FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: Blood and lymphatic system disorders Not known
Danish: Blod og lymfesystem Ikke kendt
English: • If you weigh less than 35 kg o the usual dose is 20 mg of valsartan (corresponding to 7 ml of the solution).
Danish: • Hvis du vejer mindre end 35 kg o er den sædvanlige dosis 20 mg valsartan (svarende til 7 ml opløsning).
English: In patients with bilateral renal artery stenosis or stenosis to a solitary kidney, the safe use of Diovan has not been established.
Danish: Hos patienter med bilateral nyrearteriestenose eller stenose i en enkelt nyre, er sikkerheden ved brug af Diovan ikke klarlagt.
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
English: Asthenia, Fatigue
Danish: Asteni, træthed
English: The bottle contains 160 ml of solution.
Danish: Flasken indeholder 160 ml opløsning.
English: A doubling of exposure (AUC) was observed in patients with mild to moderate hepatic impairment compared to healthy subjects.
Danish: Der blev observeret en fordobling af eksponeringen (AUC) hos patienter med let til moderat nedsat leverfunktion sammenlignet med raske forsøgspersoner.
English: Elevation of liver function values
Danish: forhøjede leverfunktionsværdier,
English: Like many other medicines used to treat high blood pressure, Diovan may in rare cases cause dizziness and affect the ability to concentrate.
Danish: Diovan kan, som megen anden medicin mod forhøjet blodtryk, i sjældne tilfælde give svimmelhed og påvirke evnen til at koncentrere sig.
English: Screw the cap back on the bottle.
Danish: Skru låget på flasken igen.
English: High blood pressure increases the workload on the heart and arteries.
Danish: Forhøjet blodtryk øger belastningen af hjertet og blodkarrene.
English: • unusual bleeding or bruising (signs of thrombocytopenia)
Danish: • usædvanlige blødninger eller blå mærker (tegn på trombocytopeni)
English: The initial dose for the Diovan oral solution is 20 mg (corresponding to 7 ml of the solution) once daily for children below 35 kg of weight and 40 mg (corresponding to 13 ml of the solution) once daily for those weighing 35 kg or more.
Danish: Startdosis med Diovan oral opløsning er 20 mg (svarende til 7 ml oral opløsningen) en gang daglig til børn, der vejer under 35 kg, og 40 mg (svarende til 13 ml oral opløsning) en gang daglig til børn, der vejer 35 kg eller mere.
English: 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 Meget sjælden: Forekommer hos færre end 1 ud af 10.000 patienter Ikke kendt: Hyppigheden kan ikke bestemmes ud fra de tilgængelige oplysninger.
English: Take Diovan solution once a day
Danish: Tag Diovan oral opløsning en gang daglig
English: If you stop taking Diovan
Danish: Hvis du holder op med at tage Diovan
English: • muscle spasms, abnormal heart rhythm (signs of hyperkalaemia)
Danish: • muskelkramper, unormal hjerterytme (tegn på hyperkaliæmi)
English: Immune system disorders Not known
Danish: Immunsystemet Ikke kendt
English: What Diovan looks like and contents of the pack Diovan 3 mg/ml oral solution is a clear, colourless to pale yellow solution.
Danish: Udseende og pakningsstørrelser Diovan 3 mg/ml oral opløsning er en klar, farveløs til svagt gul opløsning.
English: Syncope, Headache
Danish: Synkope, hovedpine
English: Valsartan shows multiexponential decay kinetics (t½ <1 h and t½ß about 9 h).
Danish: Valsartan udviser tokompartment halveringskinetik (t½ <1 time og t½ß omkring 9 timer).
English: Remove the oral syringe from the bottle adapter by gently twisting it out.
Danish: Fjern den orale sprøjte fra flaskeadaptoren ved stille og roligt at vride den ud.
English: Each ml solution contains 0.3 g sucrose, 1.62 mg methyl parahydroxybenzoate (E218) and 5 mg poloxamer (188)
Danish: Hver ml opløsning indeholder 0,3 g saccharose, 1,62 mg methylparahydroxybenzoat (E218) og 5 mg poloxamer (188).
