FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypotension - Volume-depleted patients: Irbesartan Hydrochlorothiazide BMS has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension.
Danish: Hypotension - patienter med hypovolæmi: Irbesartan Hydrochlorothiazide BMS er kun sjældent blevet associeret med symptomatisk hypotension hos hypertensive patienter uden andre risikofaktorer for hypotension.
English: Irbesartan Hydrochlorothiazide BMS 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 Hydrochlorothiazide BMS 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: Side effects reported since the launch of Irbesartan Hydrochlorothiazide BMS The frequency of these effects is not known.
Danish: Bivirkninger indberettet efter markedsføring af Irbesartan Hydrochlorothiazide BMS Hyppigheden af disse bivirkninger kendes ikke.
English: Children should not take Irbesartan Hydrochlorothiazide BMS Irbesartan Hydrochlorothiazide BMS should not be given to children under 18 years of age.
Danish: Børn må ikke bruge Irbesartan Hydrochlorothiazide BMS Irbesartan Hydrochlorothiazide BMS må ikke gives til børn under 18 år.
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 peroral absorption ved doser over 600 mg (2 gange den maksimale anbefalede dosis).
English: The PSUR cycle of Irbesartan Hydrochlorothiazide BMS is aligned with the cross-referred product, KARVEZIDE, until otherwise specified.
Danish: PSUR cyklus for Irbesartan Hydrochlorothiazide BMS er ioverenstemmelse med produktet KARVEZIDE som krydshenvises til, indtil andet er specificeret.
English: Cases of neonatal thrombocytopenia, or foetal or neonatal jaundice have been reported with maternal thiazide therapy.
Danish: Der er rapporteret tilfælde af neonatal trombocytopeni eller føtal/neonatal gulsot ved maternel thiazidbehandling.
English: If you take more Irbesartan Hydrochlorothiazide BMS than you should If you accidentally take too many tablets, contact your doctor immediately.
Danish: Hvis du har taget for meget Irbesartan Hydrochlorothiazide BMS Hvis du ved et uheld har taget for mange tabletter, skal du omgående kontakte lægen.
English: Based on its pharmacodynamic properties, Irbesartan Hydrochlorothiazide BMS is unlikely to affect this ability.
Danish: På baggrund af de farmakodynamiske egenskaber er det dog usandsynligt, at Irbesartan Hydrochlorothiazide BMS vil påvirke denne evne.
English: If you experience these, talk to your doctor before attempting to drive or use machines.
Danish: Hvis du oplever svimmelhed eller træthed, bør du tale med lægen, inden du kører bil eller betjener maskiner.
English: Like all medicines, Irbesartan Hydrochlorothiazide BMS can cause side effects, although not everybody gets them.
Danish: Irbesartan Hydrochlorothiazide BMS kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: If you get any of the above symptoms or get short of breath, stop taking Irbesartan Hydrochlorothiazide BMS and contact your doctor immediately.
Danish: Hvis du får et eller flere af disse symptomer eller får åndenød, skal du holde op med at tage Irbesartan Hydrochlorothiazide BMS og straks søge lægehjælp.
English: Irbesartan/hydrochlorothiazide combination:
Danish: Kombination af irbesartan/hydrochlorthiazid:
English: If you forget to take Irbesartan Hydrochlorothiazide BMS If you accidentally miss a daily dose, just take the next dose as normal.
Danish: Hvis du har glemt at tage Irbesartan Hydrochlorothiazide BMS Hvis du har glemt at tage en dosis, skal du blot tage den næste til sædvanlig tid.
English: Hydrochlorothiazide: 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: Hydrochlorthiazid: 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: (It is also better to avoid Irbesartan Hydrochlorothiazide BMS 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
Danish: (Du bør heller ikke tage Irbesartan Hydrochlorothiazide BMS 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
English: Colestyramine and Colestipol resins: absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins;
Danish: Colestyramin og colestipolresiner: Absorption af hydrochlorthiazid nedsættes ved tilstedeværelse af anione resiner;
English: Thiazides cross the placental barrier and appear in cord blood.
Danish: Thiazider passerer placentabarrieren og findes i navlesnorsblod.
English: Nondepolarizing skeletal muscle relaxants (e.g. tubocurarine): the effect of nondepolarizing skeletal muscle relaxants may be potentiated by hydrochlorothiazide;
Danish: Nondepolariserende skelet/muskel-relaxanter (fx tubocurarin): Virkningen af nondepolariserende skelet/muskel-relaxanter kan forstærkes af hydrochlorthiazid;
English: You may need to have blood checks if you take: potassium supplements salt substitutes containing potassium potassium sparing medicines or other diuretics (water tablets) some laxatives medicines for the treatment of gout therapeutic vitamin D supplements medicines to control heart rhythm medicines for diabetes (oral agents or insulins)
Danish: Det kan være nødvendigt at tage blodprøver, hvis du tager: kaliumtilskud salterstatninger, der indeholder kalium kalium-besparende medicin eller andre vanddrivende midler visse afføringsmidler medicin til behandling af urinsyregigt terapeutisk vitamin D-tilskud medicin til kontrol af hjerterytmen medicin for sukkersyge (tabletter eller insulin)
English: Irbesartan Hydrochlorothiazide BMS 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 Hydrochlorothiazide BMS bruges til at behandle forhøjet blodtryk, når behandling med irbesartan eller hydrochlorthiazid hver for sig ikke har givet tilstrækkelig kontrol over blodtrykket.
