FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis sensitive to tildipirosin.
Danish: Til behandling og metafylakse af luftvejsinfektioner hos svin (SRD) forårsaget af tildipirosinfølsomme Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica og Haemophilus parasuis.
English: Animal species
Danish: Indikation Dyrearter
English: MARKETING AUTHORISATION NUMBERS EU/2/11/124/005-008
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/11/124/005-008
English: Date of last renewal:
Danish: Dato for seneste fornyelse af markedsføringstilladelsen:
English: For the treatment and prevention of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni sensitive to tildipirosin.
Danish: Til forebyggende og terapeutisk behandling af luftvejsinfektioner hos kvæg (BRD) forårsaget af tildipirosin-følsomme Mannheimia haemolytica, Pasteurella multocida og Histophilus somni.
English: WITHDRAWAL PERIOD Meat and offal: 9 days.
Danish: 10. TILBAGEHOLDELSESTID Slagtning: 9 dage
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Danish: TEKSTEN "OPBEVARES UTILGÆNGELIGT FOR BØRN" Opbevares utilgængeligt for børn
English: 180 mg. For the full list of excipients, see section 6.1.
Danish: 180 mg Alle hjælpestoffer er anført under pkt.
English: ROUTE OF ADMINISTRATION
Danish: INDGIVELSESVEJ€
English: Withdrawal period: Meat and offal: 47 days.
Danish: Tilbageholdelsestid: Slagtning: 47 dage
English: Species
Danish: DYREARTER
English: During clinical trials, pain on injection and injection site swellings were seen very commonly in treated pigs.
Danish: Under kliniske studier med svin sås meget hyppigt en smertereaktion på injektionen og hævelse på injektionsstedet.
English: PHARMACEUTICAL FORM Solution for injection
Danish: LÆGEMIDDELFORM Injektionsvæske, opløsning
English: SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children.
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VEDRØRENDE OPBEVARING Opbevares utilgængeligt for børn
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES 40 mg/ml of tildipirosin
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER 40 mg/ml tildipirosin
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES 180 mg/ml of tildipirosin
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER 180 mg/ml tildipirosin
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 180 mg/ml of tildipirosin
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) 180 mg/ml tildipirosin
English: Zone diameter (mm) MIC breakpoint (µg/ml) S
Danish: MIC breakpoint (µg/ml)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/124/007
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/11/124/007
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 40 mg/ml solution for injection for pigs tildipirosin
Danish: VETERINÆRLÆGEMIDLETS NAVN ZUPREVO 40 mg/ml injektionsvæske, opløsning til svin Tildipirosin
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 180 mg/ml solution for injection for cattle tildipirosin
Danish: VETERINÆRLÆGEMIDLETS NAVN ZUPREVO 180 mg/ml injektionsvæske, opløsning til kvæg Tildipirosin
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/124/003
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/11/124/003
English: Following the maximum recommended injection site volume of 10 ml, injection site swellings may be associated with pain on palpation for about one day in individual animals.
Danish: Der kan hos enkelte dyr i forbindelse med hævelse på injektionsstedet være smerte ved palpation i op til et døgn efter administration af det maksimale doseringsvolumen på 10 ml.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 180 mg/ml solution for injection for cattle
Danish: VETERINÆRLÆGEMIDLETS NAVN ZUPREVO 180 mg/ml injektionsvæske, opløsning til kvæg
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE Veterinary medicinal product subject to prescription.
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG
English: PACKAGE LEAFLET FOR: ZUPREVO 180 mg/ml solution for injection for cattle
Danish: INDLÆGSSEDDEL TIL: ZUPREVO, 180 mg/ml, injektionsvæske, opløsning til kvæg
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 40 mg/ml solution for injection for pigs
Danish: VETERINÆRLÆGEMIDLETS NAVN ZUPREVO 40 mg/ml injektionsvæske, opløsning til svin
English: QUANTITY OF THE ACTIVE SUBSTANCE 40 mg/ml of tildipirosin
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) 40 mg/ml tildipirosin
English: 40 mg. For the full list of excipients, see section 6.1.
Danish: 40 mg Alle hjælpestoffer er anført under pkt.
English: 800 μg/kg 5,000 μg/kg 10,000 μg/kg
Danish: 5.000 µg/kg
English: Mannheimia haemolytica (n=50) Pasteurella multocida (n=50) Histophilus somni (n=50)
Danish: Mannheimia haemolytica (n=50)
English: SPECIAL WARNINGS Read the package leaflet before use.
