FrancophonIA/ELRC3.0 huggingface dataset:
English: abortion or early resorption was noted at doses causing significant maternal toxicity, including mortality.
Danish: Hos kaniner sås abort eller tidlig resorption ved doser, som forårsagede signifikant maternel toksicitet, inklusive mortalitet.
English: Corticosteroids, ACTH: electrolyte depletion, particularly hypokalaemia, may be increased;
Danish: Kortikosteroider, ACTH: elektrolytdepletering, specielt hypokaliæmi, kan forstærkes;
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Ifirmacombi, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: There is no difference in response to Ifirmacombi, regardless of age or gender.
Danish: Virkningen af Ifirmacombi afhænger ikke af alder eller køn.
English: C irbesartan, about 20% of the radioactivity is recovered in the urine, and the remainder in the faeces.
Danish: C irbesartan genfindes ca. 20% radioaktivitet i urinen og resten i afføringen.
English: Non-steroidal anti-inflammatory drugs: the administration of a non-steroidal anti-inflammatory drug may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics in some patients;
Danish: Non-steroide antiinflammatoriske lægemidler: administration af et non-steroidt antiinflammatorisk lægemiddel kan reducere den diuretiske, natriuretiske og antihypertensive virkning af thiaziddiuretika hos nogle patienter.
English: Not known: thrombocytopenia
Danish: Ikke kendt:thrombocytopeni
English: Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse reactions previously reported with one of the individual components may be potential adverse reactions with Ifirmacombi.
Danish: Yderligere information om de individuelle stoffer: Udover ovenfor nævnte bivirkninger for kombinationspræparatet, kan andre tidligere rapporterede bivirkninger i forbindelse med ét af enkeltkomponenterne være potentielle bivirkninger ved Ifirmacombi.
English: Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics.
Danish: Der er rapporteret eksacerbation eller provokation af systemisk lupus erythematosus ved brug af thiaziddiuretika.
English: Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation.
Danish: Irbesartan metaboliseres hovedsageligt af CYP2C9 og i mindre udstrækning ved glukuronidering.
English: Following oral administration of Ifirmacombi, the absolute oral bioavailability is 6080% and 50-80% for irbesartan and hydrochlorothiazide, respectively.
Danish: Ved oral administration af Ifirmacombi er den absolutte orale biotilgængelighed 60-80% for irbesartan og 50-80% for hydrochlorthiazid.
English: Pharmacotherapeutic group: angiotensin II antagonists and diuretics, ATC code: C09DA04.
Danish: Farmakoterapeutisk klassifikation: angiotensin-II-antagonister og diuretika, ATC-kode: C09DA04.
English: Such conditions should be corrected before initiating therapy with Ifirmacombi.
Danish: Sådanne tilstande skal korrigeres inden initiering af behandling med Ifirmacombi.
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid lægemidletnøjagtigt efter lægens anvisning.
English: Polyvinyl alcohol
Danish: Filmovertræk: Polyvinylalcohol
English: Your doctor will normally advise you to stop taking Ifirmacombi before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Ifirmacombi.
Danish: Din læge vil normalt anbefale, at du stopper med at tage Ifirmacombi, inden du bliver gravid, eller så snart du ved, at du er gravid.
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 irbesartan/hydrochlorthiazid på fertilitet er ikke evalueret i dyrestudier, da der ikke har været tegn på skadelig virkning på fertiliteten hos dyr eller mennesker af hverken irbesartan eller hydrochlorthiazid, når de administreres alene.
English: If a re-administration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.
Danish: Hvis det er nødvendigt at genoptage diuretikabehandlingen, anbefales det at beskytte udsatte områder mod sollys eller kunstige UVA-stråler.
English: If this medicine does not help to reduce your blood pressure as required, the doctor will prescribe additional treatment to you.
Danish: Hvis denne dosis ikke kan nedsætte dit blodtryk som ønsket, vil lægen ordinere yderligere behandling til dig.
English: Since Ifirmacombi contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy.
Danish: Ifirmacombi indeholder hydrochlorthiazid og kan derfor ikke anbefales under graviditetens første trimester.
