FrancophonIA/ELRC3.0 huggingface dataset:
English: Duloxetine Sandoz was to be used to treat major depression, pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes) and generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Danish: Duloxetine Sandoz forventedes anvendt til behandling af svær depression, smerter i lemmerne som følge af sukkersyge (diabetisk perifer neuropati) og langvarig angst eller nervøsitet over hverdagsproblemer (generaliseret angst).
English: Duloxetine Sandoz is a medicine that contains the active substance duloxetine.
Danish: Duloxetine Sandoz er et lægemiddel, der indeholder det aktive stof duloxetin.
English: What is Duloxetine Sandoz?
Danish: Hvad er Duloxetine Sandoz?
English: The active substance in Duloxetine Sandoz, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Danish: Det aktive stof i Duloxetine Sandoz, duloxetin, hæmmer genoptagelsen af serotonin og noradrenalin.
English: mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.
Danish: Ved at blokere for deres genoptagelse i nervecellerne opnår man derfor bedring i depressionssymptomer og angst og i neuropatiske smerter.
English: What was Duloxetine Sandoz expected to be used for?
Danish: Hvad forventedes Duloxetine Sandoz anvendt til?
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns about whether the two studies conducted to show bioequivalence between the medicine and the reference product had been carried out in accordance with guidelines for Good Clinical Practice (GCP) and was of the provisional opinion that Duloxetine Sandoz could not have been approved for the treatment of depression, diabetic nerve pain and generalised anxiety disorder.
Danish: Efter gennemgang af dataene var der i CHMP på tilbagetrækningstidspunktet nogen tvivl om, hvorvidt de to undersøgelser til påvisning af bioækvivalens mellem lægemidlet og referencelægemidlet var udført efter retningslinjerne for god klinisk praksis (GCP).
English: How is Duloxetine Sandoz expected to work?
Danish: Hvordan forventes Duloxetine Sandoz at virke?
English: Since these neurotransmitters are involved in maintaining high
Danish: Disse neurotransmittere er med til at holde humøret oppe og mindske smertefornemmelsen.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Danish: BETINGELSER ELLER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER
English: The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilancesystemet, som beskrevet i version 3.0 i Modul 1.8.1 i ansøgningen om markedsføringstilladelse, er på plads og fungerer før og så længe produktet er markedsført.
English: Such conditions should be corrected before the administration of Irbesartan BMS.
Danish: Sådanne tilstande skal korrigeres før administration af Irbesartan BMS.
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs denne indlægsseddel grundigt inden du begynder at bruge medicinen.
English: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000).
Danish: Meget almindelig (≥ 1/10); almindelig (≥ 1/100, < 1/10); ikke almindelig (≥ 1/1.000, < 1/100); sjælden (≥ 1/10.000, < 1/1.000); meget sjælden (< 1/10.000).
English: (It is also better to avoid Irbesartan BMS in early pregnancy - see pregnancy section)
Danish: (Det er også bedre at lade være med at tage Irbesartan BMS i begyndelsen af graviditeten - se afsnittet om graviditet)
English: If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.
Danish: Hvis lægen har fortalt dig, at du er intolerant over for bestemte sukkerarter (for eksempel laktose), bør du kontakte lægen, før du tager denne medicin.
English: The following additional adverse reactions have been reported during post-marketing experience; they are derived from spontaneous reports and therefore, the frequency of these adverse reactions is not known:
Danish: Følgende yderligere uønskede reaktioner er indberettet efter markedsføring; disse er udledt fra spontane rapporter, hvorfra forekomst kan ikke bestemmes, og hyppighed af disse uønskede reaktioner kendes derfor ikke:
English: You can take Irbesartan BMS with or without food.
Danish: Du kan tage Irbesartan BMS med eller uden mad.
English: Uxbridge UB8 1DH - United Kingdom
Danish: Uxbridge UB8 1DH - Storbritannien
English: The efficacy of Irbesartan BMS is not influenced by age or gender.
Danish: Virkningen af Irbesartan BMS afhænger ikke af alder eller køn.
English: The frequency of adverse reactions listed below is defined using the following convention:
Danish: Hyppigheden af uønskede hændelser anført nedenfor defineres i henhold til følgende konventioner:
English: No specific information is available on the treatment of overdose with Irbesartan BMS.
Danish: Der foreligger ikke specifikke oplysninger om behandling af overdosering med Irbesartan BMS.
English: C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Danish: irbesartan, kan 80-85% af den cirkulerende radioaktivitet i plasma tilskrives uomdannet irbesartan.
English: Like all medicines, Irbesartan BMS can cause side effects, although not everybody gets them.
Danish: Irbesartan BMS kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Very common: Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.
Danish: Meget almindelig: Hyperkalæmi* forekommer hyppigere blandt diabetiske patienter behandlet med irbesartan end med placebo.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.emea.europa.eu/.
English: Irbesartan BMS should not be given to children under 18 years of age.
Danish: Irbesartan BMS må ikke gives til børn under 18 år.
English: IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan BMS, amlodipine and placebo.
Danish: IDNT var et kontrolleret dobbelt-blindt morbiditets- og mortalitetsstudie, som sammenlignede Irbesartan BMS, amlodipin og placebo.
English: Irbesartan BMS should not be given to children and adolescents (under 18 years).
Danish: Irbesartan BMS må ikke gives til børn og unge (under 18 år).
English: Arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps
Danish: Artralgi, myalgi (i nogle tilfælde forbundet med øgede niveauer af plasma-creatinkinase), muskelkramper
English: Important information about some of the ingredients of Irbesartan BMS Irbesartan BMS contains lactose.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Irbesartan BMS Irbesartan BMS indeholder laktose.
English: In the 26-week open-label period of this trial the most frequent laboratory abnormalities observed were creatinine increases (6.5%) and elevated CK values in 2% of child recipients.
Danish: I den 26-ugers åbne periode i forsøget var de hyppigst observerede laboratoriemæssige abnormaliteter stigninger i creatinin (6,5%) og øgede CKværdier hos 2% af børnene.
English: Taking Irbesartan BMS with food and drink Irbesartan BMS can be taken with or without food.
Danish: Brug af Irbesartan BMS sammen med mad og drikke Irbesartan BMS kan tages med og uden mad.
English: Following oral or intravenous administration of
Danish: Efter oral eller intravenøs administration af 14C
English: Some undesirable effects have been reported since marketing of Irbesartan BMS but the frequency for them to occur is not known.
Danish: Der er indberettet bivirkninger efter markedsføring af Irbesartan BMS, men det vides ikke hvor ofte de forekommer.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE EMBALLAGE
English: In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan BMS (see section 4.5).
Danish: Specielt har tillæg af diuretika som hydrochlorthiazid vist sig at have en additiv virkning med Irbesartan BMS (se pkt.
English: Ear and labyrinth disorders: Tinnitus
Danish: Øre og labyrint: Tinnitus
English: The total body and renal clearance are 157-176 and 3-3.5 ml/min, respectively.
Danish: Total body- og nyre-clearance er henholdsvis 157-176 og 3-3,5 ml/min.
English: The PSUR cycle of Irbesartan BMS is aligned with the cross-referred product, KARVEA, until otherwise specified.
Danish: PSUR cyklus for Irbesartan BMS er ioverenstemmelse med produktet KARVEA som krydshenvises til, indtil andet er specificeret.
English: Regression to normoalbuminuria (< 30 mg/day) was more frequent in the Irbesartan BMS 300 mg group (34%) than in the placebo group (21%).
Danish: Regression til normo albuminuri (< 30 mg/dag) forekom hyppigere i gruppen, der fik Irbesartan BMS 300 mg (34%) end i placebogruppen (21%).
English: The study examined the long-term effects (2 years) of Irbesartan BMS on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30% from baseline).
Danish: Studiet undersøgte langtidsvirkningerne (2 år) af Irbesartan BMS med henblik på progression til klinisk proteinuri (urinalbumin udskillelsesrate (UAER) > 300 mg/dag, og en stigning i UAER på mindst 30% i forhold til baseline).
English: The frequency of the side effects listed below is defined using the following convention: Very common: at least 1 in 10 patients or more Common: at least 1 in 100 and less than 1 in 10 patients Uncommon: at least 1 in 1000 and less than 1 in 100 patients
Danish: Nedenstående bivirkningers hyppighed angives på følgende måde: Meget almindelig: mindst 1 ud af 10 patienter eller flere Almindelig: mindst 1 ud af 100 og færre end 1 ud af 10 patienter Ikke almindelig: mindst 1 ud af 1000 og færre end 1 ud af 100 patienter
English: Patients were titrated from 75 mg to a maintenance dose of 300 mg Irbesartan BMS, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Danish: Patienterne blev titreret fra 75 mg til en vedligeholdelsesdosis på 300 mg Irbesartan BMS, fra 2,5 mg til 10 mg amlodipin eller placebo i henhold til tolerance.
English: Irbesartan 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 BMS anbefales ikke 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: Irbesartan BMS is unlikely to affect your ability to drive or use machines.
Danish: Irbesartan BMS påvirker sandsynligvis ikke din evne til at køre bil eller betjene maskiner.
English: It is important that you continue to take Irbesartan BMS until your doctor tells you otherwise.
Danish: Det er vigtigt, at du fortsætter med at tage Irbesartan BMS, indtil lægen siger du kan stoppe.
English: The active substance is irbesartan.
Danish: Aktivt stof: irbesartan.
English: If you get any of these symptoms or get short of breath, stop taking Irbesartan 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 BMS og straks søge lægehjælp.
English: Do not use Irbesartan BMS after the expiry date which is stated on the carton and on the blister after EXP.
Danish: Brug ikke Irbesartan BMS efter den udløbsdato, der står på pakningen.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 January 2007
Danish: Dato for første markedsføringstilladelse: 19. januar 2007 Dato for seneste genregistrering:
English: The blood pressure lowering effect of Irbesartan BMS is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
Danish: Irbesartan BMSs blodtrykssænkende effekt er tydelig i løbet af 1-2 uger, og den maksimale effekt viser sig 4-6 uger efter behandlingsstart.
English: Newcastle Upon Tyne, Tyne & Wear NE3 3TT - United Kingdom
Danish: Newcastle Upon Tyne, Tyne & Wear NE3 3TT - Storbritannien
English: Children should not take Irbesartan BMS
Danish: Børn må ikke bruge Irbesartan BMS
English: Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects (18-40 years).
Danish: Irbesartan AUC- og Cmax -værdier var også noget større hos ældre patienter (≥ 65 år) end hos yngre patienter (18-40 år).
English: There is no experience regarding the administration of Irbesartan BMS in patients with a recent kidney transplantation.
Danish: Der foreligger ingen erfaring vedrørende administration af Irbesartan BMS til nyligt nyretransplanterede patienter.
English: Newcastle Upon Tyne, Tyne & Wear NE3 3TT United Kingdom
Danish: Newcastle Upon Tyne, Tyne & Wear NE3 3TT Storbritannien
English: Paediatric patients: irbesartan has been studied in paediatric populations aged 6 to 16 years old but the current data are insufficient to support an extension of the use in children until further data become available (see sections 4.8, 5.1 and 5.2).
Danish: Pædiatriske patienter: Irbesartan er undersøgt i pædiatriske populationer i aldersgruppen 6 til 16 år, men de aktuelle data er ikke tilstrækkelige til at understøtte udvidelse af brug til at omfatte børn, før der foreligger yderligere data (se pkt.
English: Take special care with Irbesartan BMS Tell your doctor if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems if you suffer from heart problems if you receive Irbesartan BMS for diabetic kidney disease.
Danish: Vær ekstra forsigtig med at bruge Irbesartan BMS Kontakt lægen hvis du oplever én eller flere af følgende: hvis du får hyppig opkastning eller diarré hvis du lider af nyreproblemer hvis du lider af hjerteproblemer hvis du får Irbesartan BMS for diabetisk nyresygdom.
