FrancophonIA/ELRC3.0 huggingface dataset:
English: Twelve out of 492 sustained responders and only 3 out of 366 sustained responders relapsed, respectively, in the studies.
Danish: Kun henholdsvis tolv ud af 492 vedvarende respondenter og 3 ud af 366 vedvarende respondenter fik tilbagefald i undersøgelserne.
English: Growth rate decrease (height and/or weight decrease for age)
Danish: Nedsat voksehastighed (højde- og/eller vægttab i forhold til alder)
English: Hold the syringe to your mouth and release the dose into your mouth (or the mouth of the patient you are caring for) by pushing in the rod.
Danish: Hold sprøjten op til din mund og frigiv dosis ind i munden (eller munden hos den patient, du tager dig af) ved at trykke stangen ind.
English: In clinical studies performed in this population, Rebetol was used in doses of 15 mg/kg/day (Table 1).
Danish: I kliniske undersøgelser udført i denne population, blev Rebetol brugt i en dosis på 15 mg/kg/dag (Tabel 1).
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 normal ALAT-niveau ved deres sidste besøg.
English: Suicide attempts, panic attack, hallucination
Danish: Selvmordsforsøg, panik anfald, hallucinationer
English: Rebetol accumulates intracellularly and is cleared from the body very slowly.
Danish: Rebetol ophobes intracellulært og udskilles meget langsomt fra kroppen.
English: You or your caregiver should call your doctor immediately if you have any of these side effects.
Danish: Du eller din plejer skal kontakte lægen omgående, hvis du oplever nogle af disse bivirkninger.
English: No ribavirin effects were observed regarding neurobehavioural or reproductive development.
Danish: Der blev ikke observeret ribavirin effekter på neuroadfærd eller reproduktiv udvikling.
English: Rebetol capsules are packaged in blisters consisting of polyvinyl chloride (PVC)/polyethylene (PE)/polyvinylidene chloride (PVdC).
Danish: Rebetol-kapsler er pakket i blisterpakninger, som består af polyvinylklorid (PVC)/polyethylen (PE)/polyvinyliden klorid (PVdC).
English: The response to treatment in both of these trials is presented in Table 11.
Danish: Respons på behandlingen i begge af disse undersøgelser er vist i Tabel 11.
English: There does not appear to be a significant age-related effect on the pharmacokinetics of Rebetol.
Danish: Der synes ikke at være en signifikant aldersrelateret effekt på Rebetols farmakokinetik.
English: These time points (treatment week 4 and treatment week 12) have been shown to be predictive for sustained response (Table 10).
Danish: Disse tidspunkter (4- og 12 behandlingsuge) har vist sig at være prædiktiv med hensyn til vedvarende respons (Tabel 10).
English: 3 capsules
Danish: 3 kapsler
English: However, this does not preclude the occurrence of hepatic events in patients with cirrhosis (including hepatocarcinoma).
Danish: Dette udelukker imidlertid ikke forekomsten af hepatitistilfælde i patienter med cirrhosis (inklusive hepatocarcinoma).
English: Hard capsule (capsule)
Danish: Hård kapsel (kapsel)
English: Taking all your medicine: Take or give the prescribed dose by mouth in the morning and evening, with a meal.
Danish: Tag al din medicin: Tag eller indgiv den foreskrevne dosis gennem munden om morgenen og aftenen, til et måltid.
English: (by Rebetol dose [mg/kg], genotype and viral load) HCV Genotype
Danish: (efter Rebetol dosis [mg/kg], genotype og virusmængde) HCV Genotype
English: The salient safety issue of Rebetol is haemolytic anaemia occurring within the first weeks of therapy.
Danish: Rebetols vigtigste sikkerhedsaspekt er hæmolytisk anæmi, der opstår inden for de første uger af behandlingen.
English: Adding treatment with an alpha interferon alone or in combination with ribavirin may increase the risk in this patient subset.
Danish: Tilføjelse af behandling med en alfa interferon alene eller i kombination med ribavirin kan øge risikoen i denne patientundergruppe.
English: No sustained Response
Danish: Intet vedvarende respons
English: For children or adolescents who cannot swallow a hard capsule, an oral solution of this medicine is available.
Danish: Til børn og unge, som ikke kan sluge en hård kapsel, findes en oral opløsning af dette lægemiddel.
