FrancophonIA/ELRC3.0 huggingface dataset:
English: Nondepolarizing skeletal muscle relaxants (e.g. tubocurarine) The effect of nondepolarizing skeletal muscle relaxants may be potentiated by hydrochlorothiazide;
Danish: Nondepolariserende skelet/muskel-relaksanter (fx tubocurarin) Virkningen af nondepolariserende skelet/muskel-relaxanter kan forstærkes af hydrochlorthiazid;
English: Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled trials.
Danish: Tabel 1 viser hyppigheden af bivirkninger rapporteret efter markedsføring og bivirkninger observeret i placebokontrollerede studier.
English: Most of the above mentioned effects appear to be due to the pharmacological activity of irbesartan (blockade of angiotensin-II-induced inhibition of renin release, with stimulation of the renin-producing cells) and occur also with angiotensin converting enzyme inhibitors.
Danish: De fleste af de nævnte virkninger synes at være forårsaget af irbesartans farmakologiske aktivitet (blokering af angiotensin-II-induceret hæmning af reninudskillelse, med stimulation af de reninproducerende celler).
English: This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1).
Danish: Denne faste dosiskombination er indiceret til voksne patienter, hvis blodtryk ikke kan reguleres tilstrækkeligt med irbesartan eller hydrochlorthiazid alene (se pkt.
English: Thiazide diuretics may increase serum calcium levels due to decreased excretion.
Danish: Thiaziddiuretika kan øge serum-calciumniveauet på grund af nedsat udskillelse.
English: Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (hypokalaemia, hyponatraemia, and hypochloremic alkalosis).
Danish: Thiazider, inklusive hydrochlorthiazid, kan medføre væske- eller elektrolytforstyrrelser (hypokaliæmi, hyponatriæmi og hypochloræmisk alkalose).
English: Patients taking HCTZ should be informed of the risk of NMSC and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions.
Danish: Patienter, der tager hydrochlorthiazid, skal informeres om risikoen for non-melanom hudkræft og have at vide, at de skal tjekke deres hud regelmæssigt for nye læsioner og straks kontakte lægen, hvis de observerer mistænkelige hudlæsioner.
English: Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with irbesartan may reduce diuretic-induced hypokalaemia.
Danish: Selvom thiaziddiuretika kan udvikle hypokaliæmi, kan samtidig behandling med irbesartan reducere diuretika-induceret hypokaliæmi.
English: Diuretic agents such as the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiaizde Teva may have an effect on other medicines.
Danish: Vanddrivende stoffer som hydrochlorthiazider, der findes i Irbesartan/Hydrochlorthiazid Teva, kan påvirke anden medicin.
English: The potassium-depleting effect of hydrochlorothiazide is attenuated by the potassium-sparing effect of irbesartan.
Danish: Den kalium-depleterende virkning af hydrochlorthiazid dæmpes af irbesartans kalium-besparende effekt.
English: Symptomatic hypotension may be expected to occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Danish: Symptomatisk hypotension kan forventes at optræde hos patienter med hypovolæmi og/eller hyponatriæmi forårsaget af kraftig diuretisk behandling, nedsat saltindtag gennem kosten, diarré eller opkastning.
English: Hypotension - Volume-depleted patients
Danish: Hypotension - patienter med hypovolæmi
English: You must tell your doctor if you think you are (or might become) pregnant.
Danish: Du skal fortælle det til din læge, hvis du tror du er gravid eller planlægger at blive gravid.
English: These findings appear to have no relevance to the use of therapeutic doses of irbesartan/hydrochlorothiazide in humans.
Danish: Disse fund synes ikke at have relevans ved anvendelse af terapeutiske doser af irbesartan/hydrochlorthiazid til mennesker.
English: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan/Hydrochlorothiazide Teva” and “Warnings and precautions”).
Danish: Hvis du samtidig tager en ACE-hæmmer eller aliskiren (se også information under overskrifterne ”Tag ikke Irbesartan/Hydrochlorthiazid Teva” og ”Advarsler og forsigtighedsregler”).
English: Pregnancy and breast-feeding Pregnancy
Danish: Graviditet og amning Graviditet
English: No dosage adjustment is necessary in older people.
