FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant administration of peginterferon alfa-2b (ViraferonPeg) with caffeine or desipramine modestly increased the exposure of caffeine and desipramine.
Danish: Samtidig administration af peginterferon alfa-2b (ViraferonPeg) og caffein eller desipramin øger i beskeden grad eksponeringen for caffein og desipramin.
English: ViraferonPeg 1.5 micrograms/kg/week in combination with ribavirin capsules.
Danish: ViraferonPeg 1,5 mikrogram/kg/uge i kombination med ribavirin kapsler.
English: If the chest X-ray shows pulmonary infiltrates or there is evidence of pulmonary function impairment, the patient is to be monitored closely, and, if appropriate, discontinue interferon alpha.
Danish: Hvis dette thorax-røntgen viser lungeinfiltrater, eller der er tegn på forringet lungefunktion, skal patienten følges nøje, og om nødvendigt skal interferon alfa seponeres.
English: Co-administered Medicine
Danish: Samtidigt administreret medicin
English: Determine TSH levels if, during the course of therapy, a patient develops symptoms consistent with possible thyroid dysfunction.
Danish: TSH-værdier bør bestemmes, hvis en patient under behandlingsforløbet udvikler symptomer der stemmer overens med mulig nedsat thyroideafunktion.
English: Detailed information on this medicinal product is available on the web-site of the European Medicines Agency http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: A clinical trial investigating the combination of telbivudine, 600 mg daily, with pegylated interferon alfa-2a, 180 micrograms once weekly by subcutaneous administration, indicates that this combination is associated with an increased risk of developing peripheral neuropathy.
Danish: Et klinisk studie, der undersøgte kombinationen af telbivudin 600 mg dagligt og pegyleret interferon alfa-2a 180 mikrogram subkutant en gang ugentligt, indikerer, at denne kombination er associeret med en øget risiko for udvikling af perifer neuropati.
English: As in adult patients, children and adolescents experienced other psychiatric adverse events (e.g. depression, emotional lability, and somnolence).
Danish: Børn og unge oplevede ligesom voksne andre psykiske bivirkninger (f.eks. depression, følelsesmæssig labilitet og døsighed)
English: When administered in combination therapy, patients with impaired renal function should be more carefully monitored with respect to the development of anaemia.
Danish: Når det gives som kombinationsbehandling, bør patienter med nedsat nyrefunktion monitoreres mere omhyggeligt for udvikling af anæmi.
English: Injection site infection, lower respiratory tract infection
Danish: Infektion på injektionsstedet, nedre luftvejsinfektion
English: When patients are administered ViraferonPeg with medications metabolized by CYP1A2 or CYP2D6, the extent of the decrease in cytochrome P 450 activity is unlikely to have a clinical impact, except with medicines which have a narrow therapeutic margin (Table 5).
Danish: Når patienterne får ViraferonPeg sammen med medicin, der metaboliseres af CYP1A2 eller CYP2D6, er det ikke sandsynligt, at faldet i CYP-aktivitet har klinisk indvirkning, undtagen med medicin, der har en snæver terapeutisk margin (Tabel 5).
English: During combination therapy for up to 48 weeks with ViraferonPeg and ribavirin, 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 ViraferonPeg og ribavirin blev der observeret væksthæmning, som medførte reduceret højde hos nogle patienter (se pkt.
English: Alopecia, dry skin
Danish: Alopeci, tør hud
English: • Remove the yellow paper from the needle cap before attaching the needle ("Push-On Needle") to the pre-filled pen (see Figure 5),
Danish: • Fjern den gule papirflig fra kanylehætten, før kanylen ("Push-On Needle") sættes på den fyldte pen (se Figur 5).
English: The most common treatment-related adverse reactions reported during clinical trials with ViraferonPeg in combination with ribavirin in adults, seen in more than half of the study subjects, were fatigue, headache, and injection site reaction.
Danish: De hyppigste behandlingsrelaterede bivirkninger, der er rapporteret under kliniske undersøgelser med ViraferonPeg i kombination med ribavirin hos voksne, og som er set hos mere end halvdelen af forsøgspersonerne, var træthed, hovedpine og reaktion på injektionsstedet.
English: HCV-RNA should be measured periodically during treatment (see section 4.2).
Danish: HVC-RNA bør måles regelmæssigt under behandling (se pkt.
English: You can save the swab to clean the skin area where you will inject the dose.
Danish: Du kan gemme servietten til at rense hudområdet, hvor du vil indsprøjte dosis.
English: - Combination of ViraferonPeg with telbivudine.
Danish: - ViraferonPeg i kombination med telbivudin.
