FrancophonIA/ELRC3.0 huggingface dataset:
English: According to “Guideline on SPCs”, the CHMP placed ADR syncope in the frequency category “not known”.
Danish: I henhold til retningslinjen vedrørende produktresuméer kategoriserede CHMP bivirkningen synkope under frekvenskategorien "ikke kendt".
English: If no relevant additional effect is seen with Diovan Comp 320 mg/25 mg after 8 weeks, treatment with an additional or alternative antihypertensive medicinal product should be considered (see section 5.1).
Danish: Hvis der ikke ses nogen relevant supplerende effekt med Diovan Comp 320 mg/25 mg efter 8 uger, skal behandling med et supplerende eller alternativt antihypertensivt lægemiddel overvejes (se pkt.
English: • medicines that affect or can be affected by potassium blood levels, such as digoxin, a medicine to control the heart rhythm, some antipsychotic medicines
Danish: • medicin, der kan påvirke eller blive påvirket af blodets kaliumindhold, såsom digoxin, et lægemiddel der kontrollerer hjerterytmen, visse antipsykotiske lægemidler
English: The mode of action of thiazides is through inhibition of the Na+Cl- symporter perhaps by competing for the Cl- site, thereby affecting electrolyte reabsorption mechanisms:directly increasing sodium and chloride excretion to an approximately equal extent, and indirectly by this diuretic action reducing plasma volume, with consequent increases in plasma renin activity, aldosterone secretion and urinary potassium loss, and a decrease in serum potassium.
Danish: Thiaziders virkningsmåde er gennem hæmning af Na+Cl- symporteren, måske ved at konkurrere om C1--sitet, hvorved elektrolytresorptionsmekanismerne påvirkes: direkte øgning af natrium- og chloridudskillelsen i omtrent samme omfang, og indirekte, gennem denne diuretiske virkning, reduktion af plasmavolumenet med deraf følgende stigninger i plasmareninaktivitet, aldosteronudskillelse og kaliumtab i urin samt en reduktion i serumkalium.
English: Regarding the concomitant use of alcohol during administration of Diovan Comp, the statement potentiation of orthostatic hypotension may occur was discussed.
Danish: I forbindelse med indtagelse af alkohol under brugen af Diovan Comp blev udtalelsen øget ortostatisk hypotension kan forekomme drøftet.
English: Valsartan is not known to bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Danish: Så vidt vides bindes valsartan ikke til eller blokerer andre hormonreceptorer eller ionkanaler, der vides at være vigtige for den kardiovaskulære regulering.
English: Side effects reported with valsartan or hydrochlorothiazide alone, but not observed with Diovan Comp:
Danish: Bivirkninger, der er set med valsartan eller hydrochlorthiazid alene, men ikke med Diovan Comp:
English: Adverse reactions reported in clinical trials and laboratory findings occurring more frequently with valsartan plus hydrochlorothiazide versus placebo and individual postmarketing reports are presented below according to system organ class.
Danish: Bivirkninger, som er rapporteret fra kliniske forsøg og laboratoriefund, og som forekommer hyppigere med valsartan plus hydrochlorthiazid versus placebo, samt individuelle rapporter, der er fremkommet efter markedsføring, er angivet nedenfor ifølge systemorganklassesystemet.
English: A number of areas of disharmony in the product information for Diovan have been considered by the CHMP.
Danish: CHMP har overvejet en række områder, hvor der fandtes uoverensstemmelser i produktinformationen for Diovan.
English: The antihypertensive effect is substantially present within 2 weeks.
Danish: Der ses en betydelig antihypertensiv effekt inden for 2 uger.
English: • if you have fever, rash and joint pain, which may be signs of systemic lupus erythematosus
Danish: • hvis du har feber, udslæt og ledsmerter, hvilket kan være tegn på systemisk lupus erythematosus (SLE, en såkaldt autoimmun sygdom).
English: Patients receiving hydrochlorothiazide concomitantly with carbamazepine may develop hyponatremia.
Danish: Patienter, der får hydrochlorthiazid samtidig med carbamazepin, kan udvikle hyponatriæmi.
English: Furthermore, concomitant use of Diovan Comp and NSAIDs may lead to worsening of renal function and an increase in serum potassium.
