FrancophonIA/ELRC3.0 huggingface dataset:
English: Since Irbesartan Hydrochlorothiazide Zentiva contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy.
Danish: Irbesartan Hydrochlorothiazide Zentiva indeholder hydrochlorthiazid og kan derfor ikke anbefales under graviditetens første trimester.
English: Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with Irbesartan Hydrochlorothiazide Zentiva.
Danish: Derudover reducerer thiazider nyreclearance af lithium og dermed øges risikoen for lithium toksicitet ved behandling med Irbesartan Hydrochlorothiazide Zentiva.
English: Your doctor will instruct you how to switch from the previous treatment to Irbesartan Hydrochlorothiazide Zentiva.
Danish: Lægen vil forklare, hvordan du skifter fra den tidligere behandling til behandling med Irbesartan Hydrochlorothiazide Zentiva.
English: Non-steroidal anti-inflammatory drugs: 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: Nonsteroide antiinflammatoriske lægemidler: 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: General: 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, azotemia, oliguria, or rarely acute renal failure (see Section 4.5).
Danish: Generelt: Hos patienter, hvis vaskulære tonus og nyrefunktion hovedsageligt afhænger af reninangiotensin-aldosteronsystemets aktivitet (fx patienter med alvorlig hjerteinsufficiens eller underliggende nyresygdom, inklusive nyrearteriestenose), er behandling med angiotensinkonverterende 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: You should also tell your doctor: if you are on a low-salt diet if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan Hydrochlorothiazide Zentiva) if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal if you are going to have an operation (surgery) or be given anaesthetics if you have changes in your vision or pain in one or both of your eyes while taking Irbesartan Hydrochlorothiazide Zentiva.
Danish: Du skal også oplyse lægen om det: hvis du er på en saltfattig diæt hvis du har symptomer som voldsom tørst, mundtørhed, følelse af svaghed, sløvhed, muskelsmerter eller -kramper, kvalme, opkastning eller en voldsom hjertebanken, som kan være tegn på for kraftig effekt af hydrochlorthiazid (der er indeholdt i Irbesartan Hydrochlorothiazide Zentiva) hvis du oplever øget følsomhed af huden for sol med solskoldningssymptomer (såsom rødme, kløe, hævelse, blæredannelse), som forekommer hurtigere end normalt hvis du skal opereres eller bedøves hvis dit syn ændrer sig, eller du får smerter i et af eller begge dine øjne, mens du tager Irbesartan Hydrochlorothiazide Zentiva.
English: Because no information is available regarding the use of Irbesartan Hydrochlorothiazide Zentiva during breast-feeding, Irbesartan Hydrochlorothiazide Zentiva 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 foreligger oplysninger om anvendelse af Irbesartan Hydrochlorothiazide Zentiva under amning, frarådes brugen af Irbesartan Hydrochlorothiazide Zentiva, og andre behandlinger med en mere veletableret sikkerhedsprofil for anvendelse under amning foretrækkes.
English: Irbesartan Hydrochlorothiazide Zentiva is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
Danish: Irbesartan Hydrochlorothiazide Zentiva er en kombination af en angiotensin-II receptorantagonist, irbesartan, og et thiaziddiuretikum, hydrochlorthiazid.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
Danish: To store randomiserede, kontrollerede studier (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) og VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) har undersøgt samtidig brug af kombinationen af en ACE-hæmmer og en angiotensin-II-receptorblokker.
English: Other medicines and Irbesartan Hydrochlorothiazide Zentiva Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Irbesartan Hydrochlorothiazide Zentiva Fortæl det altid til lægen eller apotekspersonalet, hvis du tager, anden medicin eller har gjort det for nylig.
English: The recommended dose of Irbesartan Hydrochlorothiazide Zentiva is one tablet a day.
Danish: Den anbefalede dosis af Irbesartan Hydrochlorothiazide Zentiva er en tablet dagligt.
English: Food does not affect the bioavailability of Irbesartan Hydrochlorothiazide Zentiva.
Danish: Fødeindtagelse påvirker ikke biotilgængeligheden af Irbesartan Hydrochlorothiazide Zentiva.
English: Protect your skin from sun exposure and UV rays while taking Karvezide.
Danish: Beskyt huden mod sollys og UV
English: A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/hydrochlorothiazide 150 mg/12.5 mg or to irbesartan 150 mg and systematically force-titrated (before assessing the response to the lower dose) after one week to irbesartan/hydrochlorothiazide 300 mg/25 mg or irbesartan 300 mg, respectively.