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT Læs indlægssedlen inden brug.
English: Growing-finishing Finishing/sows/boars
Danish: Opfedning-afsluttende periode 3,5 Afsluttende periode/søer/orner 4,0
English: MRL
Danish: i.m.
English: NO ENTRY Antiinfectious agents/
Danish: (3) Produktion af inaktiverende enzymer.
English: PACKAGE LEAFLET FOR: ZUPREVO 40 mg/ml solution for injection for pigs
Danish: ZUPREVO, 40 mg/ml, injektionsvæske, opløsning til svin
English: Grapefruit juice
Danish: Grapefrugt juice
English: In addition, an updated RMP should be submitted
Danish: Derudover bør en opdateret RMP insendes
English: Taking Tekturna with food and drink
Danish: Brug af Tekturna sammen med mad og drikke
English: Risk Management Plan
Danish: Risk ManagementPlan
English: Do not take Tekturna if you are pregnant.
Danish: Du må ikke tage Tekturna, hvis du er gravid.
English: If you forget to take Tekturna
Danish: Hvis du har glemt at tage Tekturna
English: Not known (frequency cannot be estimated from the available data): Kidney problems.
Danish: Ikke kendt (hyppigheden kan ikke bestemmes ud fra tilgængelige data): Nyreproblemer.
English: BLISTER (CALENDAR)
Danish: BLISTER (KALENDERPAKNING)
English: Do not use Tekturna after the expiry date which is stated on the carton and blister.
Danish: Brug ikke Tekturna efter den udløbsdato, der står på pakningen og blisterkortet.
English: This leaflet was last approved in
Danish: Denne indlægsseddel blev senest godkendt i
English: However the clinical significance of this reduction is unknown.
Danish: Den kliniske signifikans af denne reduktion er dog ikke kendt.
English: Like all medicines, Tekturna can cause side effects, although not everybody gets them.
Danish: Tekturna kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Keep your appointments with the doctor even if you are feeling well.
Danish: Overhold dine aftaler med lægen, også selvom du ler dig rask.
English: Cases of angioedema have also been reported in post-marketing experience (frequency unknown).
Danish: Tilfælde af angioødem er også rapporteret efter markedsføring (frekvens ikke kendt).
English: Tekturna has been evaluated for safety in more than 7,800 patients, including over 2,300 treated for over 6 months, and more than 1,200 for over 1 year.
Danish: Tekturna er evalueret med henblik på sikkerhed hos mere end 7.800 patienter, herunder over 2.300, som var i behandling i mere end 6 måneder, og mere end 1.200, som var i behandling i over 1 år.
English: The use of Tekturna in children and adolescents is not recommended.
Danish: Tekturna anbefales ikke til børn og unge.
English: In addition, measures necessary to ensure patient airways should be provided.
Danish: Yderligere skal der tages de nødvendige forholdsregler for at sikre patientens luftveje.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Danish: I henhold til CHMPs ”Guideline on Risk Management Systems for medicinal products for human use”, bør den opdaterede RMP indsendes samtidig som den næste Periodic Safety Update Report
English: If you have accidentally taken too many Tekturna tablets, consult a doctor immediately.
Danish: Hvis du er kommet til at tage for mange tabletter af Tekturna, skal du straks kontakte en læge.
English: If any of these apply to you, tell your doctor before you take Tekturna.
Danish: Hvis noget af dette gælder for dig, skal du fortælle det til lægen, før du tager Tekturna.
English: The MAH must ensure that the system of pharmacovigilance, as described in version 2 (dated 5 July 2006) 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 2 (dateret 5. juli 2006) præsenteret i modul 1.8.1 af ansøgningen om markedsføringstilladelse, er på plads og operativt før og mens produktet er på markedet.
English: If you forget to take a dose of Tekturna, take it as soon as you remember and then take the next dose at its usual time.
Danish: Hvis du glemmer at tage Tekturna, skal du tage det så snart, du kommer i tanker om det, og derefter tage den næste dosis til sædvanlig tid.
English: If angioedema occurs, Tekturna should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms has occurred.
Danish: Hvis angioødem opstår, skal Tekturna seponeres med det samme, og der skal iværksættes relevant behandling og monitorering, indtil komplet og vedvarende resolution af tegn og symptomer indtræffer.
English: It is not known whether aliskiren is excreted in human milk.
Danish: Det vides ikke, om aliskiren udskilles i human modermælk.
English: Your doctor may prescribe Tekturna together with other medicines used to treat high blood pressure.
Danish: læge kan ordinere Tekturna sammen med anden medicin, der bruges til at behandle forhøjet blodtryk.
English: - during the last 6 months of pregnancy or if you are breast-feeding, see section Pregnancy and
Danish: - de sidste 6 måneder af graviditeten eller hvis du ammer, se afsnittet om ”Graviditet og amning”.
English: This condition should be corrected prior to administration of Tekturna, or the treatment should start under close medical supervision.
Danish: Denne tilstand bør korrigeres før administration af Tekturna, eller behandlingen skal indledes under nøje medicinsk overvågning.
English: Angioedema has occurred during treatment with Tekturna.
Danish: Angioødem er forekommet under behandling med Tekturna.
English: Tekturna belongs to a new class of medicines called renin inhibitors.
Danish: Tekturna tilhører en ny klasse af medicin, kaldet reninhæmmere.
English: There are no special dose recommendations for patients aged 65 years or older.
Danish: Der er ingen særlige doseringsanbefalinger til patienter på 65 år og derover.
English: Other substances that act directly on the RAS have been associated with serious foetal malformations and neonatal death.
Danish: Andre stoffer, som virker direkte på RAS, associeres med alvorlige fostermisdannelser og dødsfald hos nyfødte.
English: Elderly patients (over 65 years) No adjustment of the initial dose is required for elderly patients.
Danish: Ældre patienter (over 65 år) Der kræves ingen justering af initialdosen for ældre patienter.
English: The clinical relevance of a reduction in UACR is not established in the absence of an effect on blood pressure.
Danish: Den kliniske relevans af en reduktion i UACR er ikke fastslået uden en samtidig effekt på blodtrykket.
English: The potential for drug interactions at the P-gp site will likely depend on the degree of inhibition of this transporter.
Danish: Muligheden for interaktioner med lægemidler ved P-gp's bindingssted vil sandsynligvis afhænge af denne transportørs hæmningsgrad.
English: The adverse drug reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: 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), including isolated reports.
Danish: Bivirkningerne (tabel 1) er ordnet i frekvensgrupper med den mest almindelige først og ved anvendelse af følgende definition: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000), inklusive enkeltstående rapporter.
English: Do not take Tekturna - if you are allergic (hypersensitive) to aliskiren or any of the other ingredients of Tekturna.
Danish: Tag ikke Tekturna - hvis du er overfølsom (allergisk) over for aliskiren eller et af de øvrige indholdsstoffer i
English: The increase may be higher with higher aliskiren doses.
Danish: Forøgelsen kan være større for de højere doser af aliskiren.
English: However, CYP3A4 inhibitors often also affect P-gp.
Danish: CYP3A4-hæmmere påvirker dog ofte også P-gp.
English: - ketoconazole, a medicine used to treat fungal infections.
Danish: - ketoconazol, medicin, der bruges til at behandle svampeinfektioner.
English: However, in one study where Tekturna was used in combination with an ACEI in a diabetic population, increases in serum potassium were more frequent (5.5%).
Danish: I et studie, hvor Tekturna blev anvendt sammen med en ACE-hæmmer i en diabetisk population, var stigningerne i serumkalium dog mere hyppige (5,5 %).
English: P-glycoprotein interactions
Danish: Interaktioner med P-glycoprotein
English: The proportion of patients who had UACR reduced at least 50% from baseline to endpoint was 24.7% and 12.5% for Tekturna and placebo, respectively.
Danish: Andelen af patienter, som fik UACR reduceret med mindst 50% fra baseline ved forsøgets slutning var henholdsvis 24,7 % for Tekturna og 12,5 % for placebo.
English: In experimental animals, it has been shown that P-gp is a major determinant of Tekturna bioavailability.
Danish: I forsøgsdyr er det blevet vist a P-gp har stor indflydelse på Tekturnas biotilgængelighed.
English: In the event of severe and persistent diarrhoea, Tekturna therapy should be stopped.
Danish: I tilfælde af alvorlig og vedvarende diarré bør behandling med Tekturna stoppes.
English: Tekturna helps to lower high blood pressure.
Danish: Tekturna hjælper med at sænke et forhøjet blodtryk.
English: As a result no dose adjustment for Tekturna or these co-administered medicinal products is necessary.
Danish: Dosisjustering for Tekturna eller disse samtidigt administrerede lægemidler er derfor ikke nødvendig.
English: In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of Tekturna.
Danish: I kontrollerede kliniske forsøg blev klinisk relevante ændringer i standardlaboratorieparametre i få tilfælde associeret med administration af Tekturna.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: pørg din læge eller apoteket til råds, før du tager nogen form for medicin.
English: Preliminary data suggest that irbesartan may decrease Tekturna AUC and Cmax.
Danish: Foreløbige data tyder på at irbesartan kan nedsætte AUC og Cmax for Tekturna.
English: Grapefruit juice should not be taken together with Tekturna.
Danish: Grapefrugt juice må ikke tages sammen med Tekturna.
English: You should not take Tekturna together with grapefruit juice.
Danish: Du må ikke tage Tekturna sammen med grapefrugt juice.
English: Digoxin bioavailability may be slightly decreased by Tekturna.
Danish: Biotilgængeligheden af digoxin kan blive lettere nedsat af Tekturna.
English: It is therefore recommended that the effects be monitored when initiating and adjusting furosemide therapy to avoid possible under-utilisation in clinical situations of volume overload.
Danish: Det anbefales derfor at monitorere virkningen ved initiering og justering af furosemidbehandling for at undgå potentiel underudnyttelse i kliniske situationer med volumenoverload.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 30 May 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen forpligter sig til at udføre studier og yderligere pharmacovigilance-aktiviteter som beskrevet i pharmacovigilance-planen, som aftalt i versionen af 30. maj 2007 af risk management planen (RMP), præsenteret i modul 1.8.2 af ansøgningen om markedsførringstilladelse og enhver efterfølgende opdatering af RMP aftalt af CHMP.
English: Tekturna may be used alone or in combination with other antihypertensive agents (see sections 4.4 and
Danish: Tekturna kan anvendes alene eller kombineres med andre antihypertensiva (se pkt 4.4 og 5.1).
English: Therefore the combination of aliskiren with an NSAID requires caution, especially in elderly patients.
Danish: Kombination af a liskiren og NSAID kræver derfor forsigtighed, især hos ældre patienter.
English: Tekturna is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy (see section 5.2).
Danish: Tekturna bør ikke anvendes til børn og unge under 18 år p.g.a. manglende dokumentation for sikkerhed og virkning (se pkt.
English: Aliskiren should be used with caution in patients with serious congestive heart failure (New York Heart Association [NYHA] functional class III-IV).
Danish: Aliskiren bør anvendes med forsigtighed til patienter med svær hjertesvigt (New York Heart Association [NYHA] klasse III-IV).
English: Although this has not been investigated for aliskiren, it is known that P-gp also controls tissue uptake of a variety of substrates and P-gp inhibitors can increase the tissue-to-plasma concentration ratios.
Danish: Selvom det ikke er blevet undersøgt for aliskiren, er det kendt, at P-gp også kontrollerer vævsoptaget for et stort udvalg af substrater, og P-gp kan øge koncentrationsforholdet mellem væv og plasma.
English: Lowering the blood pressure to a normal level reduces the risk of developing these disorders.
Danish: Når blodtrykket sænkes til normalt niveau, mindskes risikoen for at få d
English: Due to the lack of data a potential interaction between grapefruit juice and aliskiren cannot be excluded.
Danish: På grund af manglende data om mulig interaktion mellem grapefrugt juice og aliskiren kan denne interaktion ikke udelukkes.
English: In a 3-month study of 302 patients with mild stable heart failure, all of whom were receiving standard therapy for stable heart failure, addition of Tekturna 150 mg was well tolerated.
Danish: I et 3-måneders studie med 302 patienter med let stabilt hjertesvigt, som alle var i standardbehandling for stabilt hjertesvigt blev tillæg af Tekturna 150 mg godt tolereret.
English: Food intake Meals with a high fat content have been shown to reduce the absorption of Tekturna substantially.
Danish: Fødeindtag Måltider med højt fedtindhold reducerer absorptionen af Tekturna betragteligt.
English: Tekturna has no known clinically relevant interactions with medicinal products commonly used to treat hypertension or diabetes.
Danish: Tekturna har ingen kendte klinisk relevante interaktioner med lægemidler, som typisk bruges til behandling af hypertension eller diabetes.
English: - certain types of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).
