natgillin/translations-raw huggingface dataset:
Nyrearteriestenose Hos patienter med bilateral nyrearteriestenose eller stenose i en enkelt nyre, er sikkerheden ved brug af Diovan ikke klarlagt.
32 In patients with bilateral renal artery stenosis or stenosis to a solitary kidney, the safe use of Diovan has not been established.
Korttidsbehandling af 12 patienter med renovaskulær hypertension sekundært til unilateral nyrearteriestenose bevirkede ingen signifikant ændring af den renale hæmodynamik, serum- kreatinin eller blodurinstof (BUN).
Short-term administration of Diovan to twelve patients with renovascular hypertension secondary to unilateral renal artery stenosis did not induce any significant changes in renal haemodynamics, serum creatinine, or blood urea nitrogen (BUN).
30 stoffer, som påvirker renin- angiotensin- systemet, kan øge blodurinstof og serum- kreatinin hos patienter med unilateral nyrearteristenose.
However, other agents that affect the renin-angiotensin system may increase blood urea and serum creatinine in patients with unilateral renal artery stenosis, therefore monitoring of renal function is recommended when patients are treated with valsartan.
Nyretransplantation Der er på nuværende tidspunkt ingen erfaring med sikkerheden ved brug af Diovan til patienter, som for nyligt er blevet nyretransplanteret.
Kidney transplantation There is currently no experience on the safe use of Diovan in patients who have recently undergone kidney transplantation.
Primær hyperaldosteronisme Patienter med primær hyperaldosteronisme bør ikke behandles med Diovan, da deres renin- angiotensin - system ikke er aktiveret.
Primary hyperaldosteronism Patients with primary hyperaldosteronism should not be treated with Diovan as their renin-angiotensin system is not activated.
Aorta - og mitralklapstenose; obstruktiv hypertrofisk kardiomyopati Som ved andre vasodilatorer bør der udvises særlig forsigtighed over for patienter, med aorta - eller mitralklapstenose eller obstruktiv hypertrofisk kardiomyopati (HOCM).
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with all other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or hypertrophic obstructive cardiomyopathy (HOCM).
Nedsat nyrefunktion Der kræves ikke dosisjustering for patienter med en kreatinin- clearance > 10 ml/ min.
Impaired renal function No dosage adjustment is required for patients with a creatinine clearance > 10 ml/ min.
4. 2 og 5. 2).
There is currently no experience on the safe use in patients with a creatinine clearance < 10 ml/ min and patients undergoing dialysis, therefore valsartan should be used with caution in these patients (see sections 4.2 and 5.2).
4. 2 og 5. 2).
Hepatic impairment In patients with mild to moderate hepatic impairment without cholestasis, Diovan should be used with caution (see sections 4.2 and 5.2).
Medmindre fortsat behandling med AIIA vurderes at være nødvendig, bør patienter, som planlægger at blive gravide, skiftes til en alternativ hypertensionsbehandling med en dokumenteret sikkerhedsprofil til brug ved 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.
Nyligt myokardieinfarkt Kombinationsbehandling med captopril og valsartan har ikke vist yderligere klinisk effekt, tværtimod øges risikoen for bivirkninger sammenlignet med behandling med de respektive lægemidler alene (se pkt.
Recent myocardial infarction The combination of captopril and valsartan has shown no additional clinical benefit, instead the risk for adverse events increased compared to treatment with the respective therapies (see sections 4.2 and 5.1).
Derfor kan kombinationen af valsartan og en ACE- hæmmer ikke anbefales.
Therefore, the combination of valsartan with an ACE inhibitor is not recommended.
Der skal udvises forsigtighed når behandling af post- myokardieinfarktpatienter indledes.
Caution should be observed when initiating therapy in post-myocardial infarction patients.
4. 2).
Evaluation of post-myocardial infarction patients should always include assessment of renal function (see section 4.2).
4. 2).
Use of Diovan in post-myocardial infarction patients commonly results in some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension is not usually necessary provided dosing instructions are followed (see section 4.2).
Hjertesvigt Hos patienter med hjertesvigt har den tredobbelte kombination af en ACE- hæmmer, en beta- blokker og valsartan ikke vist nogen klinisk fordel (se pkt.
Heart Failure In patients with heart failure, the triple combination of an ACE inhibitor, a beta blocker and Diovan has not shown any clinical benefit (see section 5.1).
Brug af Diovan til patienter med hjertesvigt medfører ofte en vis reduktion af blodtrykket, men seponering af behandlingen på grund af vedvarende symptomatisk hypotension er normalt ikke nødvendigt forudsat, at doseringsvejledningen følges (se pkt.