Danish: Dosisjustering er ikke nødvendig hos ældre patienter.
English: The combination of these ingredients has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Danish: Kombinationen af disse stoffer medfører en større reduktion af blodtrykket, end der opnås med hver komponent alene.
English: In diabetic patients dosage adjustments of insulin or oral hypoglycemic agents may be required.
Danish: Hos diabetespatienter kan være nødvendig at justere dosis af insulin og af orale hypoglykæmiske lægemidler.
English: Cases of hypersensitivity reactions such as angioedema, rash, urticaria
Danish: Tilfælde af overfølsomhedsreaktioner som fx angioødem, udslæt og urticaria
English: If you experience these, talk to your doctor before attempting to drive or use machines.
Danish: Hvis du bliver svimmel eller træt, skal du tale med lægen, inden du kører bil eller betjener maskiner.
English: In vitro studies indicate that irbesartan is primarily oxidised by the cytochrome P450 enzyme CYP2C9; isoenzyme CYP3A4 has negligible effect.
Danish: In vitro-undersøgelser viser, at irbesartan primært oxideres af cytokrom P450-enzymet CYP2C9.
English: White opaque PVC-PVdC - Aluminium blisters or Aluminium - Aluminium blisters.
Danish: Hvide, uigennemsigtige PVC-PVdC - Aluminiumblistere eller Aluminium - Aluminiumblistere.
English: The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
Danish: Anvendelsen af AIIRA'er er kontraindiceret under graviditetens andet og tredje trimester (se pkt.
English: When Irbesartan/Hydrochlorothiazide Teva is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Danish: Når Irbesartan/Hydrochlorthiazid Teva anvendes til patienter med nedsat nyrefunktion, anbefales periodisk monitorering af serum-kalium, serum-kreatinin og serum-urinsyre-niveauer.
English: Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnaesemia.
Danish: Der er ved behandling med thiazider påvist øget urinudskillelse af magnesium, som kan medføre hypomagnesiæmi.
English: Management depends on the time since ingestion and the severity of the symptoms.
Danish: Behandlingen afhænger af, hvor længe det er siden, stoffet blev indtaget og graden af symptomer.
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for products containing candesartan, irbesartan, losartan, olmesartan, valsartan.
Danish: CHMP anbefaler derfor ændring af betingelserne for markedsføringstilladelserne for lægemidler indeholdende candesartan, irbesartan, losartan, olmesartan eller valsartan.
English: Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Danish: Croscarmellosenatrium Kolloid vandfri silica Magnesiumstearat
English: Irbesartan/Hydrochlorothiazide Teva is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.
Danish: Irbesartan/Hydrochlorthiazid Teva bruges til at behandle forhøjet blodtryk, når behandling med irbesartan eller hydrochlorthiazid hver for sig ikke har givet tilstrækkelig kontrol over blodtrykket.
English: Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Danish: Hvis der er givet AIIRA'er under graviditetens andet trimester, anbefales ultralydskontrol af nyrefunktionen og kraniet.
English: Uncommon side effects (may affect up to 1 in 100 people): diarrhoea low blood pressure fainting heart rate increased flushing swelling sexual dysfunction (problems with sexual performance) blood tests may show lowered levels of potassium and sodium in your blood.
Danish: Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 patienter) diarré lavt blodtryk besvimelse hjertebanken rødmen hævelse problemer med seksuel formåen blodprøver kan vise nedsat mængde af kalium og natrium i blodet.
English: The recommended dose of Irbesartan/Hydrochlorothiazide Teva is one or two tablets a day.
Danish: Den anbefalede dosis af Irbesartan/Hydrochlorthiazid Teva er en eller to tabletter dagligt.
English: When irbesartan is administered concomitantly with a low dose of hydrochlorothiazide (e.g. 12.5 mg daily), the antihypertensive response in black patients approaches that of non-black patients.
Danish: Når irbesartan administreres samtidig med en lille dosis hydrochlorthiazid (fx 12,5 mg dagligt), nærmer det antihypertensive respons hos sorte patienter sig det, der ses hos hvide.