English: Among 480 patients with > 2 log viral reduction but detectable virus at week 12, altogether 188 patients continued therapy.
Danish: Blandt 480 patienter med > 2 log viral reduktion, men målbar virus i uge 12, fortsatte sammenlagt 188 patienter behandlingen.
English: All patients were to be followed for 24 weeks post-treatment.
Danish: Alle patienter blev fulgt i 24 uger efter behandlingen.
English: Patients with low CD4 counts
Danish: Patienter med lave CD4-tællinger
English: As the solution fills the syringe, you will see the numbers on the rod go up, such as 1.5 mL, 2.0 mL, 2.5 mL, etc.
Danish: Mens opløsningen fylder sprøjten, vil du se tallene på stangen gå op, såsom 1,5 ml, 2,0 ml, 2,5 ml, etc.
English: Limited historical data indicate that treatment for 48 weeks might be associated with a higher sustained response rate (11/11) and with a lower risk of relapse (0/11 as compared to 7/96 following 24 weeks of treatment).
Danish: Begrænsede historiske data indikerer, at behandling i 48 uger kan være forbundet med en højere vedvarende responsrate (11/11) og en lavere risiko for relaps (0/11 i sammenligning med 7/96 efter 24 ugers behandling).
English: Ribavirin (Rebetol) is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses.
Danish: Ribavirin (Rebetol) er en syntetisk nukleosidanalog, der har vist in vitro aktivitet mod nogle RNA og DNA virus.
English: Effects of these covariates on ribavirin clearance appear to be of limited clinical significance due to the substantial residual variability not accounted for by the model.
Danish: Effekten af disse covariate på ribavirin clearance synes at være af begrænset klinisk betydning på grund af den kraftige restvariabilitet, der ikke tages højde for med denne model.
English: Any potential for interactions may persist for up to two months (five half-lives for Rebetol) after cessation of Rebetol therapy due to the long half-life (see section 5.2).
Danish: En mulighed for interaktioner kan være til stede i op til to måneder (fem halveringstider for Rebetol) efter ophør af Rebetol behandling på grund af den lange halveringstid (se pkt.
English: A 10 mL oral dosing syringe is provided to measure the dose.
Danish: En 10 ml oral doseringssprøjte er vedlagt for at afmåle dosis.
English: However, as in younger patients, renal function must be determined prior to administration of Rebetol (see section 5.2).
Danish: Som hos yngre patienter skal nyrefunktionen imidlertid bestemmes før administration af Rebetol påbegyndes (se pkt.
English: Therefore, do not drive or use machines if you become tired, sleepy, or confused from this treatment.
Danish: Kør derfor ikke bil og arbejd ikke med værktøj eller maskiner, hvis du bliver døsig, søvnig eller desorienteret af denne behandling.
English: Each capsule contains a small amount of lactose.
Danish: Hver kapsel indeholder en lille mængde lactose.
English: Conflicting findings are reported in literature on co-administration between abacavir and Rebetol.
Danish: Der er rapporteret modstridende resultater i litteraturen om samtidig administration af abacavir og Rebetol.
English: Rebetol dose (mg/kg)
Danish: Rebetol dosis (mg/kg)
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: Consideration should be given to replacing zidovudine in a combination anti-retroviral treatment (ART) regimen if this is already established.
Danish: Det bør overvejes, hvorvidt zidovudin kan erstattes i en kombinationsbehandling med anti-retrovirale (AR) lægemidler, hvis en sådan allerede er etableret.
English: The ratio of whole blood:plasma ribavirin concentrations is approximately 60:1; the excess of ribavirin in whole blood exists as ribavirin nucleotides sequestered in erythrocytes.
Danish: Forholdet blod:plasma ribavirinkoncentrationer er cirka 60:1; det overskydende ribavirin i blodet er til stede som ribavirinnukleotider afsondret i erytrocytter.
English: Rebetol oral solution 100 mL is packaged in 118 mL amber glass bottles (coloured EP Type IV glass, Ph Eur.
Danish: Rebetol oral opløsning 100 ml er emballeret i 118 ml ravgule glasflasker (farvet EP Type IV glas, Ph Eur.
English: Pharmacologically, Rebetol increases phosphorylated metabolites of purine nucleosides in vitro.
