FrancophonIA/ELRC3.0 huggingface dataset:
English: This combination apparently increases the risk for adverse events and is therefore not recommended.
Danish: Denne kombination øger tilsyneladende risikoen for bivirkninger, og anbefales derfor ikke.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF DIOVAN AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF DIOVAN OG TILKNYTTEDE NAVNE (SE BILAG I)
English: The CHMP considered that there is little support for the triple combination use so far.
Danish: CHMP fandt, at der indtil videre kun var ringe støtte til anvendelsen af den tredobbelte kombination.
English: This indication was approved in all Member States and the CHMP adopted the following wording:
Danish: Indikationen blev godkendt i alle medlemsstater, og CHMP vedtog følgende formulering:
English: The main areas for harmonisation were as follows.
Danish: Følgende hovedområder skulle harmoniseres:
English: The proposed harmonized text for this section is acceptable by the majority of CHMP members in regard to this indication; therefore the following wording was adopted:
Danish: Den foreslåede harmoniserede tekst for dette afsnit kan accepteres af størstedelen af CHMP's medlemmer for denne indikation, hvorfor følgende formulering blev vedtaget:
English: This medicinal product is authorised in the Member States of the EEA under the following names: [To be completed nationally]
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: [Udfyldes nationalt]
English: In addition the VALIANT study demonstrated that mortality was not increased in patients receiving the triple combination.
Danish: Derudover viste VALIANT-undersøgelsen, at dødeligheden ikke steg hos patienter, der modtog den tredobbelte kombination.
English: The following sentence has been added to Section 5.2: “Diovan has not been studied in patients with severe hepatic dysfunction”.
Danish: Følgende sætning er blevet tilføjet afsnit 5.2: "Diovan er ikke blevet undersøgt hos patienter med alvorlig leverdysfunktion".
English: Box 23490 Nicosia Cyprus
Danish: P.O. Box 23490 Nicosia Cypern
English: If you experience severe dizziness and/or fainting, lay down and contact your doctor immediately.
Danish: Hvis du oplever kraftig svimmelhed og/eller besvimer, skal du lægge dig ned og omgående kontakte lægen.
English: If you forget to take Diovan Do not take a double dose to make up for a forgotten dose.
Danish: Hvis du har glemt at tage Diovan Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: • to treat high blood pressure.
Danish: • Behandling af forhøjet blodtryk.
English: If you forget to take a dose, take it as soon as you remember.
Danish: Hvis du har glemt at tage en dosis tabletter, så tag den så snart du kommer i tanker om det.
English: However, no safety issue can be predicted because valsartan would not have specific safety issues associated with renal failure in general.
Danish: Der kan dog ikke forudsiges nogen sikkerhedsproblemer, da valsartan ikke er forbundet med nogen specifikke sikkerhedsproblemer i tilknytning til nyresvigt generelt.
English: “Treatment of essential hypertension”
Danish: "Behandling af essentiel hypertension"
English: Considering the non inferiority in clinical outcome of valsartan compared to current standard treatment, an ACEI, the CHMP adopted the following harmonised wording for this indication:
Danish: På grund af valsartans non-inferioritet i kliniske resultater sammenlignet med den aktuelle standardbehandling, en ACE-hæmmer, vedtog CHMP følgende harmoniserede formulering for denne indikation:
English: • low blood pressure with symptoms such as dizziness
Danish: • lavt blodtryk med symptomer som svimmelhed
English: There was disagreement on whether the use of Diovan should be contraindicated in patients with renal failure.
Danish: Der var uenighed om, hvorvidt anvendelsen af Diovan skulle være kontraindiceret hos patienter med nyresvigt.
English: In a subgroup of patients not receiving an ACE inhibitor (n=366), the morbidity benefits were greatest.
Danish: I en undergruppe af patienter, der ikke fik en ACE-hæmmer (n=366), var morbiditetsfordelene størst.
English: Diovan was included in the list of products for Summary of Products Characteristics (SPC) harmonization, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended, as the above-mentioned medicinal product does not have the same SPC across all EU Member States, Iceland and Norway.