Danish: Ialt 697 patienter randomiseredes i forholdet 2:1 til irbesartan/hydrochlorothiazid 150 mg/12,5 mg eller irbesartan 150 mg, og med systematisk titrering (inden evaluering af respons på den lavere dosis) efter 1 uge til henholdsvis irbesartan/hydrochlorothiazid 300 mg/25 mg eller irbesartan 300 mg.
English: Such conditions should be corrected before initiating therapy with Irbesartan Hydrochlorothiazide Zentiva.
Danish: Sådanne tilstande skal korrigeres inden initiering af behandling med Irbesartan Hydrochlorothiazide Zentiva.
English: Irbesartan Hydrochlorothiazide Zentiva is not recommended in early 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 Hydrochlorothiazide Zentiva bør ikke tages i den tidlige 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: Irbesartan Hydrochlorothiazide Zentiva can be taken once daily, with or without food.
Danish: Irbesartan Hydrochlorothiazide Zentiva kan administreres 1 gang dagligt med eller uden samtidig fødeindtagelse.
English: (It is also better to avoid Irbesartan Hydrochlorothiazide Zentiva in early pregnancy - see pregnancy section) if you have severe liver or kidney problems if you have difficulty in producing urine if your doctor determines that you have persistently high calcium or low potassium levels in your blood if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Danish: (Du bør heller ikke tage Irbesartan Hydrochlorothiazide Zentiva i begyndelsen af graviditeten - se afsnittet om graviditet) hvis du har alvorlige lever- eller nyreproblemer (spørg lægen, hvis du er i tvivl) hvis du har problemer med urinproduktionen hvis din læge har konstateret, at du har konstant forhøjet calcium eller lavt kalium i blodet hvis du har diabetes eller nedsat nyrefunktion, og du bliver behandlet med et lægemiddel, der sænker blodtrykket, som indeholder aliskiren
English: Medicinal products affected by serum potassium disturbances: periodic monitoring of serum potassium is recommended when Irbesartan Hydrochlorothiazide Zentiva 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 Hydrochlorothiazide Zentiva administreres sammen med lægemidler, der påvirkes af serum-kaliumforstyrrelser (fx digitalis glykosider, antiarytmika).
English: Irbesartan Hydrochlorothiazide Zentiva is not indicated in patients with severe hepatic impairment.
Danish: Irbesartan Hydrochlorothiazide Zentiva er ikke indiceret til patienter med svært nedsat leverfunktion.
English: Your doctor will normally advise you to stop taking Irbesartan Hydrochlorothiazide Zentiva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan Hydrochlorothiazide Zentiva.
Danish: Din læge vil normalt anbefale, at du stopper med at tage Irbesartan Hydrochlorothiazide Zentiva, inden du bliver gravid, eller så snart du ved, at du er gravid.
English: Side effects reported in clinical studies for patients treated with Irbesartan Hydrochlorothiazide Zentiva were:
Danish: Følgende bivirkninger er indberettet i medicinske forsøg med patienter, som fik Irbesartan Hydrochlorothiazide Zentiva:
English: Due to the hydrochlorothiazide component, Irbesartan Hydrochlorothiazide Zentiva is not recommended for patients with severe renal dysfunction (creatinine clearance <30 ml/min).
Danish: På grund af hydrochlorthiazid-komponenten anbefales Irbesartan Hydrochlorothiazide Zentiva ikke til patienter med alvorlig nyreinsufficiens (kreatininclearance < 30 ml/min).
English: There is no experience regarding the administration of Irbesartan Hydrochlorothiazide Zentiva in patients with a recent kidney transplantation.
Danish: Der er ingen erfaring med administration af Irbesartan Hydrochlorothiazide Zentiva til nyligt nyretransplanterede patienter.
English: Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in Irbesartan Hydrochlorothiazide Zentiva, minimal or no effects were reported.
Danish: Thiazidbehandling er associeret med forhøjede kolesterol- og triglycerid-niveauer, Der er dog rapporteret minimal eller ingen effekt ved en dosis på 12,5 mg som findes i Irbesartan Hydrochlorothiazide Zentiva.
English: Anti-doping test: hydrochlorothiazide contained in this medicinal product could produce a positive analytic 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: There is no difference in response to Irbesartan Hydrochlorothiazide Zentiva, regardless of age or gender.
Danish: Virkningen af Irbesartan Hydrochlorothiazide Zentiva afhænger ikke af alder eller køn.
English: Preparations containing lithium should not be taken with Irbesartan Hydrochlorothiazide Zentiva without close supervision by your doctor.
Danish: Tag ikke medicin, der indeholder lithium, samtidig med at du tager Irbesartan Hydrochlorothiazide Zentiva uden grundig vejledning fra lægen.
