FrancophonIA/ELRC3.0 huggingface dataset:
English: The purpose of the study was to annually evaluate the durability of sustained virologic response (SVR) and assess the impact of continued viral negativity on clinical outcomes for patients who were sustained responders 24 weeks post-treatment of the 48-week interferon alfa-2b and ribavirin treatment.
Danish: Formålet med undersøgelsen var årligt at vurdere varigheden af vedvarende virologisk respons (SVR) og vurdere virkningen af fortsat viral negativitet på de kliniske resultater hos patienter, der var vedholdende respondenter 24 uger efter behandlingen med interferon alfa-2b og ribavirin i 48uger.
English: Rebetol (800 mg/day) + interferon alfa-2b (3 MIU TIW)
Danish: Rebetol (800 mg) + interferon alfa-2b (3 MIE TIW)
English: In HCV/HIV co-infected patients receivingcART, the following other side effects have occurred with the combination of Rebetol hard capsules and peginterferon alfa-2b (not listed above in adults side effects): appetite decreased, back pain, CD4 lymphocytes decreased, defective metabolism of fat, hepatitis, limb pain, oral candidiasis (oral thrush), various laboratory blood values abnormalities.
Danish: Hos HCV/hiv co-inficerede patienter, der fik cART, er nedenstående supplerende bivirkninger forekommet ved kombinationen af Rebetol hårde kapsler og peginterferon alfa-2b (ikke listet ovenfor under bivirkninger hos voksne): - nedsat appetit, - rygsmerter, - nedsat antal CD4-lymfocytter, - ufuldkommen fedtomsætning, - leverbetændelse, - smerte i lemmer, - svamp i mundhulen (trøske), - unormale laboratorieblodværdier.
English: The additional following side effectshave occurred with the combination of this medicineand an alpha interferon product in adults but not in children:
Danish: Følgende yderligere bivirkninger er set med kombinationen af dette lægemiddel og et alfainterferonprodukt hos voksne, men ikke hos børn:
English: Table 2 provides guidelines for dose modifications and discontinuation based on the patient's haemoglobin concentration and indirect bilirubin concentration.
Danish: Tabel 2 viser retningslinjer for dosisjustering og behandlingsafbrydelse på basis af patientens hæmoglobinkoncentration og indirekte bilirubinkoncentration.
English: Lack of early virologic response by treatment week 12 (detectable HCV-RNA with a < 2 log10 reduction from baseline) was a criterion for discontinuation of treatment.
Danish: * (HCV-RNA PCR-analyse, med en nedre kvantificeringsgrænse på 27 IE/ml) Mangel på tidligt virologisk respons ved behandlingsuge 12 (detekterbar HCV-RNA med < 2 log10 reduktion fra baseline) var et kriterium for seponering af behandlingen.
English: • Rebetol (800 mg/day) + peginterferon alfa-2b (1.5 micrograms/kg/week) (n = 511).
Danish: • Rebetol (800 mg/dag) + peginterferon alfa-2b (1,5 mikrogram/kg/uge) (n = 511).
English: Pneumonia, ascariasis, enterobiasis, herpes zoster, cellulitis Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
Danish: Lungebetændelse, askariose, enterobiasis, herpes zoster, cellulitis Benigne, maligne og uspecificerede tumorer (inkl.
English: Table 15 Mean (% CV) multiple-dose pharmacokinetic parameters for interferon alfa-2b and Rebetol capsules when administered to paediatric patients with chronic hepatitis C Parameter
Danish: Tabel 15 Gennemsnitlig (% CV) flerdosis farmakokinetiske parametre for interferon alfa-2b og Rebetol kapsler ved indgift til pædiatriske patienter med kronisk hepatitis C Parameter
English: interferon alfa-2b (3 MIU TIW)
Danish: d + interferon alfa-2b (3 MIE TIW)
English: Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence, disturbance in attention, poor quality of sleep
Danish: Hyperkinesi, tremor, dysfoni, paræstesi, hypoæstesi, hyperæstesi, nedsat koncentration, døsighed, opmærksomhedsforstyrrelser, dårlig søvn kvalitet
English: Due to the lack of data in these two multicentre trials for children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of Rebetol and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Danish: Grundet manglende resultater, fra disse to multicenterforsøg med børn med alvorlig sygdomsprogression, samt muligheden for bivirkninger, bør forholdet mellem fordele og ulemper af kombinationen Rebetol og interferon alfa-2b overvejes nøje i denne population (se pkt.
