FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with Rasilez HCT had an overall incidence of adverse experiences at doses up to 300 mg/25 mg similar to placebo.
Danish: Hyppigheden af bivirkninger ved behandling med Rasilez HCT i doser op til 300 mg/25 mg svarede overordnet til placebos.
English: • High level of calcium in the blood
Danish: • Højt indhold af calcium i blodet
English: • Pale skin, tiredness, breathlessness, dark-coloured urine (haemolytic anaemia)
Danish: • Bleg hud, træthed, åndenød, mørkfarvet urin (hæmolytisk anæmi)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 January 2009
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Administration of fruit juice with aliskiren resulted in a decrease in AUC and Cmax of aliskiren.
Danish: Frugtjuice og drikkevarer indeholdende planteekstrakter Indtagelse af frugtjuice sammen med aliskiren resulterede i en reduktion i AUC og Cmax for aliskiren.
English: • Irregular heart beat
Danish: • Uregelmæssig hjerterytme (puls)
English: MDR1/Mdr1a/1b (P-gp) was found to be the major efflux system involved in intestinal absorption and biliary excretion of aliskiren in pre-clinical studies.
Danish: Prækliniske studier viste, at MDR1/Mdr1a/1b (P-gp) er det vigtigste efflukssystem involveret i aliskirens intestinale absorption og udskillelse via galden.
English: Dyspnoeaa
Danish: Dyspnøa
English: 98 (2 x 49 x 1) film-coated tablets
Danish: 98 (2x49x1) filmovertrukne tabletter
English: P-glycoprotein (P-gp) inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated (see section 4.5).
Danish: (P-gp)-hæmmere, eller andre potente P-gp-hæmmere (fx quinidin), er kontraindiceeret (se pkt.
English: Therefore, caution should be used if coadmnistering with any other hypertensive agents
Danish: Der bør derfor udvises forsigtighed ved samtidig administration med andre hypertensiva.
English: In this study, Rasilez HCT in doses from 150 mg/12.5 mg to 300 mg/25 mg produced dose-dependent blood pressure reductions (systolic/diastolic) from 17.6/11.9 mmHg to 21.2/14.3 mmHg, respectively, compared to 7.5/6.9 mmHg with placebo.
Danish: I dette studie viste Rasilez HCT i doser fra 150 mg/12,5 mg til 300 mg/25 mg dosisafhængige blodtryksreduktioner (systolisk/diastolisk) fra henholdsvis 17,6/11,9 mmHg til 21,2/14,3 mmHg, sammenlignet med 7,5/6,9 mmHg for placebo.
English: Over the 12 week period, aliskiren monotherapy lowered systolic/diastolic blood pressure by 14.0/5.1 mmHg, compared to 11.6/3.6 mmHg for ramipril, consistent with aliskiren being non-inferior to ramipril at the doses chosen and the differences in systolic and diastolic blood pressure were statistically significant.
Danish: Over 12-ugers-perioden sænkede aliskirenmonoterapi systolisk/diastolisk blodtryk med 14,0/5,1 mmHg sammenlignet med 11,6/3,6 mmHg for ramipril i overensstemmelse med aliskirens non-inferioritet til ramipril ved de valgte doser.
English: Titanium dioxide (E171) Red iron oxide (E172)
Danish: Titandioxid (E171) Rød jernoxid (E172)
English: The available clinical data do not suggest an additive effect of different types of foods and/or drinks, however the potential for decreased aliskiren bioavailability due to this additive effect has not been studied and therefore cannot be excluded.
Danish: Imidlertid er potentialet for nedsat biotilgængelighed af aliskiren pga. en additiv effekt ikke undersøgt og kan derfor ikke udelukkes.
English: No initial dose adjustment of Rasilez HCT is required in elderly patients.
Danish: Der kræves ingen justering af initialdosen hos ældre patienter.
English: When administered in hypertensive patients with markedly elevated blood pressure (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg), Rasilez HCT in doses from 150 mg/12.5 mg to 300 mg/25 mg administered without up-titration from monotherapy demonstrated significantly greater systolic/diastolic blood pressure control rates (< 140/90 mmHg) as compared to the respective monotherapies.
