FrancophonIA/ELRC3.0 huggingface dataset:
English: However, a return to higher doses is not recommended.
Danish: Tilbagevenden til højere doser anbefales ikke.
English: Date of first authorisation : 01 July 2009 Date of latest renewal : 16 January 2014
Danish: Dato for første tilladelse: 01 juli 2009 Dato for seneste fornyelse: 16. januar 2014.
English: Bilirubin - Indirect
Danish: Bilirubin - indirekte
English: This interaction is not considered to be clinically relevant.
Danish: Denne interaktion betragtes ikke som værende klinisk relevant.
English: In terms of activity, about one-third of sustained responders showed improvement and none showed worsening.
Danish: Med hensyn til aktivitet viste omkring en tredjedel af de vedvarende responderende bedring, og ingen viste forværring.
English: Do not have sex with a pregnant woman unless you use a condom.
Danish: Hav ikke samleje med en gravid kvinde, medmindre du bruger et kondom.
English: • have problems with your kidneys.
Danish: • har problemer med dine nyrer.
English: The study results are summarized in Table 9.
Danish: Undersøgelsens resultater er summerede i Tabel 9.
English: For males, clearance was approximately 20 % higher than for females.
Danish: For mænd var clearance cirka 20 % højere end for kvinder.
English: Your physician will prescribe the pack size which is best for you.
Danish: Din læge vil ordinere den pakningsstørrelse, som er bedst til dig.
English: No data are available in children below 3 years of age.
Danish: Der foreligger ingen data for børn under 3 år.
English: Talk to your doctor if you or your child you are caring for:
Danish: Tal med din læge, hvis du eller barnet du har ansvar for:
English: You should brush your teeth thoroughly twice daily and have regular dental examinations.
Danish: Du skal børste dine tænder grundigt 2 gange dagligt og gå til regelmæssigt tandeftersyn.
English: Do not take more than the recommended dosage and take the medicine for as long as prescribed.
Danish: Tag ikke mere end den anbefalede dosis og tag medicinen så længe som foreskrevet.
English: - had a serious heart problem during the past 6 months
Danish: - hvis du har haft alvorlige hjerteproblemer inden for de sidste 6 måneder.
English: • have HIV (human immunodeficiency virus) or have ever had any other problems with your immune system.
Danish: • har hiv- (humant immundefektvirus) infektion eller nogensinde har haft andre problemer med dit immunsystem.
English: If you have this reaction, be sure to rinse your mouth thoroughly afterwards
Danish: Hvis du gør det, så husk at skylle munden omhyggeligt bagefter
English: Male patients and their female partners
Danish: Mandlige patienter og deres kvindelige partnere
English: This should be discussed with your doctor.
Danish: Dette skal du tale med din læge om.
English: In all cases the treatment was for one year with a follow-up of six months.
Danish: I alle tilfælde varede behandlingen et år med en opfølgning på seks måneder.
English: Therefore, your blood will be checked regularly to be sure that the HIV infection is not getting worse.
Danish: Dit blod vil derfor blive undersøgt regelmæssigt for at sikre, at HIV-infektionen ikke forværres.
English: Caution should be exercised when both medicines are co-administered.
Danish: Der bør udvises forsigtighed, når de to lægemidler administreres samtidigt.
English: The attempt to self-harm has also been reported in adults, children, and adolescents.
Danish: Forsøg på at gøre skade på sig selv har også været rapporteret hos voksne, børn og unge.
English: General information about taking this medicine:
Danish: Generel information omkring brugen af dette lægemiddel:
English: If the child/adolescent weighs
Danish: Hvis barnet/den unge vejer
English: Sustained virological response in previously untreated children and adolescents
Danish: Vedvarende virologisk respons hos tidligere ubehandlede børn og unge
English: Routine monthly pregnancy tests must be performed during this time.
Danish: Rutinemæssige graviditetstest skal udføres månedligt i denne periode.
English: This medicine can be very damaging to your unborn baby (embryo).
Danish: Lægemidlet kan være meget skadeligt for dit ufødte barn (foster).
English: Do not drive or use any tools or machines if you feel tired or sleepy, or are confused.
Danish: Kør ikke bil og betjen ikke værktøj eller maskiner, hvis du føler dig træt eller søvnig eller er forvirret.
