FrancophonIA/ELRC3.0 huggingface dataset:
English: Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
Danish: Tabletterne skal synkes med en tilstrækkelig mængde væske (for eksempel et glas vand).
English: Initially, this was only necessary for valsartan containing APIs from few manufacturers but later also for some other sartans with a tetrazole ring.
Danish: I begyndelsen var det kun nødvendigt for valsartan-holdige aktive stoffer fra få fremstillere, men senere blev det også nødvendigt for visse andre sartaner med en tetrazolring.
English: No significant effects on the number of corpora lutea, implants, or live foetuses were observed.
Danish: Der blev ikke observeret signifikante forandringer af antallet af corpora lutea, implantater eller levende fostre.
English: Metabolic and endocrine effects
Danish: Metabolisk og endokrin virkning
English: In addition, advancing age, comorbidity and use of anticoagulants were found to be strongly associated with both gastrointestinal and non-gastrointestinal complications.
Danish: Derudover sås det, at fremskreden alder, komorbiditet og brug af antikoagulanter var tæt forbundet med både gastrointestinale og ikkegastrointestinale komplikationer.
English: Irbesartan did not affect survival, development, or reproduction of offspring.
Danish: Irbesartan påvirkede ikke overlevelse, udvikling eller reproduktion af afkommet.
English: Furthermore, the target organ(s) of NDMA/NDEA toxicity in humans are still not sufficiently clear.
Danish: Desuden er målorganerne for NDMA/NDEA-toksicitet hos mennesker stadig ikke tilstrækkeligt klarlagt.
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 tilfælde, hvor ingen anden behandling kan anvendes.
English: For an individual risk assessment, data on the exact drug products and batches used by each individual patient would be necessary.
Danish: For at kunne foretage en risikovurdering på individuelt plan ville det være nødvendigt at have adgang til data om de præcise lægemidler og batcher, som hver enkelt patient har anvendt.
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret { MM/ÅÅÅÅ }
English: Sexual dysfunction, libido changes
Danish: Seksuel dysfunktion, ændret libido
English: In long-term follow-up studies, the effect of irbesartan/hydrochlorothiazide was maintained for over one year.
Danish: I langsigtede opfølgningsstudier blev virkningen af irbesartan/hydrochlorthiazid opretholdt i mere end 1 år.
English: Plasma protein binding of irbesartan is approximately 96%, with negligible binding to cellular blood components.
Danish: Irbesartans plasma-proteinbinding er ca. 96 %, med en ubetydelig binding til cellulære blodkomponenter.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte lægemidler samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies.
Danish: Mistænkelige hudlæsioner bør straks undersøges, herunder eventuelt ved hjælp af histologisk biopsianalyse.
English: • A two-year transition period) is considered acceptable to change production processes to achieve syntheses in which N-nitrosamines are not formed, to adopt analytical methods for the control strategy and in order to avoid product shortages.
Danish: • En toårig overgangsperiode anses som acceptabel for at ændre fremstillingsprocesserne og opnå synteser, hvor N-nitrosaminer ikke dannes, vedtage analysemetoder til kontrolstrategien og undgå produktknaphed.
English: Risks resulting from multiple exposures are considered to add up in patients as mutagenic carcinogens are currently considered as summation toxins.
Danish: Risici, der opstår som følge af gentagen eksponering, anses for at være additive hos patienter, eftersom mutagene karcinogener aktuelt anses som summation toxins.
English: Steady-state plasma concentrations are attained within 3 days after initiation of a once-daily dosing regimen.
Danish: Steady-state plasmakoncentration nås i løbet af 3 dage efter påbegyndelse af behandling 1 gang dagligt.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Danish: Dobbelt hæmning af renin-angiotensin-aldosteron-systemet (RAAS)
English: There were no toxicological findings observed of relevance to human therapeutic use.
Danish: Der blev ikke observeret toksikologiske fund med relevans for human terapeutisk anvendelse.
English: All of these changes were considered to be caused by the pharmacological action of irbesartan.
Danish: Alle disse ændringer ansås for at være forårsaget af irbesartans farmakologiske virkning.
English: Hydrochlorothiazide is 68% proteinbound in the plasma, and its apparent volume of distribution is 0.83-1.14 l/kg.
Danish: Hydrochlorthiazid er 68 % proteinbundet i plasma, og dets tilsyneladende fordelingsvolumen er 0,83-1,14 l/kg.