Danish: Ved administration til hypertensive patienter med markant forhøjet blodtryk (systolisk blodtryk ≥ 160 mmHg og/eller diastolisk blodtryk ≥ 100 mmHg), viste Rasilez HCT i doser fra 150 mg/12,5 mg til 300 mg/25 mg, der blev givet uden optitrering fra monoterapi, signifikant større og hurtigere systolisk/diastolisk blodtrykskontrol (< 140/90 mmHg) sammenlignet med de respektive monoterapier.
English: You should avoid taking this medicine together with fruit juice and/or drinks containing plant extracts (including herbal teas).
Danish: Du skal undgå at tage dette lægemiddel sammen med frugtjuice og/eller drikkevarer, der indeholder planteekstrakt (inkl.
English: Optional titration of the respective study drug doses to the next highest weight-based dose level was available by doubling the dose with each of the two allowed dose titrations, up to 600 mg (highest studied dose in adults) for aliskiren and 40 mg for enalapril in the ≥80 to ≤150 kg weight group, if medically necessary to control the mean sitting systolic blood pressure (i.e. msSBP should be less than the 90th percentile for age, gender and height).
Danish: Startdoserne af enalapril var hhv. 2,5/5/10 mg i grupperne lav, middel og høj vægt, Valgfri titrering af de respektive doser af forsøgslægemiddel til det næsthøjeste vægtbaserede dosisniveau var muligt ved fordobling af dosen med hver af de to tilladte dosistitreringer, op til 600 mg (højeste undersøgte dosis hos voksne) for aliskiren og 40 mg for enalapril i vægtgruppen ≥ 80 til ≤ 150 kg, hvis det var medicinsk nødvendigt for regulering af middel systoliske blodtryk i siddende stilling (dvs. msSBP skal være under 90-percentilen for alder, køn og højde).
English: In this population, Rasilez HCT 150 mg/12.5 mg to 300 mg/25 mg provided dose-dependent systolic/diastolic blood pressure reduction from 20.6/12.4 mmHg to 24.8/14.5 mmHg, which were significantly superior to the respective monotherapies.
Danish: I denne population gav Rasilez HCT 150 mg/12,5 mg til 300 mg/25 mg en dosisafhængig systolisk/diastolisk blodtryksreduktion fra 20,6/12,4 mmHg til 24,8/14,5 mmHg, som var signifikant overlegen i forhold til de respektive monoterapier.
English: • Severe allergic reaction (anaphylactic reaction), allergic reactions (hypersensitivity) and angioedema (the symptoms of which can include difficulties in breathing or swallowing, rash, itching, hives or swelling of the face, hands and feet, eyes, lips and/or tongue, dizziness).
Danish: • Alvorlige allergiske reaktioner (anafylaktisk reaktion), overfølsomhedsreaktioner (allergiske reaktioner) og angioødem (symptomerne kan være besvær med at trække vejret eller med at synke, udslæt, kløe, nældefeber, hævet ansigt, hænder og fødder, øjenomgivelser, læber og/eller tunge eller svimmelhed) (sjældne: forekommer hos op til 1 ud af 1.000 patienter).
English: Hyperuricaemiah, hypomagnesaemiah
Danish: Hyperurikæmih, hypomagnesiæmih
English: The incidence of adverse events tended to be higher in patients with diabetes, or with GFR <60 ml/min/1.73 m², or with age ≥ 65 years; however, there was no difference between patients treated with aliskiren and those treated with enalapril.
Danish: Forekomsten af bivirkninger havde tendens til at være højere hos patienter med diabetes, patienter med GFR <60 ml/min/1,73 m² eller patienter i alderen ≥65 år.
English: • Red skin (erythema)
Danish: • Hudrødme (erytem)
English: However, since aliskiren has been shown to be a substrate for the organic anion-transporting polypeptide 1A2 (OATP1A2) (see section ‘Organic anion transporting polypeptide (OATP' below) inhibitors), there is a potential for aliskiren to reduce plasma torasemide exposure by an interference with the absorption process.