Danish: Ydermere kan samtidig brug af Diovan Comp og NSAID føre til forværring af nyrefunktionen og forhøjelse af serumkalium.
English: Alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Danish: Alternativ behandling med en bedre etableret sikkerhedsprofil bør foretrækkes i ammeperioden, især ved amning af neonatale eller spædbørn født før termin.
English: In order to evaluate a possible removal of the current restriction the CHMP assessed efficacy and safety data from a sub-group analyses in patients with baseline MSDBP < 100 mmHg and MSDBP ≥100 mmHg.
Danish: For at kunne bedømme en mulig ophævelse af den nuværende begrænsning vurderede CHMP data om sikkerhed og effekt fra en undergruppeanalyse af patienter med baseline gennemsnitligt diastolisk blodtryk i siddende stilling på < 100 mmHg og > 100 mmHg.
English: In drug interaction studies with valsartan, no interactions of clinical significance have been found with valsartan or any of the following substances: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, glibenclamide.
Danish: I lægemiddelinteraktionsstudier med valsartan er der ikke fundet klinisk signifikante interaktioner med nogen af de følgende stoffer: cimetidin, warfarin, furosemid, digoxin, atenolol, indomethacin,
English: cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol)
Danish: cyamemazin, sulpirid, sultoprid, amisulprid, tiaprid, pimozid, haloperidol, droperidol)
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: [Se bilag I - Udfyldes nationalt]
English: The CHMP, noting that the treatment effects in patients with the higher baseline blood pressure were greater, concluded that a restriction of the use of valsartan/HCTZ 160/25 and 320/25 mg to patients with severely elevated blood pressure is not anymore warranted.
Danish: CHMP bemærkede, at effekten af behandlingen var større hos patienter med det høje baseline blodtryk og konkluderede, at en begrænsning i brugen af valsartan/HCTZ 160/25 og 320/25 mg til patienter med svært forhøjet blodtryk ikke længere er påkrævet.
English: Denmark Novartis Healthcare A/S Lyngbyvej 172
Danish: Danmark Novartis Healthcare A/S Lyngbyvej 172
English: A somewhat higher systemic exposure to valsartan was observed in some elderly subjects than in young subjects; however, this has not been shown to have any clinical significance.
Danish: Hos nogle ældre patienter blev der observeret en noget højere plasmakoncentration af valsartan end hos yngre patienter, men det er ikke vist at have nogen klinisk signifikans.
English: Hepatic disease does not significantly affect the pharmacokinetics of hydrochlorothiazide.
Danish: Leversygdom har ingen signifikant indflydelse på hydrochlorthiazids farmakokinetik.
English: Gran Via de les Corts Catalanes, 764 E-08013 Barcelona
Danish: Spanien Novartis Farmacéutica S.A. Gran Via de les Corts Catalanes, 764 E-08013 Barcelona
English: The toxicological target organ was the kidney, the reaction being more marked in the marmoset than the rat.
Danish: Det toksikologiske målorgan var nyren, og reaktionen var mere markant hos silkeaber end hos rotter.
English: High blood pressure increases the workload of the heart and arteries.
Danish: Forhøjet blodtryk øger belastningen af hjertet og blodkarrene.
English: Also, should be taken into account the overall favourable benefit/risk profile of the valsartan/HCTZ 160/25 and 320/25 mg.
Danish: Det generelt gunstige risk/benefit-forhold for valsartan/HCTZ 160/25 og 320/25 mg bør også tages med i betragtningerne.
English: − Refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia.
Danish: - Refraktorisk hypokaliæmi, hyponatriæmi, hypercalcæmi og symptomatisk hyperurikæmi.
English: These medicinal products may potentiate the effect of hydrochlorothiazide on serum potassium (see section 4.4).
Danish: Disse lægemidler kan forstærke hydrochlorthiazids effekt på serumkalium (se pkt.
English: The changes produced by the combination in the chronic toxicity studies are most likely to have been caused by the valsartan component.
Danish: De ændringer, som kombinationspræparatet fremkaldte i toksicitetsforsøgene, skyldtes højst sandsynligt valsartan.
English: Hence it cannot be excluded that because of the inhibition of the renin-angiotensin-aldosterone system the application of Diovan Comp as well may be associated with impairment of the renal function.
