FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP considered the VALIANT study which demonstrated that valsartan given as monotherapy is at least as effective as captopril given as monotherapy in the reduction of total mortality after an acute myocardial infarction.
Danish: CHMP mente, at VALIANT-undersøgelsen, der viste, at valsartan givet som monoterapi er mindst lige så effektiv som captopril givet som monoterapi til nedbringelse af dødeligheden efter akut myokardieinfarkt.
English: In general, it is recommended that patients achieve a dose level of 80 mg twice daily by two weeks after treatment initiation and that the target maximum dose, 160 mg twice daily, be achieved by three months, based on the patient's tolerability.
Danish: Generelt anbefales det, at patienterne når et dosisniveau på 80 mg 2 gange daglig i løbet af 2 uger efter påbegyndt behandling og, at den maksimale måldosis på 160 mg 2 gange daglig nås i løbet af 3 måneder, afhængig af patientens tolerabilitet.
English: The main discussion for this section concerned the presentation of ADRs in the SPC.
Danish: Den vigtigste diskussion i forbindelse med dette afsnit vedrørte præsentationen af bivirkninger i produktresuméet.
English: Results appearing to favour placebo (composite mortality and morbidity was 21.9% in placebo vs. 25.4% in valsartan group) were observed for those patients receiving the triple combination of an ACE inhibitor, a beta blocker and valsartan.
Danish: Resultater, der taler til fordel for placebo (samlet mortalitet og morbiditet var 21,9 % ved placebo vs. 25,4 % i valsartan-gruppen) blev observeret for de patienter, der fik tredobbelt kombination af en ACE-hæmmer, en beta-blokker og valsartan.
English: 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 captopriltreated patients.
Danish: 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.
English: The apparent clearance of valsartan following oral administration is approximately 4.5 l/h.
Danish: Den tilsyneladende clearance for valsartan er ca. 4,5 l/t efter oral administration.
English: 130 00 Praha 3
Danish: U Nákladového nádraží 10 130 00 Praha 3
English: Heart failure: Treatment starts generally with 40 mg twice daily.
Danish: Hjertesvigt: Behandlingen starter sædvanligvis med 40 mg 2 gange daglig.
English: In Study 27 the kinetic of valsartan was also investigated in hypertensive patients with impairment of renal function (creatine clearance rate: 16-116 mL/min).
Danish: I undersøgelse 27 blev valsartans kinetik hos patienter med hypertension og nedsat nyrefunktion (kreatininclearance: 16-116 ml/min) ligeledes undersøgt.
English: The CHMP also considered that special precaution would be needed for patients with hepatic impairment and/or cholestasis, as the majority of valsartan is eliminated, mainly as unchanged drug in the bile, by hepatic clearance.
Danish: CHMP fandt også, at der var behov for særlige forsigtighedsregler for patienter med leverinsufficiens og/eller cholestasis, da størstedelen af valsartan hovedsageligt elimineres som uforandret lægemiddel i galden via leverclearance.
English: If not treated it can damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure, or kidney failure.
Danish: Hvis det ikke behandles, kan det føre til, at blodkarrene i hjernen, hjertet og nyrerne beskadiges, hvilket kan ende med hjerneblødning, hjertesvigt eller nyresvigt.
English: Allcause mortality was similar in the valsartan (19.9%), captopril (19.5%), and valsartan + captopril (19.3%) groups.
Danish: Totalmortaliteten var ensartet i valsartan- (19,9 %), captopril- (19,5 %) og valsartan + captopril- (19,3 %) grupperne.
English: • elevation of liver function values (which can indicate liver damage) including an increase of bilirubin in the blood (which can, in severe cases, trigger yellow skin and eyes)
Danish: • forhøjede leverfunktionstal (hvilket kan være tegn på leverskader) herunder et forhøjet niveau af bilirubin i blodet (hvilket i alvorlige tilfælde kan medføre gulfarvning af hud og øjne)
English: • purplished-red spots, fever, itching (signs of inflammation of blood vessels also called vasculitis)
Danish: • purpurrøde pletter, feberkløe (tegn på betændelse i blodkar også kaldet vasculitis)
English: 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).