33 Use of Diovan in patients with heart failure commonly results in some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension is not usually necessary provided dosing instructions are followed (see section 4.2).
Hos patienter, hvis nyrefunktion kan afhænge af aktiviteten af renin- angiotensin- systemet (f. eks. patienter med alvorlig kongestiv hjerteinsufficiens), er behandling med ACE- hæmmere blevet relateret til oliguri og/ eller progressiv azotæmi og i sjældne tilfælde til akut nyresvigt og/ eller død.
In patients whose renal function may depend on the activity of the renin-angiotensin system (e. g patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been associated with oliguria and/ or progressive azotaemia and in rare cases with acute renal failure and/ or death.
Da valsartan er en angiotensin II- antagonist, kan det ikke udelukkes, at anvendelse af Diovan kan associeres med forringelse af nyrefunktionen.
As valsartan is an angiotensin II antagonist, it cannot be excluded that the use of Diovan may be associated with impairment of the renal function.
31 Nyligt myokardieinfarkt Kombinationsbehandling med captopril og valsartan har ikke vist yderligere klinisk effekt, tværtimod øges risikoen for bivirkninger sammenlignet med behandling med de respektive lægemidler alene (se pkt.
Recent myocardial infarction The combination of captopril and valsartan has shown no additional clinical benefit, instead the risk for adverse events increased compared to treatment with the respective therapies (see sections 4.2 and 5.1).
4. 2).
Evaluation of patients with heart failure should always include assessment of renal function (see section 4.2).
Andre tilstande med stimulation af renin- angiotensin- systemet Hos patienter, hvis nyrefunktion kan afhænge af aktiviteten af renin- angiotensin- systemet (f. eks. patienter med alvorlig kongestiv hjerteinsufficiens), er behandling med ACE- hæmmere blevet relateret til oliguri og/ eller progressiv azotæmi og i sjældne tilfælde til akut nyresvigt og/ eller død.
Other conditions with stimulation of the renin-angiotensin system In patients whose renal function may depend on the activity of the renin-angiotensin system (e. g patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been associated with oliguria and/ or progressive azotaemia and in rare cases with acute renal failure and/ or death.
Lithium Reversible forhøjelser af serum- lithium- koncentrationer og toksicitet er blevet rapporteret ved samtidig brug af ACE- hæmmere.
Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of ACE inhibitors.
Hvis kombinationen viser sig nødvendig, anbefales omhyggelig monitorering af serum- lithium- niveauerne.
If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Kaliumbesparende diuretika, kaliumtilskud, salterstatninger indeholdende kalium og andre stoffer, der kan forhøje kalium- niveauerne Hvis et lægemiddel, som påvirker kaliumniveauerne, vurderes nødvendigt i kombination med valsartan, tilrådes monitorering af kalium- plasma- veauerne.
Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, monitoring of potassium plasma levels is advised.
Forsigtighed er påkrævet ved samtidig brug
34 Caution required with concomitant use
32 Når angiotensin II- antagonister administreres samtidigt med NSAID’ er, kan der forekomme en svækkelse af den antihypertensive effekt.
Non-steroidal anti-inflammatory medicines (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid > 3 g/ day), and non-selective NSAIDs When angiotensin II antagonists are administered simultaneously with NSAIDs, attenuation of the antihypertensive effect may occur.
Yderligere kan samtidig brug af angiotensin II- antagonister og NSAID’ er føre til en øget risiko for forværring af nyrefunktionen og forhøjet kaliumindhold i serum.
Furthermore, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function and an increase in serum potassium.
Andet I lægemiddelinteraktionsstudier med valsartan er der ikke fundet klinisk signifikante interaktioner med valsartan eller med nogen af de følgende stoffer: cimetidin, warfarin, furosemid, digoxin, atenolol, indometacin, hydrochlorthiazid, amlodipin, glibenclamid.
Others In drug interaction studies with valsartan, no interactions of clinical significance have been found with valsartan or any of the following substances: cimetidine, warfarin, furosemide, digoxin, atenolol, indometacin, hydrochlorothiazide, amlodipine, glibenclamide.
Det frarådes at bruge angiotensin II- antagonister (AIIA) under første trimester af graviditeten (se pkt.
The use of Angiotensin II Receptor Antagonists (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 second and third trimester of pregnancy (see sections 4.3 and 4.4).
En let forhøjet risiko kan dog ikke udelukkes.
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.
5. 3 ” Prækliniske sikkerhedsdata ”.
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, hyperkalemia); see also section 5.3 “ Preclinical safety data”.