Danish: Aliskiren kan dog potentielt reducere plasmakoncentrationen af torasemid ved at interferere med absorptionsprocessen, da aliskiren er vist at være substrat for det organisk anion-transporterende polypeptid 1A2 (OATP1A2) (se punktet ‘Interaktion med hæmmere af organisk anion-transporterende polypeptid (OATP' nedenfor )).
English: - medicines that may reduce the amount of potassium in your blood, such as diuretics (water tablets), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G. - medicines that may induce “torsades de pointes” (irregular heart beat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics.
Danish: Dette omfatter kaliumtilskud eller salterstatninger, der indeholder kalium, kaliumbesparende medicin og heparin; - medicin, som kan nedsætte mængden af kalium i dit blod, som fx diuretika (vanddrivende tabletter), kortikosteroider, afføringsmidler, carbenoxolon, amphotericin eller benzylpenicillin; - medicin, som kan medføre ”torsades de pointes” (uregelmæssig hjerterytme), som fx antiarytmika (medicin, som bruges til behandling af hjerteproblemer) og visse antipsykotika; - medicin, som kan nedsætte mængden af natrium i dit blod, såsom antidepressiva, antipsykotika,
English: • Confusion, tiredness, muscle twitching and spasm, rapid breathing (hypochloraemic alkalosis)
Danish: • Forvirring, træthed, muskelsammentrækninger og -kramper, hurtigt åndedræt (hypokloræmisk alkalose)
English: Multi-packs containing 280 (20 packs of 14) tablets.
Danish: Multipakninger med 280 (20 pakninger med 14) tabletter.
English: Multi-packs containing 90 (3 packs of 30), 98 (2 packs of 49) or 280 (20 packs of 14) tablets.
Danish: Multipakninger med 90 (3 pakninger med 30), 98 (2 pakninger med 49) eller 280 (20 pakninger med 14) tabletter.
English: • Facial rash, joint pain, muscle disorder, fever (lupus erythematosus)
Danish: • Udslæt i ansigtet, ledsmerter, muskelsygdomme, feber (lupus erythematosus)
English: Coadministration of orange or apple juice with aliskiren 150 mg resulted in a 62% decrease in aliskiren AUC or in a 63% decrease in aliskiren AUC, respectively.
Danish: Indtagelse af appelsin- eller æblejuice sammen med aliskiren 150 mg resulterede i en reduktion i AUC for aliskiren på hhv. 62 % eller 63 %.
English: − History of angioedema with aliskiren.
Danish: − Angioødem forårsaget af aliskiren i anamnesen.
English: The change in plasma levels of aliskiren in the presence of ketoconazole or verapamil is expected to be within the range that would be achieved if the dose of aliskiren were doubled; aliskiren doses of up to 600 mg, or twice the highest recommended therapeutic dose, have been found to be well tolerated in controlled clinical studies.
Danish: Ændring af aliskirens plasmaniveau ved tilstedeværelse af ketoconazol eller verapamil forventes at ligge inden for det område, der ville være opnået, hvis aliskirendosis blev fordoblet.
English: In a study in 722 randomised patients not adequately responsive to hydrochlorothiazide 25 mg treatment, the combination of aliskiren/hydrochlorothiazide 300 mg/25 mg produced systolic/diastolic blood pressure reductions of 16.78/10.7 mmHg, which were significantly greater than hydrochlorothiazide 25 mg monotherapy.
Danish: I et studie med 722 randomiserede patienter, der ikke responderede tilstrækkeligt på behandling med hydrochlorthiazid 25 mg, viste kombinationen af aliskiren/hydrochlorthiazid 300 mg/25 mg systoliske/diastoliske blodtryksreduktioner på 16,78/10,7 mmHg, hvilket var signifikant større end for hydrochlorthiazid 25 mg monoterapi.
English: There are no data with Rasilez HCT in patients with hepatic impairment.
Danish: Der er ingen data fra brug af Rasilez HCT hos patienter med nedsat leverfunktion.
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps) Not known
Danish: Benigne, maligne og uspecificerede tumorer (inkl.
English: Very rare (may affect up to 1 in 10,000 people):
Danish: Meget sjælden (kan forekomme hos op til 1 ud af 10.000 patienter):
English: Acute angle-closure glaucomah
Danish: Akut lukketvinklet glaukomh
English: If you take more Rasilez HCT than you should If you have accidentally taken too many tablets of this medicine, talk to a doctor immediately.
