FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will recommend the best course of therapy.
Danish: Din læge vil anbefale det bedste behandlingsforløb.
English: General information about taking this medicine:
Danish: Generelle oplysninger om indtagelse af dette lægemiddel:
English: Depending on the genotype of the hepatitis C virus that you have, your doctor may choose to treat you with a combination of this medicine with other medicines.
Danish: Afhængigt af genotypen for den hepatitis C-virus, du har, kan din læge vælge at behandle dig med en kombination af dette lægemiddel med andre lægemidler.
English: Based on the results of clinical trials, it is recommended that patients be treated for at least six months.
Danish: På baggrund af resultater fra kliniske fosøg anbefales det, at patienterne behandles i mindst seks måneder.
English: • Genotype 2 or 3: The recommended duration of treatment is 24 weeks.
Danish: • Genotype 2 eller 3: Den anbefalede behandlingsvarighed er 24 uger.
English: The attempt to self-harm has also been reported in adults, children, and adolescents.
Danish: Forsøg på selvskade er også registreret hos voksne, børn og unge.
English: • Inability to achieve full adult height may occur in some children and adolescents
Danish: Manglende evne til at opnå fuld voksenhøjde kan forekomme hos nogle børn og unge
English: If an entire day has gone by, check with your doctor.
Danish: Hvis der er gået en hel dag, skal du kontakte din læge.
English: Although data are limited, no evidence of long-term effects on sexual maturation was noted in the 5 year observational follow-up study.
Danish: Selv om data er begrænsede, blev der ikke set tegn på langtidsvirkning på kønsmodningen i det 5-årige opfølgende observationsstudie.
English: You or your caregiver should call your doctor immediately if you have any of these side effects.
Danish: Du eller din værge skal omgående ringe til din læge, hvis du oplever nogen af disse bivirkninger.
English: This appears to be due to reduction of apparent clearance in these patients.
Danish: Det ser ud til at skyldes reduktion af tilsyneladende clearance hos disse patienter.
English: Paediatric population No data are available in children below 3 years of age.
Danish: Pædiatrisk population: Der foreligger ingen data for børn under 3 år.
English: There are no special storage conditions for capsules packed in blisters.
Danish: Der er ingen særlige opbevaringsbetingelser for kapsler i blisterpakning.
English: METAVIR Fibrosis Score F2
Danish: METAVIR Fibrose score F2
English: These studies suggest that a carcinogenic potential of ribavirin in humans is unlikely.
Danish: Disse undersøgelser antyder, at potentiel carcinogenicitet af ribavirin hos mennesker, er usandsynlig.
English: Your physician will prescribe the pack size which is best for you.
Danish: Din læge vil ordinere den pakningsstørrelse, der passer bedst til dig.
English: Both female and male patients must take special precautions in their sexual activity if there is any possibility for pregnancy to occur:
Danish: Både kvindelige og mandlige patienter skal tage særlige forholdsregler i forbindelse med deres seksuelle aktivitet for at undgå graviditet:
English: This medicine can be very damaging to your unborn baby (embryo).
Danish: Dette lægemiddel kan være yderst skadeligt for dit ufødte barn (foster).
English: In clinical trial C/I98-580, 1,530 naïve patients were treated for one year with one of the following combination regimens:
Danish: I klinisk undersøgelse C/I98-580 blev 1.530 naive patienter behandlet i et år med et af følgende kombinationsregimen:
English: With zidovudine or stavudine, it is not certain if this medicine will change the way these medicines work.
Danish: - Med zidovudin eller stavudin er det ikke sikkert, at dette lægemiddel vil ændre på den måde, disse lægemidler fungerer på.
English: Routine monthly pregnancy tests must be performed during this time.
Danish: Regelmæssige månedlige graviditetstest skal udføres i dette tidsrum.
English: Duration of treatment - Retreatment
Danish: Behandlingens varighed - genbehandling:
English: If the child/adolescent weighs (kg)
Danish: Hvis barnet/ den unge vejer (kg)
English: - Blood tests will be done regularly to help your doctor to know if this treatment is working.
Danish: Der bliver regelmæssigt taget blodprøver for at hjælpe din læge med at opdage det, hvis denne behandling virker.
English: 3 capsules a
Danish: 3 kapsler a
English: This medicine stops the multiplication of hepatitis C virus.
Danish: Dette lægemiddel standser formering af hepatitis C-virus.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: Sustained virologic response
Danish: Vedvarende virologisk respons
English: Ribavirin capsules are to be administered orally each day in two divided doses (morning and evening) with food.