English: However, another angiotensin-II antagonist affected fertility parameters in animal studies when given alone.
Danish: Derimod har en anden angiotensin-II-antagonist påvirket fertilitetsparametre i dyrestudier, når denne blev givet alene.
English: It is unknown whether irbesartan or its metabolites are excreted in human milk.
Danish: Det er ukendt, om irbesartan eller dets metabolitter udskilles i human mælk.
English: When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or weariness may occur during treatment of hypertension.
Danish: Ved bilkørsel eller betjening af maskiner, skal der tages hensyn til, at der lejlighedsvis kan opstå svimmelhed eller træthed under behandling af hypertension.
English: No dosage adjustment is necessary in female patients.
Danish: Dosisjustering er ikke nødvendig hos kvindelige patienter.
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).
Danish: Hyppigheden af bivirkninger anført nedenfor defineres i henhold til følgende konventioner: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden
English: Less than 2 % of the dose is excreted in the urine as unchanged irbesartan.
Danish: Mindre end 2 % af dosis udskilles uomdannet i urinen som irbesartan.
English: The terminal elimination half-life of irbesartan is 11-15 hours.
Danish: Den terminale halveringstid for irbesartan er 11-15 timer.
English: Whilst the measures are focused on NDMA and NDEA, the principles used in this procedure in terms of toxicology assessment, control strategy and changes to the manufacturing processes for drug substances should be applied by analogy to other nitrosamines.
Danish: Selvom foranstaltningerne er fokuseret på NDMA og NDEA, bør principperne vedrørende toksikologisk vurdering, kontrolstrategi og ændringer af fremstillingsprocessen for stoffer i denne procedure anvendes analogt på andre nitrosaminer.
English: For these reasons, N-nitrosamine impurities in pharmaceuticals such as sartans intended for long-term use should be reduced as much as possible.
Danish: Derfor bør forekomsten af N-nitrosamin-urenheder i lægemidler som f.eks. sartaner, der er beregnet til langvarig brug, reduceres mest muligt.
English: The above stated very small theoretical risk has to be balanced against the risks of potential measures to monitor patients such as colonoscopy or gastroscopy which may exceed the theoretical excess cancer risk.
Danish: Den førnævnte meget lave teoretiske risiko skal afvejes mod risiciene ved potentielle foranstaltninger til monitorering af patienter som f.eks. koloskopi eller gastroskopi, der kan overstige den teoretiske forhøjede risiko for kræft.
English: The primary objective of this study was to compare the proportion of patients whose SeDBP was controlled (SeDBP < 90 mmHg) at Week 5 of treatment.
Danish: Det primære formål med forsøget var at sammenligne andelen af patienter hvis SeDBT var kontrolleret (SeDBT < 90 mm Hg) ved Uge 5.
English: Hydrochlorothiazide is excreted in human milk in small amounts.
Danish: Hydrochlorthiazid udskilles i små mængder i human mælk.
English: Pregelatinized starch (maize) Poloxamer 188
Danish: Prægelatineret stivelse (majs) Poloxamer 188
English: The major circulating metabolite is irbesartan glucuronide (approximately 6 %).
Danish: Den vigtigste cirkulerende metabolit er glucuronidet af irbesartan (ca. 6 %).
English: - aliskiren if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Danish: • hvis du har haft hudkræft, eller hvis du udvikler en uventet hudlæsion under behandlingen.
English: • The CHMP reviewed data on quality regarding the manufacturing processes of sartans with a tetrazole group, analytical data including test results and available methods, and toxicological data available for the N-nitrosamines found in some of these products.
Danish: • CHMP gennemgik data for kvalitet vedrørende fremstillingsprocesserne for sartaner med en tetrazolgruppe, analysedata, herunder testresultater og tilgængelige metoder, og toksikologiske data for de N-nitrosaminer, der er til stede i nogle af disse produkter.
English: An interim limit based on daily intakes according to principles in ICH M7(R1) using toxicology data are set in order to control these impurities in the meantime at an acceptable level.
Danish: Der er fastsat en midlertidig grænseværdi baseret på daglige indtag i henhold til principperne i ICH M7 (R1) ved hjælp af toksikologidata med henblik på i mellemtiden at holde disse urenheder på et acceptabelt niveau.
English: These findings were also observed with lower doses of this other angiotensin-II antagonist when given in combination with hydrochlorothiazide.