English: Among children and adolescents treated with interferon alfa-2b in combination with ribavirin, 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: Blandt børn og unge behandlet med interferon alfa-2b i kombination med ribavirin er selvmordstanker eller -forsøg hyppigere rapporteret sammenlignet med voksne patienter (2,4 % vs. 1 %) under behandling og under 6 måneders efterbehandling.
English: ViraferonPeg is a well characterized polyethylene glycol-modified (“pegylated”) derivative of interferon alfa-2b and is predominantly composed of monopegylated species.
Danish: ViraferonPeg er et velkarakteriseret polyethylenglycol-modificeret (“pegyleret”) derivat af interferon alfa-2b og består hovedsageligt af monopegylerede arter.
English: Liver graft rejection has also been reported.
Danish: Afstødelse af levertransplantat er også rapporteret.
English: - have the skin disorders, psoriasis or sarcoidosis, which may become worse while you are using this medicine.
Danish: - har hudsygdommene psoriasis eller sarkoidose, idet de kan forværres, mens du tager dette lægemiddel.
English: These events included suicidal ideation and attempted suicide (see section 4.4).
Danish: Disse bivirkninger omfattede selvmordstanker og selvmordsforsøg (se pkt.
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 tage i betragtning, at kombinationsbehandlingen inducerede væksthæmning, som medførte reduceret højde hos nogle patienter.
English: Only 5 children and adolescents with Genotype 4 were treated in the ViraferonPeg/ribavirin clinical trial.
Danish: Kun 5 børn og unge med Genotype 4 blev behandlet i kliniske undersøgelser med ViraferonPeg/ribavirin.
English: - This risk should be weighed against the disease characteristics of the child, such as evidence of disease progression (notably fibrosis), co-morbidities that may negatively influence the disease progression (such as HIV co-infection), as well as prognostic factors of response (HCV genotype and viral load).
Danish: - Denne risiko skal vægtes mod sygdomskarakteristika hos barnet, såsom tegn på sygdomsudvikling (især fibrose), co-morbiditet der kan have en negativ effekt på sygdomsudviklingen (såsom hiv coinfektion) såvel som prognostiske faktorer på respons (hcv-genotype og virusbelastning).
English: Each pre-filled pen is for single use only.
Danish: Hver pen kan kun bruges en gang.
English: Cases of pulmonary arterial hypertension (PAH) have been reported with interferon alfa products, notably in patients with risk factors for PAH (such as portal hypertension, HIV-infection, cirrhosis).
Danish: Der er indberettet tilfælde af pulmonal arteriel hypertension (PAH) i forbindelse med lægemidler indeholdende interferon alfa, navnlig hos patienter med risikofaktorer for PAH (såsom portalhypertension, hivinfektion og cirrose).
English: * (HCV-RNA PCR assay, with a lower limit of quantitation of 27 IU/ml) 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: Dapsone (N-acetyltransferase substrate)
Danish: Dapson (N-acetyltransferasesubstrat)
English: Do not use the solution if it is discoloured (changed its colour from the original) or if there are bits of particles in the solution.
Danish: Brug ikke opløsningen, hvis den er misfarvet (ændret farve fra originalen) eller hvis der er partikler i opløsningen.
English: No pharmacokinetic interactions were noted between ViraferonPeg and ribavirin in a multiple-dose pharmacokinetic study.
Danish: Der sås ingen farmakokinetiske interaktioner mellem ViraferonPeg og ribavirin i en flerdosis farmakokinetisk undersøgelse.
English: If you are very thin, you should only use the thigh for injection.
Danish: Hvis du er meget tynd, skal du bruge låret til indsprøjtning.
English: Multiple-dose pharmacokinetic properties for ViraferonPeg and ribavirin (capsules and oral solution) in children and adolescent patients with chronic hepatitis C have been evaluated during a clinical study.
Danish: Flerdosis farmakokinetiske egenskaber for ViraferonPeg og ribavirin (kapsler og oral opløsning) hos børn og unge patienter med kronisk hepatitis C er blevet evalueret i en klinisk undersøgelse.
English: If such a reaction develops during treatment with ViraferonPeg, discontinue treatment and institute appropriate medical therapy immediately.
Danish: Hvis en sådan reaktion udvikles under behandling med ViraferonPeg, skal behandlingen seponeres, og passende behandling omgående iværksættes.
English: Paediatric population - Existence of, or history of severe psychiatric condition, particularly severe depression, suicidal ideation or suicidal attempt.
Danish: Pædiatrisk population - Eksisterende eller tidligere alvorlig psykiatrisk lidelse, især alvorlig depression, selvmordstanker eller selvmordsforsøg.