Danish: Hvis du er kommet til at tage for mange tabletter af dette lægemiddel, skal du straks kontakte en læge.
English: Rasilez HCT is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Rasilez HCT er kontraindiceret til patienter med stærkt nedsat leverfunktion (se pkt.
English: Agranulocytosish, bone marrow depressionh, haemolytic anaemiah, leucopeniah
Danish: Agranulocytoseh, knoglemarvsdepressionh, hæmolytisk anæmih, leukopenih
English: Muscle spasmh
Danish: Muskelspasmerh
English: Acute renal failurea,h, renal impairmenta
Danish: Akut nyresvigta,h, nedsat nyrefunktiona
English: In a study in 880 randomised patients not adequately responsive to aliskiren 300 mg treatment, the combination of aliskiren/hydrochlorothiazide 300 mg/25 mg produced systolic/diastolic blood pressure reductions of 15.8/11.0 mmHg, which were significantly greater than aliskiren 300 mg monotherapy.
Danish: I et studie med 880 randomiserede patienter, der ikke responderede tilstrækkeligt på behandling med aliskiren 300 mg, viste kombinationen af aliskiren/hydrochlorthiazid 300 mg/25 mg systoliske/diastoliske blodtryksreduktioner på 15,8/11,0 mmHg, hvilket var signifikant større end for aliskiren 300 mg monoterapi.
English: MDR1/Mdr1a/1b (P-gp) was found to be the major efflux system involved in intestinal absorption and biliary excretion of aliskiren in preclinical studies (see section 5.2).
Danish: Interaktioner med P-glykoprotein I prækliniske studier er det vist, at MDR1/Mdr1a/1b (P-gp) er det vigtigste efflukssystem involveret i aliskirens intestinale absorption og biliære udskillelse (se pkt 5.2).
English: The incidence of adjudicated stroke was not significantly different between the aliskiren and enalapril groups (4.4% versus 4.0%; HR 1.12, 95% CI 0.848, 1.485) or between the combination and enalapril groups (3.7% versus 4.0%; HR 0.93, 95% CI 0.697, 1.251).
Danish: Forekomsten af fastslået slagtilfælde var ikke signifikant anderledes i patientgruppen, der fik aliskiren sammenlignet med patientgruppen, der fik enalapril (4,4 % versus 4,0 %, HR 1,12; 95 % konfidensinterval: 0,848; 1,485), eller i patientgruppen, der fik kombinationen sammenlignet med patientgruppen, der fik enalapril (3,7 % versus 4,0 %; HR 0,93; 95 % konfidensinterval: 0,697; 1,251).
English: This medicine is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.
Danish: Hvis du ønsker at amme, kan din læge vælge en anden behandling til dig.
English: NSAIDs may reduce the anti-hypertensive effect of aliskiren.
Danish: Non-steroide anti-inflammatoriske lægemidler (NSAID) NSAID kan reducere aliskirens antihypertensive effekt.
English: Protect your skin from sun exposure and UV rays while taking Rasilez HCT.
Danish: Beskyt huden mod sollys og UV
English: • Vision disorder
Danish: • Synsforstyrrelser
English: Conversely, concomitant use of other agents affecting the RAAS, of NSAIDs or of agents that increase serum potassium levels (e.g. potassiumsparing diuretics, potassium supplements, salt substitutes containing potassium, heparin) may lead to increases in serum potassium.
Danish: Omvendt kan samtidig brug af andre stoffer, som påvirker RAAS, af NSAID'er eller af stoffer, som øger serumkalium (fx kaliumbesparende diuretika, kaliumtilskud, kaliumholdige salterstatninger, heparin), medføre stigning i serumkalium.
English: 56 x 1 film-coated tablet
Danish: 56 x 1 filmovertrukken tablet
English: Other inducers of Pgp (St. John's wort) might decrease the bioavailability of aliskiren.
Danish: Andre P-gpinduktorer (perikon) kan muligvis nedsætte aliskirens biotilgængelighed.
