FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, monitoring of renal function at the beginning of the treatment is recommended, as well as adequate hydration of the patient.
Danish: Det anbefales derfor at monitorere nyrefunktionen i begyndelsen af behandlingen, lige som tilstrækkelig hydrering af patienten anbefales.
English: When driving vehicles or operating machines it should be taken into account that occasionally dizziness or weariness may occur.
Danish: Når man fører motorkøretøj eller betjener maskiner, bør der tages hensyn til, at svimmelhed og træthed undertiden kan forekomme.
English: This is a disease in which your adrenal glands make too much of the hormone aldosterone.
Danish: Dette er en sygdom, hvor dine binyrer producerer for meget af hormonet aldosteron.
English: Patients with primary hyperaldosteronism should not be treated with Diovan as their renin-angiotensin system is not activated.
Danish: Patienter med primær hyperaldosteronisme bør ikke behandles med Diovan, da deres renin-angiotensinsystem ikke er aktiveret.
English: Taking Diovan with food and drink You can take Diovan with or without food.
Danish: Brug af Diovan sammen med mad og drikke Du kan tage Diovan med eller uden mad.
English: This applies particularly when valsartan is given in the presence of other conditions (fever, dehydration) likely to impair renal function.
Danish: Dette gælder særligt, når valsartan gives ved tilstedeværelsen af andre tilstande (feber, dehydrering), som kan forringe nyrefunktionen.
English: This makes it all the more important for you to keep your appointments with the doctor even if you are feeling well.
Danish: Det er derfor vigtigt, at du overholder dine lægebesøg, selvom du føler dig rask.
English: CARTON/BOTTLE LABEL
Danish: KARTON/ETIKET TIL FLASKE
English: • sudden loss of consciousness (syncope)
Danish: • pludseligt tab af bevidsthed (synkope)
English: • that consists of a clear plastic tube with a plunger inside.
Danish: • der består af en klar plasticsprøjte med et stempel indeni.
English: • that can be used if the prescribed dose requires filling the syringe several times.
Danish: • der kan anvendes, hvis den ordinerede dosis kræver, at sprøjten fyldes flere gange.
English: The incidence of ADRs did not appear to be related to dose or treatment duration and also showed no association with gender, age or race.
Danish: Forekomsten af bivirkninger syntes ikke at være relateret til dosis eller behandlingsvarighed og viste heller ingen forbindelse med køn, alder eller race.
English: A hydroxy metabolite has been identified in plasma at low concentrations (less than 10% of the valsartan AUC).
Danish: En hydroxymetabolit er blevet identificeret i plasma i lave koncentrationer (mindre end 10 % af valsartans AUC).
English: • if you are more than 3 months pregnant (it is also better to avoid Diovan in early pregnancy see pregnancy section).
Danish: • hvis du er mere end 3 måneder henne i en graviditet (det er også bedre at undgå Diovan tidligt i graviditeten) - se afsnittet Graviditet.
English: Due to the lack of experience with concomitant use of valsartan and lithium, this combination is not recommended.
Danish: På grund af den manglende erfaring med samtidig brug af valsartan og lithium, kan denne kombination ikke anbefales.
English: The amount of sucrose in the Diovan solution may be harmful to your teeth.
Danish: Mængden af saccharose i Diovan oral opløsning kan være skadelig for dine tænder.
English: This applies to both prescription and non-prescription medicines, especially:
Danish: Dette gælder både for medicin på recept og håndkøbsmedicin, især:
English: Valsartan is not biotransformed to a high extent as only about 20% of dose is recovered as metabolites.
Danish: Valsartan biotransformeres ikke i stort omfang, idet kun cirka 20 % af dosen genfindes som metabolitter.
English: The protocol of the study will be submitted by the applicant in the second quarter of 2010 for agreement with the CHMP with input from the PDCO.
Danish: Ansøgeren vil fremsende undersøgelsesprotokollen i andet kvartal af 2010 med henblik på godkendelse af CHMP efter input fra PDCO.
English: Hypotension, Orthostatic hypotension
Danish: Hypotension, ortostatisk hypotension
English: Always take Diovan exactly as your doctor has told you in order to get the best results and reduce the risk of side effects.
