FrancophonIA/ELRC3.0 huggingface dataset:
English: Increase of dosage of probenecid or sulfinpyrazone may be necessary.
Danish: En øget dosis af probenecid eller sulfinpyrazol kan være nødvendig.
English: Section 4.5 - Interaction with Other Medicinal Products and Other Forms of Interaction
Danish: Afsnit 4.5 - Interaktion med andre lægemidler og andre former for interaktion
English: Adverse drug 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), not known (cannot be estimated from the available data).
Danish: Bivirkninger er angivet efter frekvens 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); meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Antidiabetic agents (oral agents and insulin)
Danish: Antidiabetika (orale præparater og insulin)
English: Method of administration Diovan Comp can be taken with or without food and should be administered with water.
Danish: Administrationsmetode Diovan Comp kan tages uafhængigt af måltider og bør administreres sammen med vand.
English: Pressor amines (e.g. noradrenaline, adrenaline) Possible decreased response to pressor amines but not sufficient to preclude their use.
Danish: Pressoraminer (f.eks. noradrenalin, adrenalin) Muligvis nedsat respons på pressoraminer, men ikke tilstrækkeligt til at udelukke brugen af dem.
English: The first area of disagreement regards the proposal to adapt the posology for the higher dose strengths emphasizing that when a direct switch is made this should only be done in those patients who are on valsartan monotherapy.
Danish: Det første område, hvor der findes uoverensstemmelser, omhandler forslaget om at tilpasse doseringsanvisningen for de højere dosisstyrker, så der lægges vægt på, at der kun bør skiftes direkte, når det drejer sig om patienter, som får valsartan monoterapi.
English: Diovan Comp should not be used to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, since blood urea and serum creatinine may increase in such patients.
Danish: Diovan Comp bør ikke anvendes til behandling af hypertension hos patienter med unilateral eller bilateral nyrearteriestenose eller stenose i arterien til en enkelt nyre, da blodurea og serumkreatinin kan øges hos sådanne patienter.
English: • medicines to treat cancer, such as methotrexate or cyclophosphamide
Danish: • medicin mod kræft, såsom methotrexat eller cyclophosphamid
English: Since a proportion of patients might achieve blood pressure control by only increasing one of the components, and considering a safety issue, with regards to ADR allowing dose titration with both components, the CHMP recommended the titration of only one component at the same time.
Danish: Da en del patienter vil kunne opnå blodtrykskontrol ved kun at øge dosis af den ene komponent og set i lyset af sikkerheden i forbindelse med bivirkninger, der tillader dosistitrering med begge komponenter, anbefalede CHMP titreringen med kun den ene komponent ad gangen.
English: Diovan Comp is used to treat high blood pressure which is not adequately controlled by a single substance alone.
Danish: Diovan Comp bruges til behandling af forhøjet blodtryk, som ikke kontrolleres tilstrækkeligt af et enkelt stof alene.
English: Therefore the use of Diovan Comp during breast feeding is not recommended.
Danish: Anvendelse af Diovan Comp under amning anbefales derfor ikke.
English: The combination of valsartan/HCTZ was generally well-tolerated and the adverse event and adverse drug reaction profiles were consistent with the pharmaceutical class.
Danish: Kombinationen valsartan/HCTZ var generelt veltolereret, og bivirkningsprofilerne stemte overens med lægemiddeltypen.
English: The use of Diovan Comp in patients with severe chronic heart failure has not been established.
Danish: Brugen af Diovan Comp til patienter med alvorlig kronisk hjertesvigt er ikke klarlagt.
English: Concomitant administration with food has been reported to both increase and decrease the systemic availability of hydrochlorothiazide compared with the fasted state.
Danish: Det er blevet rapporteret, at samtidig indtagelse af mad både øger og reducerer hydrochlorthiazids systemiske tilgængelighed sammenlignet med den fastende tilstand.
English: Belgium N.V. Novartis Pharma S.A. Medialaan 40, bus 1
Danish: Novartis Pharma S.A. Medialaan 40, bus 1
English: Thiazide-induced hypokalaemia or hypomagnesaemia may occur as unwanted effects favouring the onset of digitalis-induced cardiac arrhythmias.
