natgillin/translations-raw huggingface dataset:
Den anden undersøgelse så på, om Irbesartan BMS forlænger den tid, der går, inden patienterne oplever en fordobling af deres blodkreatininniveauer (en markør for nyresygdom), får behov for en nyretransplantation eller dialyse, eller inden patienterne dør.
The second study looked at whether Irbesartan BMS increased the time taken until the patients ’ blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died.
I de undersøgelser, der så på Irbesartan virkning på blodtrykket, var Irbesartan BMS mere effektivt end placebo til at nedsætte det diastoliske blodtryk, og virkningerne af Irbesartan BMS svarede til virkningerne af de andre lægemidler mod forhøjet blodtryk.
In the blood pressure studies, Irbesartan BMS was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Når Irbesartan BMS blev anvendt sammen med hydrochlorothiazid, var virkningerne additive.
When used with hydrochlorothiazide, the effects of the two medicines were additive.
I den første undersøgelse vedrørende nyresygdom var Irbesartan BMS mere effektivt end placebo til at reducere risikoen for at udvikle nyreskade, som målt ved proteinudskillelse.
In the first kidney disease study, Irbesartan BMS was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion.
I den anden undersøgelse vedrørende nyresygdom reducerede Irbesartan BMS i løbet af undersøgelsen den relative risiko for en fordobling af blodkreatininniveauerne, behovet for en nyretransplantation eller dialyse, eller risikoen for dødsfald i løbet af undersøgelsen med 20%, sammenlignet med placebo.
In the second kidney disease study, Irbesartan BMS reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant or dialysis, or death during the study by 20% in comparison with placebo.
De mest almindelige bivirkninger (observeret hos mellem 1 og 10 patienter ud af 100) er svimmelhed, kvalme, opkastning, træthed, en forøgelse af kreatinkinaseindholdet i blodet (et enzym, der findes i musklerne).
The most common side effects with Irbesartan BMS (seen in more than 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, fatigue (tiredness) and increases in blood creatine kinase levels (an enzyme found in muscles).
Desuden er der hos mere end 1 af 100 patienter med type 2 diabetes og nyresygdom indberettet om følgende bivirkninger: hyperkaliæmi (højt indhold af kalium i blodet), ortostatisk svimmelhed (svimmelhed i stående stilling), ortostatisk hypotension (lavt blodtryk i stående stilling) og muskel - og ledsmerter.
In addition, more than 1 patient in 100 with type 2 diabetes and kidney disease have the following side effects: hyperkalaemia (high blood potassium levels), orthostatic dizziness (dizziness when standing up), orthostatic hypotension (low blood pressure when standing up) and musculoskeletal (joint) pain.
Irbesartan BMS bør ikke anvendes til folk, som kan være overfølsomme (allergiske) over for irbesartan eller nogen af de øvrige indholdsstoffer.
Irbesartan BMS should not be used in people who may be hypersensitive (allergic) to irbesartan or any of the other ingredients.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Irbesartan BMS er større end risiciene ved behandling af hypertension og nyresygdom hos patienter med hypertension og type 2- diabetes mellitus.
The Committee for Medicinal Products for Human Use (CHMP) decided that Irbesartan BMS’ s benefits are greater than its risks for the treatment of essential hypertension and of renal disease in patients with hypertension and type 2 diabetes mellitus.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Irbesartan BMS til Bristol- Myers Squibb Pharma EEIG den 19. januar 2007.
The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan BMS to Bristol-Myers Squibb Pharma EEIG on 19 January 2007.
Dette sammendrag blev sidst ajourført i 06- 2008
This summary was last updated in 06-2008.
Hver tablet indeholder 75 mg irbesartan.
Each tablet contains 75 mg irbesartan.
Hvide til mathvide, bikonvekse og ovale med et hjerte indgraveret på den ene side, og nummeret 2771 indgraveret på den anden side.
White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Ved en dosis på 150 mg, 1 gang dagligt giver Irbesartan BMS generelt en bedre 24 - timers blodtrykskontrol end 75 mg.
Irbesartan BMS at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Hos patienter, som ikke er tilstrækkeligt kontrolleret på 150 mg, 1 gang dagligt, kan dosis af Irbesartan BMS øges til 300 mg, eller andre antihypertensiva kan tilføjes.
In patients insufficiently controlled with 150 mg once daily, the dose of Irbesartan BMS 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 BMS (see section 4.5).
Dosis bør efterfølgende titreres op til 300 mg 1 gang dagligt, som den foretrukne vedligeholdelsesdosering til behandling af nyresygdom.
In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease.
5. 1).
The demonstration of renal benefit of Irbesartan BMS 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).
Det er ikke nødvendigt, at dosisjustere hos patienter med nedsat nyrefunk - tion.
Renal impairment: no dosage adjustment is necessary in patients with impaired renal function.
En lavere startdosis (75 mg) bør overvejes hos patienter i hæmodialyse.
A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis.