Danish: 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).
English: Regarding renal impairment, the use of valsartan 80 mg as the starting dose, with no dosage adjustment, in patients with reduced renal function (creatinine clearance rate >10 ml/min) is supported by both efficacy and safety data from Study 27 and by pharmacokinetic data from Study 12.
Danish: Med hensyn til nyreinsufficiens understøttes brugen af valsartan 80 mg som startdosis uden dosisjustering hos patienter med nedsat nyrefunktion (kreatininclearance >10 ml/min) af både data om sikkerhed og effekt fra undersøgelse 27 og af farmakokinetiske data fra undersøgelse 12.
English: Following intravenous administration, plasma clearance of valsartan is about 2 l/h and its renal clearance is 0.62 l/h (about 30% of total clearance).
Danish: l/t, og den renale clearance er 0,62 l/t (cirka 30 % af den totale clearance).
English: • decrease of level of haemoglobin and decrease of the percentage of red blood cells in the blood (which can, in severe cases, lead to anaemia)
Danish: • nedsat hæmoglobintal og fald i procenten af røde blodlegemer i blodet (hvilket i alvorlige tilfælde kan føre til anæmi)
English: The CHMP considered that the elimination of valsartan at steady-state is similar in patients with renal impairment when compared with healthy volunteers and adopted the following wording: “No dosage adjustment is required for patients with a creatinine clearance >10 ml/min.”
Danish: CHMP fandt, at elimineringen af valsartan ved steady-state hos patienter med nedsat nyrefunktion svarede til elimineringen hos raske frivillige, og vedtog følgende formulering: "Der kræves ingen dosisjustering for patienter med en kreatininclearance ≥ 10 ml/min."
English: 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.
Danish: 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.
English: All cause mortality was similar (p=NS) in the valsartan (19.7%) and placebo (19.4%) groups.
Danish: Mortalitet af enhver årsag var ensartet (p=NS) i valsartan- (19,7 %) og placebo- (19,4 %) grupperne.
English: “Treatment of clinically stable patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours - 10 days) myocardial infarction”
Danish: "Behandling af klinisk stabile patienter med symptomatisk hjerteinsufficiens eller asymptomatisk systolisk dysfunktion i venstre ventrikel efter en nylig (12 timer - 10 dage) myokardieinfarkt"
English: 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).
Danish: Hos patienter med hjertesvigt har den tredobbelte kombination af en ACE-hæmmer, en beta-blokker og valsartan ikke vist nogen klinisk fordel (se pkt.
English: Regarding hepatic impairment, the CHMP noted that the majority of valsartan is eliminated, mainly as unchanged drug in the bile, through hepatic clearance.
Danish: Med hensyn til leverinsufficiens bemærkede CHMP, at størstedelen af valsartan elimineres, hovedsageligt som uforandret lægemiddel i galden via leverclearance.
English: In controlled clinical studies in patients with hypertension, the overall incidence of adverse reactions (ADRs) was comparable with placebo and is consistent with the pharmacology of valsartan.
Danish: I kontrollerede, kliniske undersøgelser af patienter med hypertension var den samlede forekomst af bivirkninger sammenlignelig med placebos og overensstemmende med valsartans farmakologi.
English: He may also combine Diovan with an additional medicine (e.g. a diuretic).
Danish: Lægen kan også kombinere Diovan med yderligere medicin (fx vanddrivende medicin).
English: 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).
Danish: 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 %).
English: High blood pressure: The usual dose is 80 mg daily.
Danish: Forhøjet blodtryk Den sædvanlige dosis er 80 mg daglig.
English: Based on the modest magnitude of the observed increase in AUC, and the wide therapeutic index for valsartan, no initial dose adjustment is considered necessary in patients with mild to moderate impairment of hepatic function (without cholestasis).