Danish: Thiazidinduceret hypokaliæmi eller hypomagnesiæmi kan forekomme som uønskede virkninger, der favoriserer indtræden af digitalisinducerede hjertearytmier.
English: • medicines to increase blood sugar levels, such as diazoxide
Danish: • medicin, der skal øge blodsukkeret, såsom diazoxid
English: Frequent monitoring of serum potassium is recommended.
Danish: Hyppig monitorering af serumkalium anbefales.
English: Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Inhibitors (AIIRAs), similar risks may exist for this class of drugs.
Danish: Der er ingen kontrollerede epidemiologiske data angående risikoen ved brug af angiotensin-II antagonister, men lignende risici kan eksistere for denne gruppe af lægemidler.
English: The above mentioned effects appear to be due to the pharmacological effects of high valsartan doses (blockade of angiotensin II-induced inhibition of renin release, with stimulation of the reninproducing cells) and also occur with ACE inhibitors.
Danish: Ovennævnte virkninger skyldes tilsyneladende de farmakologiske effekter af høje doser valsartan (blokering af den angiotensin II-inducerede hæmning af reninfrigivelsen med stimulering af de reninproducerende celler) og forekommer også med ACE-hæmmere.
English: The distribution and elimination kinetics have generally been described by a bi-exponential decay function.
Danish: Distributions- og eliminationskinetikken er generelt blevet beskrevet ved tokompartments henfaldsfunktion.
English: Digoxin and indomethacin could interact with the hydrochlorothiazide component of Diovan Comp (see interactions related to hydrochlorothiazide).
Danish: Digoxin og indomethacin kan muligvis interagere med hydrochlortiazidkomponenten af Diovan Comp (se interaktioner relateret til hydrochlortiazid).
English: Constipation, gastrointestinal discomfort
Danish: Forstoppelse, gastrointestinalt ubehag
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Danish: Hvis kombinationen viser sig nødvendig, anbefales omhyggelig monitorering af serumlithium.
English: In case of diuretic-induced dehydration, there is an increased risk of acute renal failure, especially with high doses of the iodine product.
Danish: I tilfælde af diuretikuminduceret dehydrering er der en øget risiko for akut nyresvigt, særlig ved høje doser af iodpræparater.
English: The absorption of hydrochlorothiazide, after an oral dose, is rapid (tmax about 2 h), with similar absorption characteristics for both suspension and tablet formulations.
Danish: Efter en oral dosis er absorptionen af hydrochlorthiazid hurtig (tmax omkring 2 t) med lignende absorptionskarakteristika for både suspensions- og tabletformulering.
English: The efficacy of valsartan/HCTZ was maintained long-term (1-3 yrs) with no significant adverse events being observed compared to short-term therapy.
Danish: Effektiviteten af valsartan/HCTZ opretholdtes ved langtidsbehandling (et til tre år) uden observation af signifikante bivirkninger i forhold til korttidsbehandling.
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 flere 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: • if you are more than 3 months pregnant (it is also better to avoid Diovan Comp in early pregnancy - see pregnancy section).
Danish: • hvis du er mere end 3 måneder henne i graviditeten (det er også bedre at undgå Diovan
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: Following oral administration of valsartan alone, peak plasma concentrations of valsartan are reached in 2-4 hours.
Danish: Efter oral administration af valsartan alene nås maksimale plasmakoncentrationer af valsartan efter 24 timer.
English: Dose adjustment of the antidiabetic medicinal product may be necessary.
Danish: Dosisjustering af antidiabetika kan være nødvendig.
English: The potential toxicity of the valsartan - hydrochlorothiazide combination after oral administration was investigated in rats and marmosets in studies lasting up to six months.
Danish: Den potentielle toksicitet af kombinationen valsartan og hydrochlorthiazid efter oral administration er blevet undersøgt hos rotter og silkeaber i forsøg på op til seks måneders varighed.
English: Respiratory distress including pneumonitis and pulmonary oedema
Danish: Åndedrætsbesvær, herunder pneumonitis og lungeødem
English: As expected for a compound which is cleared almost exclusively via the kidneys, renal function has a marked effect on the kinetics of hydrochlorothiazide (see section 4.3).
Danish: Som forventet af en forbindelse, der udskilles næsten udelukkende via nyrerne, har nyrefunktionen en markant virkning på hydrochlorthiazids kinetik (se pkt.