English: While this is not documented with Irbesartan BMS, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Danish: Selvom dette ikke er dokumenteret for Irbesartan BMS, kan der forventes en lignende effekt med angiotensin-IIreceptorantagonister.
English: You may need to have blood checks if you take: potassium supplements salt substitutes containing potassium potassium-sparing medicines (such as certain diuretics) medicines containing lithium
Danish: Det kan være nødvendigt at tage blodprøver, hvis du tager: kaliumtilskud kaliumsparende medicin (som visse vanddrivende lægemidler)
English: Lithium: the combination of lithium and Irbesartan BMS is not recommended (see section 4.5).
Danish: Lithium: Kombination af lithium og Irbesartan BMS frarådes (se pkt.
English: Skin and subcutaneous tissue disorders: Leukocytoclastic vasculitis
Danish: Hud og subkutane væv: Leukocytoklastisk vaskulitis
English: Nervous system disorders: Headache
Danish: Nervesystemet: Hovedpine
English: Gastrointestinal disorders: Dysgeusia
Danish: Mave-tarmkanalen: Dysgeusia
English: Immune system disorders: Hypersensitivity reactions such as angioedema, rash, urticaria
Danish: Immunsystemet: Overfølsomhedsreaktioner, fx angioødem, udslæt, urticaria
English: If you forget to take Irbesartan BMS
Danish: Hvis du har glemt at tage Irbesartan BMS
English: Metabolism and nutrition disorders: Hyperkalaemia
Danish: Metabolisme og ernæring: Hyperkalæmi
English: Primary aldosteronism: patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Danish: Primær aldosteronisme: Patienter med primær aldosteronisme responderer generelt ikke på antihypertensive lægemidler, der virker gennem hæmning af renin-angiotensin systemet.
English: Therefore, the use of Irbesartan BMS is not recommended.
Danish: Derfor frarådes brug af Irbesartan BMS.
English: If you take more Irbesartan BMS than you should If you accidentally take too many tablets, contact your doctor immediately.
Danish: Hvis du har taget for meget Irbesartan BMS Hvis du ved et uheld har taget for mange tabletter, skal du omgående kontakte lægen.
English: Your doctor will normally advise you to stop taking Irbesartan 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 BMS.
Danish: Du skal fortælle det til din læge, hvis du tror du er gravid eller planlægger at blive gravid; din læge vil normalt anbefale, at du stopper med at tage Irbesartan BMS, inden du bliver gravid, eller så snart du ved, at du er gravid og vil anbefale, at du tager anden medicin i stedet for Irbesartan BMS.
English: Paediatric patients: in a randomised trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following related adverse events occurred in the 3-week double-blind phase: headache (7.9%), hypotension (2.2%), dizziness (1.9%), cough (0.9%).
Danish: Pædatriske patienter: I et randomiseret forsøg med 318 hypertensive børn og unge i aldersgruppen 6 til 16 år sås følgende relaterede bivirkninger i den 3-ugers dobbeltblinde fase: hovedpine (7,9%), hypotension (2,2%), svimmelhed (1,9%), hoste (0,9%).
English: Irbesartan BMS belongs to a group of medicines known as angiotensin-II receptor antagonists.
Danish: Irbesartan BMS tilhører en medicingruppe, der kaldes angiotensin-II receptorantagonister.
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 AIIRAer under graviditetens anden trimester, anbefales ultralydskontrol af nyrefunktionen og kraniet.
English: These undesirable effects are: headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).
Danish: Disse bivirkninger er: hovedpine, smagsforstyrrelser, ringen for ørerne, muskelkramper, led- og muskelsmerter, unormal leverfunktion, forhøjet mængde af kalium i blodet, nedsat nyrefunktion samt betændelseslignende tilstand i de små blodkar, der primært påvirker huden (en tilstand der kaldes leukocytoklastisk vaskulitis).
English: Renal and urinary disorders: Impaired renal function including cases of renal failure in patients at risk (see section 4.4)
Danish: Nyrer og urinveje: Nedsat nyrefunktion, inklusive tilfælde af nyresvigt hos risikopatienter (se pkt.
English: Side effects reported in clinical studies for patients treated with Irbesartan BMS were: Very common: if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
Danish: Følgende bivirkninger blev indberettet i kliniske forsøg med patienter, der fik Irbesartan BMS: Meget almindeligt: hvis du har højt blodtryk og type 2 diabetes med nyresygdom, kan blodprøver vise, at du har for meget kalium i blodet.
English: In patients insufficiently controlled with 150 mg once daily, the dose of Irbesartan BMS can be increased to 300 mg, or other antihypertensive agents can be added.
Danish: Hos patienter som ikke er tilstrækkeligt kontrolleret på 150 mg, 1 gang dagligt, kan dosis af Irbesartan BMS øges til 300 mg, eller andre antihypertensiva kan tilføjes.
English: Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see section 5.1).
Danish: Behandling af nyresygdom hos patienter med hypertension og type 2 diabetes mellitus, som del af et antihypertensivt lægemiddelregime (se pkt.
English: Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Irbesartan BMS (see section 4.4).
Danish: En forudgående behandling med høje doser diuretika kan medføre hypovolæmi og risiko for hypotension, når behandling med Irbesartan BMS påbegyndes (se pkt.
English: Hepato-biliary disorders: Hepatitis, abnormal liver function
Danish: Lever og galdeveje: Hepatitis, abnorm leverfunktion
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 AIIRAer er kontraindiceret under graviditetens anden og tredje trimester (se pkt.
English: Irbesartan BMS at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Danish: Ved en dosis på 150 mg, 1 gang dagligt, giver Irbesartan BMS generelt en bedre 24timers blodtrykskontrol end 75 mg.
English: Paediatric patients: irbesartan is not recommended for use in children and adolescents due to insufficient data on safety and efficacy (see sections 4.8, 5.1 and 5.2).
Danish: Pædiatriske patienter: irbesartan anbefales ikke til brug hos børn og unge på grund af utilstrækkelige data vedrørende sikkerhed og effekt (se pkt.
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: Ligesom for andre lægemidler, der påvirker renin-angiotensinsystemet, gælder det, at sorte hypertensionpatienter responderer betydeligt dårligere på irbesartanmonoterapi.
English: Exposure to AIIRA therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Danish: Det er kendt, at eksponering for behandling med AIIRA under anden og tredje trimester kan inducere human føtotoksicitet (nedsat nyrefunktion, oligohydramnios, hæmning af kraniets knogledannelse) og neonatal toksicitet (nyresvigt, hypotension, hyperkalæmi) (se pkt.
English: Cardiac disorders: Uncommon: tachycardia
Danish: Hjerte: Ikke almindelig: Takykardi
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 nonselektive NSAID) kan den antihypertensive virkning svækkes.
English: Approximately 33% of patients in the irbesartan group reached the primary renal composite endpoint compared to 39% and 41% in the placebo and amlodipine groups [20% relative risk reduction versus placebo (p = 0.024) and 23% relative risk reduction compared to amlodipine (p = 0.006)].
Danish: Ca. 33% af patienterne i irbesartan gruppen nåede det primære kombinerede nyreendepunkt sammenlignet med henholdsvis 39% og 41% i placebo- og amlodipin-gruppen (20% relativ risikoreduktion versus placebo (p= 0,024)
English: What Irbesartan BMS contains
Danish: Irbesartan BMS indeholder:
English: Do not take Irbesartan BMS if you are allergic (hypersensitive) to irbesartan or any other ingredients of Irbesartan BMS if you are more than 3 months pregnant.
Danish: Brug ikke Irbesartan BMS: hvis du er overfølsom (allergisk) over for irbesartan eller et af de øvrige indholdsstoffer i hvis du er længere end 3 måneder henne i din graviditet.
English: WHAT IRBESARTAN BMS IS AND WHAT IT IS USED FOR
Danish: IRBESARTAN BMSS VIRKNING OG HVAD DU SKAL BRUGE DET TIL