FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of darunavir in combination with ritonavir taken twice daily in 14 treatmentexperienced paediatric patients, aged 3 to < 6 years and weighing at least 15 kg to < 20 kg, showed that weight-based dosages resulted in darunavir exposure that was comparable to that achieved in adults receiving darunavir/ritonavir 600/100 mg twice daily (see section 4.2).
Danish: De farmakokinetiske egenskaber af darunavir i kombination med ritonavir to gange dagligt hos 14 behandlingserfarne pædiatriske patienter i alderen 3 til < 6 år med en legemsvægt på ≥15 kg til < 20 kg viste, at vægtbaseret dosering resulterede i en darunavireksponering, der var sammenlignelig med eksponeringen hos voksne, der fik darunavir/ritonavir 600/100 mg to gange dagligt (se pkt.
English: Psychiatric disorders Common
Danish: Psykiske forstyrrelser Almindelig søvnløshed
English: The evidence of efficacy of darunavir/ritonavir 800/100 mg once daily is based on the analyses of 192 week data from the randomised, controlled, open-label Phase III trial ARTEMIS in antiretroviral treatment-naïve HIV-1 infected patients comparing darunavir/ritonavir 800/100 mg once daily with lopinavir/ritonavir 800/200 mg per day (given as a twice-daily or as a once-daily regimen).
Danish: Dokumentationen for virkning af darunavir/ritonavir 800/100 mg en gang dagligt hos ART-naive hiv1-patienter er baseret på 192 ugers-analysen af det randomiserede, kontrollerede, åbne fase III-studie ARTEMIS.
English: Darunavir/ ritonavir 600/100 mg twice daily N=296
Danish: Darunavir/ ritonavir 600/100 mg to gange dagligt N=296
English: in combination with other antiretroviral agents in 21 ART-experienced HIV-1 infected paediatric patients aged 3 to < 6 years and weighing 10 kg to < 20 kg was evaluated in an open-label, Phase II trial, ARIEL.
Danish: ART-erfarne pædiatriske patienter i alderen 3 til < 6 år Farmakokinetik, sikkerhed, tolerabilitet og virkning af darunavir/ritonavir to gange dagligt i kombination med andre antiretrovirale lægemidler hos 21 ART-erfarne hiv-1-smittede pædiatriske patienter i alderen 3 til < 6 år med en legemsvægt på 10 kg til < 20 kg blev evalueret i et åbent fase IIstudie, ARIEL.
English: (-4.6; 9.2)d d d
Danish: 4.2, 4.4 og
English: Boosted darunavir is expected to increase these antipsychotic plasma concentrations.
Danish: Boostet darunavir forventes at øge plasmakoncentrationen af disse antipsykotika.
English: CD4+ cell count mean change from baseline (x 106/l)b c c a
Danish: Med CD4+ celletal ≥ 200 ved baseline Median CD4+ celletals ændring fra baseline (x 6/l)
English: Darunavir Mylan 400 milligram and 800 milligram tablets are only to be used to construct the once daily 800 milligram regimen.
Danish: Darunavir Mylan-tabletter på 400 mg og 800 mg må kun anvendes ved dosis på 800 mg, der tages en gang dagligt.
English: When administration of pravastatin and darunavir co-administered with low dose ritonavir is required, it is recommended to start with the lowest possible dose of pravastatin and titrate up to the desired clinical effect while monitoring for safety.
Danish: Hvis der er behov for administration af pravastatin og darunavir administreret sammen med lavdosis ritonavir, anbefales det at starte med den lavest mulige dosis af pravastatin og optitrere til den ønskede kliniske effekt samtidig med overvågning af sikkerhed/ bivirkninger.
English: CD4+ percent change from baselineb CD4+ cell count mean change from baseline b a
Danish: CD4+-celletal procentændring fra baseline b
English: Co-administration with strong CYP3A4 inhibitors is not recommended and caution is warranted, these interactions are described in the interaction table below (e.g. indinavir, azole antifungals like clotrimazole).
Danish: Disse interaktioner er beskrevet i nedenstående interaktionstabel (f.eks. indinavir, systemisk azolantimykotika som clotrimazol).
English: patients receiving the combination with darunavir co-administered with ritonavir.
Danish: Der er dog rapporteret om svimmelhed hos nogle patienter under behandlingen med regimer, der indeholder darunavir, co-administreret med lavdosis ritonavir.