Danish: Det kan derfor ikke udelukkes, at anvendelse af Diovan Comp, pga. hæmning af renin-angiotensinaldosteron-systemet, også kan være forbundet med nedsættelse af nyrefunktionen.
English: Regarding Hepatic impairment the majority of valsartan is eliminated, mainly as unchanged drug in the bile, by hepatic clearance.
Danish: Med hensyn til leverinsufficiens elimineres størstedelen af valsartan, hovedsageligt som uforandret lægemiddel i galden via leverclearance.
English: The AIIR (angiotensin II receptor) antagonists should not be contraindicated during breast-feeding.
Danish: AIIR (angiotensin II-receptor) antagonister bør ikke kontraindiceres under amning.
English: The site of action of thiazide diuretics is primarily in the renal distal convoluted tubule.
Danish: Thiaziddiuretikas virkningssted er primært i tubulus contortus distalis.
English: The data from the 2 factorial and 6 non-responders phase III clinical trials, demonstrate that valsartan administered in combination with HCTZ is effective in reducing BP in patients with essential hypertension without any added concern for safety and tolerability.
Danish: Data fra to faktorielle og seks fase III kliniske undersøgelser med ikkeresponderende patienter viser, at valsartan givet i kombination med HCTZ effektivt reducerer blodtrykket hos patienter med essentiel hypertension, uden at det giver anledning til yderligere betænkeligheder i forhold til sikkerhed og tolerabilitet.
English: If you take more Diovan Comp than you should 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 have diarrhoea or severe vomiting.
Danish: • hvis du har diarré eller voldsom opkastning.
English: Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: If hypotension occurs, the patient should be placed in the supine position and salt and volume supplementation should be given rapidly.
Danish: Ved hypotension skal patienten lægges på ryggen, og der bør hurtigt gives salt- og væskesupplement.
English: FURTHER INFORMATION What Diovan Comp contains [To be completed nationally]
Danish: YDERLIGERE OPLYSNINGER Diovan Comp indeholder [Udfyldes nationalt]
English: Diovan Comp film-coated tablets contain two active substances called valsartan and hydrochlorothiazide.
Danish: Diovan Comp filmovertrukne tabletter indeholder to aktive stoffer, der kaldes valsartan og hydrochlorthiazid.
English: In patients with mild to moderate hepatic impairment without cholestasis the dose of valsartan should not exceed 80 mg (see section 4.4).
Danish: Hos patienter med let til moderat leverinsufficiens uden kolestase bør dosis af valsartan ikke overskride 80 mg (se pkt.
English: There have been isolated reports of haemolytic anaemia in patients receiving concomitant treatment with methyldopa and hydrochlorothiazide.
Danish: Der har været isolerede rapporter om hæmolytisk anæmi hos patienter, der fik samtidig behandling med methyldopa og hydrochlorthiazid.
English: Beta blockers and diazoxide
Danish: Betablokkere og diazoxid
English: Valsartan does not inhibit ACE, also known as kininase II, which converts Ang I to Ang II and degrades bradykinin.
Danish: Valsartan hæmmer ikke ACE (også kendt som kininase II), som omdanner angiotensin I til angiotensin II og nedbryder bradykinin.
English: − Severe renal impairment (creatinine clearance <30 ml/min), anuria.
Danish: - Stærkt nedsat nyrefunktion (kreatininclearance <30 ml/min), anuri.
English: Medicinal products used in the treatment of gout (probenecid, sulfinpyrazone and allopurinol) Dose adjustment of uricosuric medications may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Danish: Lægemidler, der anvendes til behandling af arthritis urica (probenecid, sulfinpyrazon og allopurinol) Dosisjustering af lægemidler mod urinsyregigt kan være nødvendig, da hydrochlorthiazid kan øge niveauet af serumurinsyre.
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Danish: Epidemiologiske data vedrørende risikoen for teratogenicitet efter eksponering for ACE-hæmmere i graviditetens første trimester er ikke entydige.
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, hyperkalaemia) (see also section 5.3).
Danish: Eksponering for behandling med AIIA i andet og tredje trimester er kendt for at medføre human føtotoksicitet (nedsat nyrefunktion, oligohydramnion, forsinket kranieossifikation) og neonatal toksicitet (nyresvigt, hypotension, hyperkaliæmi) (se også pkt.
