FrancophonIA/ELRC3.0 huggingface dataset:
English: The study examined the long-term effects (2 years) of Aprovel 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 Aprovel 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: What you need to know before you take Aprovel
Danish: Det skal du vide, før du begynder at tage Aprovel
English: If you get any of these symptoms or get short of breath, stop taking Aprovel 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 Aprovel og straks søge lægehjælp.
English: The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.
Danish: Den maksimale blodtryksnedsættende virkning skal være nået 4-6 uger efter behandlingsstart.
English: Blood and lymphatic system disorders Not known:
Danish: Blod og lymfesystem Ikke kendt:
English: Some undesirable effects have been reported since marketing of Aprovel.
Danish: Der er indberettet bivirkninger efter markedsføring af Aprovel.
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: However, there was no difference in the half-life and accumulation of irbesartan.
Danish: Der var dog ingen forskel på halveringstid og akkumulering.
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Danish: Såfremt samtidig administration skønnes nødvendig, anbefales det at kontrollere serum-lithium værdier omhyggeligt.
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 creatinin (6,5%) og øgede kreatinkinase (CK)-værdier hos 2% af børnene.
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 marekatte ved ≥ 10 mg/kg/dag).
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: There is no clinically important effect on serum uric acid or urinary uric acid secretion.
Danish: Der er ingen klinisk vigtig effekt på serum-urinsyre eller urinsyreudskillelse.
English: Therefore, this combination is not recommended (see section 4.4).
Danish: Derfor frarådes denne kombination (se pkt.
English: Irbesartan exhibits linear and dose proportional pharmacokinetics over the dose range of 10 to 600 mg. A less than proportional increase in oral absorption at doses beyond 600 mg (twice the maximal recommended dose) was observed; the mechanism for this is unknown.
Danish: Irbesartan udviser lineær og dosisproportional farmakokinetik i dosisinterval på 10-600 mg. Der blev observeret en mindre end proportional øgning af oral absorption ved doser over 600 mg (2 gange den maksimale anbefalede dosis).
English: Excipients: also contains lactose monohydrate.
Danish: Indholdsstoffer: indeholder også lactosemonohydrat.
English: While this is not documented with Aprovel, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Danish: Selvom dette ikke er dokumenteret for Aprovel, kan der forventes en lignende effekt med angiotensin-IIreceptorantagonister.
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, slutstadium af nyresygdom (ESRD) eller total mortalitet.
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: arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps
Danish: Artralgi, myalgi (i nogle tilfælde forbundet med øgede niveauer af plasmakreatinkinase), muskelkramper
English: There is no experience regarding the administration of Aprovel in patients with a recent kidney transplantation.
Danish: Der foreligger ingen erfaring vedrørende administration af Aprovel til nyligt nyretransplanterede patienter.
English: Fertility and reproductive performance were not affected in studies of male and female rats even at oral doses of irbesartan causing some parental toxicity (from 50 to 650 mg/kg/day), including mortality at the highest dose.
Danish: Fertilitet og reproduktionsevne blev ikke påvirket i studier med han- og hunrotter, selv ved orale doser af irbesartan, der fremkaldte nogen toksicitet hos forældrene (fra 50-650 mg/kg/dag), herunder mortalitet ved den højeste dosis.
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4).
Danish: Spædbørn, hvis mødre har taget AIIRAer, skal observeres omhyggeligt for hypotension (se pkt.
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 irbesartanbaserede regime versus det amlodipin-baserede regime, mens frekvensen af hospitalindlæggelse på grund af hjertefejl blev reduceret i den samlede population.
English: The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated.
Danish: Effekten af CYP2C9-induktorer, som fx rifampicin, på irbesartans farmakokinetik er ikke evalueret.
English: dizziness, orthostatic dizziness*
Danish: Svimmelhed, ortostatisk svimmelhed*
English: Peak reduction of blood pressure is achieved within 3-6 hours after administration and the blood pressure lowering effect is maintained for at least 24 hours.