Danish: Tag altid Diovan nøjagtigt efter lægens anvisning for at opnå den bedste behandling og mindske risikoen for bivirkninger.
English: Combined with hydrochlorothiazide, a significant additional reduction in blood pressure is achieved.
Danish: Ved kombination med hydrochlorthiazid opnås yderligere signifikant additiv blodtrykssænkning.
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Danish: Hvis kombinationen viser sig nødvendig, anbefales omhyggelig monitorering af serum-lithium-niveauerne.
English: If the prescribed dose requires filling the syringe several times, you can empty the measured doses of medicine from the syringe into the dosing cup and then check the total volume of solution.
Danish: Hvis den ordinerede dosis gør det nødvendigt at fylde sprøjten flere gange, kan du tømme den afmålte dosis af medicin i sprøjten ud i doseringskoppen og derefter tjekke den totale volumen af opløsningen.
English: Hypertension (paediatric population)
Danish: Hypertension (pædiatrisk population)
English: Mean absolute bioavailability is 23% and 39% with tablets and solution formulation, respectively.
Danish: Den gennemsnitlige absolutte biotilgængelighed er henholdsvis 23 % og 39 % med tabletter og oral opløsning.
English: The rats in the juvenile valsartan study were dosed up to day 70, and effects on renal maturation (postnatal 4-6 weeks) cannot be excluded.
Danish: Rotterne i juvenil valsartanforsøget blev doseret op til dag 70, og virkningen på nyreudviklingen (4-6 uger postnatal) kan ikke udelukkes.
English: If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down.
Danish: Hvis du oplever kraftig svimmelhed og/eller besvimer, skal du omgående kontakte lægen og lægge dig ned.
English: Note: The total amount of solution that can be measured into the oral syringe is 5 ml.
Danish: Bemærk: Den totale mængde opløsning, som kan afmåles i den orale sprøjte, er 5 ml.
English: Approximately 70% of the dose absorbed is eliminated in the bile, essentially in the unchanged form.
Danish: Cirka 70 % af den absorberede dosis udskilles i galden, hovedsageligt i uændret form.
English: Kemistvägen 1B P.O.
Danish: Kemistvägen 1B P.O. Box 1150
English: Valsartan is not known to bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Danish: 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.
English: For example, if the prescribed dose is 13 ml, it will be necessary to measure out the solution in three separate stages: 5 ml + 5 ml + 3 ml.
Danish: Fx,hvis den ordinerede dosis er 13 ml, vil det være nødvendigt at afmåle opløsningen i tre separate faser: 5 ml + 5 ml + 3 ml.
English: Patients were re-randomized to either continue receiving the same dose of valsartan or were switched to placebo.
Danish: Patienter blev igen randomiseret til enten at fortsætte med at få den samme dosis af valsartan eller blev skiftet til placebo.
English: Whilst there is no controlled epidemiological data on the risk with AIIRAs, similar risks may exist for this class of drugs.
Danish: Der er ingen kontrollerede epidemiologiske data angående risikoen ved brug af AIIA, men lignende risici kan eksistere for denne gruppe af lægemidler.
English: Important information about some of the ingredients of Diovan solution
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Diovan oral opløsning
English: The applicant will initiate a scientific dialogue via the CHMP's Scientific Advice with the involvement of the PDCO for protocol assistance with the aim of gaining further insight on a hypertensive clinical trial in younger children with valsartan and to define objectives and design parameters in investigating the efficacy in this population.
Danish: Ansøgeren skal indlede en videnskabelig dialog via CHMP's videnskabelige rådgivning og med inddragelse af PDCO for protokolassistance med det formål at få yderligere indsigt i en klinisk undersøgelse af mindre børn med hypertension med valsartan og at opstille målsætninger og fastlægge parametre ved undersøgelsen af virkningen hos denne population.
English: Diovan 3 mg/ml oral solution can be used to treat high blood pressure in children and adolescents 6 to 18 years of age.
Danish: Diovan 3 mg/ml oral opløsning kan bruges til behandling af forhøjet blodtryk hos børn og unge i alderen 6 til 18 år.
English: Use a new bottle adapter and oral dosing syringe each time you start a new bottle of medicine.
