FrancophonIA/ELRC3.0 huggingface dataset:
English: This has led to divergences among Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Danish: Dette har medført, at lægemidlet anvendes på forskellige måder i medlemsstaterne, sådan som det fremgår af forskellene i produktresuméerne, etiketteringen og indlægssedlerne i de lande, hvor lægemidlerne bliver markedsført.
English: For heart failure, the starting dose is 4 mg once a day, which can also be increased at intervals of at least two weeks up to a maximum of 32 mg once daily.
Danish: Startdosis ved hjerteinsufficiens er 4 mg én gang daglig, men dosis kan øges i intervaller på mindst to uger til maksimalt 32 mg én gang daglig.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Atacand in the European Union (EU).
Danish: EMA's Udvalg for Humanmedicinske Lægemidler (CHMP) har konkluderet, at der er behov for at harmonisere ordinationsoplysningerne for Atacand i Den Europæiske Union (EU).
English: By blocking the receptors to which angiotensin II normally attaches, candesartan cilexetil stops the hormone having an effect, allowing the blood vessels to widen.
Danish: Ved at blokere de receptorer, som angiotensin II normalt binder sig til, blokerer candesartan cilexetil virkningen af hormonet og gør det muligt for blodkarrene at udvide sig.
English: The active substance in Atacand, candesartan cilexetil, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Danish: Det aktive stof i Atacand, candesartan cilexetil, er en "angiotensin II-receptorantagonist", hvilket betyder, at det blokerer virkningen af et hormon i kroppen kaldet angiotensin II.
English: The Committee recommend that Atacand must not be used in patients who are hypersensitive (allergic) to candesartan cilexetil or to any of the ingredients.
Danish: Udvalget anbefalede, at Atacand ikke må anvendes hos patienter, som er overfølsomme (allergiske) over for candesartan cilexetil eller andre af indholdsstofferne i lægemidlet.
English: The Committee harmonised the warning on hyperkalaemia (high blood potassium levels) across all Member States' SmPCs.
Danish: Udvalget harmoniserede advarslen om hyperkaliæmi (forhøjet indhold af kalium i blodet) i alle medlemsstaters produktresumé.
English: It is also used to treat heart failure in adult patients with impaired left ventricular systolic function who are receiving treatment with ‘angiotensin converting enzyme (ACE) inhibitors' or who cannot be given ACE inhibitors.
Danish: Lægemidlet anvendes også til behandling af hjerteinsufficiens hos voksne patienter med systolisk dysfunktion i venstre ventrikel, som modtager behandling med "angiotensinkonverterende enzymhæmmere (ACE-hæmmere)", eller som ikke må behandles med ACE-hæmmere.
English: The recommended starting dose for treating hypertension is 8 mg once a day, which can be increased to a maximum of 32 mg once a day, depending on how the patient's blood pressure responds.
Danish: Dosis kan øges til maksimalt 32 mg én gang daglig, afhængig af hvordan patientens blodtryk responderer på behandlingen.
English: Atacand was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Det blev bestemt af den humanmedicinske koordineringsgruppe for gensidig anerkendelse og decentraliserede procedurer (CMD(h)), at Atacand skulle harmoniseres.
English: Company responses provided on: 8 October 2009, 12 February 2010 Opinion date:
Danish: 8. oktober 2009, 12. februar 2010
English: • heart failure and impaired left ventricular systolic function as ‘add-on' therapy to ACE inhibitors or when ACE inhibitors are not tolerated.
Danish: • hjerteinsufficiens og systolisk dysfunktion i venstre ventrikel som tillægsbehandling til ACE
English: EMEA/CHMP/169828/2010 rev.
Danish: Spørgsmål og svar vedrørende Atacand og relaterede navne (candesartan cilexetil 2 mg, 4 mg, 8 mg, 16 mg og 32 mg tabletter) EMEA/CHMP/169828/2010 rev.
English: The full EPAR for Darunavir Krka can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Darunavir Krka findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Darunavir Krka may be given to adults or children from 3 years of age and weighing at least 15 kg.