English: Table 4 Dosage Modification for Renal Impairment in Adult Patients Creatinine Clearance
Danish: Tabel 4 Dosisjustering for voksne patienter med nedsat nyrefunktion Kreatininclearance
English: During combination therapy for up to 48 weeks with interferon alfa-2b and Rebetol, growth inhibition was observed that resulted in reduced final adult height in some patients.
Danish: Under kombinationsbehandlingen i op til 48 uger med interferon alfa-2b og Rebetol, blev væksthæmning observeret, som medførte reduceret sluthøjde hos nogle patienter.
English: Rebetol in combination with peginterferon alfa-2b Children and adolescents 3 to 17 years of age with compensated chronic hepatitis C and detectable HCV-RNA were enrolled in a multicentre trial and treated with Rebetol 15 mg/kg per day plus pegylated interferon alfa-2b 60 µg/m2 once weekly for 24 or 48 weeks, based on HCV genotype and baseline viral load.
Danish: Børn og unge i alderen 3 til 17 år med kompenseret kronisk hepatitis C og påviselig HCV-RNA blev indrulleret i et multicenter forsøg og behandlet med Rebetol 15 mg/kg per dag plus pegyleret interferon alfa-2b 60 μg/m2 én gang ugentligt i 24 eller 48 uger, baseret på HCV genotype og baseline viral load.
English: Rebetol dose based on body weight when used in combination with interferon alfa-2b or peginterferon alfa-2b in children above 3 years of age and adolescents If the child/adolescent weighs (kg)
Danish: Rebetol-dosis baseret på kropsvægt ved anvendelse sammen med med interferon alfa-2b eller peginterferon alfa-2b hos børn over 3 år og unge Hvis barnet/den unge vejer (kg)
English: Stevens Johnson syndrome*, toxic epidermal necrolysis*, erythema multiforme* Musculoskeletal and connective tissue disorders Very common:
Danish: Stevens Johnson syndrom٭, toksisk epidermal nekrolyse٭, erythema multiforme٭
English: Rebetol 200 mg capsules
Danish: Rebetol 200 mg kapsler
English: For patients receiving a 800 mg (< 65 kg)-1,000 mg (65-80 kg)-1,200 mg (81-105 kg) or 1,400 mg (> 105 kg) dose, 1
Danish: For patienter, som får en dosis på 800 mg (< 65 kg)-1.000 mg (65-80 kg)-1.200 mg (81-105 kg) eller en dosis på 1.400 mg (> 105 kg), er 1. dosisreduktion af Rebetol med 200 mg/dag (undtagen hos patienter, der fik 1.400 mg, her skal dosis nedsættes med 400 mg/dag).
English: Thrombocytopenia, lymphadenopathy
Danish: Trombocytopeni, lymfadenopati,
English: Previously treated patients - Retreatment of prior treatment failures (relapse and non-responder patients) with peginterferon alfa-2b in combination with Rebetol:
Danish: Tidligere behandlede patienter - Genbehandling af patienter hvor behandling med peginterferon alfa 2b i kombination med Rebetol tidligere har været uden effekt (relaps og non responder patienter):
English: No pharmacokinetic interactions were noted between Rebetol and interferon alfa-2b in a multiple-dose pharmacokinetic study.
Danish: Der sås ingen farmakokinetiske interaktioner mellem Rebetol og interferon alfa-2b i en flerdosis farmakokinetisk undersøgelse.