Danish: Diovan stod på den liste over produkter, for hvilke produktresuméerne skulle harmoniseres, som CMD(h) havde udarbejdet i henhold til artikel 30, stk. 2, i direktiv 2001/83/EF, med senere ændringer, da produktresuméet for ovennævnte lægemiddel ikke er det samme i alle EU-medlemsstater, Island og Norge.
English: After a recent heart attack: After a heart attack the treatment is generally started as early as after 12 hours, usually at a low dose of 20 mg twice daily.
Danish: Efter et nyligt hjerteanfald: Efter et hjerteanfald starter behandlingen generelt så tidligt som 12 timer efter anfaldet, sædvanligvis med en lav dosis på 20 mg 2 gange daglig.
English: cannot be used.
Danish: kan ikke anbefales.
English: In CHMP's opinion the wording “not recommended” should be used until there is more solid supportive benefit/risk-profile evidence to triple combination.
Danish: Efter CHMP's opfattelse bør formuleringen "frarådes" anvendes, indtil der foreligger et mere fast understøttende risk/benefit-forhold for den tredobbelte kombination.
English: 4.5 - Interaction with other medicinal products and other forms of interaction
Danish: 4.5 - Interaktion med andre lægemidler og andre former for interaktion
English: Valsartan does not undergo extensive biotransformation and 70% of the available dose is excreted.
Danish: Valsartan undergår ikke nogen omfattende biotransformation, og 70 % af den tilgængelige dosis udskilles.
English: Hypertension Treatment of essential hypertension.
Danish: Hypertension Behandling af essentiel hypertension.
English: The results for the pre-specified secondary endpoints support that valsartan is as effective as captopril.
Danish: Resultaterne for de forud bestemte sekundære endepunkter underbygger påstanden om, at valsartan er lige så effektiv som captopril.
English: The mean daily dose of Diovan in Val-HeFT was 254 mg.
Danish: Gennemsnitlig daglig dosis af Diovan i Val-HeFT var 254 mg.
English: Some symptoms need immediate medical attention: You may experience symptoms of angioedema, such as
Danish: Nogle bivirkninger kan være alvorlige og kræver omgående lægebehandling: Du kan opleve symptomer på angioødem, som f.eks.
English: The CHMP considered it acceptable to remove this contraindication, as the primary route of elimination of valsartan is via biliary route and renal clearance accounts for less than 30% of plasma clearance.
Danish: CHMP fandt det acceptabelt at fjerne denne kontraindikation, da den primære eliminationsvej for valsartan er biliær, og nyreclearance tegner sig for mindre end 30 % af plasmaclearance.
English: • if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Diovan .
Danish: • hvis du er overfølsom (allergisk) over for valsartan eller et af de øvrige indholdsstoffer i Diovan.
English: Valsartan also demonstrated beneficial effects on signs and symptoms of HF.
Danish: Valsartan viste sig også at have gavnlige virkninger på tegn og symptomer på hjertesvigt.
English: If symptomatic hypotension or renal dysfunction occur, consideration should be given to a dosage reduction.
Danish: Hvis der opstår symptomatisk hypotension eller nyreinsufficiens, skal dosisreduktion overvejes.
English: The CHMP was also of the opinion that the 320 milligram dose provides a modest, statistically significant additional reduction in MSDBP and MSSBP compared to 160mg and a similarly modest increase in the rate of blood pressure control.
Danish: CHMP var også af den opfattelse, at en dosis på 320 mg giver en beskeden, statistisk signifikant supplerende nedsættelse af MSDBP og MSSBP sammenlignet med en dosis på 160 mg og en tilsvarende beskeden forøgelse af blodtrykskontrollen.
English: • certain type of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).
Danish: • en bestemt type smertestillende medicin, der kaldes non-steroidal anti-inflammatorisk medicin
English: • if you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water pills
Danish: • hvis du har mistet meget væske (er dehydreret) på grund af diarré, opkastninger, eller høje doser af vanddrivende medicin (diuretika).
English: A number of areas of disharmony in the product information for Diovan have been evaluated by the CHMP and a revised PI was adopted.
Danish: CHMP har vurderet en række områder, hvor der fandtes uoverensstemmelser i produktinformationen for Diovan, og en revideret produktinformation blev vedtaget.