Danish: Farmakologisk øger Rebetol fosforylerede metabolitter af purinnukleosider in vitro.
English: This Package Leaflet contains information for the paediatric patient (child or adolescent, 3 through 17 years of age), or for his or her parent or caregiver.
Danish: Denne indlægsseddel indeholder information til den pædiatriske patient (barn eller teenager i alderen 3 til 17 år) eller til hans eller hendes forældre eller værge.
English: Clear, colourless to pale or light yellow oral solution
Danish: Klar, farveløs til svag eller lys gul oral opløsning
English: Measure and give this dose Morning Dose
Danish: Afmål og indgiv denne dosis Morgendosis
English: Discontinue Rebetol if:
Danish: Afbryd Rebetolbehandlingen, hvis:
English: Gelatine Titanium dioxide
Danish: Gelatine Titandioxid
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can also help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: 1 capsule in the morning and 2 capsules in the evening
Danish: 1 kapsel om morgenen og 2 kapsler om aftenen
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: Both female and male patients must take special precautions in their sexual activity if there is any possibility for pregnancy to occur: - Girl or woman of childbearing age:
Danish: Både kvindelige og mandlige patienter skal tage særlige forholdsregler i forbindelse med deres seksuelle aktivitet for at undgå graviditet: - Piger eller kvinder i den fødedygtige alder:
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 i rotter var negativ, hvilket tyder på, at hvis mutationer forekom i rotter, blev de ikke overført via mandlige kønsceller.
English: This medicine is a white, opaque, hard capsule imprinted with blue ink.
Danish: Dette lægemiddel er en hvid, uigennemsigtig, hård kapsel mærket med blåt tryk.
English: Do not take Rebetol Do not take Rebetol if any of the following apply to you or the child you are caring for.
Danish: Tag ikke Rebetol, hvis noget af følgende gælder for dig eller det barn, du har ansvar for.
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 prøver, kan din læge ændre/tilpasse antallet af hårde kapsler, du eller barnet skal have, ordinere en anden pakningsstørrelse af dette lægemiddel, og/eller ændre varigheden af din behandling.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Rebetol, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Male: impotence, prostatitis, erectile dysfunction.
Danish: Mænd: Impotens, prostatitis, erektil dysfunktion.
English: Pharmacotherapeutic group: antivirals for systemic use, antivirals for treatment of HCV infections, ATC code: J05AP01.
Danish: Farmakoterapeutisk klassifikation: antivirale midler til systemisk brug, antivirale midler til behandling af HCV-infektioner, ATC-kode: J05AP01
English: Due to the risk of lactic acidosis (a build-up of lactic acid in the body) and pancreatitis, the use of ribavirin and didanosine is not recommended and the use of ribavirin and stavudine should be avoided.
Danish: - På grund af risikoen for mælkesyreacidose (ophobning af mælkesyre i kroppen) og pankreatitis kan brugen af ribavirin og didanosin ikke anbefales, og brugen af ribavirin og stavudin skal undgås.
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 omgående læge, hvis du udvikler symptomer på en svær allergisk reaktion (såsom vanskeligheder med at trække vejret, hvæsende vejrtrækning eller nældefeber) under denne behandling.
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, er en opløsning tilgængelig.
English: Among patients with undetectable HCV-RNA at the end of treatment, the relapse rate was 24 %.
Danish: Blandt patienter med ikke-detekterbart HCV-RNA efter endt behandling, var tilbagefald raten 24 %.
English: Rebetol contains lactose
Danish: Rebetol indeholder lactose
English: The use of pegylated alpha interferons and Rebetol concomitantly with azathioprine should be avoided.
Danish: Brug af pegylerede alfa-interferoner og Rebetol sammen med azathioprin bør undgås.
English: Reminder: This medicine is used in combination with other medicines for hepatitis C virus infection.
Danish: Bemærk: Dette lægemiddel anvendes i kombination med andre lægemidler mod hepatitis C virusinfektion.
English: Ribavirin concentration in seminal fluid is approximately two-fold higher compared to serum.
Danish: Ribavirin-koncentrationen i sædvæske er cirka to gange højere end i serum.