English: The Summary of Product
Danish: FREMSTILLERENS BATCHNUMMER
English: Darunavir is used to treat adults and children (3 years of age and above, at least 40 kilograms body weight) who are infected by HIV and - who have not used antiretroviral medicines before.
Danish: Darunavir Mylan anvendes til at behandle voksne og børn (fra 3 år og opefter, som vejer mindst 40 kg), som er smittet med hiv, og - som ikke før har fået medicin til behandling af hiv - hos nogle patienter, som før har fået medicin til behandling af hiv (din læge vil afgøre dette).
English: Darunavir Mylan 600 mg film-coated tablets darunavir
Danish: Darunavir Mylan 600 mg tabletter, filmovertrukne darunavir
English: Concomitant use of darunavir co-administered with low dose ritonavir with lovastatin and simvastatin is therefore contraindicated (see section 4.3).
Danish: Samtidig brug af lovastatin eller simvastatin og darunavir administreret sammen med lavdosis ritonavir er derfor kontraindiceret (se pkt.
English: Darunavir Mylan 400 mg
Danish: Danunavir Mylan 400 mg
English: * For children aged 12 or more and weighing at least 40 kilograms, your child's doctor will determine if Darunavir Mylan 800 milligram once daily dosing may be used.
Danish: 600 mg darunavir + 100 mg ritonavir to gange dagligt * Til børn fra 12 år og opefter med en legemsvægt på mindst 40 kg afgør barnets læge, om Darunavir Mylan 800 mg kan anvendes.
English: - Itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole (to treat fungal infections).
Danish: - Fentanyl, oxycodon, tramadol (til behandling af smerter).
English: Darunavir/ ritonavir 800/100 mg once daily N=343
Danish: Darunavir/ ritonavir 800/100 m g en gang dagligt N=343
English: - In the evening, take one 600 milligram darunavir tablet together with 100 milligram ritonavir.
Danish: - Tag to 600 mg darunavir -tabletter om aftenen sammen med 100 mg ritonavir.
English: Darunavir 400 mg tablets are only to be used to construct the once daily 800 mg regimen.
Danish: Darunavir 400 mg tabletter må kun bruges til doseringenmåden med 800 mg én gang om dagen.
English: Silica, colloidal anhydrous Cellulose microcrystalline Crospovidone Sodium starch glycolate Hypromellose Magnesium stearate
Danish: Kolloid vandfrit silica Mikrokrystallinsk cellulose Crospovidon
English: CCR5 ANTAGONIST Maraviroc
Danish: CCR5-HÆMMER Maraviroc 150 mg x 2
English: Amlodipine Diltiazem Felodipine Nicardipine Nifedipine Verapamil
Danish: Varnavas Hadjipanayis LtdVarnavas Hadjipanayis Ltd
English: Darunavir Mylan 400 mg film-coated tablets are white to off-white, oval shaped with two curved sides, marked with M on one side and DV4 on the other side.
Danish: Darunavir Mylans udseende og pakningsstørrelser Darunavir Mylan 400 mg filmovertrukne tabletter er hvide/offwhite, ovale med to kurvede sider, mærket med M på den ene side og DV4 på den anden side .
English: - Tell your doctor if you have haemophilia.
Danish: - Giv din læge besked, hvis du har hæmofili.
English: - In the morning, take one 600 milligram darunavir tablet together with 100 milligram ritonavir.
Danish: - Tag to 600 mg darunavir -tabletter om morgenen sammen med 100 mg ritonavir.
English: problems with your balance - difficulty breathing, cough, nosebleed, throat irritation - inflammation of the stomach or mouth, heartburn, retching, dry mouth, discomfort of the abdomen, constipation, belching - kidney failure, kidney stones, difficult discharge of urine, frequent or excessive passage of urine, sometimes at night
Danish: hukommelsestab, balanceproblemer - åndedrætsbesvær, hoste, næseblod, halsirritation - betændelse i mave eller mund, halsbrand, opkastningsfornemmelser, tør mund, ubehag i maven,
English: Concomitant use of darunavir with low dose ritonavir and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids)
Danish: Samtidig administration af darunavir med lavdosis ritonavir og kortikosteroider, som metaboliseres af CYP3A (f.eks. fluticasonpropionat eller andre inhalerede eller intranasalt administrerede kortikosteroider), kan øge risikoen for udvikling af systemiske kortikosteroidvirkninger, herunder Cushings syndrom og adrenal suppression.