English: For example, side effects such as dizziness, and decreased kidney function, were seen less frequently in patients treated with high blood pressure than in patients treated for heart failure or after a recent heart attack.
Danish: For eksempel blev bivirkninger som svimmelhed og nedsat nyrefunktion set mindre hyppigt hos patienter, der var i behandling for forhøjet blodtryk end hos patienter, der var i behandling for hjertesvigt, eller patienter, der nylig havde haft et hjerteanfald.
English: Therefore in the situation of potential use of the triple combination the text within the SPC has been adjusted to indicate that caution (rather than “not recommended”) is appropriate
Danish: Derfor er den potentielle anvendelse af den tredobbelte kombination i produktresuméet blevet tilpasset, så det fremgår, at forsigtighed (frem for "frarådes") er hensigtsmæssig.
English: Regarding the indication in recent myocardial infarction the CHMP noted that this indication was limited to patients intolerants to ACE inhibitors in some Member States.
Danish: Med hensyn til indikationen ved nyligt myokardieinfarkt bemærkede CHMP, at denne indikation i nogle medlemsstater var begrænset til patienter, der er intolerante over for ACE-hæmmere.
English: 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.
Danish: Bivirkninger er angivet efter hyppighed med de hyppigste først efter følgende regler: 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.
English: In Heart failure patients:
Danish: Patienter med hjertesvigt:
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ, ANSØGERE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: In Study 46, the exposure to valsartan was determined in patients with mild and moderate impairment of liver function.
Danish: I undersøgelse 46 blev eksponeringen for valsartan bestemt hos patienter med mild eller moderat nedsat leverfunktion.
English: The first area of disagreement is about the use of triple combination (Valsartan + ACEI+ BB) in chronic HF.
Danish: Det første område, hvor der findes uoverensstemmelser, er anvendelsen af den tredobbelte kombination (Valsartan + ACE-hæmmer + betablokker) ved kronisk hjertesvigt.
English: • to treat symptomatic heart failure.
Danish: • Behandling af symptomatisk hjertesvigt.
English: • other medicines that lower blood pressure, especially water pills (diuretics).
Danish: • anden medicin mod forhøjet blodtryk, især vanddrivende medicin (diuretika).
English: It acts selectively on the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Danish: Det virker selektivt på AT1receptor subtypen, som er ansvarlig for angiotensin II's kendte virkninger.
English: Diovan is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.
Danish: Pædiatriske patienter Diovan bør ikke anvendes til børn under 18 år pga. manglende dokumentation for sikkerhed og virkning.
English: Irrespective of treatment, mortality was lower in the group of patients treated with a beta blocker, suggesting that the known beta blocker benefit in this population was maintained in this trial.
Danish: Uafhængigt af forsøgsmedicinen var mortaliteten lavere i den gruppe af patienter der blev behandlet med betablokkere, hvilket tyder på, at den kendte fordel ved betablokkere hos denne population opretholdtes i dette forsøg.
English: • allergic reaction with symptoms such as rash, itching, dizziness, swelling of face or lips or tongue or throat, difficulty breathing or swallowing (signs of angioedema)
Danish: • allergisk reaktion med symptomer som udslæt, kløe, svimmelhed, hævelse af ansigt, læber, tunge eller hals, vanskeligt ved at trække vejret eller synke, svimmelhed (tegn på angioødem)
English: Consideration should be given to reducing the dose of concomitant diuretics.
Danish: Det bør overvejes at nedsætte dosis af de diuretika, der gives samtidig.
English: Regarding the indication in hypertension, the CHMP considered that valsartan is an established therapy for hypertension and there is no substantial discrepancy between the national SPCs.
Danish: Med hensyn til indikationen for hypertension fandt CHMP, at valsartan er en etableret terapi for hypertension, og der er ikke nogen væsentlig uoverensstemmelse mellem de nationale produktresuméer.
English: 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.
Danish: 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.
English: Hard gelatine capsules
Danish: Hårde gelatinekapsler oral
English: -Severe hepatic impairment, biliary cirrhosis and cholestasis.
Danish: - Alvorlig leverinsufficiens, biliær cirrose og cholestasis.
English: -Hypersensitivity to the active substance or to any of the excipients.