English: Table 3 Dosage Modification for Renal Impairment in Adult Patients Creatinine Clearance
Danish: Tabel 3 Dosisjustering for voksne patienter med nedsat nyrefunktion Kreatininclearance
English: Contact your doctor immediately if you notice any of the following side effects occurring during combination treatment with other medicines: chest pain or persistent cough, changes in the way your heart beats, fainting, confusion, feeling depressed, suicidal thoughts or aggressive behaviour, attempt suicide, thoughts about threatening the life of others, feelings of numbness or tingling, trouble sleeping, thinking or concentrating, severe stomach pain; black or tar-like stools, blood in stool or urine, lower back or side pain, painful or difficult urination, severe bleeding from your nose, fever or chills beginning after a few weeks of treatment, problems with your eyesight or hearing, severe skin rash or redness.
Danish: Kontakt din læge omgående, hvis du oplever nogle af følgende bivirkninger, der kan forekomme under kombinationsbehandling med andre lægemidler: - brystsmerte eller vedvarende hoste, ændringer i måden, dit hjerte slår på, besvimelse, - forvirring, nedtrykthed, selvmordstanker eller aggressiv opførsel, selvmordsforsøg, tanker om at true andre på livet, - følelsesløshed eller prikkende fornemmelse, - besvær med at sove, tænke eller koncentrere sig, - kraftige mavesmerter, sort eller tjærelignende afføring, blod i afføring eller urin, smerter i nederste del af ryggen eller siden, - smertefuld eller vanskelig vandladning, - alvorlig blødning fra din næse, - feber eller kulderystelser begyndende efter nogle få ugers behandling, - problemer med synet eller hørelsen, - kraftig hududslæt eller rødme.
English: Arthralgia, myalgia, musculoskeletal pain
Danish: Artralgi, myalgi, muskoloskeletale smerter
English: Table 1 Rebetol oral solution - Children and adolescents dosage to be administered with interferon alfa-2b or peginterferon alfa-2b Body Weight (kg)
Danish: Tabel 1 Rebetol oral opløsning - Børn og unge dosering som skal administreres med interferon alfa-2b eller peginterferon alfa-2b
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or sucrose-isomaltase insufficiency should not take this medicine.
Danish: Dette præparat indeholder saccharose og sorbitol og bør ikke anvendes til patienter med arvelig fruktoseintolerans, glucose-galaktose malabsorptionssyndrom eller sucrase-isomaltase insufficiens.
English: Hypothyroidism, hyperthyroidism
Danish: Hypotyroidisme, hypertyroidisme
English: If you are aHCV/HIV co-infected adult patient receiving anti-HIV treatment, the addition of this medicineand peginterferon alfa may increase your risk of worsening liver function (combined anti-retroviral therapy (cART))and increase your risk of lactic acidosis, liver failure, and blood abnormalities development (reduction in number of red blood cells which carry oxygen, certain white blood cells that fight infection, and blood clotting cells called platelets) (NRTI).
Danish: Hvis du er en voksen patient med både HCV- og hiv-infektion, der får anti-hiv-behandling, kan samtidig indtagelse af dette lægemiddel og peginterferon alfa øge din risiko for forværring af leverfunktionen (antiretroviral kombinationsbehandling (cART)) og øge risikoen for mælkesyreacidose, leverskader og udvikling af unormaliteter af blodet (nedsat antal røde blodlegemer, der transporterer ilt, visse hvide blodlegemer, der bekæmper infektion og celler, som får blodet til at størkne og som kaldes blodplader) (NRTI).
English: Only the description of the use of Rebetol from the original development with (peg)interferon alfa-2b is detailed in the current SmPC:
Danish: I det aktuelle SmPC er kun brugen af Rebetol fra den originale udvikling med (peg)interferon alfa-2b beskrevet:
English: HCV-RNA negative or ≥ 1 log decrease in viral load
Danish: HCV-RNA negativ eller log fald i viral load
English: An increase in uric acid and indirect bilirubin values associated with haemolysis was observed in some patients treated with Rebetol used in combination with interferon alfa-2b in clinical trials, but values returned to baseline levels by four weeks after the end of therapy.
Danish: En stigning i urinsyre og indirekte bilirubin værdier forbundet med hæmolyse blev set hos nogle patienter behandlet med Rebetol anvendt i kombination med interferon alfa-2b i kliniske undersøgelser, men værdierne vendte tilbage til baseline niveau fire uger efter afsluttet behandling.