English: However, absolute bioavailability is approximately 45 %-65 %, which appears to be due to first pass metabolism.
Danish: Den absolutte biotilgængelighed er imidlertid omkring 45 % - 65 %, hvilket synes at skyldes first pass-metabolisme.
English: Not known side effects (frequency cannot be estimated from the available data):
Danish: Ikke kendte bivirkninger (hyppighed kan ikke vurderes ud fra tilgængelige data):
English: Do not use this medicine if you notice any change in the appearance of the tablets.
Danish: Brug ikke dette lægemiddel, hvis du bemærker en ændring i udseendet af tabletterne.
English: Tell your doctor or pharmacist as soon as possible.
Danish: Fortæl det til din læge eller apotekspersonalet så hurtigt som muligt.
English: - Blood tests will be done regularly to help your doctor to know if this treatment is working.
Danish: - Blodprøver vil blive taget regelmæssigt for at hjælpe din læge til at vide, om denne behandling virker.
English: If you are pregnant you must not take this medicine.
Danish: Hvis du er gravid, må du ikke tage dette lægemiddel.
English: Clearance increased as a function of body weight and was reduced at ages greater than 40 years.
Danish: Clearance steg som en funktion af kropsvægten og faldt ved højere alder end 40 år.
English: Histological response
Danish: Histologisk respons
English: This was true for all HCV genotypes.
Danish: Dette var tilfældet for alle HCV-genotyper.
English: This will lessen the possibility for ribavirin to be left in the woman's body.
Danish: Dette vil reducere muligheden for, at ribavirin efterlades i kvindens krop.
English: The response to treatment in both of these trials is presented in Table 8.
Danish: Respons på behandlingen i begge af disse undersøgelser er vist i Tabel 8.
English: If an entire day has gone by, check with your doctor.
Danish: Hvis der er gået en hel dag, skal du tale med din læge.
English: There was no improvement in terms of fibrosis observed in this study.
Danish: Der var ingen bedring i relation til fibrosen, der blev observeret i undersøgelsen.
English: Of these, sixty-three were sustained responders.
Danish: Heraf var 63 vedvarende respondenter.
English: Take your prescribed dose by mouth with water and during your meal.
Danish: Tag den ordinerede dosis gennem munden med vand og sammen med mad.
English: You may want to consider asking a family member or close friend to help you stay alert to signs of depression or changes in your behaviour
Danish: Måske bør du overveje at bede et familiemedlem eller en god ven om at hjælpe dig med at være opmærksom på tegn på depression eller ændringer i din adfærd
English: Survival of foetuses and offspring was reduced.
Danish: Overlevelsen af fostre og afkom var reduceret.
English: Overall Responsea (n=118) Genotype 1 (n=92) Genotype 2/3/4 (n=26)
Danish: Samlet responsa (n=118) Genotype 1 (n=92) Genotype 2/3/4 (n=26)
English: Potential to exacerbate immunosuppression
Danish: Mulighed for forværret immunsuppression
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, om dette lægemiddel vil ændre måden, disse lægemidler virker på.
English: Ribavirin was active in the Balb/3T3 in vitro transformation assay.
Danish: Ribavirin var aktiv i Balb/3T3 in vitro transformation assay.
English: - If you have or develop severe kidney or liver problems, this treatment will be stopped.
Danish: - Hvis du har eller udvikler alvorlige nyre- eller leverlidelser, vil denne behandling blive stoppet.
English: Combination therapy also decreased the relapse rate.
Danish: Kombinationsbehandling sænkede også tilbagefaldsraten.
English: - Depending upon the results of these tests, your doctor may change/adjust the number of tablets 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 prøver, kan din læge ændre/tilpasse antallet af tabletter, du eller barnet skal have, ordinere en anden pakningsstørrelse af dette lægemiddel, og/eller ændre varigheden af din behandling.
English: This medicine stops the multiplication of many types of viruses, including hepatitis C virus.
Danish: Dette lægemiddel stopper mangfoldiggørelsen af mange former for virus, herunder hepatitis C virus.
English: At least 5 years of long-term follow-up was completed after treatment in 462 patients and 327 patients, respectively.
Danish: Mindst 5 års langtidsopfølgning er fuldført efter behandling af henholdsvis 462 patienter og 327 patienter.
English: This type of transporter is present on virtually all cell types and may account for the high volume of distribution of ribavirin.