Danish: Disse fund er også observeret ved lavere doser af denne anden angiotensin-II-antagonist, når den blev givet i kombination med hydrochlorthiazid.
English: In rabbits, abortion or early resorption was noted at doses causing significant maternal toxicity, including mortality.
Danish: Hos kaniner sås abort eller tidlig resorption ved doser, som forårsagede signifikant maternel toksicitet, inklusive mortalitet.
English: Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Danish: Patienter med primær aldosteronisme responderer generelt ikke på antihypertensive stoffer, der virker gennem hæmning af renin-angiotensinsystemet.
English: Non-melanoma skin cancer
Danish: Non-melanom hudkræft
English: In addition to NDMA and NDEA, other N-nitrosamines have been detected in a few sartan-containing medicinal products.
Danish: I tillæg til NDMA og NDEA er der opdaget andre N-nitrosaminer i en række sartan-holdige lægemidler.
English: Respiratory distress (including pneumonitis and pulmonary oedema)
Danish: Åndenød (inklusive pneumoni og pulmonalt ødem)
English: Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs.
Danish: Der findes ingen kontrollerede epidemiologiske data vedrørende risikoen med Angiotensin II-Receptor-Antagonister (AIIRA'er), men lignende risici kan findes for denne lægemiddelgruppe.
English: There was no evidence of mutagenicity, clastogenicity or carcinogenicity.
Danish: Der var ingen tegn på mutagenicitet, clastogenicitet eller karcinogenicitet.
English: Epidemiological studies have shown that long term treatment with hydrochlorothiazide reduces the risk of cardiovascular mortality and morbidity.
Danish: Epidemiologiske undersøgelser har vist, at langtidsbehandling med hydrochlorthiazid reducerer risikoen for kardiovaskulær mortalitet og morbiditet.
English: Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation.
Danish: Symptomerne omfatter akut synsnedsættelse eller øjensmerter og opstår typisk inden for timer til uger efter behandlingsstart.
English: Twelve percent (12 %) of patients were diabetic, 34 % were hyperlipidemic and the most frequent cardiovascular condition was stable angina pectoris in 3.5 % of the participants.
Danish: 12 % af patienterne var diabetikere, 34 % var hyperlipidæmiske, og den hyppigste kardiovaskulære tilstand var stabil angina pectoris hos 3,5 % af patienterne.
English: Renal artery stenosis - Renovascular hypertension
Danish: Renal arteriestenose - renovaskulær hypertension
English: • Risk Management plan
Danish: • Risikostyringsplan (RMP)
English: Should NDMA and NDEA be detected in parallel in an API batch, this should lead to rejection of the respective batch, considering that a combined contamination would translate into a combined risk, which may be higher than one additional case of cancer in 100.000 individuals.
Danish: Hvis NDMA og NDEA detekteres samtidigt i en batch af aktivt stof, bør dette føre til afvisning af den pågældende batch, idet en kombineret forurening vil medføre en kombineret risiko, der kan være større end ét yderligere tilfælde af kræft pr. 100.000 patienter.
English: Titanium Dioxide
Danish: Titandioxid
English: During this time period, MAHs and manufacturers are requested to introduce relevant changes to the manufacturing processes of the drug substances, as well as develop appropriate analytical methods while ensuring adequate supply of the market for these essential medicinal products.
Danish: I denne periode skal indehavere af markedsføringstilladelse og fremstillere gennemføre relevante ændringer af fremstillingsprocesserne for stofferne og udvikle hensigtsmæssige analysemetoder samt sikre tilstrækkelige forsyninger til markedet af disse vigtige lægemidler.
English: Sartan-containing medicinal products are important treatment options of serious or potentially serious conditions such as hypertension or certain heart or kidney diseases.
Danish: Sartan-holdige lægemidler er vigtige behandlingsmuligheder ved alvorlige eller potentielt alvorlige tilstande som f.eks. hypertension eller visse hjerte- eller nyresygdomme.
English: Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics.
Danish: Der er rapporteret exacerbation eller provokation af systemisk lupus erythematosus ved brug af thiaziddiuretika.
English: The CHMP also carried out a risk assessment for patients previously exposed to NDMA and NDEA in sartans and calculated daily intake levels based on the principles of ICH M7(R1) which are associated with an additional lifetime risk of 1 in 100,000 patients.