English: daily vs. darunavir/ritonavir 400/100 mg in combination with saquinavir 1,000 mg twice daily.
Danish: Darunavir: sammenligning af darunavir/ritonavir 400/100 mg x 2 vs darunavir/ritonavir 400/100 mg i kombination med saquinavir 1.000 mg x 2.
English: Darunavir Mylan 300 mg film-coated tablets are white to off-white, oval shaped, with two curved sides, marked with M on one side and DV3 on the other side.
Danish: Darunavirs Mylans udseende og pakningsstørrelser Darunavir Mylan 300 mg filmovertrukne tabletter er hvide/offwhite, ovale med to kurvede sider, mærket med M på den ene side og DV3 på den anden side.
English: The expiry date refers to the last day of that month.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og tabletbeholderen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Danish: Kombinationen kan medføre en øget risiko for kardiovaskulære bivirkninger af salmeterol inklusive QTforlængelse, palpitationer og sinustakykardi.
English: Darunavir/ritonavir 800/100 mg once daily + OBR
Danish: Lopinavir/ritonavir 400/100 mg x 2 + OBR
English: - Buprenorphine/naloxone (medicines to treat opioid dependence) - Salmeterol (medicine to treat asthma) - Artemether/lumefantrine (a combination medicine to treat malaria) - Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine (to treat cancer) - Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension) - Glecaprevir/pibrentasvir, simeprevir (to treat hepatitis C infection) - Fentanyl, oxycodone, tramadol (to treat pain) - Fesoterodine, solifenacin (to treat urologic disorders).
Danish: - Dasatinib, everolimus, irinotecan, nilotinib, vinblastin, vincristin (til behandling af cancer) - Sildenafil, tadalafil, vardenafil (til behandling af rejsningsbesvær eller af en hjerte- og lungesygdom, der hedder pulmonal arteriel hypertension) - Glecaprevir/pibrentasvir, simeprevir (til behandling af hepatitis C-infektion).
English: Date of first authorisation: 13/04/2000 Date of last renewal: 22/03/2010
Danish: Dato for første tilladelse: 13/04/2000 Dato for seneste fornyelse: 22/03/2010
English: It is recommended that a test for FeLV antigenaemia be carried out prior to vaccination.
Danish: Det anbefales, at en test for FeLV antigenæmi udføres forud for vaccination.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (European Medicines Agency) http://www.ema.europa.eu.
English: No undesirable effect has been observed after the administration of several doses except those mentioned in the “Adverse reactions” section.
Danish: Ingen bivirkninger er observeret efter administration af adskillige doser, undtagen de under punktet ”Bivirkninger” nævnte.
English: Duration of immunity:1 year after the last vaccination.
Danish: Varighed af immunitet: 1 år efter sidste vaccination.
English: Store and transport refrigerated (2°C - 8°C), Protect from light.
Danish: Opbevares og transporteres nedkølet (2°C - 8°C).
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years Use immediately after broaching.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år Bør anvendes umiddelbart efter anbrud.
English: Vaccination of FeLV positive cats is of no benefit.
Danish: Der er ingen fordel ved vaccination af FeLV positive katte
English: Active immunisation of cats of 8 weeks of age or older against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease.
Danish: Aktiv immunisering af katte, der er 8 uger gamle eller ældre, mod felin leukæmi til beskyttelse mod persistent viræmi og kliniske tegn på sygdommen.
English: Plastic box containing 10, 20 or 50 type I glass bottle with a Butyl elastomer closure and sealed with an aluminium cap.
Danish: Plastikæske indeholdende 10, 20 eller 50 type I-glasflasker med en butylelastomer-prop og forseglet med en aluminiumskapsel.
English: Transient lethargy and hyperthermia may occur for 1 day, exceptionally 2 days.
Danish: Forbigående letargi og hyperthermi kan forekomme i 1 dag, undtagelsesvis i 2 dage.
English: Use immediately after broaching.
Danish: Bør anvendes umiddelbart efter anbrud.
English: Potassium dihydrogen phosphate Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate Water for injections.