Danish: Ribavirin-kapsler skal administreres oralt hver dag fordelt på to doser (morgen og aften) indtaget sammen med mad.
English: Ninety-four of 107 children enrolled in the 5 year long-term follow-up trial.
Danish: Firehalvfems af 107 børn blev inkluderet i det opfølgende 5-årige langtidsstudie.
English: The selection of formulation is based on individual characteristics of the patient.
Danish: Valget af formulering er baseret på patientens individuelle egenskaber.
English: Ribavirin transport in non-plasma compartments has been most extensively studied in red cells, and has been identified to be primarily via an es-type equilibrative nucleoside transporter.
Danish: Ribavirin transport i non-plasmacompartments er blevet meget omfattende undersøgt i røde blodlegemer og er blevet identificeret til hovedsageligt at foregå via en es-type equilibrativ nukleosid transporter.
English: The overall sustained response rate after a 24-week treatment duration was 50%.
Danish: Den totale vedvarende responsrate efter en 24 ugers behandlingsperiode var 50 %.
English: Any patient complaining of decrease or loss of vision must have a prompt and complete eye examination.
Danish: Patienter, der klager over nedsat eller tabt syn bør, omgående have en komplet undersøgelse af øjet.
English: If you have this reaction, be sure to rinse your mouth thoroughly afterwards
Danish: Hvis du får denne reaktion, skal du skylle munden grundigt bagefter
English: This decline was significant among responders (0.3 for Metavir and -1.2 for Ishak) and stable (-0.1 for Metavir and -0.2 for Ishak) among nonresponders.
Danish: Dette fald var signifikant blandt de responderende (-0,3 for Metavir og -1,2 for Ishak) og stabile (-0,1 for Metavir og -0,2 for Ishak) blandt de ikke-responderende.
English: Tell your doctor or pharmacist if you or the child you are caring for are taking, have recently taken or might take any other medicines:
Danish: Fortæl det til din læge eller apoteker, hvis du eller det barn, du er værge for, tager, for nylig har taget eller måske vil tage andre lægemidler:
English: Men whose partners are pregnant must be instructed to use a condom to minimise delivery of ribavirin to the partner.
Danish: Mænd, hvis partnere er gravide, skal informeres om at anvende kondom for at minimere overførsel af ribavirin til partneren.
English: Some children did not reach their projected height within 1-12 years after completing treatment.
Danish: Nogle børn nåede ikke den forventede højde inden for 1-2 år efter behandlingen.
English: The study results are summarized in Table 14.
Danish: Undersøgelsens resultater er summerede i Tabel 14.
English: If it gets worse, your doctor will decide whether or not your Ribavirin Mylan treatment needs to be changed.
Danish: Hvis den forværres, vil din læge beslutte, om din Ribavirin Mylan-behandling skal ændres.
English: This should be discussed with your doctor (see section “Do not take Ribavirin Mylan”).
Danish: Dette skal drøftes med din læge (se afsnittet "Undgå at tage Ribavirin Mylan").
English: Reduce only interferon alfa-2b dose (see note 2) if:
Danish: Reducer kun interferon alfa-2b dosis (se note 2), hvis:
English: In addition some patients may experience vomiting.
Danish: Derudover kan nogle patienter opleve opkastning.
English: Discontinue breastfeeding before starting to take this medicine.
Danish: Afbryd amning, før du begynder at tage dette lægemiddel.
English: It is unknown whether the ribavirin that is contained in sperm will exert its potential teratogenic or genotoxic effects on the human embryo/foetus.
Danish: Det er uvist, om ribavirin i sædvæske vil udøve de potentielle teratogene eller genotoksiske virkninger på det humane embryo/foster.
English: Some people get depressed when taking Ribavirin in combination treatment with an interferon, and in some cases people had thoughts about threatening the life of others, suicidal thoughts or aggressive behaviour (sometimes directed against others).
Danish: Nogle mennesker bliver deprimerede, når de anvender ribavirin i kombinationsbehandling med et interferon, og i nogle tilfælde har personer haft tanker om at true andre på livet, selvmordstanker eller aggressiv opførsel (sommetider rettet mod andre).
English: - History of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease, in the previous six months (see section 4.4).
Danish: - Anamnese med allerede eksisterende alvorlig hjertesygdom, inklusive ustabil eller ukontrolleret hjertesygdom, i de foregående seks måneder (se pkt.
English: If necessary, an interdisciplinary approach including a mental health care provider or addiction specialist should be considered to evaluate, treat and follow the patient.
Danish: Om nødvendigt bør en interdisciplinær tilgang, der involverer en psykiatrisk behandler eller misbrugsspecialist overvejes, for at evaluere, behandle og følge patienten.
English: You should brush your teeth thoroughly twice daily and have regular dental examinations.
Danish: Du skal børste dine tænder grundigt to gange dagligt og få foretaget regelmæssige tandundersøgelser.
English: The salient safety issue of ribavirin is haemolytic anaemia occurring within the first weeks of therapy.
Danish: Det mest fremtrædende sikkerhedsproblem for ribavirin er hæmolytisk anæmi, der forekommer inden for de første uger af behandlingen.
English: The use of Ribavirin Mylan is contraindicated during pregnancy.
Danish: Anvendelsen af Ribavirin Mylan er kontraindiceret under graviditet.
English: Children and adolescents should be monitored every 3 months for evidence of thyroid dysfunction (e.g. TSH).
Danish: Børn og unge patienter bør monitoreres hver 3. måned for tegn på thyroideadysfunktion (f.eks. TSH).
English: Population pharmacokinetic analysis was performed using sparsely sampled serum concentration values from four controlled clinical trials.
Danish: Populations farmakokinetisk analyse blev udført ved hjælp af spredte, indsamlede serumkoncentrationsværdier fra fire kontrollerede kliniske undersøgelser.
English: < 12 g/dL despite 4 weeks at reduced dose
Danish: < 12 g/dl trods 4 uger med reduceret dosis dosisreduktion)
English: Pack sizes of 84, 112, 140 and 168 capsules.
Danish: Pakningsstørrelser med 84, 112, 140 og 168 kapsler.
English: • have another liver problem in addition to hepatitis C infection.
Danish: har et andet leverproblem ud over hepatitis C-infektion,
English: Dose modifications were required in 30% of patients, most commonly for anaemia and neutropenia.
Danish: Dosisjusteringer var nødvendige hos 30 % af patienterne, mest almindeligt for anæmi og neutropeni.
English: In addition these events have occurred in patients taking Ribavirin Mylan:
Danish: Derudover er disse hændelser sket hos patienter, der tog Ribavirin Mylan:
English: • have HIV (human immunodeficiency virus) or have ever had any other problems with your immune system.
Danish: har problemer med dine nyrer, har HIV (human immundefekt-virus) eller nogensinde har haft andre problemer med dit immunforsvar.
English: All Genotypes Genotype 1 Genotype 2 Genotype 3c Genotype 4
Danish: Alle Genotyper Genotype 1 Genotype 2 Genotype 3
English: Anorexia, increased appetite, decreased appetite
Danish: Anoreksi, øget appetit, nedsat appetit
English: * Number (%) of patients a. Defined as HCV-RNA below limit of detection using a research based RT-PCR assay at end of treatment and during follow-up period.
Danish: *Antal (%) patienter a. Defineret som HCV RNA under detektionsgrænsen ved brug af en forskningsbaseret RT-PCR analyse ved afslutningen af behandlingen og i opfølgningsperioden
English: Dose modification for paediatric patients
Danish: Dosisændring for pædiatriske patienter
English: PVC/Aclar
Danish: PVC/Aclar - Aluminium
English: Treatment should be initiated, and monitored, by a physician experienced in the management of chronic hepatitis C.
Danish: Behandlingen skal indledes og monitoreres af en læge med erfaring i behandling af kronisk hepatitis C.
English: If your female partner is not pregnant now but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped.
Danish: Hvis din kvindelige partner ikke er gravid i øjeblikket, men er i den fødedygtige alder, skal hun testes for graviditet hver måned under behandlingen, og i 7 måneder efter behandlingen er stoppet.
English: Please refer to the Package Leaflet of (peg)interferon alfa for more detailed information on these safety issues.
Danish: Der henvises til indlægssedlen for (peg)interferon alfa for mere detaljerede oplysninger om disse sikkerhedsspørgsmål.
English: Duration of treatment - Naïve patients
Danish: Behandlingens varighed - Naive patienter:
English: ≥ 2 g/dL decrease in haemoglobin during any 4 week period during treatment (permanent dose reduction)
Danish: ≥ 2 g/dl reduktion af hæmoglobin i en 4 ugers periode under behandlingen (permanent
English: Gwent, NP22 3AA United Kingom
Danish: Gwent, NP22 3AA Storbritannien
English: There may be some further treatment limitations if you have or have not been previously treated for chronic hepatitis C infection.