Da der ikke foreligger tilgængelig dokumentation vedrørende brug af valsartan under amning, kan det ikke anbefales at bruge Diovan, og alternative behandlinger med bedre etableret sikkerhedsprofil bør foretrækkes i ammeperioden, især ved amning af neonatale eller spædbørn født før termin.
Lactation Because no information is available regarding the use of valsartan during breastfeeding, Diovan is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Bivirkninger rapporteret i kliniske undersøgelser, erfaring efter markedsføring og laboratoriefund er angivet i nedenstående tabel ordnet efter organklassesystemet.
35 The ADRs reported from clinical studies, post-marketing experience and laboratory findings are listed below according to system organ class.
Meget almindelig (≥1/ 10), almindelig (≥1/ 100 til < 1/ 10), ikke almindelig (≥1/ 1. 000 til < 1/ 100), sjælden (≥1/ 10. 000 til < 1/ 1. 000) eller meget sjælden (< 1/ 10. 000) inklusive isolerede rapporter.
Adverse reactions are ranked by frequency, the most frequent first, using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000) very rare (< 1/ 10,000), including isolated reports.
For alle bivirkninger rapporteret fra erfaring efter markedsføring og laboratoriefund er det ikke muligt at anføre bivirkningsfrekvens, de er derfor nævnt med hyppighed angivet som “ ikke kendt ”.
For all the ADRs reported from post-marketing experience and laboratory findings, it is not possible to apply any ADR frequency and therefore they are mentioned with a "not known" frequency.
 Overfølsomhed
 Hypertension
Blod og lymfesystem Ikke kendt Immunsystemet
Blood and lymphatic system disorders Not known Immune system disorders
Ikke kendt Metabolisme og ernæring
Not known Metabolism and nutrition disorders
Ikke kendt Øre og labyrint
Not known Ear and labyrinth system disorders
Øget serum- kalium
Increase of serum potassium
Ikke almindelig Vaskulære sygdomme
Uncommon Vascular disorders
Ikke kendt Luftveje, thorax og mediastinum
Not known Respiratory, thoracic and mediastinal disorders
Ikke almindelig Mave- tarm- kanalen
Uncommon Gastrointestinal disorders
Ikke almindelig Lever og galdeveje
Uncommon Hepato-biliary disorders
Ikke kendt Hud og subkutane væv
Not known Skin and subcutaneous tissue disorders
Forhøjede leverfunktionstal herunder forhøjet serum- bilirubin
Elevation of liver function values including increase of serum bilirubin
Ikke kendt Knogler, led, muskler og bindevæv
Not known Musculoskeletal and connective tissue disorders
Ikke kendt Nyrer og urinveje
Not known Renal and urinary disorders
Nyresvigt og nyreinsufficiens, forhøjet serum - kreatinin
Renal failure and impairment, Elevation of serum creatinine
Den sikkerhedsprofil, der er set i kontrollerede, kliniske forsøg hos patienter med post- myokardieinfarkt og/ eller hjertesvigt, er anderledes end den overordnede sikkerhedsprofil, der er set hos hypertensive patienter.
The safety profile seen in controlled-clinical studies in patients with post-myocardial infarction and/ or heart failure varies from the overall safety profile seen in hypertensive patients.
Bivirkninger, der forekom hos patienter med post- myokardieinfarkt og/ eller hjertesvigt, er angivet i nedenstående tabel:
ADRs that occurred in post-myocardial infarction and/ or heart failure patients are listed below:
 Post- myokardieinfarkt og/ eller hjertesvigt
 Post-myocardial infarction and/ or heart failure
Ikke almindelig Ikke kendt Nervesystemet
Uncommon Not known Nervous system disorders
Hyperkaliæmi Øget serum- kalium
Hyperkalaemia Increase of serum potassium
34 Almindelig Ikke almindelig Øre og labyrint
36 Common Uncommon Ear and labyrinth system disorders
Svimmelhed, stillingsbetinget svimmelhed Synkope, hovedpine
Dizziness, Postural dizziness Syncope, Headache
Ikke almindelig Hjerte
Uncommon Cardiac disorders
Almindelig Ikke kendt Luftveje, thorax og mediastinum
Common Not known Respiratory, thoracic and mediastinal disorders
Hypotension, ortostatisk hypotension Vasculitis
Hypotension, Orthostatic hypotension Vasculitis
Ikke almindelig Ikke kendt Knogler, led, muskler og bindevæv
Uncommon Not known Musculoskeletal and connective tissue disorders
Angioødem Udslæt, pruritus
Angioedema Rash, Pruritis
Nyresvigt og nyreinsufficiens Akut nyresvigt, forhøjet serum- kreatinin Forhøjet blodurinstof
Renal failure and impairment Acute renal failure, Elevation of serum creatinine Increase in Blood Urea Nitrogen
Symptomer Overdosering med Diovan kan resultere i udtalt hypotension, som kan føre til nedsat bevidsthedsniveau, kredsløbskollaps og/ eller chok.