Danish: Darunavir Krka kan gives til voksne eller børn i alderen 3 år og opefter, som vejer mindst 15 kg.
English: This is a summary of the European public assessment report (EPAR) for Darunavir Krka.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Darunavir Krka.
English: As for every medicine, the company provided studies on the quality of Darunavir Krka.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Darunavir Krka.
English: This means that Darunavir Krka contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Prezista.
Danish: Det betyder, at Darunavir Krka indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Prezista.
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Prezista, and do not need to be repeated for Darunavir Krka.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i den godkendte anvendelse med referencelægemidlet, Prezista, og det er ikke nødvendigt at gentage disse med Darunavir Krka.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Darunavir Krka has been shown to have comparable quality and to be bioequivalent to Prezista.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Darunavir Krka er af sammenlignelig kvalitet og er bioækvivalent med Prezista.
English: What measures are being taken to ensure the safe and effective use of Darunavir Krka?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Darunavir Krka?
English: The Agency recommended that Darunavir Krka be approved for use in the EU.
Danish: Agenturet anbefalede, at Darunavir Krka godkendes til anvendelse i EU.
English: The medicine is always taken with low-dose ritonavir and with other HIV medicines, and should be taken with food.
Danish: Lægemidlet skal altid tages med lavdosis-ritonavir og andre lægemidler mod hiv, og det bør tages sammen med et måltid.
English: It is not intended to provide practical advice on how to use Darunavir Krka.
Danish: Det er ikke en praktisk vejledning i, hvordan Darunavir Krka bør anvendes.
English: Darunavir Krka does not cure HIV infection or AIDS, but HIV treatment may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Darunavir Krka helbreder ikke hiv-infektion eller aids, men hiv-behandling kan forsinke den beskadigelse af immunsystemet og den udvikling af infektioner og sygdomme, der er forbundet med aids.
English: Darunavir Krka is an antiviral medicine used with other HIV medicines to treat patients with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Darunavir Krka er et antiviralt lægemiddel, der anvendes sammen med andre hiv-lægemidler til behandling af patienter med humant immundefektvirus type 1 (hiv-1, et virus, som forårsager erhvervet immundefektsyndrom (aids)).
English: Darunavir Krka is a ‘generic medicine'.
Danish: Darunavir Krka er et "generisk lægemiddel".
English: What are the benefits and risks of Darunavir Krka?
Danish: Hvilken fordel og risiko er der forbundet med Darunavir Krka?
English: Because Darunavir Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Darunavir Krka er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Other information about Darunavir Krka
Danish: Andre oplysninger om Darunavir Krka
English: For more information about treatment with Darunavir Krka, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Darunavir Krka, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Darunavir Krka, darunavir, is a protease inhibitor.
Danish: Det aktive stof i Darunavir Krka, darunavir, er en proteasehæmmer.
English: Darunavir Krka, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Når Darunavir Krka tages i kombination med andre hiv-lægemidler, nedsættes mængden af hiv i blodet, og den holdes på et lavt niveau.
English: Darunavir Krka can only be obtained with a prescription and treatment should be started by a healthcare professional who has experience in the management of HIV.
Danish: Darunavir Krka udleveres kun efter recept, og behandlingen bør iværksættes af en sundhedsperson med erfaring i behandling af hiv-infektion.
English: What is Darunavir Krka and what is it used for?
Danish: Hvad er Darunavir Krka, og hvad anvendes det til?
English: Darunavir Krka is always given with ritonavir.
Danish: Darunavir Krka gives altid sammen med ritonavir.
English: For practical information about using Darunavir Krka, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Darunavir Krka, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Why is Darunavir Krka approved?
Danish: Hvorfor blev Darunavir Krka godkendt?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Darunavir Krka have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Darunavir Krka.
English: How has Darunavir Krka been studied?
Danish: Hvordan blev Darunavir Krka undersøgt?
English: How is Darunavir Krka used?
Danish: Hvordan anvendes Darunavir Krka?
English: How does Darunavir Krka work?