Danish: - Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
English: Post-myocardial infarction and/or heart failure
Danish: Post-myokardieinfarkt og/eller hjertesvigt
English: In marmosets at similar doses, the changes were similar though more severe, particularly in the kidney where the changes developed to a nephropathy which included raised urea and creatinine.
Danish: Hos silkeaber, som fik lignende doser, sås det samme, skønt mere alvorlige ændringer, især i nyrerne, hvor ændringerne udviklede sig til nefropati, som omfattede forhøjet urinstof og serum-kreatinin.
English: swollen lymph nodes and/or flu-like symptoms (signs of serum sickness)
Danish: hævede lymfeknuder og/eller influenza-lignende symptomer (tegn på serumsyge)
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUME, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF EMEA
English: 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.
Danish: Forsøget havde 2 primære effektmål: 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.
English: After an initial dose of 20 mg twice daily, valsartan should be titrated to 40 mg, 80 mg, and 160 mg twice daily over the next few weeks.
Danish: Efter en initial dosis på 20 mg 2 gange daglig, skal valsartan titreres til 40 mg, 80 mg og 160 mg 2 gange daglig over de næste få uger.
English: • rash, itching, together with some of the following signs or symptoms: fever, joint pain, muscle pain,
Danish: • udslæt, kløe sammen med nogle af følgende tegn eller symptomer: feber, ledsmerter, muskelsmerter,
English: The potential for hepatic function per se to affect the kinetics of valsartan is therefore limited, except in the case of biliary obstruction or cholestatic liver disease (defined as an alkaline phosphatase concentration > 2 X Upper Limit of Normal).
Danish: Muligheden for, at selve leverfunktionen vil påvirke valsartans kinetik, er derfor begrænset undtagen ved biliær obstruktion eller kolestatisk leversygdom (defineret som en alkalisk fosfatasekoncentration > 2 x den øvre grænse for normalområdet).
English: • swollen face, tongue or throat
Danish: • hævelse i ansigt, tunge eller svælg
English: Novartis Sverige AB Kemistvägen 1B P.O.
Danish: Novartis Sverige AB Kemistvägen 1B P.O. Box 1150
English: Exposure to valsartan is not correlated with the degree of liver dysfunction, although the presence of liver disease tended to increase the valsartan plasma AUC.
Danish: Eksponering for valsartan er ikke korreleret med graden af leverdysfunktion, selv om leversygdom øgede plasma AUC for valsartan.
English: Diovan contains valsartan, an orally Angiotensin II Receptor Antagonist (AIIRA).
Danish: Diovan indeholder valsartan, en oral angiotensin II-receptorantagonist (AIIRA).
English: The CHMP considered the precautions for the concomitant use of other medicinal products containing or raising the level of potassium and adopted the following wording: “If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, monitoring of potassium plasma levels is advised”.
Danish: CHMP vurderede forsigtighedsreglerne for samtidig brug af andre lægemidler, der indeholder eller øger kaliumindholdet, og vedtog følgende formulering: "Hvis et lægemiddel, der påvirker kaliumindholdet, anses for at være nødvendigt i kombination med valsartan, anbefales overvågning af plasmakaliumniveau".
English: • to treat people after a recent heart attack (myocardial infarction).
Danish: • Behandling af patienter, som for nylig har haft et hjerteanfald (myokardieinfarkt).
English: The safety and tolerability of valsartan in patients with severe renal failure (creatinine clearance of <10 ml/min) was not evaluated in any clinical study.
Danish: Sikkerheden og tolerabiliteten for valsartan hos patienter med alvorlig nyreinsufficiens (kreatininclearance <10 ml/min) blev ikke vurderet i nogen klinisk undersøgelse.
English: Based on a pharmacokinetic study, the dose of valsartan should not exceed 80 mg in these patients and should be used with caution.
Danish: På grundlag af en farmakokinetisk undersøgelse bør valsartan-dosis ikke overstige 80 mg hos disse patienter, og det bør anvendes med forsigtighed.
English: AUC and Cmax values of valsartan are almost proportional with increasing dose over the clinical dosing range (40 to 160 mg twice a day).