Symptoms Overdose with Diovan may result in marked hypotension, which could lead to depressed level of consciousness, circulatory collapse and/ or shock.
I behandlingen er stabilisering af kredsløbet det vigtigste.
Treatment The therapeutic measures depend on the time of ingestion and the type and severity of the symptoms; stabilisation of the circulatory condition is of prime importance.
Såfremt der opstår hypotension, skal patienten placeres i rygliggende stilling, og der bør hurtigt gives salt - og væskesupplement.
If hypotension occurs, the patient should be placed in a supine position and blood volume correction should be undertaken.
Angiotensin II- antagonister, almindelig, ATC- kode:
Angiotensin II Antagonists, plain, ATC code:
Valsartan er en oralt, aktiv, potent og specifik angiotensin II- receptorantagonist.
Valsartan is an orally active, potent, and specific angiotensin II (Ang II) receptor antagonist.
Det virker selektivt på AT 1 - receptor subtypen, som er ansvarlig for angiotensin II' s kendte virkninger.
It acts selectively on the AT 1 receptor subtype, which is responsible for the known actions of angiotensin II.
Dette kan stimulere den ublokerede AT 2 - receptor subtype, som tilsyneladende modvirker effekten af AT 1 - receptoren.
The increased plasma levels of Ang II following AT 1 receptor blockade with valsartan may stimulate the unblocked AT 2 receptor, which appears to counterbalance the effect of the AT 1 receptor.
20. 000 gange) affinitet for AT 1 - receptoren end for AT 2 - receptoren.
Valsartan does not exhibit any partial agonist activity at the AT 1 receptor and has much (about 20,000 fold) greater affinity for the AT 1 receptor than for the AT 2 receptor.
Valsartan er ikke kendt for at binde sig til eller blokere andre hormonreceptorer eller ion- kanaler, der vides at være vigtige for den kardiovaskulære regulering.
Valsartan is not known to bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
35 Valsartan hæmmer ikke ACE (også kendt som kininase II), som omdanner angiotensin I til angiotensin II og nedbryder bradykinin.
37 Valsartan does not inhibit ACE (also known as kininase II) which converts Ang I to Ang II and degrades bradykinin.
Da der ikke er nogen virkning på ACE og ingen potensering af bradykinin eller substans P, er det usandsynligt, at angiotensin II- antagonister vil være forbundet med hoste.
Since there is no effect on ACE and no potentiation of bradykinin or substance P, angiotensin II antagonists are unlikely to be associated with coughing.
I kliniske undersøgelser, hvor valsartan blev sammenlignet med en ACE- hæmmer, var incidensen af tør hoste signifikant (P < 0, 05) mindre hos patienter i valsartanbehandling end hos patienter i behandling med en ACE- hæmmer (henholdsvis 2, 6% versus 7, 9%).
In clinical trials where valsartan was compared with an ACE inhibitor, the incidence of dry cough was significantly (P < 0.05) less in patients treated with valsartan than in those treated with an ACE inhibitor (2.6% versus 7.9% respectively).
I en klinisk undersøgelse med patienter, som tidligere havde haft tør hoste under behandling med en ACE- hæmmer, konstateredes tør hoste hos 19, 5% af patienterne i valsartanbehandling, 19, 0% i thiazidbehandling, sammenholdt med 68, 5% i behandling med en ACE- hæmmer (P < 0, 05).
In a clinical trial of patients with a history of dry cough during ACE inhibitor therapy, 19.5% of trial subjects receiving valsartan and 19.0% of those receiving a thiazide diuretic experienced cough compared to 68.5% of those treated with an ACE inhibitor (P < 0.05).
Nyligt myokardieinfarkt VALIANT- undersøgelsen (The VALsartan In Acute myocardial iNfarcTion trial) var en randomiseret, kontrolleret, multinational, dobbeltblindet undersøgelse med 14. 703 patienter med akut myokardieinfarkt og tegn, symptomer eller radiologisk verificeret kongestivt hjertesvigt og/ eller venstre ventrikulær systolisk dysfunktion (påvist ved en uddrivningsfraktion på ≤ 40% ved radionukleid ventrikulografi eller ≤ 35% ved ekkokardiografi eller ventrikulær kontrast- angiografi).