English: During combination therapy for up to 48 weeks with pegylated interferon alfa-2b and Rebetol, growth inhibition was observed that resulted in reduced height in some patients (see section 4.4).
Danish: Ved kombinationsbehandling i op til 48 uger med pegyleret interferon alfa-2b og Rebetol, blev der observeret væksthæmning, som medførte reduceret højde hos nogle patienter (se pkt.
English: For complete information be sure to read the “How to use” section of the Package Leaflet for the other medicines used in combination with Rebetol.
Danish: For fuldstændig information læs afsnittet ”Sådan skal du bruge” i indlægssedlen for de andre lægemidler, du tager sammen med Rebetol.
English: The following side effects have been reported with the combination of this medicine and an interferon alfa-2b product in children and adolescents:
Danish: Følgende bivirkninger er blevet rapporteret ved kombinationen af dette lægemiddel og et interferon alfa2b produkt hos børn og unge:
English: th percentile, which was below the median of the normative population and less than their mean baseline height (48
Danish: Inden for de 5 års opfølgning efter behandlingsperioden, havde børnene en gennemsnitlig højde af 44. percentil, der lå under medianen af den normative population og mindre end deres gennemsnitlige baseline-højde (48. percentil).
English: For example, the body weight dosing used in conjunction with interferon alfa-2b or peginterferon alfa-2b is shown in Table 1.
Danish: For eksempel er dosering baseret på legemsvægt ved anvendelse i kombination med interferon alfa-2b eller peginterferon alfa-2b vist i Tabel 1.
English: From pre-treatment to end of long-term follow-up among children treated for 24 or 48 weeks, height-for-age percentiles decreased 1.3 and 9.0 percentiles, respectively.
Danish: Blandt de børn, der blev behandlet i 24 eller 48 uger, reduceredes percentilen for alderen henholdsvis 1,3 og 9,0 percentiler fra før behandling til afslutning af langtidsopfølgningen.
English: Reminder: Please read the “Other medicines” section of the Package Leaflet for the other medicines used in combination with Rebetol before you begin combination treatment with this medicine.
Danish: Bemærk: Læs afsnittet ”Brug af anden medicin” i indlægssedlen for de andre lægemidler, der anvendes sammen med Rebetol, før du begynder kombinationsbehandlingen med dette lægemiddel.
English: Rebetol 200 mg hard capsules ribavirin
Danish: Rebetol 200 mg hårde kapsler ribavirin
English: Female: amenorrhea, menorrhagia, menstrual disorder, vaginal disorder, Male: testicular pain
Danish: Kvinder: Amenorre, menorragi, menstruationsforstyrrelser, vaginallidelse, Mænd: testikulær smerte
English: Please read the “Possible side effects” section of the Package Leaflet for the other medicines used in combination with Rebetol.
Danish: Læs afsnittet “Bivirkninger” i indlægssedlen for de andre lægemidler, du tager sammen med Rebetol.
English: Extreme care must be taken to avoid pregnancy in partners of male patients taking Rebetol (see sections 4.3, 4.4 and 5.3).
Danish: Den yderste forsigtighed skal udvises for at undgå graviditet hos partnere til mandlige patienter, der tager Rebetol (se pkt.
English: Bitherapy with peginterferon alfa-2b or interferon alfa-2b:
Danish: 2-stofsbehandling med peginterferon alfa-2b eller interferon alfa-2b:
English: Please refer to the corresponding SmPC of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with Rebetol.
Danish: For de antiretrovirale lægemidler, der skal tages samtidig med HCV-behandling, henvises der til de tilsvarende SmPC'er for opmærksomhed på og håndtering af toksicitet, der er specifik for det enkelte præparat og potentialet for overlappende toksiciteter med Rebetol.
English: Haemoglobin levels dropped below 10 g/dL in up to 14 % of adult patients and 7 % of children and adolescents treated with Rebetol in combination with either peginterferon alfa-2b or interferon alfa-2b.
Danish: Hæmoglobinværdierne faldt til under 10 g/dl hos op til 14 % voksne patienter og 7 % børn og unge behandlet med Rebetol i kombination med enten peginterferon alfa-2b eller interferon alfa-2b.
English: An increase in uric acid and indirect bilirubin values associated with haemolysis was observed in some patients treated with Rebetol used in combination with peginterferon alfa-2b or interferon alfa-2b in clinical trials, but values returned to baseline levels by four weeks after the end of therapy.
Danish: En stigning i urinsyre og indirekte bilirubin værdier forbundet med hæmolyse blev set hos nogle patienter behandlet med Rebetol anvendt i kombination med peginterferon alfa-2b eller interferon alfa-2b i kliniske undersøgelser, men værdierne vendte tilbage til baseline niveau fire uger efter afsluttet behandling.
English: Female: amenorrhea, menorrhagia, menstrual disorder, dysmenorrhea, breast pain, ovarian disorder, vaginal disorder.
Danish: Kvinder: Amenorre, menorragi, menstruationsforstyrrelser, dysmenorrhea, brystsmerte, ovarielidelse, vaginallidelse.
English: Swallow the dose.
Danish: Synk dosis.
English: Please refer to the corresponding SmPC of medicinal products used in combination with Rebetol for contraindications specific to these products.
Danish: Der henvises til SmPC'erne for de lægemidler, der anvendes i kombination med Rebetol, for oplysninger om kontraindikationer, der er specifikke for disse præparater.
English: • Haemoglobin
Danish: • Hæmoglobin
English: How to store Rebetol
Danish: Sådan skal du tage Rebetol
English: Only the description of the use of Rebetol from the original development with (peg)interferon alfa-2b is detailed in the current SmPC.
Danish: I det aktuelle SmPC er kun brugen af Rebetol fra den originale udvikling med (peg)interferon alfa-2b beskrevet.
English: Uncommonly reported side effects (may affect up to 1 in 100 people): hearing or seeing images that are not present, heart attack, panic attack, hypersensitivity reaction to the medication, inflammation of pancreas, pain in bone, diabetes mellitus, muscle weakness.
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer): - at høre eller se billeder, der ikke er til stede, - hjerteanfald, panikanfald, - overfølsomhedsreaktion overfor medicinen, - betændelse i bugspytkirtlen, knoglesmerte, diabetes mellitus (sukkersyge), - muskelsvaghed.
English: Rebetol in combination with interferon alfa-2b
Danish: Rebetol i kombination med interferon alfa-2b
English: Please refer to the corresponding SmPC of medicinal products used in combination with Rebetol for further dosage recommendations on co-administration.
Danish: Der henvises til SmPC'erne for de lægemidler, der anvendes i kombination med Rebetol, for yderligere anbefalinger vedrørende dosering ved samtidig administration.
English: Reminder: Please read the “Warnings and precautions” section of the Package Leaflet for the other medicines used in combination with Rebetol before you begin combination treatment.
Danish: Bemærk: Læs afsnittet ”Advarsler og forsigtighedsregler” i indlægssedlen for de andre lægemidler, du tager sammen med Rebetol, før du begynder kombinationsbehandlingen.
English: Relapse
Danish: Relaps
English: Please refer to the corresponding Summary of Product Characteristics (SmPC) of medicinal products used in combination with Rebetol for additional prescribing information particular to that product and for further dosage recommendations on co-administration with Rebetol.
Danish: Der henvises til produktresuméerne (SmPC) for de lægemidler, som anvendes i kombination med Rebetol, for yderligere information vedrørende ordination af disse specifikke lægemidler og for yderligere anbefalinger vedrørende dosering ved administration sammen med Rebetol.
English: Rebetol 200 mg hard capsules
Danish: Rebetol 200 mg hårde kapsler
English: Capsule imprint
Danish: Kapselindhold
English: No pharmacokinetic interactions were noted between Rebetol and peginterferon alfa-2b or interferon alfa-2b in a multiple-dose pharmacokinetic study.
Danish: Der sås ingen farmakokinetiske interaktioner mellem Rebetol og peginterferon alfa-2b eller interferon alfa-2b i en flerdosis farmakokinetisk undersøgelse.
English: loss of consciousness, loss of use, drooping or loss of power of facial muscles, loss of feeling sensation, loss of vision.
Danish: kæbesmerte, - bevidstløshed, - tab af brugsevne, hængende eller tab af kraft i ansigtsmuskler, tab af følesans, - synstab.
English: Please refer to the corresponding SmPC of medicinal products that are used in combination with Rebetol for additional undesirable effects reported with these products.
Danish: Der henvises til SmPC'erne for de lægemidler, der anvendes i kombination med Rebetol, vedrørende yderligere bivirkninger rapporteret i forbindelse med disse præparater.
English: Usual dosage to be used with interferon alfa-2b or peginterferon alfa-2b in children above 3 years of age and adolescents
Danish: Rebetol oral opløsning Almindelig dosering som skal anvendes med interferon alfa-2b eller peginterferon alfa-2b til børn over 3 år og unge
English: • have any blood disorders, such as anaemia (low blood count), thalassemia, sickle-cell anaemia.
Danish: • hvis du har en eller anden form for blodsygdom, såsom blodmangel (lavt blodtal), talassæmi,
English: Reported adverse reactions listed in Table 6 are based on experience from the two multicentre children and adolescents clinical trials using Rebetol with interferon alfa-2b or peginterferon alfa-2b.
Danish: Rapporterede bivirkninger i Tabel 6 er baseret på erfaring fra de to multicenter kliniske undersøgelser med børn og unge i behandling med Rebetol med interferon alfa-2b eller peginterferon alfa-2b.
English: Adverse Reactions
Danish: Tidligere respons
English: Reported adverse reactions listed in Table 4 are based on experience from the two multicentre children and adolescents clinical trials using Rebetol with interferon alfa-2b or peginterferon alfa-2b.
Danish: Rapporterede bivirkninger i Tabel 4 er baseret på erfaring fra de to multicenter kliniske undersøgelser med børn og unge i behandling med Rebetol med interferon alfa-2b eller peginterferon alfa-2b.
English: Adult patients with moderate renal impairment (creatinine clearance of 30-50 mL/minute) should be administered alternating daily doses of 200 mg and 400 mg.
Danish: Voksne patienter med moderat nedsat nyrefunktion (kreatininclearance på 30-50 ml/minut) skal have administreret daglige doser på skiftevis 200 mg og 400 mg.
English: Amnesia, memory impairment, syncope, migraine, ataxia, paraesthaesia, dysphonia, taste loss, hypoaesthesia, hyperaesthesia, hypertonia, somnolence, disturbance in attention, tremor, dysgeusia
Danish: Amnesi, svigtende hukommelse, synkope, migræne, ataksi, paræstesi, dysfoni, tab af smagssans, hypæstesi, hyperæstesi, hypertoni, døsighed, opmærksomhedsforstyrrelser, tremor, smagsforstyrrelser
English: - Breast-feeding.
Danish: - Amning.
English: A decrease in haemoglobin levels to < 10 g/dL was observed in up to 14 % of adult patients and in 7 % of children and adolescents treated with Rebetol in combination with peginterferon alfa-2b or interferon alfa-2b in clinical trials.
Danish: Et fald i hæmoglobin niveau til < 10 g/dl blev set hos op til 14 % af voksne patienter og hos 7 % af børn og unge behandlet med Rebetol i kombination med peginterferon alfa-2b eller interferon alfa-2b i kliniske undersøgelser.
English: 1 morning, 2 evening 2 morning, 2 evening
Danish: 4 kapsler Se anbefalinger for dosering til voksne a: 1 morgen, 2 aften b: 2 morgen, 2 aften
English: The recommended dose of Rebetol combined with interferon alfa-2b or peginterferon alfa-2b, is shown in the below table.
Danish: Den anbefalede dosis af Rebetol i kombination med interferon alfa-2b eller peginterferon alfa-2b er vist i nedenstående tabel.
English: Rebetol in combination with peginterferon alfa-2b A five-year long-term, observational, follow-up study enrolled 94 paediatric chronic hepatitis C patients after treatment in a multicentre trial.
Danish: Et fem-årigt langtidsopfølgende observationsstudie indrullerede 94 pædiatriske patienter med kronisk hepatitis-C efter behandling i et multicenterstudie.