English: The usual dose of Irbesartan Hydrochlorothiazide BMS is one or two tablets a day.
Danish: Den sædvanlige dosis af Irbesartan Hydrochlorothiazide BMS er en eller to tabletter dagligt.
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.
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.
English: It is important that you continue to take Irbesartan Hydrochlorothiazide BMS until your doctor tells you otherwise.
Danish: Det er vigtigt, at du fortsætter med at tage Irbesartan Hydrochlorothiazide BMS, indtil lægen siger, du kan stoppe.
English: Irbesartan Hydrochlorothiazide BMS 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 BMS bør ikke tages i begyndelsen af graviditeten, og må ikke tages, hvis du er længere end 3 måneder henne i din graviditet, da det kan skade dit barn alvorligt, hvis det bruges efter tredje måned af graviditeten.
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-calcium niveauet måles, og calcium-dosis justeres herefter;
English: Taking Irbesartan Hydrochlorothiazide BMS with food and drink Irbesartan Hydrochlorothiazide BMS can be taken with or without food.
Danish: Brug af Irbesartan Hydrochlorothiazide BMS sammen med mad og drikke Irbesartan Hydrochlorothiazide BMS kan tages med og uden mad.
English: Uncommon side effects (affect 1 to 10 users in 1,000) 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 (forekommer hos mellem 1 og 10 ud af 1.000 patienter) diarré lavt blodtryk besvimelse hjertebanken rødmen hævelse problemer med seksuel formåen blodprøver kan vise nedsat mængde af kalium og natrium i blodet.
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 BMS) 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
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 BMS) 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
English: Important information about some of the ingredients of Irbesartan Hydrochlorothiazide BMS Irbesartan Hydrochlorothiazide BMS contains lactose.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Irbesartan Hydrochlorothiazide BMS Irbesartan Hydrochlorothiazide BMS indeholder lactose.
English: Elderly patients: no dosage adjustment of Irbesartan Hydrochlorothiazide BMS is necessary in elderly patients.
Danish: Ældre patienter: Dosisjustering af Irbesartan Hydrochlorothiazide BMS til ældre patienter er ikke nødvendig.
English: Side effects associated with hydrochlorothiazide alone Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (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: Bivirkninger forbundet med hydrochlorthiazid alene Appetitmangel; maveirritation; mavekramper; forstoppelse; gulsot (hvor hud og/eller det hvide i øjne 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 eller ophobning af væske i lungerne; 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, hals og 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 urinsyregigt.
English: Since Irbesartan Hydrochlorothiazide BMS contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy.
Danish: Irbesartan Hydrochlorothiazide BMS indeholder hydrochlorthiazid og kan derfor ikke anbefales under graviditetens første trimester.
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, beperiden) kan øge biotilgængeligheden af thiaziddiuretika ved at nedsætte den gastrointestinale bevægelighed og ventrikeltømningshastigheden.
English: No specific information is available on the treatment of overdose with Irbesartan Hydrochlorothiazide BMS.
Danish: Der foreligger ikke specifikke oplysninger om behandling af overdosering med Irbesartan Hydrochlorothiazide BMS.
English: Severe hepatic impairment, biliary cirrhosis and cholestasis
Danish: Alvorlig leverfunktionsnedsættelse, biliær cirrhose og cholestase
English: Lactose monohydrate Hypromellose Titanium dioxide Macrogol 3350
Danish: Lactosemonohydrat Hypromellose Titandioxid Macrogol 3350
English: You can take Irbesartan Hydrochlorothiazide BMS with or without food.
Danish: Du kan tage Irbesartan Hydrochlorothiazide BMS med eller uden mad.
English: LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate.
Danish: LISTE OVER HJÆLPESTOFFER Hjælpestoffer: indeholder også lactosemonohydrat.
English: Do not use Irbesartan Hydrochlorothiazide BMS after the expiry date which is stated on the carton and on the blister after EXP.
Danish: Brug ikke Irbesartan Hydrochlorothiazide BMS efter den udløbsdato, der står på pakningen.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Danish: BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
English: Table 1: Adverse Reactions in Placebo-Controlled Trials and Spontaneous Reports* Common:
Danish: Tabel 1: Bivirkninger fra placebokontrollerede studier, og bivirkninger rapporteret efter markedsføring*
English: Irbesartan Hydrochlorothiazide BMS is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
Danish: Irbesartan Hydrochlorothiazide BMS er en kombination af en angiotensin-II receptorantagonist, irbesartan, og et thiaziddiuretikum, hydrochlorthiazid.
English: Renal artery stenosis - Renovascular hypertension: 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: Renal arteriestenose - Renovaskulær hypertension: 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 receptor-antagonister.