Recent myocardial infarction The VALsartan In Acute myocardial iNfarcTion trial (VALIANT) was a randomised, controlled, multinational, double-blind study in 14,703 patients with acute myocardial infarction and signs, symptoms or radiological evidence of congestive heart failure and/ or evidence of left ventricular systolic dysfunction (manifested as an ejection fraction ≤ 40% by radionuclide ventriculography or ≤ 35% by echocardiography or ventricular contrast angiography).
Totalmortaliteten var ensartet i valsartan - (19, 9%), captopril - (19, 5%) og valsartan + captopril - (19, 3%) grupperne.
All- cause mortality was similar in the valsartan (19.9%), captopril (19.5%), and valsartan + captopril (19.3%) groups.
Der var ingen forskel mellem valsartan og captopril med hensyn til totalmortalitet, baseret på alder, køn, race, baseline- behandlinger eller tilgrundliggende sygdom.
There was no difference between valsartan and captopril in all-cause mortality based on age, gender, race, baseline therapies or underlying disease.
Valsartan var også effektivt med hensyn til forlængelse af tiden til og reduktion af kardiovaskulær mortalitet, hospitalisering for hjertesvigt, recidiverende myokardieinfarkt, genoplivning ved hjertestop samt non- fatal apopleksi (sekundært sammensat endepunkt).
Valsartan was also effective in prolonging the time to and reducing cardiovascular mortality, hospitalisation for heart failure, recurrent myocardial infarction, resuscitated cardiac arrest, and non-fatal stroke (secondary composite endpoint).
Sikkerhedsprofilen for valsartan stemte overens med det kliniske forløb hos patienter behandlet efter myokardieinfarkt.
The safety profile of valsartan was consistent with the clinical course of patients treated in the post- myocardial infarction setting.
Med hensyn til nyrefunktion blev der observeret fordobling af serumkreatinin hos 4, 2% af de valsartan- behandlede patienter, 4, 8% af patienterne behandlet med valsartan+captopril og 3, 4% af de captopril- behandlede patienter.
Regarding renal function, doubling of serum creatinine was observed in 4.2% of valsartan-treated patients, 4.8% of valsartan+captopril-treated patients, and 3.4% of captopril- treated patients.
Ophør som følge af forskellige former for nyreinsufficiens forekom hos 1, 1% af de valsartan- behandlede patienter, 1, 3% af patienterne behandlet med valsartan+captopril og 0, 8% af de captopril- behandlede patienter.
Discontinuations due to various types of renal dysfunction occurred in 1.1% of valsartan-treated patients, 1.3% in valsartan+captopril patients, and 0.8% of captopril patients.
Hjertesvigt Val- HeFT var et randomiseret, kontrolleret, multinationalt, klinisk forsøg, hvor valsartan blev sammenlignet med placebo med hensyn til morbiditet og mortalitet hos 5010 patienter med hjertesvigt NYHA- klasse II (62%), III (36%) og IV (2%) i konventionel behandling samt LVEF < 40% og LVIDD (left ventricular internal diastolic diameter) > 2, 9 cm/ m2.
Heart failure Val-HeFT was a randomised, controlled, multinational clinical trial of valsartan compared with placebo on morbidity and mortality in 5,010 NYHA class II (62%), III (36%) and IV (2%) heart failure patients receiving usual therapy with LVEF< 40% and left ventricular internal diastolic diameter (LVIDD) > 2.9 cm/m2.
Basis behandling inkluderede ACE- hæmmere (93%), diuretika (86%), digoxin (67%) og betablokkere (36%).
Baseline therapy included ACE inhibitors (93%), diuretics (86%), digoxin (67%) and beta blockers (36%).
Gennemsnitlig daglig dosis af Diovan i Val- HeFT var 254 mg.
The mean daily dose of Diovan in Val-HeFT was 254 mg.
Mortalitet af enhver årsag (tid til død) og samlet mortalitet og hjertesvigtsmorbiditet (tid til første sygdomshændelse) defineret som død, pludselig død med genoplivning, hospitalisering for hjertesvigt eller administration af intravenøse inotropika eller vasodilatorer i 4 timer eller derover uden hospitalisering.
The study had two primary endpoints: all cause mortality (time to death) and composite mortality and heart failure morbidity (time to first morbid event) defined as death, sudden death with resuscitation, hospitalisation for heart failure, or administration of intravenous inotropic or vasodilator agents for four hours or more without hospitalisation.
Mortalitet af enhver årsag var ensartet (p=NS) i valsartan - (19, 7%) og placebo - (19, 4%) grupperne.
All cause mortality was similar (p=NS) in the valsartan (19.7%) and placebo (19.4%) groups.