English: Abdominal discomforth, constipationh
Danish: Abdominalt ubehagh, obstipationh
English: Intrahepatic cholestasish, jaundicea,h
Danish: Intrahepatisk kolestaseh, gulsota,h
English: Food interactions
Danish: Fødeindtagelse
English: Eye disorders Rare
Danish: Øjne Sjælden
English: Medicinal products affecting serum potassium levels The potassium-depleting effect of hydrochlorothiazide is attenuated by the potassium-sparing effect of aliskiren.
Danish: Hydrochlorthiazids kaliumudtømmende virkning dæmpes ved aliskirens kaliumbesparende virkning.
English: Renal artery stenosis and renovascular hypertension No controlled clinical data are available on the use of Rasilez HCT in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Danish: Der er ingen tilgængelige kontrollerede kliniske data om brug af Rasilez HCT til patienter med unilateral eller bilateral nyrearteriestenose eller brug af Rasilez HCT hos patienter med en nyre.
English: − Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to other sulphonamide-derived substances.
Danish: − Overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne anført i pkt.
English: PA/Alu/PVC - Alu blisters:
Danish: Alu-blisterpakninger af PA/Alu/PVC:
English: CYP450 interactions
Danish: - Interaktioner med CYP
English: Rasilez HCT 150 mg/12.5 mg film-coated tablets Rasilez HCT 150 mg/25 mg film-coated tablets Rasilez HCT 300 mg/12.5 mg film-coated tablets Rasilez HCT 300 mg/25 mg film-coated tablets
Danish: Rasilez HCT 150 mg/12,5 mg filmovertrukne tabletter Rasilez HCT 150 mg/25 mg filmovertrukne tabletter Rasilez HCT 300 mg/12,5 mg filmovertrukne tabletter Rasilez HCT 300 mg/25 mg filmovertrukne tabletter
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelig (forekommer hos flere end 1 ud af 10 patienter):
English: In a post-authorisation observational study, the co-administration of aliskiren with ACEIs or ARBs has been associated with an increased risk of angioedema.
Danish: I et observationsstudie udført efter markedsføring er der set øget risiko for angioødem ved administration af aliskiren sammen med ACE-hæmmere eller ARB'er.
English: The use of Rasilez HCT during breast-feeding is not recommended.
Danish: Brug af Rasilez HCT frarådes under amning.
English: Rasilez HCT 150 mg/12.5 mg film-coated tablets Rasilez HCT 150 mg/25 mg film-coated tablets Rasilez HCT 300 mg/12.5 mg film-coated tablets Rasilez HCT 300 mg/25 mg film-coated tablets Aliskiren/hydrochlorothiazide
Danish: Rasilez HCT 150 mg/12,5 mg filmovertrukne tabletter Rasilez HCT 150 mg/25 mg filmovertrukne tabletter Rasilez HCT 300 mg/12,5 mg filmovertrukne tabletter Rasilez HCT 300 mg/25 mg filmovertrukne tabletter Aliskiren/hydrochlorthiazid
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 98 (2 packs of 49) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets Multipack: 90 (3 packs of 30) film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakning: 98 (2 pakninger med 49) filmovertrukne tabletter Multipakning: 280 (20 pakninger med 14) filmovertrukne tabletter Multipakning: 90 (3 pakninger med 30) filmovertrukne tabletter
English: • Increase of lipids in the blood
Danish: • Forhøjet indhold af lipider (fedt) i blodet
English: Rasilez HCT contains wheat starch.
Danish: Rasilez HCT indeholder hvedestivelse.
English: No overall clinically relevant adverse impact in paediatric patients aged 6 to 17 years was observed after treatment with aliskiren for up to one year based on physical development, assessed in patients with primary or secondary hypertension, and neurocognitive development assessed only in patients with secondary hypertension (19 patients: 9 previously treated with aliskiren and 10 previously treated with enalapril).
Danish: Ud fra en vurdering af fysisk udvikling hos patienter med primær eller sekundær hypertension og en vurdering af neurokognitiv udvikling udelukkende hos patienter med primær eller sekundær hypertension (19 patienter: 9 tidligere behandlet med aliskiren og 10 tidligere behandlet med enalapril).