Danish: Der kan være yderligere behandlingsbegrænsninger, hvis du har eller ikke har været i behandling for kronisk hepatitis Cinfektion.
English: Standard blood tests will be taken to check your blood, kidney and liver function.
Danish: Der bliver taget almindelige blodprøver for at undersøge dit blod samt din nyre- og leverfunktion.
English: Dose reduction in paediatric patients without cardiac disease follows the same guidelines as adult patients without cardiac disease regarding haemoglobin levels (Table 2).
Danish: Dosisreduktion hos pædiatriske patienter uden hjertesygdom følger de samme retningslinjer som voksne patienter uden hjertesygdom hvad angår hæmoglobinindhold (Tabel 2).
English: - are allergic to ribavirin or any of the other ingredients of this medicine (listed in section 6).
Danish: • er allergisk over for ribavirin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i pkt.
English: Co-administration of Ribavirin Mylan and didanosine is not recommended.
Danish: Samtidig administration af Ribavirin Mylan og didanosin anbefales ikke.
English: Duration of treatment in children and adolescents
Danish: Varighed af behandling af børn og unge
English: Current treatment guidelines should be consulted as to whether a liver biopsy is needed prior to commencing treatment.
Danish: Gældende behandlingsvejledninger bør tages i betragtning med hensyn til, om en leverbiopsi er nødvendig før start af behandling.
English: Ribavirin Mylan must not be used alone.
Danish: Ribavirin Mylan må altså ikke bruges alene.
English: Study 22
Danish: Undersøgelse 2
English: • Girl or woman of childbearing age:
Danish: - Piger eller kvinder i den fødedygtige alder:
English: Seek medical help immediately if you develop symptoms of a severe allergic reaction (such as difficulty in breathing, wheezing or hives) while taking this treatment.
Danish: Søg læge omgående, hvis du udvikler symptomer på en svær allergisk reaktion (såsom vanskeligheder med at trække vejret, hvæsende vejrtrækning eller nældefeber) under denne behandling.
English: Dose modification for adults
Danish: Dosisændring for voksne
English: Acceptable baseline values that may be considered as a guideline prior to initiation of Ribavirin Mylan therapy:
Danish: Acceptable baselineværdier, der kan betragtes som en vejledning før initiering af Ribavirin Mylan behandling:
English: Blood thyroid stimulating hormone increased, thyroglobulin increased
Danish: Øget blod thyroid stimulerende hormone, øget thyroglobulin
English: Decrease in mean height percentile at year 1 of long-term follow-up was most prominent in prepubertal age children.
Danish: Reduktion i den gennemsnitlige højdepercentil efter 1 års langtidsopfølgning var mest fremtrædende hos børn i præpuberteten.
English: Patients with impaired renal function should be more carefully monitored with respect to the development of anaemia.
Danish: Patienter med nedsat nyrefunktion skal overvåges mere omhyggeligt med hensyn til udvikling af anæmi.
English: This was true for all HCV genotypes, particularly Genotype 1, in which the relapse rate was reduced by 30% compared with interferon alfa2b monotherapy.
Danish: Dette var tilfældet for alle HCV genotyper, især genotype 1, i hvilken relapsraten blev reduceret med 30 % sammenlignet med interferon alfa-2b monoterapi.
English: Ribavirin (Ribavirin Mylan) is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses.
Danish: Ribavirin (Ribavirin Mylan) er en syntetisk nukleosidanalog, der har vist in vitro aktivitet mod nogle RNA og DNA virus.
English: All patients in selected chronic hepatitis C studies had a liver biopsy before inclusion, but in certain cases (i.e. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Danish: Alle patienter i de valgte undersøgelser af kronisk hepatitis C fik foretaget en leverbiopsi før inklusion, men i visse tilfælde (eksempelvis patienter med genotype 2 og 3) kan behandling være mulig uden histologisk bekræftelse.
English: Furthermore, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6 month follow-up after treatment.
Danish: Derudover blev selvmordstanker eller -forsøg rapporteret hyppigere sammenlignet med voksne patienter (2,4 % mod 1 %) under behandling og i den 6 måneder lange opfølgningsperiode efter behandling.
English: Patients progressing to hepatic decompensation should have their anti-hepatitis treatment immediately discontinued and the ARV treatment reassessed.
Danish: Patienter som udvikler hepatisk inkompensation, bør have deres antihepatiske behandling seponeret øjeblikkeligt, og ARV behandlingen skal revurderes.