English: Upper limit of normal
Danish: Øvre grænse for normalområdet
English: If treatment with alpha interferon is judged necessary in these patients, the presence of psychiatric co-morbidities and the potential for other substance use should be carefully assessed and adequately managed before initiating therapy.
Danish: Hvis behandling med interferon alfa bedømmes som værende nødvendig hos disse patienter, skal tilstedeværelsen af samtidig psykisk sygdom og potentialet for anden misbrug vurderes omhyggeligt og håndteres i tilstrækkelig grad, før behandling påbegyndes.
English: Table 1 Dosing for combination therapy* Body weight (kg)
Danish: Tabel 1 - Dosering ved kombinationsbehandling* Legemsvægt (kg)
English: The recommended duration of treatment with bitherapy is 1 year.
Danish: Den anbefalede behandlingsvarighed ved 2-stofsbehandling er 1 år.
English: The following instructions explain how to inject this medicine yourself.
Danish: Følgende vejledning forklarer, hvordan du selv indsprøjter dette lægemiddel.
English: After the needle is inserted, remove the hand used to pinch the skin and use it to hold the syringe barrel.
Danish: Når kanylen er isat, så fjern hånden, der blev brugt til at sammenklemme huden, og brug den til at holde sprøjtecylinderen.
English: If psychiatric symptoms persist or worsen, or suicidal or homicidal ideation is identified, it is recommended that treatment with ViraferonPeg be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Danish: Hvis psykiatriske symptomer vedvarer eller forværres, eller hvis selvmords- eller drabstanker identificeres, anbefales det, at ViraferonPeg seponeres, og at patienten følges med passende psykiatrisk intervention.
English: Hypocalcemia, hyperuricemia, dehydration, increased appetite
Danish: Hypokalcæmi, hyperurikæmi, dehydrering, øget appetit
English: Patients with existence of, or history of severe psychiatric conditions If treatment with peginterferon alfa-2b is judged necessary in adult patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
Danish: Patienter med aktuelle eller tidligere alvorlige psykiatriske tilstande Hvis behandling med peginterferon alfa-2b bedømmes som værende nødvendig hos voksne patienter med aktuelle eller tidligere alvorlige psykiske lidelser, bør dette kun initieres efter sikring af en passende individuel diagnostisk og terapeutisk behandling af den psykiatriske lidelse.
English: Dispose of the used pre-filled pen safely in a closed container.
Danish: Læg på forsvarlig vis den brugte pen sikkert i en lukket beholder.
English: • Turn the dial to number 1 (see Figure 1).
Danish: • Drej doseringsknappen til tallet 1 (se figur 1).
English: Patients co-infected with HIV and receiving Highly Active Anti-Retroviral Therapy (HAART) may be at increased risk of developing lactic acidosis.
Danish: Patienter, der samtidig er inficeret med hiv og modtager høj-aktiv anti-retroviral terapi (HAART), kan have øget risiko for at udvikle mælkesyreacidose.
English: Reproduction studies of ViraferonPeg have not been performed.
Danish: Der er ikke foretaget reproduktionsstudier med ViraferonPeg.
English: Dose modification guidelines for adult patients who use ViraferonPeg monotherapy are shown in Table 3a.
Danish: Retningslinjer for dosisjustering hos voksne patienter, som anvender ViraferonPeg monoterapi, fremgår af Tabel 3a.
English: Note: The needle shield will automatically SNAP UP as you dial (see Figure 9).
Danish: Bemærk: Nålebeskyttelsen vil automatisk ”SNAP UP”, når du drejer doseringsknappen (se Figur 9).
English: ViraferonPeg increases the risk of hepatic decompensation and death in patients with cirrhosis.
Danish: ViraferonPeg øger risikoen for leverdekompensation og død hos patienter med cirrose.
English: Reports of mitochondrial toxicity, in particular lactic acidosis and pancreatitis, of which some fatal, have been reported (see ribavirin SmPC).
Danish: Tilfælde af mitokondrietoksicitet, særligt mælkesyreacidose og pankreatitis, nogle dødelige, er rapporteret (se ribavirin SPC).
English: Subcutaneous use Read the package leaflet before use.
Danish: Subkutan anvendelse Læs indlægssedlen inden brug.
English: You should tell your doctor before starting treatment if you, or the child you are caring for: - are allergic to peginterferon alfa-2b or any of the other ingredients of this medicine (listed in section 6).