English: 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).
Danish: 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).
English: Metabolism and nutrition disorders Not known
Danish: Metabolisme og ernæring Ikke kendt
English: Available data are described in sections 4.8, 5.1 and 5.2.
Danish: 4.8, 5.1 og 5.2.
English: Valsartan dose to provide when switching
Danish: Valsartandosis ved skift
English: - Second and third trimester of pregnancy (see sections 4.4 and 4.6).
Danish: - Andet og tredje trimester af graviditet (se pkt.
English: In controlled clinical studies in adult 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 voksne patienter med hypertension var den samlede forekomst af bivirkninger sammenlignelig med placebos og overensstemmende med valsartans farmakologi.
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: Others
Danish: Andet
English: Renal failure and impairment, Elevation of serum creatinine General disorders and administration site conditions Uncommon
Danish: Nyresvigt og nyreinsufficiens, forhøjet serumkreatinin Almene symptomer og reaktioner på administrationsstedet Ikke almindelig
English: • purplish-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: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml solution contains 3 mg of valsartan.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml opløsning indeholder 3 mg valsartan.
English: • elevation of liver function values (which can indicate liver damage) including an increase of bilirubin in the blood (which can trigger yellow skin and eyes in severe cases)
Danish: • forhøjede leverfunktionstal (hvilket kan være tegn på leverskader) herunder et forhøjet niveau af bilirubin i blodet (hvilket kan medføre gulfarvning af hud og øjne i alvorlige tilfælde)
English: • Tell your doctor if you are breast-feeding or about to start breast-feeding.
Danish: • Fortæl det til din læge, hvis du ammer eller skal til at begynde at amme.
English: In patients who continued to receive the medium and high doses of valsartan, systolic blood pressure at trough was -4 and -7 mm Hg lower than patients who received the placebo treatment.
Danish: Hos patienter, som forsatte med at få middel og højdosis af valsartan, var systolisk blodtryk ved trough -4 og -7 mmHg lavere end hos patienter, som fik placebobehandling.
English: There is limited clinical experience with Diovan in paediatric patients with mild to moderate hepatic impairment.
Danish: Der er begrænset klinisk erfaring med Diovan hos pædiatriske patienter med mildt til moderat nedsat leverfunktion.
English: Diovan belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure.
Danish: Diovan tilhører en gruppe medicin, der kaldes angiotensin-II-hæmmere, der hjælper med at sænke forhøjet blodtryk.
English: In patients receiving the low dose of valsartan, systolic blood pressure at trough was similar to that of patients who received the placebo treatment.
Danish: Hos patienter, som fik den lave dosis af valsartan, var systolisk blodtryk ved trough tilsvarende det for patienter, som fik placebobehandling.
English: At 24 weeks, UAE was reduced (p<0.001) by 42% (-24.2 µg/min; 95% CI: -40.4 to -19.1) with valsartan and approximately 3% (-1.7 µg/min; 95% CI: -5.6 to 14.9) with amlodipine despite similar rates of blood pressure reduction in both groups.
Danish: Efter 24 uger var UAE reduceret (p<0,001) med 42 % (-24,2 µg/min; 95 % konfidensinterval: -40,4 til -19,1) med valsartan og cirka 3 % (-1.7 µg/min; 95 % konfidensinterval: -5,6 til 14,9) med amlodipin trods ensartet reduktion af blodtryksværdierne i begge grupper.
English: Hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take Diovan oral solution as it contains sucrose.
Danish: Arvelig fructoseintolerans, glucose/galactosemalabsorption og sucrase-isomaltasemangel Bør ikke anvendes til patienter med arvelig fructoseintolerans, glucose/galactosemalabsorption og sucrase-isomaltasemangel, da Diovan oral opløsning indeholder saccharose.
English: Unless continued AIIRA 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.
Danish: 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.
