natgillin/translations-raw huggingface dataset:
Hos patienter, hvis vaskulære tonus og nyrefunktion hovedsageligt afhænger af renin - angiotensin- aldosteronsystemets aktivitet, (fx patienter med alvorlig hjerteinsufficiens eller underliggende nyresygdom, inklusive nyrearteriestenose), er behandling med angiotensin - konverterende enzymhæmmere eller angiotensin- II receptorantagonister, der påvirker dette system, blevet forbundet med akut hypotension, azotæmi, oliguri og i sjældne tilfælde med akut nyresvigt.
General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e. g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure.
Ved behandling med et antihypertensivt stof kan en voldsom sænkning af blodtrykket hos patienter med iskæmisk kardiopati eller iskæmisk kardiovaskulær sygdom medføre myokardieinfarkt eller slagtilfælde.
As with any anti- hypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
5. 1).
As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see section 5.1).
3 Graviditet:
Pregnancy:
Behandling med Angiotensin II- Receptor- Antagonister (AIIRAer) bør ikke påbegyndes under graviditet.
Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Patienter, der planlægger at blive gravide, bør ændre til anden antihypertensiv behandling hvor sikkerhedsprofilen for anvendelse under graviditet er veletableret, medmindre fortsat behandling med AIIRA skønnes nødvendig.
3 changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
4. 3 og 4. 6).
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Dette lægemiddel indeholder lactose.
Lactose: this medicinal product contains lactose.
Patienter med sjældne, arvelige problemer med galactoseintolerans, Lappisk lactasemangel eller glucose- galactosemalabsorption bør ikke anvende dette lægemiddel.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
4. 8, 5. 1 and 5. 2).
Paediatric patients: 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).
På trods af dette er Aprovel uden risiko blevet administreret sammen med andre antihypertensive lægemidler som beta- blokkere, langtidsvirkende calcium- antagonister samt diuretika af thiazidtypen.
Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however Aprovel has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
4. 4).
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).
4. 4).
Potassium supplements and potassium-sparing diuretics: based on experience with the use of other medicinal products that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e. g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Der er rapporteret reversibel øgning af serum- lithium koncentrationer og toksicitet ved samtidig administration af lithium og angiotensin- konverterende enzymhæmmere.
Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
4. 4).
Therefore, this combination is not recommended (see section 4.4).
Såfremt samtidig administration skønnes nødvendig, anbefales det at kontrollere serum- lithium værdier omhyggeligt.
If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Når angiotensin II antagonister administreres samtidig med nonsteroide antiinflammatoriske lægemidler (fx selektive COX- 2 hæmmere, acetylsalicylsyre (> 3 g/ dag) og nonselektive NSAID) kan den antihypertensive virkning svækkes.
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.
Dette gælder især hos patienter som i forvejen har dårlig nyrefunktion.
As with ACE inhibitors, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Der bør overvejes at monitorerenyrefunktionen efter samtidig behandling er initieret og periodisk derefter.
Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Irbesartans farmakokinetik er i kliniske forsøg ikke påvirket af hydrochlorthiazid.
Additional information on irbesartan interactions: in clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
4 4. 6 Graviditet og amning
4.6 Pregnancy and lactation
AIIRAer bør ikke anvendes under graviditetens første trimester (se pkt.
Pregnancy: the use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4).
4. 3 og 4. 4).
The use of AIIRAs is contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Imidlertid kan en lille øget risiko ikke udelukkes.
4 Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Der findes ingen kontrollerede epidemiologiske data vedrørende risikoen med Angiotensin II- Receptor - Antagonister (AIIRAer), men lignende risici kan findes for denne lægemiddelgruppe.
Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs.
Patienter, der planlægger at blive gravide, bør ændre til anden antihypertensiv behandling hvor sikkerhedsprofilen for anvendelse under graviditet er veletableret, medmindre fortsat behandling med AIIRAer skønnes nødvendig.
Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Der er kendt at behandling med AIIRAer under anden og tredje trimester kan inducere human føtotoksicitet (nedsat nyrefunktion, oligohydramnios, hæmning af kraniets knogledannelse) og neonatal toksicitet (nyresvigt, hypotension, hyperkalæmi) (se pkt.
AIIRAs therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
5. 3).
(see section 5.3).
4. 3 og 4. 4).
Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see also sections 4.3 and 4.4).
4. 3) under amning.
Aprovel is contraindicated (see section 4.3) during breast-feeding.
Det vides ikke, om irbesartan udskilles i human modermælk.