Danish: Denne type transporter er til stede hos praktisk taget alle celletyper og kan være årsag til det høje fordelingsvolumen for ribavirin.
English: Liver biopsies were obtained before and after treatment in Study 1 and were available for 210 of the 412 subjects (51 %).
Danish: Leverbiopsier blev indhentet før og efter behandling i Undersøgelse 1 og var tilgængelige for 210 af de 412 forsøgspersoner (51 %).
English: Upon discontinuation of dosing the half-life was approximately 298 hours, which probably reflects slow elimination from non-plasma compartments.
Danish: Efter ophørt dosering var halveringstiden cirka 298 timer, hvilket sandsynligvis afspejler langsom elimination fra nonplasmacompartments.
English: Teratogenic risk
Danish: Teratogen risiko
English: The clinical relevance of results from this single dose study is unknown.
Danish: Den kliniske relevans af resultaterne fra denne enkeltdosis-undersøgelse er uvis.
English: The effects on growth were less in those children treated for 24 weeks than those treated for 48 weeks.
Danish: Virkningen på væksten var mindre hos de børn, der var blevet behandlet i 24 uger end hos dem, der var blevet behandlet i 48 uger.
English: These studies suggest that a carcinogenic potential of ribavirin in humans is unlikely.
Danish: Disse undersøgelser antyder, at potentiel karcinogenicitet af ribavirin hos mennesker er usandsynlig.
English: Sustained response was assessed by the response rate six months after the cessation of treatment.
Danish: Vedvarende respons blev vurderet som responsraten seks måneder efter afsluttet behandling.
English: Do not use this medicine after the expiry date which is stated on the outer packaging.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen.
English: Take/administer the missed dose as soon as possible during the same day.
Danish: Tag/giv den glemte dosis så hurtigt som muligt samme dag.
English: The patient was observed for two days in the emergency room, during which time no adverse reaction from the overdose was noted.
Danish: Patienten blev observeret i to dage på skadestue, og i denne periode blev der ikke noteret nogen bivirkning fra overdoseringen.
English: A dominant lethal assay in rats was negative, indicating that if mutations occurred in rats they were not transmitted through male gametes.
Danish: En dominant letal test hos rotter var negativ, hvilket tyder på, at hvis mutationer forekom i rotter, blev de ikke overført via mandlige kønsceller.
English: • had a previous heart condition or have heart disease.
Danish: • tidligere har haft en hjertelidelse eller har en hjertesygdom.
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 seksuel aktivitet for at undgå graviditet:
English: Previously treated adult patients:
Danish: Tidligere behandlede voksne patienter:
English: • Girl or woman of childbearing age:
Danish: • Piger eller kvinder i den fødedygtige alder:
English: Although not all of these unwanted effects may occur, they may need medical attention if they do occur.
Danish: Selvom ikke alle bivirkningerne forekommer, kan de kræve lægelig behandling, hvis de forekommer.
English: These doses in animals produce systemic exposures well below those achieved in humans at therapeutic doses.
Danish: Disse doser til dyr giver systemiske eksponeringer et godt stykke under dem, der opnås hos mennesker ved terapeutiske doser.
English: Naïve patients
Danish: Naive patienter
English: Not done
Danish: Ikke udført
English: Use of nucleoside analogs, alone or in combination with other nucleosides, has resulted in lactic acidosis.
Danish: Anvendelse af nukleosid-analoger, alene eller i kombination med andre nukleosider, har resulteret i lactacidose.
English: MIU = million international units; TIW = three times a week.
Danish: MIE = millioner internationale enheder; TIW = tre gange ugentligt.
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: Growth rate decrease (height and/or weight decrease for age)
Danish: Nedsat voksehastighed (højde- og/eller vægtfald i forhold til alder)
English: No ribavirin effects were observed regarding neurobehavioural or reproductive development.
Danish: Der blev ikke observeret ribavirin-effekter på neuroadfærd eller reproduktiv udvikling.
English: The majority of adverse reactions reported in the study were mild or moderate in severity.
Danish: Flertallet af bivirkninger i studiet var milde eller moderate i sværhedsgrad.
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: Long-term efficacy data
Danish: Data for langtidsvirkning
English: No histopathological effects on bone were observed.
Danish: Der blev ikke observeret histopatologiske effekter på knogler.
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 studie C/I98-580 blev 1.530 naive patienter behandlet i et år med et af følgende kombinationsregimen:
English: Therefore, there is a minimal potential for P450 enzyme-based interactions.
Danish: Der er således minimal mulighed for P450-enzymbaserede interaktioner.
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 under opfølgningsperioden
English: Do not chew the film-coated tablets.
Danish: Tyg ikke de filmovertrukne tabletter.
English: Previously untreated patients:
Danish: Tidligere ubehandlede patienter:
English: HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
Danish: HCV-genotype og baselinevirusmængde er prognostiske faktorer, som er kendt for at påvirke responsrater.
English: Specific pharmacokinetic evaluations for elderly subjects have not been performed.
Danish: Specifikke farmakokinetikundersøgelser hos ældre personer er ikke blevet udført.
English: Additionally, 98 % (51/52) with normal ALT levels at follow-up week 24 maintained normal ALT levels at their last visit.
Danish: Hertil kommer, at 98 % (51/52) med normale ALAT-niveauer ved opfølgningsuge 24 havde normalt ALAT-niveau ved deres sidste besøg.
English: This appears to be due to reduction of apparent clearance in these patients.
Danish: Dette synes at være forårsaget af en reduktion den tilsyneladende clearance hos disse patienter.
English: Steatosis was significantly improved in patients infected with HCV Genotype 3.
Danish: Steatose var signifikant forbedret hos patienter, der var inficeret med HCV Genotype 3.
English: A total of 118 patients were enrolled: 57 % male, 80 % Caucasian, and 78 % genotype 1, 64 % ≤ 12 years of age.
Danish: I alt 118 patienter blev inkluderet: 57 % mænd, 80 % kaukasiske og 78 % genotype 1, 64 % i alderen ≤ 12 år.
English: Therefore, it is recommended that renal function be evaluated in all patients prior to initiation of ribavirin.
Danish: Det anbefales derfor, at nyrefunktionen vurderes hos alle patienter før initiering af ribavirin.
English: The mechanism by which ribavirin in combination with other medicinal products exerts its effects against HCV is unknown.
Danish: Mekanismen ved hvilken ribavirin i kombination med andre lægemidler udøver sine virkninger mod HCV er ukendt.
English: You or your caregiver should call your doctor immediately if you have any of these side effects.
Danish: Du eller din plejer bør kontakte din læge omgående, hvis du oplever nogle af disse bivirkninger.
English: Like all medicines, this medicine used in combination with other medicines can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel, der er anvendt i kombination med andre lægemidler, kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The major treatment-related change was a reversible mild to moderate anaemia, the severity of which was greater than that produced by either active substance alone.
Danish: Den væsentligste behandlingsrelaterede ændring var en reversibel mild til moderat anæmi, hvis sværhedsgrad var større, end hvad der sås med hvert aktivt stof for sig.
English: < 12 g/dL despite 4 weeks at reduced dose
Danish: < 12 g/dl trods 4 ugers behandling ved reduceret dosis
English: Paediatric patients (children 3 years of age and older and adolescents)
Danish: Pædiatriske patienter (børn i alderen 3 år og ældre samt unge)
English: Standard blood tests will be taken to check your blood, kidney and liver function.
Danish: Standardblodprøver vil blive taget for at tjekke dit blod samt nyre- og leverfunktion.
English: However, in a population pharmacokinetic study, age was not a key factor in the kinetics of ribavirin; renal function is the determining factor.
Danish: I en farmakokinetisk populationsundersøgelse var alder imidlertid ikke en afgørende faktor i kinetikken for ribavirin; nyrefunktionen er den afgørende faktor.
English: The clearance model developed showed that body weight, gender, age, and serum creatinine were the main covariates.
Danish: Den fremkomne clearancemodel viste, at kropsvægt, køn, alder og serumkreatinin var de vigtigste kovarianser.
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 optaget i sædvæske vil udøve de potentielle teratogene eller genotoksiske virkninger på det humane embryo/foster.
English: Ribavirin accumulates intracellularly and is cleared from the body very slowly.
Danish: Ribavirin opbobes intracellulært og udskilles meget langsomt fra kroppen.
English: Twelve out of 492 sustained responders and only 3 out of 366 sustained responders relapsed, respectively, in the studies.
Danish: Kun henholdsvis 12 ud af 492 vedvarende respondenter og 3 ud af 366 vedvarende respondenter fik tilbagefald i undersøgelserne.
English: Suicide*
Danish: Selvmord٭
English: Reminder: This medicine is only to be used in combination with other medicines for hepatitis C virus infection.
Danish: Bemærk: Dette lægemiddel er kun til anvendelse i kombination med andre lægemidler mod hepatitis C virus infektion.
English: Alternating doses, 200 mg and 400 mg every other day
Danish: Skiftende doser, 200 mg og 400 mg hver anden dag
English: Do not take Ribavirin Teva Pharma B.V. if any of the following apply to you or the child you are caring for.
Danish: Tag ikke Ribavirin Teva Pharma B.V., hvis noget af følgende gælder for dig eller det barn, du har ansvar for.
English: Caution is therefore warranted in the treatment of patients with low CD4 counts.
Danish: Der er derfor grund til at udvise forsigtighed i behandlingen af patienter med lave CD4-tællinger.
English: Female patients
Danish: Kvindlige patienter
English: There is a linear relationship between dose and AUCtf following single doses of 200-1,200 mg ribavirin.
Danish: Der er en lineær relation mellem dosis og AUCtf efter enkelte doser på 200-1.200 mg ribavirin.
English: However, this does not preclude the occurrence of hepatic events in patients with cirrhosis (including hepatocarcinoma).
Danish: Dette udelukker imidlertid ikke forekomsten af hepatitis-tilfælde hos patienter med cirrhosis (inklusive hepatocarcinoma).
English: The incidence and severity of teratogenic effects increased with escalation of the dose.
Danish: Hyppigheden og sværhedsgraden af de teratogene påvirkninger steg med stigende doser.
English: Thus, patients who develop fatigue, somnolence, or confusion during treatment must be cautioned to avoid driving or operating machinery.
Danish: Patienter, der udvikler træthed, søvnighed eller forvirring under behandling, skal således advares mod at køre bil eller betjene maskiner.
English: 30 to 50 mL/min
Danish: 30 til 50 ml/min
English: At the end of the recovery period, tibial and femoral changes were minimal although generally statistically significant compared to controls in males at all dose levels and in females dosed with the two highest doses compared to controls.
Danish: I slutningen af restitutionsperioden var tibiale og femorale forandringer minimale, selvom de generelt var statistisk signifikante sammenlignet med kontrolgruppen hos hanner ved alle doseringsniveauer og hos hunner, der fik de to højeste doser sammenlignet med kontrolgruppen.
English: Population pharmacokinetic analysis was performed using sparsely sampled serum concentration values from four controlled clinical trials.
Danish: Farmakokinetisk populationsanalyse blev udført ved hjælp af spredte, indsamlede serumkoncentrationsværdier fra fire kontrollerede kliniske undersøgelser.
English: Older people (≥ 65 years of age)
Danish: Ældre (≥ 65 år)
English: The selection of ribavirin formulation is based on individual characteristics of the patient.
Danish: Valg af ribavirin-formulering er baseret på patientens individuelle karakteristika.
English: Be sure to seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour.
Danish: Søg omgående hjælp, hvis du bemærker, at du bliver deprimeret eller får selvmordstanker, eller hvis din adfærd ændrer sig.
English:  2 g/dL decrease in haemoglobin during any 4 week period during treatment (permanent dose reduction)
Danish:  2 g/dl fald i hæmoglobin i løbet af en hvilken som helst 4 ugers periode under behandling (permanent dosisreduktion)
English: Reduce ribavirin dose* if:
Danish: Reducer ribavirin-dosis*, hvis:
English: Ribavirin is absorbed rapidly following oral administration of a single dose (mean Tmax=1.5 hours), followed by rapid distribution and prolonged elimination phases (single dose half-lives of absorption, distribution and elimination are 0.05, 3.73 and 79 hours, respectively).
Danish: Ribavirin absorberedes hurtigt efter oral administration af en enkelt dosis (gennemsnitlig Tmax=1,5 timer), efterfulgt af hurtig fordeling og forlængede eliminationsfaser (enkeltdosis halveringstid for absorption, distribution og elimination er hhv. 0,05, 3,73 og 79 timer).
English: Ribavirin (800 mg/day)
Danish: Ribavirin (800 mg/dag)