English: Irbesartan/Hydrochlorothiazide Teva should be taken at least one hour before or four hours after these medications;
Danish: Absorption af hydrochlorthiazid nedsættes ved tilstedeværelse af anione resiner; Irbesartan/Hydrochlorthiazid Teva bør tages mindst en time før eller fire timer efter disse lægemidler;
English: Irbesartan and hydrochlorothiazide (at doses up to 300 mg irbesartan/25 mg hydrochlorothiazide) have been safely administered with other antihypertensive agents including calcium channel blockers and beta-adrenergic blockers.
Danish: Irbesartan og hydrochlorthiazid (i doser på op til 300 mg irbesartan/25 mg hydrochlorthiazid) er administreret samtidig med andre antihypertensive stoffer, inklusive calciumkanalblokkere og beta-adrenerge blokkere, uden problemer.
English: Although equivocal evidence for a genotoxic or carcinogenic effect was found in some experimental models, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
Danish: Selvom der er fundet modstridende resultater vedrørende genotoksisk eller karcinogen effekt, har det, på trods af et stort humant materiale, ikke været muligt at påvise en sammenhæng mellem anvendelse af hydrochlorthiazid og en stigning i antallet af neoplasmer.
English: Metabolism and nutrition disorders:
Danish: Metabolisme og ernæring
English: Irbesartan/Hydrochlorothiazide Teva is not recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Danish: Irbesartan/Hydrochlorthiazid Teva bør ikke tages under graviditet, og må ikke tages, hvis du er længere end 3 måneder henne i graviditeten, da det kan skade dit barn alvorligt, hvis det tages efter tredje måned af graviditeten.
English: Limit in ppm in API
Danish: Grænseværdi i ppm i det aktive stof
English: In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure (see section 4.5).
Danish: Hos patienter, hvis vaskulære tonus og nyrefunktion hovedsageligt afhænger af renin-angiotensin-aldosteronsystemets aktivitet (fx patienter med alvorlig hjerteinsufficiens eller underliggende nyresygdom, inklusive nyrearteriestenose), er behandling med angiotensin-konverterende enzymhæmmere eller angiotensin-II-receptorantagonister, der påvirker dette system, blevet forbundet med akut hypotension, azotæmi, oliguri og i sjældne tilfælde akut nyresvigt (se pkt.
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Danish: Epidemiologiske data vedrørende risikoen for teratogenicitet efter anvendelse af ACE-hæmmere under graviditetens første trimester er ikke entydige.
English: Available pharmacodynamic/toxicological data in rats have shown excretion of irbesartan or its metabolites in milk (for details see 5.3).
Danish: De tilgængelige farmakodynamiske/toksikologiske data fra rotteforsøg viser, at irbesartan eller dets metabolitter udskilles i mælk (se pkt.
English: Due to the hydrochlorothiazide component, Irbesartan/Hydrochlorothiazide Teva is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/min).
Danish: På grund af hydrochlorthiazid-komponenten anbefales Irbesartan/Hydrochlorthiazid Teva ikke til patienter med alvorlig nyreinsufficiens (kreatininclearance < 30 ml/min).
English: As with any anti-hypertensive agent, excessive blood pressure decrease in patients with ischemic cardiopathy or ischemic cardiovascular disease could result in a myocardial infarction or stroke.
Danish: Ved behandling med et antihypertensivt stof kan en voldsom sænkning af blodtrykket hos patienter med iskæmisk kardiopati eller iskæmisk kardiovaskulær sygdom medføre myokardieinfarkt eller slagtilfælde.
English: Pharmachemie B.V. Swensweg 5
Danish: Pharmachemie B.V.
English: Manufacturers:
Danish: Fremstiller:
English: The antihypertensive effect of Irbesartan/Hydrochlorothiazide Teva may be increased with the concomitant use of other antihypertensive agents.
Danish: Den antihypertensive virkning af Irbesartan/Hydrochlorthiazid Teva kan øges ved samtidig administration af andre antihypertensive stoffer.
English: Medicinal products affecting potassium
Danish: Lægemidler, der påvirker kalium
English: Anticholinergic agents (e.g. atropine, beperiden) may increase the bioavailability of thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate.
Danish: Antikolinerge stoffer (fx atropin, biperiden) kan øge biotilgængeligheden af thiaziddiuretika ved at nedsætte den gastrointestinale bevægelighed og ventrikeltømningshastigheden.