It is not known whether irbesartan is excreted in human milk.
Irbesartan udskilles i mælk hos diegivende rotter.
Irbesartan is excreted in the milk of lactating rats.
I placebokontrollerede forsøg med patienter med hypertension afveg den overordnede forekomst af bivirkninger med irbesartan (56, 2%) ikke fra placebogruppernes (56, 5%).
In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan (56.2%) and the placebo groups (56.5%).
Seponering på grund af kliniske eller laboratoriemæssige bivirkninger var mindre hyppig blandt irbesartanbehandlede patienter (3, 3%) end blandt placebobehandlede (4, 5%).
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%).
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.
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.
Meget almindelig (≥ 1/ 10); almindelig (≥ 1/ 100, < 1/ 10); ikke almindelig (≥ 1/ 1. 000, < 1/ 100); sjælden (≥ 1/ 10. 000, < 1/ 1. 000); meget sjælden (< 1/ 10. 000).
The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000).
5 Undersøgelser:
Investigations:
Hyperkalæmi * forekommer hyppigere blandt diabetiske patienter behandlet med irbesartan end med placebo.
Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.
Hos diabetiske, hypertensive patienter med mikroalbuminuri og normal nyrefunktion sås hyperkalæmi (≥5, 5 mEq/ l) hos 29, 4% af patienterne i irbesartan 300 mg- gruppen og 22% af patienterne i placebogruppen.
In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥ 5.5 mEq/ L) occurred in 29.4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group.
Blandt diabetiske, hypertensive patienter med kronisk nyreinsufficiens og udtalt proteinuri sås hyperkalæmi (≥5, 5 mEq/ l) hos 46, 3% af patienterne i irbesartangruppen og 26, 3% af patienterne i placebogruppen.
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/ L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo group.
Almindelig:
5 Common:
Betydelige stigninger i plasma- creatinkinase rapporteredes hyppigt (1, 7%) blandt irbesartanbehandlede patienter.
significant increases in plasma creatine kinase were commonly observed (1.7%) in irbesartan treated subjects.
Der er set fald i hæmoglobin, som ikke var klinisk signifikant, hos 1, 7% (dvs almindelig) af de hypertensive patienter med fremskreden diabetisk nyresygdom behandlet med irbesartan.
In 1.7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed.
Takykardi
tachycardia
Almindelig:
Nervous system Common:
Svimmelhed, ortostatisk svimmelhed *
disorders: dizziness, orthostatic dizziness*
Hoste
cough
Kvalme/ opkastning Diarré, dyspepsi/ halsbrand
nausea/ vomiting diarrhoea, dyspepsia/ heartburn
Knogler, led, muskler og bindevæv:
and connective tissue disorders:
Smerter i bevægeapparatet *
musculoskeletal pain*
Ortostatisk hypotension * Rødme
orthostatic hypotension* flushing
Træthed Brystsmerter
fatigue chest pain
Seksuel dysfunktion
sexual dysfunction
Følgende yderligere uønskede reaktioner er indberettet efter markedsføring; disse er udledt fra spontane rapporter, hvorfra forekomst kan ikke bestemmes, og hyppighed af disse uønskede reaktioner kendes derfor ikke:
The following additional adverse reactions have been reported during post– marketing experience; they are derived from spontaneous reports and therefore, the frequency of these adverse reactions is not known:
Dysgeusia
Dysgeusia
4. 4)
Impaired renal function including cases of renal failure in patients at risk (see section 4.4)
6 Hud og subkutane væv:
Skin and subcutaneous tissue disorders:
Artralgi, myalgi (i nogle tilfælde forbundet med øgede niveauer af plasma- creatinkinase), muskelkramper
Arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps
Metabolisme og ernæring:
6 Metabolism and nutrition disorders:
Pædatriske patienter: i et randomiseret forsøg med 318 hypertensive børn og unge i aldersgruppen 6 til 16 år sås følgende relaterede bivirkninger i den 3- ugers dobbeltblinde fase: hovedpine (7, 9%), hypotension (2, 2%), svimmelhed (1, 9%), hoste (0, 9%).
Paediatric patients: in a randomised trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following related adverse events occurred in the 3-week double-blind phase: headache (7.9%), hypotension (2.2%), dizziness (1.9%), cough (0.9%).
I den 26- ugers åbne periode i forsøget var de hyppigst observerede laboratoriemæssige abnormaliteter stigninger i creatinin (6, 5%) og øgede CK - værdier hos 2% af børnene.
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.
Erfaringerne med behandling af voksne med doser op til 900 mg/ dag i 8 uger, viste ingen toksicitet.
Experience in adults exposed to doses of up to 900 mg/ day for 8 weeks revealed no toxicity.
Der kan også opstå bradykardipå grund af overdosering.
The most likely manifestations of overdose are expected to be hypotension and tachycardia; bradycardia might also occur from overdose.
Foreslåede tiltag omfatter induktion af opkastning og/ eller gastrisk udskylning.
Suggested measures include induction of emesis and/ or gastric lavage.
Angiotensin- II antagonister, almindelige ATC- kode:
ATC code:
Irbesartan er en potent, peroralt aktiv, selektiv angiotensin- II receptor (type AT1) antagonist.
Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
Stoffet antages at blokere alle virkninger af angiotensin- II, som bliver medieret af AT1 receptoren, uafhængigt af angiotensin- II- syntesens kilde eller rute.
It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II.
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.
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.
Serum- kalium påvirkes ikke nævneværdigt, når irbesartan administreres alene ved de anbefalede doser.
Serum potassium levels are not significantly affected by irbesartan alone at the recommended doses.
Irbesartan hæmmer ikke ACE (kininase- II), et enzym som producerer angiotensin- II og også nedbryder bradykinin til inaktive metabolitter.
Irbesartan does not inhibit ACE (kininase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites.
Hypertension Irbesartan sænker blodtrykket med en minimal ændring af hjerteaktionen.
Hypertension Irbesartan lowers blood pressure with minimal change in heart rate.
Doser på 150- 300 mg, 1 gang i døgnet, giver en sænkning af det liggende eller siddende blodtryk i
Doses of 150-300 mg once daily lower supine or seated blood pressures at trough (i. e.
24 timer efter dosering), som i gennemsnit er 8- 13/ 5- 8 mm Hg (systolisk/ diastolisk) større end ved placebo- behandling.
24 hours after dosing) by an average of 8-13/ 5-8 mm Hg (systolic/ diastolic) greater than those associated with placebo.
Spidsreduktion af blodtrykket opnås 3- 6 timer efter administration, og den blodtrykssænkende effekt holder sig i mindst 24 timer.
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.
Efter 24 timer var blodtryksreduktionen 60- 70% af den tilsvarende diastoliske og systoliske spidsrespons ved de anbefalede doser.
At 24 hours the reduction of blood pressure was 60-70% of the corresponding peak diastolic and systolic responses at the recommended doses.
150 mg, 1 gang dagligt, gav minimums - og gennemsnitlig 24 timers respons svarende til samme døgndosis givet 2 gange dagligt.
Once daily dosing with 150 mg produced trough and mean 24 hour responses similar to twice daily dosing on the same total dose.
Aprovels blodtrykssænkende effekt er tydelig i løbet af 1- 2 uger, og den maksimale effekt viser sig 4- 6 uger efter behandlingsstart.
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.
Den blodtrykssænkende effekt af irbesartan og diuretika af thiazidtypen er additiv.
7 The blood pressure lowering effects of irbesartan and thiazide-type diuretics are additive.
Dette resulterer i en yderligere placebo - korrigeret blodtryksreduktion på 7- 10/ 3- 6 mm Hg (systolisk/ diastolisk) i gennemsnit.
In patients not adequately controlled by irbesartan alone, the addition of a low dose of hydrochlorothiazide (12.5 mg) to irbesartan once daily results in a further placebo-adjusted blood pressure reduction at trough of 7-10/ 3-6 mm Hg (systolic/ diastolic).
Ligesom for andre lægemidler, der påvirker renin- angiotensinsystemet, gælder det, at sorte hypertensionpatienter responderer betydeligt dårligere på irbesartan monoterapi.
As is the case with other medicinal products that affect the renin-angiotensin system, black hypertensive patients have notably less response to irbesartan monotherapy.
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.
12.5 mg daily), the antihypertensive response in black patients approaches that of white patients.
Der er ingen klinisk vigtig effekt på serum- urinsyre eller urinsyreudskillelse.
There is no clinically important effect on serum uric acid or urinary uric acid secretion.
Reduktion af blodtryk med 0, 5 mg/ kg (lav), 1, 5 mg/ kg (middel) og 4, 5 mg/ kg (høj) mål- titrerede doser af irbesartan evalueredes, over en periode på 3 uger, hos 318 børn og unge eller børn med hypertension eller i risiko for at udvikle hypertension (diabetes, familiær disposition for hypertension) i aldersgruppen 6 til 16 år..
Reduction of blood pressure with 0.5 mg/ kg (low), 1.5 mg/ kg (medium) and 4.5 mg/ kg (high) target titrated doses of irbesartan was evaluated in 318 hypertensive or at risk (diabetic, family history of hypertension) children and adolescents aged 6 to 16 years over a three week period.
Efter de 3 uger var den gennemsnitlige reduktion fra baseline i det primære effektvariabel, dalniveau af systolisk blodtryk (SeSBP), 11, 7 mmHg (lav dosis), 9, 3 mmHg (middel dosis), 13, 2 mmHg (høj dosis).
At the end of the three weeks the mean reduction from baseline in the primary efficacy variable, trough seated systolic blood pressure (SeSBP) was 11.7 mmHg (low dose), 9.3 mmHg (medium dose), 13.2 mmHg (high dose).
Den justerede gennemsnitlige ændring i dalniveau af diastolisk blodtryk i siddende stilling (SeDBP) var som følger:
Adjusted mean change of trough seated diastolic blood pressure (SeDBP) was as follows:
3, 8 mmHg (lav dosis), 3, 2 mmHg (middel dosis), 5, 6 mmHg (høj dosis).
3.8 mmHg (low dose), 3.2 mmHg (medium dose), 5.6 mmHg (high dose).
4. 2).
Over a subsequent two week period where patients were re-randomized to either active medicinal product or placebo, patients on placebo had increases of 2.4 and 2.0 mmHg in SeSBP and SeDBP compared to +0.1 and -0.3 mmHg changes respectively in those on all doses of irbesartan (see section 4.2).
Hypertensive patienter med type 2 diabetisk nyresygdom IDNT studiet (Irbesartan Diabetic Nephropathy Trial) har vist, at irbesartan nedsætter progression af nyresygdom hos patienter med kronisk nyre insufficiens og klinisk proteinuri.
Hypertension and type 2 diabetes with renal disease The “ Irbesartan Diabetic Nephropathy Trial (IDNT )” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria.
IDNT var et kontrolleret dobbelt- blindt morbiditets - og mortalitetsstudie, som sammenlignede Aprovel, amlodipin og placebo.
IDNT was a double blind, controlled, morbidity and mortality trial comparing Aprovel, amlodipine and placebo.
Hos 1715 hypertensive patienter med type 2 diabetes, proteinuri ≥ 900 mg/ dag og serum - kreatininværdier i intervallet 1, 0- 3, 0 mg/ dl, evalueredes langtidseffekterne (median 2, 6 år) ved Aprovel med henblik på progression af nyresygdom og total mortalitet.
In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/ day and serum creatinine ranging from 1.0-3.0 mg/ dl, the long-term effects (mean 2.6 years) of Aprovel on the progression of renal disease and all-cause mortality were examined.
Patienterne blev titreret fra 75 mg til en vedligeholdelsesdosis på 300 mg Aprovel, fra 2, 5 mg til 10 mg amlodipin eller placebo i henhold til tolerance.
Patients were titrated from 75 mg to a maintenance dose of 300 mg Aprovel, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
I samtlige af behandlingsgrupperne fik patienterne typisk mellem 2 og 4 antihypertensive lægemidler (f. eks. diuretikum, betablokkere, alfablokkere) l for at opnå en foruddefineret blodtryksværdi på ≤ 135/ 85 mmHg eller en 10 mmHg reduktion i systolisk tryk, hvis baseline var > 160 mmHg.
Patients in all treatment groups typically received between 2 and 4 antihypertensive agents (e. g., diuretics, beta blockers, alpha blockers) to reach a predefined blood pressure goal of ≤ 135/ 85 mmHg or a 10 mmHg reduction in systolic pressure if baseline was > 160 mmHg.
Irbesartan reducerede signifikant den relative risiko i det kombinerede primære endepunkt med fordobling af serum- kreatinin, slutstadium af nyresygdom (ESRD) eller total mortalitet.
Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all- cause mortality.
33% af patienterne i irbesartan gruppen nåede det primære kombinerede nyreendepunkt sammenlignet med henholdsvis39% 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).
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)].
Da de individuelle komponenter af det primære endepunkt blev analyseret, blev der ikke observeret nogen effekt ved total mortalitet, mens der sås en positiv tendens i reduktionen i ESRD og en signifikant reduktion i fordoblingen af serum- kreatinin.
When the individual components of the primary endpoint were analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed.