FrancophonIA/ELRC3.0 huggingface dataset:
English: the CHMP has recommended the amendment of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Diovan and associated names (see Annex I).
Danish: - Produktresuméet, etiketteringen og indlægssedlen, som indehaveren af markedsføringstilladelsen har foreslået, er blevet vurderet på baggrund af den indsendte dokumentation og udvalgets faglige drøftelseanbefaler CHMP en ændring af de(n) markedsføringstilladelse(r), for hvilke(n) produktresuméet, etiketteringen og indlægssedlen fremgår af bilag III for Diovan og tilknyttede navne (se bilag I).
English: Treatment of clinically stable patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours-10 days) myocardial infarction (see sections 4.4 and 5.1).
Danish: Behandling af klinisk stabile patienter med symptomatisk hjertesvigt eller asymptomatisk venstre ventrikulær systolisk dysfunktion efter nyligt (12 timer - 10 dage) myokardieinfarkt (se pkt.
English: The therapeutic indication for heart failure is supported primarily by a large long-term morbidity trial Valsartan Heart Failure Trial (Val-HeFT) Valsartan reduced the risk related to first morbid event, mortality, the total number of Heart Failure (HF) hospitalizations.
Danish: Den terapeutiske indikation for hjertesvigt støttes primært af en stor langsigtet morbiditetsundersøgelse, Valsartan Heart Failure Trial (Val-HeFT).
English: (diuretics).
Danish: (NSAID).
English: Evaluation of post-myocardial infarction patients should always include assessment of renal function.
Danish: Evaluering af patienter med post-myokardieinfarkt bør altid inkludere vurdering af nyrefunktionen.
English: The CHMP proposed wording has been accepted by the MAH.
Danish: Indehaveren af markedsføringstilladelsen har accepteret CHMP's forslag til en formulering.
English: “Treatment of symptomatic heart failure when Angiotensin Converting Enzyme (ACE) inhibitors could not be used, or as add-on therapy to ACE inhibitors when beta blockers could not be used”
Danish: "Behandling af symptomatisk hjertesvigt, når ACE-hæmmere (Angiotensin Converting Enzyme) ikke kan anvendes, eller som supplerende behandling til ACE-hæmmere, når betablokkere ikke kan anvendes"
English: Diovan and associated names (see Annex I) 320 mg film-coated tablets Valsartan [See Annex I - To be completed nationally]
Danish: Diovan og tilhørende navne (se bilag I) 320 mg filmovertrukne tabletter Valsartan [Se Bilag I - Udfyldes nationalt]
English: In patients with a creatinine clearance <10 ml/min and patients undergoing dialysis no data are available, therefore valsartan should be used with caution in these patients.
Danish: Der findes ingen data for patienter med en kreatininclearance <10 ml/min og patienter i dialysebehandling, og valsartan bør derfor anvendes med forsigtighed hos disse patienter.
English: Evaluation of patients with heart failure should always include assessment of renal function.”
Danish: Vurderingen af patienter med hjertesvigt bør altid omfatte en vurdering af nyrefunktionen."
English: Diovan is used when a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors (a medication to treat heart failure) cannot be used or it may be used in addition to ACE inhibitors when beta blockers (another medication to treat heart failure) cannot be used.
Danish: Diovan bruges, når en gruppe lægemidler kaldet angiotensinkonverterende enzym (ACE)-hæmmere (et lægemiddel til behandling af hjertesvigt) ikke kan bruges, eller det kan bruges som supplement til ACE-hæmmere, når betablokkere (et andet lægemiddel til behandling af hjertesvigt) ikke kan bruges.
English: Therefore the MAH should address the lack of (additional) clinical benefit and increased adverse events In conclusion; the CHMP adopts the revised text: “The recommended starting dose of Diovan is 40 mg twice daily.
Danish: Afslutningsvis vedtog CHMP den ændrede tekst: "Den anbefalede startdosis for Diovan er 40 mg to gange daglig.
English: 4.8 - Undesirable effect
Danish: 4.8 - Bivirkninger
English: Evaluation of post-myocardial infarction patients should always include assessment of renal function (see section
Danish: Evaluering af post-myokardieinfarktpatienter bør altid inkludere vurdering af nyrefunktionen (se pkt.
English: Having assessed the data available, the CHMP considered that the use of valsartan 80 mg as the starting dose, with no dosage adjustment, in patients with reduced renal function (creatinine clearance rate >10 ml/min) is supported by both efficacy and safety data from various studies.
Danish: Efter vurdering af alle tilgængelige data fandt CHMP, at brugen af valsartan 80 mg som startdosis uden dosisjustering hos patienter med nedsat nyrefunktion (kreatininclearance >10 ml/min)
English: Each film-coated tablet contains 320 mg valsartan.
Danish: Hver filmovertrukken tablet indeholder 320 mg valsartan.
English: There is currently no experience on the safe use in patients with a creatinine clearance <10 ml/min and patients undergoing dialysis, therefore valsartan should be used with caution in these patients (see sections 4.2 and 5.2).
Danish: Der foreligger endnu ingen erfaring med sikkerheden ved brug til patienter med en kreatinin-clearance <10 ml/min og patienter i dialysebehandling, derfor bør valsartan anvendes med forsigtighed til disse patienter (se pkt.
English: Czech Republic NOVARTIS s.r.o.
Danish: NOVARTIS s.r.o.
English: Diovan 40 mg film-coated tablets can be used for two different conditions:
Danish: Diovan 40 mg filmovertrukne tabletter kan bruges til to forskellige tilstande:
English: Each film-coated tablet contains 160 mg valsartan.
Danish: Hver filmovertrukken tablet indeholder 160 mg valsartan.
English: Each film-coated tablet contains 40 mg valsartan.
Danish: Hver filmovertrukken tablet indeholder 40 mg valsartan.
English: Each capsule contains 40 mg valsartan.
Danish: Hver kapsel indeholder 40 mg valsartan.
English: Diovan 160 mg capsules, hard can be used for three different conditions:
Danish: Diovan 160 mg hårde kapsler kan bruges til tre forskellige tilstande:
English: Each capsule contains 160 mg valsartan.
Danish: Hver kapsel indeholder 160 mg valsartan.
English: Diovan 40 mg capsules, hard can be used for two different conditions:
Danish: Diovan 40 mg hårde kapsler kan bruges til to forskellige tilstande:
English: Diovan 80 mg capsules, hard can be used for three different conditions:
Danish: Diovan 80 mg hårde kapsler kan bruges til tre forskellige tilstande:
English: Treatment of symptomatic heart failure when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used, or as add-on therapy to ACE inhibitors when beta blockers cannot be used (see sections 4.4 and 5.1).
Danish: Behandling af symptomatisk hjertesvigt når ACE-hæmmere ikke kan anvendes, eller som tillægsbehandling til ACE-hæmmere når betablokkere ikke kan anvendes (se pkt.
English: Diovan and associated names (see Annex I) 320 mg film-coated tablets Valsartan
Danish: Diovan og tilhørende navne (se bilag I) 320 mg filmovertrukne tabletter Valsartan
English: Each film-coated tablet contains 80 mg valsartan.
Danish: Hver filmovertrukken tablet indeholder 80 mg valsartan.
English: Each capsule contains 80 mg valsartan.
Danish: Hver kapsel indeholder 80 mg valsartan.
English: • dizziness, postural dizziness
Danish: • svimmelhed, svimmelhed når du står op
English: Diovan and associated names (see Annex I) 160 mg film-coated tablets Valsartan
Danish: Diovan og tilhørende navne (se bilag I) 160 mg filmovertrukne tabletter Valsartan
English: If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.
Danish: Kontakt lægen, skadestuen eller apoteket, hvis du er kommet til at tage for mange tabletter.
English: Diovan and associated names (see Annex I) 160 mg capsules, hard Valsartan
Danish: Diovan og tilhørende navne (se bilag I) 160 mg kapsler, hårde Valsartan
English: Diovan and associated names (see Annex I) 40 mg capsules, hard Valsartan
Danish: Diovan og tilhørende navne (se bilag I) 40 mg kapsler, hårde Valsartan
English: Diovan and associated names (see Annex I) 40 mg film-coated tablets Valsartan
Danish: Diovan og tilhørende navne (se bilag I) 40 mg filmovertrukne tabletter Valsartan
English: Diovan and associated names (see Annex I) 80 mg film-coated tablets Valsartan
Danish: Diovan og tilhørende navne (se bilag I) 80 mg filmovertrukne tabletter Valsartan
English: Diovan and associated names (see Annex I) 80 mg capsules, hard Valsartan
Danish: Diovan og tilhørende navne (se bilag I) 80 mg kapsler, hårde Valsartan
English: Novartis Pharma B.V. Postbus 241
Danish: Novartis Pharma B.V.
English: [To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally] 6.5 Nature and contents of container [To be completed nationally] 6.6 Special precautions for disposal No special requirements.
Danish: 6.6 Regler for destruktion og anden håndtering Ingen særlige forholdsregler.
English: What Diovan looks like and contents of the pack [To be completed nationally]
Danish: Udseende og pakningsstørrelser [Udfyldes nationalt]
English: In patients with mild to moderate hepatic impairment without cholestasis, Diovan should be used with caution (see sections 4.2 and 5.2).
Danish: Diovan bør anvendes med forsigtighed til patienter med mildt til moderat leverinsufficiens uden cholestasis (se pkt.
English: Diovan may also be administered with other antihypertensive agents.
Danish: Når angiotensin II-antagonister administreres samtidigt med NSAID'er, kan der forekomme en svækkelse af den antihypertensive effekt.
English: Lactation
Danish: • træthed
English: No dosage adjustment is required for patients with a creatinine clearance >10 ml/min (see sections 4.4 and 5.2)
Danish: Nedsat nyrefunktion Der kræves ingen dosisjustering for patienter med en kreatinin-clearance >10 ml/min (se pkt.
English: Box 1150
Danish: Postbus 241
English: --1 Per 1 ml dose: live feline calicivirus (strain F9) 104.6-106.1 CCID50; live feline viral rhinotracheitis virus (strain F2) 105.0-106.6 CCID50 ; live feline panleucopenia virus (strain LR 72) 103.7-104.5 CCID50; and purified p45 FeLV-envelope antigen, minimum quantity 102 μg
Danish: --1 Hver dosis (1 ml) indeholder: levende felin calicivirus (stamme F9) 104.6 -106.1 CCID50 ; levende felin viral rhinotracheitis virus (stamme F2) 105.0 -106.6 CCID50 ; levende felin panleucopeni virus (stamme LR 72) 103.7 -104.5 CCID50 ; minimum mængde renset p45 FeLV-envelope antigen 102 µg
English: 150 (3x50) capsules
Danish: 150 (3x50) kapsler
English: 150 mg Film-coated tablet Oral use
Danish: 150 mg Filmovertrukket tablet
English: The full EPAR for Hirobriz Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Hirobriz Breezhaler findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: European Commission granted a marketing authorisation valid throughout the European Union for Hirobriz Breezhaler on 30 November 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Hirobriz Breezhaler den 30. november 2009.
English: The increase in FEV1 was 130 ml with tiotropium, and 80 ml with formoterol.
Danish: Forbedringen i FEV1 var 130 ml med tiotropium og 80 ml med formoterol.
English: It works by attaching to beta-2 receptors that are found in the muscle cells of many organs and that cause the muscles to relax.
Danish: Det virker ved at binde sig til beta 2-receptorer, som findes i muskelcellerne i mange organer, og som får musklerne til at slappe af.
English: The main measure of effectiveness was based on changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 12 weeks.
Danish: Hovedeffektmålet var ændringer i patienternes forcerede eksspirationsvolumen (FEV1, den maksimale luftmængde, en person kan udånde på et sekund) efter 12 uger.
English: The doctor may increase the dose to one 300 microgram capsule once a day in cases of severe COPD.
Danish: Lægen kan øge dosis til en kapsel på 300 mikrogram én gang dagligt i tilfælde af svær KOL.
English: This is a summary of the European public assessment report (EPAR) for Hirobriz Breezhaler.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Hirobriz Breezhaler.
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.
Danish: KOL er en langvarig sygdom, hvor luftvejene og luftsækkene i lungerne bliver beskadiget eller blokeret, så vejrtrækningen vanskeliggøres.
English: Other common side effects include chest pain, cough and muscle cramps.
Danish: Andre hyppige bivirkninger er brystsmerter, hoste og muskelkramper.
English: On average, the increase in FEV1 in patients who received Hirobriz Breezhaler was between 150 to 190 ml, while for patients who received placebo the change in FEV1 ranged from a decrease of 10 ml to an increase of 20 ml.
Danish: Gennemsnitligt var forbedringen i FEV1 hos patienter, som fik Hirobriz Breezhaler, mellem 150 og 190 ml, mens ændringen i FEV1 hos patienter, som fik placebo, varierede fra et fald på 10 ml til en forøgelse på 20 ml.
English: This causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.
Danish: Dette får musklerne i luftvejene til at slappe af, så luftvejene bedre holdes fri, og patienten får lettere ved at trække vejret.
English: Overall, the effects of the 150 and 300 microgram doses of Hirobriz Breezhaler were similar, but the results showed that the 300 microgram dose may provide better relief in patients with more severe disease.
Danish: Som helhed var virkningerne af 150- og 300-mikrogramsdoserne af Hirobriz Breezhaler ens, men resultaterne viste, at 300-mikrogramsdosen gav bedre lindring hos patienter med en sværere grad af sygdommen.
English: In three main studies involving over 4,000 patients with COPD, Hirobriz Breezhaler was compared with placebo (a dummy treatment), tiotropium or formoterol (other inhaled medicines used to treat COPD).
Danish: I tre hovedundersøgelser, som omfattede over 4 000 patienter med KOL, blev Hirobriz Breezhaler sammenlignet med placebo (en uvirksom behandling), tiotropium eller formoterol (andre inhalationslægemidler, som anvendes til behandling af KOL).
English: The most common side effects with Hirobriz Breezhaler (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat) and upper respiratory tract infection (infection of the nose and throat).
Danish: De hyppigste bivirkninger ved Hirobriz Breezhaler (som optræder hos mere end 1 ud af 10 patienter) er nasopharyngitis (betændelse i næse og hals) og infektioner i de øvre luftveje (infektioner i næse og hals).
English: Hirobriz Breezhaler is used for maintenance (regular) treatment.
Danish: Hirobriz Breezhaler anvendes til (regelmæssig) vedligeholdelsesbehandling.
English: The active substance in Hirobriz Breezhaler, indacaterol, is a beta-2 adrenergic receptor agonist.
Danish: Det aktive stof i Hirobriz Breezhaler, indacaterol, er en beta 2-adrenerg receptoragonist.
English: Hirobriz Breezhaler is a medicine that is used to keep the airways open in adults with chronic obstructive pulmonary disease (COPD).
Danish: Hirobriz Breezhaler er et lægemiddel, der anvendes til at holde luftvejene fri hos voksne med kronisk obstruktiv lungesygdom (KOL).
English: When Hirobriz Breezhaler is inhaled, indacaterol reaches the receptors in the airways and activates them.
Danish: Når Hirobriz Breezhaler inhaleres, når indacaterol frem til receptorerne i luftvejene og aktiverer dem.
English: Therefore, the Agency decided that Hirobriz Breezhaler's benefits are greater that its risks and recommended that it be given marketing authorisation.
Danish: Agenturet besluttede derfor, at fordelene ved Hirobriz Breezhaler opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Hirobriz Breezhaler.
English: For more information about treatment with Hirobriz Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Hirobriz Breezhaler, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The Agency also noted that there were no major safety concerns with Hirobriz Breezhaler, with side effects being manageable and similar to other beta-2 adrenergic receptor agonist medicines.
Danish: Agenturet bemærkede desuden, at der ikke var nogen væsentlige sikkerhedsproblemer forbundet med Hirobriz Breezhaler, idet bivirkningerne kunne behandles og svarede til bivirkningerne ved andre beta 2-adrenerge receptoragonister.
English: What measures are being taken to ensure the safe and effective use of Hirobriz Breezhaler?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Hirobriz Breezhaler?
English: Hirobriz Breezhaler was more effective than placebo at improving how well the lungs work in patients with COPD.
Danish: Hirobriz Breezhaler var mere effektivt end placebo til at forbedre lungefunktionen hos patienter med KOL.
English: Other information about Hirobriz Breezhaler
Danish: Andre oplysninger om Hirobriz Breezhaler
English: The European Medicines Agency concluded that Hirobriz Breezhaler was shown to be effective at improving lung function in COPD.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at Hirobriz Breezhaler havde vist sig at være effektivt til at forbedre lungefunktionen ved KOL.
English: For the full list of all side effects and restrictions with Hirobriz Breezhaler, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Hirobriz Breezhaler fremgår af indlægssedlen.
English: Hirobriz Breezhaler can only be obtained with a prescription.
Danish: Hirobriz Breezhaler udleveres kun efter recept.
English: It is not intended to provide practical advice on how to use Hirobriz Breezhaler.
Danish: Det er ikke en praktisk vejledning i, hvordan Hirobriz Breezhaler bør anvendes.
English: For practical information about using Hirobriz Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Hirobriz Breezhaler, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What is Hirobriz Breezhaler and what is it used for?
Danish: Hvad er Hirobriz Breezhaler, og hvad anvendes det til?