English: Common side effects (may affect up to 1 in 10 people): nausea/vomiting abnormal urination fatigue dizziness (including when getting up from a lying or sitting position) blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine).
Danish: Almindelige bivirkninger (kan påvirke op til 1 ud af 10 patienter) kvalme/opkastning unormal vandladning træthed svimmelhed (også når man rejser sig fra liggende eller siddende stilling) blodprøver, der viser en forhøjet mængde af et enzym, der måler muskel- og hjertefunktionen (kreatinkinase) eller stigning i stoffer, som måler nyrefunktionen (carbamid, kreatinin).
English: Since Irbesartan/Hydrochlorothiazide Teva contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy.
Danish: Irbesartan/Hydrochlorothiazide Teva indeholder hydroclorthiazid og kan derfor ikke anbefales under graviditetens første trimester.
English: For Irbesartan/Hydrochlorothiazide Teva packaged in aluminium - aluminium blisters: This medicinal product does not require any special storage conditions.
Danish: Irbesartan/Hydrochlorthiazid Teva pakket i aluminium-aluminiumblistere: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: The hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test.
Danish: Doping-test Indholdet af hydrochlorthiazid i dette lægemiddel kan medføre et positivt fund ved en doping-test.
English: Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended.
Danish: Højere doser end 300 mg irbesartan/25 mg hydrochlorthiazid, 1 gang dagligt, frarådes.
English: Tell your doctor if you are breast-feeding or about to start breast-feeding.
Danish: Fortæl det til lægen, hvis du ammer eller skal begynde at amme.
English: In a study, somewhat higher plasma concentrations of irbesartan were observed in female hypertensive patients.
Danish: Der er i en undersøgelse med kvindelige, hypertensive patienter observeret noget højere plasmakoncentrationer af irbesartan.
English: There was no evidence of mutagenicity or clastogenicity with the irbesartan/hydrochlorothiazide combination.
Danish: Der var ingen tegn på mutagenicitet eller clastogenicitet med irbesartan/hydrochlorthiazidkombinationen.
English: Medicinal products affected by serum potassium disturbances Periodic monitoring of serum potassium is recommended when Irbesartan/Hydrochlorothiazide Teva is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics).
Danish: Lægemidler, der påvirkes af serum-kaliumforstyrrelser Det anbefales at måle serum-kalium periodisk, når Irbesartan/Hydrochlorthiazid Teva administreres sammen med lægemidler, der påvirkes af serum-kaliumforstyrrelser (fx digitalisglykosider, antiarytmika).
English: Antidiabetic medicinal products (oral agents and insulins) Dosage adjustment of the antidiabetic medicinal product may be required (see section 4.4);
Danish: Antidiabetika (orale stoffer og insuliner) Det kan være nødvendigt at dosisjustere den antidiabetiske behandling (se pkt.
English: if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Danish: • hvis du har sukkersyge eller nedsat nyrefunktion, og du også tager et blodtrykssænkende lægemiddel, der indeholder aliskiren.
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
Danish: Ved konstateret graviditet, bør behandling med AIIRA'er seponeres øjeblikkeligt, og hvis det skønnes hensigtsmæssigt bør anden behandling iværksættes.
English: The two active ingredients in Irbesartan/Hydrochlorothiazide Teva work together to lower blood pressure further than if either was given alone.
Danish: Når de to aktive stoffer i Irbesartan/Hydrochlorthiazid Teva gives samtidigt, er deres effekt på blodtrykket større, end hvis de blev givet hver for sig.
English: No specific information is available on the treatment of overdose with irbesartan and hydrochlorothiazide combinations.
Danish: Der foreligger ikke specifikke oplysninger om behandling af overdosering med kombinationer af irbesartan og hydrochlorthiazid.
English: In patients not adequately controlled on 25 mg hydrochlorothiazide alone, the addition of irbesartan gave an added placebo-subtracted systolic/diastolic mean reduction of 11.1/7.2 mmHg.
Danish: Hos patienter, der ikke var tilstrækkeligt kontrolleret med 25 mg hydrochlorthiazid alene, gav et tillæg af irbesartan en yderligere placebo-korrigeret systolisk/diastolisk gennemsnitlig reduktion på 11,1/7,2 mm Hg.
