % and 26 % of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it. As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebobased regimen.
Danish: I subgrupper bestående af kvinder og sorte patienter, henholdsvis 32 % og 26 % af den samlede forsøgspopulation, sås der ingen evidens for nyrefordel, selvom sikkerhedsintervallerne ikke udelukker det. Der sås forøget hyppighed af ikke-fatalt MI hos kvinder og en reduceret hyppighed af ikke-fatalt MI hos mænd i irbesartangruppen versus det placebo-baserede regime.
English: Lithium The combination of lithium and irbesartan is not recommended (see section 4.5).
Danish: Lithium Kombination af lithium og irbesartan frarådes (se pkt.
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, hvis patienter med bilateral nyrearteriestenose eller stenose af arterien til deres eneste fungerende nyre behandles med lægemidler der påvirker renin-angiotensin-aldosteronsystemet.
English: In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function.
Danish: I dette tilfælde kan lægen tage regelmæssige blodprøver med særlig henblik på at måle kaliumniveauet i blodet, hvis nyrefunktionen er nedsat.
English: Approximately 33 % of patients in the irbesartan group reached the primary renal composite endpoint compared to 39 % and 41 % in the placebo and amlodipine groups [20 % relative risk reduction versus placebo (p = 0.024) and 23 % relative risk reduction compared to amlodipine (p = 0.006)].
Danish: Ca. 33 % af patienterne i irbesartan-gruppen nåede det primære kombinerede nyreendepunkt sammenlignet med henholdsvis 39 % og 41 % i placebo- og amlodipin-gruppen (20 % relativ risikoreduktion versus placebo (p = 0,024) og 23 % relativ risikoreduktion sammenlignet med amlodipin (p = 0,006)).
English: The active substance is irbesartan.
Danish: - Aktivt stof: Irbesartan
English: Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
Danish: • Meget almindelig (kan forekomme hos flere end 1 ud af 10 patienter): hvis du har højt blodtryk og type 2 diabetes med nyresygdom, kan blodprøver vise, at du har for meget kalium i blodet.
English: In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Danish: Hos patienter med højt blodtryk og type 2 diabetes er 300 mg 1 gang dagligt den foretrukne vedligeholdelsesdosis til behandling af ledsagende nyresygdom.
English: Based on its pharmacodynamic properties, irbesartan is unlikely to affect the ability to drive and use machines.
Danish: På baggrund af de farmakodynamiske egenskaber er det dog usandsynligt, at irbesartan vil påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: The pharmacokinetics of irbesartan were evaluated in 23 hypertensive children after the administration of single and multiple daily doses of irbesartan (2 mg/kg) up to a maximum daily dose of 150 mg for four weeks.
Danish: Farmakokinetik af irbesartan blev evalueret hos 23 hypertensive børn efter administration af enkeltdosis irbesartan og gentagne doser irbesartan (2 mg/kg) i doser på op til maksimalt 150 mg daglig i 4 uger.
English: Uncommon: sexual dysfunction
Danish: Seksuel dysfunktion
English: The following presents the adverse drug reactions that were reported in placebo-controlled trials in which 1,965 hypertensive patients received irbesartan.
Danish: Følgende tabel viser bivirkninger indberettet i placebokontrollerede forsøg, hvor 1965 hypertensive patienter har modtaget irbesartan.