English: Potassium-sparing diuretics, potassium supplements or potassiumcontaining salts substitutes should be co-administered cautiously with Irbesartan Hydrochlorothiazide Zentiva (see section 4.5).
Danish: Kaliumbesparende diuretika, kaliumtilskud eller kaliumholdige saltsubstitutioner skal derfor gives med forsigtighed sammen med Irbesartan Hydrochlorothiazide Zentiva (se pkt.
English: There is no clinical experience with Irbesartan Hydrochlorothiazide Zentiva in patients with hepatic impairment.
Danish: Der er ingen klinisk erfaring med Irbesartan Hydrochlorothiazide Zentiva hos patienter med nedsat leverfunktion.
English: No dosage adjustment of Irbesartan Hydrochlorothiazide Zentiva is necessary in older people.
Danish: Dosisjustering af Irbesartan Hydrochlorothiazide Zentiva til ældre personer er ikke nødvendig.
English: Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskirenis therefore not recommended ( see sections 4.5 and 5.1).
Danish: Dobbelt hæmning af RAAS ved kombination af ACE-hæmmere, angiotensin-II-receptorblokkere eller aliskiren anbefales derfor ikke (se pkt.
English: Due to the hydrochlorothiazide contained in Irbesartan Hydrochlorothiazide Zentiva, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, specially when getting up from a sitting position.
Danish: Hvis du drikker alkohol, mens du er i behandling med dette produkt, kan du opleve, at du bliver mere svimmel, især når du rejser dig op fra siddende stilling.
English: Irbesartan Hydrochlorothiazide Zentiva will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough.
Danish: Lægen vil sandsynligvis starte behandling med Irbesartan Hydrochlorothiazide Zentiva, hvis den tidligere behandling ikke sænkede dit blodtryk tilstrækkeligt.
English: Lithium: the combination of lithium and Irbesartan Hydrochlorothiazide Zentiva is not recommended (see section 4.5).
Danish: Lithium: Kombination af lithium og Irbesartan Hydrochlorothiazide Zentiva frarådes (se pkt.
English: Irbesartan Hydrochlorothiazide Zentiva is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Danish: Irbesartan Hydrochlorothiazide Zentiva frarådes tidligt i graviditeten, og du må ikke tage Irbesartan Hydrochlorothiazide Zentiva, hvis du er længere end 3 måneder henne i din graviditet, da det kan skade dit barn alvorligt, hvis det tages i denne periode (se afsnittet om graviditet).
English: Tables 2 and 3 below detail the adverse reactions reported with the individual components of Irbesartan Hydrochlorothiazide Zentiva.
Danish: Tabel 2 og 3 viser bivirkningerne af de individuelle stoffer i Irbesartan Hydrochlorothiazide Zentiva.
English: Lactose monohydrate Hypromellose Titanium dioxide Macrogol 3350
Danish: Lactosemonohydrat Hypromellose Titaniumdioxid (E 171) Macrogol 3350
English: Severe hepatic impairment, biliary cirrhosis and cholestasis The concomitant use of Irbesartan Hydrochlorothiazide Zentiva with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73 m²) (see sections4.5 and 5.1).
Danish: Alvorlig leverfunktionsnedsættelse, biliær cirrhose og cholestase Samtidig behandling med Irbesartan Hydrochlorothiazide Zentiva og aliskiren-holdige lægemidler er kontraindiceret til patienter med diabetes mellitus eller nedsat nyrefunktion (glomerulær filtrationshastighed (GFR) < 60 ml/min/1,73 m2 ) (se pkt.
English: What you need to know before you take Irbesartan Hydrochlorothiazide Zentiva
Danish: Det skal du vide, før du begynder at tage Irbesartan Hydrochlorothiazide Zentiva
English: What Irbesartan Hydrochlorothiazide Zentiva contains The active substances are irbesartan and hydrochlorothiazide.
Danish: Irbesartan Hydrochlorothiazide Zentiva indeholder: De aktive stoffer er irbesartan og hydrochlorthiazid.
English: Irbesartan Hydrochlorothiazide Zentiva is a combination of two active substances, irbesartan and hydrochlorothiazide.
Danish: Irbesartan Hydrochlorothiazide Zentiva indeholder en kombination af to aktive lægemidler, irbesartan og hydrochlorthiazid.
English: No dosage adjustment of Irbesartan Hydrochlorothiazide Zentiva is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Danish: Dosisjustering af Irbesartan Hydrochlorothiazide Zentiva til patienter med mild eller moderat leverfunktionsnedsættelse er ikke nødvendig (se pkt.
English: • decreases in serum potassium due to hydrochlorothiazide and partly prevented when hydrochlorothiazide was given in combination with irbesartan.
Danish: Disse læsioner blev ikke observeret hos makakaber; et fald i serum-kalium på grund af hydrochlorthiazid og delvis forebyggelse, når hydrochlorthiazid blev givet i kombination med irbesartan.
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: Therefore, the use of Irbesartan Hydrochlorothiazide Zentiva is not recommended.
Danish: Derfor frarådes brug af Irbesartan Hydrochlorothiazide Zentiva.
English: Common side effects (may affect more than 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: Do not throw awy any medicines via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet , toilettet eller skraldespanden.
English: The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3350, red, yellow and black ferric oxides, pregelatinized starch, carnauba wax.
Danish: Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose, croscarmellosenatrium, hypromellose, silica, magnesiumstearat, titaniumdioxid (E 171), macrogol 3350, rød, gul og sort jernoxid, prægelatiniseret majsstivelse, carnaubavoks.
English: How to take Irbesartan Hydrochlorothiazide Zentiva
Danish: Sådan skal du tage Irbesartan Hydrochlorothiazide Zentiva
English: MARKETING AUTHORISATION NUMBERS
Danish: Betingelser for markedsføringstilladelse
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: Therefore, the combination of lithium and Irbesartan Hydrochlorothiazide Zentiva is not recommended (see section 4.4).
Danish: Derfor frarådes kombination af lithium og Irbesartan Hydrochlorothiazide Zentiva (se pkt.
English: Please see section 2 “Irbesartan Hydrochlorothiazide Zentiva contains lactose”.
Danish: Se punkt 2 ”CoAprovel indeholder lactose”
English: The use of Irbesartan Hydrochlorothiazide Zentiva during breast feeding is not recommended.
Danish: Anvendelse af Irbesartan Hydrochlorothiazide Zentiva i ammeperioden frarådes.
English: The trough to peak effects measured by cuff during office visits were 68% and 76% for Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg and Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg, respectively.
Danish: Forholdet mellem den laveste og den maksimale effekt var henholdsvis 68% og 76% for Irbesartan Hydrochlorothiazide Zentiva 150 mg /12,5 mg og Irbesartan Hydrochlorothiazide Zentiva 300 mg /12,5 mg, når effekten blev målt med blodtryksmanchet ved kontrolbesøg.
English: if you get excessive vomiting or diarrhoea if you suffer from kidney problems or have a kidney transplant if you suffer from heart problems if you suffer from liver problems if you suffer from diabetes if you suffer from lupus erythematosus (also known as lupus or SLE) if you suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).
Danish: hvis du får hyppig opkastning eller diarré hvis du lider af nyreproblemer eller er nyretransplanteret hvis du lider af hjerteproblemer hvis du lider af leverproblemer hvis du lider af sukkersyge hvis du lider af erytematøs lupus (også kaldet lupus eller systemisk lupus erythematosus) hvis du lider af primær aldosteronisme (tilstand med høj produktion af hormonet aldosteron, som gør, at der ophobes natriumsalt i kroppen, og blodtrykket derfor stiger) hvis du tager en af følgende lægemidler, der anvendes til at behandle forhøjet blodtryk:
English: Severe hepatic impairment, biliary cirrhosis and cholestasis The concomitant use of Irbesartan Hydrochlorothiazide Zentiva with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73 m²) (see sections 4.5 and 5.1).
Danish: Samtidig behandling med Irbesartan Hydrochlorothiazide Zentiva og aliskiren-holdige lægemidler er kontraindiceret til patienter med diabetes mellitus eller nedsat nyrefunktion (glomerulær filtrationshastighed (GFR) < 60 ml/min/1,73 m2 ) (se pkt.
English: Corticosteroids, ACTH: electrolyte depletion, particularly hypokalaemia, may be increased; Digitalis glycosides: thiazide induced hypokalaemia or hypomagnaesemia favour the onset of digitalis-induced cardiac arrhythmias (see section 4.4);
Danish: Digitalisglykosider: Thiazidinduceret hypokaliæmi eller hypomagnesiæmi øger forekomsten af digitalisinducerede kardielle arytmier (se pkt.
English: • stomach discoloration, ulcers and focal necrosis of gastric mucosa were observed in few rats in a 6 months toxicity study at irbesartan 90 mg/kg/day, hydrochlorothiazide 90 mg/kg/day, and irbesartan/hydrochlorothiazide 10/10 mg/kg/day.
Danish:  i et 6 måneders toksicitetsstudie med irbesartan 90 mg/kg/dag, hydrochlorthiazid 90 mg/kg/dag, og irbesartan/hydrochlorthiazid 10/10 mg/kg/dag blev der observeret misfarvning, sår og fokal nekrose af ventrikelslimhinden hos rotter.