Danish: På grundlag af den beskedne observerede stigning i AUC og det høje terapeutiske indeks for valsartan, blev ingen indledende dosisjustering anset for at være nødvendig hos patienter med mildt til moderat nedsat leverfunktion (uden cholestasis).
English: The CHMP also considered that in view of the fact that Diovan is eliminated via the biliary route, it should be contraindicated in patients with severe liver diseases and “should not be administered in patients with severe hepatic impairment, cirrhosis or biliary obstruction.
Danish: Da Diovan elimineres biliært fandt CHMP også, at der skulle fastsættes en kontraindikation for patienter med alvorlige leversygdomme, og at det "ikke bør gives til patienter med alvorlig leverinsufficiens, cirrhose eller biliær obstruktion".
English: -Second and third trimester of pregnancy (see sections 4.4 and 4.6).
Danish: - Andet og tredje trimester af graviditet (se pkt.
English: The Diovan Reduction of Proteinuria (DROP) study further examined the efficacy of valsartan in reducing UAE in 391 hypertensive patients (BP=150/88 mmHg) with type 2 diabetes, albuminuria (mean=102 µg/min; 20-700 µg/min) and preserved renal function (mean serum creatinine = 80 µmol/l).
Danish: DROP (Diovan Reduction of Proteinuria)-undersøgelsen undersøgte yderligere effektiviteten af valsartan mht. reduktion af UAE hos 391 hypertensive patienter (BT=150/88 mmHg) med type -diabetes, albuminuri (gennemsnit=102 µg/min; 20-700 µg/min) og bevaret nyrefunktion (gennemsnitlig serumkreatinin = 80 µmol/l).
English: 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).
Danish: Brug af Diovan til post-myokardieinfarktpatienter 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.
English: In some patients whose blood pressure is not adequately controlled, the dose can be increased to 160 mg and to a maximum of 320 mg.
Danish: Hos nogle patienter, hvis blodtryk ikke er tilstrækkelig kontrolleret, kan dosis øges til 160 mg og til maksimalt 320 mg. Diovan kan også administreres sammen med andre antihypertensive lægemidler.
English: 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).
Danish: 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.
English: • if you are being treated after a heart attack, a combination with ACE inhibitors (a medication to treat heart attack) is not recommended.
Danish: • hvis du er i behandling efter et hjerteanfald, frarådes en kombination med ACE-hæmmere (medicin mod hjerteanfald).
English: 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.
Danish: Non-steroide anti-inflammatoriske lægemidler (NSAID‘er), herunder selektive COX-2-hæmmere, acetylsalicylsyre >3 g/dag,og ikke-selektive NSAIDer
English: Caution should be observed when initiating therapy in post-myocardial infarction patients.
Danish: Der skal udvises forsigtighed når behandling af post-myokardieinfarktpatienter indledes.
English: The CHMP agreed about the proposed wording for precautions in dosing Diovan, considering that no dosage adjustment is required for patients with a creatinine clearance >10ml/min and that in patients with mild to moderate hepatic impairment without cholestasis the dose of valsartan should not exceed 80 mg (see section 4.4).
Danish: CHMP var enig i den foreslåede formulering af forsigtighedsreglerne for dosering af Diovan, da der ikke kræves dosisjustering for patienter med en kreatininclearance >10 ml/min, og da valsartan-dosis hos patienter med mild til moderat leverinsufficiens uden cholestasis ikke bør overstige 80 mg (jf. afsnit 4.4).
English: Based on the wide therapeutic index for valsartan, no initial dose adjustment is considered necessary in patients with mild to moderate impairment of hepatic function (without cholestasis).
Danish: På grund af det høje terapeutiske indeks for valsartan anses ingen indledende dosisjustering for at være nødvendig hos patienter med mildt til moderat nedsat leverfunktion (uden cholestasis).