English: (%)) in previously untreated children and adolescents by genotype and treatment duration - All subjects n = 107 24 weeks
Danish: (%)) i tidligere ubehandlede børn og unge med genotype og behandlingsvarighed - Alle forsøgspersoner n = 107 24 uger
English: In this subgroup, there was a 56 % (463/823) sustained virological response rate.
Danish: I denne undergruppe opretholdt 56 % (463/823) den virologiske respons rate.
English: Rebetol contains the active substance ribavirin.
Danish: Rebetol indeholder det aktive stof ribavirin.
English: The 6 month treatment duration in this trial was better tolerated than one year of treatment in the pivotal combination trial; for discontinuation 5 % vs. 14 %, for dose modification 18 % vs. 49 %.
Danish: Den 6 måneders behandlingsvarighed i denne undersøgelse blev tolereret bedre end et års behandling i den grundlæggende kombinationsundersøgelse; seponering hos 5 % mod 14 %, dosisjustering hos 18 % mod 49 %.
English: If pregnancy does occur during treatment or within four months from stopping treatment, the patient must be advised of the significant teratogenic risk of Rebetol to the foetus (see section 4.4).
Danish: Hvis der opstår graviditet under behandlingen eller inden for fire måneder efter ophørt behandling, skal patienten informeres om den betydelige teratogene risiko ved Rebetol for fosteret (se pkt.
English: The 10 mL oral dosing syringe consists of a natural polyethylene barrel, with a white polystyrene plunger rod.
Danish: Den 10 ml orale doseringssprøjte består af en naturlig polyethylentromle, med en hvid polystyren stempelstang.
English: Treatment with Rebetol in combination with peginterferon alfa-2b was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Danish: Behandling med Rebetol i kombination med peginterferon alfa-2b blev associeret med fald i absolut CD4+ celletælling inden for de 4 første uger uden en reduktion i CD4+ celleprocenten.
English: Calibrations are marked at 0.5 mL increments from 1.5 mL to 10 mL.
Danish: Kalibreringer er markeret med 0,5 m1 stigninger fra 1,5 ml til 10 ml.
English: (-0.3 for Metavir and -1.2 for Ishak) and stable (-0.1 for Metavir and -0.2 for Ishak) among non-responders.
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: Name and address of the manufacturer responsible for batch release for the hard capsules
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse af de hårde kapsler
English: A. Insert the assembled dosing syringe into the bottle of Rebetol oral solution.
Danish: A. Indfør den samlede doseringssprøjte i flasken af Rebetol oral opløsning.
English: The decrease in CD4+ cell counts was reversible upon dose reduction or cessation of therapy.
Danish: Faldet i CD4+ celletællinger var reversible efter dosisreduktion eller behandlingsophør.
English: 2 capsules in the morning and 2 capsules in the evening See adult dose
Danish: 2 kapsler om morgenen og 2 kapsler om aftenen Se voksendosis
English: Predictive Value
Danish: Positiv prædiktiv værdi
English: The sustained response at the end of follow-up was significantly increased by the addition of Rebetol to interferon alfa-2b (41 % vs 16 %, p < 0.001).
Danish: Det vedvarende respons ved slutningen af opfølgningen var signifikant forhøjet ved tilføjelsen af Rebetol til interferon alfa-2b (41 % mod 16 %, p < 0,001).
English: Prior to initiation of treatment with Rebetol the physician must comprehensively inform both male and female patients of the teratogenic risk of Rebetol, the necessity of effective and continuous contraception, the possibility that contraceptive methods may fail and the possible consequences of pregnancy should it occur during or following treatment with Rebetol (see section 4.6).
Danish: Før initiering af behandling med Rebetol skal lægen grundigt informere både mandlige og kvindelige patienter om den teratogene risiko ved Rebetol, om nødvendigheden af effektiv og vedvarende kontraception, herunder at præventionsmetoden kan svigte, og om de mulige konsekvenser af graviditet, hvis en sådan skulle indtræffe under eller efter behandling med Rebetol (se pkt.
English: 2, rue Louis Pasteur 14200 Hérouville-Saint-Clair France
Danish: 2, rue Louis Pasteur 14200 Hérouville-Saint-Clair Frankrig
English: White, opaque and imprinted with blue ink.
Danish: Hvide, uigennemsigtige og mærket med blåt tryk.
