natgillin/translations-raw huggingface dataset:
Hos patienter som ikke er tilstrækkeligt kontrolleret på 150 mg, 1 gang dagligt, kan dosis af Irbesartan Krka øges til 300 mg, eller andre antihypertensiva kan tilføjes.
In patients insufficiently controlled with 150 mg once daily, the dose of Irbesartan Krka can be increased to 300 mg, or other anti-hypertensive agents can be added.
4. 5).
In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan Krka (see section 4.5).
5. 1).
The demonstration of renal benefit of Irbesartan Krka in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see section 5.1).
Nyrefunktionsnedsættelse:
Renal impairment:
Det er ikke nødvendigt at dosisjustere patienter med nedsat nyrefunktion.
No dosage adjustment is necessary in patients with impaired renal function.
Dosisjustering er ikke nødvendig hos patienter med let/ moderat leverfunktionsnedsættelse.
No dosage adjustment is necessary in patients with mild to moderate hepatic impairment.
Selvom initialdosis på 75 mg bør overvejes til patienter > 75 år, er det sædvanligvis ikke nødvendigt at dosisjustere ældre patienter.
2 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 the elderly.
2 Pædiatriske patienter:
Paediatric patients:
4. 8, 5. 1 og 5. 2).
Irbesartan is not recommended for use in children and adolescents due to insufficient data on safety and efficacy (see sections 4.8, 5.1 and 5.2).
Nedsat intravaskulært volumen:
Intravascular volume depletion:
Specielt efter første dosis kan der forekomme symptomatisk hypotension hos patienter, med hypovolæmi og/ eller hyponatriæmi forårsaget af kraftig diuretisk behandling, nedsat saltindtag gennem kosten, diarré eller opkastning.
Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/ or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Sådanne tilstande skal korrigeres før administration af Irbesartan Krka.
Such conditions should be corrected before the administration of Irbesartan Krka.
Renovaskulær hypertension:
Renovascular hypertension:
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.
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.
Selvom dette ikke er dokumenteret for Irbesartan Krka, kan der forventes en lignende effekt med angiotensin- II receptorantagonister.
While this is not documented with Irbesartan Krka, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Nyrefunktionsnedsættelse og nyretransplantation:
Renal impairment and kidney transplantation:
Der anbefales periodisk kontrol af serum- kalium og serum- kreatinin, hvis Irbesartan Krka anvendes til patienter med nedsat nyrefunktion.
When Irbesartan Krka is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Der foreligger ingen erfaring vedrørende administration af Irbesartan Krka til nyligt nyretransplanterede patienter.
There is no experience regarding the administration of Irbesartan Krka in patients with a recent kidney transplantation.
Hypertensive patienter med type 2 diabetes og nyresygdom:
Hypertensive patients with type 2 diabetes and renal disease:
I en undersøgelse med patienter med fremskreden nyresygdom var effekten af irbesartan på nyrer og kardiovaskulære hændelser ikke den samme i alle sub- grupper.
The effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease.
Hyperkaliæmi:
Hyperkalemia:
Som med andre lægemidler, der påvirker renin- angiotensin- aldosteronsystemet, kan der opstå hyperkaliæmi under behandling med Irbesartan Krka, specielt i tilfælde af nyrefunktionsnedsættelse, klinisk proteinuri på grund af diabetisk nyresygdom, og/ eller hjertefejl.
As with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalemia may occur during the treatment with Irbesartan Krka, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/ or heart failure.
4. 5).
The combination of lithium and Irbesartan Krka is not recommended (see section 4.5).
Aorta - og mitralklapstenose, obstruktiv hypertrofisk kardiomyopati:
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy:
Som ved behandling med andre vasodilatorer, skal der udvises ekstra forsigtighed hos patienter, der lider af aorta - eller mitralstenose eller obstruktiv hypertrofisk kardiomyopati.
As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Patienter med primær aldosteronisme responderer generelt ikke på antihypertensive lægemidler, der virker gennem hæmning af renin- angiotensinsystemet.
Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Derfor frarådes brug af Irbesartan Krka.
Therefore, the use of Irbesartan Krka is not recommended.
3 Generelt:
General:
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 angiotensinkonverterende enzymhæmmere eller angiotensin- II receptorantagonister, der påvirker dette system, blevet forbundet med akut hypotension, azotæmi, oliguri og i sjældne tilfælde med akut nyresvigt.
3 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.
Som ved behandling med et hvilket som helst 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.
Behandling med angiotensin- II receptorantagonister må ikke påbegyndes under graviditet.
AIIRAs should not be initiated during pregnancy.
Med mindre det anses for strengt nødvendigt at fortsætte behandlingen med angiotensin- II receptorantagonister skal patienter, som planlægger at blive gravide skifte til alternativ antihypertensiv behandling, som har en etableret sikkerhedsprofil for brug under graviditet.
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.
4. 8, 5. 1 and 5. 2).
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 Irbesartan Krka uden risiko blevet administreret sammen med andre antihypertensive lægemidler som beta- blokkere, langtidsvirkende calcium- antagonister samt diuretika af thiazidtypen.
Other antihypertensive agents may increase the hypotensive effects of irbesartan; however Irbesartan Krka 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 Irbesartan Krka (see section 4.4).
Kaliumtilskud og kalium- besparende diuretika:
Potassium supplements and potassium-sparing diuretics:
4. 4).
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 angiotensinkonverterende enzymhæmmere.
Rreversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
4 Nonsteroide antiinflammatoriske lægemidler:
Non-steroidal anti-inflammatory medicinal products:
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.
When angiotensin II antagonists are administered simultaneously with non-steroidal anti- inflammatory medicinal products (i. e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/ day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Patienterne skal være tilstrækkelig hydrerede.
Patients should be adequately hydrated and
Der bør overvejes at monitorere nyrefunktionen efter samtidig behandling er initieret og periodisk derefter.
4 consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
4. 6 Graviditet og amning Graviditet:
Pregnancy:
Brugen af angiotensin- II receptorantagonister frarådes i 1. trimester af graviditeten (se pkt.
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 contra-indicated during the 2nd and 3rd trimester of pregnancy (see section 4.3 and 4.4).
Det kan dog ikke udelukkes at der er en lille forøget risiko.
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 er ingen kontrollerede epidemiologiske data vedrørende risikoen ved angiotensin- II receptorantagonister, men lignende risiko kan eksistere for denne klasse af lægemidler.
Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Inhibitors( AIIRAs), similar risks may exist for this class of medicinal products.
Med mindre fortsat angiotensin- receptorblokerende behandling anses for at være strengt nødvendigt skal patienter, som planlægger at blive gravide skiftes til en alternativ antihypertensiv behandling, som har en etableret sikkerhedsprofil for brug under graviditet.
Unless continued ARB 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.
Hvis en patient bliver gravid skal behandlingen med angiotensin- II receptorantagonister afbrydes øjeblikkeligt og om nødvendigt skal en alternativ behandling påbegyndes.
When pregnancy is diagnosed, treatment with AIIRAsshould be stopped immediately and, if appropriate, alternative therapy should be started.
Det er kendt, at behandling med angiotensin- II receptorantagonister i 2. og 3. trimester af graviditeten inducerer human føtotoksicitet (nedsat nyrefunktion, oligohydramnios, føtal kraniel hypoplasi) og neonatal toksicitet (nyresvigt, hypotention, hyperkaliæmi) (se også 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 also section 5.3)
Hvis moderen har været eksponeret for angiotensin- II receptorantagonister fra 2. trimester af graviditeten anbefales det, at lave en ultralydundersøgelse af nyrefunktion og kranium.
Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
4. 3) under amning.
Irbesartan Krka is contraindicated (see section 4.3) during breast-feeding.
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.
5 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).
Signifikante 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% 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.
Ikke almindelig:
Cardiac disorders:
Takykardi
Uncommon: tachycardia
Svimmelhed, ortostatisk svimmelhed *
dizziness, orthostatic dizziness*
Ualmindelig:
Uncommon: cough
Ualmindelig:
nausea/ vomiting
Kvalme/ opkastning Diarré, dyspepsi/ halsbrand
Uncommon: diarrhoea, dyspepsia/ heartburn
Ualmindelig:
Uncommon: flushing
Ualmindelig:
fatigue
Træthed Brystsmerter
Uncommon: chest pain
Det reproduktive system og mammae:
6 Reproductive system and breast disorders:
Følgende yderligere uønskede reaktioner er indberettet efter markedsføring; disse er udledt fra spontane rapporter, 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:
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
I den 26- ugers åbne periode i forsøget var de hyppigst observerede laboratoriemæssige abnormaliteter stigninger i kreatinin (6, 5%) og øgede CKværdier 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.
Erfaringer fra voksen eksponering for doser op til 900 mg/ dag i 8 uger afslørede 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 overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose.
Der foreligger ikke specifikke oplysninger om behandling af overdosering med Irbesartan Krka.
No specific information is available on the treatment of overdosage with Irbesartan Krka.