Danish: Hvordan virker Darunavir Krka?
English: Darunavir Krka is available as tablets.
Danish: Darunavir Krka fås som tabletter.
English: Elderly people (over 65 years)
Danish: Ældre (over 65 år)
English: - if the patient is less than 2 years of age.
Danish: - hvis patienten er under 2 år.
English: These combinations were efficacious and well tolerated.
Danish: Disse kombinationer var effektive og veltolererede.
English: In other patients, one or the other effect may be dominant.
Danish: Hos andre patienter kan den ene eller den anden virkning være dominerende.
English: Povidone, K-30
Danish: Povidon, K-30
English: Mean duration of follow-up was 3.5 years.
Danish: Den gennemsnitlige opfølgningsvarighed var 3,5 år.
English: This is because the safety and benefits of this medicine are not known in this population.
Danish: Dette skyldes, at sikkerheden og fordelene ved dette lægemiddel ikke kendes for denne population.
English: - if you are more than 3 months pregnant.
Danish: - hvis du er mere end 3 måneder henne i graviditeten.
English: • Inability to achieve or maintain erection
Danish: • Manglende evne til at få eller vedligeholde erektion
English: Investigations Very common
Danish: Undersøgelser Meget almindelig
English: There were no new or unexpected findings observed of relevance to human use.
Danish: Der var ingen nye eller uventede resultater, der har relevans for human brug.
English: - angioedema without any known cause.
Danish: angioødem uden kendt årsag.
English: The treatment with aliskiren was well tolerated in this study.
Danish: Behandling med aliskiren var veltolereret i dette studie.
English: This medicine may make you feel dizzy.
Danish: Denne medicin kan få dig til at føle dig svimmel.
English: Side effects associated with each individual component cannot be excluded.
Danish: Bivirkninger forbundet med de enkelte komponenter kan ikke udelukkes.
English: Additional information on individual components
Danish: Yderligere oplysninger om individuelle komponenter
English: The age at which the transporter system is mature cannot be determined.
Danish: Alderen, hvor transportersystemet er modent, kan ikke fastslås.
English: Caution required with concomitant use
Danish: Forsigtighed påkrævet ved samtidig brug
English: Results of the neurocognitive assessments showed some improvements in most of the test scores, with no meaningful difference between the treatment groups.
Danish: Resultater af de neurokognitive vurderinger viste forbedringer i de fleste testscorer, uden nogen meningsfuld forskel mellem behandlingsgrupperne.
English: Both of these active substances help to control high blood pressure (hypertension).
Danish: Begge disse aktive stoffer hjælper med at kontrollere for højt blodtryk (hypertension).
English: Other antihypertensive medicinal products
Danish: Andre antihypertensive lægemidler
English: The antihypertensive effect of a single dose of the combination persisted for 24 hours.
Danish: Den antihypertensive virkning af en enkelt dosis af kombinationen varede ved i 24 timer.
English: A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.
Danish: Der skal skiftes til en egnet, alternativ behandling før en planlagt graviditet.
English: - if you have serious congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body).
Danish: - hvis du har alvorligt hjertesvigt (en hjertesygdom, hvor dit hjerte ikke kan pumpe tilstrækkeligt blod rundt i kroppen).
English: Chloride deficit is generally mild and usually does not require treatment.
Danish: Kloridmangel er generelt mildt og kræver sædvanligvis ingen behandling.
English: • Sugar in the urine
Danish: • Sukker i urinen
English: It reduces the amount of angiotensin II the body can make.
Danish: Det nedsætter den mængde angiotensin-II, kroppen kan producere.
English: Mechanisms responsible for the deviation from dose proportionality have not been identified.
Danish: Den mekanisme, der er årsag til afvigelsen fra dosisproportionalitet, er ikke blevet identificeret.
English: The safety of Rasilez HCT has been evaluated in more than 3,900 patients, including over 700 treated for over 6 months, and 190 for over 1 year.
Danish: Rasilez HCT's sikkerhed er blevet evalueret hos mere end 3.900 patienter, herunder over 700 behandlet i over 6 måneder og 190 i over 1 år.
