FrancophonIA/ELRC3.0 huggingface dataset:
English: Increase in dosage of probenecid or sulfinpyrazone may be necessary.
Danish: Det kan være nødvendigt at øge dosis af probenecid eller sulfinpyrazon.
English: When clinically appropriate direct change from monotherapy to the fixed combinations may be considered:
Danish: Når en direkte ændring fra monoterapi til de faste kombinationer påtænkes, bør følgende retningslinjer overvejes:
English: Latent diabetes mellitus may become manifest during thiazide therapy.
Danish: Latent diabetes mellitus kan blive manifest under thiazidbehandling.
English: Pharmacotherapeutic group: angiotensin-II antagonists, combinations ATC code: C09D A04
Danish: Farmakoterapeutisk klassifikation: angiotensin-II-antagonister, kombinationer ATC-kode: C09D A04.
English: Jaundice Hepatitis, abnormal liver function
Danish: Hepatitis, abnorm leverfunktion
English: Angiotensin II Receptor Antagonists (AIIRAs)
Danish: Angiotensin II-receptorantagonister (AIIRAer)
English: The blood pressure lowering effect of irbesartan in combination with hydrochlorothiazide is apparent after the first dose and substantially present within 1-2 weeks, with the maximal effect occurring by 6-8 weeks.
Danish: Den blodtryksnedsættende effekt af irbesartan i kombination med hydrochlorthiazid viser sig efter første dosis og varer ved i 1-2 uger, med maksimal effekt efter 6-8 uger.
English: Overall, taking into account the available data assessed in this procedure, the benefit risk balance of medicines containing a sartan with a tetrazole ring remains positive subject to the conditions imposed.
Danish: I betragtning af de tilgængelige data, der er blevet vurderet i denne procedure, er det overordnede benefit/risk-forhold for lægemidler, der indeholder et sartan med en tetrazolring, samlet set stadig positivt under forudsætning af, at de pålagte betingelser opfyldes.
English: Obligatory risk assessments to be performed for manufacturing processes of the drug substances in order to evaluate the theoretical risk of N-nitrosamine formation and contamination
Danish: Obligatoriske risikovurderinger skal udføres for fremstillingsprocesser for lægemiddelstofferne med henblik på evaluering af den teoretiske risiko for N-nitrosamin-dannelse og -forurening.
English: As is the case with other medicinal products that affect the renin-angiotensin system, black hypertensive patients have notably less response to irbesartan monotherapy.
Danish: Som med andre lægemidler, der påvirker renin-angiotensinsystemer, har sorte, hypertensive patienter betydelig mindre respons på enkeltstofbehandling med irbesartan.
English: In addition increases in blood urea nitrogen (BUN) (2.3%), creatine kinase (1.7%) and creatinine (1.1%) were also commonly observed in the trials.
Danish: Desuden blev også øget blodurinstof (2,3 %), kreatinkinase (1,7 %) og kreatinin (1,1 %) hyppigt rapporteret i forsøgene.
English: Corticosteroids, ACTH Electrolyte depletion, particularly hypokalaemia, may be increased;
Danish: Kortikosteroider, ACTH Elektrolytdepletion, specielt hypokaliæmi, kan forstærkes;
English: In addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock) and decrease in the number of platelets (a blood cell essential for the clotting of the blood) have also been reported.
Danish: Foruden de ovennævnte bivirkninger er der også indberettet brystsmerter, alvorlige allergiske reaktioner (anafylaktisk shock) og fald i antallet af blodplader (en blodcelle, der er afgørende for størkning af blodet).
English: Peak effects occurred at 3-6 hours.
Danish: Den maksimale effekt blev opnået efter 3-6 timer.
English: It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II.
Danish: Stoffet antages at blokere alle virkninger af angiotensin-II, som bliver medieret af AT1-receptoren, uafhængigt af angiotensin-II-syntesens kilde eller rute.
English: • kidney changes, characterized by slight increases in serum urea and creatinine, and hyperplasia/hypertrophy of the juxtaglomerular apparatus, which are a direct consequence of the interaction of irbesartan with the renin-angiotensin system;
Danish: • nyreforandringer karakteriseret ved let øgning af serum-urea og kreatinin samt hyperplasi/hypertrofi af det juxtaglomerulære apparat, hvilket er en direkte konsekvens af interaktion mellem irbesartan og renin-angiotensinsystemet;
English: In comparison to the daily intake levels calculated based on ICH M7(R1) using non-clinical toxicology, it is possible to generate additional safety factors ranging from 2.73 - 27.3 for NDMA and 10.0 - 100 for NDEA, by defining 0.03 ppm as the common technical target limit for NDEA and NDMA in tetrazole sartan APIs.