Danish: Spidsreduktion af blodtrykket opnås 3-6 timer efter administration, og den blodtrykssænkende effekt holder sig i mindst 24 timer.
English: 30 - 56 x 1 - 90 tablets:
Danish: 30 - 56 x 1 - 90 tabletter:
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: 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 Aprovel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - France
Danish: sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - Frankrig
English: significant increases in plasma creatine kinase were commonly observed (1.7%) in irbesartan treated subjects.
Danish: Betydelige stigninger i plasma-creatinkinase rapporteredes hyppigt (1,7%) blandt irbesartanbehandlede patienter.
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 usandsynligt, at irbesartan vil påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: Other medicines and Aprovel
Danish: Brug af anden medicin sammen med Aprovel
English: The blood pressure lowering effects of irbesartan and thiazide-type diuretics are additive.
Danish: Den blodtrykssænkende effekt af irbesartan og diuretika af thiazidtypen er additiv.
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: 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: The pharmacokinetic of digoxin was not altered by coadministration of irbesartan.
Danish: Digoxins farmakokinetik blev ikke ændret ved samtidig administration af irbesartan.
English: After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80%.
Danish: Efter oral administration absorberes irbesartan godt: studier af absolut biotilgængelighed gav værdier på ca. 60-80%.
English: PHARMACEUTICAL FORM AND CONTENTS 14 tablets 28 tablets 56 tablets 56 x 1 tablets 98 tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 14 tabletter 28 tabletter 56 tabletter 56 x 1 tabletter 98 tabletter ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Oral anvendelse.
English: The blood pressure lowering effect of Aprovel is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
Danish: Aprovels blodtrykssænkende effekt er tydelig i løbet af 1-2 uger, og den maksimale effekt viser sig 4-6 uger efter behandlingsstart.
English: Adverse reactions additionally reported from post-marketing experience are also listed.
Danish: Bivirkninger, der er indberettet efter markedsføring, er også anført.
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: The total body and renal clearance are 157176 and 3-3.5 ml/min, respectively.
Danish: Total body- og nyre-clearance er henholdsvis 157-176 og 3-3,5 ml/min.
English: hypersensitivity reactions such as angioedema, rash, urticaria, anaphylactic reaction, anaphylactic shock Metabolism and nutrition disorders Not known:
Danish: Overfølsomhedsreaktioner, fx angioødem, udslæt, urticaria, anafylaktisk reaktion/shock Metabolisme og ernæring Ikke kendt:
English: o an ACE-inhibitor ( for example enalapril, lisinopril, ramipril) in particular if you have diabetes-related kidney problems.
Danish: o en ACE-hæmmer (f.eks. enalapril, lisinopril, remipril) især hvis du har nyreproblemer, der skyldes diabetes.
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: hepatitis, abnormal liver function Skin and subcutaneous tissue disorders Not known:
Danish: Hepatitis, abnorm leverfunktion Hud og subkutane væv Ikke kendt:
English: What Aprovel contains  The active substance is irbesartan.
Danish: Aprovel indeholder:  Aktivt stof: irbesartan.
English: The following table 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.
English: Lithium: the combination of lithium and Aprovel is not recommended (see section 4.5).
Danish: Lithium: Kombination af lithium og Aprovel frarådes (se pkt.
English: Irbesartan AUC and Cmax values were also somewhat greater in older 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: The usual dose is 150 mg once a day.
Danish: Den sædvanlige dosis er 150 mg 1 gang dagligt.
English: In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/kg/day in rats and ≥ 100 mg/kg/day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
Danish: I ikke-kliniske sikkerhedsstudier forårsagede høje doser af irbesartan (≥ 250 mg/kg/dag hos rotter og ≥ 100 mg/kg/dag hos marekatte) en reduktion af røde blodlegeme-parametre (erytrocytter, hæmoglobin, hæmatokrit).