English: Why is Hirobriz Breezhaler approved?
Danish: Hvorfor blev Hirobriz Breezhaler godkendt?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hirobriz Breezhaler have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Hirobriz Breezhaler.
English: What are the risks associated with Hirobriz Breezhaler?
Danish: Hvilke risici er der forbundet med Hirobriz Breezhaler?
English: Hirobriz Breezhaler capsules, which contain a powder for inhalation, are only used with a Hirobriz Breezhaler inhaler and must not be swallowed.
Danish: De anvendes udelukkende med en Hirobriz Breezhaler-inhalator og må ikke sluges.
English: How is Hirobriz Breezhaler used?
Danish: Hvordan anvendes Hirobriz Breezhaler?
English: How does Hirobriz Breezhaler work?
Danish: Hvordan virker Hirobriz Breezhaler?
English: What benefits of Hirobriz Breezhaler have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Hirobriz Breezhaler?
English: OPTIMIST-1 and OPTIMIST-2
Danish: OPTIMIST-1 og OPTIMIST-2
English: 4 Patients with these combinations are also included in other rows describing the individual substitutions.
Danish: 4 Patienter med disse kombinationer er også inkluderet i andre rækker med beskrivelse af de individuelle substitutioner.
English: Phase 3 study in Asian patients
Danish: Fase 3-studie med asiatiske patienter
English: 2 Alone or in combination with other substitutions (includes mixtures).
Danish: 2 Alene eller i kombination med andre substitutioner (herunder blandinger).
English: Propulsive Cisapride
Danish: Propulsiva Cisaprid
English: Effect of food on absorption
Danish: Virkningen af føde på absorptionen
English: Do not press the capsule from the center of the pocket.
Danish: Tryk ikke på kapslen på midten af lommen.
English: Laboratory parameter
Danish: Laboratorieparameter
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: ULN = Upper Limit of Normal.
Danish: ULN = Øvre normalgrænse.
English: Pack sizes of 7 or 28 capsules.
Danish: Pakningsstørrelser med 7 eller 28 kapsler.
English: Emerging amino-acid substitutions in NS3
Danish: Opståede aminosyresubstitutioner i NS3
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 May 2014
Danish: Dato for første markedsføringstilladelse: 14. maj 2014
English: 5 Two patients had emerging single substitution I170T.
Danish: 5 To patienter havde en opstået enkelt substitution I170T.
English: Resistance in cell culture
Danish: Resistens i cellekultur
English: Sensitivity to sunlight
Danish: Følsomhed for sollys
English: Antiviral activity in vivo
Danish: Antiviral aktivitet in vivo
English: Triazolam (oral)
Danish: Triazolam (oralt)
English: Oral: 0.075 mg/kg Intravenous:
Danish: Oralt: 0,075 mg/kg Intravenøst:
English: Maximum plasma concentrations (Cmax) are typically achieved between 4 to 6 hours post dose.
Danish: De maksimale plasmakoncentrationer (Cmax) opnås typisk mellem 4 og 6 timer efter dosering.
English: These blood tests help your doctor to - check if the treatment is working for you - check your liver function.
Danish: Disse blodprøver tages, så din læge bedre kan - kontrollere, om behandlingen virker på dig - kontrollere din leverfunktion.
English: The clinical relevance of this difference in viral breakthrough rates is unknown.
Danish: Den kliniske relevans af denne forskel i viralt gennembrud er ukendt.
English: You may be more sensitive to sunlight (photosensitivity) when taking OLYSIO (see section 4 for information about side effects).
Danish: Du vil muligvis blive mere følsom for sollys (fotosensibilitet), når du tager OLYSIO (se afsnit 4 for mere information om bivirkninger).
English: Fluconazole Voriconazole
Danish: Fluconazol Voriconazol
English: Carcinogenicity studies with simeprevir have not been conducted.
Danish: Der er ikke udført karcinogenicitetsstudier med simeprevir.
English: Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for 48 hours in an appropriate clinical setting.
Danish: Patienter, der konstateres at have stor risiko for bradyarytmi, bør monitoreres kontinuerligt i 48 timer under passende kliniske forhold.
English: Persistence of resistance-associated substitutions
Danish: Varighed af resistensrelaterede substitutioner
English: There were no adverse effects of simeprevir on vital functions (cardiac, respiratory and central nervous system) in animal studies.
Danish: Der var ingen negative virkninger af simeprevir på vitale funktioner (hjerte, luftveje og centralnervesystem) i dyrestudier.