English: If you forget to take Diovan
Danish: Hvis du har glemt at tage Diovan
English: Renal function and serum potassium should be closely monitored during treatment with valsartan.
Danish: Nyrefunktion og serumkalium skal monitoreres tæt under behandling med valsartan.
English: Diovan oral solution contains poloxamer (188) which may cause softened stools.
Danish: Diovan oral opløsning indeholder poloxamer (188), som kan give løs afføring.
English: • 1 ml oral solution contains 3 mg of valsartan.
Danish: • 1 ml oral opløsning indeholder 3 mg valsartan.
English: The use of AIIRAs is contra-indicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Danish: Brug af AIIA er kontraindiceret under andet og tredje trimester af graviditeten (se pkt.
English: To clean the oral syringe:
Danish: Rengøring af oral sprøjte:
English: Angioedema, Rash, Pruritus
Danish: Angioødem, udslæt, pruritus
English: At 30 weeks, the percentage change in UAE was significantly reduced by 36% from baseline with valsartan 160 mg (95%CI: 22 to 47%), and by 44% with valsartan 320 mg (95%CI: 31 to 54%).
Danish: Efter 30 uger var den procentmæssige ændring af UAE signifikant reduceret med 36 % i forhold til baseline med valsartan 160 mg (95 % konfidensinterval: 22 til 47 %) og med 44 % med valsartan 320 mg (95 % konfidensinterval: 31 til 54 %).
English: In rats, maternally toxic doses (600 mg/kg/day) during the last days of gestation and lactation led to lower survival, lower weight gain and delayed development (pinna detachment and ear-canal opening) in the offspring (see section 4.6).
Danish: Hos rotter førte maternelle toksiske doser (600 mg/kg/dag) i de sidste dage af drægtighedsperioden samt i dieperioden til lavere overlevelse, lavere vægtforøgelse og forsinket udvikling (pinna-løsning og åbning af øregang) hos ungerne (se pkt.
English: • Once opened, the bottle can be stored for up to 3 months at temperatures below 30°C.
Danish: • Efter åbning kan flasken opbevares i op til 3 måneder ved temperaturer under 30 °C.
English: • decrease of level of haemoglobin and decrease of the percentage of red blood cells in the blood (which can lead to anaemia in severe cases)
Danish: • nedsat hæmoglobintal og fald i procenten af røde blodlegemer i blodet (hvilket kan føre til anæmi i alvorlige tilfælde)
English: Czech Republic
Danish: Den Tjekkiske republic
English: Measuring a dose of medicine
Danish: Afmåling af en dosis medicin
English: • This medicine has been prescribed for you.
Danish: • Lægen har ordineret Diovan til dig personligt.
English: Diovan oral solution contains 0,3 g sucrose per mililiter.
Danish: Diovan oral opløsning indeholder 0,3 g saccharose per milliliter.
English: Keeping the bottle upright, insert the oral syringe firmly into the bottle adapter.
Danish: Hold flasken opretstående og sæt den orale sprøjte fast ned i flaskeadaptoren.
English: The antihypertensive effect of valsartan has been evaluated in two randomised, double-blind clinical studies in 561 paediatric patients from 6 to 18 years of age.
Danish: Valsartans antihypertensive virkning er blevet evalueret i to randomiserede, dobbeltblindede kliniske forsøg med 561 pædiatriske patienter i alderen 6 til 18 år.
English: Metabolism and nutrition disorders Uncommon
Danish: Metabolisme og ernæring Ikke almindelig
English: Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how Diovan affects you.
Danish: Du skal være sikker på, hvordan Diovan påvirker dig, før du kører bil, bruger værktøj eller betjener maskiner eller udfører andre aktiviteter, der kræver koncentration.
English: Once opened, the bottle can be stored for up to 3 months at temperatures below 30°C.
Danish: Efter åbning kan flasken opbevares i op til 3 måneder ved temperaturer under 30 °C.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se Bilag I - Udfyldes nationalt]
English: • that has a child- resistant screw cap.