English: Irbesartan/Hydrochlorothiazide Teva can be taken once daily, with or without food.
Danish: Irbesartan/Hydrochlorthiazid Teva kan administreres 1 gang dagligt med eller uden samtidig fødeindtagelse.
English: Pack sizes of 7, 14, 15, 20, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets in non-perforated blisters.
Danish: Pakningsstørrelser a 7, 14, 15, 20, 28, 30, 56, 60, 84, 90, 98 og 100 filmovertrukne tabletter i ikkeperforerede blisterpakninger.
English: Transient blurred vision, xanthopsia, acute myopia and secondary acute angle-closure glaucoma
Danish: Forbigående sløret syn, xanthopsia, akut myopi og sekundært snævervinklet glaukom
English: Thiazide therapy may impair glucose tolerance.
Danish: Thiazidbehandling kan svække glukosetolerancen.
English: Thiazide diuretic-associated azotaemia may occur in patients with impaired renal function.
Danish: Der kan forekomme thiaziddiuretika-associeret azotæmi hos patienter med nedsat nyrefunktion.
English: The use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4).
Danish: AIIRA'er bør ikke anvendes under graviditetens første trimester (se pkt.
English: Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.
Danish: Der kan forekomme overfølsomhedsreaktioner over for hydrochlorthiazid hos patienter med eller uden allergisk eller bronkial astma-anamnese.
English: Hydrochlorothiazide contained in this medicinal product could produce a positive analytic result in an anti-doping test.
Danish: Indholdet af hydrochlorthiazid i medicinen kan give et positivt analysesvar ved dopingtest.
English: Food does not affect the bioavailability of irbesartan/hydrochlorothiazide.
Danish: Fødeindtagelse påvirker ikke biotilgængeligheden af irbesartan/hydrochlorthiazid.
English: General disorders and administration site conditions:
Danish: Almene symptomer og reaktioner på administrationsstedet
English: Irbesartan and its metabolites are eliminated by both biliary and renal pathways.
Danish: Irbesartan og dets metabolitter udskilles gennem både galde og nyrer.
English: Exposure to AIIRAs therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Danish: Der er kendt at behandling med AIIRA'er under andet og tredje trimester kan inducere human føtotoksicitet (nedsat nyrefunktion, oligohydramnios, hæmning af kraniets ossifikation) og neonatal toksicitet (nyresvigt, hypotension, hyperkaliæmi) (se pkt.
English: The effects of the irbesartan/hydrochlorothiazide combination on fertility have not been evaluated in animal studies, as there is no evidence of adverse effect on fertility in animals or humans with either irbesartan or hydrochlorothiazide when administered alone.
Danish: Effekten af kombinationen af irbesartan og hydrochlorthiazid på fertilitet er ikke evalueret i dyrestudier, da der ikke har været tegn på skadelig effekt på fertiliteten hos dyr eller mennesker med de individuelle stoffer.
English: Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Danish: Det bør overvejes at monitorere nyrefunktionen efter samtidig behandling er initieret og periodisk derefter.
English: The degree to which hydrochlorothiazide is removed by haemodialysis has not been established.
Danish: Det er ikke fastlagt i hvor stor udstrækning hydrochlorthiazid fjernes ved hæmodialyse.
English: Based on its pharmacodynamic properties, Irbesartan/Hydrochlorothiazide Teva is unlikely to affect the ability to drive and use machines.
Danish: På baggrund af de farmakodynamiske egenskaber er det dog usandsynligt, at Irbesartan/Hydrochlorthiazid Teva vil påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Such conditions should be corrected before initiating therapy with Irbesartan/Hydrochlorothiazide Teva.
Danish: Sådanne tilstande skal korrigeres inden initiering af behandling med Irbesartan/Hydrochlorthiazid Teva.
English: No dosage adjustment is necessary in patients with renal impairment whose creatinine clearance is ≥ 30 ml/min.
Danish: Det er ikke nødvendigt at justere dosis hos patienter med nedsat nyrefunktion, hvis kreatininclearance er ≥ 30 ml/min.
English: Skin and subcutaneous tissue disorders:
Danish: Hud og subkutane væv