FrancophonIA/ELRC3.0 huggingface dataset:
English: Fertavid 150 IU/0.5 mL solution for injection EU/1/09/510/010
Danish: Fertavid 150 IE/0,5 ml injektionsvæske, opløsning EU/1/09/510/010
English: Fertavid 50 IU/0.5 mL solution for injection EU/1/09/510/001
Danish: Fertavid 50 IE/0,5 ml injektionsvæske, opløsning EU/1/09/510/001
English: Fertavid 100 IU/0.5 mL solution for injection
Danish: Fertavid 100 IE/0,5 ml injektionsvæske, opløsning
English: Fertavid 200 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 200 IU in 0.5 mL aqueous solution per vial.
Danish: Fertavid 200 IE/0,5 ml injektionsvæske, opløsning: Hvert hætteglas indeholder det aktive stof follitropin beta, et hormon kendt som follikelstimulerende hormon (FSH), i en styrke på 200 IE i 0,5 ml vandig opløsning pr. hætteglas.
English: Solution for injection 1 cartridge
Danish: Injektionsvæske, opløsning 1 cylinderampul 1 pakke med 3 kanyler
English: 1.08 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
Danish: Fertavid 900 IE/1,08 ml injektionsvæske, opløsning 1,08 ml opløsning i 1,5 ml cylinderampul (type I-glas) med et gråt gummistempel og et aluminiumslåg med en gummimembran.
English: OUTER CARTON TEXT Fertavid 50 IU/0.5 mL 1, 5 or 10 vials
Danish: TEKST PÅ YDRE KARTON Fertavid 50 IE/0,5 ml 1, 5 eller 10 hætteglas
English: 0.36 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
Danish: Fertavid 300 IE/0,36 ml injektionsvæske, opløsning 0,36 ml opløsning i 1,5 ml cylinderampul (type I-glas) med et gråt gummistempel og et aluminiumslåg med en gummimembran.
English: What Fertavid is and what it is used for What you need to know before you use Fertavid How to use Fertavid
Danish: Det skal du vide, før du begynder at tage Fertavid Sådan skal du tage Fertavid Bivirkninger
English: First, you should remove the flip-off cap of the vial.
Danish: Fjern først hætten på hætteglasset.
English: 1 vial contains 0.5 mL follitropin beta corresponding to: 50 IU (100 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.
Danish: 1 hætteglas indeholder 0,5 ml injektionsvæske med follitropin beta svarende til aktiviteten af 50 IE (100 IE/ml) rekombinant follikelstimulerende hormon (FSH).
English: You should vary the injection site a little with each injection.
Danish: For hver indsprøjtning skal du indsprøjte Fertavid et nyt sted i samme område.
English: Fertavid 150 IU/0.5 mL solution for injection
Danish: Fertavid 150 IE/0,5 ml injektionsvæske, opløsning
English: 1 vial contains 0.5 mL follitropin beta corresponding to: 100 IU (200 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.
Danish: 1 hætteglas indeholder 0,5 ml injektionsvæske med follitropin beta svarende til aktiviteten af 100 IE (200 IE/ml) rekombinant follikelstimulerende hormon (FSH).
English: Fertavid 150 IU/0.5 mL injection follitropin beta
Danish: Fertavid 150 IE/0,5 ml injektionsvæske, opløsning follitropin beta
English: Fertavid 900 IU/1.08 mL solution for injection follitropin beta
Danish: Fertavid 900 IE/1,08 ml injektionsvæske, opløsning follitropin beta
English: You should use sterile disposable syringes and needles for the administration of Fertavid.
Danish: Til injektion af Fertavid skal der bruges sterile engangssprøjter og -nåle.
English: Fertavid 200 IU/0.5 mL injection follitropin beta
Danish: Fertavid 200 IE/0,5 ml injektionsvæske, opløsning follitropin beta
English: Fertavid 100 IU/0.5 mL injection follitropin beta
Danish: Fertavid 100 IE/0,5 ml injektionsvæske follitropin beta i.m./s.c.
English: One vial contains 100 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution.
Danish: Et hætteglas indeholder 100 IE rekombinant follikelstimulerende hormon (FSH) i 0,5 ml vandig opløsning.
English: One vial contains 50 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution.
Danish: Et hætteglas indeholder 50 IE rekombinant follikelstimulerende hormon (FSH) i 0,5 ml vandig opløsning.
English: One vial contains 5 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Danish: Et hætteglas indeholder 5 mikrogram protein (specifik in vivo-bioaktivitet er ækvivalent med ca. 10.000 IE FSH / mg protein).
English: Fertavid 200 IU/0.5 mL solution for injection
Danish: Fertavid 200 IE/0,5 ml injektionsvæske, opløsning
English: 0.72 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
Danish: Fertavid 600 IE/0,72 ml injektionsvæske, opløsning 0,72 ml opløsning i 1,5 ml cylinderampul (type I-glas) med et gråt gummistempel og et aluminiumslåg med en gummimembran.
English: Fertavid 50 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 50 IU in 0.5 mL aqueous solution per vial.
Danish: Fertavid 50 IE/0,5 ml injektionsvæske, opløsning: Hvert hætteglas indeholder det aktive stof follitropin beta, et hormon kendt som follikelstimulerende hormon (FSH), i en styrke på 50 IE i 0,5 ml vandig opløsning pr. hætteglas.
English: Fertavid 50 IU/0.5 mL solution for injection
Danish: Fertavid 50 IE/0,5 ml injektionsvæske, opløsning
English: One vial contains 20 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Danish: Et hætteglas indeholder 20 mikrogram protein (specifik in vivo-bioaktivitet er ækvivalent med ca. 10.000 IE FSH / mg protein).
English: Fertavid 75 IU/0.5 mL solution for injection follitropin beta
Danish: Fertavid 75 IE/0,5 ml injektionsvæske, opløsning follitropin beta
English: For posology and method of administration, see section 4.2.
Danish: 4.2 for dosering og indgivelsesmåde.
English: Fertavid 100 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 100 IU in 0.5 mL aqueous solution per vial.
Danish: Fertavid 100 IE/0,5 ml injektionsvæske, opløsning: Hvert hætteglas indeholder det aktive stof follitropin beta, et hormon kendt som follikelstimulerende hormon (FSH), i en styrke på 100 IE i 0,5 ml vandig opløsning pr. hætteglas.
English: 0.18 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
Danish: Fertavid 150 IE/0,18 ml injektionsvæske, opløsning 0,18 ml opløsning i 1,5 ml cylinderampul (type I glas) med et gråt gummistempel og et aluminiumslåg med en gummimembran.
English: Fertavid 300 IU/0.36 mL solution for injection follitropin beta
Danish: Fertavid 300 IE/0,36 ml injektionsvæske, opløsning follitropin beta
English: One vial contains 15 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Danish: Et hætteglas indeholder 15 mikrogram protein (specifik in vivo-bioaktivitet er ækvivalent med ca. 10.000 IE FSH / mg protein).
English: One vial contains 10 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Danish: Et hætteglas indeholder 10 mikrogram protein (specifik in vivo-bioaktivitet er ækvivalent med ca. 10.000 IE FSH / mg protein).
English: Fertavid 600 IU/0.72 mL solution for injection follitropin beta
Danish: Fertavid 600 IE/0,72 ml injektionsvæske, opløsning follitropin beta
English: In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other methods, Fertavid can bring about the development of multiple follicles.
Danish: Fertavid kan fremkalde udvikling af mange follikler hos kvinder, som gennemgår reproduktionsbehandling (kunstig befrugtning), inklusive reagensglasbefrugtning (in vitro fertilisation (IVF)) eller andre behandlinger.