English: During repeated dosing, the maximum reduction in blood pressure with any dose is generally attained within 24 weeks and is sustained during long-term therapy.
Danish: Ved gentagen dosering opnås den maksimale blodtryksnedsættelse, uanset dosis, som regel inden for 2-4 uger, og den opretholdes under langvarige behandlingsforløb.
English: Aortic and mitral valve stenosis, hypertrophic obstructive 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, hypertrofisk obstruktiv kardiomyopati Som ved andre vasodilatatorer bør der udvises særlig forsigtighed over for patienter med aorta- eller mitralklapstenose eller hypertrofisk obstruktiv kardiomyopati (HOCM).
English: Reduction in serum potassium occurred more frequently in patients given 25 mg hydrochlorothiazide than in those given 12.5 mg hydrochlorothiazide.
Danish: Nedsat serumkalium forekom hyppigere hos patienter, der fik 25 mg hydrochlorthiazid end hos dem, der fik 12,5 mg hydrochlorthiazid.
English: No information is available regarding the use of valsartan during breastfeeding.
Danish: Der foreligger ikke tilgængelig dokumentation vedrørende brug af valsartan under amning.
English: Hydrochlorothiazide increases urine output, which also lowers blood pressure.
Danish: Hydrochlorthiazid øger urinmængden, som udskilles, hvilket ligeledes sænker blodtrykket.
English: Thiazides may reduce urinary calcium excretion and cause an intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism.
Danish: Thiazider kan nedsætte calciumudskillelsen i urin og forårsage en tilbagevendende og let stigning i serumcalcium uden tilstedeværelse af kendte calciummetabolismesygdomme.
English: The renin-aldosterone link is mediated by angiotensin II, so with co-administration of valsartan the reduction in serum potassium is less pronounced as observed under monotherapy with hydrochlorothiazide.
Danish: Renin-aldosteron-koblingen medieres af angiotensin II, så reduktionen i serumkalium er mindre udtalt ved samtidig administration af valsartan end den observeret ved monoterapi med hydrochlorthiazid.
English: In controlled clinical trials with valsartan/hydrochlorothiazide the potassium lowering effect of hydrochlorothiazide was attenuated by the potassium-sparing effect of valsartan.
Danish: I kontrollerede kliniske forsøg med valsartan/hydrochlorthiazid blev hydrochlorthiazids kaliumsænkende virkning svækket af valsartans kaliumbesparende virkning.
English: The CHMP finding a little rationale to support this proposal of switch from HCTZ monotherapy to a combination therapy containing 160 or 320 mg of valsartan, found preferable a step-wise dose titration.
Danish: CHMP fandt et lille rationale for at understøtte skiftet fra HCTZ monoterapi til en kombinationsterapi bestående af 160 eller 320 mg valsartan, og anbefalede en trinvis dosistitrering.
English: Regarding the highest dose only, the CHMP agreed the following: “If no relevant additional effect is seen with Diovan Comp 320 mg/25 mg after 8 weeks, treatment with an additional or alternative antihypertensive medicinal product should be considered (see section 5.1)”.
Danish: I forbindelse med den højeste dosis besluttede CHMP følgende: "Hvis der ikke ses nogen yderligere relevant effekt af Diovan Comp 320 mg/25 mg efter otte uger, bør det overvejes, om behandling med et yderligere eller et alternativt antihypertensivt lægemiddel skal iværksættes (se afsnit 5.1)".
English: In rats, maternally toxic doses of valsartan (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 (pinnaløsning og åbning af øregang) hos ungerne (se pkt.
English: The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents, apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Danish: Antikolinerge midler kan øge biotilgængeligheden af diuretika af thiazidtypen, tilsyneladende ved at reducere den gastrointestinale motilitet og mavetømningshastigheden.
English: • Others (e.g. bepridil, cisapride, diphemanil, erythromycin i.v., halofantrin, ketanserin,
Danish: • Andre (f.eks. bepridil, cisaprid, diphemanil, erythromycin i.v., halofantrin, ketanserin,
English: • medicines that may reduce the amount of potassium in your blood, such as corticosteroids, some laxatives
Danish: • medicin, der kan mindske mængden af kalium i dit blod, såsom kortikosteroider, visse afføringsmidler
English: Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive 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 under graviditet.