English: • You must tell your doctor if you think that you are (or might become) pregnant Your doctor will normally advise you to stop taking Diovan Comp before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Diovan Comp. Diovan Comp is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy.
Danish: Normalt vil din læge råde dig til at stoppe med at tage Diovan Comp, før du bliver gravid, eller så snart du ved, at du er gravid, og råde dig til at tage anden medicin i stedet for Diovan Comp. Diovan Comp frarådes i den tidlige periode af graviditeten, og du må ikke tage det, hvis du er mere end 3 måneder henne i graviditeten, da det kan forårsage alvorlig skade på dit barn, hvis det bruges efter graviditetens tredje måned.
English: Beneficial effects of valsartan in combination with hydrochlorothiazide on cardiovascular mortality and morbidity are currently unknown.
Danish: Den gavnlige virkning af valsartan i kombination med hydrochlorthiazid på kardiovaskulær mortalitet og morbiditet er ikke kendt i øjeblikket.
English: To support this evidence two studies were submitted: the Placebo-controlled studies and the non-Responder to Valsartan Monotherapy Trials.
Danish: To undersøgelser blev indgivet for at understøtte disse data: de placebokontrollerede undersøgelser og undersøgelserne med patienter, der ikke responderede på valsartan monoterapi.
English: Patients with severe chronic heart failure or other conditions with stimulation of the reninangiotensin-aldosterone-system
Danish: Patienter med alvorlig kronisk hjertesvigt eller andre lidelser med stimulation af renin-angiotensinaldosteron-systemet.
English: Overdose with valsartan may result in marked hypotension, which could lead to depressed level of consciousness, circulatory collapse and/or shock.
Danish: Overdosering med valsartan kan resultere i udtalt hypotension, som kan føre til nedsat bevidsthedsniveau, kredsløbskollaps og/eller shock.
English: Considering that valsartan should not be administered in patients with severe hepatic impairment, biliary cirrhosis and cholestasis, the CHMP recommended to incorporate cross-references to sections 4.3, 4.4 and 5.2.
Danish: Da valsartan ikke bør gives til patienter med stærkt nedsat leverfunktion, biliær cirrhose og kolestase, anbefalede CHMP, at der bliver indarbejdet krydshenvisninger i afsnit 4.3, 4.4 og 5.2.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt { MM/ÅÅÅÅ } [Udfyldes nationalt]
English: The CHMP adopted the following: “The recommended dose of Diovan Comp X mg/Y mg is one film-coated tablet once daily.
Danish: CHMP vedtog følgende: "Den anbefalede dosis for Diovan Comp X mg/Y mg er én filmovertrukken tablet én gang dagligt.
English: Non-steroidal anti-inflammatory medicines (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid >3 g/day), and non-selective NSAIDs NSAIDS can attenuate the antihypertensive effect of both angiotensin II antagonists and hydrochlorothiazide when administered simultaneously.
Danish: Non-steroide anti-inflammatoriske lægemidler (NSAID), herunder selektive COX-2-hæmmere, acetylsalicylsyre >3 g/dag og ikke-selektive NSAID NSAID kan svække den antihypertensive effekt af både angiotensin II-antagonister og hydrochlorthiazid, når de administreres samtidig.
English: Valsartan is an orally active and specific angiotensin II (Ang II) receptor antagonist.
Danish: Valsartan er en oralt aktiv og specifik angiotensin II-receptorantagonist.
English: Due to the risk of hypokalaemia, hydrochlorothiazide should be administered with caution when associated with medicinal products that could induce torsades de pointes.
Danish: På grund af risikoen for hypokalæmi bør hydrochlortiazid gives med forsigtighed, når det administreres sammen med lægemidler, der kan fremkalde torsades de pointes.
English: Periodic monitoring of serum potassium, creatinine and uric acid levels is recommended when Diovan Comp is used in patients with renal impairment.
Danish: Periodisk monitorering af serumkalium, serumkreatinin og serumurinsyre anbefales, når Diovan Comp anvendes til patienter med nedsat nyrefunktion.
English: Pharmacotherapeutic group: Angiotensin II antagonists and diuretics, valsartan and diuretics; ATC code: C09D A03.