Danish: Natriumchlorid Kaliumdihydrogenphosphat Dinatriumphosphatdihydrat Magnesiumchloridhexahydrat Calciumchloriddihydrat Vand til injektion
English: EU/2/00/019/005 10 doses: 1-ml suspension (10 bottles) EU/2/00/019/006 20 doses: 1-ml suspension (20 bottles) EU/2/00/019/007 50 doses: 1-ml suspension (50 bottles)
Danish: EU/2/00/019/005 10 doser: 1 ml injektionsvæske (suspension) (10 flasker) EU/2/00/019/006 20 doser: 1 ml injektionsvæske (suspension) (20 flasker) EU/2/00/019/007 50 doser: 1 ml injektionsvæske (suspension) (50 flasker)
English: Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant or by appropriate channels approved for use by the competent authorities.
Danish: Affaldsmateriale skal destrueres ved kogning, forbrænding eller opblanding i et egnet desinfektionsmiddel eller via andre kanaler, som er godkendt til brug af den relevante kompetente myndighed.
English: ATC vet code: QI06AD
Danish: Farmakoterapeutisk gruppe: ATCvet-kode: QI06AD
English: As a consequence, the vaccine induces an immune status against feline leukaemia virus.
Danish: Som en følge heraf inducerer vaccinen immunstatus over for felin leukæmi virus.
English: Do not mix with any other vaccine or immunological product except Merial non-adjuvanted vaccine range.
Danish: Må ikke blandes med andre vacciner eller immunologiske lægemidler end Merials vacciner uden adjuvans.
English: Laboratoire Lyon Gerland 254, rue Marcel Mérieux F-69007 Lyon FRANCE
Danish: Laboratoire Lyon Gerland 254 rue Marcel Mérieux F-69007 LYON Frankrig
English: 10 x 1-ml suspension (10 doses) 20 x 1-ml suspension (20 doses) 50 x 1-ml suspension (50 doses)
Danish: 10 x 1 ml injektionsvæske (suspension) (10 doser) 20 x 1 ml injektionsvæske (suspension) (20 doser) 50 x 1 ml injektionsvæske (suspension) (50 doser)
English: Laboratoire Porte des Alpes Rue de l'Aviation F-69800 SAINT PRIEST FRANCE
Danish: Laboratoire Porte des Alpes Rue de l'Aviation F-69800 SAINT PRIEST Frankrig
English: EXP (mm/yy) Use immediately after broaching
Danish: EXP. {måneder/år} Anvendes umiddelbart efter anbrud.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER {Suspension}
English: Name and address of the manufacturer of the biological active substance(s)
Danish: Navn og adresse på fremstilleren af den biologisk aktive substans
English: first injection: from 8 weeks of age, second injection: 3 to 5 weeks later.
Danish: anden injektion: 3 - 5 uger senere.
English: A temporary small (< 2 cm) nodule may appear at the site of injection which regresses within 1 to 4 weeks.
Danish: En mindre, midlertidig hævelse (<2cm) kan forekomme på injektionsstedet; denne vil forsvinde inden for 1-4 uger.
English: Marketing authorisation holder Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Danish: Markedsføringstilladelsens indehaver Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein TYSKLAND
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på den ansvarlige for batch frigivelse
English: Each dose of 1 ml contains:
Danish: 1 dosis (1 ml) indeholder:
English: Under field conditions, only sub-group A is infective and immunisation against sub-group A provides full protection against A, B and C. After inoculation, the virus expresses the protective proteins, but does not replicate in the cat.
Danish: Vaccinestammen er en rekombinant canarypox virus, der afgiver env og gag generne i FeLV-A, idet det er kendt, at kun subgruppe A er infektiv under praktiske forhold, og at immunisering over for subgruppe A giver fuld beskyttelse over for A, B og C. Efter inokulering afgiver virus beskyttende proteiner, men repliceres ikke hos kat.
English: Plastic box containing 10, 20 or 50 bottles Not all pack sizes may be marketed.
Danish: Plastikæske med 10, 20 eller 50 flasker.
English: FeLV recombinant Canarypox virus (vCP97) ........ ≥ 10 7.2 CCID50
Danish: FeLV rekombinant Canarypox virus (vCP97) ............................. ≥10 7,2 CCID50
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Danish: Hypersensitivitetsreaktion kan i sjældne tilfælde forekomme.
English: Administer one dose of 1ml - according to the following schedule: Basic vaccination:
Danish: Injicer en dosis (1ml) i henhold til følgende program: Basisvaccination:
English: annual
Danish: årligt.
English: FeLV recombinant Canarypox virus (vCP97) ........ ≥ 10 7.2 CCID50 (cell culture infective dose 50%)
Danish: FeLV rekombinant Canarypox virus (vCP97) ................................................................. ≥ 10 7,2 CCID50 (cellekultur infektiøs dosis 50 %)
English: Onset of immunity:2 weeks after primary vaccination course.