English: What Diovan contains [To be completed nationally]
Danish: Diovan indeholder [Udfyldes nationalt]
English: Acknowledging the comments from the CHMP and the Rapporteurs and in the absence of any new data regarding triple therapy with valsartan, the MAH proposed to substitute the wording “the triple combination of an ACE inhibitor, a beta blocker and valsartan is not recommended” in chronic heart failure as requested in the relevant sections of the SPC (sections 4.2 and 4.4).
Danish: Indehaveren af markedsføringstilladelsen accepterede CHMP's og ordførernes bemærkninger og foreslog, da der ikke fandtes nye data om tredobbelt behandling med valsartan, at indsætte formuleringen "den tredobbelte kombination med en ACE-hæmmer, en betablokker og valsartan frarådes" ved konisk hjertesvigt, som krævet i de relevante afsnit af produktresuméet (afsnit 4.2 og 4.4).
English: Valsartan may be used in patients treated with other post-myocardial infarction therapies, e.g. thrombolytics, acetylsalicylic acid, beta blockers, statins, and diuretics.
Danish: Valsartan kan anvendes af patienter, som er i anden behandling for post-myokardieinfarkt, f.eks. trombolytika, acetylsalicylsyre, betablokkere, statiner og diuretika.
English: 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).
Danish: 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).
English: The MAH proposed to add indication-specific foot-notes, but the CHMP considered that the proposed extensive use of footnotes has little value for the prescriber and ADRs have been moved to the frequency category representing the highest frequency (see attached SPC and PIL).
Danish: CHMP anmodede dog om, at alle indikationerne blev sammenfattet i en enkelt tabel i overensstemmelse med vejledningen vedrørende produktresuméer: Indehaveren af markedsføringstilladelsen foreslog, at der blev indsat indikationsspecifikke fodnoter, men CHMP fandt, at den foreslåede omfattende brug af fodnoter har ringe værdi for den ordinerende læge, og bivirkningerne er blevet flyttet til den kategori, der repræsenterer den højeste frekvens (jf. det vedhæftede produktresumé og indlægsseddel).
English: Diovan and associated names (see Annex I) 40 mg film-coated tablets Diovan and associated names (see Annex I) 40 mg capsules, hard Diovan and associated names (see Annex I) 80 mg film-coated tablets Diovan and associated names (see Annex I) 80 mg capsules, hard Diovan and associated names (see Annex I) 160 mg film-coated tablets Diovan and associated names (see Annex I) 160 mg capsules, hard Diovan and associated names (see Annex I) 320 mg film-coated tablets [See Annex I - To be completed nationally]
Danish: Diovan og tilhørende navne (se bilag I) 40 mg filmovertrukne tabletter Diovan og tilhørende navne (se bilag I) 40 mg kapsler, hårde Diovan og tilhørende navne (se bilag I) 80 mg filmovertrukne tabletter Diovan og tilhørende navne (se bilag I) 80 mg kapsler, hårde Diovan og tilhørende navne (se bilag I) 160 mg filmovertrukne tabletter Diovan og tilhørende navne (se bilag I) 160 mg kapsler, hårde Diovan og tilhørende navne (se bilag I) 320 mg filmovertrukne tabletter [Se Bilag I - Udfyldes nationalt]
English: In section 4.2 there are also differences in SPC across Member States in relation to the dosage recommendation in patients with renal and hepatic impairment.
Danish: I produktresuméets afsnit 4.2 vedrørende den anbefalede dosering til patienter med nyre- og leverinsufficiens, er der også forskelle mellem medlemsstaterne.
English: 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.
Danish: 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.
English: In this subgroup all-cause mortality was significantly reduced with valsartan compared to placebo by 33% (95% CI: -6% to 58%) (17.3% valsartan vs. 27.1% placebo) and the composite mortality and morbidity risk was significantly reduced by 44% (24.9% valsartan vs. 42.5% placebo).
Danish: I denne undergruppe blev mortaliteten uanset årsag signifikant reduceret med valsartan sammenlignet med placebo med 33 % (95 % konfidensinterval: -6 % til 58 %) (17,3 % valsartan vs. 27,1 % placebo) og den samlede mortalitets- og morbiditetsrisiko blev signifikant reduceret med 44 % (24,9 % valsartan vs. 42,5 % placebo).