English: Acceptable baseline values that may be considered as a guideline prior to initiation of Rebetol therapy in children and adolescents:
Danish: Acceptable baselineværdier, der kan betragtes som en vejledning før initiering af Rebetol behandling af børn og unge:
English: The plastic oral dosing syringe consists of two parts, an opaque barrel, and a white plunger rod that fits into the barrel.
Danish: Den orale plastik doseringssprøjte består af to dele, en uigennemsigtig tromle, og en hvid stempelstang, der passer ind i tromlen.
English: Therefore, there is a minimal potential for P450 enzyme-based interactions.
Danish: Der er således minimal mulighed for CYP-enzymbaserede interaktioner.
English: Ribavirin has been shown to produce high inter- and intra-subject pharmacokinetic variability following single oral doses (intrasubject variability of approximately 30 % for both AUC and Cmax), which may be due to extensive first pass metabolism and transfer within and beyond the blood compartment.
Danish: Ribavirin giver høj inter- og intraindividuel variabilitet efter en enkelt oral dosis (intraindividuel variabilitet på cirka 30 % for både AUC og Cmax), hvilket kan skyldes stor first pass metabolisme og overførsel inden for og uden for blodfordelingsrummet.
English: Results of these investigations showed that Rebetol monotherapy had no effect on eliminating hepatitis virus (HCV-RNA) or improving hepatic histology after 6 to 12 months of therapy and 6 months of follow-up.
Danish: Resultater fra disse undersøgelser viste, at Rebetol monoterapi ikke havde nogen effekt på at fjerne hepatitis virus (HCV-RNA) eller forbedre leverhistologien efter 6 til 12 måneders behandling og 6 måneders opfølgning.
English: The capsule shell contains gelatine, titanium dioxide.
Danish: Kapselskallen indeholder gelatine og titandioxid.
English: Table 9 Virologic response at treatment week 12, end of treatment response, relapse rate* and Sustained Virologic Response (SVR) Treatment group
Danish: Tabel 9 Virologisk respons ved behandlingsuge 12, respons ved afslutning af behandlingen, tilbagefaldsrate *og vedvarende virologisk respons (SVR) Behandlingsgruppe
English: No response at Treatment Week
Danish: Ingen respons ved behandlingsuge
English: Acceptable baseline values that may be considered as a guideline prior to initiation of Rebetol therapy:
Danish: Acceptable baselineværdier, der kan betragtes som en vejledning før initiering af Rebetolbehandling:
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 de tilfælde, hvor der ikke er angivet specifikke anbefalinger vedrørende dosis, skal følgende dosis anvendes: Patientens vægt < 75 kg: 1.000 mg og > 75 kg: 1.200 mg.
English: If you have been told by your doctor that you have an intolerance to some sugars, discuss with your doctor before taking this medicine.
Danish: Hvis du har fået at vide af din læge, at du ikke kan tåle visse sukkerstoffer, så tal med din læge, før du anvender dette lægemiddel.
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: If a patient has a serious adverse reaction potentially related to Rebetol, the Rebetol dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity.
Danish: Hvis en patient har en alvorlig bivirkning, som potentielt er relateret til Rebetol, skal Rebetol-dosis justeres eller behandlingen afbrydes efter behov, indtil bivirkningen aftager eller reduceres i sværhedsgrad.
English: The rod is marked with 0.5 mL markings starting at 1.5 mL (at the very top of the rod) and ending at 10 mL.
Danish: Stangen er markeret med 0,5 ml markeringer startende ved 1,5 ml (øverst på toppen af stangen) og sluttende ved 10 ml.
English: In addition, injection site disorders, pyrexia, anorexia, vomiting and emotional lability occurred more frequently in children and adolescents compared to adult patients.
Danish: Derudover forekom lidelser på injektionsstedet, feber, anoreksi, opkastning og emotionel labilitet hyppigere hos børn og unge sammenlignet med voksne patienter.
English: Patients who are treated with interferon alfa-2b and Rebetol after previous relapse from interferon therapy or who are treated for a shorter period are likely to have an improved safety profile than that described below.
Danish: Patienter, som behandles med interferon alfa-2b og Rebetol efter tidligere relaps efter interferon behandling, eller som behandles i en kortere periode, har sandsynligvis en bedre sikkerhedsprofil end den nedenfor beskrevne.