English: The clinical implications of the effects on PRA are not known at the present time.
Danish: Den kliniske betydning af effekt på PRA er ikke kendt på nuværende tidspunkt.
English: Erythema multiformeh
Danish: Erytem multiformeh
English: The blood pressure lowering effect is present within one week after beginning treatment.
Danish: Den blodtrykssænkende virkning ses inden for en uge efter behandlingsstart.
English: Thrombocytopenia sometimes with purpurah
Danish: Trombocytopeni, sommetider med purpurah
English: The average differences between aliskiren and placebo for the low and mid dose groups were <0.2 mmHg.
Danish: De gennemsnitlige forskelle mellem aliskiren og placebo for lav- og middeldosisgrupperne var < 0,2 mmHg.
English: Do not take this medicine if you are pregnant (see section ‘Do not take Rasilez HCT').
Danish: Du må ikke tage dette lægemiddel, hvis du er gravid (se afsnittet ”Tag ikke Rasilez HCT”).
English: The study also evaluated the combination of aliskiren and enalapril.
Danish: Studiet undersøgte desuden kombinationen af aliskiren og enalapril.
English: Over 3,900 hypertensive patients received Rasilez HCT once daily in clinical study.
Danish: Mere end 3.900 hypertensive patienter har fået Rasilez HCT en gang dagligt i kliniske studier.
English: If this is the case, your doctor will tell you how to switch from that treatment to Rasilez HCT.
Danish: Hvis dette er tilfældet, vil din læge fortælle dig, hvordan du kan skifte fra den behandling til Rasilez HCT.
English: A possible mechanism is saturation of transporters at the absorption site or at the hepatobiliary clearance route.
Danish: En mulig mekanisme er mætning af transportørerne på absorptionsstedet eller ved den hepatobiliære udskillelsesvej.
English: See section 4.2, 4.8, 5.1 and 5.2 for information on paediatric use.
Danish: 4.2, 4.8, 5.1 og 5.2 for information om brug til pædiatriske patienter.
English: If you only remember the forgotten dose the next day, you should simply take the next tablet at the usual time.
Danish: Hvis du først husker den glemte dosis næste dag, skal du bare tage den næste tablet til sædvanlig tid.
English: Your doctor will normally advise you to stop taking this medicine before you become pregnant and will advise you to take another medicine instead of this medicine.
Danish: Normalt vil din læge råde dig til at stoppe med at tage dette lægemiddel, inden du bliver gravid, og råde dig til at tage anden medicin i stedet for dette lægemiddel.
English: The frequency, type and severity of adverse reactions in children were generally similar to those seen in hypertensive adults.
Danish: Frekvens, type og alvorlighed af bivirkninger hos børn var generelt sammenligneligt med det, der ses hos hypertensive voksne.
English: ** Including one case of “liver failure fulminant” reported in the post-marketing experience, for which a causal relationship with aliskiren cannot be excluded.
Danish: **Inklusive et tilfælde af 'fulminant leversvigt', der er rapporteret post-marketing, og hvor en kausal sammenhæng med aliskiren ikke kan udelukkes.
English: Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare situations where no other treatment could be used.
Danish: Hydrochlorthiazid bør ikke anvendes til essentiel hypertension hos gravide kvinder, undtagen i sjældne situationer hvor anden behandling ikke kan anvendes.
English: Therefore, aliskiren is not expected to affect the systemic exposure of substances that inhibit, induce or are metabolised by these enzymes.
Danish: Det forventes derfor ikke, at aliskiren påvirker den systemiske eksponering af stoffer, som hæmmer, inducerer eller metaboliseres af disse enzymer.
English: − Second and third trimesters of pregnancy (see section 4.6).
Danish: − 2. og 3. trimester af graviditet (se pkt.
English: It should not be used in children from 2 to less than 6 years of age, and is not recommended for use in children and adolescents from 6 to less than 18 years of age.