English: The wording proposed by the MAH in the SPC was acceptable to the CHMP and the following wording was adopted: “In patients with mild to moderate hepatic impairment without cholestasis the dose of valsartan should not exceed 80 mg (see section 4.4).”
Danish: CHMP kunne acceptere den formulering, som indehaveren af markedsføringstilladelsen havde foreslået i produktresuméet, og følgende formulering blev vedtaget: "Hos patienter med mildt til moderat nedsat leverfunktion uden cholestasis bør valsartandosis ikke overstige 80 mg (jf. afsnit 4.4)."
English: Diovan and associated names (see Annex I) 40 mg film-coated tablets Diovan and associated names (see Annex I) 40 mg capsules, hard Diovan and associated names (see Annex I) 80 mg film-coated tablets Diovan and associated names (see Annex I) 80 mg capsules, hard Diovan and associated names (see Annex I) 160 mg film-coated tablets Diovan and associated names (see Annex I) 160 mg capsules, hard Diovan and associated names (see Annex I) 320 mg film-coated tablets [See Annex I -To be completed nationally] Valsartan
Danish: Diovan og tilhørende navne (se bilag I) 40 mg filmovertrukne tabletter Diovan og tilhørende navne (se bilag I) 40 mg kapsler, hårde Diovan og tilhørende navne (se bilag I) 80 mg filmovertrukne tabletter Diovan og tilhørende navne (se bilag I) 80 mg kapsler, hårde Diovan og tilhørende navne (se bilag I) 160 mg filmovertrukne tabletter Diovan og tilhørende navne (se bilag I) 160 mg kapsler, hårde Diovan og tilhørende navne (se bilag I) 320 mg filmovertrukne tabletter [Se Bilag I - Udfyldes nationalt] Valsartan
English: In patients with mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg. Diovan is contraindicated in patients with severe hepatic impairment and in patients with cholestasis (see sections 4.3, 4.4 and 5.2).
Danish: Hos patienter med let til moderat leverinsufficiens uden cholestasis bør dosis af valsartan ikke overskride 80 mg. Diovan er kontraindiceret hos patienter med alvorlig leverinsufficiens og hos patienter med cholestasis (se pkt.
English: No dosage adjustment is required for patients with a creatinine clearance >10 ml/min.
Danish: Der kræves ikke dosisjustering for patienter med en kreatinin-clearance >10 ml/min.
English: ADRs that occurred in post-myocardial infarction and/or heart failure patients are listed below:
Danish: Bivirkninger, der forekom hos patienter med post-myokardieinfarkt og/eller hjertesvigt, er angivet i nedenstående tabel:
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUME, ETIKETTERING OG INDLÆGSSEDDEL
English: • increase of level of potassium in the blood (which can, in severe cases, trigger muscle spasms, abnormal heart rhythm)
Danish: • forhøjet niveau af kalium i blodet (hvilket i alvorlige tilfælde kan medføre muskelkramper, unormal hjerterytme)
English: However, if it is almost time for your next dose, skip the dose you missed.
Danish: Hvis du snart skal tage den næste dosis tabletter, så spring den glemte dosis tabletter over.
English: • diarrhea
Danish: • diarré
English: • spinning sensation
Danish: • snurrende/svimlende følelse
English: - the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling and package leaflet.
Danish: Ud fra følgende betragtninger: - Formålet med indbringelsen af sagen var at harmonisere produktresuméet, etiketteringen og indlægssedlen.
English: Hard capsules
Danish: Hårde kapsler oral
English: However, the triple combination of an ACE inhibitor, a beta blocker and valsartan is not recommended (see sections 4.4 and 5.1).
Danish: Den tredobbelte kombination med en ACE-hæmmer, en betablokker og valsartan frarådes dog (jf. afsnit 4.4 og 5.1).
English: P.O.
Danish: N.V.