English: • Severe skin disease that causes rash, red skin, blistering of the lips, eyes or mouth, skin peeling,
Danish: • Alvorlig hudsygdom med udslæt, hudrødme, blæredannelse på læber, i øjne eller mund,
English: Rare (may affect up to 1 in 1,000 people):
Danish: Sjældne (forekommer hos op til 1 ud af 1.000 patienter):
English: Concomitant intake with fruit juice and/or drinks containing plant extracts (including herbal teas) should be avoided (see section 4.5).
Danish: Indtagelse af frugtjuice og/eller drikkevarer indeholdende planteekstrakter (inklusive urteteer)sammen med Rasilez HCT bør undgås (se pkt.
English: • High level of uric acid in the blood
Danish: • Højt indhold af urinsyre i blodet
English: 280 film-coated tablets (20 packs of 14)
Danish: 280 filmovertrukne tabletter (20 pakninger med 14)
English: Arthralgiaa
Danish: Artralgia
English: What Rasilez HCT is used for
Danish: Rasilez HCTs anvendelse
English: Multi-packs (perforated unit dose blister) containing 98 (2 packs of 49 x 1) tablets.
Danish: Multipakninger (perforeret enkeltdosisblister) med 98 (2 pakninger med 49 x 1) tabletter.
English: • High level of sugar in the blood
Danish: • Højt blodsukker
English: MARKETING AUTHORISATION NUMBER(S) Rasilez HCT 150 mg/12.5 mg film-coated tablets EU/1/08/491/001-020
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) Rasilez HCT 150 mg/12,5 mg filmovertrukne tabletter EU/1/08/491/001-020
English: (asthenia)
Danish: (overfølsomhedsreaktioner)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING PVC/PCTFE BLISTERS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON MED PVC/PCTFE-BLISTERKORT
English: Medicinal products affecting serum potassium levels Concomitant use of other agents affecting the RAAS, of NSAIDs or of agents that increase serum potassium levels (e.g. potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, heparin) may lead to increases in serum potassium.
Danish: Samtidig brug af andre stoffer, som påvirker RAAS, af NSAID eller af stoffer, som øger serumkalium (fx kaliumbesparende diuretika, kaliumtilskud, kaliumholdige salterstatninger, heparin), kan medføre stigning i serumkalium.
English: Amantadine
Danish: Hvedestivelse
English: - if you have diabetes or impaired kidney function and you are treated with either of the following classes of medicines used to treat high blood pressure: - an angiotensin converting enzyme inhibitor such as enalapril, lisinopril, ramipril or - an angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan.
Danish: Bruges også til andre tilstande fx gigt eller hudeksem), itraconazol (medicin, der bruges til behandling af svampeinfektioner) eller quinidin (medicin, som bruges til at korrigere hjerterytmen); - hvis du har sukkersyge eller nedsat nyrefunktion, og du bliver behandlet med nogen af følgende typer lægemidler, som bruges til at behandle for højt blodtryk: en angiotensin-konverteringsenzym (ACE)-hæmmer, som fx enalapril, lisinopril, ramipril.
English: Currently available data are described in sections 4.8, 5.1, and 5.2.
Danish: 4.8, 5.1 og 5.2.
English: 90 film-coated tablets.
Danish: 90 filmovertrukne tabletter.
English: − Severe hepatic impairment.
Danish: − Stærkt nedsat leverfunktion.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 98 (2 packs of 49 x 1) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakning: 98 (2 pakninger med 49 x 1) filmovertrukne tabletter Multipakning: 280 (20 pakninger med 14) filmovertrukne tabletter
English: or an angiotensin II receptor blockers (ARB) is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Danish: − Samtidig brug af Rasilez HCT sammen med en angiotensin-konverteringsenzym-hæmmere (ACE) eller en angiotension-II receptorblokkere (ARB) er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: Consistent with standard medical practice, periodic determination of renal function including serum electrolytes is advised if coadministration is considered necessary.
Danish: Hvis samtidig brug skønnes nødvendig, tilrådes regelmæssig kontrol af nyrefunktion inklusive serumelektrolytter i overensstemmelse med standardpraksis.