Danish: I forhold til niveauet af det daglige indtag, der er beregnet på grundlag af ICH M7 (R1) ved hjælp af nonklinisk toksikologi, er det muligt at generere yderligere sikkerhedsfaktorer i intervallet 2,73-27,3 for NDMA og 10,0-100 for NDEA ved at definere 0,03 ppm som den fælles tekniske målværdi for NDEA og NDMA i aktive stoffer, der indeholder sartan med en tetrazolring.
English: Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Danish: Thiazider skal anvendes med forsigtighed til patienter med nedsat leverfunktion eller progressiv leversygdom, da mindre ændringer af væske- og elektrolytbalancen kan fremskynde hepatisk koma.
English: Fertility and reproductive performance were not affected in studies of male and female rats even at oral doses of irbesartan causing some parental toxicity (from 50 to 650 mg/kg/day), including mortality at the highest dose.
Danish: Fertilitet og reproduktionsevne blev ikke påvirket ved studier af han- og hunrotter, selv ved orale doser af irbesartan, der fremkaldte nogen toksicitet hos forældrene (fra 50-650 mg/kg/dag), herunder mortalitet ved den højeste dosis.
English: After either oral or intravenous administration of 14C irbesartan, about 20 % of the radioactivity is recovered in the urine, and the remainder in the faeces.
Danish: Efter enten oral eller intravenøs administration af 14C irbesartan, genfindes ca. 20 % radioaktivitet i urinen og resten i afføringen.
English: Hydrochlorothiazide should not be used for gestational oedema, gestational hypertension or preeclampsia due to the risk of decreased plasma volume and placental hypoperfusion, without a beneficial effect on the course of the disease.
Danish: Hydrochlorthiazid bør ikke anvendes til gestationelt ødem, gestationel hypertension eller præeklampsi på grund af risiko for nedsat plasmavolumen og hypoperfusion af placenta uden en gavnlig effekt på sygdomsforløbet.
English: If a child swallows some tablets, contact your doctor immediately.
Danish: Hvis et barn sluger en eller flere tabletter, skal du straks kontakte lægen.
English: Thus, the risk assessment is based on a potential worst case scenario, which would be a partially combined exposure to the highest levels of NDEA for 4 years (2011 - 2015) and to NDMA for 6 years (2012 - 2018) reported from a sartan, resulting in a cumulative theoretical excess cancer risk of 29.5:100,000 or 1:3390 (0.029%) when extrapolated from the available rat studies according to ICH M7(R1).
Danish: Risikovurderingen er derfor baseret på et potentielt værst tænkeligt scenarie, som er en delvis kombineret eksponering for de højeste niveauer af NDEA i fire år (2011-2015) og NDMA i seks år (2012-2018), der er indberettet for et sartan, hvilket resulterer i en kumulativ, teoretisk, forhøjet risiko for kræft på 29,5:100.000 eller 1:3.390 (0,029 %) ved ekstrapolering fra de tilgængelige rottestudier i henhold til ICH M7 (R1).
English: • CHMP could not identify cancer screening methods that patients would benefit from, considering the uncertainty of the target organ(s) of NDMA/NDEA toxicity in humans and the risks of measures to monitor patients such as colonoscopy or gastroscopy which may exceed the theoretical excess cancer risk.
Danish: • CHMP kunne ikke identificere kræftscreeningsmetoder, som patienterne ville have gavn af, da der hersker usikkerhed om målorganerne for NDMA-/NDEA-toksicitet hos mennesker, og da der er risici forbundet med foranstaltninger til overvågning af patienter, herunder koloskopi og gastroskopi, som kan overstige den teoretisk forhøjede risiko for kræft.
English: Another study showed a possible association between lip cancer (SCC) and exposure to HCTZ: 633 cases of lip-cancer were matched with 63,067 population controls, using a risk-set sampling strategy.
Danish: Et andet studie viste en mulig forbindelse mellem læbekræft (pladecellekarcinom) og eksponering for hydrochlorthiazid: 633 tilfælde af læbekræft blev matchet med 63.067 forsøgspersoner i kontrolgrupper under anvendelse af en risk set sampling-strategi.
English: Given their similar pharmacodynamic properties, these results are also relevant for other ACE- inhibitors and angiotensin II receptor blockers.
Danish: På baggrund af de fælles farmakodynamiske egenskaber er disse resultater også relevante for andre ACE-hæmmere og angiotensin II-receptorantagonister.
English: For example, a recent review has estimated risks of perforation of 4 per 10,000 (95% confidence interval, 2-5) and major haemorrhage of 8 per 10,000 (95% confidence interval, 5-14) with screening colonoscopy.
Danish: For eksempel har en nylig gennemgang skønnet risikoen for perforation til 4 ud af 10.000 tilfælde (95 %-konfidensinterval: 2-5) og for alvorlig blødning til 8 ud af 10.000 (95 %-konfidensinterval: 5-14) ved screeningskoloskopi.
English: Similar effects have been very rarely reported with irbesartan so far.
Danish: Med irbesartan er en lignende effekt hidtil kun rapporteret i meget sjældne tilfælde.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre æske
English: Nitrosamines are chemically simple molecules and can be formed in pharmaceutical manufacturing steps whenever there is a presence of a secondary (or tertiary) amines and nitrites, usually in acidic conditions.
Danish: Nitrosaminer er kemisk enkle molekyler, som kan dannes i farmaceutiske fremstillingsprocesser, når sekundære (eller tertiære) aminer og nitritter er til stede, typisk under sure betingelser.
English: There is no evidence that irbesartan would reduce or prevent diuretic-induced hyponatraemia.
Danish: Der er ingen tegn på, at irbesartan reducerer eller forebygger diuretika-induceret hyponatriæmi.
English: Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse reactions previously reported with one of the individual components may be potential adverse reactions with Irbesartan/Hydrochlorothiazide Teva.
Danish: Yderligere information om de individuelle stoffer: Udover ovenfor nævnte bivirkninger for kombinationspræparatet, kan andre tidligere rapporterede bivirkninger i forbindelse med ét af de individuelle stoffer være potentielle bivirkninger ved Irbesartan/Hydrochlorthiazid Teva.
English: Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma)
Danish: Non-melanom hudkræft (basalcellekarcinom og pladecellekarcinom)
English: The combination of irbesartan and hydrochlorothiazide has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension.
Danish: Kombinationen af irbesartan og hydrochlorthiazid er kun sjældent blevet associeret med symptomatisk hypotension hos hypertensive patienter uden andre risikofaktorer for hypotension.
English: Hydrochlorothiazide crosses the placental but not the blood-brain barrier, and is excreted in breast milk.
Danish: Hydrochlorthiazid passerer placentabarrieren, men ikke blod/hjernebarrieren, og det udskilles i modermælk.
English: For therapeutic doses of irbesartan in humans, the hyperplasia/hypertrophy of the renal juxtaglomerular cells does not appear to have any relevance.
Danish: Ved terapeutiske doser af irbesartan til mennesker, synes hyperplasi/hypertrofi af de renale juxtaglomerulære celler ikke at have nogen relevans.
English: Detailed information on this medicinal product is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Peak plasma concentration occurs at 1.5-2 hours after oral administration for irbesartan and 1-2.5 hours for hydrochlorothiazide.
Danish: Den maksimale plasmakoncentration optræder i løbet af 1,5-2 timer efter oral administration af irbesartan og 1-2,5 timer efter administration af hydrochlorthiazid.
English: if your doctor determines that you have persistently high calcium or low potassium levels in your blood.
Danish: • hvis din læge har konstateret, at du har konstant forhøjet calcium eller lavt kalium i blodet.
English: Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts.
Danish: Thiazider påvirker den renale tubulære mekanisme for elektrolyt-reabsorption og øger udskillelsen af natrium og chlorid i omtrent ækvivalente mængder.
English: Serum electrolytes and creatinine should be monitored frequently.
Danish: Serum-elektrolytter og kreatinin skal monitoreres tæt.
English: TEVA UK Ltd Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG United Kingdom
Danish: TEVA UK Ltd Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG Storbritannien
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har brugt det for nylig.
English: The most commonly reported ADRs were dizziness (5.6%), fatigue (4.9%), nausea/vomiting (1.8%), and abnormal urination (1.4%).
Danish: De hyppigst rapporterede bivirkninger var svimmelhed (5,6 %), træthed (4,9 %), kvalme/opkastning (1,8 %) og unormal vandladning (1,4 %).
English: The determination of an acceptable intake (AI) is based on extrapolation of carcinogenic risk from rodent carcinogenicity data, as the dose resulting in one cancer case among 100,000 individuals exposed for a life-time to the impurity.
Danish: Bestemmelsen af et acceptabelt indtag er baseret på ekstrapolering af den karcinogene risiko ud fra karcinogenicitetsdata for gnavere og fastsættes til den dosis, der medfører ét kræfttilfælde for hver 100.000 personer med livslang eksponering for urenheden.
English: TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG UK
Danish: TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG
English: Irbesartan exhibits linear and dose proportional pharmacokinetics over the dose range of 10 to 600 mg. A less than proportional increase in oral absorption at doses beyond 600 mg was observed; the mechanism for this is unknown.
Danish: Irbesartan udviser lineær og dosisproportionel farmakokinetik i et dosisinterval på 10-600 mg. Der blev observeret en mindre end proportional øgning af oral absorption ved doser over 600 mg.
English: The carcinogenic potential of irbesartan and hydrochlorothiazide in combination has not been evaluated in animal studies.
Danish: Det karcinogene potentiale af irbesartan og hydrochlorthiazid i kombination er ikke evalueret i dyrestudier.
English: Aluminium - Aluminium blisters: This medicinal product does not require any special storage conditions.
Danish: Aluminium - Aluminiumblistere: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Studies have not been performed in patients with severe hepatic impairment.
Danish: Der er ikke foretaget undersøgelser af patienter med alvorligt nedsat leverfunktion.
English: With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak effect occurs at about 4 hours, while the action persists for approximately 6-12 hours.
Danish: Ved behandling med hydrochlorthiazid starter diuresen inden for 2 timer og topper efter ca. 4 timer, mens virkningen varer ved i ca. 6-12 timer.
English: Hydrochlorothiazide crosses the placenta.
Danish: Hydrochlorthiazid passerer placenta.
English: Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Danish: Graviditet Behandling med Angiotensin-II-Receptor-Antagonister (AIIRA'er) bør ikke påbegyndes under graviditet.
English: Irbesartan and hydrochlorothiazide are orally active agents and do not require biotransformation for their activity.
Danish: Irbesartan og hydrochlorthiazid er oralt aktive stoffer, som ikke kræver biotransformation for at være aktive.
English: There were 0.6 % and 0 % of patients with hypotension and 2.8 % and 3.1 % of patients with dizziness as adverse reactions reported in the combination and monotherapy groups, respectively.
Danish: Henholdsvis 0,6 % og 0 % af patienterne oplevede hypotension og henholdsvis 2,8 % og 3,1 % oplevede svimmelhed som bivirkning ved kombinationsbehandling og enkeltstofbehandling.
English: Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled.
Danish: Øjeblikkelig lægehjælp eller operation kan overvejes, hvis det intraokulære tryk ikke kommer under kontrol.
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 føto-placentale perfusion og forårsage føtale og neonatale effekter, såsom icterus, forstyrrelse i elektrolytbalancen og trombocytopeni.
English: • During this period, NDMA and NDEA impurities in the API should be controlled for a transition period at limits calculated based on the principles of ICH M7(R1) using validated assays
Danish: • I denne periode bør NDMA- og NDEA-urenhederne i det aktive stof kontrolleres ved grænseværdier, der er beregnet på grundlag af principperne i ICH M7 (R1), ved hjælp af validerede test.
English: Hydrochlorothiazide is a thiazide diuretic.
Danish: Hydrochlorthiazid er et thiaziddiuretikum.
English: The mechanism of antihypertensive effect of thiazide diuretics is not fully known.
Danish: Mekanismen for thiaziddiuretikas antihypertensive virkning er ikke afklaret.
English: If calcium supplements or calcium sparing medicinal products (e.g. vitamin D therapy) must be prescribed, serum calcium levels should be monitored and calcium dosage adjusted accordingly;
Danish: Hvis der gives calciumsupplement eller calciumbesparende lægemiddel (fx D-vitamin), skal serum-calciumniveauet måles, og calciumdosis justeres herefter;
English: This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. filmovertrukket tablet, dvs. det er i det væsentligte natrium-frit.
English: Side effects associated with irbesartan alone:
Danish: Bivirkninger forbundet med irbesartan alene
English: Irbesartan does not inhibit ACE (kininase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites.
Danish: Irbesartan hæmmer ikke ACE (kininase-II), et enzym, som producerer angiotensin-II og også nedbryder bradykinin til inaktive metabolitter.
English: Hydrochlorothiazide is not metabolized but is eliminated rapidly by the kidneys.
Danish: Hydrochlorthiazid metaboliseres ikke, men udskilles hurtigt via nyrerne.
English: Furthermore, irbesartan induced hyperplasia/hypertrophy of the juxtaglomerular cells (in rats at ≥ 90 mg/kg/day, in macaques at ≥ 10 mg/kg/day).
Danish: Derudover inducerede irbesartan hyperplasi/hypertrofi af de juxtaglomerulære celler (hos rotter ved ≥ 90 mg/kg/dag, hos makakaber ved ≥ 10 mg/kg/dag).
English: The risk of hypokalaemia is greatest in patients with cirrhosis of the liver, in patients experiencing brisk diuresis, in patients who are receiving inadequate oral intake of electrolytes and in patients receiving concomitant therapy with corticosteroids or ACTH.
Danish: Risikoen for hypokaliæmi er størst hos patienter med levercirrhose, patienter med hyppig vandladning, patienter der indtager utilstrækkelig mængde elektrolytter oralt, og hos patienter i samtidig behandling med kortikosteroider eller ACTH.
English: The following changes, observed in rats and macaques receiving the irbesartan/hydrochlorothiazide combination at 10/10 and 90/90 mg/kg/day, were also seen with one of the two medicinal products alone and/or were secondary to decreases in blood pressure (no significant toxicologic interactions were observed):
Danish: Følgende ændringer, observeret hos rotter og makakaber, der fik en kombination af irbesartan/hydrochlorthiazid på 10/10 og 90/90 mg/kg/dag, blev også set ved anvendelse af de individuelle stoffer og/eller var sekundære til blodtryksnedsættelse (der blev ikke observeret signifikante toksikologiske interaktioner):
English: If Irbesartan/Hydrochlorothiazide Teva is used during breast feeding, doses should be kept as low as possible.
Danish: Hvis Irbesartan/Hydrochlorothiazide Teva anvendes i ammeperioden, bør dosis være så lav som muligt.
English: Irbesartan had no effect upon fertility of treated rats and their offspring up to the dose levels inducing the first signs of parental toxicity (see section 5.3).
Danish: Irbesartan påvirkede ikke fertiliteten hos behandlede rotter eller deres afkom i doser op til det niveau, der fremkaldte de første tegn på toksicitet hos forældrene (se pkt.
English: Following oral or intravenous administration of 14C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Danish: Efter oral eller intravenøs administration af 14C irbesartan, kan 80-85 % af den cirkulerende radioaktivitet i plasma tilskrives uomdannet irbesartan.
English: One study included a population comprised of 71,533 cases of BCC and of 8,629 cases of SCC matched to 1,430,833 and 172,462 population controls, respectively.
Danish: Et studie omfattede en population med 71.533 tilfælde af basalcellekarcinom og 8.629 tilfælde af placecellekarcinom, der blev matchet med hhv. 1.430.833 og 172.462 forsøgspersoner i kontrolgrupper.
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Danish: Såfremt samtidig administration skønnes nødvendig, anbefales det at kontrollere serum-lithiumværdier omhyggeligt.
English: • After the transition period, a limit for NDMA and NDEA of maximum 0.03 ppm should be implemented, which reflects the lowest quantifiable level based on capability of the available analytical methods.
Danish: • Efter overgangsperioden bør en grænseværdi for NDMA og NDEA på højst 0,03 ppm implementeres, idet dette er det laveste kvantificerbare niveau ved hjælp af de tilgængelige analysemetoder.
English: Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.
Danish: Der er i sjældne tilfælde også indberettet gulsot (gulfarvning af huden og/eller det hvide i øjnene).
English: Irbesartan is excreted in the milk of lactating rats.
Danish: Irbesartan udskilles i mælken hos diegivende rotter.
English: The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated.
Danish: Effekten af CYP2C9-induktorer, som fx rifampicin på irbesartans farmakokinetik er ikke evalueret.
English: Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists.
Danish: Irbesartan tilhører en medicingruppe der kaldes angiotensin-II-receptorantagonister.
English: Frequency ‘not known': Skin and lip cancer (Non-melanoma skin cancer)
Danish: Hyppighed ikke kendt: Hud- og læbekræft (non-melanom hudkræft)