Danish: Før du begynder behandlingen, skal du fortælle lægen, hvis du eller barnet, du har ansvar for: - er allergisk over for peginterferon alfa-2b eller et af de øvrige indholdsstoffer i dette lægemiddel
English: Long-term data available in children treated with the combination therapy of pegylated interferon/ribavirin are indicative of substantial growth retardation.
Danish: Tilgængelige langtidsdata hos børn i kombinationsbehandling med pegyleret interferon/ribavirin er indikative for betragtelig højdereduktion.
English: The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4).
Danish: Samtidig anvendelse af ribavirin med zidovudin kan ikke anbefales som følge af en øget risiko for anæmi (se pkt.
English: In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of ViraferonPeg and ribavirin.
Danish: Herudover kan mundtørhed have en skadelig virkning på tænder og mundslimhinder under langtidsbehandling med kombinationen af ViraferonPeg og ribavirin.
English: A clinically significant pharmacokinetic interaction was not observed between peginterferon alfa-2b (ViraferonPeg) and tolbutamide, midazolam or dapsone; therefore, no dosing adjustment is necessary when peginterferon alfa-2b (ViraferonPeg) is administered with medicines metabolized by CYP2C9, CYP3A4 and N-acetyltransferase.
Danish: Der sås ingen klinisk signifikant farmakokinetisk interaktion mellem peginterferon alfa-2b (ViraferonPeg) og tolbutamid, midazolam eller dapson; dosisjustering er derfor ikke nødvendig, når peginterferon alfa-2b (ViraferonPeg) administreres sammen med lægemidler, der metaboliseres af CYP2C9, CYP3A4 og N-acetyltransferase.
English: The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load < 800,000 IU/ml (Amplicor) who were treated for 24 weeks with a 6-month follow-up period.
Danish: Behandlingsvarigheden var 48 uger med en opfølgningsperiode på 6 måneder med undtagelse af patienter, der var inficeret med genotyper 2 og 3 og virusbelastning < 800.000 IE/ml (Amplicor), som blev behandlet i 24 uger med en 6 måneders opfølgningsperiode.
English: Teeth and mouth problems have been reported in patients receiving this medicine in combination with ribavirin.
Danish: Tand- og mundproblemer er blevet rapporteret hos patienter, der fik dette lægemiddel i kombination med ribavirin.
English: The dose administered in adults depends on whether it is used in combination therapy (bitherapy or tritherapy) or as monotherapy.
Danish: Den indgivne dosis hos voksne afhænger af, om den anvendes som kombinationsbehandling (2-stofs- eller 3-stofsbehandling) eller som monoterapi.
English: Limited safety data (N= 25) are available in co-infected patients with CD4+ cell counts < 200/µl (see section 4.4).
Danish: Begrænsede sikkerhedsdata er tilgængelige (N = 25) hos co-inficerede patienter med CD4+-celletællinger < 200/μl (se pkt.
English: In vitro and in vivo studies suggest that the biological activity of ViraferonPeg is derived from its interferon alfa-2b moiety.
Danish: In vitro og in vivo undersøgelser tyder på, at den biologiske aktivitet af ViraferonPeg stammer fra dets interferon alfa-2b-del.
English: ViraferonPeg Cmax and AUC measurements increase in a dose-related manner.
Danish: ViraferonPeg Cmax- og AUC målinger stiger på en dosis-relateret måde.
English: ViraferonPeg monotherapy was not studied in HCV/HIV co-infected patients.
Danish: ViraferonPeg monoterapi blev ikke undersøgt i hcv/hiv co-inficerede patienter.
English: Ribavirin capsules are to be administered orally each day in two divided doses with food (morning and evening).
Danish: Ribavirin kapsler skal indtages oralt hver dag fordelt på to doser samtidig med et måltid (morgen og aften).
English: Because of the potential for adverse reactions in breast-fed infants, breast-feeding should be discontinued prior to initiation of treatment.
Danish: På grund af risikoen for bivirkninger hos det ammede barn, bør amning afbrydes før behandlingsstart.
English: When administered in combination with other interferon preparations, effect of immunosuppressive therapy may be weakened in transplant (kidney, bone marrow, etc.) patients.
Danish: Immunsuppressiva Ved administration i kombination med andre interferonpræparater kan virkningen af immunsupprimerende behandling svækkes hos transplanterede (nyre, knoglemarv, etc.) patienter.
English: At the ViraferonPeg 1.5 µg/kg plus ribavirin dose, sustained virologic response rates were lower in patients with cirrhosis, in patients with normal ALT levels, in patients with a baseline viral load > 600,000 IU/ml, and in patients > 40 years old.
Danish: Ved ViraferonPeg 1,5 μg/kg plus ribavirin-dosen, var den vedvarende virologiske responsrate lavere hos patienter med cirrose, end patienter med normal ALAT-værdi, hos patienter med en baseline virusbelastning > 600.000 IE/ml, og hos patienter > 40 år.
English: Standard haematologic tests, blood chemistry and a test of thyroid function must be conducted in all patients prior to initiating therapy.
Danish: Hæmatologiske og klinisk-kemiske standardanalyser samt kontrol af thyroideafunktionen skal udføres hos alle patienter, før behandling påbegyndes.
English: Caution should be used when adding ViraferonPeg and ribavirin to HAART therapy (see ribavirin SmPC).
Danish: Forsigtighed bør udvises, når ViraferonPeg og ribavirin adderes til HAART terapi (se ribavirin SPC).
English: If you take telbivudine with this medicine or any type of injectable interferon product, your risk of developing peripheral neuropathy (numbness, tingling and/or burning sensations in the arms and/or legs) is higher.
Danish: Hvis du tager telbivudin sammen med dette lægemiddel eller en anden form for interferonmedicin til injektion, har du større risiko for at få perifer neuropati (følelsesløshed, snurrende og/eller brændende fornemmelser i arme og/eller ben).
English: Therefore, the combination of ViraferonPeg with telbivudine is contraindicated (see section 4.3).
Danish: Kombination af ViraferonPeg og telbivudin er derfor kontraindiceret (se pkt.
English: Two trials have been conducted in patients co-infected with HIV and HCV.
Danish: Der er udført to undersøgelser hos patienter med samtidig infektion af hcv og hiv.
English: In the ViraferonPeg monotherapy study, the Quality of Life was generally less affected by 0.5 microgram/kg of ViraferonPeg than by either 1.0 microgram/kg of ViraferonPeg once weekly or 3 MIU of interferon alfa-2b three times a week.
Danish: I ViraferonPeg monoterapiundersøgelsen var livskvaliteten generelt mindre påvirket ved 0,5 mikrogram/kg ViraferonPeg end ved enten 1,0 mikrogram/kg ViraferonPeg en gang om ugen eller 3 MIE interferon alfa-2b tre gange om ugen.
English: By extrapolation from clinical data on combination therapy with standard interferon in paediatric patients (negative predictive value 96 % for interferon alfa-2b/ribavirin), patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders.
Danish: Ved ekstrapolation fra kliniske data fra kombinationsbehandling med standard interferon hos pædiatriske patienter (negativ prædikativ værdi 96 % for interferon alfa-2b/ribavirin), har patienter, der ikke opnår virologisk respons efter 12 uger, meget lille sandsynlighed for at blive vedvarende virologisk responderende.
English: In this trial, the combination of ViraferonPeg (1.5 micrograms/kg/week) and ribavirin was significantly more effective than the combination of interferon alfa-2b and ribavirin (Table 8), particularly in patients infected with Genotype 1 (Table 9).
Danish: I denne undersøgelse var kombinationen af ViraferonPeg (1,5 mikrogram/kg/uge) og ribavirin signifikant mere effektivt end kombinationen af interferon alfa-2b og ribavirin (Tabel 8), især hos patienter inficeret med genotype 1 (Tabel 9).
English: Contusion class effect of interferon-alfa containing products - reported with standard interferon therapy in adult and paediatric patients; with ViraferonPeg reported in adult patients.
Danish: Kontusion klasseeffekt for lægemidler som indeholder interferon-alfa - rapporteret ved standard interferon-behandling af voksne og pædiatriske patienter; med ViraferonPeg er det rapporteret for voksne patienter.
English: 9/l, and
Danish: 9/l, og
English: ViraferonPeg pharmacodynamics were assessed in a rising single-dose trial in healthy subjects by examining changes in oral temperature, concentrations of effector proteins such as serum neopterin and 2'5'-oligoadenylate synthetase (2'5'-OAS), as well as white cell and neutrophil counts.
Danish: Farmakodynamikken af ViraferonPeg blev undersøgt i en undersøgelse med stigende enkeltdoser hos raske forsøgspersoner ved at undersøge ændringer i mundtemperatur, koncentrationer af effektorproteiner så som serum neopterin og 2'5'-oligoadenylatsyntetase (2'5'-OAS), og ligeledes antal leukocytter og neutrofiler.
English: Girls or women of childbearing potential need to use effective birth control during the treatment with this medicine.
Danish: Piger eller kvinder i den fødedygtige alder skal anvende effektiv prævention under behandling med dette lægemiddel.
English: NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN OG, OM NØDVENDIGT, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E)