Danish: Det bør ikke bruges til børn fra 2 år og op til 6 år og anbefales ikke til børn og unge fra 6 år og op til 18 år.
English: The systemic exposure to aliskiren in 8-day old rats was >400-fold higher than in adult rats.
Danish: Den systemiske eksponering for aliskiren hos 8 dage gamle rotter var >400 gange højere end hos voksne rotter.
English: Different treatment effects of aliskiren were reported for overall mortality within 12 months dependent on diabetes mellitus status.
Danish: Der blev rapporteret om forskellige behandlingseffekter af aliskiren på den samlede mortalitet inden for 12 måneder, afhængigt af diabetes-status.
English: Additional information on aliskiren interactions
Danish: Yderligere information om interaktioner med aliskiren
English: Hydrochlorothiazide has been extensively prescribed for many years, frequently in higher doses than those contained in Rasilez HCT.
Danish: Hydrochlorthiazid er blevet ordineret i stor udstrækning i mange år, ofte i højere dosis end indholdet i Rasilez HCT.
English: The combination of these substances with complementary mechanisms of action provides an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Danish: Kombinationen af disse stoffer, som har en supplerende virkningsmekanisme, giver en yderligere antihypertensiv virkning og reducerer blodtrykket i større grad end begge komponenter alene.
English: There was no evidence that this finding was enhanced in the aliskiren/hydrochlorothiazide combination as it was only apparent at a minimal severity in all animals.
Danish: Der er intet bevis for, at disse resultater var forøget i aliskiren/hydrochlorthiazidkombinationen, da de kun var synlige i minimal sværhedsgrad hos alle dyr.
English: The frequency of adverse reactions listed below is defined 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) and not known (cannot be estimated from the available data).
Danish: Hyppigheden af de herunder angivne bivirkninger er defineret ved brug af følgende konvention: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Date of latest renewal: 27 August 2018
Danish: Dato for første markedsføringstilladelse: 16. januar 2009 Dato for seneste fornyelse: 27. august 2018
English: During your treatment, your doctor may adjust your dose depending on your blood pressure response.
Danish: I løbet af behandlingen kan lægen justere dosis afhængigt af dit blodtryk.
English: A high inter-individual variability of mRNA expression levels was observed (up to 600-fold).
Danish: Der blev observeret en høj inter-individuel variation i niveauet af mRNA-ekspression (op til 600 gange).
English: For adverse reactions observed with more than one component of a fixed-dose combination, the highest frequency is listed in the table below.
Danish: For bivirkninger, der er observeret med mere end en komponent af en fast-dosis kombination, er den højeste frekvens anført i tabellen nedenfor.
English: Renal dysfunctionh
Danish: Renal dysfunktionh
English: • Worsening of the diabetic metabolic state
Danish: • Forværring af den metaboliske tilstand ved diabetes
English: Ear and labyrinth disorders Not known
Danish: Øre og labyrinth Ikke kendt
English: The antihypertensive effect is largely manifested within 1 week and the maximum effect is generally seen within 4 weeks.
Danish: Den antihypertensive effekt er normalt til stede inden for 1 uge og den maksimale effekt ses generelt inden for 4 uger.
English: Rasilez HCT may have been prescribed to you because your previous treatment with a medicine containing one of the active components of Rasilez HCT did not lower your blood pressure enough.
Danish: Rasilez HCT kan være blevet ordineret til dig, fordi din tidligere behandling med et lægemiddel, der indeholder et af de aktive stoffer i Rasilez HCT ikke sænkede dit blodtryk tilstrækkeligt.
English: • Reduced appetite
Danish: • Nedsat appetit
English: Exposure to aliskiren increased slightly more than in proportion to the increase in dose.
Danish: Eksponeringen for aliskiren øgedes lidt mere end proportionalt sammenlignet med stigningen i dosis.
English: - some medicines used to treat infections, such as ketoconazole.
Danish: - nogle typer medicin, der anvendes til at behandle infektioner, såsom ketoconazol.
English: Rasilez HCT has minor influence on the ability to drive and use machines.
Danish: Rasilez HCT påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.