English: Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
Danish: Irbesartan er en potent, oral aktiv, selektiv angiotensin-II receptor (type AT1) antagonist.
English: Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Danish: Lithium: Der er rapporteret reversibel øgning af serum-lithium koncentrationer og toksicitet ved samtidig administration af lithium og angiotensin-konverterende enzymhæmmere.
English: You may need to have blood checks if you take: potassium supplements salt substitutes containing potassium potassium-sparing medicines (such as certain diuretics) medicines containing lithium
Danish: Det kan være nødvendigt at tage blodprøver, hvis du tager: kaliumtilskud salterstatninger, der indeholder kalium kaliumsparende medicin (som visse vanddrivende lægemidler) medicin, der indeholder lithium
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, medens tallet var henholdsvis 76% og 78% for irbesartan og amlodipin.
English: Aprovel belongs to a group of medicines known as angiotensin-II receptor antagonists.
Danish: Aprovel tilhører en medicingruppe, der kaldes angiotensin-II receptorantagonister.
English: Additional information on irbesartan interactions: in clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
Danish: Yderligere information om irbesartan interaktioner: Irbesartans farmakokinetik er i kliniske forsøg ikke påvirket af hydrochlorthiazid.
English: When irbesartan is administered concomitantly with a low dose of hydrochlorothiazide (e.g. 12.5 mg daily), the antihypertensive response in black patients approaches that of white patients.
Danish: Når irbesartan administreres samtidig med en lille dosis hydrochlorthiazid (fx 12,5 mg daglig) nærmer det antihypertensive respons hos sorte sig det, der forekommer hos hvide.
English: The most likely manifestations of overdose are expected to be hypotension and tachycardia; bradycardia might also occur from overdose.
Danish: De mest sandsynlige tegn på overdosering forventes at være hypotension og takykardi.
English: Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
Danish: To store randomiserede, kontrollerede studier (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) og VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) har undersøgt samtidig brug af kombinationen af en ACE-hæmmer og en angiotensin-II-receptorblokker.
English: Non-steroidal anti-inflammatory drugs: when angiotensin II antagonists are administered simultaneously with non-steroidal anti-inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Danish: Non-steroide anti-inflammatoriske lægemidler: Når angiotensin II-antagonister administreres samtidig med non-steroide anti-inflammatoriske lægemidler (fx selektive COX 2-hæmmere, acetylsalicylsyre (> 3 g/dag) og nonselektive NSAID) kan den antihypertensive virkning svækkes.
English: Close monitoring of serum potassium in patients at risk is recommended (see section 4.5).
Danish: Der anbefales tæt kontrol af serum-kalium hos patienter, der tilhører en risikogruppe (se pkt.
English: Although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for older people.
Danish: Selvom initialdosis på 75 mg bør overvejes til patienter > 75 år, er det sædvanligvis ikke nødvendigt at dosisjustere ældre personer.
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 risiko reduktion sammenlignet med amlodipin (p= 0,006).
English: The usual dose is 150 mg once a day (two tablets a day).
Danish: Den sædvanlige dosis er 150 mg 1 gang dagligt (to tabletter dagligt).
English: If you take more Aprovel than you should If you accidentally take too many tablets, contact your doctor immediately.
Danish: Hvis du har taget for mange Aprovel Hvis du ved et uheld har taget for mange tabletter, skal du omgående kontakte lægen.
English: In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function if you are going to have an operation (surgery) or be given anaesthetics if you are taking any of the following medicines used to treat high blood pressure: o an ACE-inhibitor ( for example enalapril, lisinopril, ramipril) in particular if you have diabetes-related kidney problems.
Danish: I dette tilfælde kan lægen tage regelmæssige blodprøver med særlig henblik på at måle kaliumniveauet i blodet, hvis nyrefunktionen er nedsat hvis du skal opereres eller bedøves hvis du tager en af følgende lægemidler, der anvendes til at behandle forhøjet blodtryk: o en ACE-hæmmer (f.eks. enalapril, lisinopril, remipril) især hvis du har nyreproblemer, der skyldes diabetes.