Danish: Farmakoterapeutisk klassifikation: Angiotensin II-antagonister og diuretika, valsartan og diuretika, ATC-kode: C09DA03
English: Concomitant use requiring caution
Danish: Forsigtighed er påkrævet ved samtidig brug
English: Section 4.6 - Pregnancy and Lactation
Danish: Afsnit 4.6 - Graviditet og amning
English: The valsartan - hydrochlorothiazide combination was not tested for mutagenicity, chromosomal breakage or carcinogenicity, since there is no evidence of interaction between the two substances.
Danish: Kombinationen valsartan-hydrochlorthiazid er ikke blevet testet for mutagenicitet, kromosombrydning eller carcinogenicitet, da der ikke er evidens for interaktioner mellem de to stoffer.
English: In addition, the following signs and symptoms may occur due to an overdose of the hydrochlorothiazide component: nausea, somnolence, hypovolaemia, and electrolyte disturbances associated with cardiac arrhythmias and muscle spasms.
Danish: Derudover kan følgende tegn og symptomer forekomme som følge af overdosis af hydrochlorthiazid: kvalme, døsighed, hypovolæmi og elektrolytforstyrrelser forbundet med hjertearytmier og muskelkramper.
English: Adverse reactions known to occur with each component given individually but which have not been seen in clinical trials may occur during treatment with valsartan/hydrochlorothiazide.
Danish: Bivirkninger, der vides at forekomme, når hver af komponenterne gives enkeltvis, men som ikke er set i kliniske forsøg, kan forekomme under behandling med valsartan/hydrochlorthiazid.
English: You must tell your doctor if you think you are (or might become) pregnant.
Danish: Du skal fortælle det til din læge, hvis du tror, du er (eller planlægger at blive) gravid.
English: National Road No. 1 12th Km Metamorphosis GR-144 51
Danish: National Road No. 1 12th Km Metamorphosis
English: In hypertensive patients with type 2 diabetes and microalbuminuria, valsartan has been shown to reduce the urinary excretion of albumin.
Danish: Hos hypertensive patienter med type 2 diabetes og mikroalbuminuri er det vist, at valsartan reducerer udskillelse af albumin i urinen.
English: mizolastin, pentamidine, sparfloxacine, terfenadine, vincamine i.v.)
Danish: mizolastin, pentamidin, sparfloxacin, terfenadin, vincamin i.v.)
English: Valsartan works by blocking the effect of angiotensin II.
Danish: Valsartan hæmmer virkningen af angiotensin-II.
English: In most patients, after administration of a single oral dose, onset of antihypertensive activity occurs within 2 hours, and the peak reduction of blood pressure is achieved within 4-6 hours.
Danish: Efter oral indtagelse af en enkelt dosis, sætter den antihypertensive effekt hos de fleste patienter ind i løbet af 2 timer, og den maksimale reduktion af blodtrykket opnås i løbet af 4-6 timer.
English: Based on the pharmacological mechanism of action of hydrochlorothiazide its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.
Danish: Baseret på hydrochlorthiazids farmakologiske virkningsmekanisme kan brugen i andet og tredje trimester kompromittere den føtoplacentale perfusion og forårsage føtale og neonatale effekter, såsom icterus, forstyrrelse i elektrolytbalancen og trombocytopeni.
English: Valsartan is an orally active angiotensin II receptor blocker (ARB) and hydrochlorothiazide (HCTZ) is a diuretic.
Danish: Valsartan er en oralt aktiv angiotensin IIreceptorblokker (ARB), og hydrochlorotiazid (HCTZ) er et diuretikum.
English: It has been shown that there is a high-affinity receptor in the renal cortex as the primary binding site for the thiazide diuretic action and inhibition of NaCl transport in the distal convoluted tubule.
Danish: Det er blevet påvist, at der er en højaffinitetsreceptor i cortex renalis som det primære bindingssted for den thiaziddiuretiske virkning og hæmning af NaCl-transport i tubulus contortus distalis.
English: However, these tests were performed separately with valsartan and hydrochlorothiazide, and produced no evidence of mutagenicity, chromosomal breakage or carcinogenicity.