Angiotensin- II antagonister, almindelige ATC- kode:
5.1 Pharmacodynamic properties Pharmacotherapeutic group: angiotensin II antagonist, plain, ATC code:
Virkningsmekanisme:
7 Mechanism of action:
Serum- kalium påvirkes ikke signifikant, når irbesartan administreres alene ved de anbefalede doser.
Serum potassium levels are not significantly affected by irbesartan alone at the recommended doses.
Doser på 150- 300 mg, 1 gang daglig, giver en sænkning af det liggende eller siddende blodtryk i minimumpunktet (dvs.
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 mmHg (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.
150 mg, 1 gang dagligt, gav minimums - og gennemsnitlig 24 timers respons svarende til samme døgndosis givet 2 gange dagligt. irbesartans 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 irbesartan is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
Hos patienter, hvis blodtryk ikke kan kontrolleres tilfredsstillende med irbesartan alene, kan irbesartan suppleres med en lille dosis hydrochlorthiazid (12, 5 mg), 1 gang dagligt.
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).
Dette resulterer i en yderligere placebokorrigeret blodtryksreduktion på 7- 10/ 3- 6 mmHg (systolisk/ diastolisk) i minimumsrespons.
The efficacy of irbesartan is not influenced by age or gender.
Virkningen af irbesartan afhænger ikke af alder eller køn.
As is the case with other medicinal products that affect the renin-angiotensin system, black hypertensive patients have notably less response to irbesartan monotherapy.
Ligesom for andre lægemidler, der påvirker renin- angiotensinsystemet, gælder det, at sorte hypertensionpatienter responderer betydeligt dårligere på irbesartan monoterapi.
When irbesartan is administered concomitantly with a low dose of hydrochlorothiazide (e. g.
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 patienter.
12.5 mg daily), the antihypertensive response in black patients approaches that of white patients.
8 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 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.
IDNT var et kontrolleret dobbelt- blindt morbiditets - og mortalitetsstudie, som sammenlignede irbesartan, amlodipin og placebo.
IDNT was a double blind, controlled, morbidity and mortality trial comparing irbesartan, amlodipine and placebo.
Hos 1715 hypertensive patienter med type 2 diabetes, proteinuri ≥ 900 mg/ dag og serumkreatininværdier i intervallet 1, 0- 3, 0 mg/ dl, evalueredes langtidseffekterne (median 2, 6 år) ved irbesartan 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 irbesartan on the progression of renal
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.
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.
Tres procent (60%) af patienterne i placebogruppen nåede denne blodtryksværdi, mens tallet var henholdvis 76% og 78% for irbesartan - og amlodipingrupperne.
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.
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 allcause mortality.
33% af patienterne i irbesartangruppen 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).
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)].
Subgrupper opdelt efter køn, race, alder, varighed af diabetes, baseline- blodtryk, serum- kreatinin, og udskillelseshastighed af albumin blev undersøgt for behandlingseffekt.
Subgroups consisting of gender, race, age, duration of diabetes, baseline blood pressure, serum creatinine, and albumin excretion rate were assessed for treatment effect.
IRMA 2 var et placebo- kontrolleret dobbelt blindt morbiditets studie med 590 patienter med type 2 diabetes, mikroalbuminuri (30- 300 mg/ dag) og normal nyrefunktion (serumkreatinin ≤ 1, 5 mg/ dl hos mænd og < 1, 1 mg/ dl hos kvinder).
IRMA 2 was a placebo-controlled double blind morbidity study in 590 patients with type 2 diabetes, microalbuminuria (30-300 mg/ day) and normal renal function (serum creatinine ≤ 1.5 mg/ dl in males and < 1.1 mg/ dl in females).
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
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).
Yderligere antihypertensive præparater (eksklusiv ACE- hæmemer, angiotensin II- receptorantagonister og dihydropyridin - calciumblokkere) blev tilføjet efter behov for at nå blodtryksmålet.
Additional antihypertensive agents (excluding ACE inhibitors, angiotensin II receptor antagonists and dihydropyridine calcium blockers) were added as needed to help achieve the blood pressure goal.
Regression til normo albuminuri (< 30 mg/ dag) forekom hyppigere i gruppen, der fik irbesartan 300 mg (34%) end i placebogruppen (21%).
Regression to normoalbuminuria (< 30 mg/ day) was more frequent in the irbesartan 300 mg group (34%) than in the placebo group (21%).
96% med ubetydelig binding til cellulære blodkomponenter.
Plasma protein binding is approximately 96%, with negligible binding to cellular blood components.