English: Ifirmacombi is unlikely to affect your ability to drive or use machines.
Danish: Ifirmacombi påvirker sandsynligvis ikke din evne til at køre bil eller betjene maskiner.
English: Not known: respiratory distress (including pneumonitis and pulmonary oedema)
Danish: Ikke kendt: åndenød (inklusive pneumoni og lungødem)
English: Your doctor will instruct you how to switch from the previous treatment to Ifirmacombi.
Danish: Lægen vil forklare, hvordan du skifter fra den tidligere behandling til behandling med Ifirmacombi.
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 renin- og angiotensin-II-niveauerne i plasma og i nedsat aldosteronkoncentration i plasma.
English: If you get any of the above symptoms or get short of breath, stop taking Ifirmacombi 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 Ifirmacombi og straks søge lægehjælp.
English: film-coated tablet
Danish: Filmovertrukket tablet
English: Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Danish: Thiazider skal anvendes med forsigtighed til patienter med nedsat leverfunktion eller progressiv leversygdom, da mindre ændringer i væske- og elektrolytbalancen kan fremskynde hepatisk koma.
English: As is the case with other medicinal products that affect the renin-angiotensin system, black hypertensive patients have notably less response to irbesartan monotherapy.
Danish: Som med andre lægemidler, der påvirker renin-angiotensinsystemer, har sorte, hypertensive patienter betydeligt mindre respons på enkeltstofbehandling med irbesartan.
English: Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels causing them to tighten.
Danish: Angiotensin II er et stof, der produceres i kroppen, og som binder sig til receptorer i blodårerne og får dem til at trække sig sammen.
English: Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Danish: Patienterne skal være tilstrækkeligt hydrerede og kontrol af nyrefunktionen bør overvejes efter samtidig behandling er initieret og periodisk derefter.
English: Ifirmacombi 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: Ifirmacombi frarådes til ammende mødre, og lægen vil sædvanligvis vælge anden behandling til dig, hvis du ønsker at amme dit barn, især hvis dit barn er nyfødt eller født for tidligt.
English: Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Danish: Behandling med angiotensin-II-receptor-antagonister (AIIRA'ere) bør ikke påbegyndes under graviditet.
English: In addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock), and decrease in the number of platelets (a blood cell essential for the clotting of the blood) have also been reported.
Danish: Foruden de ovennævnte bivirkninger er der også indberettet brystsmerter,alvorlige allergiske reaktioner (anafylaktisk shock),og fald i antallet af blodplader (en blodcelle, der er afgørende for størkning af blodet).
English: It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II.
Danish: Stoffet antages at blokere alle virkninger af angiotensin-II, som bliver medieret af AT1-receptoren, uafhængigt af angiotensin II-syntesens kilde eller vej.
English: Do not take Ifirmacombi - if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to hydrochlorothiazide or any other sulfonamide-derived medicines - if you are more than 3 months pregnant.
Danish: Tag ikke Ifirmacombi hvis du er allergisk over for irbesartan eller et af de øvrige indholdsstoffer i Ifirmacombi (angivet i punkt 6) hvis du er allergisk over for hydrochlorthiazid eller over for sulphonamidholdig medicin hvis du er længere end 3. måned henne i din graviditet.
English: If you take more Ifirmacombi than you should If you accidentally take too many tablets, contact your doctor immediately.
Danish: Hvis du har taget for mange Ifirmacombi filmovertrukne tabletter Hvis du ved et uheld har taget for mange tabletter, skal du omgående kontakte lægen.
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 56 filmovertrukne tabletter 56 x 1 filmovertrukne tabletter 84 filmovertrukne tabletter 90 filmovertrukne tabletter 98 filmovertrukne tabletter
English: It is also important to tell your doctor if you are taking other medicines to reduce your blood pressure, steroids, and 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, medicin mod kræft, smertestillende medicin, gigtmedicin, eller colestyramin og colestipolresiner til at sænke blodets indhold af kolesterol.
English: Other antihypertensive agents:
Danish: Andre antihypertensive stoffer:
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: The blood pressure lowering effect of irbesartan in combination with hydrochlorothiazide is apparent after the first dose and substantially present within 1-2 weeks, with the maximal effect occurring by 68 weeks.