English: Fertavid 50 IU/0.5 mL injection follitropin beta
Danish: Fertavid 50 IE/0,5 ml injektionsvæske, opløsning follitropin beta
English: OUTER CARTON TEXT Fertavid 200 IU/0.5 mL 1.
Danish: TEKST PÅ YDRE KARTON Fertavid 200 IE/0,5 ml 1, 5 eller 10 hætteglas
English: The Reference Member State was Germany and the Concerned Member States were Austria, France, the Netherlands, Spain and the United Kingdom.
Danish: Referencemedlemsstaten var Tyskland, og de berørte medlemsstater var Østrig, Frankrig, Nederlandene, Spanien og Det Forenede Kongerige.
English: London, 23 October 2007 EMEA/331678/2007
Danish: London, den 23. oktober 2007 EMEA/331678/2007
English: The Rapporteur was Dr Karl Broich and Co-Rapporteur was Dr Eric Abadie.
Danish: Dr. Karl Broich var rapportør, og dr. Eric Abadie var medrapportør.
English: The Mutual Recognition Procedure started on 06 July 2006.
Danish: Den gensidige anerkendelsesprocedure blev indledt den 6. juli 2006.
English: Germany referred the reasons for disagreement to the EMEA on 20 December 2006.
Danish: Tyskland fremsendte begrundelserne for uenigheden til EMEA den 20. december 2006.
English: A positive opinion was adopted by consensus 19 July 2007.
Danish: En positiv udtalelse blev vedtaget med konsensus den 19. juli 2007.
English: The Marketing Authorisation Holder provided written explanations on 13 April 2007.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 13. april 2007.
English: The final opinion was converted into a Decision by the European Commission on 23 October 2007.
Danish: Den endelige udtalelse blev den 23. oktober 2007 omdannet til en afgørelse truffet af Europa-Kommissionen.
English: The arbitration procedure started on 24 January 2007 with the adoption of a list of questions.
Danish: Voldgiftsproceduren blev indledt den 24. januar 2007 med vedtagelse af en række spørgsmål.
English: During their July 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Fentanylratiopharm 25/50/75/100 µg/h TTS and associated names, that the objections raised by France should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Danish: På sit møde i juli 2007 fandt CHMP på baggrund af alle forelagte oplysninger og den faglige drøftelse i udvalget, at benefit/risk-forholdet er gunstigt for Fentanyl-ratiopharm 25/50/75/100 µg/h TTS og tilknyttede navne, at de af Frankrig rejste indvendinger ikke bør forhindre udstedelse af en markedsføringstilladelse, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel bør ændres.
English: Fentanyl-ratiopharm 25/50/75/100 µg/h TTS and associated names, is an opioid analgesic which is indicated in severe chronic pain which can be adequately managed only with opioid analgesics.
Danish: Fentanyl-ratiopharm 25/50/75/100 µg/h TTS og tilknyttede navne er et opioidanalgetikum, der er indiceret til svære kroniske smerter, som kun kan behandles tilfredsstillende med opioidanalgetika.
English: This refers to the extension of the indication to non-cancer patients, the choice of conversion tables, whether contraindication for breastfeeding and for interactions with partial agonist opioids should be given inn the product information and the studies needed to demonstrate bioequivalence with the reference medicinal product.
Danish: Betænkelighederne gælder udvidelsen af indikationen til andre patienter end kræftpatienter, valget af omregningstabeller, hvorvidt produktoplysningerne bør indeholde en kontraindikation ved amning og ved interaktioner med opioider af typen partielle agonister, samt de undersøgelser, der er nødvendige til påvisning af bioækvivalens med referencelægemidlet.
English: Significant difference has been identified with regard to the proposed indication, posology and contraindications in the product information and the demonstration of bioequivalence and this was considered to be of serious public health concern.
Danish: Vedrørende den foreslåede indikation, dosering og kontraindikationer i produktoplysningerne og påvisningen af bioækvivalens blev der påpeget væsentlige forskelle, som fandtes at give anledning til alvorlige sundhedsmæssige betænkeligheder.