Hypovolæmi og/ eller hyponatriæmi skal korrigeres forud for behandling med Irbesartan BMS.
Intravascular volume depletion: volume and/ or sodium depletion should be corrected prior to administration of Irbesartan BMS.
Selvom initialdosis på 75 mg bør overvejes til patienter > 75 år, er det sædvanligvis ikke nødvendigt at dosisjustere ældre patienter.
2 Elderly patients: 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.
Overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne (se pkt.
Hypersensitivity to the active substances or to any of the excipients (see section 6.1).
Graviditet i 2. og 3. trimester (se pkt.
Second and third trimester of pregnancy (see sections 4.4 and 4.6).
Amning (se pkt.
Lactation (see section 4.6).
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.
Intravascular volume depletion: 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.
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.
Renovascular hypertension: 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 BMS, kan der forventes en lignende effekt med angiotensin- II - receptorantagonister.
While this is not documented with Irbesartan BMS, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Der anbefales periodisk kontrol af serum- kalium og serum- kreatinin, hvis Irbesartan BMS anvendes til patienter med nedsat nyrefunktion.
Renal impairment and kidney transplantation: when Irbesartan BMS is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Som med andre stoffer, der påvirker renin- angiotensin- aldosteronsystemet kan der opstå hyperkaliæmi under behandling med Irbesartan BMS, specielt i tilfælde af nyrefunktions - nedsættelse, klinisk proteinuri på grund af diabetisk nyresygdom og/ eller hjertefejl.
Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan BMS, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/ or heart failure.
4. 5).
Lithium: the combination of lithium and Irbesartan BMS is not recommended (see section 4.5).
5. 1).
3 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).
Dette produkt indeholder lactose.
Lactose: this medicinal product contains lactose.
4. 8, 5. 1 og 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 Irbesartan BMS uden risiko blevet administreret sammen med andre antihypertensive stoffer 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 Irbesartan BMS 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 BMS (see section 4.4).
Der skal udvises forsigtighed når denne kombination anvendes, især hos ældre.
The combination should be administered with caution, especially in the elderly.
Irbesartan er metaboliseres hovedsageligt af CYP2C9 og i mindre udstrækning ved glucuronidering.
Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation.
Effekten af CYP2C9- induktorer, som fx rifampicin, på irbesartans farmakokinetik er ikke evalueret.
The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated.
Der er kendt at behandling med angiotensin II- receptor- antagonister 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).
4. 3) under amning.
Irbesartan BMS is contraindicated (see section 4.3) during lactation.
Det vides ikke om irbesartan udskilles i human modermælk.
It is not known whether irbesartan is excreted in human milk.
Ved bilkørsel eller betjening af maskiner, skal der tages hensyn til at der kan opstå svimmelhed eller træthed under behandling.
When driving vehicles or operating machines, it should be taken into account that dizziness or weariness may occur during treatment.
Meget almindelig (≥ 1/ 10); almindelig (≥ 1/ 100, < 1/ 10); usædvanlig (≥ 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).
Der er i placebokontrollerede undersøgelser med hypertensive patienter ikke set forskel i den samlede bivirkningshyppighed mellem irbesartangrupperne (56, 2%) og placebogrupperne (56, 5%).
Hypertension: 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 forekom mindre hyppigt for irbesartan- behandlede (3, 3%) patienter end for placebo- behandlede (4, 5%) patienter.
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%).
Bivirkningshyppigheden havde ingen relation til dosis (inden for det rekommanderede dosisinterval), køn, alder, race eller behandlingsvarighed.
The incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race, or duration of treatment.
Følgende bivirkninger er rapporteret i placebokontrollerede studier, hvor 1. 965 patienter fik irbesartan:
In placebo-controlled trials in which 1,965 patients received irbesartan, the following adverse drug reactions were reported:
Hjertesygdomme:
Cardiac disorders:
Rødme
flushing
5 Sygdomme i åndedrætsorganer, brysthule og mediastinum:
5 Respiratory, thoracic and mediastinal disorders:
Kvalme/ opkastning Diarré, dyspepsi, halsbrand
nausea/ vomiting diarrhea, dyspepsia/ heartburn
Lidelser i det reproduktive system og brystsygdomme:
Reproductive system and breast disorders:
Der blev almindeligvis observeret en signifikant stigning i plasma- kreatinkinasen (1, 7%) hos irbesartan- behandlede patienter.
significant increases in plasma creatine kinase were commonly observed (1.7%) in irbesartan treated subjects.
Ingen af disse stigninger blev forbundet med identificerbare kliniske muskuloskeletale hændelser.
None of these increases were associated with identifiable clinical musculoskeletal events.
Dette er hyppigere end med placebo.
Hypertension and type 2 diabetes with renal disease: in addition to the adverse drug reactions mentioned under hypertension, 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.
Dette er hyppigere end med placebo:
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, the following additional adverse reactions were reported in > 2% of patients and in excess of placebo:
Ortostatisk hypotension
orthostatic hypotension
Sygdomme i bevægeapparat, bindevæv og knogler:
Musculoskeletal, connective tissue and bone disorders:
Muskelskeletale smerter
musculoskeletal pain
Hyperkaliæmi forekom hyppigere hos diabetespatienter, der modtog behandling med irbesartan end ved behandling med placebo.
Hyperkalaemia occurred more often in diabetic patients treated with irbesartan than with placebo.
Hos hypertensive diabetespatienter med mikroalbuminuri og normal nyrefunktion forekom hyperkaliæmi (≥ 5, 5 mEq/ l) hos 29, 4% (dvs. meget almindelig) af patienterne i 300 mg irbesartan- gruppen og hos 22% af patienterne i placebo- gruppen.
In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥ 5.5 mEq/ L) occurred in 29.4% (i. e. very common) of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group.
Hos hypertensive diabetespatienter med kronisk nyreinsufficiens og åbenlys proteinuri forekom hyperkaliæmi (≥ 5, 5 mEq/ l) hos 46, 3% (dvs. meget almindelig) af patienterne i irbesartan- gruppen og 26, 3% af patienterne i placebo- gruppen.
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/ L) occurred in 46.3% (i. e. very common) of the patients in the irbesartan group and 26.3% of the patients in the placebo group.
Der er observeret et fald i hæmoglobin, som ikke er klinisk signifikant, hos 1, 7% (dvs. almindelig) af hypertensive patienter med fremskreden diabetisk nyresygdom, der modtog behandling med irbesartan.
A decrease in haemoglobin, which was not clinically significant, has been observed in 1.7% (i. e. common) of hypertensive patients with advanced diabetic renal disease treated with irbesartan.
Der er efter markedsføring indberettet følgende yderligere bivirkninger; disse stammer fra spontane rapporter, hvor incidens ikke kan fastsættes:
The following additional adverse reactions have been reported during post– marketing experience; they are derived from spontaneous reports for which incidences cannot be determined:
Som med andre angiotensin II- receptorantagonister er der rapporteret sjældne tilfælde af overfølsomhedsreaktioner, fx udslæt, urticaria, angioødem
As with other angiotensin-II receptor antagonists, rare cases of hypersensitivity reactions such as rash, urticaria, angioedema have been reported
Stofskiftesygdomme og ernæringsbetingede sygdomme:
Metabolism and nutrition disorders:
6 Sygdomme i nervesystemet:
6 Nervous system disorders:
Sygdomme i det ydre og det indre øre:
Ear and labyrinth disorders:
Sygdomme i lever og galde:
Hepato-biliary disorders:
Artralgi, myalgi (nogle tilfælde har været forbundet med øgning i kreatinkinase- værdier i plasma), muskelkramper
Arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps
Leukocytoclastisk vasculitis
Leukocytoclastic vasculitis
I et randomiseret forsøg med 318 hypertensive børn og unge i aldersgruppen 6 til 16 år sås følgende relaterede bivirkningshændelser 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.
Erfaringer med behandling af voksne, med doser på op til 900 mg/ dag i 8 uger, har ikke vist toksicitet.
Experience in adults exposed to doses of up to 900 mg/ day for 8 weeks revealed no toxicity.
Angiotensin II- antagonister, almindelige.
Angiotensin-II antagonists, plain.
Irbesartan er en potent, oral 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.
Mechanism of action: 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.
Serum- kalium påvirkes ikke nævneværdigt, når irbesartan administeres alene ved de anbefalede doser.
Serum potassium levels are not significantly affected by irbesartan alone at the recommended doses.
7 Klinisk effekt:
7 Clinical efficacy:
Doser på 150- 300 mg, 1 gang i døgnet, giver en sænkning af det liggende eller siddende blodtryk i minimumspunktet (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.
Once daily dosing with 150 mg produced trough and mean 24 hour responses similar to twice daily dosing on the same total dose.
Irbesartan BMSs 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 BMS is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
Dette resulterer i en yderligere placebo - korrigeret blodtryksreduktion på 7- 10/ 3- 6 mmHg (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 hypertensionspatienter responderer betydeligt dårligere på irbesartanmonoterapi.
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 dagligt) nærmer det antihypertensive respons hos sorte patienter sig det, der ses hos hvide.
12.5 mg daily), the antihypertensive response in black patients approaches that of white patients.
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 med 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.
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 nyreinsufficiens 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 er et kontrolleret dobbeltblindt morbiditets - og mortalitetsstudie, som sammenlignede Irbesartan BMS, amlodipin og placebo.
IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan BMS, amlodipine and placebo.
Hos 1. 715 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 Irbesartan BMS med henblik på progression af nyresygdom og totalmortalitet.
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 BMS on the progression of renal disease and all-cause mortality were examined.
Patienterne blev titreret fra 75 mg til en vedligeholdelsesdosis på 300 mg Irbesartan BMS, 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 BMS, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.