English: Valsartan shows multiexponential decay kinetics (t½α <1 h and t½ß about 9 h).
Danish: Valsartan udviser tokompartment halveringskinetik (t½α <1 time og t½ß omkring 9 timer).
English: Diovan Comp contains valsartan and hydroclortiazide.
Danish: Diovan Comp indeholder valsartan og hydrochlorotiazid.
English: The clinical response to Diovan Comp should be evaluated after initiating therapy and if blood pressure remains uncontrolled, the dose may be increased by increasing either one of the components to a maximum dose of Diovan Comp 320 mg/25 mg.
Danish: Det kliniske respons på Diovan Comp skal evalueres, når behandlingen er påbegyndt, og hvis blodtrykket forbliver ukontrolleret, kan dosis øges ved at øge enten den ene eller den anden komponent til en maksimal dosis af Diovan Comp på 320 mg/25 mg.
English: • muscle relaxing medicines, such as tubocurarine
Danish: • muskelafslappende midler, såsom tubocurarin
English: The difference in BP reductions between the 160/25 mg and 160/12.5 mg doses also reached statistical significance.
Danish: Forskellen i blodtryksreduktion mellem doserne 160/25 mg og 160/12,5 mg opnåede også statistisk signifikans.
English: The renal clearance is composed of passive filtration and active secretion into the renal tubule.
Danish: Renal clearance består af passiv filtration og aktiv udskillelse i de renale tubuli.
English: At the recommended dose of Diovan Comp no dose adjustment is required for patients with a creatinine clearance of 30-70 ml/min.
Danish: Ved den anbefalede dosis af Diovan Comp er dosisjustering ikke nødvendig for patienter med kreatininclearance på 30-70 ml/min.
English: The second issue raised in the LoOI was about the step titration.
Danish: Det andet spørgsmål på listen med uafklarede spørgsmål drejede sig om dosistitrering.
English: As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Danish: Som for alle patienter, der er i diuretikabehandling, skal der foretages bestemmelse af serumelektrolytter med passende intervaller.
English: • Class III antiarrhythmics (e.g. amiodarone, sotalol, dofetilide, ibutilide)
Danish: • Klasse III antiarytmika (f.eks. amiodaron, sotalol, dofetilid, ibutilid)
English: Dose-dependent decreases in serum potassium occurred in controlled clinical studies with valsartan + hydrochlorothiazide.
Danish: Dosisafhængige fald i serumkalium forekom i kontrollerede kliniske forsøg med valsartan + hydrochlorthiazid.
English: • diuretics (water tablets), medicines for the treatment of gout, such as allopurinol, therapeutic vitamin D and calcium supplements, medicines for the treatment of diabetes (oral agents or insulins)
Danish: • diuretika (vanddrivende tabletter), medicin til behandling af urinsyregigt (podagra), såsom allopurinol, lægeordineret D-vitamin eller kalktilskud, medicin mod sukkersyge (midler, der synkes, eller insulin)
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: Serum uric acid increased, Serum bilirubin and Serum creatinine increased, Hypokalaemia, Hyponatraemia, Elevation of Blood Urea Nitrogen, Neutropenia
Danish: Forhøjet serumurinsyre, forhøjet serumbilirubin og serumkreatinin, hypokaliæmi, hyponatriæmi, forhøjet blodureanitrogen, neutropeni
English: In clinical trials where valsartan was compared with an ACE inhibitor, the incidence of dry cough was significantly (P <0.05) lower 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: • low level of white cells in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
Danish: • lavt antal hvide blodlegemer i blodet (med symptomer som feber, infektioner i huden, ondt i halsen eller mundsår pga. infektion, svaghed)
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately and, if appropriate, alternative therapy should be started.
Danish: Ved konstateret graviditet skal behandlingen med AIIA afbrydes med det samme, og om nødvendigt skal anden behandling påbegyndes.
English: − Severe hepatic impairment, biliary cirrhosis and cholestasis.
Danish: - Alvorlig leverinsufficiens, biliær cirrose og cholestasis.