Danish: CHMP gennemførte også en risikovurdering af patienter, der tidligere har været eksponeret for NDMA og NDEA i sartaner, og beregnede niveauer for dagligt indtag på grundlag af principperne i ICH M7 (R1), der er forbundet med en yderligere livstidsrisiko på 1 pr. 100.000 patienter.
English: Implement a control strategy to detect and control N-nitrosamine impurities in the API (or intermediate, if justified).
Danish: Gennemførelse af en kontrolstrategi til detektion og kontrol af N-nitrosamin-urenheder i det aktive stof (eller mellemproduktet, hvis det er berettiget).
English: Irbesartan does not require metabolic activation for its activity.
Danish: Irbesartan kræver ingen metabolisk aktivering for at blive aktivt.
English: A full risk assessment for patients previously exposed to NDMA and/or NDEA impurities in sartans, especially valsartan which was found to contain the highest nitrosamine contamination, is not possible as the real extent of exposure of patients is unknown.
Danish: En fuld risikovurdering for patienter, der tidligere har været eksponeret for NDMA- og/eller NDEAurenheder i sartaner, især valsartan, som indeholdt det højeste niveau af nitrosamin-forurening, er ikke mulig, da det reelle omfang af eksponering blandt patienter er ukendt.
English: If you accidentally take too many tablets, contact your doctor immediately.
Danish: Hvis du ved et uheld har taget for mange tabletter, skal du omgående kontakte lægen.
English: The mean plasma half-life of hydrochlorothiazide reportedly ranges from 5-15 hours.
Danish: Den gennemsnitlige plasmahalveringstid for hydrochlorthiazid angives at være på 5-15 timer.
English: There was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses.
Danish: Der var ikke tegn på abnorm systemisk eller målorgan-toksicitet ved klinisk relevante doser.
English: Suggested measures include induction of emesis and/or gastric lavage.
Danish: Foreslåede tiltag omfatter induktion af opkastning og/eller gastrisk udskylning.
English: The potential toxicity of the irbesartan/hydrochlorothiazide combination after oral administration was evaluated in rats and macaques in studies lasting up to 6 months.
Danish: Potentiel toksicitet for irbesartan/hydrochlorthiazid-kombinationen efter oral administration blev undersøgt hos rotter og makakaber i studier af op til 6 måneders varighed.
English: Thiazides in high doses causing intense diuresis can inhibit the milk production.
Danish: Thiazider i høje doser, som forårsager kraftig diurese, kan hæmme mælkeproduktionen.
English: The key issue of this referral concerns the detection of N-nitrosamine (esp. NDMA and/or NDEA) contaminations in sartans, the resulting potential long-term risk to patients and measures to minimise as much as possible these contaminations.
Danish: Det centrale problem i denne procedure vedrører opdagelsen af N-nitrosamin (især NDMA og/eller NDEA)-forurening i sartaner, den deraf følgende mulige langvarige risiko for patienter og foranstaltninger til at minimere denne forurening mest muligt.
English: N-nitrosamines belong to a “cohort of concern” compounds in this guideline.
Danish: N-nitrosaminer tilhører en gruppe af problematiske stoffer i denne vejledning.
English: if you have severe liver or kidney problems.
Danish: • hvis du har alvorlige lever- eller nyreproblemer.
English: If any of these side effects causes you problems, talk to your doctor.
Danish: Hvis nogen af disse bivirkninger medfører problemer for dig, kontakt da lægen.
English: Irbesartan is a potent, orally active, selective angiotensin-II receptor (AT1 subtype) antagonist.
Danish: Irbesartan er en potent, oralt aktiv, selektiv angiotensin-II-receptor (AT1-undergruppe) antagonist.
English: Marked hypercalcaemia may be evidence of hidden hyperparathyroidism.
Danish: Markant hypercalcæmi kan være tegn på skjult hyperparathyreoidisme.
English: Limited accumulation of irbesartan (< 20%) is observed in plasma upon repeated once-daily dosing.
Danish: Der er set begrænset akkumulering af irbesartan (< 20 %) i plasma efter gentagne doseringer, 1 gang dagligt.
English: The volume of distribution for irbesartan is 53-93 litres.
Danish: Fordelingsvolumen er 53-93 liter for irbesartan.
English: • The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for products containing sartans with a tetrazole group (candesartan, irbesartan, losartan, olmesartan, valsartan)
Danish: • CHMP har behandlet sagen i henhold til artikel 31 i direktiv 2001/83/EF for produkter, der indeholder sartaner med en tetrazolgruppe (candesartan, irbesartan, losartan, olmesartan og valsartan).