English: Ratiopharm GmbH submitted applications for mutual recognition of Fentanyl-ratiopharm 25/50/75/100 µg/h TTS and associated names, transdermal patch on the basis of the marketing authorisation granted by Germany 04 April 2006.
Danish: Ratiopharm GmbH indgav ansøgninger om gensidig anerkendelse af Fentanyl-ratiopharm 25/50/75/100 µg/h TTS og tilknyttede navne, depotplaster, baseret på den markedsføringstilladelse, der var udstedt af Tyskland den 4. april 2006.
English: OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Fentanyl-ratiopharm 25/50/75/100 µg/h TTS and associated names
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 41, OM Fentanyl-ratiopharm 25/50/75/100 µg/h TTS og tilknyttede navne Internationalt fællesnavn (INN): fentanyl
English: e. These are drugs within class where similar interactions could be predicted.
Danish: e. Disse er lægemidler inden for klassen, hvor lignende interaktioner kunne forventes.
English: • if you are awaiting a liver transplant;
Danish: • hvis du venter på en levertransplantation;
English: Ribavirin was discontinued in 19% of the patients.
Danish: Ribavirin blev seponeret hos 19 % af patienterne.
English: a. TE: number of treatment-experienced patients.
Danish: a. TE: antal behandlingserfarne patienter.
English: Like all medicines, this medicine may cause side effects.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger.
English: Distribution Ledipasvir is > 99.8% bound to human plasma proteins.
Danish: Ledipasvir er >99,8 % bundet til humane plasmaproteiner.
English: Such patients may therefore be dependent on other drug classes for clearance of HCV infection.
Danish: Sådanne patienter kan derfor være afhængige af andre lægemiddelklasser med henblik på clearance af HCV-infektion.
English: If you forget to take Harvoni It is important not to miss a dose of this medicine.
Danish: Hvis du har glemt at tage Harvoni Det er vigtigt ikke at glemme en dosis af dette lægemiddel.
English: The active substances in the medicine work together by blocking two different proteins that the virus needs to grow and reproduce itself, allowing the infection to be permanently eliminated from the body.
Danish: De aktive stoffer i dette lægemiddel arbejder sammen ved at blokere to forskellige proteiner, som virusset skal bruge til at vokse og reproducere, og derved gøre det muligt at eliminere infektionen permanent fra kroppen.
English: h. Bioequivalence/Equivalence boundary 80-125%.
Danish: h. Bioækvivalens/ækvivalensgrænse 80-125 %.
English: g. This study was conducted in the presence of another two direct-acting antiviral agents.
Danish: g. Studiet blev udført, mens der var to andre direkte virkende antivirale midler til stede.
English: Patients with a CPT score > 12 were excluded.
Danish: Patienter med en CPT-score >12 blev ekskluderet.
English: A carcinogenicity study in rats is ongoing.
Danish: Der udføres aktuelt et karcinogenicitetsstudie med rotter.
English: Driving and using machines Do not drive or operate machines if you feel tired after taking your medicine.
Danish: Trafik- og arbejdssikkerhed Du må ikke føre motorkøretøj eller betjene maskiner, hvis du føler sig træt efter du tager lægemidlet.
English: If this applies to you, do not take Harvoni and tell your doctor immediately.
Danish: Hvis dette gælder for dig, må du ikke tage Harvoni og du skal straks fortælle det til lægen.
English: Medicinal products that have a narrow therapeutic range and which are metabolised by these isoenzymes should be used with caution and carefully monitored.
Danish: Lægemidler, der har et snævert terapeutisk interval, og som metaboliseres af disse isoenzymer, skal anvendes med forsigtighed og nøje overvåges.
English: It is very important that you complete the full course of treatment to give the medicine the best chance to treat your hepatitis C virus infection.