Danish: Brug en ny flaskeadapter og en ny oral doseringssprøjte hver gang, du begynder på en ny flaske medicin.
English: Before you measure your dose you need to get rid of any large bubbles that may be trapped in the oral syringe.
Danish: Inden du afmåler din dosis, skal du fjerne store bobler, som kan være fanget i den orale sprøjte.
English: • lithium, a medicine used to treat some types of psychiatric illness.
Danish: • lithium, medicin mod visse psykiske lidelser.
English: Slowly pull the plunger out until the top edge of the black ring inside is exactly level with the marker.
Danish: Træk langsomt stemplet ud, indtil toppen af kanten på den sorte ring inden i sprøjten er nøjagtig i samme niveau som mærket.
English: It may be necessary to check the amount of potassium in your blood at regular intervals.
Danish: Det kan være nødvendigt at tjekke blodets kaliumindhold med regelmæssige mellemrum.
English: • The oral syringe fits into the bottle adapter and is used to measure out the required amount of medicine from the bottle.
Danish: • Den orale sprøjte passer i flaskeadaptoren og bruges til at afmåle den nødvendige mængde medicin fra flasken.
English: Valsartan does not exhibit any partial agonist activity at the AT1 receptor and has much (about 20,000 fold) greater affinity for the AT1 receptor than for the AT2 receptor.
Danish: Valsartan udviser ikke partiel agonistaktivitet på AT1-receptoren og har en meget højere (ca. 20.000 gange) affinitet for AT1-receptoren end for AT2-receptoren.
English: It is not recommended to switch between Diovan tablets and Diovan oral solution unless clinically required as there is insufficient information to guide an appropriate dose on switching between the two formulations.
Danish: Det anbefales ikke at skifte mellem Diovan-tabletter og Diovan oral opløsning, medmindre det er en klinisk nødvendighed, fordi der er mangelfuld information til vejledning om en passende dosis ved skift mellem de to formuleringer.
English: • swollen face, lips, tongue or throat
Danish: • hævelse i ansigt, læber, tunge eller svælg
English: Nausea, Diarrhoea
Danish: Kvalme, diarré
English: • if you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water tablets (diuretics).
Danish: • hvis du har mistet meget væske (er dehydreret) på grund af diarré, opkastninger, eller høje doser af vanddrivende medicin (diuretika).
English: Take this into account if you have diabetes mellitus.
Danish: Du skal tage dette i betragtning, hvis du har sukkersyge (diabetes mellitus).
English: Find the marker on the oral syringe that corresponds to the required amount of medicine.
Danish: Find mærket på den orale sprøjte, som svarer til den mængde medicin, du behøver.
English: If any of these apply to you, tell your doctor before you take Diovan.
Danish: Hvis noget af dette gælder for dig, skal du fortælle det til din læge, inden du tager Diovan.
English: Sit upright.
Danish: Sid oprejst.
English: The steady-state volume of distribution of valsartan after intravenous administration is about 17 litres, indicating that valsartan does not distribute into tissues extensively.
Danish: Steady-state fordelingsvolumen af valsartan efter intravenøs administration er cirka 17 liter, hvilket tyder på, at valsartan ikke fordeles i omfattende grad i væv.
English: • Always put the dosing cup back onto the cap after use and cleaning.
Danish: • Sæt altid doseringskoppen tilbage på låget efter brug og rengøring.
English: Overall, the dose-dependent antihypertensive effect of valsartan was consistent across all the demographic subgroups.
Danish: Samlet var den dosisafhængige antihypertensive virkning af valsartan konstant tværs over alle demografiske undergrupper.
English: Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppering er bivirkningerne ordnet i faldende sværhedsgrad.
English: • Do not use Diovan if you notice that the pack is damaged or shows signs of tampering.
Danish: • Brug ikke Diovan, hvis du opdager, at pakningen er beskadiget eller har været åbnet.
English: Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC code: C09CA03
Danish: Farmakoterapeutisk klassifikation: Angiotensin II-antagonister, almindelig, ATC-kode: C09CA03
English: Valsartan is an orally active, potent, and specific angiotensin II (Ang II) receptor antagonist.
Danish: Valsartan er en oralt, aktiv, potent og specifik angiotensin II-receptorantagonist.
English: As expected for a compound where renal clearance accounts for only 30% of total plasma clearance, no correlation was seen between renal function and systemic exposure to valsartan.
Danish: Som forventet for et stof med en nyre-clearance på kun 30 % af total plasmaclearance, er der ikke observeret nogen korrelation mellem nyrefunktion og systemisk eksponering af valsartan.
English: Sodium and/or volume depletion should be corrected before starting treatment with Diovan, for example by reducing the diuretic dose.
Danish: Natrium- og/eller væskemangel bør derfor korrigeres før behandlingsstart med Diovan som for eksempel ved reduktion af diuretikadosis.
English: To clean the cup:
Danish: Rengøring af koppen:
English: Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Graviditet og amning Spørg din læge eller apoteket til råds, før du tager nogen form for medicin.
English: 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.
Danish: 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.
English: Diovan is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Danish: Diovan frarådes til mødre, der ammer, og din læge kan vælge en anden behandling, hvis du gerne vil amme, især hvis dit barn er nyfødt eller er født for tidligt.
English: • that you insert into the neck of the bottle.
Danish: • som du presser ned i flaskehalsen.
English: Use in children under 6 years of age.
Danish: Brug hos børn under 6 år.
English: - Post-myocardial infarction and/or heart failure (studied in adult patients only)
Danish: Post-myokardieinfarkt og/eller hjertesvigt (kun undersøgt hos voksne patienter)
English: The final study report should be submitted by the last quarter of 2010.
Danish: Den endelige undersøgelsesrapport skal senest fremsendes i sidste kvartal af 2010.
English: Valsartan is highly bound to plasma protein and is unlikely to be removed by dialysis.
Danish: Valsartan er i høj grad bundet til plasmaproteiner, og det er derfor usandsynligt, at det kan fjernes ved dialyse.
English: However safety and efficacy of Diovan in children aged 1 to 6 years have not been established.
Danish: Sikkerhed og effekt er imidlertid ikke fastsat for børn i aldersgruppen 1 til 6 år.
English: During repeated dosing, the antihypertensive effect is substantially present within 2 weeks, and maximal effects are attained within 4 weeks and persist during long-term therapy.
Danish: Ved gentagen dosering opnås den antihypertensive effekt i væsentlig grad inden for 2 uger, og maksimale effekter opnås inden for 4 uger og opretholdes under vedvarende behandling.
English: POSSIBLE SIDE EFFECTS Like all medicines, Diovan can cause side effects, although not everybody gets them.
Danish: Diovan kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: 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.
Danish: 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”.
English: • if you are below 18 years of age and you take Diovan in combination with other medicines that inhibit the renin angiotensin aldosterone system (medicines that lower blood pressure), your doctor may check your kidney function and the amount of potassium in your blood at regular intervals.
Danish: • Hvis du er under 18 år, og du tager Diovan i kombination med andet medicin, som hæmmer renin-angiotensin-aldosteron-systemet (medicin, der sænker blodtrykket), vil din læge checke din nyrefunktion og indholdet af kalium i dit blod med jævne mellemrum.
English: N.V. Novartis Pharma S.A. Medialaan 40, bus 1
Danish: Novartis Pharma S.A. Medialaan 40, bus 1
English: At the end of 2 weeks, valsartan reduced both systolic and diastolic blood pressure in a dose-dependent manner.
Danish: Ved slutningen af 2 uger reducerede valsartan både systolisk og diastolisk blodtryk på en dosisafhængigt måde.
English: The antihypertensive effect persists over 24 hours after dosing.
Danish: Den antihypertensive effekt varer i 24 timer efter dosis.
English: High blood pressure increases the risk of heart attacks.
Danish: Forhøjet blodtryk øger risikoen for hjerteanfald.
English: The purpose of the study was to determine the optimal dose of valsartan for reducing UAE in hypertensive patients with type 2 diabetes.
Danish: Formålet med undersøgelsen var at bestemme den optimale valsartandosis til reduktion af UAE hos hypertensive patienter med type -diabetes.
English: 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.
Danish: Da valsartan er en angiotensin II-antagonist, kan det ikke udelukkes, at anvendelse af Diovan kan associeres med forringelse af nyrefunktionen.
English: This may soften your stools.
Danish: Det kan give løs afføring.
English: Consistent results were observed for diastolic blood pressure with reductions of 9.1 mmHg and 8.5 mmHg with valsartan and enalapril, respectively.
Danish: Der blev set ensartede resultater for diastolisk blodtryk med reduktioner på 9,1 mmHg og 8,5 mmHg med henholdsvis valsartan og enalapril.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: [Udfyldes nationalt]
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: Efter intravenøs administration er valsartans plasmaclearence cirka 2 l/t, og den renale clearance er 0,62 l/t (cirka 30 % af den totale clearance).
English: Overdose with Diovan may result in marked hypotension, which could lead to depressed level of consciousness, circulatory collapse and/or shock.
Danish: Overdosering med Diovan kan resultere i udtalt hypotension, som kan føre til nedsat bevidsthedsniveau, kredsløbskollaps og/eller chok.
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 resultere i en hjerneblødning, hjertesvigt eller nyresvigt.
English: There is currently no experience on the safe use of Diovan in patients who have recently undergone kidney transplantation.
Danish: Der er på nuværende tidspunkt ingen erfaring med sikkerheden ved brug af Diovan til patienter, som for nyligt er blevet nyretransplanteret.
English: No children below the age of 1 year were enrolled in these studies.
Danish: I disse forsøg blev der ikke inkluderet børn under 1 år.
English: • angioedema (see section “Some symptoms need immediate medical attention”)
Danish: • angioødem (se afsnittet ”Nogle bivirkninger kan være alvorlige og kræver omgående lægebehandling”)
English: Diovan oral solution is not bioequivalent to the tablet formulation and patients should not be switched unless clinically essential.
Danish: Diovan oral opløsning er ikke bioækvivalent med tabletformuleringen, og patienter bør ikke skifte lægemiddelform, medmindre det er klinisk nødvendigt.
English: Neurocognitive and developmental assessment of paediatric patients aged 6 to 16 years of age revealed no overall clinically relevant adverse impact after treatment with Diovan for up to one year.
Danish: Neurokognitive og udviklingsmæssige vurderinger af pædiatriske patienter i aldersgruppen 6 til 16 år viste ingen overordnet klinisk relevant uønsket virkning efter behandling med Diovan i op til et år.
English: Renal and urinary disorders, and obesity were the most common underlying medical conditions potentially contributing to hypertension in the children enrolled in these studies.
Danish: Nyre- og urinvejslidelser og fedme var de mest almindelige underliggende medicinske tilstande, som bidrog til hypertension hos børnene inkluderet i disse forsøg.
English: With the exception of isolated gastrointestinal disorders (like abdominal pain, nausea, vomiting) and dizziness, no relevant differences in terms of type, frequency and severity of adverse reactions were identified between the safety profile for paediatric patients aged 6 to 18 years and that previously reported for adult patients.
Danish: Med undtagelse af enkeltstående gastrointestinale bivirkninger (som mavesmerter, kvalme, opkastning) og svimmelhed, er der ikke set relevante forskelle i form af bivirkningernes type, frekvens eller alvorlighed mellem sikkerhedsprofilerne for pædiatriske patienter i aldersgruppen 6 til 18 år og det der tidligere er rapporteret for voksne patienter.
English: PHARMACEUTICAL FORM Clear, colourless to pale yellow solution.
Danish: LÆGEMIDDELFORM Klar, farveløs til svag gul opløsning.
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: Children and adolescents 6 to 18 years of age
Danish: Børn og unge i aldersgruppen 6 til 18 år
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet.
English: It was concluded that 160-320 mg of valsartan produced clinically relevant reductions in UAE in hypertensive patients with type 2 diabetes.
Danish: Heraf udledtes, at 160-320 mg valsartan gav klinisk relevante reduktioner af UAE hos hypertensive patienter med type -diabetes.
English: Indirect comparisons suggest that, the oral bioavailability of valsartan with the solution is approximately 2-fold higher than the tablets.
Danish: Indirekte sammenligninger antyder, at valsartans orale biotilgængelighed af opløsningen er cirka 2 gange højere end for tabletterne.
English: Children less than 6 years of age
Danish: Børn under 6 år