English: In this regard, a limit of quantification of 0.03 ppm for NDMA and NDEA would be achievable according to the available data on analytical methods.
Danish: I den forbindelse vil en kvantificeringsgrænse på 0,03 ppm for NDMA og NDEA være opnåeligt i henhold til de tilgængelige data for analysemetoder.
English: Irbesartan/Hydrochlorothiazide Teva should not be given to children and adolescents (under 18 years).
Danish: Irbesartan/Hydrochlorthiazid Teva må ikke gives til børn og unge (under 18 år).
English: The total body and renal clearance are 157-176 and 3.0-3.5 ml/min, respectively.
Danish: Total body- og nyreclearance er henholdsvis 157-176 og 3,0-3,5 ml/min.
English: After the transitional period of 2 years, a limit for NDMA and NDEA of maximum 0.03 ppm should be implemented.
Danish: Efter overgangsperioden på to år bør en grænseværdi for NDMA og NDEA på højst 0,03 ppm implementeres.
English: Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation.
Danish: Irbesartan metaboliseres hovedsageligt af CYP2C9 og i mindre udstrækning ved glucuronidering.
English: Cmax values were also somewhat greater in older subjects (≥ 65 years) than those of young subjects (18
Danish: Irbesartan AUC- og Cmax-værdier var også noget højere hos ældre patienter (≥ 65 år) end hos yngre patienter (18-40 år).
English: If you accidentally miss a daily dose, just take the next dose as normal.
Danish: Hvis du har glemt at tage en dosis, skal du blot tage den næste til sædvanlig tid.
English: The limit of 0.03 ppm for NDMA and NDEA will be enforceable after a transitional period of 2 years from the notification of the Commission Decision.
Danish: Grænsen på 0,03 ppm for NDMA og NDEA vil blive håndhævet efter en overgangsperiode på to år fra offentliggørelsen af Kommissionens afgørelse.
English: As for any combination of two active substances, side effects associated with each individual component cannot be excluded.
Danish: Som ved al behandling med kombination af 2 aktive stoffer, kan det ikke udelukkes, at der forekommer bivirkninger, som er forårsaget af hvert af de enkelte stoffer.
English: No teratogenic effects were observed in the rat or rabbit.
Danish: Der blev ikke observeret teratogen effekt hos hverken rotter eller kaniner.
English: For N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) the MAH must introduce the following specifications for the drug substance:
Danish: For N-nitrosodimethylamin (NDMA) og N-nitrosodiethylamin (NDEA) skal indehaverne af markedsføringstilladelse indføre følgende specifikationer for stoffet:
English: • decreases in serum potassium due to hydrochlorothiazide and partly prevented when hydrochlorothiazide was given in combination with irbesartan.
Danish: • et fald i serum-kalium på grund af hydrochlorthiazid og delvis forebyggelse, når hydrochlorthiazid blev givet i kombination med irbesartan.
English: This could be a sign that you are developing glaucoma, increased pressure in your eye(s).
Danish: Det kan være et tegn på, at du er ved at få grøn stær (glaukom, øget tryk i øjet/øjnene).
English: Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels causing them to tighten.
Danish: Angiotensin-II er et stof, der produceres i kroppen, og som binder sig til receptorer i blodårerne og får dem til at trække sig sammen.
English: If a re-administration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.
Danish: Hvis det er nødvendigt at genoptage diuretika-behandlingen, anbefales det at beskytte udsatte områder mod sol og kunstige UVA-stråler.
English: Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer).
Danish: Behandling med hydrochlorthiazid, navnlig ved langtidsbrug af høje doser, kan øge risikoen for visse typer hud- og læbekræft (non-melanom hudkræft).
English: The types and incidences of adverse events reported for patients treated with the combination were similar to the adverse event profile for patients on monotherapy.
Danish: Typen og forekomsten af de bivirkninger, der er indberettet hos patienter, som har modtaget behandling med kombinationen, svarede til bivirkningsprofilen for patienter i enkeltstofbehandling.
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and
Danish: Spædbørn, hvis mødre har taget AIIRA'er skal observeres omhyggeligt for hypotension (se pkt.
English: The hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
Danish: Den hyperglykæmiske effekt af beta-blokkere og diazoxid kan forstærkes af thiazider.