Danish: Det er meget vigtigt, at du gennemfører hele behandlingsprogrammet, for at give lægemidlet de bedste betingelser for at behandle din infektion med hepatitis C.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 November 2014
Danish: Dato for første markedsføringstilladelse: 17. november 2014
English: In clinical studies - Genotype 1
Danish: I kliniske studier - genotype 1
English: Cimetidine e
Danish: Cimetidin e
English: • kidney problems, since Harvoni has not been fully tested in patients with severe kidney problems;
Danish: • nyreproblemer, da Harvoni ikke er helt undersøgt hos patienter med alvorlige nyreproblemer;
English: 10% of liver transplant recipients had a modification of their immunosuppressive agents.
Danish: 10 % af de levertransplantaterede patienter fik modificeret deres immunsupprimerende lægemidler.
English: INFORMATION IN BRAILLE Harvoni [Outer packaging only]
Danish: INFORMATION I BRAILLESKRIFT Harvoni [Kun på den ydre emballage]
English: GT n TE
Danish: GT n TEa
English: Mean ratio (90% confidence interval) for AUC, Cmax, Cmin a, b
Danish: Gennemsnitligt forhold (90 % konfidensinterval) for AUC, Cmax, Cmin a,b
English: Table 3: Interactions between Harvoni and other medicinal products Medicinal product by therapeutic areas
Danish: Tabel 3: Interaktioner mellem Harvoni og andre lægemidler Lægemiddel i henhold til terapeutiske områder
English: • Do not take any other medicine that contains sofosbuvir, one of the active substances in Harvoni.
Danish: • Tag ikke nogen andre lægemidler, der indeholder sofosbuvir, et af de aktive stoffer i Harvoni.
English: These studies did not include any control group not receiving ledipasvir/sofosbuvir.
Danish: Disse studier inkluderede ikke nogen kontrolgrupper, der ikke fik ledipasvir/sofosbuvir.
English: These should be taken at least 4 hours before or 4 hours after Harvoni;
Danish: De bør tages mindst 4 timer før eller 4 timer efter Harvoni.
English: Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AX65
Danish: Farmakoterapeutisk klassifikation: Direkte virkende antivirale midler, ATC-kode: J05AX65
English: Effect of baseline HCV resistance-associated variants on treatment outcome Genotype 1
Danish: Virkning af baseline HCV-resistensassocierede varianter på behandlingsresultatet Genotype 1
English: If the starting dose is not well-tolerated, the dose should be reduced as clinically indicated based on haemoglobin levels.
Danish: Hvis startdosis ikke er veltolereret, bør dosis reduceres efter klinisk indikation, baseret på hæmoglobinniveauer.
English: It is given to treat chronic (long-term) hepatitis C virus infection in adults of 18 years and older.
Danish: Det gives til behandling af kronisk (langvarig) infektion med hepatitis C-virus hos voksne i alderen 18 år og derover.
English: If you are lactose intolerant, or if you have been told that you have an intolerance to other sugars, talk to your doctor before taking this medicine.
Danish: Hvis du er lactoseintolerant, eller hvis du har fået at vide, at du er intolerant over for nogle andre sukkerformer, skal du tale med din læge, før du tager denne medicin.
English: (Inhibition of drug transporters OATP and BCRP)
Danish: (Hæmning af lægemiddeltransporterne OATP og BCRP)
English: • dabigatran used to thin the blood;
Danish: • dabigatran, anvendes til at fortynde blodet
English: • Do not take any of these medicines with Harvoni:
Danish: • Tag ikke nogen af disse lægemidler med Harvoni:
English: c. Administered as Harvoni.
Danish: c. Administreret som Harvoni.
English: Harvoni is not recommended for use in children and adolescents under 18 years of age because the safety and efficacy have not been established in this population.
Danish: Harvoni bør ikke anvendes til børn og unge under 18 år, da sikkerhed og virkning ikke er klarlagt for denne population.
English: Metavir score F0-F3 96% (53/55) CPT A
Danish: Efter transplantation Metavir-score F0-F3 96 % (53/55) CPT A
English: • if you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
Danish: • hvis du har eller har haft en infektion med hepatitis B-virus, da din læge måske vil overvåge dig tættere;
English: • statins used to treat high cholesterol.