Danish: • den har et børnesikret skruelåg.
English: An oral dosing syringe:
Danish: En oral doseringssprøjte:
English: Contains sucrose, methyl parahydroxybenzoate (E218) and poloxamer (188) (see leaflet for further information).
Danish: Indeholder saccharose, methylparahydroxybenzoat (E218) og poloxamer (188) (se indlægssedlen for mere information).
English: The use of Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during the first trimester of pregnancy (see section 4.4).
Danish: Det frarådes at bruge angiotensin II-antagonister (AIIA) under første trimester af graviditeten (se pkt.
English: • Restart the cycle of PSUR submission for Diovan as follows: o Six-monthly PSURs until two full years of experience with the paediatric indication in the EU has been gained o Yearly PSURs for the following two years o Thereafter submission at 3-yearly intervals The PSURs should focus on the use in the paediatric population.
Danish: • Genoptagelse af proceduren for fremsendelse af en periodisk, opdateret sikkerhedsindberetning (PSUR) for Diovan som følger: o Periodiske, opdaterede sikkerhedsindberetninger hvert halve år, indtil der er opnået to hele års erfaring med den pædiatriske indikation i EU.
English: Fitting the press in bottle adapter into a new bottle of medicine
Danish: Montering af doseringsadaptoren i en ny flaske medicin
English: Respiratory, thoracic and mediastinal disorders Uncommon
Danish: Luftveje, thorax og mediastinum Ikke almindelig
English: You may experience symptoms of angioedema (a specific allergic reaction), such as
Danish: Nogle bivirkninger kan være alvorlige og kræver omgående lægebehandling: Du kan opleve symptomer på angioødem (en specifik allergisk reaktion), som f.eks.
English: Clinical experience in children less than 6 years of age Two clinical studies were conducted in patients aged 1 to 6 years with 90 and 75 patients, respectively.
Danish: Der er blevet gennemført to kliniske forsøg med patienter i aldersgruppen 1 til 6 år med henholdsvis 90 og 75 patienter.
English: ADRs that occurred in adult patients with post-myocardial infarction and/or heart failure are listed below.
Danish: Bivirkninger, der forekom hos voksne patienter med post-myokardieinfarkt og/eller hjertesvigt, er angivet i nedenstående tabel.
English: The antihypertensive effect of valsartan have been evaluated in four randomized, double-blind clinical studies in 561 paediatric patients from 6 to 18 years of age and 165 paediatric patients 1 to 6 years of age.
Danish: Valsartans antihypertensive virkning er blevet evalueret i fire randomiserede, dobbeltblindede kliniske forsøg med 561 pædiatriske patienter i alderen 6 til 18 år og med 165 pædiatriske patienter i alderen 1 til 6 år.
English: • Medicines should not be disposed of via wastewater or household waste.
Danish: • Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
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, så spring den glemte dosis over.
English: Paediatric heart failure and recent myocardial infarction Diovan is not recommended for the treatment of heart failure or recent myocardial infarction in children and adolescents below the age of 18 years due to the lack of data on safety and efficacy.
Danish: På grund af manglende dokumentation for sikkerhed og virkning anbefales Diovan ikke til behandling af hjertesvigt eller nyligt myokardieinfarkt hos børn og unge under 18 år.
English: The MARVAL (Micro Albuminuria Reduction with Valsartan) study assessed the reduction in urinary albumin excretion (UAE) with valsartan (80-160 mg/od) versus amlodipine (5-10 mg/od), in 332 type 2 diabetic patients (mean age: 58 years; 265 men) with microalbuminuria (valsartan: 58 µg/min; amlodipine: 55.4 µg/min), normal or high blood pressure and with preserved renal function (blood creatinine <120 µmol/l).