Danish: Disse test er imidlertid blevet udført separat for valsartan og hydrochlorthiazid, og det gav ingen evidens for mutagenicitet, kromosombrydning eller carcinogenicitet.
English: Administration of valsartan to patients with hypertension results in reduction of blood pressure without affecting pulse rate.
Danish: Når valsartan administreres til hypertensive patienter, sker der en reduktion af blodtrykket uden påvirkning af pulsen.
English: Important information about some of the ingredients of Diovan Comp [To be completed nationally]
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Diovan Comp [Udfyldes nationalt]
English: Calcium excretion is decreased by thiazide diuretics.
Danish: Calciumudskillelsen nedsættes af thiaziddiuretika.
English: Interactions related to valsartan
Danish: Interaktioner relateret til valsartan
English: In a pharmacokinetics trial in patients with mild (n=6) to moderate (n=5) hepatic dysfunction, exposure to valsartan was increased approximately 2-fold compared with healthy volunteers.
Danish: I farmakokinetiske forsøg omfattende patienter med let (n=6) til moderat (n=5) leverinsufficiens var eksponeringen for valsartan omtrent fordoblet sammenlignet med raske frivillige.
English: Food decreases exposure (as measured by AUC) to valsartan by about 40% and peak plasma concentration (Cmax) by about 50%, although from about 8 h post dosing plasma valsartan concentrations are similar for the fed and fasted groups.
Danish: Føde reducerer eksponeringen (målt ved AUC) for valsartan med cirka 40 %, og den maksimale plasmakoncentration (Cmax) med cirka 50 %, selv om valsartankoncentrationen i plasma fra cirka 8 timer efter doseringen er ens for gruppen med føde og en fastende gruppe.
English: No studies on the effect of Diovan Comp on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner med Diovan Comp.
English: Regarding the Sodium and/or volume-depleted patients, the CHMP agreed to delete the last sentence of this paragraph considering this was textbook knowledge: “Warning signs of fluid or electrolyte imbalance are dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular weakness, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea or vomiting”
Danish: I forbindelse med natrium- og/eller volumendepleterede patienter besluttede CHMP at slette den sidste sætning i dette afsnit, da dette skønnedes at være alment tilgængelig viden: "Symptomerne på væske- eller elektrolytforstyrrelser er tørhed i munden, tørst, svækkelse, letargi, sløvhed, rastløshed, muskelsmerter eller -kramper, muskelsvaghed, hypotension, oligouri, takykardi og mave-tarmforstyrrelser såsom kvalme eller opkastning".
English: The CHMP considered mentioning in this section a text on transporter proteins involved in uptake and elimination of valsartan and hydrochlorothiazide.
Danish: CHMP overvejede at medtage et stykke tekst om transportproteiner involveret i optagelsen og elimineringen af valsartan og hydrochlorothiazid under dette afsnit.
English: • Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists”, which help to control high blood pressure.
Danish: • Valsartan tilhører en gruppe medicin, der kaldes ”angiotensin-II-hæmmere”, der hjælper med at sænke forhøjet blodtryk.
English: Intrahepatic cholestasis or jaundice
Danish: Intrahepatisk kolestase eller gulsot
English: Marked hypercalcaemia may be evidence of underlying hyperparathyroidism.
Danish: Markant hypercalcæmi kan være tegn på underliggende hyperparatyroidisme.
English: In each case, up-titration of individual components to the next dose should be followed in order to reduce the risk of hypotension and other adverse events.
Danish: I de enkelte tilfælde bør optitrering af individuelle komponenter til den næste dosis følges for at mindske risikoen for hypotension og andre bivirkninger.
English: In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been associated with oliguria and/or progressive azotaemia, and in rare cases with acute renal failure.
Danish: Hos patienter, hvis nyrefunktion kan afhænge af aktiviteten af renin-angiotensin-aldosteron-systemet (f.eks. patienter med alvorlig kongestiv hjertesvigt), er behandling med ACE-hæmmere blevet relateret til oliguri og/eller progressiv azotæmi og i sjældne tilfælde til akut nyresvigt.
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see also section 4.3 and 4.4).
Danish: Spædbørn, hvis mødre har taget AIIA skal observeres tæt for hypotension (se pkt.
English: Section 4.4 - Special Warnings and Precautions for Use
Danish: Afsnit 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen