FrancophonIA/ELRC3.0 huggingface dataset:
English: Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with irbesartan with or without thiazide diuretics unless the volume depletion is corrected first (see section 4.4).
Danish: Forudgående behandling med store doser diuretika kan resultere i hypovolæmi og risiko for hypotension, når der påbegyndes behandling med irbesartan med eller uden thiaziddiuretika, medmindre hypovolæmien korrigeres først (se pkt.
English: The MAH must ensure that the manufacturing processes of the drug substances used for their drug products are reviewed for the potential risk of formation of Nnitrosamines and changed as necessary to minimise nitrosamine contamination as much as possible.
Danish: Indehaverne af markedsføringstilladelse skal sikre, at fremstillingsprocesserne for de stoffer, der anvendes i deres lægemidler, gennemgås for den mulige risiko for dannelse af N-nitrosaminer og ændres i nødvendigt omfang for at minimere nitrosamin-forureningen mest muligt.
English: Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.
Danish: Både kardiovaskulære dødsfald og apopleksi var numerisk hyppigere forekommende i aliskiren-gruppen end i placebogruppen, og bivirkninger og relevante alvorlige bivirkninger (såsom hyperkaliæmi, hypotension og nedsat nyrefunktion) blev rapporteret hyppigere i aliskiren-gruppen end i placebogruppen.
English: Thiazides may decrease 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 sænke urin-calciumudskillelsen og forårsage intermitterende og let forhøjelse af serum-calcium uden kendte forstyrrelser af calciummetabolismen.
English: Fever
Danish: Feber
English: Thiazides should be used with caution in patients with impaired hepatic function.
Danish: Thiazider skal anvendes med forsigtighed til patienter med leverfunktionsnedsættelse.
English: In case of identification of other nitrosamines, this should be forthwith reported to the competent authorities, together with a toxicology assessment of the impurity, a clinical assessment for the exposed patients, a root cause analysis and a corrective action plan (e.g. changes to the manufacturing process).
Danish: Hvis der konstateres andre nitrosaminer, bør det omgående indberettes til de kompetente myndigheder, ligesom der bør indsendes en toksikologisk vurdering af urenheden, en klinisk vurdering af de eksponerede patienter, en kerneårsagsanalyse og en plan for korrigerende handling (f.eks. ændringer i fremstillingsprocessen).
English: When angiotensin II antagonists are administered simultaneously with non-steroidal anti-inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Danish: Når angiotensin II-antagonister administreres samtidig med nonsteroide antiinflammatoriske lægemidler (fx selektive COX-2-hæmmere, acetylsalicylsyre (> 3 g/dag) og non-selektive NSAID) kan den antihypertensive virkning svækkes.
English: • Based on the analysis of potential root causes the CHMP considered that all the MAHs should perform risk assessment of the manufacturing processes used for the APIs in their finished products to evaluate the risk of N-nitrosamine formation and contamination.
Danish: • På grundlag af analysen af mulige kerneårsager konkluderede CHMP, at alle indehavere af markedsføringstilladelse bør gennemføre en risikovurdering af fremstillingsprocesserne for de aktive stoffer i de færdige produkter for at evaluere risikoen for N-nitrosamin-dannelse og -forurening.
English: Concomitant use of carbamazepine and hydrochlorothiazide has been associated with the risk of symptomatic hyponatraemia.
Danish: Samtidig brug af carbamazepin og hydrochlorthiazid har været forbundet med risiko for symptomatisk hyponatriæmi.
English: Thiazides may reduce the renal excretion of cytotoxic medicinal products (e.g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects.
Danish: Thiazider kan reducere nyreudskillelsen af cytotoksiske stoffer (fx cyclophosphamid, methotrexat) og forstærke deres myelosuppressive effekt.
English: There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester.
Danish: Der er utilstrækkelige data fra anvendelse af hydrochlorthiazid til gravide kvinder, særligt i første trimester.
English: Because no information is available regarding the use of Irbesartan/Hydrochlorothiazide Teva during breast-feeding, Irbesartan/Hydrochlorothiazide Teva is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Danish: Da der ikke er tilstrækkelige data vedrørende brugen af Irbesartan/Hydrochlorthiazid Teva under amning, anbefales Irbesartan/Hydrochlorthiazid Teva ikke og alternative behandlinger med bedre sikkerhedsprofiler under amning foretrækkes, især ved amning af nyfødte eller for tidligt fødte spædbørn.
English: Following oral administration of irbesartan/hydrochlorothiazide, the absolute oral bioavailability is 60-80% and 50-80% for irbesartan and hydrochlorothiazide, respectively.
Danish: Ved oral administration af irbesartan/hydrochlorthiazid er den absolutte orale biotilgængelighed henholdsvis 60-80 % for irbesartan og 50-80 % for irbesartan og hydrochlorthiazid.
English: The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration.
Danish: Den selektive antagonisme mod angiotensin-II (AT1) receptorerne resulterer i en forhøjelse af plasma-renin- og angiotensin-II-niveauerne og i nedsat aldosteron i plasma.
English: Studies in animals indicate that the radiolabelled irbesartan is detected in rat and rabbit foetuses.
Danish: Dyrestudier indikerer, at radioaktivt mærket irbesartan kan påvises i rotteog kaninfostre.
English: A cumulative dose-response relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4).
Danish: Der blev påvist en kumulativ dosis/respons relation med en justeret OR-værdi på 2,1 (95 %-KI: 1,7-2,6), der steg til OR 3,9 (3,0-4,9) ved et stort forbrug (~25.000 mg) og OR 7,7 (5,7-10,5) ved den højeste kumulative dosis (~100.000 mg) (se også pkt.
English: Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide) may be recommended.
Danish: Dosistitrering af de enkelte komponenter (dvs. irbesartan og hydrochlorthiazid) kan anbefales.
English: Film-coated tablets
Danish: Filmovertrukne tabletter
English: It is important that you continue to take Irbesartan/Hydrochlorothiazide Teva until your doctor tells you otherwise.
Danish: Det er vigtigt, at du fortsætter med at tage Irbesartan/Hydrochlorthiazid Teva, indtil lægen siger, du kan stoppe.
English: You can take Irbesartan/Hydrochlorothiazide Teva with or without food.
Danish: Du kan tage Irbesartan/Hydrochlorthiazid Teva med eller uden mad.
English: Thiazides may increase the risk of adverse effects caused by amantadine.
Danish: Thiazider kan øge risikoen for bivirkninger forårsaget af amantadin.
English: • In case of detection of other N-nitrosamines this should be forthwith reported to the competent authorities, together with a toxicology assessment of the impurity, a clinical assessment for the exposed patients, a root cause analysis and a corrective action plan.
Danish: • Hvis der konstateres andre N-nitrosaminer, bør det omgående indberettes til de kompetente myndigheder, ligesom der bør indsendes en toksikologisk vurdering af urenheden, en klinisk vurdering af de eksponerede patienter, en kerneårsagsanalyse og en plan for korrigerende handling.
English: Loop diuretics are preferred to thiazides in this population.
Danish: Loop-diuretika er at foretrække frem for thiazider til denne patientgruppe.
English: Jaundice (intrahepatic cholestatic jaundice)
Danish: Gulsot (intrahepatisk kolestatisk gulsot)
English: However, this effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, laxatives, amphotericin, carbenoxolone, penicillin G sodium).
Danish: En sådan indvirkning af hydrochlorthiazid på serum-kalium kan dog forventes at blive forstærket af andre stoffer associeret med kaliumtab og hypokaliæmi (fx andre kalium-diuretika, laxantia, amphotericin, carbenoxolon, penicillin G natrium).
English: As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Danish: Som for alle patienter i diuretisk behandling, skal der med passende mellemrum foretages periodisk kontrol af serum-elektrolytter.
English: Anaphylactic reactions, toxic epidermal necrolysis, necrotizing angitis (vasculitis, cutaneous vasculitis), cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, photosensitivity reactions, rash, urticaria
Danish: Anafylaktiske reaktioner, toksisk epidermal nekrolyse, nekrotiserende angitis (vasculitis, kutan vasculitis), kutan lupus erythematosuslignende reaktioner, reaktivering af kutan lupus erythematosus, fotosensitivitetsreaktioner, udslæt, urticaria
English: No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a medicinal product metabolised by CYP2C9.
Danish: Der er ikke observeret signifikante farmakokinetiske eller farmakodynamiske interaktioner ved samtidig administration af irbesartan og warfarin, et lægemiddel, som metaboliseres af CYP2C9.
English: Rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan.
Danish: Der er indberettet sjældne tilfælde af allergiske hudreaktioner (udslæt, nældefeber) samt opsvulmet ansigt, læber og/eller tunge hos patienter, der har modtaget behandling med irbesartan.
English: Alcohol Potentiation of orthostatic hypotension may occur;
Danish: Alkohol Der kan forekomme forstærket ortostatisk hypotension;
English: While hydrochlorothiazide is a sulfonamide, only isolated cases of acute angle-closure glaucoma have been reported so far with hydrochlorothiazide.
Danish: Selvom hydrochlorthiazid er et sulfonamid, er der kun rapporteret om isolerede tilfælde af akut snævervinklet glaukom med hydrochlorthiazid.
English: See also information under the heading “Do not take Irbesartan/Hydrochlorothiazide Teva”.
Danish: Se også information under overskriften ”Tag ikke Irbesartan/Hydrochlorthiazid Teva”.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Danish: Der er blevet rapporteret reversibel øgning af serum-lithiumkoncentrationer og toksicitet ved samtidig administration af lithium og angiotensin-konverterende enzymhæmmere.
English: Calcium salts
Danish: Calciumsalte
English: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists.
Danish: Der er øget risiko for alvorlig hypotension og nyreinsufficiens, hvis patienter med bilateral nyrearteriestenose eller stenose af arterien til den eneste fungerende nyre, behandles med angiotensin-konverterende enzymhæmmere eller angiotensin-II-receptorantagonister.
English: It is also important to tell your doctor if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers, arthritis medicines, or colestyramine and colestipol resins for lowering blood cholesterol.
Danish: Det er også vigtigt at fortælle lægen, hvis du tager anden medicin for at nedsætte blodtrykket, steroider, kræftmedicin, smertestillende medicin, gigtmedicin, eller colestyramin og colestipolresiner til at sænke blodets kolesterol.
English: Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloremia, hyponatraemia) and dehydration resulting from excessive diuresis.
Danish: En overdosis af hydrochlorthiazid er associeret med elektrolyt-depletion (hypokaliæmi, hypochloræmi, hyponatriæmi) og dehydrering, der skyldes voldsom diurese.
English: Irbesartan/Hydrochlorothiazide Teva is unlikely to affect your ability to drive or use machines.
Danish: Irbesartan/Hydrochlorthiazid Teva påvirker sandsynligvis ikke din evne til at køre bil eller betjene maskiner.
English: The diuretic action of hydrochlorothiazide reduces plasma volume, increases plasma renin activity, increases aldosterone secretion, with consequent increases in urinary potassium and bicarbonate loss, and decreases in serum potassium.
Danish: Den diuretiske virkning af hydrochlorthiazid reducerer plasmavolumen, øger plasma-reninaktiviteten, øger aldosteronudskillelsen med heraf følgende øget urinært kalium- og bikarbonat-tab og nedsat serum-kalium.
English: Additional information on hydrochlorothiazide interactions When administered concurrently, the following medicinal products may interact with thiazide diuretics:
Danish: Yderligere information om hydrochlorthiazids interaktioner Ved samtidig administration kan følgende stoffer give anledning til interaktioner med thiaziddiuretika:
English: Pancreatitis, anorexia, diarrhoea, constipation, gastric irritation, sialadenitis, loss of appetite
Danish: Pancreatitis, anoreksi, diarré, forstoppelse, gastrisk irritation, sialoadenitis, tab af appetit
English: Adequate monitoring of serum potassium in patients at risk is recommended.
Danish: Adækvat monitorering af serum-kalium anbefales hos patienter i risikogruppen.
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Danish: Aorta- og mitralklapstenose, obstruktiv hypertrofisk kardiomyopati Som ved behandling med andre vasodilatorer skal der udvises ekstra forsigtighed hos patienter, der lider af aorta- eller mitralstenose eller obstruktiv hypertrofisk kardiomyopati.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne opstillet efter hvor alvorlige de er.
English: Other antihypertensive agents
Danish: Andre antihypertensive stoffer
English: Among 898 hypertensive patients who received various doses of irbesartan/hydrochlorothiazide (range: 37.5 mg/6.25 mg to 300 mg/25 mg) in placebo-controlled trials, 29.5% of the patients experienced adverse reactions.
Danish: Blandt 898 hypertensive patienter, der fik forskellige doser af irbesartan/hydrochlorthiazid (interval: 37,5 mg/6.25 mg til 300 mg/25 mg) i placebokontrollerede forsøg, oplevede 29,5 % af patienterne bivirkninger.
English: However, occasionally dizziness or weariness may occur during treatment of high blood pressure.
Danish: Men man kan opleve svimmelhed eller træthed, når man behandles for forhøjet blodtryk.
English: The combination of hydrochlorothiazide and irbesartan produces dose-related additive reductions in blood pressure across their therapeutic dose ranges.
Danish: Kombinationen af hydrochlorthiazid og irbesartan giver en dosisrelateret additiv reduktion af blodtrykket over hele det terapeutiske dosisinterval for de enkelte lægemidler.
English: The effect of the combination of irbesartan and hydrochlorothiazide on morbidity and mortality has not been studied.
Danish: Effekten af en kombinationsbehandling med irbesartan og hydrochlorthiazid på morbiditet og mortalitet er ikke undersøgt.
English: You should discontinue Irbesartan/Hydrochlorothiazide Teva treatment and seek medical attention.
Danish: Du skal stoppe behandlingen med Irbesartan/Hydrochlorthiazid Teva og søge lægehjælp.
English: While this is not documented with Irbesartan/Hydrochlorothiazide Teva, a similar effect should be anticipated.
Danish: Selvom dette ikke er dokumenteret for Irbesartan/Hydrochlorthiazid Teva, kan der forventes en tilsvarende effekt.
English: Carbamazepine
Danish: Carbamazepin
English: • slight decreases in erythrocyte parameters (erythrocytes, haemoglobin, haematocrit);
Danish: • let fald i erytrocytparametre (erytrocytter, hæmoglobin, hæmatokrit);
English: Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice seen as yellowing of the skin and/or whites of the eyes; inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which can result in frequent infections, fever; decrease in the number of platelets (a blood cell essential for the clotting of the blood), decreased number of red blood cells (anaemia) characterised by tiredness, headaches, being short of breath when exercising, dizziness and looking pale; kidney disease; lung problems including pneumonia or build-up of fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disease characterized by the peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasm; altered heart rate; reduced blood pressure after a change in body position; swelling of the salivary glands; high sugar levels in the blood; sugar in the urine; increases in some kinds of blood fat; high uric acid levels in the blood, which may cause gout.
Danish: Appetitmangel; maveirritation; mavekramper; forstoppelse; gulsot, hvor huden og/eller det hvide i øjnene bliver gulfarvet; bugspytkirtelbetændelse, med stærke smerter i øvre maveregion, ofte forbundet med kvalme og opkastning; søvnproblemer; depression; sløret syn; mangel på hvide blodceller, som kan resultere i hyppige infektioner; feber; nedsat antal blodplader (blodceller, som er nødvendige for, at blodet kan størkne); nedsat antal af røde blodceller (blodmangel), som karakteriseres ved træthed, hovedpine, forpustethed ved motion, svimmelhed og bleghed; nyresygdom; lungeproblemer, inklusive lungebetændelse og væske i lunger; øget følsomhed af huden for sol; årebetændelse; hudsygdom som karakteriseres ved afskalning af huden over hele kroppen; kutan lupus erythematosus, som ses i form af udslæt i ansigt, på hals og i hovedbund; allergiske reaktioner; svækkelse og muskelkramper; ændring i puls; nedsat blodtryk efter ændringer i kropsstilling; hævelse af spytkirtler; højt sukkerindhold i blodet; sukker i urinen; øgning i bestemte typer af fedt i blod; høj mængde urinsyre i blodet, som kan lede til gigt.
English: Cases of photosensitivity reactions have been reported with thiazides diuretics (see section 4.8).
Danish: Der er rapporteret fotosensitivitetsreaktioner med thiaziddiuretika (se pkt.
English: Irbesartan/Hydrochlorothiazide Teva is not recommended for use in children and adolescents because the safety and efficacy have not been established.
Danish: Irbesartan/Hydrochlorthiazid Teva frarådes til behandling af børn og unge , da sikkerhed og virkning ikke er klarlagt.
English: Hypokalaemia may result in muscle spasms and/or accentuate cardiac arrhythmias associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products.
Danish: Hypokaliæmi kan medføre muskelkramper og/eller medvirke til kardiel arytmi, som er forbundet med samtidig anvendelse af digitalisglykosider eller visse antiarytmiske lægemidler.
English: The pharmacokinetic of digoxin was not altered by co-administration of irbesartan.
Danish: Digoxins farmakokinetik blev ikke ændret ved samtidig administration af irbesartan.
English: Untreated acute angle-closure glaucoma can lead to permanent vision loss.
Danish: Ubehandlet akut snævervinklet glaukom kan medføre permanent synstab.
English: Do not use this medicine after the expiry date that is stated on the carton and on the blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og blisterpakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Irbesartan/Hydrochlorothiazide Teva is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Danish: Irbesartan/Hydrochlorthiazid Teva frarådes til ammende mødre, og lægen vil sædvanligvis vælge en anden behandling til dig, hvis du ønsker at amme dit barn, især hvis dit barn er nyfødt eller født for tidligt.
English: Renal impairment and kidney transplantation
Danish: Nedsat nyrefunktion og nyretransplantation
English: Forty-seven percent (47.2 %) of patients on the combination achieved trough SeDBP < 90 mmHg compared to 33.2 % of patients on irbesartan (p = 0.0005).
Danish: 47,2 % af patienterne i kombinationsbehandling nåede et dal-SeDBT < 90 mm Hg sammenlignet med 33,2 % af patienterne behandlet med irbesartan (p = 0,0005).
English: Co-administration of thiazide diuretics may increase the incidence of hypersensitivity reactions to allopurinol;
Danish: Samtidig administration af thiaziddiuretika kan øge hyppigheden af overfølsomhedsreaktioner over for allopurinol;
English: The MAH shall complete, within the stated timeframe, the below measures:
Danish: Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: Abnormal urination Impaired renal function including isolated cases of renal failure in patients at risk (see section 4.4)
Danish: Nedsat nyrefunktion inklusive isolerede tilfælde af nyresvigt hos risikopatienter (se pkt.
English: The CHMP, as a consequence, considers that the benefit-risk balance of products containing candesartan, irbesartan, losartan, olmesartan, valsartan remains favourable subject to the conditions described above.
Danish: CHMP finder følgelig, at benefit/risk-forholdet for lægemidler, der indeholder candesartan, irbesartan, losartan, olmesartan eller valsartan, fortsat er positivt under forudsætning af, at de nævnte betingelser opfyldes.
English: Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with irbesartan and hydrochlorothiazide combinations.
Danish: Derudover reducerer thiazider nyreclearance af lithium og dermed øges risikoen for lithiumtoksicitet ved behandling med kombinationer af irbesartan og hydrochlorthiazid.
English: Concomitant administration of hydrochlorothiazide and irbesartan has no effect on the pharmacokinetics of either medicinal product.
Danish: Samtidig administration af hydrochlorthiazid og irbesartan har ingen effekt på de 2 lægemidlers farmakokinetik.
English: Colestyramine and Colestipol resins
Danish: Colestyramin og colestipolresiner
English: Non-steroidal anti-inflammatory drugs
Danish: Nonsteroide antiinflammatoriske lægemidler
English: Dosage adjustments of antigout medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Danish: Det kan være nødvendigt at justere dosis af lægemidlet mod arthritis urica, da hydrochlorthiazid kan øge niveauet af urinsyre i serum.
English: Protect your skin from sun exposure and UV rays while taking Irbesartan/Hydrochlorothiazide Teva
Danish: Beskyt huden mod sollys og UV-stråler, mens du tager Irbesartan/Hydrochlorthiazid Teva.
English: Syncope, hypotension, tachycardia, oedema
Danish: Synkope, hypotension, takykardi, ødem