Danish: • statiner, anvendes til at behandle højt kolesterol.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/958/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/958/001
English: HCV RNA < 6 million IU/mL HCV RNA ≥ 6 million IU/mL
Danish: HCV-rna <6 millioner IE/ml HCV-rna ≥6 millioner IE/ml
English: • Tell your doctor if you are lactose intolerant or intolerant to other sugars.
Danish: • Fortæl det til lægen, hvis du lider af lactoseintolerans eller er intolerant over for andre sukkerformer.
English: d. 3/3 of these patients had cirrhosis.
Danish: d. 3/3 af disse patienter havde cirrose.
English: Only patients who demonstrated SVR12 or relapse were included in relapse analyses.
Danish: Kun patienter, der udviste SVR12 eller recidiv, blev inkluderet i recidivanalyserne.
English: (≥ 1/10,000 to < 1/1,000) or very rare (< 1/10,000).
Danish: <1/1.000) eller meget sjælden (<1/10.000).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/958/001 28 film-coated tablets EU/1/14/958/002 84 (3 bottles of 28) film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/958/001 28 filmovertrukne tabletter EU/1/14/958/002 84 (3 tabletbeholdere med 28) filmovertrukne tabletter
English: e. 0/4 of these patients had cirrhosis.
Danish: e. 0/4 af disse patienter havde cirrose.
English: Rabeprazolee Pantoprazole e
Danish: Rabeprazole Pantoprazol e
English: Race: Black/ African American
Danish: Race: Sort/ amerikaner af afrikansk herkomst
English: SVR rates for selected subgroups Genotype Genotype 1a Genotype 1b Cirrhosis No c c
Danish: SVR-rater for udvalgte undergrupper Genotype Genotype 1a Genotype 1b Cirrose Nej c c
English: Women of childbearing potential / contraception in males and females When Harvoni is used in combination with ribavirin, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.
Danish: Kvinder i den fertile alder/kontraception hos mænd og kvinder Når Harvoni anvendes i kombination med ribavirin, skal der udvises ekstrem forsigtighed, så graviditet undgås hos kvindelige patienter og hos mandlige patienters kvindelige partnere.
English: Patients with genotype 3 CHC Patients with compensated cirrhosis and/or prior treatment failure
Danish: Patienter med genotype 3-CHC Patienter med kompenseret cirrose og/eller tidligere behandlingssvigt
English: Genotype 2, 3, 4, 5 and 6
Danish: Genotype 2, 3, 4, 5 og 6
English: Each film-coated tablet contains 156.8 mg of lactose (as monohydrate) and 261 micrograms of sunset yellow FCF aluminium lake.
Danish: Hver filmovertrukken tablet indeholder 156,8 mg lactose (som monohydrat) og 261 mikrogram sunset yellow FCF aluminiumpigment.
English: a. Mean ratio (90% CI) of co-administered drug pharmacokinetics of study medicinal products alone or in combination.
Danish: a. Det gennemsnitlige forhold (90 % CI) af farmakokinetiske parametre for lægemidler, der administreres sammen med et studielægemiddel alene eller i kombination med begge studielægemidler.
English: Warnings and precautions Your doctor will know if any of the following conditions apply to you.
Danish: Din læge vil vide, om nogle af de følgende sygdomme gælder for dig.
English: Patients with decompensated cirrhosis, irrespective of transplant status
Danish: Patienter med dekompenseret cirrose, uanset transplantationsstatus
English: Table 4: Adverse drug reactions identified with Harvoni Frequency
Danish: Tabel 4: Bivirkninger identificeret med Harvoni Hyppighed
English: Gender Male Female IL28 genotype CC Non-CC Baseline HCV RNAa
Danish: Køn Mand Kvinde IL28 genotype CC Non-CC Baseline HCV-rna a