Danish: Indtræden af immunitet: 2 uger efter basisvaccination.
English: Administer one dose of 1ml according to the following schedule: Basic vaccination:
Danish: Injicer en dosis (1 ml) af vaccinen i henhold til følgende program: Basisvaccination:
English: Potassium chloride Sodium chloride
Danish: Kaliumchlorid
English: Suspension for injection
Danish: Injektionsvæske, suspension.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial non-adjuvanted vaccine range (various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components) and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Danish: Der foreligger oplysninger om sikkerhed og virkning, som viser, at denne vaccine kan blandes med Merials vacciner uden adjuvans (forskellige kombinationer af felin viral rhinotracheitis, calicivirose, panleukopeni og chlamydia komponenter) og/eller anvendes den samme dag men ikke blandes med Merial vaccine med adjuvans mod rabies.
English: 4.2 Indications for use,specifying the target species
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Merial adjuvanted vaccines (various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and rabies components).
Danish: Der foreligger oplysninger om sikkerhed og virkning, som viser, at vaccinen kan anvendes samme dag som men ikke blandet med Merials vacciner med adjuvans (forskellige kombinationer af felin viral rhinotracheitis, calicivirose, panleukopeni og rabies komponenter).
English: Purevax FeLV suspension for injection
Danish: Purevax FeLV Injektionsvæske, suspension
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Merial non-adjuvanted vaccine range (various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components)
Danish: Der foreligger oplysninger om sikkerhed og virkning, som viser, at vaccinen kan blandes og gives med Merials vacciner uden adjuvans (forskellige kombinationer af felin viral rhinotracheitis, calicivirose, panleukopeni og chlamydia-komponenter).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE {NATURE/TYPE}
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Suspension
English: F-69800 SAINT PRIEST
Danish: Laboratoire Porte des Alpes Rue de l'Aviation F-69800 SAINT PRIEST FRANKRIG
English: EXP
Danish: EXP {måneder/år}
English: Manufacturing authorisation holder responsible for batch release MERIAL
Danish: Ansvarlig for batchfrigivelse:
English: The use is not recommended during lactation.
Danish: Opbevares utilgængeligt for børn.
English: The recommended starting dose is one capsule three times a day.
Danish: Den anbefalede startdosis er én kapsel tre gange dagligt.
English: This is a summary of the European public assessment report (EPAR) for Yargesa.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Yargesa.
English: The full EPAR for Yargesa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Yargesa findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Committee recommended that Yargesa be approved for use in the EU.
Danish: Udvalget anbefalede, at Yargesa godkendes til anvendelse i EU.
English: Yargesa is a ‘generic medicine'.
Danish: Yargesa er et "generisk lægemiddel".
English: Other information about Yargesa
Danish: Andre oplysninger om Yargesa
English: This means that it contains the same active substance (miglustat) and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Zavesca.
Danish: Det betyder, at det indeholder det samme aktive stof (miglustat) og virker på samme måde som et "referencelægemiddel" kaldet Zavesca, der allerede er godkendt i Den Europæiske Union (EU).
English: A lower dose should be used in patients with reduced kidney function and those who develop diarrhoea.
Danish: En lavere dosis bør anvendes hos patienter med nedsat nyrefunktion og hos dem, der får diarré.
English: What measures are being taken to ensure the safe and effective use of Yargesa?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Yargesa?
English: What is Yargesa and what is it used for?
Danish: Hvad er Yargesa, og hvad anvendes det til?
English: Yargesa is used in patients who cannot receive enzyme-replacement therapy.
Danish: Yargesa bruges hos patienter, der ikke kan få enzymsubstitutionsbehandling.
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Zavesca, and do not need to be repeated for Yargesa.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i den godkendte anvendelse med referencelægemidlet, Zavesca, og det er ikke nødvendigt at gentage disse med Yargesa.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Yargesa has been shown to have comparable quality and to be bioequivalent to Zavesca.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Yargesa er af sammenlignelig kvalitet og er bioækvivalent med Zavesca.
English: As for every medicine, the company provided studies on the quality of Yargesa.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Yargesa.
English: As a result, glucosylceramide builds up in different parts of the body, such as the spleen, liver and bones.
Danish: Det medfører, at glucosylceramid ophobes flere steder i kroppen, f.eks. i milten, leveren og knoglerne.