Danish: - visse typer af smertestillende medicin kaldet ikke-steroide antiinflammatoriske lægemidler
English: By inhibiting the enzyme renin, aliskiren inhibits the RAS at the point of activation, blocking the conversion of angiotensinogen to angiotensin I and decreasing levels of angiotensin I and angiotensin II.
Danish: Ved at hæmme enzymet renin hæmmer aliskiren RAS-systemets aktiveringspunkt og blokerer konverteringen af angiotensinogen til angiotensin I og mindsker niveauet af angiotensin I og angiotensin II.
English: Its use is therefore not recommended in women who are breast-feeding.
Danish: Det anbefales derfor ikke til kvinder der ammer.
English: Warfarin The effects of Tekturna on warfarin pharmacokinetics have not been evaluated.
Danish: Effekten af Tekturna på warfarins farmakokinetik er ikke blevet evalueret.
English: Tekturna was secreted in the milk of lactating rats.
Danish: Tekturna udskilles i mælken hos diegivende rotter.
English: Healthcare professionals prescribing any agents acting on the RAS should counsel women of childbearing potential about the potential risk of these agents during pregnancy.
Danish: Læger, som ordinerer præparater, der virker på RAS, bør rådgive kvinder i den fertile alder om den potentielle risiko ved disse stoffer under graviditet.
English: Tekturna was not teratogenic in rats or rabbits (see section 5.3).
Danish: Tekturna var ikke teratogent i rotter eller kaniner (se pkt.
English: Tekturna has been studied in 1,864 patients aged 65 years or older, and in 426 patients aged 75 years or older.
Danish: Tekturna er undersøgt i 1.864 patienter i alderen 65 år eller derover og i
English: Meals with a high fat content reduce Cmax by 85% and AUC by 70%.
Danish: Måltider med højt fedtindhold reducerer Cmax med 85 % og 70 %.
English: Steady-state-plasma concentrations are reached within 5-7 days following once-daily administration and steady-state levels are approximately 2-fold greater than with the initial dose.
Danish: Steady state-plasmakoncentrationerne nås inden for 5-7 dage efter administration en aAUC med gang dagligt, og steady state-niveauerne er ca. 2 gange større end ved initialdosen.
English: Serum potassium: Increases in serum potassium were minor and infrequent in patients with essential hypertension treated with Tekturna alone (0.9% compared to 0.6% with placebo).
Danish: Serumkalium: Stigningerne i serumkalium var minimale og ikke hyppige hos patienter med essentiel hypertension, som blev behandlet med Tekturna alene (0,9 % kontra 0,6 % med placebo).
English: Whereas other agents that inhibit the RAS (ACEI and angiotensin II receptor blockers (ARB)) cause a compensatory rise in plasma renin activity (PRA), treatment with aliskiren decreases PRA in hypertensive patients by approximately 50 to 80%.
Danish: Mens andre stoffer, som hæmmer RAS (ACE-hæmmere og angiotensin-II-antagonister (ARB)) forårsager en kompensatorisk stigning i plasmareninaktiviteten (PRA), mindsker behandling med aliskiren PRA hos hypertensive patienter med ca. 50-80 %.
English: No controlled clinical data are available on the use of Tekturna 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 Tekturna til patienter med unilateral eller bilateral nyrearteriestenose eller brug af Tekturna til patienter med stenose i en enkelt nyre.
English: Excessive hypotension was uncommonly (0.1%) seen in patients with uncomplicated hypertension treated with Tekturna alone.
Danish: Kraftig hypotension var usædvanlig (0,1 % hos patienter med ukompliceret hypertension, som blev behandlet med Tekturna alene.
English: • When new information is received that may impact on the current Safety Specification,
Danish: • Når ny information modtages som kan have indflydelse på den nuværende sikkerhedsspecifikation, pharmacovilanceplan eller risikominimeringsaktiviteter.
English: Increased aliskiren exposure during co-administration of CYP3A4 inhibitors that also inhibit P-gp can therefore be expected (see P-glycoprotein interactions below).
Danish: Øget aliskiren-eksponering ved samtidig administration af CYP3A4-hæmmere, som også hæmmer P-gp, kan derfor forventes (se også P-glycoprotein interaktioner herunder).
English: Preclinical studies indicate that aliskiren and ketoconazole co-administration enhances aliskiren gastrointestinal absorption and decreases biliary excretion.
Danish: Prækliniske forsøg tyder på, at samtidig administration af aliskiren og ketoconazol øger aliskirens gastrointestinale absorption og mindsker den biliære udskillelse.