English: Ribavirin Mylan should be administered orally with food.
Danish: Ribavirin Mylan skal administreres oralt med mad.
English: Combination therapy with alpha interferons should be discontinued in patients who develop new or worsening ophthalmologic disorders.
Danish: Kombinationsbehandling med alfa-interferoner skal ophøre hos patienter, der udvikler ny eller forværring af øjensygdom.
English: You or your female partner must use an effective contraceptive during the time you are taking ribavirin and for 7 months after stopping treatment.
Danish: Du eller din kvindlige partner skal bruge sikker prævention i den periode, du tager ribavirin og i 7 måneder efter, behandlingen er stoppet.
English: There does not appear to be a significant age-related effect on the pharmacokinetics of ribavirin.
Danish: Der ser ikke ud til at være en betydelig aldersbetinget påvirkning af farmakokinetikken for ribavirin.
English: Although data on approximately 300 prospectively followed pregnancies with paternal exposure to ribavirin have not shown an increased risk of malformation compared to the general population, nor any specific pattern of malformation, either male patients or their female partners of childbearing age must be advised to use an effective contraceptive during treatment with Ribavirin Mylan and for seven months after treatment.
Danish: Selvom resultater fra omkring 300 prospektivt fulgte graviditeter med paternal eksponering for ribavirin ikke har vist en øget risiko for misdannelse sammenlignet med den almindelige population og heller intet specifikt mønster for misdannelser, skal mandlige patienter eller deres kvindelige fertile partnere rådes til at anvende effektiv kontraception under behandling med Ribavirin Mylan og i syv måneder efter behandlingen.
English: Absorption is extensive with approximately 10% of a radiolabelled dose excreted in the faeces.
Danish: Absorptionen er omfattende med omkring 10 % af en radioaktivt mærket dosis udskilt i fæces.
English: − It is important to consider that the combination therapy induced a growth inhibition that resulted in reduced height in some patients.
Danish: Det er vigtigt at betænke at kombinationsterapien inducerede væksthæmning, som medførte reduceret højde hos nogle patienter.
English: If a patient has a serious adverse reaction potentially related to ribavirin, the dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity.
Danish: Hvis en patient får en alvorlig bivirkning, som kan være relateret til ribavirin, skal dosen ændres eller seponeres, hvis det er passende, indtil bivirkningen aftager eller falder i sværhedsgrad.
English: - Depending upon the results of these tests, your doctor may change/adjust the number of hard capsules you or the child you are caring for take, prescribe a different pack size of this medicine, and/or change the length of time to take this treatment.
Danish: Afhængigt af resultaterne af disse test kan din læge ændre/justere antallet af hårde kapsler, som du eller det barn, du er værge for, tager, ordinere en anden størrelse pakke af dette lægemiddel og/eller ændre det tidsrum, som denne behandling skal tages i. Hvis du har eller udvikler alvorlige nyre- eller leverproblemer, bliver denne behandling afbrudt.
English: In the cases in which no specific dose recommendation is made, the following dose should be used: Patient weight: < 75 kg = 1,000 mg and > 75 kg = 1,200 mg.
Danish: I tilfælde, hvor der ikke er en specifik dosisanbefaling, skal følgende dosis anvendes: Patientens vægt: < 75 kg = 1.000 mg og > 75 kg = 1.200 mg.
English: Injury, poisoning and procedural complications Common:
Danish: Traumer, forgiftninger og behandlingskomplikationer Almindelig
English: Discontinue treatment in patients who develop prolongation of coagulation markers which might indicate liver decompensation.
Danish: Afbryd behandling hos patienter, der udvikler forlængede koagulationsmarkører, hvilket kan være tegn på leverdekompensation.
English: • Men:
Danish: - Mænd:
English: For paediatric patients (children and adolescents) weighing less than 47 kg a solution formulation is available.
Danish: Til pædiatriske patienter (børn og unge), der vejer mindre end 47 kg, findes der en opløsning.
English: Note: For patients who weigh < 47 kg, or are unable to swallow capsules, ribavirin oral solution is available and should be used if appropriate.
Danish: Bemærk: For patienter, der vejer <47 kg eller ikke er i stand til at sluge kapslerne, findes der en oral opløsning af ribavirin, som bør bruges.
English: Table 3 provides guidelines for discontinuation based on the patient's indirect bilirubin concentration.
Danish: Tabel 3 giver retningslinjer for seponering baseret på patientens indirekte bilirubinkoncentration.