English: Aprovel contains lactose.
Danish: Aprovel indeholder lactose
English: The concomitant use of Aprovel with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Danish: Samtidig behandling med Aprovel og aliskiren-holdige lægemidler er kontraindiceret til patienter med diabetes mellitus eller nedsat nyrefunktion (glomerulær filtrationshastighed (GFR) < 60 ml/min/1,73 m2 ) (se pkt.4.4 og 4.5).
English: The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.
Danish: Lægen kan anbefale en lavere dosis, specielt til patienter, som bliver behandlet med hæmodialyse eller til ældre patienter over 75 år.
English: impaired renal function including cases of renal failure in patients at risk (see section 4.4)
Danish: Nedsat nyrefunktion, inklusive tilfælde af nyresvigt hos risikopatienter (se pkt.
English: The frequency of the side effects listed below is defined using the following convention: Very common: may affect more than 1 in 10 people Common: may affect up to 1 in 10 people
Danish: Hyppigheden af nedenstående bivirkninger er angivet på følgende måde: Meget almindelig: kan påvirke flere end 1 ud af 10 patienter Almindelig: kan påvirke op til 1 ud af 10 patienter Ikke almindelig: kan påvirke op til 1 ud af 100 patienter
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid Aprovel nøjagtigt efter lægens anvisning.
English: Adjusted mean change of trough seated diastolic blood pressure (SeDBP) was as follows: 3.8 mmHg (low dose), 3.2 mmHg (medium dose), 5.6 mmHg (high dose).
Danish: Den justerede gennemsnitlige ændring i dalniveau af diastolisk blodtryk i siddende stilling (SeDBP) var som følger: 3,8 mmHg (lav dosis), 3,2 mmHg (middel dosis), 5,6 mmHg (høj dosis).
English: Reproductive system and breast disorders Uncommon: sexual dysfunction
Danish: Ikke almindelig: Seksuel dysfunktion
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Danish: Aorta- og mitralklapstenose, obstruktiv hypertrofisk kardiomyopati: Som ved behandling med andre vasodilatorer, skal der udvises ekstra forsigtighed hos patienter, der lider af aorta- eller mitralstenose eller obstruktiv hypertrofisk kardiomyopati.
English: In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect.
Danish: In vitro-undersøgelser viser, at irbesartan primært oxideres af cytokrom P450 enzymet CYP2C9.
English: Aprovel 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: Aprovel frarådes tidligt i graviditeten, og du må ikke tage det, hvis du er længere end 3 måneder henne i graviditeten, da det kan skade dit barn alvorligt, hvis du tager det efter tredje måned af graviditeten.
English: Aprovel slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Danish: Aprovel mindsker faldende nyrefunktion hos patienter med forhøjet blodtryk og type 2 diabetes (sukkersyge).
English: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Aprovel” and “Warnings and precautions”).
Danish: Din læge kan blive nødt til at ændre din dosis og/eller tage andre forholdsregler: Hvis du tager en ACE-hæmmer eller aliskiren (se også information under ”Tag ikke Aprovel” og ”Advarsler og forsigtighedsregler”).
English: In diabetic hypertensive patients with microalbuminuria and normal renal function, orthostatic dizziness and orthostatic hypotension were reported in 0.5% of the patients (i.e., uncommon) but in excess of placebo.
Danish: Hos diabetiske, hypertensive patienter med mikroalbuminuri og normal nyrefunktion indberettedes ortostatisk svimmelhed og ortostatisk hypotension blandt 0,5% af patienterne (dvs ikke almindelig), men i større grad end med placebo.
English: Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Aprovel (see section 4.4).
Danish: En forudgående behandling med høje doser diuretika kan medføre hypovolæmi og risiko for hypotension, når behandlingen med Aprovel påbegyndes (se pkt.