Danish: Den blodtryksnedsættende effekt af irbesartan i kombination med hydrochlorthiazid viser sig efter første dosis og varer ved i 1-2 uger med maksimal effekt efter 6-8 uger.
English: Ifirmacombi can be taken once daily, with or without food.
Danish: Ifirmacombi kan administreres 1 gang dagligt med eller uden samtidig fødeindtagelse.
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 dosisproportional farmakokinetik i et dosisinterval på 10-600 mg. Der blev observeret en mindre end proportional øgning i oral absorption ved doser over 600 mg.
English: Other interactions: the hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
Danish: Andre interaktioner: den hyperglykæmiske effekt af betablokkere og diazoxid kan forstærkes af thiazider.
English: Not known Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma)
Danish: Ikke kendt: Non-melanom hudkræft (basalcellekarcinom og pladecellekarcinom)
English: These lesions were not observed in macaques; - 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; fald i serum-kalium på grund af hydrochlorthiazid, som blev delvis forebygget, når hydrochlorthiazid blev givet i kombination med irbesartan.
English: Hydroxypropylcellulose Hydroxypropylcellulose, low-substituted Sodium starch glycolate Talc
Danish: Hydroxypropylcellulose Hydroxypropylcellulose, lav-substituteret Natriumstivelsesglycolat Talcum
English: Ifirmacombi 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: Ifirmacombi bør ikke tages under graviditet, 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: 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: There is no evidence that irbesartan would reduce or prevent diuretic-induced hyponatraemia.
Danish: Der er ingen tegn på, at irbesartan begrænser eller forebygger diuretika-induceret hyponatriæmi.
English: When angiotensin II antagonists are administered simultaneously with non-steroidal antiinflammatory 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: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially "sodiumfree".
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium per tablet, dvs. den er i det væsentlige natrium-fri.
English: Ifirmacombi is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.
Danish: Ifirmacombi bruges til at behandle forhøjet blodtryk, når behandling med irbesartan eller hydrochlorthiazid hver for sig ikke har givet tilstrækkelig blodtrykskontrol.
English: swelling extremity arthralgia, myalgia
Danish: hævede ekstremiteter artralgi, myalgi
English: Medicinal products affected by serum potassium disturbances:
Danish: Lægemidler, der påvirkes af serum-kaliumforstyrrelser:
English: The total body and renal clearance are 157-176 and 3.0-3.5 ml/min, respectively.
Danish: Total-clearance og renal clearance er henholdsvis 157-176 og 3-3,5 ml/min.
English: Irbesartan does not inhibit ACE (kininase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites.
Danish: Irbesartan hæmmer ikke ACE (kininase-II), et enzym, som producerer angiotensin II og også nedbryder bradykinin til inaktive metabolitter.
English: Common: Uncommon: Not known:
Danish: Almindelig: Ikke almindelig: Ikke kendt:
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: Syvogfyrre procent (47,2%) af patienterne i kombinationsbehandling nåede et dal-SeDBT < 90 mmHg sammenlignet med 33,2% af patienterne behandlet med irbesartan (p = 0,0005).
English: There were 0.6% and 0% of patients with hypotension and 2.8% and 3.1% of patients with dizziness as adverse reactions reported in the combination and monotherapy groups, respectively.
Danish: Henholdsvis 0,6% og 0% af patienterne oplevede hypotension og henholdsvis 2,8% og 3,1% oplevede svimmelhed i kombinationsbehandling og enkeltstofbehandling.
English: There is no experience regarding the administration of Ifirmacombi in patients with recent kidney transplantation.
Danish: Der er ingen erfaring med administration af Ifirmacombi til nyligt nyretransplanterede patienter.
English: The risk of hypokalaemia is greatest in patients with cirrhosis of the liver, in patients experiencing brisk diuresis, in patients who are receiving inadequate oral intake of electrolytes and in patients receiving concomitant therapy with corticosteroids or ACTH.
Danish: Risikoen for hypokaliæmi er størst hos patienter med levercirrose, patienter med hyppig vandladning, patienter, der indtager utilstrækkelig mængde elektrolytter oralt, og hos patienter i samtidig behandling med kortikosteroider eller ACTH.
English: Therefore, the use of Ifirmacombi is not recommended.
Danish: Derfor frarådes brug af Ifirmacombi.
English: Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Danish: Brug ikke Ifirmacombi efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Alcohol: potentiation of orthostatic hypotension may occur;
Danish: Alkohol: der kan forekomme forstærket ortostatisk hypotension.
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 nedsætte urin-calciumudskillelsen og forårsage en intermitterende og let forhøjelse af serumcalcium uden kendte forstyrrelser i calciummetabolismen.
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Danish: Såfremt samtidig administration skønnes nødvendig, anbefales det at monitorere serum-lithium omhyggeligt.
English: The effect of the combination of irbesartan and hydrochlorothiazide on morbidity and mortality has not been studied.
Danish: Effekten af kombinationsbehandling med irbesartan og hydrochlorthiazid på morbiditet og mortalitet er ikke undersøgt.
English: Ifirmacombi should not be given to children under 18 years of age.
Danish: Børn under 18 år må ikke få Ifirmacombi.
English: The antihypertensive effect of Ifirmacombi may be increased with the concomitant use of other antihypertensive agents.
Danish: Ifirmacombis antihypertensive virkning kan øges ved samtidig administration af andre antihypertensive stoffer.
English: Pressor amines (e.g. noradrenaline): the effect of pressor amines may be decreased, but not sufficiently to preclude their use;
Danish: Pressoraminer (fx noradrenalin): virkningen af pressoraminer, kan nedsættes, men ikke i en grad, der udelukker deres anvendelse.
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 måles og calcium-dosis justeres herefter.
English: Cases of photosensitivity reactions have been reported with thiazides diuretics (see section 4.8).
Danish: Der er rapporteret tilfælde af fotosensitivitetsreaktioner med thiaziddiuretika (se pkt.
English: Tables 2 and 3 below detail the adverse reactions reported with the individual components of Ifirmacombi.
Danish: Tabel 2 og 3 viser rapporterede bivirkningerne for enkeltkomponenterne i Ifirmacombi.
English: Table 3: Adverse reactions reported with the use of hydrochlorothiazide alone Investigations
Danish: Tabel 3: Bivirkninger rapporteret ved anvendelse af hydrochlorthiazid alene
English: A cumulative doseresponse 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 (3,04,9) 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: Ifirmacombi 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: Ifirmacombi frarådes tidligt i graviditeten, og du må ikke tage Ifirmacombi, 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: 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 virkning af hydrochlorthiazid på serum-kalium kan dog forventes at blive forstærket af andre stoffer associeret med kaliumtab og hypokaliæmi (fx andre kaliuretiske diuretika, laksantia, amphotericin, carbenoxolon, benzylpenicillin-natrium).
English: Hypotension - Volume-depleted patients:
Danish: Hypotension - patienter med hypovolæmi:
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 myelosuppressiveeffekt.
English: Adequate monitoring of serum potassium in patients at risk is recommended.
Danish: Adækvat monitorering af serumkalium anbefales hos patienter i risikogruppe.
English: Calcium salts: thiazide diuretics may increase serum calcium levels due to decreased excretion.
Danish: Calciumsalte: thiaziddiuretika kan øge serum-calcium på grund af nedsat udskillelse.
English: There was no evidence of mutagenicity or clastogenicity with the irbesartan/hydrochlorothiazide combination.
Danish: Der var ingen tegn på mutagenicitet eller klastogenicitet med irbesartan/hydrochlorthiazidkombinationen.
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 substitutionsresiner.
English: Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure.
Danish: Hydrochlorthiazid tilhører en medicingruppe (kaldet thiaziddiuretika), som øger urinudskillelse og sænker derved blodtrykket.
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 foretages periodisk kontrol af serum-elektrolytter med passende intervaller.
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 aldosteronsekretionen med deraf følgende øget kalium og hydrogencarbonat via urinen og nedsat serum-kalium.