Danish: AUC- og cmax værdier for valsartan er omtrent proportionale med stigende dosis over det kliniske dosisspænd (40-160 mg, 2 gange daglig).
English: With reference to the contraindication for the use of Diovan during pregnancy or lactation, the CHMP in line with the recommendations of the Pharmacovigilance experts considered that the contraindication shall be removed and the following recommendation included in the specific section relevant to pregnancy and lactation as follows: “Because no information is available regarding the use of valsartan during breastfeeding, Diovan (Valsartan) is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant”.
Danish: Med henvisning til kontraindikationen for brug af Diovan under graviditet og amning fandt CHMP i overensstemmelse med henstillingen fra eksperterne i lægemiddelovervågning, at kontraindikationen skal fjernes og følgende henstilling medtages i et specifikt afsnit vedrørende graviditet og amning: "Da der ikke foreligger nogen oplysninger om brugen af valsartan under amning, frarådes Diovan (Valsartan), og alternativ behandling med bedre sikkerhedsprofiler under amning foretrækkes, navnlig ved amning af nyfødte eller for tidligt fødte spædbørn".
English: One film-coated tablet contains 40 mg of valsartan One capsule contains 40 mg of valsartan One film-coated tablet contains 80 mg of valsartan One capsule contains 80 mg of valsartan One film-coated tablet contains 160 mg of valsartan One capsule contains 160 mg of valsartan One film-coated tablet contains 320 mg of valsartan
Danish: En filmovertrukken tablet indeholder 40 mg valsartan En kapsel indeholder 40 mg valsartan En filmovertrukken tablet indeholder 80 mg valsartan En kapsel indeholder 80 mg valsartan En filmovertrukken tablet indeholder 160 mg valsartan En kapsel indeholder 160 mg valsartan En filmovertrukken tablet indeholder 320 mg valsartan
English: The MAH created a single table containing all relevant ADRs from all three indications: hypertension, post- MI, and CHF.
Danish: Indehaveren af markedsføringstilladelsen udarbejdede en enkelt tabel indeholdende alle relevante bivirkninger ved alle tre indikationer: hypertension, post-myokardieinfarkt og CHF.
English: Important information about some ingredients of Diovan [To be completed nationally]
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Diovan [Udfyldes nationalt]
English: Baseline therapy included ACE inhibitors (93%), diuretics (86%), digoxin (67%) and beta blockers (36%).
Danish: Basis behandling inkluderede ACE-hæmmere (93 %), diuretika (86 %), digoxin (67 %) og betablokkere (36 %).
English: Valsartan should not be administered in patients with severe hepatic impairment, cirrhosis or biliary obstruction.
Danish: Valsartan bør ikke gives til patienter med alvorlig leverinsufficiens, cirrhose eller biliær obstruktion.
English: There was no difference in all-cause mortality, cardiovascular mortality or morbidity when beta blockers were administered together with the combination of valsartan + captopril, valsartan alone, or captopril alone.
Danish: Der var ingen forskel i totalmortalitet, kardiovaskulær mortalitet eller morbiditet når betablokkere blev administreret sammen med kombinationen af valsartan og captopril, valsartan alene eller captopril alene.
English: The dosing schedule for the therapeutic use of valsartan in heart failure was based on the Val-HeFT study.
Danish: Doseringsplanen for den terapeutiske anvendelse af valsartan ved hjertesvigt var baseret på Val-HeFTundersøgelsen.
English: These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
Danish: Bivirkningerne kan forekomme med en bestemt hyppighed, der defineres på denne måde: Meget almindelig: Forekommer hos mere end 1 ud af 10 patienter Almindelig: Forekommer hos mellem 1 og 10 ud af 100 patienter Ikke almindelig: Forekommer hos mellem 1 og 10 ud af 1.000 patienter Sjælden: Forekommer hos mellem 1 og 10 ud af 10.000 patienter
English: Patients treated with valsartan had a better quality of life as demonstrated by change in the Minnesota Living with Heart Failure Quality of Life score from baseline at endpoint than placebo.
Danish: Patienter behandlet med valsartan havde bedre livskvalitet, påvist ved ændring i livskvalitetsscore (Minnesota Living with Heart Failure Quality of Life score) fra baseline ved effektmål end placebo.