Danish: MARVAL (Micro Albuminuria Reduction with Valsartan)undersøgelsen vurderede reduktionen i udskillelse af albumin via urinen (UAE) med valsartan (80160 mg/od) versus amlodipin (5-10 mg/od), hos 332 type diabetespatienter (gennemsnitsalder: 58 år; 265 mænd) med mikroalbuminuri (valsartan: 58 µg/min; amlodipin: 55,4 µg/min) og normalt eller højt blodtryk og med bevaret nyrefunktion (blodkreatinin <120 µmol/l).
English: Renal function and serum potassium should be closely monitored.
Danish: Nyrefunktion og serumkalium skal monitoreres tæt.
English: Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels
Danish: Kaliumbesparende diuretika, kaliumtilskud, salterstatninger indeholdende kalium og andre stoffer, der kan forhøje kalium-niveauerne
English: If hypotension occurs, the patient should be placed in a supine position and blood volume correction should be undertaken.
Danish: Såfremt der opstår hypotension, skal patienten placeres i rygliggende stilling, og der bør hurtigt gives salt- og væskesupplement.
English: • severely decreased kidney function (signs of acute renal failure)
Danish: • stærkt nedsat nyrefunktion (tegn på akut nyresvigt)
English: • increase of level of blood urea nitrogen and increase of level of serum creatinine (which can indicate abnormal kidney function)
Danish: • forhøjet niveau af urinstof i blodet og forhøjet niveau af serumkreatinin (hvilket kan være tegn på unormal nyrefunktion)
English: Remove the cap from the bottle by pushing it down firmly and turning it anti-clockwise (as shown on the top of the cap).
Danish: Fjern låget fra flasken ved at trykke det fast ned og dreje det mod uret (som vist øverst på låget).
English: 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”.
Danish: Eksponering for behandling med AIIA under andet og tredje trimester er kendt for at medføre human føtotoksicitet (nedsat nyrefunktion, oligohydramnion, forsinket kranieossifikation) og neonatal toksicitet (nyresvigt, hypotension, hyperkalæmi), se også pkt.
English: 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.
Danish: Den terapeutiske vurdering afhænger af tidspunktet for indtagelse og af symptomernes art og alvor.
English: In non-clinical safety studies, high doses of valsartan (200 to 600 mg/kg body weight) caused in rats a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit) and evidence of changes in renal haemodynamics (slightly raised plasma urea, and renal tubular hyperplasia and basophilia in males).
Danish: I prækliniske sikkerhedsundersøgelser på rotter forårsagede høje doser valsartan (200-600 mg/kg legemsvægt) reduktion af blodtal (erytrocytter, hæmoglobin og hæmatokritværdi) og tegn på ændringer i den renale hæmodynamik (lettere forhøjet plasma-urinstof, samt renal tubulær hyperplasi og basofili hos hanner).
English: Instructions for using the oral syringe and the dosing cup
Danish: Brugsanvisning til oral sprøjte og doseringskop
English: • increase of level of potassium in the blood (which can trigger muscle spasms and abnormal heart rhythm in severe cases)
Danish: • forhøjet niveau af kalium i blodet (hvilket kan medføre muskelkramper og unormal hjerterytme i alvorlige tilfælde)
English: However, no correlation was observed between plasma valsartan concentration versus degree of hepatic dysfunction.
Danish: Der blev dog ikke observeret nogen korrelation mellem valsartan-koncentrationer i blodet og graden af leverinsufficiens.
English: Novartis Farma S.p.A. Largo Umberto Boccioni 1
Danish: Largo Umberto Boccioni 1
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 typediabetes, albuminuri (gennemsnit=102 µg/min; 20-700 µg/min) og bevaret nyrefunktion (gennemsnitlig serumkreatinin = 80 µmol/l).
English: • if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Diovan listed at the end of this leaflet.
Danish: • hvis du er overfølsom (allergisk) over for valsartan eller et af de øvrige indholdsstoffer i
English: Carefully turn the bottle and oral syringe back upright.
Danish: Vend forsigtigt flasken og den orale sprøjte tilbage til opretstående position.
English: Skin and subcutaneous tissue disorders Not known
Danish: Hud og subkutane væv Ikke kendt