English: The two active ingredients in Irbesartan Hydrochlorothiazide BMS work together to lower blood pressure further than if either was given alone.
Danish: Når de to aktive stoffer i Irbesartan Hydrochlorothiazide BMS gives samtidigt, er deres effekt på blodtrykket større, end hvis de blev givet hver for sig.
English: Other antihypertensive agents: the antihypertensive effect of Irbesartan Hydrochlorothiazide BMS may be increased with the concomitant use of other antihypertensive agents.
Danish: Andre antihypertensive stoffer: Irbesartan Hydrochlorothiazide BMSs antihypertensive virkning kan øges ved samtidig administration af andre antihypertensive stoffer.
English: Renal impairment and kidney transplantation: when Irbesartan Hydrochlorothiazide BMS is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Danish: Nyrefunktionsnedsættelse og nyretransplantation: Når Irbesartan Hydrochlorothiazide BMS anvendes til patienter med nedsat nyrefunktion, anbefales periodisk monitorering af serum-kalium, serumkreatinin og serum-urinsyre-niveauer.
English: Renal impairment: due to the hydrochlorothiazide component, Irbesartan Hydrochlorothiazide BMS is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/min).
Danish: Nyrefunktionsnedsættelse: På grund af hydrochlorthiazid-komponenten anbefales Irbesartan Hydrochlorothiazide BMS ikke til patienter med alvorlig nyreinsufficiens (kreatininclearance < 30 ml/min).
English: Diuretic agents such as the hydrochlorothiazide contained in Irbesartan Hydrochlorothiazide BMS may have an effect on other medicines.
Danish: Vanddrivende stoffer som hydrochlorthiazider, der findes i Irbesartan Hydrochlorothiazide BMS, kan påvirke anden medicin.
English: Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with Irbesartan Hydrochlorothiazide BMS.
Danish: Derudover reducerer thiazider nyreclearance af lithium og dermed øges risikoen for lithium toksicitet ved behandling med Irbesartan Hydrochlorothiazide BMS.
English: FOR
Danish: On
English: Irbesartan Hydrochlorothiazide BMS 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 BMS frarådes tidligt i graviditeten, og du må ikke tage Irbesartan Hydrochlorothiazide BMS, hvis du er længere end 3 måneder henne i din graviditet, da det kan skade dit barn alvorligt, hvis det bruges i denne periode (se afsnittet om graviditet).
English: Your doctor will instruct you how to switch from the previous treatment to Irbesartan Hydrochlorothiazide BMS.
Danish: Lægen vil forklare, hvordan du skifter fra den tidligere behandling til behandling med Irbesartan Hydrochlorothiazide BMS.
English: The usual dose of Irbesartan Hydrochlorothiazide BMS is one tablet a day.
Danish: Den sædvanlige dosis af Irbesartan Hydrochlorothiazide BMS er en tablet dagligt.
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 cyklofosfamid, methotrexat) og forstærke deres myelosuppresive effekt.
English: Paediatric patients: Irbesartan Hydrochlorothiazide BMS is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Danish: Børn: Irbesartan Hydrochlorothiazide BMS frarådes til behandling af børn og unge pga. manglende viden om sikkerhed og virkning.
English: Common side effects (affect 1 to 10 users in 100) 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 (forekommer hos mellem 1 og 10 ud af 100 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: Potassium-sparing diuretics, potassium supplements or potassium-containing salts substitutes should be co-administered cautiously with Irbesartan Hydrochlorothiazide BMS (see section 4.5).
Danish: Kaliumbesparende diuretika, kaliumtilskud eller kaliumholdige saltsubstitutioner skal derfor gives med forsigtighed sammen med Irbesartan Hydrochlorothiazide BMS (se pkt.
English: Your doctor will normally advise you to stop taking Irbesartan Hydrochlorothiazide BMS 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 BMS.
Danish: Din læge vil normalt anbefale, at du stopper med at tage Irbesartan Hydrochlorothiazide BMS, inden du bliver gravid, eller så snart du ved, at du er gravid.
English: Food does not affect the bioavailability of Irbesartan Hydrochlorothiazide BMS.
Danish: Fødeindtagelse påvirker ikke biotilgængeligheden af Irbesartan Hydrochlorothiazide BMS.
English: Digitalis glycosides: thiazide induced hypokalaemia or hypomagnaesemia favour the onset of digitalis-induced cardiac arrhythmias (see section 4.4);
Danish: Digitalis glykosider: Thiazidinduceret hypokaliæmi eller hypomagnesiæmi øger forekomsten af digitalisinducerede kardielle arytmier (se pkt.
English: Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled trials in which 898 hypertensive patients received various doses (range: 37.5 mg/6.25 mg to 300 mg/25 mg irbesartan/hydrochlorothiazide).
Danish: Tabel 1 viser hyppigheden af bivirkninger rapporteret efter markedsføring og bivirkninger observeret i placebokontrollerede studier, hvor 898 hypertensive patienter blev behandlet med forskellige doser (interval: 37,5 mg/6,25 mg til 300 mg/25 mg irbesartan/hydrochlorthiazid).